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. 2023 Jan 6;2023(1):CD013778. doi: 10.1002/14651858.CD013778.pub2

Risk of bias for analysis 1.5 Functional exercise capacity: 6‐minute walk distance (6MWD) (meters) (subgroup analysis: with or without respiratory muscle weakness).

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Subgroup 1.5.1 With respiratory muscle weakness
Charususin 2018 Low risk of bias The allocation sequence was random, concealed, and baseline characteristics were similar. Low risk of bias ITT analysis was conducted. Low risk of bias There is evidence that missingness did not bias the results. Low risk of bias Outcome assessors were blinded. Low risk of bias A trial protocol is available with no differences with the journal article. Low risk of bias No detected issues with the five domains.
Dellweg 2017 Low risk of bias The sequence was random, concealed, and baseline characteristics were similar between the groups. Low risk of bias ITT analysis was conducted. Low risk of bias No missing data. Low risk of bias Outcome assessors were blinded. Low risk of bias A trial register is available, and no differences between the methods and the results sections. Low risk of bias No detected issues with the five domains.
Tout 2013 High risk of bias No details about randomisation in the trial (we only discovered that it was a RCT in a personal communication). Low risk of bias No deviations were reported and all participants were analysed according to their initial allocation. Low risk of bias All the data are available. Low risk of bias Outcome measurement was appropriate and it is an observer reported outcome that do not involve judgements Low risk of bias Only the journal article is available, and no differences between the methods and the results sections. High risk of bias Lack of details about the randomisation process and only the journal article is available.
Subgroup 1.5.2 Without respiratory muscle weakness
Beaumont 2015 Some concerns No information about allocation concealment. Low risk of bias All participants were analysed according to their allocation. Low risk of bias No loss of follow up or exclusion. Low risk of bias Observer‐reported outcome that do not involve judgements. Low risk of bias A trial register is available, and both adjustet and unadjusted analysis were reported. Some concerns Lack of information about the randomisation process.
Beaumont 2018 Low risk of bias Allocation sequence was random, concealed, and baseline characteristics were similar. Low risk of bias "All analyses were performed on an intention‐to‐treat basis". Low risk of bias The data from two participants out of 149 were missing. Low risk of bias "All the data were collected by a research nurse blinded to treatment allocation". Low risk of bias A trial register is available and there is only one way to measure the outcome. Low risk of bias No detected issues with the five domains.
De Farias 2019 Some concerns The allocation sequence was random, lack of details about allocation concealment, and no baseline differences. Some concerns  2 participants out of 33 were not analysed Low risk of bias The data of 2 participants out of 33 are missing (6%) Low risk of bias Outcome assessors were blinded Some concerns Only the abstract and the trial protocol are available Some concerns Lack of details about the randomisation process, reason for missingness, and only the abstract et the protocol are available.
De Farias 2019 Some concerns The allocation sequence was random, lack of details about allocation concealment, and no baseline differences. Some concerns  2 participants out of 33 were not analysed Low risk of bias The data of 2 participants out of 33 are missing (6%) Low risk of bias Outcome assessors were blinded Some concerns Only the abstract and the trial protocol are available Some concerns Lack of details about the randomisation process, reason for missingness, and only the abstract et the protocol are available.
Mador 2005 Some concerns Randomisation was reported only as a sentence. Some concerns The reasons for exclusion were not reported, and it is unlikely that a per‐protocol analysis was conducted. Some concerns The data of 9 participants out of 38 were missing, and the proportion of missingness was balanced between the two groups. Low risk of bias Observer‐reported outcome that do not involve judgements Some concerns Only the journal is available, and no adjusted analysis were conducted. Some concerns Lack of details about the randomisation process, reasons for exclusion and/or loss of follow up were not explained, and only the journal article is available.
Magadle 2007 Some concerns No information about allocation concealment. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias the data of 2 participants out of 31 were missing (6%). Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available, and there is only one way to measure the outcome. Some concerns Lack of details about allocation concealement and only the trial register is available.
Paneroni 2018 Low risk of bias Allocation sequence was concealed. Low risk of bias No participants were excluded. High risk of bias 11% of the participants discontinued the intervention. The reasons were: intolerance to the intervention and low compliance. Low risk of bias Outcome assessors were blinded. Low risk of bias A trial register is available, with no differences with the journal article. No adusted analysis were conducted. High risk of bias Missingness is likely to be dependant on its true value.
Schultz 2018 Some concerns No information about allocation concealment. Low risk of bias ITT analysis was conducted. Low risk of bias Missingness was balanced between the groups. Low risk of bias The outcome was adequately measured, and it is an observer reported outcome that do not involve judgements. Low risk of bias No differences between the trial register, the abstracts, the methods and the results sections. Some concerns Lack of details about allocation concealment, and no issues with the other domains.
Tounsi 2021 Low risk of bias The allocation sequence was random, concealed, and baseline characteristics were similar. Low risk of bias ITT analysis was conducted. Low risk of bias Missingness was independent on its true value. Low risk of bias The outcome was measured according to the guidelines and it is an observer‐reported outcome that does not involve judgement. Low risk of bias No differences between the journal article and the trial register. Low risk of bias No detected issues with the five domains.
Wang 2017 Low risk of bias The allocation sequence was random, concealed, and baseline characteristics were similar between the groups. Low risk of bias ITT analysis was conducted. Low risk of bias Taking account that only 7% of the data are missing, we considered LOCF imputation a valid method for this kind on intervention. Low risk of bias Outcome measurement was appropriate and outcome assessors were blinded. Some concerns Only the journal article is available, both adjusted and unadjusted analysis were reported. Some concerns Only the journal article is available.