{"text_format":"1","workbook":"xlsx","n_sheets":11,"sheets":["Intro","Results","Summary","Figure (ITT)","Figure (PP)","Print (ITT)","Print (PP)","Check","Print_format (PP)","Print_format (ITT)","Function Tab"],"not_rendered":{"charts":2,"images":1,"macros":1,"external_links":0,"defined_names":4,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"Intro","index":0,"n_rows":17,"n_cols":8,"rows_kept":17,"cut":false,"hidden":false,"merged":[]}
[]
[]
[]
[]
[]
[]
[]
[]
[]
[null,null,null,null,null,null,null,"V9 update:"]
[null,null,null,null,null,null,null,"*Add a new button in Summary tab to synchronize results between Results and Summary tabs"]
[]
[]
[null,null,null,null,null,null,null,"V8 update:"]
[null,null,null,null,null,null,null,"*Added judgement-level comment in the summary table"]
[null,null,null,null,null,null,null,"*Removed \"Double click on this column…\" label in the comments after enter"]
[null,null,null,null,null,null,null,"*Corrected spelling mistakes"]

{"sheet":"Results","index":1,"n_rows":49,"n_cols":85,"rows_kept":49,"cut":false,"hidden":false,"merged":[[0,0,0,12],[0,13,0,22],[0,80,0,83],[0,23,0,40],[0,41,0,53],[0,54,0,68],[0,69,0,79]]}
["Basic information",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 1. Randomization process",null,null,null,null,null,null,null,null,null,"Domain 2. Deviations from intended interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 3. Mising outcome data",null,null,null,null,null,null,null,null,null,null,null,null,"Domain 4. Measurement of the outcome",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Domain 5. Selection of the reported result",null,null,null,null,null,null,null,null,null,null,"Domain 6. Overall Bias"]
["Time","Unique ID","Assessor","Study ID","Reference","Experimental","Comparator","Outcome","Results","Aim","Effect of adhering to intervention?","Weight","Sources","1.1","1.2","Note for 1.1&1.2","1.3","Note for 1.3","1.0 Algorithm result","1.0 Assessor's Judgement","1.0 General note","1.0 Optional Question","1.0 Note for optional question","2.1","2.2","Note for 2.1&2.2","2.3","Note for 2.3","2.4","Note for 2.4","2.5","Note for 2.5","2.6","Note for 2.6","2.7","Note for 2.7","2.0 Algorithm result","2.0 Assessor's Judgement","2.0 General Notes","2.0 Optional Question","2.0 Note for optional question","3.1","Note for 3.1","3.2","Note for 3.2","3.3","Note for 3.3&3.4","3.4","Note for 3.4 (not use)","3.0 Algorithm result","3.0 Assessor's judgement","3.0 Gerenal notes","3.0 Optional Question","3.0 Note for optional question","4.1","Note for 4.1","4.2","Note for 4.2","4.3","Note for 4.3","4.4","Note for 4.4&4.5","4.5","Note for 4.5 (not use)","4.0 Algorithm result","4.0 Assessor's Judgement","4.0 General note","4.0 Optional Question","4.0 Note for optional question","5.1","Note for 5.1","5.2","Note for 5.2","5.3","Note for 5.3","5.0 Algorithm result","5.0 Assessor's Judgement","5.0 General note","5.0 Optional Question","5.0 Note for optional question","Algorithm's overall Judgement","Assessor's overall Judgement","6.0 General Note","6.0 Optional Question","6.0 Note for optional question"]
["2022/10/29 12.08","Moor_2020_HRQoL_K-BILD-total","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-total","2.67 (-1.85 to 7.17); 0.24","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. This is an open label trial. \r\n2.2. This is an open label trial. ","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. ","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with  independent Students’ t tests\r\nin the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns"," \r\n",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. ","N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data.","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.","NI",null,"High","High",null,null,null,"N","4.1. \"K_BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain.","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). ","Y","4.3. This is an open label study.","Y","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".","NI","5.3. Analysis intentions are not available.","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/29 12.11","Moor_2020_HRQoL_GRC","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_GRC","1.03 (-0.02 to 2.09); 0.055","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. This is an open label study.\r\n2.2. This is an open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.","PY","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. However, as p_value is close to significance, it may have affected the result.","PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\".","Y","2.6. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. ","N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data.","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.","NI",null,"High","High",null,null,null,"PY","4.1. \"On the GRC scale, patients indicate whether their quality of life improved or deteriorated over time, on a scale from 27 to 7.\" No further informations are provided. No information regarding the validity and reliability for this outcome measure on the literature. Measuring such a complex outcome (HRQoL) with a GRC could be insufficient.","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). ","NA",null,"NA",null,"NA",null,"High","High",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".","NI","5.3. Analysis intentions are not available.","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/29 12.09","Moor_2020_HRQoL_EQ-5D-5L","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_EQ-5D-5L","0.05 (-0.01 to 0.10); 0.11","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.\r\n","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. This is an open label study.\r\n2.2. This is an open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.","PY","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. However, p_values is close to significance, so it may have affected the results.","PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\".","Y","2.6. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. ","N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data.\r\n","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.","NI",null,"High","High",null,null,null,"N","4.1. \"The EQ_5D_5L is a generic\r\ninstrument to assess HRQoL.\" ","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). ","Y","4.3. This is an open label study.","Y","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n","N","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/29 12.14","Moor_2020_HRQoL_VAS-General-WellBeing","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_VAS-General-WellBeing","1.04 (0.09 to 2.00); 0.032","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2. Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.","PY","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. However, p_values is close to significance, so it may have affected the results.","PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\".","Y","2.6. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. ","N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data.","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.","NI",null,"High","High",null,null,null,"PN","4.1. Here we use this measure to assess QoL, however they assess well_being as a symptom. Insufficient as a QoL measure, but here it is more a sense of well_being.","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). ","Y","4.3. Open label study.","PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".","NI","5.3. Analysis intentions are not available","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/29 12.21","Moor_2020_HRQoL_EQ-VAS","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_EQ-VAS","3.95 (-5.20 to 13.10); 0.39","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2. Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. This is an open label study.\r\n2.2. This is an open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\nmay be due to the fact that they knew the group assinment.","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. ","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. \r\n","N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data.","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.\r\n","NI",null,"High","High",null,null,null,"N","4.1. The EQ_VAS is a part from the EQ_5D_5L. The EQ_5D_5L is a generic\r\ninstrument to assess HRQoL. Very used.","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). ","Y","4.3. Openal label trial.","PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".","NI","5.3. Analysis intentions are not available.","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/29 12.40","Moor_2020_Psychological-and-social-outcomes_HADS-Anxiety","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Psychological-and-social-outcomes_HADS-Anxiety","-0.05 (-1.08 to 0.99); 0.93","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.\r\n ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"PY","PY","2.1. This is an open label trial. \r\n2.2. This is an open label trial. ","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\nnot interested\" that may be due to the fact that they knew the group assinment. Deviation baucause of trial context?","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. \r\n","N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data.","PN","3.3. The missing data is likely to not be related to the anxiety status. ","NA",null,"Low","Low",null,null,null,"N","4.1. \"The HADS is a validated questionnaire with a subscale for\r\nanxiety and depression: a score of 8 or\r\ngreater is used as the cut_off for anxiety\r\nor depressive symptoms.\"","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). ","Y","4.3. Open label study.","PY","4.4. This is a patient_reported outcome in a context of an open label study. \r\n4.5. As the EG include an intervention where the participant is more followed in his health, maybe it will cause some effect in the measurements of the control group. As the intervention in not something revolutionary it is most likely that the knowledge of the group would not affect the outcome. Additionally, as the overaal results don't tend to favor the EG (nor CG),we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. HADS was stated on the clinical trials platform and it is reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"Some concerns","Some concerns"]
["2022/10/30 18.58","Moor_2020_Psychological-and-social-outcomes_HADS-Depression","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Psychological-and-social-outcomes_HADS-Depression","-0.40 (-1.61 to 0.81); 0.51","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.\r\n","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. This is an open label trial. \r\n2.2. This is an open label trial. \r\n","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.5. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. ","N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data.","NI","3.3. No clear information about the reasons for missing data. Althout depression status could have affected the completion of PROMs, from the given information about the reasons for excluding patient data it seems that the depression status was not at the origin.","PN",null,"Some concerns","Some concerns",null,null,null,"N","4.1. \"The HADS is a validated questionnaire with a subscale for\r\nanxiety and depression: a score of 8 or\r\ngreater is used as the cut_off for anxiety\r\nor depressive symptoms.\"","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). ","Y","4.3. Open label study.","PY","4.4. This is a patient_reported outcome in a context of an open label study. \r\n4.5. As the EG include an intervention where the participant is more followed in his health, maybe it will cause some effect in the measurements of the control group. As the intervention in not something revolutionary it is most likely that the knowledge of the group would not affect the outcome. Additionally, as the overaal results don't tend to favor the EG (nor CG),we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. HADS was stated on the clinical trials platform and it is reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"Some concerns","Some concerns"]
["2022/10/30 19.03","Moor_2020_HRQoL_K-BILD-Psychological-domain","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-Psychological-domain","5.6 (-1.13 to 12.3); 0.10","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.\r\n","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PY","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. However, p_value is close to significance, so it may have affected the results.\r\n","PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\".\r\n","Y","2.6. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"\r\n","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. \r\n","N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data.\r\n","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.\r\n","NI",null,"High","High",null,null,null,"N","4.1. \"K_BILD has\r\nbeen developed and validated in interstitial\r\nlung diseases (ILDs) and consists of 15\r\nitems in three domains: breathlessness and\r\nactivities, chest symptoms, and a\r\npsychological domain (15).\"","N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). \r\n","PY","4.3. Open label study.\r\n","PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/30 19.28","Moor_2020_Symptoms_VAS-Cough","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Symptoms_VAS-Cough","0.82 (-0.52 to 2.17); 0.23","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention_to_treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. ","N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","PY","3.3. One case in the EG a participant was excluded because of problems due to cough. However in the other cases it does not seem as cough could be the reason for the missing outcome. Considering that only one case is confirmed and the other are questions, the final judgement is that it is not likely that all the missing data is related to outcome true value. ","PN",null,"Some concerns","Some concerns",null,null,null,"PN","4.1. VAS is a generic form of evaluation. Cough could be assess with more complete scales as it could be assessed in it's intensity, urge, frequency, severity, etc. and the study just mentions cough. However it is not a totally inapropriate measure to assess cough.","PN","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). ","Y","4.3. Open label study.\r\n","PY","4.4. This is a patient_reported outcome in a context of an open label study. \r\n4.5. As the EG include an intervention where the participant is more followed in his health, maybe it will cause some effect in the measurements of the control group. As the intervention in not something revolutionary it is most likely that the knowledge of the group would not affect the outcome. Additionally, as the overaal results don't tend to favor the EG (nor CG),we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","NI","5.2. VAS cough was not reported in the outcomes for this trial. \r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"Some concerns","Some concerns"]
["2022/10/30 19.39","Moor_2020_Symptoms_VAS-Dyspnea","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Symptoms_VAS-Dyspnea","0.63 (-0.23 to 1.50); 0.15","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PY","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. However, p_values is close to significance, so it may have affected the results.\r\n","PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\".\r\n","Y","2.6. \"Between_group differences in PROMs were analyzed with independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"\r\n","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. 3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","PN","3.3. The missing data is likely to not be related to the dyspnea of the participants. ","NA",null,"Low","Low",null,null,null,"PN","4.1. VAS is a generic form of evaluation. Dyspneia could be assess with more complete scales as it could be assessed in it's intensity, frequency, severity, etc. However it is not a totally inapropriate measure to assess dyspneia.","PN","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). ","Y","4.3. Open label study.","PY","4.4. This is a patient_reported outcome in a context of an open \r\nlabel study. \r\n4.5. As the EG include an intervention where the participant is \r\nmore followed in his health, maybe it will cause some effect in \r\nthe measurements of the control group. As the intervention in not \r\nsomething vary revolutionary it is most likely that the knowledge \r\nof the group would not affect the outcome. It would be different in \r\ncase the CG have to everyday go to the clinic to measure the FVC \r\nto match the EG rate of measurments (hell for them wich would lead \r\nto vary poor outcomes in the CG). ","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","NI","5.2. VAS dyspneia was not reported in the trial protocol. ","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"Some concerns","Some concerns"]
["2022/10/30 19.34","Moor_2020_Symptoms_VAS-Fatigue","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Symptoms_VAS-Fatigue","0.18 (-0.88 to 1.23); 0.74","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention_to_treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. ","N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","PN","3.3. The missing data is likely to not be related to the dyspnea of the participants. ","NA",null,"Low","Low",null,null,null,"PN","4.1. VAS is a generic form of evaluation. Fatigue could be assess with more complete scales as it could be assessed in it's intensity, frequency, severity, etc. However it is not a totally inapropriate measure to assess fatigue.","PN","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). ","Y","4.3. Open label study.","PY","4.4. This is a patient_reported outcome in a context of an open \r\nlabel study. \r\n4.5. As the EG include an intervention where the participant is \r\nmore followed in his health, maybe it will cause some effect in \r\nthe measurements of the control group. As the intervention in not \r\nsomething vary revolutionary it is most likely that the knowledge \r\nof the group would not affect the outcome. It would be different in \r\ncase the CG have to everyday go to the clinic to measure the FVC \r\nto match the EG rate of measurments (hell for them wich would lead \r\nto vary poor outcomes in the CG).","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","NI","5.2. VAS fatigue was not reported in the trial protocol. \r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"Some concerns","Some concerns"]
["2022/10/30 19.39","Moor_2020_HRQoL_KBILD-Chest-symptoms","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-Chest-Symptoms","3.7 (-4.5 to 11.5); 0.35","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention_to_treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. ","N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.","NI",null,"High","High",null,null,null,"N","4.1. \"K_BILD has\r\nbeen developed and validated in interstitial\r\nlung diseases (ILDs) and consists of 15\r\nitems in three domains: breathlessness and\r\nactivities, chest symptoms, and a\r\npsychological domain.\"","N","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). ","Y","4.3. Open label study.","PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/30 19.41","Moor_2020_HRQoL_KBILD-Breathless-and-activities","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-Breathless-and-activities","0.9 (-6.3 to -4.4); 0.73","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with  independent Students’ t tests in the intention_to_treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"\r\n","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. ","N","3.2. No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","PY","3.3. No clear information about the reasons for missing data. The missing data about K_BILD may suggest that the missing data it's related to the health status (including psychological). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think tthat for this outcome measure it's best to report NI in 3.4.","NI",null,"High","High",null,null,null,"N","4.1. \"K_BILD has\r\nbeen developed and validated in interstitial\r\nlung diseases (ILDs) and consists of 15\r\nitems in three domains: breathlessness and\r\nactivities, chest symptoms, and a\r\npsychological domain.\"","N","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). ","PY","4.3. Open label study.","PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well_being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/06 16.07","Moor_2020_Healthcare-utilization_Hospitalizations","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Healthcare-utilization_Hospitalizations","NR; p-value = 0.27","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention_to_treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant.","N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","PN","3.3. It is not likely that the reasons of missing data are related to the true value of the outcome.","NA",null,"Low","Low",null,null,null,"PY","4.1. No outcome definition of hospitalizations nor it is appointed the method of collection. ","NI","4.2. It is not stated how this outcome was assessed, I do not have enough information to decide. ","NA",null,"NA",null,"NA",null,"High","High",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.","N","5.2. Healthcare contacts are reported in the trial protocol, and the measurment at 24 weeks is the only timeframe reported. ","NI","5.3. Analysis intentions are not available.","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/10/30 19.48","Moor_2020_Healthcare-utilization_Extra-visits","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Healthcare-utilization_Extra-visits","1.1898 (0.5693 to 2.4868), 0.6440 ","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","NI","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add_on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. ","N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n","Some concerns","Some concerns",null,null,null,"PY","PY","2.1. Open label study.\r\n2.2. Open label study.","PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n","PN","2.4. As it is 1_2 people that withrew with questionable reasons, in a sample of 44_46 it is not likely to have affected the result. \r\n","NA",null,"Y","2.6. \"Between_group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention_to_treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\"","NA",null,"Some concerns","Some concerns",null,null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant.","N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data.","PN","3.3. It is not likely that the reasons of missing data are related to the true value of the outcome.","NA",null,"Low","Low",null,null,null,"PY","4.1. No outcome definition of extra visits nor it is appointed the method of collection. ","PY","4.2. In the experimental group there is the eConsultation function wich may lead to professionals to advise more face_to_face consultations (as they are more followed), while also be an opportunity to EG participants to have more consultations without being accounted as being \"extra visits\". ","NA",null,"NA",null,"NA",null,"High","High",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","N","5.2. Healthcare contacts are reported in the trial protocol, and the measurment at 24 weeks is the only timeframe reported. \r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.08","Lindell_2021_HRQoL_ATAQ-IPF-total","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","HRQoL_ATAQ-IPF-total","-0.93 (-8.57 to 6.71); 0.81","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG. \r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm\r\nwas 35 out of 50 (70%) compared with 19 out\r\nof 26 (73%) for the control arm (P . 0.9,\r\nFigure 1).\"","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.","PN","3.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death and lung transplant, and drop_out before study completion. Although the reasons for drop_out are not clearly stated, the HRQoL is probably not responsible for the drop_outs. \r\n","NA",null,"Low","Low",null,null,null,"N","4.1. The Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis is a validaded questionarire to asses HRQoL in ILD patients. \r\n\r\n","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. ","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. ","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in the patient_reported outcomes. ","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. ATAQ was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n","NI","5.3. Analysis intentions are not available.","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.06","Lindell_2021_HRQoL_ATAQ-IPF-Impact","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","HRQoL_ATAQ-IPF-Impact","-0.95 (-8.88 to 7.98); 0.83","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PN","3.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death and lung transplant, and drop_out before study completion. Although the reasons for drop_out are not clearly stated, the HRQoL is probably not responsible for the drop_outs. \r\n","NA",null,"Low","Low",null,null,null,"N","4.1. The Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis is a validaded questionarire to asses HRQoL in ILD patients. \r\n","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. ATAQ was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 10.34","Lindell_2021_Psychological-and-social-outcomes_PSS","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PSS","1.23 (-1.59 to 4.05); 0.39","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PN","3.3. and 3.4. This is a patient_reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. However, participant with more stress, are probably not subjected to more drop_out. \r\n","NA",null,"Low","Low",null,null,null,"N","4.1. The PSS is a general scale for assessing stress. Is measures the outcome \"properly\" and has some validity to it. ","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","PN","5.2. PSS was the only outcome measure that was stated on the clinical trials platform to assess stress and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.14","Lindell_2021_Psychological-and-social-outcomes_PROMIS-29-Anxiety/fear","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PROMIS-29-Anxiety/fear","0.01 (-5.55 to 5.57); 0.99","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) \r\ncompared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PY","3.3. and 3.4. This is a patient_reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. Althougth the intervention discuss some \"sensible\" topics that may affect drop_outs, anxiety status is not likely the cause for drop_outs. ","PN",null,"Some concerns","Some concerns",null,null,null,"N","4.1. PROMIS_29 is a tool to asses different domains of the health status.","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n","NI","5.3.Reported with the pre_specified analisys.","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.14","Lindell_2021_Psychological-and-social-outcomes_PROMIS-29-Depression/sadness","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PROMIS-29-Depression/sadness","-0.12 (-6.10 to 5.86); 0.97","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n\r\n","PY","3.3. and 3.4. This is a patient_reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. Participant with more symptoms of depression could be subjected to more drop_out. Althougth the intervention discuss some \"sensible\" topics that could affect drop_outs, it is not likely that it would cause them in reality. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"N","4.1. PROMIS_29 is a tool to asses different domains of the health status.","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n\r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.15","Lindell_2021_Psychological-and-social-outcomes_PROMIS-29-Satisfaction-with-social-roles","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PROMIS-29-Satisfaction-with-social-roles","3.66 (1.02 to 8.34); 0.12","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the\r\nrandomization of patients was based on\r\nclinic day to reduce contamination, but\r\nthis resulted in a 2:1 unequal distribution\r\nbetween intervention and control arms,\r\nlimiting statistical power.\"","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","N","3.3. and 3.4. 3.3. Althogth this is a patient_reported outcome regarding an aspect of the health status of the participant and there is some data regarding the missing results that lack information, it is not probable that satisfaction with social roles, considering the overall reasons for missing data, would be the cause for data missingness.\r\n","NA",null,"Low","Low",null,null,null,"N","4.1. PROMIS_29 is a tool to asses different domains of the health status.","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n\r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.01","Lindell_2021_HRQoL_ATAQ-IPF-Symptom","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","HRQoL_ATAQ-IPF-Symptom","-0.90 (-8.44 to 6.63); 0.81","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PN","3.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death and lung transplant, and drop_out before study completion. Although the reasons for drop_out are not clearly stated, the HRQoL is probably not responsible for the death and transplants that caused the majority of missing data. \r\n","NA",null,"Low","Low",null,null,null,"N","4.1. The Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis is a validaded questionarire to asses HRQoL in ILD patients. \r\n","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","PN","5.2. ATAQ was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.20","Lindell_2021_Symptoms_PROMIS-29-Pain-interference","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Symptoms_PROMIS-29-Pain-interference","-1.35 (-5.78 to 3.07); 0.54","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) \r\ncompared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PN","3.3. and 3.4. This is a patient_reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. However, it is not likely that more pain  would cause more drop_out in this trial. \r\n","NA",null,"Low","Low",null,null,null,"N","4.1. PROMIS_29 is a tool to asses different domains of the health status.","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n\r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.22","Lindell_2021_Symptoms_PROMIS-29-Fatigue","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Symptoms_PROMIS-29-Fatigue","1.38 (-5.37 to 2.62); 0.49","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PY","3.3. and 3.4. This is a patient_reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. Participant with more fatigue could be more subjected to drop_out (some patient didn't participate in the trial because of fatigue). However, there is no information about the participants that dropped_out, and I don't think that participants in the study are likely to drop_out because of fatigue. ","PN",null,"Some concerns","Some concerns",null,null,null,"N","4.1. PROMIS_29 is a tool to asses different domains of the health status.\r\n","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.25","Lindell_2021_Symptoms_PROMIS-29-Sleep-disturbance","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Symptoms_PROMIS-29-Sleep-disturbance","2.63 (-0.53 to 5.79); 0.10","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PN","3.3. and 3.4. Althogth this is a patient_reported outcome regarding an aspect of the health status of the participant and there is some data regarding the missing results that lack information, it is not probable that morr sleep disturbance would be the cause for data missingness in this trial.\r\n","NA",null,"Low","Low",null,null,null,"N","4.1. PROMIS_29 is a tool to asses different domains of the health status.\r\n","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","Y","4.3. Patient_reported outcome in a trial were the participants were aware of their arm group. \r\n","Y","4.4. and 4.5. As it is a patient_reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre_post an intervention of 6 to 8_month long.\r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.50","Lindell_2021_Healthcare-utilization_Outpatient-visits","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Healthcare-utilization_Outpatient-visits","RR: 0.93 (95%CI: 0.796 to 1.09), p-value: 0.38","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n\r\n","PY","3.3. and 3.4. Participants with more hospital visits may be more inclined to participate in the meetings (to know how to dealt with their condition) or more inclined to not participate (more fatigued, don't want to be more than necessary in a health facility, etc.), i.e. if a person has less / more hospital visits they may be inclined to participate or no in the project, hence resulting or not in drop_outs. However, as this is just an hypotesis and because of the low value of drop_outs it is not likely that the true value of the outcome lies in the missing data. ","PN",null,"Some concerns","Some concerns",null,null,null,"NI","4.1. They accounted for the hospital visits in different settings, they do not describe how they collected the data.","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","PY","4.3. Although there is no information about how the data was assessed, as in every other outcome the assessor, the participant and interventionist are aware of thearm of the participant I will say \"PY\".\r\n","NI","4.4. and 4.5. Depending on how the data was collected it could have been influenced (e.g. reported visits from the participant) or could not have been influenced (e.g., count from an electronic system). However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","NI","5.2. Outpatient visits was not stated as an outcome in the trial protocol. \r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.48","Lindell_2021_Healthcare-utilization_Inpatient-visits","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Healthcare-utilization_Inpatient-visits","RR: 1.69 (95%CI: 0.61 to 4.67), p-value: 0.31","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PY","3.3. and 3.4. Participants with more hospital visits may be more inclined to participate in the meetings (to know how to dealt with their condition) or more inclined to not participate (more fatigued, don't want to be more than necessary in a health facility, etc.), i.e. if a person has less / more hospital visits they may be inclined to participate or no in the project, hence resulting or not in drop_outs. However, as this is just an hypotesis and because of the low value of drop_outs it is not likely that the true value of the outcome lies in the missing data. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","4.1. They accounted for the hospital visits in different settings, they do not describe how they collected the data.\r\n\r\n","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n","PY","4.3. Although there is no information about how the data was assessed, as in every other outcome the assessor, the participant and interventionist are aware of thearm of the participant I will say \"PY\".\r\n","NI","4.4. and 4.5. Depending on how the data was collected it could have been influenced (e.g. reported visits from the participant) or could not have been influenced (e.g., count from an electronic system). However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n","NI","5.2. Inpatient visits was not stated as an outcome in the trial protocol. \r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 11.49","Lindell_2021_Healthcare-utilization_Emergency-visits","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Healthcare-utilization_Emergency-visits","RR: 1.39 (95%CI: 0.40 to 4.79), p-value: 0.61","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","N","N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic_day visit. Physicians have assigned clinic_day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic_day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n","Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n","High","High",null,null,null,"Y","Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n","PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop_out before study completion. Althout the reasons for drop_out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n","NA",null,"NA",null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n\r\n","NA",null,"Low","Low",null,null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n\r\n","PY","3.3. and 3.4. Participants with more hospital visits may be more inclined to participate in the meetings (to know how to dealt with their condition) or more inclined to not participate (more fatigued, don't want to be more than necessary in a health facility, etc.), i.e. if a person has less / more hospital visits they may be inclined to participate or no in the project, hence resulting or not in drop_outs. However, as this is just an hypotesis and because of the low value of drop_outs it is not likely that the true value of the outcome lies in the missing data. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","4.1. They accounted for the hospital visits in different settings, they do not describe how they collected the data.\r\n","N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n\r\n","PY","4.3. Although there is no information about how the data was assessed, as in every other outcome the assessor, the participant and interventionist are aware of thearm of the participant I will say \"PY\".\r\n","NI","4.4. and 4.5. Depending on how the data was collected it could have been influenced (e.g. reported visits from the participant) or could not have been influenced (e.g., count from an electronic system). However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n","NI","5.2. Emergency visits was not stated as an outcome in the trial protocol. \r\n\r\n","NI","5.3. Analysis intentions are not available.\r\n\r\n","Some concerns","Some concerns",null,null,null,"High","High"]
["2022/11/01 12.33","Khor_2021_HRQoL_K-BILD-total","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-total","0.7 (-3.3 to 4.7); 0.33","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). ","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  ","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. ","NA",null,"Low","Low",null,null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. ","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. K_BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a sychological domain.\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.","N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported.","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Functional-performance_MRADLQ","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_MRADLQ","-2.5 (-4.8 to 0.3); 0.08","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n","NA",null,"Low","Low",null,null,null,"PN","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is near the 5% target, as the p_value is vary close to significance and the sample size is little I think that it could affect the effect estimate.\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.","N","3.3. As reported: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". So, the missigness for this outcome didn't depend on the value of functional performance factor. ","NA",null,"Low","Low",null,null,null,"N","4.1. Functional performance was measured using validated questionnaires to quantify physical disability for activities of daily living (Manchester Respiratory Activities of Daily Living Questionnaire). It is valid measure to assess performance on daily activities. \r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Some concerns","Some concerns",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n","N","5.2. This questionaire was was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Functional-performance_Life-space-mobility","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Life-space-mobility","2.4 (-10.4 to 15.2); 0.72","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n","NA",null,"Low","Low",null,null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. Functional performance was measured using validated questionnaires to quantify physical disability for activities of daily living (space_life mobility). It is a valid measure to assess performance on daily activities. ","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. This questionaire was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Functional-performance_Steps-per-day","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Steps-per-day","74 (-807 to 956); 0.87","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n","NA",null,"Low","Low",null,null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"PN","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n","N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Functional-performance_Total-energy-expenditure","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Total-energy-expenditure","104 (-197 to 404); 0.50","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n","NA",null,"Low","Low",null,null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"PN","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Functional-performance_Total-METs","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Total-METs","0.003 (-0.04 to 0.44); 0.88","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n\r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n","NA",null,"Low","Low",null,null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Functional-performance_Duration-of-sedentary-time-per-day","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Duration-of-sedentary-time-per-day","66 (-30 to 162); 0.18","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n\r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n","NA",null,"Low","Low",null,null,null,"PN","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is near the 5% target, as the p_value is close to significance and the sample size is little I think that it could affect the effect estimate.","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.","N","3.3. As reported: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". It is not likely that the missines on this outcome relates to the true value of the effect estimate, based on the reason for missinignes of the participant. ","NA",null,"Low","Low",null,null,null,"N","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Functional-performance_Duration-of-time-above-3-METs-per-day ","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Duration-of-time-above-3-METs-per-day ","26 (-16.1 to 68.3); 0.23","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n\r\n","NA",null,"Low","Low",null,null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.58","Khor_2021_Psychological-and-social-outcomes_SEMCD6","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Psychological-and-social-outcomes_SEMCD6","0.07 (-1.9 to 2.0); 0.94","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n","NA",null,"Low","Low",null,null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. This short questionaire assess the self_efficacy of a person. In the study it was used to \"measure participants’ confdence in self_management\". Self_efficacy relates to the confidence of a person in managing ones condition, so it is apropriate. ","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. This questionaire was stated as the only measure on the clinical trials platform to assess self_efficacy, and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 17.59","Khor_2021_HRQoL_K-BILD-Psychological-domain","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-Psychological-domain","1.1 (-4.1 to 6.3); 0.40","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s); Trial protocol","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n","NA",null,"Low","Low",null,null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. K_BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain.\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported.\r\n \r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 18.27","Khor_2021_Symptoms_Dyspnea-12","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Symptoms_Dyspnea-12","-2.2 (-6.4 to 1.9); 0.29","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n","NA",null,"Low","Low",null,null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. \"Te Dyspnoea_12, a 12_item validated assessment tool with both physical and afective components, was used to evaluate the severity of dyspnoea.\"","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. This questionaire was stated as the only measure on the clinical trials platform to assess symptoms (dyspneia), and it is reported.\r\n\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 18.30","Khor_2021_HRQoL_KBILD-Breathless-and-activities","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-Breathless-and-activities","-1.5 (-8.9 to 5.9); 0.69","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n","NA",null,"Low","Low",null,null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p_value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. K_BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain.\r\n\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 18.33","Khor_2021_HRQoL_KBILD-Chest-symptoms","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-Chest-symptoms","10 (-5.1 to 25.1); 0.19","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer_generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n","N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n","Low","Low",null,null,null,"Y","Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n\r\n\r\n","PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n","NA",null,"NA",null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post_randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n","NA",null,"Low","Low",null,null,null,"PN","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is near the 5% target, as the p_value is close to significance and the sample size is little I think that it could affect the effect estimate.\r\n","N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n","PN","3.3. As reported: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". The missines on this outcome does not relate to the true value of the HRQoL, based on the reason for missinignes of the participant. \r\n","NA",null,"Low","Low",null,null,null,"N","4.1. K_BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain.\r\n","N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n","PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n","NA",null,"NA",null,"Low","Low",null,null,null,"N","5.1. From trial registration _ \"For comparisons of two groups, t_tests or Mann_whitney tests will be used for parametric and non_parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n","N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported.\r\n\r\n","PY","5.3. Authors should had reported the results for the t_test or Mann_Whitney, as initally thought.\r\n","High","Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n",null,null,"Some concerns","Some concerns"]
["2022/11/01 19.54","Lindell_2010_HRQoL_SF-36-Physical","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","HRQoL_SF-36-Physical","p-value: 0.038","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","NI","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n","PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. ","NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n","NA",null,"NA",null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n","NA",null,"Some concerns","Some concerns",null,null,null,"PN","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial the number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result (especially considering that the p_value is close to significance).\r\n","N","3.2. Not information about statistical tests for accertainment.\r\n","PN","3.3. \"Reasons for attrition were lung transplantation and death\". HRQoL was probably not at the origin for data missingness considering these reasons.\r\n","NA",null,"Low","Low",null,null,null,"N","4.1. SF_36 is a questionaire validated to measure QOL. \r\n","N","4.2. Same questionaires, same timepoints. \r\n","Y","4.3. It is a patient_reported outcome, and the participants were aware of the arm they were in.\r\n","Y","4.4. As it is a patient_reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n","NI","5.2. Analysis intentions are not available.\r\n","Y","5.3. The results according to the \"non_asjusted analysis\" are not provided.\r\n","High","High",null,null,null,"High","High"]
["2022/11/01 19.45","Lindell_2010_Psychological-and-social-outcomes_BAI","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Psychological-and-social-outcomes_BAI","p-value: 0.077","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","NI","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n\r\n","PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n\r\n","NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n\r\n","NA",null,"NA",null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n\r\n","NA",null,"Some concerns","Some concerns",null,null,null,"PN","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial the number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result (especially considering that the p_value is close to significance).\r\n\r\n","N","3.2. Not information about statistical tests for accertainment.\r\n\r\n","PN","3.3. \"Reasons for attrition were lung transplantation and death\". Anxiety was probably not at the origin for data missingness considering these reasons.\r\n\r\n","NA",null,"Low","Low",null,null,null,"N","4.1. BAI is a questionaire validated to measure anxiety. \r\n","N","4.2. Same questionaires, same timepoints. \r\n","Y","4.3. It is a patient_reported outcome, and the participants were aware of the arm they were in.\r\n","Y","4.4. As it is a patient_reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n\r\n","NI","5.2. Analysis intentions are not available.\r\n\r\n","Y","5.3. The results according to the \"non_asjusted analysis\" are not provided.\r\n\r\n","High","High",null,null,null,"High","High"]
["2022/11/01 19.45","Lindell_2010_Psychological-and-social-outcomes_BDI-II","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Psychological-and-social-outcomes_BDI-II","p-value: 0.894","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","NI","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n","PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n","NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n","NA",null,"NA",null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n\r\n","NA",null,"Some concerns","Some concerns",null,null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p_value is far from the significance, the 1_2 pateints that are missing don't probably affect the value sufficiently. \r\n","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. The BDI_II is a questionaire validated to measure depression. \r\n","N","4.2. Same questionaires, same timepoints. \r\n","Y","4.3. It is a patient_reported outcome, and the participants were aware of the arm they were in.\r\n","Y","4.4. As it is a patient_reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available.  \r\n","NI","5.2. Analysis intentions are not available.\r\n\r\n","Y","5.3. The results according to the \"non_asjusted analysis\" are not provided.\r\n\r\n","High","High",null,null,null,"High","High"]
["2022/11/01 19.45","Lindell_2010_Psychological-and-social-outcomes_PSS","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Psychological-and-social-outcomes_PSS","p-value: 0.531","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","NI","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n","PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n\r\n\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n\r\n","NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n","NA",null,"NA",null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n\r\n","NA",null,"Some concerns","Some concerns",null,null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p_value is far from the significance, the 1_2 pateints that are missing don't probably affect the value sufficiently. ","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. The PSS is a questionaire validated to measure stress. \r\n","N","4.2. Same questionaires, same timepoints. \r\n","Y","4.3. It is a patient_reported outcome, and the participants were aware of the arm they were in.\r\n","Y","4.4. As it is a patient_reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n\r\n","NI","5.2. Analysis intentions are not available.\r\n\r\n","Y","5.3. The results according to the \"non_asjusted analysis\" are not provided.\r\n\r\n","High","High",null,null,null,"High","High"]
["2022/11/01 19.47","Lindell_2010_HRQoL_SF-36-Mental","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","HRQoL_SF-36-Mental","p-value: 0.772","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","NI","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n","PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n\r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n\r\n","NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n","NA",null,"NA",null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n","NA",null,"Some concerns","Some concerns",null,null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p_value is far from the significance, the 1_2 pateints that are missing don't probably affect the value sufficiently. ","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. SF_36 is a questionaire validated to measure QOL. \r\n\r\n","N","4.2. Same questionaires, same timepoints. \r\n\r\n","Y","4.3. It is a patient_reported outcome, and the participants were aware of the arm they were in.\r\n","Y","4.4. As it is a patient_reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n\r\n","PN",null,"Some concerns","Some concerns",null,null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n","NI","5.2. Analysis intentions are not available.\r\n","Y","5.3. The results according to the \"non_asjusted analysis\" are not provided.\r\n","High","High",null,null,null,"High","High"]
["2022/11/01 19.54","Lindell_2010_Symptoms_UCSDSoBQ","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Symptoms_UCSDSoBQ","p-value: 0.972","assignment to intervention (the 'intention_to_treat' effect)","NA",1," Journal article(s)","Y","NI","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.","PN","1.3. \"No statistically significant differences were found between the intervention and the control group in regard to demographic variables or FVC.\" Additionally, examination of the table of demographics, it doesn't seem that there exists imbalances that may be not due to chance. However they also state: \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL [...]\". In this case, as the intervention is intented to work symptom burden, QOL, etc., the randomization should have been done so that baseline Symptoms, QOL, etc. would be the same and not FVC. I will put PN as the process itself was done correctly and the imbalances may be due to chance because fo low number of participants. \r\n","Some concerns","Some concerns",null,null,null,"Y","Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n","NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n\r\n","NA",null,"NA",null,"PY","2.6. An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n","NA",null,"Some concerns","Some concerns",null,null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p_value is far from the significance, the 1_2 pateints that are missing don't probably affect the value sufficiently. ","NA",null,"NA",null,"NA",null,"Low","Low",null,null,null,"N","4.1. SOBQ is a questionaire validated to measure dyspneia. \r\n","N","4.2. Same questionaires, same timepoints. \r\n","Y","4.3. It is a patient_reported outcome, and the participants were aware of the arm they were in.\r\n","Y","4.4. As it is a patient_reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n","PN",null,"Some concerns","Some concerns",null,null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n\r\n","NI","5.2. Analysis intentions are not available.\r\n\r\n","Y","5.3. The results according to the \"non_asjusted analysis\" are not provided.\r\n","High","High",null,null,null,"High","High"]

{"sheet":"Summary","index":2,"n_rows":48,"n_cols":33,"rows_kept":48,"cut":false,"hidden":false,"merged":[]}
["Unique ID","Reviewer","Study ID","Reference","Experimental","Comparator","Outcome","Result","Aim","Effect of adhering to intervention?","Weight","Randomization process","Comment for randomization process","Deviations from intended interventions","Comment for deviations from intended interventions","Missing outcome data","Comment for missing outcome data","Measurement of the outcome","Comment for measurement of the outcome","Selection of the reported result","Comment for selection of the reported result","Overall Bias","Comment for overall bias",null,null,null,null,"Randomization process","Deviations from intended interventions","Mising outcome data","Measurement of the outcome","Selection of the reported result","Overall Bias"]
["Moor_2020_HRQoL_K-BILD-total","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-total","2.67 (-1.85 to 7.17); 0.24","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns"," \r\n","High",null,"Some concerns",null,"Some concerns",null,"High",null,null,null,null,"Assignment to intervention (the 'intention-to-treat' effect)"]
["Moor_2020_HRQoL_GRC","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_GRC","1.03 (-0.02 to 2.09); 0.055","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"High",null,"High",null,"Some concerns",null,"High",null,null,null,null,"Total number of study = 0"]
["Moor_2020_HRQoL_EQ-5D-5L","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_EQ-5D-5L","0.05 (-0.01 to 0.10); 0.11","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"High",null,"Some concerns",null,"Some concerns",null,"High",null,null,null,null,"Low risk"]
["Moor_2020_HRQoL_VAS-General-WellBeing","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_VAS-General-WellBeing","1.04 (0.09 to 2.00); 0.032","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"High",null,"Some concerns",null,"Some concerns",null,"High"]
["Moor_2020_HRQoL_EQ-VAS","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_EQ-VAS","3.95 (-5.20 to 13.10); 0.39","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"High",null,"Some concerns",null,"Some concerns",null,"High",null,null,null,null,"High risk"]
["Moor_2020_Psychological-and-social-outcomes_HADS-Anxiety","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Psychological-and-social-outcomes_HADS-Anxiety","-0.05 (-1.08 to 0.99); 0.93","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,null,null,null,"Adhering to intervention (the 'per-protocol' effect)"]
["Moor_2020_Psychological-and-social-outcomes_HADS-Depression","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Psychological-and-social-outcomes_HADS-Depression","-0.40 (-1.61 to 0.81); 0.51","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,null,null,null,"Total number of study = 0"]
["Moor_2020_HRQoL_K-BILD-Psychological-domain","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-Psychological-domain","5.6 (-1.13 to 12.3); 0.10","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"High",null,"Some concerns",null,"Some concerns",null,"High",null,null,null,null,"Low risk"]
["Moor_2020_Symptoms_VAS-Cough","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Symptoms_VAS-Cough","0.82 (-0.52 to 2.17); 0.23","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,null,null,null,"Some concerns"]
["Moor_2020_Symptoms_VAS-Dyspnea","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Symptoms_VAS-Dyspnea","0.63 (-0.23 to 1.50); 0.15","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,null,null,null,"High risk"]
["Moor_2020_Symptoms_VAS-Fatigue","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Symptoms_VAS-Fatigue","0.18 (-0.88 to 1.23); 0.74","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns"]
["Moor_2020_HRQoL_KBILD-Chest-symptoms","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-Chest-Symptoms","3.7 (-4.5 to 11.5); 0.35","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"High",null,"Some concerns",null,"Some concerns",null,"High"]
["Moor_2020_HRQoL_KBILD-Breathless-and-activities","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","HRQoL_K-BILD-Breathless-and-activities","0.9 (-6.3 to -4.4); 0.73","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"High",null,"Some concerns",null,"Some concerns",null,"High"]
["Moor_2020_Healthcare-utilization_Hospitalizations","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Healthcare-utilization_Hospitalizations","NR; p-value = 0.27","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"High",null,"Some concerns",null,"High"]
["Moor_2020_Healthcare-utilization_Extra-visits","Steve_Freitas","Moor_2020",null,"Home monitoring program","Standard care","Healthcare-utilization_Extra-visits","1.1898 (0.5693 to 2.4868), 0.6440 ","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"High",null,"Some concerns",null,"High"]
["Lindell_2021_HRQoL_ATAQ-IPF-total","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","HRQoL_ATAQ-IPF-total","-0.93 (-8.57 to 6.71); 0.81","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_HRQoL_ATAQ-IPF-Impact","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","HRQoL_ATAQ-IPF-Impact","-0.95 (-8.88 to 7.98); 0.83","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Psychological-and-social-outcomes_PSS","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PSS","1.23 (-1.59 to 4.05); 0.39","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Psychological-and-social-outcomes_PROMIS-29-Anxiety/fear","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PROMIS-29-Anxiety/fear","0.01 (-5.55 to 5.57); 0.99","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Psychological-and-social-outcomes_PROMIS-29-Depression/sadness","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PROMIS-29-Depression/sadness","-0.12 (-6.10 to 5.86); 0.97","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Psychological-and-social-outcomes_PROMIS-29-Satisfaction-with-social-roles","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Psychological-and-social-outcomes_PROMIS-29-Satisfaction-with-social-roles","3.66 (1.02 to 8.34); 0.12","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_HRQoL_ATAQ-IPF-Symptom","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","HRQoL_ATAQ-IPF-Symptom","-0.90 (-8.44 to 6.63); 0.81","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Symptoms_PROMIS-29-Pain-interference","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Symptoms_PROMIS-29-Pain-interference","-1.35 (-5.78 to 3.07); 0.54","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Symptoms_PROMIS-29-Fatigue","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Symptoms_PROMIS-29-Fatigue","1.38 (-5.37 to 2.62); 0.49","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Symptoms_PROMIS-29-Sleep-disturbance","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Symptoms_PROMIS-29-Sleep-disturbance","2.63 (-0.53 to 5.79); 0.10","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Healthcare-utilization_Outpatient-visits","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Healthcare-utilization_Outpatient-visits","RR: 0.93 (95%CI: 0.796 to 1.09), p-value: 0.38","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Healthcare-utilization_Inpatient-visits","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Healthcare-utilization_Inpatient-visits","RR: 1.69 (95%CI: 0.61 to 4.67), p-value: 0.31","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"High"]
["Lindell_2021_Healthcare-utilization_Emergency-visits","Steve_Freitas","Lindell_2021",null,"A Program of SUPPORT","Usual care","Healthcare-utilization_Emergency-visits","RR: 1.39 (95%CI: 0.40 to 4.79), p-value: 0.61","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"High",null,"Low",null,"Some concerns",null,"Some concerns",null,"Some concerns",null,"High"]
["Khor_2021_HRQoL_K-BILD-total","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-total","0.7 (-3.3 to 4.7); 0.33","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Functional-performance_MRADLQ","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_MRADLQ","-2.5 (-4.8 to 0.3); 0.08","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Some concerns",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Functional-performance_Life-space-mobility","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Life-space-mobility","2.4 (-10.4 to 15.2); 0.72","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Functional-performance_Steps-per-day","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Steps-per-day","74 (-807 to 956); 0.87","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Functional-performance_Total-energy-expenditure","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Total-energy-expenditure","104 (-197 to 404); 0.50","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Functional-performance_Total-METs","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Total-METs","0.003 (-0.04 to 0.44); 0.88","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Functional-performance_Duration-of-sedentary-time-per-day","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Duration-of-sedentary-time-per-day","66 (-30 to 162); 0.18","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Functional-performance_Duration-of-time-above-3-METs-per-day ","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Functional-performance_Duration-of-time-above-3-METs-per-day ","26 (-16.1 to 68.3); 0.23","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Psychological-and-social-outcomes_SEMCD6","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Psychological-and-social-outcomes_SEMCD6","0.07 (-1.9 to 2.0); 0.94","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_HRQoL_K-BILD-Psychological-domain","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-Psychological-domain","1.1 (-4.1 to 6.3); 0.40","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_Symptoms_Dyspnea-12","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","Symptoms_Dyspnea-12","-2.2 (-6.4 to 1.9); 0.29","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_HRQoL_KBILD-Breathless-and-activities","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-Breathless-and-activities","-1.5 (-8.9 to 5.9); 0.69","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Khor_2021_HRQoL_KBILD-Chest-symptoms","Steve_Freitas","Khor_2021",null,"Handheld fan","Usual care","HRQoL_K-BILD-Chest-symptoms","10 (-5.1 to 25.1); 0.19","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Low",null,"Low",null,"Low",null,"Low",null,"Some concerns","__>I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t_test or Mann_whitney.\r\n","Some concerns"]
["Lindell_2010_HRQoL_SF-36-Physical","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","HRQoL_SF-36-Physical","p-value: 0.038","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"High",null,"High"]
["Lindell_2010_Psychological-and-social-outcomes_BAI","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Psychological-and-social-outcomes_BAI","p-value: 0.077","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"High",null,"High"]
["Lindell_2010_Psychological-and-social-outcomes_BDI-II","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Psychological-and-social-outcomes_BDI-II","p-value: 0.894","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"High",null,"High"]
["Lindell_2010_Psychological-and-social-outcomes_PSS","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Psychological-and-social-outcomes_PSS","p-value: 0.531","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"High",null,"High"]
["Lindell_2010_HRQoL_SF-36-Mental","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","HRQoL_SF-36-Mental","p-value: 0.772","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"High",null,"High"]
["Lindell_2010_Symptoms_UCSDSoBQ","Steve_Freitas","Lindell_2010",null,"PRISIM program","Usual care","Symptoms_UCSDSoBQ","p-value: 0.972","assignment to intervention (the 'intention_to_treat' effect)","NA",1,"Some concerns",null,"Some concerns",null,"Low",null,"Some concerns",null,"High",null,"High"]

{"sheet":"Figure (ITT)","index":3,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Intention-to-treat","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

{"sheet":"Figure (PP)","index":4,"n_rows":1,"n_cols":13,"rows_kept":1,"cut":false,"hidden":false,"merged":[]}
["Per-protocol","Unique ID","Study ID","Experimental","Comparator","Outcome","Weight","D1","D2","D3","D4","D5","Overall"]

{"sheet":"Print (ITT)","index":5,"n_rows":1608,"n_cols":6,"rows_kept":1608,"cut":false,"hidden":false,"merged":[[9,0,16,0],[9,1,9,3],[9,5,10,5],[10,1,10,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[14,1,14,3],[15,1,15,3],[16,1,16,3],[4,1,4,3],[5,0,8,0],[5,1,5,3],[5,5,6,5],[6,1,6,3],[7,1,7,3],[8,1,8,3],[28,0,31,0],[28,1,28,3],[29,1,29,3],[30,1,30,3],[31,1,31,3],[32,1,32,3],[22,0,27,0],[22,1,22,3],[23,1,23,3],[24,1,24,3],[25,1,25,3],[25,5,26,5],[26,1,26,3],[27,1,27,3],[17,0,21,0],[17,1,17,3],[18,1,18,3],[19,1,19,3],[19,5,20,5],[20,1,20,3],[21,1,21,3],[44,0,51,0],[44,1,44,3],[44,5,45,5],[45,1,45,3],[46,1,46,3],[47,1,47,3],[48,1,48,3],[49,1,49,3],[50,1,50,3],[51,1,51,3],[39,1,39,3],[40,0,43,0],[40,1,40,3],[40,5,41,5],[41,1,41,3],[42,1,42,3],[43,1,43,3],[63,0,66,0],[63,1,63,3],[64,1,64,3],[65,1,65,3],[66,1,66,3],[67,1,67,3],[57,0,62,0],[57,1,57,3],[58,1,58,3],[59,1,59,3],[60,1,60,3],[60,5,61,5],[61,1,61,3],[62,1,62,3],[52,0,56,0],[52,1,52,3],[53,1,53,3],[54,1,54,3],[54,5,55,5],[55,1,55,3],[56,1,56,3],[79,0,86,0],[79,1,79,3],[79,5,80,5],[80,1,80,3],[81,1,81,3],[82,1,82,3],[83,1,83,3],[84,1,84,3],[85,1,85,3],[86,1,86,3],[74,1,74,3],[75,0,78,0],[75,1,75,3],[75,5,76,5],[76,1,76,3],[77,1,77,3],[78,1,78,3],[98,0,101,0],[98,1,98,3],[99,1,99,3],[100,1,100,3],[101,1,101,3],[102,1,102,3],[92,0,97,0],[92,1,92,3],[93,1,93,3],[94,1,94,3],[95,1,95,3],[95,5,96,5],[96,1,96,3],[97,1,97,3],[87,0,91,0],[87,1,87,3],[88,1,88,3],[89,1,89,3],[89,5,90,5],[90,1,90,3],[91,1,91,3],[114,0,121,0],[114,1,114,3],[114,5,115,5],[115,1,115,3],[116,1,116,3],[117,1,117,3],[118,1,118,3],[119,1,119,3],[120,1,120,3],[121,1,121,3],[109,1,109,3],[110,0,113,0],[110,1,110,3],[110,5,111,5],[111,1,111,3],[112,1,112,3],[113,1,113,3],[133,0,136,0],[133,1,133,3],[134,1,134,3],[135,1,135,3],[136,1,136,3],[137,1,137,3],[127,0,132,0],[127,1,127,3],[128,1,128,3],[129,1,129,3],[130,1,130,3],[130,5,131,5],[131,1,131,3],[132,1,132,3],[122,0,126,0],[122,1,122,3],[123,1,123,3],[124,1,124,3],[124,5,125,5],[125,1,125,3],[126,1,126,3],[149,0,156,0],[149,1,149,3],[149,5,150,5],[150,1,150,3],[151,1,151,3],[152,1,152,3],[153,1,153,3],[154,1,154,3],[155,1,155,3],[156,1,156,3],[144,1,144,3],[145,0,148,0],[145,1,145,3],[145,5,146,5],[146,1,146,3],[147,1,147,3],[148,1,148,3],[168,0,171,0],[168,1,168,3],[169,1,169,3],[170,1,170,3],[171,1,171,3],[172,1,172,3],[162,0,167,0],[162,1,162,3],[163,1,163,3],[164,1,164,3],[165,1,165,3],[165,5,166,5],[166,1,166,3],[167,1,167,3],[157,0,161,0],[157,1,157,3],[158,1,158,3],[159,1,159,3],[159,5,160,5],[160,1,160,3],[161,1,161,3],[184,0,191,0],[184,1,184,3],[184,5,185,5],[185,1,185,3],[186,1,186,3],[187,1,187,3],[188,1,188,3],[189,1,189,3],[190,1,190,3],[191,1,191,3],[179,1,179,3],[180,0,183,0],[180,1,180,3],[180,5,181,5],[181,1,181,3],[182,1,182,3],[183,1,183,3],[203,0,206,0],[203,1,203,3],[204,1,204,3],[205,1,205,3],[206,1,206,3],[207,1,207,3],[197,0,202,0],[197,1,197,3],[198,1,198,3],[199,1,199,3],[200,1,200,3],[200,5,201,5],[201,1,201,3],[202,1,202,3],[192,0,196,0],[192,1,192,3],[193,1,193,3],[194,1,194,3],[194,5,195,5],[195,1,195,3],[196,1,196,3],[219,0,226,0],[219,1,219,3],[219,5,220,5],[220,1,220,3],[221,1,221,3],[222,1,222,3],[223,1,223,3],[224,1,224,3],[225,1,225,3],[226,1,226,3],[214,1,214,3],[215,0,218,0],[215,1,215,3],[215,5,216,5],[216,1,216,3],[217,1,217,3],[218,1,218,3],[238,0,241,0],[238,1,238,3],[239,1,239,3],[240,1,240,3],[241,1,241,3],[242,1,242,3],[232,0,237,0],[232,1,232,3],[233,1,233,3],[234,1,234,3],[235,1,235,3],[235,5,236,5],[236,1,236,3],[237,1,237,3],[227,0,231,0],[227,1,227,3],[228,1,228,3],[229,1,229,3],[229,5,230,5],[230,1,230,3],[231,1,231,3],[254,0,261,0],[254,1,254,3],[254,5,255,5],[255,1,255,3],[256,1,256,3],[257,1,257,3],[258,1,258,3],[259,1,259,3],[260,1,260,3],[261,1,261,3],[249,1,249,3],[250,0,253,0],[250,1,250,3],[250,5,251,5],[251,1,251,3],[252,1,252,3],[253,1,253,3],[273,0,276,0],[273,1,273,3],[274,1,274,3],[275,1,275,3],[276,1,276,3],[277,1,277,3],[267,0,272,0],[267,1,267,3],[268,1,268,3],[269,1,269,3],[270,1,270,3],[270,5,271,5],[271,1,271,3],[272,1,272,3],[262,0,266,0],[262,1,262,3],[263,1,263,3],[264,1,264,3],[264,5,265,5],[265,1,265,3],[266,1,266,3],[289,0,296,0],[289,1,289,3],[289,5,290,5],[290,1,290,3],[291,1,291,3],[292,1,292,3],[293,1,293,3],[294,1,294,3],[295,1,295,3],[296,1,296,3],[284,1,284,3],[285,0,288,0],[285,1,285,3],[285,5,286,5],[286,1,286,3],[287,1,287,3],[288,1,288,3],[308,0,311,0],[308,1,308,3],[309,1,309,3],[310,1,310,3],[311,1,311,3],[312,1,312,3],[302,0,307,0],[302,1,302,3],[303,1,303,3],[304,1,304,3],[305,1,305,3],[305,5,306,5],[306,1,306,3],[307,1,307,3],[297,0,301,0],[297,1,297,3],[298,1,298,3],[299,1,299,3],[299,5,300,5],[300,1,300,3],[301,1,301,3],[324,0,331,0],[324,1,324,3],[324,5,325,5],[325,1,325,3],[326,1,326,3],[327,1,327,3],[328,1,328,3],[329,1,329,3],[330,1,330,3],[331,1,331,3],[319,1,319,3],[320,0,323,0],[320,1,320,3],[320,5,321,5],[321,1,321,3],[322,1,322,3],[323,1,323,3],[343,0,346,0],[343,1,343,3],[344,1,344,3],[345,1,345,3],[346,1,346,3],[347,1,347,3],[337,0,342,0],[337,1,337,3],[338,1,338,3],[339,1,339,3],[340,1,340,3],[340,5,341,5],[341,1,341,3],[342,1,342,3],[332,0,336,0],[332,1,332,3],[333,1,333,3],[334,1,334,3],[334,5,335,5],[335,1,335,3],[336,1,336,3],[359,0,366,0],[359,1,359,3],[359,5,360,5],[360,1,360,3],[361,1,361,3],[362,1,362,3],[363,1,363,3],[364,1,364,3],[365,1,365,3],[366,1,366,3],[354,1,354,3],[355,0,358,0],[355,1,355,3],[355,5,356,5],[356,1,356,3],[357,1,357,3],[358,1,358,3],[378,0,381,0],[378,1,378,3],[379,1,379,3],[380,1,380,3],[381,1,381,3],[382,1,382,3],[372,0,377,0],[372,1,372,3],[373,1,373,3],[374,1,374,3],[375,1,375,3],[375,5,376,5],[376,1,376,3],[377,1,377,3],[367,0,371,0],[367,1,367,3],[368,1,368,3],[369,1,369,3],[369,5,370,5],[370,1,370,3],[371,1,371,3],[394,0,401,0],[394,1,394,3],[394,5,395,5],[395,1,395,3],[396,1,396,3],[397,1,397,3],[398,1,398,3],[399,1,399,3],[400,1,400,3],[401,1,401,3],[389,1,389,3],[390,0,393,0],[390,1,390,3],[390,5,391,5],[391,1,391,3],[392,1,392,3],[393,1,393,3],[413,0,416,0],[413,1,413,3],[414,1,414,3],[415,1,415,3],[416,1,416,3],[417,1,417,3],[407,0,412,0],[407,1,407,3],[408,1,408,3],[409,1,409,3],[410,1,410,3],[410,5,411,5],[411,1,411,3],[412,1,412,3],[402,0,406,0],[402,1,402,3],[403,1,403,3],[404,1,404,3],[404,5,405,5],[405,1,405,3],[406,1,406,3],[429,0,436,0],[429,1,429,3],[429,5,430,5],[430,1,430,3],[431,1,431,3],[432,1,432,3],[433,1,433,3],[434,1,434,3],[435,1,435,3],[436,1,436,3],[424,1,424,3],[425,0,428,0],[425,1,425,3],[425,5,426,5],[426,1,426,3],[427,1,427,3],[428,1,428,3],[448,0,451,0],[448,1,448,3],[449,1,449,3],[450,1,450,3],[451,1,451,3],[452,1,452,3],[442,0,447,0],[442,1,442,3],[443,1,443,3],[444,1,444,3],[445,1,445,3],[445,5,446,5],[446,1,446,3],[447,1,447,3],[437,0,441,0],[437,1,437,3],[438,1,438,3],[439,1,439,3],[439,5,440,5],[440,1,440,3],[441,1,441,3],[464,0,471,0],[464,1,464,3],[464,5,465,5],[465,1,465,3],[466,1,466,3],[467,1,467,3],[468,1,468,3],[469,1,469,3],[470,1,470,3],[471,1,471,3],[459,1,459,3],[460,0,463,0],[460,1,460,3],[460,5,461,5],[461,1,461,3],[462,1,462,3],[463,1,463,3],[483,0,486,0],[483,1,483,3],[484,1,484,3],[485,1,485,3],[486,1,486,3],[487,1,487,3],[477,0,482,0],[477,1,477,3],[478,1,478,3],[479,1,479,3],[480,1,480,3],[480,5,481,5],[481,1,481,3],[482,1,482,3],[472,0,476,0],[472,1,472,3],[473,1,473,3],[474,1,474,3],[474,5,475,5],[475,1,475,3],[476,1,476,3],[499,0,506,0],[499,1,499,3],[499,5,500,5],[500,1,500,3],[501,1,501,3],[502,1,502,3],[503,1,503,3],[504,1,504,3],[505,1,505,3],[506,1,506,3],[494,1,494,3],[495,0,498,0],[495,1,495,3],[495,5,496,5],[496,1,496,3],[497,1,497,3],[498,1,498,3],[518,0,521,0],[518,1,518,3],[519,1,519,3],[520,1,520,3],[521,1,521,3],[522,1,522,3],[512,0,517,0],[512,1,512,3],[513,1,513,3],[514,1,514,3],[515,1,515,3],[515,5,516,5],[516,1,516,3],[517,1,517,3],[507,0,511,0],[507,1,507,3],[508,1,508,3],[509,1,509,3],[509,5,510,5],[510,1,510,3],[511,1,511,3],[534,0,541,0],[534,1,534,3],[534,5,535,5],[535,1,535,3],[536,1,536,3],[537,1,537,3],[538,1,538,3],[539,1,539,3],[540,1,540,3],[541,1,541,3],[529,1,529,3],[530,0,533,0],[530,1,530,3],[530,5,531,5],[531,1,531,3],[532,1,532,3],[533,1,533,3],[553,0,556,0],[553,1,553,3],[554,1,554,3],[555,1,555,3],[556,1,556,3],[557,1,557,3],[547,0,552,0],[547,1,547,3],[548,1,548,3],[549,1,549,3],[550,1,550,3],[550,5,551,5],[551,1,551,3],[552,1,552,3],[542,0,546,0],[542,1,542,3],[543,1,543,3],[544,1,544,3],[544,5,545,5],[545,1,545,3],[546,1,546,3],[569,0,576,0],[569,1,569,3],[569,5,570,5],[570,1,570,3],[571,1,571,3],[572,1,572,3],[573,1,573,3],[574,1,574,3],[575,1,575,3],[576,1,576,3],[564,1,564,3],[565,0,568,0],[565,1,565,3],[565,5,566,5],[566,1,566,3],[567,1,567,3],[568,1,568,3],[588,0,591,0],[588,1,588,3],[589,1,589,3],[590,1,590,3],[591,1,591,3],[592,1,592,3],[582,0,587,0],[582,1,582,3],[583,1,583,3],[584,1,584,3],[585,1,585,3],[585,5,586,5],[586,1,586,3],[587,1,587,3],[577,0,581,0],[577,1,577,3],[578,1,578,3],[579,1,579,3],[579,5,580,5],[580,1,580,3],[581,1,581,3],[604,0,611,0],[604,1,604,3],[604,5,605,5],[605,1,605,3],[606,1,606,3],[607,1,607,3],[608,1,608,3],[609,1,609,3],[610,1,610,3],[611,1,611,3],[599,1,599,3],[600,0,603,0],[600,1,600,3],[600,5,601,5],[601,1,601,3],[602,1,602,3],[603,1,603,3],[623,0,626,0],[623,1,623,3],[624,1,624,3],[625,1,625,3],[626,1,626,3],[627,1,627,3],[617,0,622,0],[617,1,617,3],[618,1,618,3],[619,1,619,3],[620,1,620,3],[620,5,621,5],[621,1,621,3],[622,1,622,3],[612,0,616,0],[612,1,612,3],[613,1,613,3],[614,1,614,3],[614,5,615,5],[615,1,615,3],[616,1,616,3],[639,0,646,0],[639,1,639,3],[639,5,640,5],[640,1,640,3],[641,1,641,3],[642,1,642,3],[643,1,643,3],[644,1,644,3],[645,1,645,3],[646,1,646,3],[634,1,634,3],[635,0,638,0],[635,1,635,3],[635,5,636,5],[636,1,636,3],[637,1,637,3],[638,1,638,3],[658,0,661,0],[658,1,658,3],[659,1,659,3],[660,1,660,3],[661,1,661,3],[662,1,662,3],[652,0,657,0],[652,1,652,3],[653,1,653,3],[654,1,654,3],[655,1,655,3],[655,5,656,5],[656,1,656,3],[657,1,657,3],[647,0,651,0],[647,1,647,3],[648,1,648,3],[649,1,649,3],[649,5,650,5],[650,1,650,3],[651,1,651,3],[674,0,681,0],[674,1,674,3],[674,5,675,5],[675,1,675,3],[676,1,676,3],[677,1,677,3],[678,1,678,3],[679,1,679,3],[680,1,680,3],[681,1,681,3],[669,1,669,3],[670,0,673,0],[670,1,670,3],[670,5,671,5],[671,1,671,3],[672,1,672,3],[673,1,673,3],[693,0,696,0],[693,1,693,3],[694,1,694,3],[695,1,695,3],[696,1,696,3],[697,1,697,3],[687,0,692,0],[687,1,687,3],[688,1,688,3],[689,1,689,3],[690,1,690,3],[690,5,691,5],[691,1,691,3],[692,1,692,3],[682,0,686,0],[682,1,682,3],[683,1,683,3],[684,1,684,3],[684,5,685,5],[685,1,685,3],[686,1,686,3],[709,0,716,0],[709,1,709,3],[709,5,710,5],[710,1,710,3],[711,1,711,3],[712,1,712,3],[713,1,713,3],[714,1,714,3],[715,1,715,3],[716,1,716,3],[704,1,704,3],[705,0,708,0],[705,1,705,3],[705,5,706,5],[706,1,706,3],[707,1,707,3],[708,1,708,3],[728,0,731,0],[728,1,728,3],[729,1,729,3],[730,1,730,3],[731,1,731,3],[732,1,732,3],[722,0,727,0],[722,1,722,3],[723,1,723,3],[724,1,724,3],[725,1,725,3],[725,5,726,5],[726,1,726,3],[727,1,727,3],[717,0,721,0],[717,1,717,3],[718,1,718,3],[719,1,719,3],[719,5,720,5],[720,1,720,3],[721,1,721,3],[744,0,751,0],[744,1,744,3],[744,5,745,5],[745,1,745,3],[746,1,746,3],[747,1,747,3],[748,1,748,3],[749,1,749,3],[750,1,750,3],[751,1,751,3],[739,1,739,3],[740,0,743,0],[740,1,740,3],[740,5,741,5],[741,1,741,3],[742,1,742,3],[743,1,743,3],[763,0,766,0],[763,1,763,3],[764,1,764,3],[765,1,765,3],[766,1,766,3],[767,1,767,3],[757,0,762,0],[757,1,757,3],[758,1,758,3],[759,1,759,3],[760,1,760,3],[760,5,761,5],[761,1,761,3],[762,1,762,3],[752,0,756,0],[752,1,752,3],[753,1,753,3],[754,1,754,3],[754,5,755,5],[755,1,755,3],[756,1,756,3],[779,0,786,0],[779,1,779,3],[779,5,780,5],[780,1,780,3],[781,1,781,3],[782,1,782,3],[783,1,783,3],[784,1,784,3],[785,1,785,3],[786,1,786,3],[774,1,774,3],[775,0,778,0],[775,1,775,3],[775,5,776,5],[776,1,776,3],[777,1,777,3],[778,1,778,3],[798,0,801,0],[798,1,798,3],[799,1,799,3],[800,1,800,3],[801,1,801,3],[802,1,802,3],[792,0,797,0],[792,1,792,3],[793,1,793,3],[794,1,794,3],[795,1,795,3],[795,5,796,5],[796,1,796,3],[797,1,797,3],[787,0,791,0],[787,1,787,3],[788,1,788,3],[789,1,789,3],[789,5,790,5],[790,1,790,3],[791,1,791,3],[814,0,821,0],[814,1,814,3],[814,5,815,5],[815,1,815,3],[816,1,816,3],[817,1,817,3],[818,1,818,3],[819,1,819,3],[820,1,820,3],[821,1,821,3],[809,1,809,3],[810,0,813,0],[810,1,810,3],[810,5,811,5],[811,1,811,3],[812,1,812,3],[813,1,813,3],[833,0,836,0],[833,1,833,3],[834,1,834,3],[835,1,835,3],[836,1,836,3],[837,1,837,3],[827,0,832,0],[827,1,827,3],[828,1,828,3],[829,1,829,3],[830,1,830,3],[830,5,831,5],[831,1,831,3],[832,1,832,3],[822,0,826,0],[822,1,822,3],[823,1,823,3],[824,1,824,3],[824,5,825,5],[825,1,825,3],[826,1,826,3],[849,0,856,0],[849,1,849,3],[849,5,850,5],[850,1,850,3],[851,1,851,3],[852,1,852,3],[853,1,853,3],[854,1,854,3],[855,1,855,3],[856,1,856,3],[844,1,844,3],[845,0,848,0],[845,1,845,3],[845,5,846,5],[846,1,846,3],[847,1,847,3],[848,1,848,3],[868,0,871,0],[868,1,868,3],[869,1,869,3],[870,1,870,3],[871,1,871,3],[872,1,872,3],[862,0,867,0],[862,1,862,3],[863,1,863,3],[864,1,864,3],[865,1,865,3],[865,5,866,5],[866,1,866,3],[867,1,867,3],[857,0,861,0],[857,1,857,3],[858,1,858,3],[859,1,859,3],[859,5,860,5],[860,1,860,3],[861,1,861,3],[884,0,891,0],[884,1,884,3],[884,5,885,5],[885,1,885,3],[886,1,886,3],[887,1,887,3],[888,1,888,3],[889,1,889,3],[890,1,890,3],[891,1,891,3],[879,1,879,3],[880,0,883,0],[880,1,880,3],[880,5,881,5],[881,1,881,3],[882,1,882,3],[883,1,883,3],[903,0,906,0],[903,1,903,3],[904,1,904,3],[905,1,905,3],[906,1,906,3],[907,1,907,3],[897,0,902,0],[897,1,897,3],[898,1,898,3],[899,1,899,3],[900,1,900,3],[900,5,901,5],[901,1,901,3],[902,1,902,3],[892,0,896,0],[892,1,892,3],[893,1,893,3],[894,1,894,3],[894,5,895,5],[895,1,895,3],[896,1,896,3],[919,0,926,0],[919,1,919,3],[919,5,920,5],[920,1,920,3],[921,1,921,3],[922,1,922,3],[923,1,923,3],[924,1,924,3],[925,1,925,3],[926,1,926,3],[914,1,914,3],[915,0,918,0]],"merged_total":1748,"flags":["merged_cut"]}
["Unique ID","Moor_2020_HRQoL_KBILD_total","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQoL-KBILD","Results","2.67 (-1.85 to 7.17); 0.24","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\""]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. This is an open label trial. \r\n2.2. This is an open label trial. "]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment."]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. "]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with  independent Students’ t tests\r\nin the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"," \r\n"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"K-BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. This is an open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\"."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available."]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor_2020_HRQoL_GRC","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQoL-GRC","Results","1.03 (-0.02 to 2.09); 0.055","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\""]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. This is an open label study.\r\n2.2. This is an open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment."]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PY","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. However, as p-value is close to significance, it may have affected the result."]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\"."]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PY","4.1. \"On the GRC scale, patients indicate whether their quality of life improved or deteriorated over time, on a scale from 27 to 7.\" No further informations are provided. No information regarding the validity and reliability for this outcome measure on the literature. Measuring such a complex outcome (HRQoL) with a GRC could be insufficient."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"NA"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\"."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available."]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor_2020_HRQoL_EQ-5D-5L","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQoL-EQ5D5L","Results","0.05 (-0.01 to 0.10); 0.11","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\""]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. This is an open label study.\r\n2.2. This is an open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment."]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PY","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. However, p-values is close to significance, so it may have affected the results."]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\"."]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"The EQ-5D-5L is a generic\r\ninstrument to assess HRQOL.\" "]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. This is an open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"N","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor_2020_HRQoL_VAS_wellBeing","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQoL-VASgeneralwellbeing","Results","1.04 (0.09 to 2.00); 0.032","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2. Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\""]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. Open label study.\r\n2.2. Open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment."]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PY","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. However, p-values is close to significance, so it may have affected the results."]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\"."]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","4.1. Here we use this measure to assess QoL, however they assess well-being as a symptom. Insufficient as a QoL measure, but here it is more a sense of well-being."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\"."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor_2020_HRQoL_EQ-VAS","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQoL-EQVAS","Results","3.95 (-5.20 to 13.10); 0.39","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2. Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\""]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. This is an open label study.\r\n2.2. This is an open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\nmay be due to the fact that they knew the group assinment."]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. "]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. \r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.\r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The EQ-VAS is a part from the EQ-5D-5L. The EQ-5D-5L is a generic\r\ninstrument to assess HRQOL. Very used."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Openal label trial."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\"."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available."]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor-2020-Psychologicalandsocialoutcomes-HADSanxiety","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","Psychologicalandsocialoutcomes-HADSanxiety","Results","-0.05 (-1.08 to 0.99); 0.93","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.\r\n "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"PY","2.1. This is an open label trial. \r\n2.2. This is an open label trial. "]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"PY"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\nnot interested\" that may be due to the fact that they knew the group assinment. Deviation baucause of trial context?"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. \r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. \r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. The missing data is likely to not be related to the anxiety status. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"The HADS is a validated questionnaire with a subscale for\r\nanxiety and depression: a score of 8 or\r\ngreater is used as the cut-off for anxiety\r\nor depressive symptoms.\""]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. This is a patient-reported outcome in a context of an open label study. \r\n4.5. As the EG include an intervention where the participant is more followed in his health, maybe it will cause some effect in the measurements of the control group. As the intervention in not something revolutionary it is most likely that the knowledge of the group would not affect the outcome. Additionally, as the overaal results don't tend to favor the EG (nor CG),we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment."]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. HADS was stated on the clinical trials platform and it is reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Moor-2020-Psychologicalandsocialoutcomes-HADSdepression","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","Psychologicalandsocialoutcomes-HADSdepression","Results","-0.40 (-1.61 to 0.81); 0.51","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a centralized electronic system using varying block sizes.\"\r\n1.2.  Allocation of each subject was done with a centralized electronic system using varying block sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. This is an open label trial. \r\n2.2. This is an open label trial. \r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. \r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.5. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analisys for missing data. They just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NI","3.3. No clear information about the reasons for missing data. Althout depression status could have affected the completion of PROMs, from the given information about the reasons for excluding patient data it seems that the depression status was not at the origin."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"The HADS is a validated questionnaire with a subscale for\r\nanxiety and depression: a score of 8 or\r\ngreater is used as the cut-off for anxiety\r\nor depressive symptoms.\""]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. This is a patient-reported outcome in a context of an open label study. \r\n4.5. As the EG include an intervention where the participant is more followed in his health, maybe it will cause some effect in the measurements of the control group. As the intervention in not something revolutionary it is most likely that the knowledge of the group would not affect the outcome. Additionally, as the overaal results don't tend to favor the EG (nor CG),we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment."]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. HADS was stated on the clinical trials platform and it is reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Moor-2020-HrQOL-KBILDpsychologicaldomain","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQOL-KBILDpsychologicaldomain","Results","5.6 (-1.13 to 12.3); 0.10","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add-on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized system is controlled by an external unit or organization, independent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. Open label study.\r\n2.2. Open label study.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PY","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. However, p-value is close to significance, so it may have affected the results.\r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\".\r\n"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46) and 39 for CG (from 44). There is a lost of participants of 17% and 11% respectively so it is significant. \r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analissi for missing data. They just analyse the available data.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4.\r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"K-BILD has\r\nbeen developed and validated in interstitial\r\nlung diseases (ILDs) and consists of 15\r\nitems in three domains: breathlessness and\r\nactivities, chest symptoms, and a\r\npsychological domain (15).\""]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), comparing the same endpoints (althouth the EG measured more often the outcome). \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PY","4.3. Open label study.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor-2020-Symptoms-VAScough","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","Symptoms-VAScough","Results","0.82 (-0.52 to 2.17); 0.23","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add-on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. Open label study.\r\n2.2. Open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. \r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention-to-treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. One case in the EG a participant was excluded because of problems due to cough. However in the other cases it does not seem as cough could be the reason for the missing outcome. Considering that only one case is confirmed and the other are questions, the final judgement is that it is not likely that all the missing data is related to outcome true value. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","4.1. VAS is a generic form of evaluation. Cough could be assess with more complete scales as it could be assessed in it's intensity, urge, frequency, severity, etc. and the study just mentions cough. However it is not a totally inapropriate measure to assess cough."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Open label study.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. This is a patient-reported outcome in a context of an open label study. \r\n4.5. As the EG include an intervention where the participant is more followed in his health, maybe it will cause some effect in the measurements of the control group. As the intervention in not something revolutionary it is most likely that the knowledge of the group would not affect the outcome. Additionally, as the overaal results don't tend to favor the EG (nor CG),we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment."]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. VAS cough was not reported in the outcomes for this trial. \r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Moor-2020-Symptoms-VASdyspnea","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","Symptoms-VASdyspnea","Results","0.63 (-0.23 to 1.50); 0.15","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add-on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. Open label study.\r\n2.2. Open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PY","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. However, p-values is close to significance, so it may have affected the results.\r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"PY","2.5 They start with 46 (EG) and 44 (CG) participants and end with 38 and 39 respectively. As they end with similar number of partcipants in each group I will evaluate \"PY\".\r\n"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. 3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. The missing data is likely to not be related to the dyspnea of the participants. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","4.1. VAS is a generic form of evaluation. Dyspneia could be assess with more complete scales as it could be assessed in it's intensity, frequency, severity, etc. However it is not a totally inapropriate measure to assess dyspneia."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. This is a patient-reported outcome in a context of an open \r\nlabel study. \r\n4.5. As the EG include an intervention where the participant is \r\nmore followed in his health, maybe it will cause some effect in \r\nthe measurements of the control group. As the intervention in not \r\nsomething vary revolutionary it is most likely that the knowledge \r\nof the group would not affect the outcome. It would be different in \r\ncase the CG have to everyday go to the clinic to measure the FVC \r\nto match the EG rate of measurments (hell for them wich would lead \r\nto vary poor outcomes in the CG). "]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. VAS dyspneia was not reported in the trial protocol. "]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Moor-2020-Symptoms-VASfatigue","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","Symptoms-VASfatigue","Results","0.18 (-0.88 to 1.23); 0.74","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add-on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. Open label study.\r\n2.2. Open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. \r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention-to-treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. The missing data is likely to not be related to the dyspnea of the participants. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","4.1. VAS is a generic form of evaluation. Fatigue could be assess with more complete scales as it could be assessed in it's intensity, frequency, severity, etc. However it is not a totally inapropriate measure to assess fatigue."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PN","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. This is a patient-reported outcome in a context of an open \r\nlabel study. \r\n4.5. As the EG include an intervention where the participant is \r\nmore followed in his health, maybe it will cause some effect in \r\nthe measurements of the control group. As the intervention in not \r\nsomething vary revolutionary it is most likely that the knowledge \r\nof the group would not affect the outcome. It would be different in \r\ncase the CG have to everyday go to the clinic to measure the FVC \r\nto match the EG rate of measurments (hell for them wich would lead \r\nto vary poor outcomes in the CG)."]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. VAS fatigue was not reported in the trial protocol. \r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Moor-2020-HrQOL-KBILDchestsymptoms","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQOL-KBILDchestsymptoms","Results","3.7 (-4.5 to 11.5); 0.35","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add-on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. Open label study.\r\n2.2. Open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. \r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention-to-treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including QOL). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think that for this outcome measure it's best to report NI in 3.4."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"K-BILD has\r\nbeen developed and validated in interstitial\r\nlung diseases (ILDs) and consists of 15\r\nitems in three domains: breathlessness and\r\nactivities, chest symptoms, and a\r\npsychological domain.\""]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor-2020-HrQOL-KBILDbreathlessandactivities","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQOL-KBILDbreathlessandactivities","Results","0.9 (-6.3 to -4.4); 0.73","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add-on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. Open label study.\r\n2.2. Open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. \r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with  independent Students’ t tests in the intention-to-treat population. We performed complete case analyses, as missing data were considered to be independent of the primary outcome (e.g., missing questionnaires due to technical errors).\"\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. No clear information about the reasons for missing data. The missing data about K-BILD may suggest that the missing data it's related to the health status (including psychological). Proportion of missing data between groups is similar 5 (CG) vs 7 (EG), final groups is 39 (EG) vs 38 (CG). As the specific reason for not completing the outcome measure is not reported, and for the other questions arising from the other reasons for exlusion from the study, I think tthat for this outcome measure it's best to report NI in 3.4."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NI"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"K-BILD has\r\nbeen developed and validated in interstitial\r\nlung diseases (ILDs) and consists of 15\r\nitems in three domains: breathlessness and\r\nactivities, chest symptoms, and a\r\npsychological domain.\""]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner (patient), \r\ncomparing the same endpoints (althouth the EG measured more often \r\nthe outcome). "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PY","4.3. Open label study."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"PY","4.4. and 4.5. HRQoL measured with a PROM is likely to be influenced by the knowledge of the intervention. Participants know they are using a tool that was developed to improve their disease management and health status. However, overall, the results on HRQoL did not favour the EG, thus, we can hypothetise that the knowledge of the group intervention did not influenced the outcome assessment.\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. All the outcome measures intended to assess HRQoL that were stated on the clinical trials platform are reported. However, authors state that they collected data at 12weeks but no results are reported. Either way, the answer assigned will be \"PN\" since the intervention lasted for 24 weeks and all outcome measures are reported at that timepoint. Addtionally, the VAS for general well-being, is the only outcome measure that was not proposed in the clinical trials registration, and also the only one where results favoured the EG. However, as all the remaining outcome measures are reported, I still judged this question as \"PN\".\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Moor-2020-Healthcareuse-extravisits","Study ID","Moor-2020","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","home monitoring program","Comparator","standard care","Source"," Journal article(s); Trial protocol"]
["Outcome","Healthcareuse-extravisits","Results","1.1898 (0.5693 to 2.4868), 0.6440 ","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. Participants were randomly\r\nassigned in a 1:1 ratio to a home monitoring\r\nprogram as add-on to standard care\r\nor standard care alone for 24 weeks.\r\nRandomization was stratified per site and\r\nfor use of nintedanib or pirfenidone.\"\r\n1.2. Allocation of each subject was done with a\r\ncentralized electronic system using varying\r\nblock sizes. It does not inform if the centralized \r\nsystem is controlled by an external unit or organization, \r\nindependent of the enrolment personnel or not. "]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. \"Baseline characteristics of patients were evenly distributed between treatment groups (Table 1). The percentage of males was numerically higher in the standard care group, but the difference was not statistically significant (P = 0.06).\"\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"PY","2.1. Open label study.\r\n2.2. Open label study."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"PY"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PY","2.3. There is not information in the text or protocol about deviations, discontinuations, etc. However there is information in figure 1, where 1 withrew from EG because of physician decision and 2 from CG because \"not time\" and \"not interested\" that may be due to the fact that they knew the group assinment.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"PN","2.4. As it is 1-2 people that withrew with questionable reasons, in a sample of 44-46 it is not likely to have affected the result. \r\n"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"Y","2.6. \"Between-group differences in PROMs were analyzed with \r\nindependent Students’ t tests in the intention-to-treat population.\r\n We performed complete case analyses, as missing data were \r\nconsidered to be independent of the primary outcome \r\n(e.g., missing questionnaires due to technical errors).\""]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1.Number of participants data at endpoint is 38 for EG (from 46)\r\n and 39 for CG (from 44). There is a lost of participants of 17% \r\nand 11% respectively so it is significant."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2.No sensitivity analysis or other analisys for missing data. \r\nThey just analyse the available data."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. It is not likely that the reasons of missing data are related to the true value of the outcome."]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PY","No outcome definition of extra visits nor it is appointed the method of collection. "]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"PY","In the experimental group there is the eConsultation function wich may lead to professionals to advise more face-to-face consultations (as they are more followed), while also be an opportunity to EG participants to have more consultations without being accounted as being \"extra visits\". "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"NA"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. Healthcare contacts are reported in the trial protocol, and the measurment at 24 weeks is the only timeframe reported. \r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell_2021_HRQoL_ATAQ-IPF","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQOL-ATAQIPFtotal","Results","-0.93 (-8.57 to 6.71); 0.81","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG. \r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person."]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option."]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm\r\nwas 35 out of 50 (70%) compared with 19 out\r\nof 26 (73%) for the control arm (P . 0.9,\r\nFigure 1).\""]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death and lung transplant, and drop-out before study completion. Although the reasons for drop-out are not clearly stated, the HRQoL is probably not responsible for the drop-outs. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis is a validaded questionarire to asses HrQOL in ILD patients. \r\n\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. "]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. "]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in the patient-reported outcomes. "]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. ATAQ was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available."]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell_2021_HRQoL_ATAQ-IPF-Impact","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQoL-ATAQIPFImpactsubscale","Results","-0.95 (-8.88 to 7.98); 0.83","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death and lung transplant, and drop-out before study completion. Although the reasons for drop-out are not clearly stated, the HRQoL is probably not responsible for the drop-outs. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis is a validaded questionarire to asses HrQOL in ILD patients. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. ATAQ was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-Psychologicalandsocialoutcomes-PSS","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","Psychologicalandsocialoutcomes-PSS","Results","1.23 (-1.59 to 4.05); 0.39","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. and 3.4. This is a patient-reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. However, participant with more stress, are probably not subjected to more drop-out. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The PSS is a general scale for assessing stress. Is measures the outcome \"properly\" and has some validity to it. "]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. PSS was the only outcome measure that was stated on the clinical trials platform to assess stress and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-Psychologicalandsocialoutcomes-PROMIS29Anxietyfear","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","Psychologicalandsocialoutcomes-PROMIS29Anxietyfear","Results","0.01 (-5.55 to 5.57); 0.99","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) \r\ncompared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. and 3.4. This is a patient-reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. Althougth the intervention discuss some \"sensible\" topics that may affect drop-outs, anxiety status is not likely the cause for drop-outs. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. PROMIS-29 is a tool to asses different domains of the health status."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3.Reported with the pre-specified analisys."]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-Psychologicalandsocialoutcomes-PROMIS29Depressionsadness","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","Psychologicalandsocialoutcomes-PROMIS29Depressionsadness","Results","-0.12 (-6.10 to 5.86); 0.97","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. and 3.4. This is a patient-reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. Participant with more symptoms of depression could be subjected to more drop-out. Althougth the intervention discuss some \"sensible\" topics that could affect drop-outs, it is not likely that it would cause them in reality. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. PROMIS-29 is a tool to asses different domains of the health status."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-Psychologicalandsocialoutcomes-PROMIS29Satisfactionwithsocialroles","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","Psychologicalandsocialoutcomes-PROMIS29Satisfactionwithsocialroles","Results","3.66 (1.02 to 8.34); 0.12","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the\r\nrandomization of patients was based on\r\nclinic day to reduce contamination, but\r\nthis resulted in a 2:1 unequal distribution\r\nbetween intervention and control arms,\r\nlimiting statistical power.\""]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"N","3.3. and 3.4. 3.3. Althogth this is a patient-reported outcome regarding an aspect of the health status of the participant and there is some data regarding the missing results that lack information, it is not probable that satisfaction with social roles, considering the overall reasons for missing data, would be the cause for data missingness.\r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. PROMIS-29 is a tool to asses different domains of the health status."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-HrQOL-ATAQIPFSymptomsubscale","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQOL-ATAQIPFSymptomsubscale","Results","-0.90 (-8.44 to 6.63); 0.81","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death and lung transplant, and drop-out before study completion. Although the reasons for drop-out are not clearly stated, the HRQoL is probably not responsible for the death and transplants that caused the majority of missing data. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis is a validaded questionarire to asses HrQOL in ILD patients. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. ATAQ was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-Symptoms-PROMIS29Paininterference","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","Symptoms-PROMIS29Paininterference","Results","-1.35 (-5.78 to 3.07); 0.54","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) \r\ncompared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. and 3.4. This is a patient-reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. However, it is not likely that more pain  would cause more drop-out in this trial. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. PROMIS-29 is a tool to asses different domains of the health status."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-Symptoms-PROMIS29Fatigue","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","Symptoms-PROMIS29Fatigue","Results","1.38 (-5.37 to 2.62); 0.49","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. and 3.4. This is a patient-reported outcome regarding an aspect of the health status of the participant additionally there is some data regarding the missing results that lack information. Participant with more fatigue could be more subjected to drop-out (some patient didn't participate in the trial because of fatigue). However, there is no information about the participants that dropped-out, and I don't think that participants in the study are likely to drop-out because of fatigue. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. PROMIS-29 is a tool to asses different domains of the health status.\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-Symptoms-PROMIS29Sleepdisturbance","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","Symptoms-PROMIS29Sleepdisturbance","Results","2.63 (-0.53 to 5.79); 0.10","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. and 3.4. Althogth this is a patient-reported outcome regarding an aspect of the health status of the participant and there is some data regarding the missing results that lack information, it is not probable that morr sleep disturbance would be the cause for data missingness in this trial.\r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. PROMIS-29 is a tool to asses different domains of the health status.\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. Patient-reported outcome in a trial were the participants were aware of their arm group. \r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. and 4.5. As it is a patient-reported outcome in a trial were the participants are aware of their arm group the reporting could have been influenced by the knowing the arm group they were in. However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"PN","5.2. PROMIS was the only outcome measure that was stated on the clinical trials platform to assess symptom burden and it is reported. However, in clinical trials authors refer to a 3 year time frame, whereas in this paper the results are pre-post an intervention of 6 to 8-month long.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-HealthcareUtilization-Outpatientvisits","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","HealthcareUtilization-Outpatientvisits","Results","RR: 0.9317 (0.7959 to 1.0906 95%CI), p-value: 0.3786","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. and 3.4. Participants with more hospital visits may be more inclined to participate in the meetings (to know how to dealt with their condition) or more inclined to not participate (more fatigued, don't want to be more than necessary in a health facility, etc.), i.e. if a person has less / more hospital visits they may be inclined to participate or no in the project, hence resulting or not in drop-outs. However, as this is just an hypotesis and because of the low value of drop-outs it is not likely that the true value of the outcome lies in the missing data. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","4.1. They accounted for the hospital visits in different settings, they do not describe how they collected the data."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PY","4.3. Although there is no information about how the data was assessed, as in every other outcome the assessor, the participant and interventionist are aware of thearm of the participant I will say \"PY\".\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NI","4.4. and 4.5. Depending on how the data was collected it could have been influenced (e.g. reported visits from the participant) or could not have been influenced (e.g., count from an electronic system). However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Outpatient visits was not stated as an outcome in the trial protocol. \r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-HealthcareUtilization-Inpatientvisits","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","HealthcareUtilization-Inpatientvisits","Results","RR: 1.6900 (0.6121 to 4.6658 95%CI), p-value: 0.3112","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. and 3.4. Participants with more hospital visits may be more inclined to participate in the meetings (to know how to dealt with their condition) or more inclined to not participate (more fatigued, don't want to be more than necessary in a health facility, etc.), i.e. if a person has less / more hospital visits they may be inclined to participate or no in the project, hence resulting or not in drop-outs. However, as this is just an hypotesis and because of the low value of drop-outs it is not likely that the true value of the outcome lies in the missing data. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","4.1. They accounted for the hospital visits in different settings, they do not describe how they collected the data.\r\n\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PY","4.3. Although there is no information about how the data was assessed, as in every other outcome the assessor, the participant and interventionist are aware of thearm of the participant I will say \"PY\".\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NI","4.4. and 4.5. Depending on how the data was collected it could have been influenced (e.g. reported visits from the participant) or could not have been influenced (e.g., count from an electronic system). However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Inpatient visits was not stated as an outcome in the trial protocol. \r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2021-HealthcareUtilization-Emergencyvisits","Study ID","Lindell-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","a Program of SUPPORT","Comparator","usual care","Source"," Journal article(s); Trial protocol"]
["Outcome","HealthcareUtilization-Emergencyvisits","Results","RR: 1.3867 (0.4015 to 4.7890 95%CI), p-value: 0.6052","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"N","1.1. \"to avoid intervention contamination, the patient/caregiver dyads were randomized to the intervention or control group (routine care) based on clinic-day visit. Physicians have assigned clinic-day slots, and patients return to clinic on the same day of the week as the original visit to see their assigned\". Clinic-day visit is not a proper random element and by using it the sequence is easily predictable. \r\n1.2. From the moment mondays were atributed to the EG (for instance), the cliniciais already knew that if a patient first visit was scheduled for monday that patient would pertain to the EG.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"N"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"Y","1.3. \"In addition, the randomization of patients was based on clinic day to reduce contamination, but this resulted in a 2:1 unequal distribution between intervention and control arms, limiting statistical power.\"\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. As the experimental and control interventions are clearly difference in practice. The participant would know from the first consultation which group they were assigned.\r\n2.2. They don't clearly say if the nurse interventionist is the same in both groups. However it seems that it is the same person to me as they just refer o \"the nurse interventionist\" with no reference to assignement of that person.\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. The most important reasons for not receiving the full dose of allocated intervention in both groups were death, lung transplant, and drop-out before study completion. Althout the reasons for drop-out are not clearly stated, the rest of the cases (great majority) seem to not be related to the trial content. \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. They calculated intervention effectiveness based on the final available values of those participants who completed the intervention. It could be ITT or MITT, either way, by the guideline it is an acceptable method of analisis. However no clear statement is made, so I chose the \"PY\" option.\r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"N","3.1. \"The total retention rate for the intervention arm was 35 out of 50 (70%) compared with 19 out of 26 (73%) for the control arm (P . 0.9, Figure 1).\"\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PY","3.3. and 3.4. Participants with more hospital visits may be more inclined to participate in the meetings (to know how to dealt with their condition) or more inclined to not participate (more fatigued, don't want to be more than necessary in a health facility, etc.), i.e. if a person has less / more hospital visits they may be inclined to participate or no in the project, hence resulting or not in drop-outs. However, as this is just an hypotesis and because of the low value of drop-outs it is not likely that the true value of the outcome lies in the missing data. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"NI","4.1. They accounted for the hospital visits in different settings, they do not describe how they collected the data.\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same timepoints, thresholds and methods of assessment between the two groups. \r\n\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PY","4.3. Although there is no information about how the data was assessed, as in every other outcome the assessor, the participant and interventionist are aware of thearm of the participant I will say \"PY\".\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NI","4.4. and 4.5. Depending on how the data was collected it could have been influenced (e.g. reported visits from the participant) or could not have been influenced (e.g., count from an electronic system). However as there is little difference between the experimental (were they read the book with the nurse and discuss the content and other concerns) and the control group (were they just give the book) I don't think there is a real concern regarding the bias in assessing this outcomes. \r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"NI","5.1. A clinical trial registration is provided. However, no details are provided regarding the statistical analysis.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Emergency visits was not stated as an outcome in the trial protocol. \r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"NI","5.3. Analysis intentions are not available.\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Khor_2021_HRQoL_KBILD_total","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQoL-KBILD","Results","0.7 (-3.3 to 4.7); 0.33","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\""]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). "]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\""]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  "]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. "]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. K-BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a sychological domain.\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer."]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models."]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported."]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought."]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Functionalperformance-Manchesterrespiratoryactivitiesofdailylivingquestionnaire","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Functionalperformance-Manchesterrespiratoryactivitiesofdailylivingquestionnaire","Results","-2.5 (-4.8 to 0.3); 0.08","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PN","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is near the 5% target, as the p-value is vary close to significance and the sample size is little I think that it could affect the effect estimate.\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"N","3.3. As reported: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". So, the missigness for this outcome didn't depend on the value of functional performance factor. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. Functional performance was measured using validated questionnaires to quantify physical disability for activities of daily living (Manchester Respiratory Activities of Daily Living Questionnaire). It is valid measure to assess performance on daily activities. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. This questionaire was was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Functionalperformance-Lifespacemobility","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Functionalperformance-Lifespacemobility","Results","2.4 (-10.4 to 15.2); 0.72","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. Functional performance was measured using validated questionnaires to quantify physical disability for activities of daily living (space-life mobility). It is a valid measure to assess performance on daily activities. "]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. This questionaire was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Functionalperformance-Sensewearstepsperday","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Functionalperformance-Sensewearstepsperday","Results","74 (-807 to 956); 0.87","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants."]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Functionalperformance-Totalenergyexpenditure","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Functionalperformance-Totalenergyexpenditure","Results","104 (-197 to 404); 0.50","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"PN","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Functionalperformance-TotalMETs","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Functionalperformance-TotalMETs","Results","0.003 (-0.04 to 0.44); 0.88","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n\r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Functionalperformance-Durationofsedentarytimeperday","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Functionalperformance-Durationofsedentarytimeperday","Results","66 (-30 to 162); 0.18","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n\r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PN","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is near the 5% target, as the p-value is close to significance and the sample size is little I think that it could affect the effect estimate."]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated."]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"N","3.3. As reported: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". It is not likely that the missines on this outcome relates to the true value of the effect estimate, based on the reason for missinignes of the participant. "]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Functionalperformance-Durationoftimeabove3METsperday ","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Functionalperformance-Durationoftimeabove3METsperday ","Results","26 (-16.1 to 68.3); 0.23","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The sensewear is an objective measure for functional performance were it assesses various variables for that outcome. However the authors do not state when the device is given, and how many days it remained with the participants.\r\n\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. SenseWear activity monitor was stated on the clinical trials platform to assess physical activity and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Psychologicalandsocialoutcomes-Selfefficacyformanagingchronicdisease6itemscale","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","Psychologicalandsocialoutcomes-Selfefficacyformanagingchronicdisease6itemscale","Results","0.07 (-1.9 to 2.0); 0.94","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. This short questionaire assess the self-efficacy of a person. In the study it was used to \"measure participants’ confdence in self-management\". Self-efficacy relates to the confidence of a person in managing ones condition, so it is apropriate. "]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. This questionaire was stated as the only measure on the clinical trials platform to assess self-efficacy, and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-HrQOL-KBILDpsychologicaldomain","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s); Trial protocol"]
["Outcome","HrQOL-KBILDpsychologicaldomain","Results","1.1 (-4.1 to 6.3); 0.40","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. K-BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain.\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported.\r\n \r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-Symptoms-Dyspnoea12","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s)"]
["Outcome","Symptoms-Dyspnoea12","Results","-2.2 (-6.4 to 1.9); 0.29","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. \"Te Dyspnoea-12, a 12-item validated assessment tool with both physical and afective components, was used to evaluate the severity of dyspnoea.\""]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. This questionaire was stated as the only measure on the clinical trials platform to assess symptoms (dyspneia), and it is reported.\r\n\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-HrQOL-KBILDbreathlessnessactivities","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s)"]
["Outcome","HrQOL-KBILDbreathlessnessactivities","Results","-1.5 (-8.9 to 5.9); 0.69","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"Y","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is above the 5% target, as the p-value is high above the significance level, it is not likely that the data form that person would affect the outcome. \r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. K-BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain.\r\n\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Khor-2021-HrQOL-KBILDchestsymptoms","Study ID","Khor-2021","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","Handheld fan","Comparator","No intervention","Source"," Journal article(s)"]
["Outcome","HrQOL-KBILDchestsymptoms","Results","10 (-5.1 to 25.1); 0.19","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Tirty participants were randomised in a 1:1 ratio [...] using a computer-generated sequence.\"\r\n1.2. \"Allocation concealment was achieved using sequentially numbered, opaque,  sealed envelopes and was performed by an investigator without patient contact (A.E.H.).\"\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"Y"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"N","1.3. Althougth even small differences would show significance in this study with small sample sizes, the characterisitcs at baseline are similar in nearly all the characteristics, with domicilary oxigen, and FVC% predicted being the only variables with significant differences (that most probably may be due to chance). \r\n"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. \"Given the lack of a plausible placebo, participants and clinicians were unblinded to the group assignments.\"\r\n\r\n\r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"PN","2.3. In the sole participant that dropped out the study they state: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". Could this case the trial context affected the participantion of this person? The social stress is vary vague, however even if it was because of the fan, it could also appen outcside the trial context (i.e. in real life). So it is probable that the deviations did not appen bacuse of trial context. Note:The authors do not state other means to deviate from intervetion (e.g., ask the participants if they bought a fan, etc.) and do not explore if the participants have other interventions that could bias the results.  \r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. It does not state clearly if they did an ITT or a mITT analysis. But considering the detailed description of the tests and calculations used, and the whole accurate description of the methods, it is probably true that they either did a ITT or m ITT and that they didn't exclude eligible participants post-randomization. Considering that they do not describe excluding patients for not completing an outcome, they probably did a ITT analysis. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PN","3.1. One patient dropped out in the experimental group (6.6%). Althougth it is near the 5% target, as the p-value is close to significance and the sample size is little I think that it could affect the effect estimate.\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. No analysis methods that correct for bias; or sensitivity analyses are stated.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. As reported: \"Only one participant (the fan group) withdrew from the study afer randomisation due to social stresses with difculty continuing study participation\". The missines on this outcome does not relate to the true value of the HRQOL, based on the reason for missinignes of the participant. \r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. K-BILD has been developed and validated in interstitial lung diseases (ILDs) and consists of 15 items in three domains: breathlessness and activities, chest symptoms, and a psychological domain.\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same outcome measure, meausured in the same manner, comparing the same endpoints.\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"PN","4.3. As stated: \"Evaluation of assessor blinding using the Bang’s blinding index revealed random guessing for the fan group [Index=−0.08 (95% confdence interval: − 0.45, 0.30)] and unsuccessful blinding for the control group  Index=0.47 (95% confdence interval: 0.12, 0.81)].\" This means that in absolute terms that the assessor was not blinded. However as the question given to the assess is dichotomous, there is always a 50% chance that the asssessor gives the correct answer.\r\n\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"NA"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"N","5.1. From trial registration - \"For comparisons of two groups, t-tests or Mann-whitney tests will be used for parametric and non-parametric data, respectively.\" Instead, the authors used linear mixed models.\r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"N","5.2. KBILD was the only outcome measure that was stated on the clinical trials platform to assess HRQoL and it is reported.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"PY","5.3. Authors should had reported the results for the t-test or Mann-Whitney, as initally thought.\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns","-->I will judge nas \"some concerns\" instead of high, because linear mixed models are considered more robust than t-test or Mann-whitney.\r\n"]
["Overall bias","Risk of bias judgement",null,null,"Some concerns"]
[]
[]
["Unique ID","Lindell_2010_HRQoL_SF36-physical","Study ID","Lindell-2010","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","PRISIM program","Comparator","Usual care","Source"," Journal article(s)"]
["Outcome","HrQOL-SF36physicalcomponent","Results","p-value: 0.038","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. "]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PN","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial the number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result (especially considering that the p-value is close to significance).\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. Not information about statistical tests for accertainment.\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. \"Reasons for attrition were lung transplantation and death\". HRQOL was probably not at the origin for data missingness considering these reasons.\r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. SF-36 is a questionaire validated to measure QOL. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same questionaires, same timepoints. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. It is a patient-reported outcome, and the participants were aware of the arm they were in.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. As it is a patient-reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Analysis intentions are not available.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"Y","5.3. The results according to the \"non-asjusted analysis\" are not provided.\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2010-Psychologicalandsocialoutcomes-BAI","Study ID","Lindell-2010","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","PRISIM program","Comparator","Usual care","Source"," Journal article(s)"]
["Outcome","Psychologicalandsocialoutcomes-BAI","Results","p-value: 0.077","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PN","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial the number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result (especially considering that the p-value is close to significance).\r\n\r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"N","3.2. Not information about statistical tests for accertainment.\r\n\r\n"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"PN","3.3. \"Reasons for attrition were lung transplantation and death\". Anxiety was probably not at the origin for data missingness considering these reasons.\r\n\r\n"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. BAI is a questionaire validated to measure anxiety. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same questionaires, same timepoints. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. It is a patient-reported outcome, and the participants were aware of the arm they were in.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. As it is a patient-reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Analysis intentions are not available.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"Y","5.3. The results according to the \"non-asjusted analysis\" are not provided.\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2010-Psychologicalandsocialoutcomes-BDIII","Study ID","Lindell-2010","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","PRISIM program","Comparator","Usual care","Source"," Journal article(s)"]
["Outcome","Psychologicalandsocialoutcomes-BDIII","Results","p-value: 0.894","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p-value is far from the significance, the 1-2 pateints that are missing don't probably affect the value sufficiently. \r\n"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The BDI-II is a questionaire validated to measure depression. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same questionaires, same timepoints. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. It is a patient-reported outcome, and the participants were aware of the arm they were in.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. As it is a patient-reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available.  \r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Analysis intentions are not available.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"Y","5.3. The results according to the \"non-asjusted analysis\" are not provided.\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2010-Psychologicalandsocialoutcomes-PSS","Study ID","Lindell-2010","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","PRISIM program","Comparator","Usual care","Source"," Journal article(s)"]
["Outcome","Psychologicalandsocialoutcomes-PSS","Results","p-value: 0.531","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n\r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p-value is far from the significance, the 1-2 pateints that are missing don't probably affect the value sufficiently. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. The PSS is a questionaire validated to measure stress. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same questionaires, same timepoints. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. It is a patient-reported outcome, and the participants were aware of the arm they were in.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. As it is a patient-reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Analysis intentions are not available.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"Y","5.3. The results according to the \"non-asjusted analysis\" are not provided.\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell_2010_HRQoL_SF36-mental","Study ID","Lindell-2010","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","PRISIM program","Comparator","Usual care","Source"," Journal article(s)"]
["Outcome","HRQoL_SF36-mental","Results","p-value: 0.772","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment.\r\n"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","1.3. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).  theoretically, baseline differences should not occur with randomization.\" Althought differences between important prognostic factors (anxiety and HRQoL) were present at baseline, there is no evidence to believe those were not compatible with chance (considering also that participants were randomized according to severity).\r\n\r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n\r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6 An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p-value is far from the significance, the 1-2 pateints that are missing don't probably affect the value sufficiently. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. SF-36 is a questionaire validated to measure QOL. \r\n\r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same questionaires, same timepoints. \r\n\r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. It is a patient-reported outcome, and the participants were aware of the arm they were in.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. As it is a patient-reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n\r\n\r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Analysis intentions are not available.\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"Y","5.3. The results according to the \"non-asjusted analysis\" are not provided.\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Overall bias","Risk of bias judgement",null,null,"High"]
[]
[]
["Unique ID","Lindell-2010-Symptoms-SOBQ","Study ID","Lindell-2010","Assessor","Steve-Freitas"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental","PRISIM program","Comparator","Usual care","Source"," Journal article(s)"]
["Outcome","Symptoms-SOBQ","Results","p-value: 0.972","Weight",1]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?",null,null,"Y","1.1. \"Participants were randomized to group after baseline questionnaires were completed. A permutated blocked design was used to ensure that equal numbers of patients with moderate (FVC 55%–70% predicted) and severe (FVC < 55% predicted) disease were assigned to each group.\"\r\n1.2. No information about concealment."]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?",null,null,"NI"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?",null,null,"PN","1.3. \"No statistically significant differences were found between the intervention and the control group in regard to demographic variables or FVC.\" Additionally, examination of the table of demographics, it doesn't seem that there exists imbalances that may be not due to chance. However they also state: \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL [...]\". In this case, as the intervention is intented to work symptom burden, QOL, etc., the randomization should have been done so that baseline Symptoms, QOL, etc. would be the same and not FVC. I will put PN as the process itself was done correctly and the imbalances may be due to chance because fo low number of participants. \r\n"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?",null,null,"Y","2.1. and 2.2. As the inteventions between control and experimental group are clearly diffferent. A person in one group can understand if it was in the experimental group or not. The same goes for the interventionist. \r\n"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,null,"Y"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?",null,null,"NI","2.3. No information is provided regarding the adherence to the intervention. There were no sufficient elements to judge this question.\r\n\r\n"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,null,"NA"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,"NA"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?",null,null,"PY","2.6. An mITT seem to have been used for the analysis of results and data, where they use the data if the participants who completed the trial. \r\n"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?",null,null,"PY","3.1. Althougth the data presented is a little confusing, it seems that the number of patients lost is inferior to 5% (4.76%). However, in this trial number of participant is low, so, even if the number of participants lost is little it could potencially influence the final result. However as the p-value is far from the significance, the 1-2 pateints that are missing don't probably affect the value sufficiently. "]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?",null,null,"NA"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,null,"NA"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,null,"NA"]
[null,"Risk of bias judgement",null,null,"Low"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?",null,null,"N","4.1. SOBQ is a questionaire validated to measure dyspneia. \r\n"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?",null,null,"N","4.2. Same questionaires, same timepoints. \r\n"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?",null,null,"Y","4.3. It is a patient-reported outcome, and the participants were aware of the arm they were in.\r\n"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?",null,null,"Y","4.4. As it is a patient-reported outcome it could be manipulated by the knowledge of the arm. However, even in the control the participants are given the same material and they are not left unsopported. So it not likely that the particiapnts altered actively the results because of the arm they were in. \r\n"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?",null,null,"PN"]
[null,"Risk of bias judgement",null,null,"Some concerns"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,"PN","5.1. \"Because differences in intervention and control groups were found in baseline scores for anxiety and the physical aspect of HRQoL, questionnaire responses were analyzed using analysis of covariance (ANCOVA).\" This statement suggests that ANCOVA analysis was not the previously thought analysis. No clinical trial registration is provided, nor statistical analysis intentions are available. \r\n\r\n"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,"NI","5.2. Analysis intentions are not available.\r\n\r\n"]
[null,"5.3 ... multiple eligible analyses of the data?",null,null,"Y","5.3. The results according to the \"non-asjusted analysis\" are not provided.\r\n"]
[null,"Risk of bias judgement",null,null,"High"]
["Overall bias","Risk of bias judgement",null,null,"High"]

{"sheet":"Print (PP)","index":6,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[]}

{"sheet":"Check","index":7,"n_rows":0,"n_cols":0,"rows_kept":0,"cut":false,"hidden":false,"merged":[[0,80,0,83],[0,0,0,12],[0,13,0,22],[0,23,0,40],[0,41,0,53],[0,54,0,68],[0,69,0,79]]}

{"sheet":"Print_format (PP)","index":8,"n_rows":32,"n_cols":6,"rows_kept":32,"cut":false,"hidden":true,"merged":[[31,1,31,3],[21,0,26,0],[21,1,21,3],[22,1,22,3],[26,1,26,3],[23,1,23,3],[25,1,25,3],[24,1,24,3],[29,1,29,3],[27,0,30,0],[27,1,27,3],[28,1,28,3],[30,1,30,3],[14,1,14,3],[15,1,15,3],[16,0,20,0],[16,1,16,3],[17,1,17,3],[18,1,18,3],[20,1,20,3],[19,1,19,3],[18,5,19,5],[24,5,25,5],[4,1,4,3],[5,0,8,0],[5,1,5,3],[5,5,6,5],[6,1,6,3],[7,1,7,3],[8,1,8,3],[9,5,10,5],[10,1,10,3],[11,1,11,3],[12,1,12,3],[13,1,13,3],[9,0,15,0],[9,1,9,3]]}
["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","adhering to intervention (the 'per-protocol' effect)","The effect of adhering to intervention…"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1 Were participants aware of their assigned intervention during the trial?"]
[null,"2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups?"]
[null,"2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?"]
[null,"2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?"]
[null,"2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

{"sheet":"Print_format (ITT)","index":9,"n_rows":33,"n_cols":6,"rows_kept":33,"cut":false,"hidden":true,"merged":[[19,1,19,3],[21,1,21,3],[32,1,32,3],[22,0,27,0],[22,1,22,3],[23,1,23,3],[27,1,27,3],[24,1,24,3],[25,1,25,3],[26,1,26,3],[30,1,30,3],[28,0,31,0],[28,1,28,3],[29,1,29,3],[31,1,31,3],[4,1,4,3],[9,0,16,0],[9,1,9,3],[13,1,13,3],[14,1,14,3],[16,1,16,3],[15,1,15,3],[19,5,20,5],[25,5,26,5],[5,0,8,0],[5,1,5,3],[5,5,6,5],[6,1,6,3],[7,1,7,3],[8,1,8,3],[9,5,10,5],[10,1,10,3],[11,1,11,3],[12,1,12,3],[20,1,20,3],[17,0,21,0],[17,1,17,3],[18,1,18,3]]}
["Unique ID",null,"Study ID",null,"Assessor"]
["Ref or Label",null,"Aim","assignment to intervention (the 'intention-to-treat' effect)\n\n"]
["Experimental",null,"Comparator",null,"Source"]
["Outcome",null,"Results",null,"Weight"]
["Domain","Signalling question",null,null,"Response","Comments"]
["Bias arising from the randomization process","1.1 Was the allocation sequence random?"]
[null,"1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?"]
[null,"1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?"]
[null,"Risk of bias judgement"]
["Bias due to deviations from intended interventions","2.1.Were participants aware of their assigned intervention during the trial?"]
[null,"2.2.Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?"]
[null,"2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the experimental context?"]
[null,"2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?"]
[null,"2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?"]
[null,"2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
[null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Risk of bias judgement"]
["Bias due to missing outcome data","3.1 Were data for this outcome available for all, or nearly all, participants randomized?"]
[null,"3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data?"]
[null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?"]
[null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?"]
[null,"Risk of bias judgement"]
["Bias in measurement of the outcome","4.1 Was the method of measuring the outcome inappropriate?"]
[null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?"]
[null,"4.3 Were outcome assessors aware of the intervention received by study participants?"]
[null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
[null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
[null,"Risk of bias judgement"]
["Bias in selection of the reported result","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?"]
[null,"5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?"]
[null,"5.3 ... multiple eligible analyses of the data?"]
[null,"Risk of bias judgement"]
["Overall bias","Risk of bias judgement"]

{"sheet":"Function Tab","index":10,"n_rows":12,"n_cols":19,"rows_kept":12,"cut":false,"hidden":true,"merged":[]}
[null,"Journal article(s)","NA","Yes",null,"1.1 Was the allocation sequence random?",null,"2.1 Were participants aware of their assigned intervention during the trial?","2.1 Were participants aware of their assigned intervention during the trial?",null,"3.1 Were data for this outcome available for all, or nearly all, participants randomized?","Individually Randomized, Parallel Group Trials","4.1 Was the method of measuring the outcome inappropriate?","assignment to intervention (the 'intention-to-treat' effect)","5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?",null,null,null,"occurance of non-protocol interventions"]
["NA","Trial protocol","Favours experimental ","No (Please include reasons in the note)","Y","1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?","Low","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?","2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?",null,"3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data?",null,"4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?","adhering to intervention (the 'per-protocol' effect)","5.2 ... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?",null,null,null,"failures in implementing the intervention that could have affected the outcome"]
["Y","Statistical analysis plan (SAP)","Favours comparator ",null,"PY","1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?","High","2.3 [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important nonprotocol interventions balanced across intervention groups?","2.3 If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context?",null,"3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value?",null,"4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants?",null,"5.3 ... multiple eligible analyses of the data?",null,null,null,"non-adherence to their assigned intervention by trial participants"]
["PY","Non-commercial trial registry record (e.g. ClinicalTrials.gov record)","Towards null ",null,"PN",null,"Some concerns","2.4 [If applicable:] Were there failures in implementing the intervention that could have affected the outcome?","2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome?",null,"3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value?",null,"4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received?"]
["PN","Company-owned trial registry record (e.g. GSK Clinical Study Register record)","Away from null ",null,"N",null,null,"2.5 [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes?","2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups?",null,null,null,"4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received?"]
["N","“Grey literature” (e.g. unpublished thesis)","Unpredictable",null,"NI",null,null,"2.6 If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention?","2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?"]
["NI","Conference abstract(s) about the trial",null,null,null,null,null,null,"2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?"]
[null,"Regulatory document (e.g. Clinical Study Report, Drug Approval Package)"]
[null,"Research ethics application"]
[null,"Grant database summary (e.g. NIH RePORTER, Research Councils UK Gateway to Research)"]
[null,"Personal communication with trialist"]
[null,"Personal communication with the sponsor"]