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

Risk of bias for analysis 2.17 Inspiratory muscle strength: PImax (cmH2O) (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 2.17.1 With respiratory muscle weakness
Chuang 2017 Some concerns Only a statement about randomisation was reported, and the two groups had similar baseline characteristics. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias The reason of missingness was loss of contact. Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process, and only the journal article is available.
Harver 1989 Some concerns Randomisation was reported only as a sentence, and both groups had similar baseline characteristics. Low risk of bias All participants were analysed according to their initial allocation. High risk of bias Missingness in each group was not explained. Low risk of bias Observer reported outcome that do not involve judgement, and the method of measurement was valid. Some concerns Only the journal article is available. High risk of bias Lack of details about the randomisation process, missingness, and only the journal article is available.
Leelarungrayub 2017 Some concerns Randomisation was reported only as a sentence, and the two groups had similar baseline characteristics. Low risk of bias No participants were excluded. High risk of bias 6 participants discontinued training, but there is no mention of the proportion of missingness in each group. Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available. High risk of bias Lack of details about the randomisation process and only the journal article is available. Missingness may be dependant on its true value.
Preusser 1994 Some concerns No information about allocation concealment, and both groups had similar baseline characteristics. Low risk of bias No participants were excluded. Low risk of bias Missingness is independent on its true value. Low risk of bias Observer reported outcome that do not involve judgement Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process and only the journal article is available.
Saher 2021 Some concerns Randomisation was reported only as a sentence. Authors used concealed envelopes without mentioning if they were opaque High risk of bias ITT analysis was not applied Some concerns Missingness could depend on its true value Low risk of bias Observer reported outcome that do not involve judgement Some concerns Only the journal article is available High risk of bias Lack of details about the randomisation process, only the journal article is available, missingness could depend on its true value, and ITT analysis was not conducted.
Sanchez Riera 2001 Some concerns Randomisation was reported only as a sentence, and baseline characteristics were similar between the groups. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias No missing data. Low risk of bias Outcome assessors were blinded Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process and only the journal article is available.
Weiner 2006 Some concerns Randomisation was reported only as a sentence, and both groups had similar PImax level. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias No missing data. Low risk of bias Outcome assessors were blinded. Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process and only the journal article is available.
Wu 2017 Some concerns Randomisation was reported only as a sentence, and both groups had similar baseline characteristics. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias No missing data. Low risk of bias Observer reported outcome that do not involve judgements, and the method of measurement was valid. Some concerns There were some differences between the trial register and the journal article, without biasing the results. Some concerns Lack of details about the randomisation process and there are differences in reporting blinding between the trial register and journal article.
Wu 2017 Some concerns Randomisation was reported only as a sentence, and both groups had similar baseline characteristics. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias No missing data. Low risk of bias Observer reported outcome that do not involve judgements, and the method of measurement was valid. Some concerns There were some differences between the trial register and the journal article, without biasing the results. Some concerns Lack of details about the randomisation process and there are differences in reporting blinding between the trial register and journal article.
Xu 2018 Low risk of bias The sequence was random, concealed, and the two groups had similar baseline characteristics. Low risk of bias ITT analysis was conducted. Low risk of bias Missingness is independent on its true value. Low risk of bias Outcome assessors were blinded. Low risk of bias No differences between the trial register, the conference abstracts and the journal article. Low risk of bias No detected issue with the five domains. 
ZhouL 2016 Low risk of bias Allocation was concealed. Some concerns 3 participants were excluded (6%) Some concerns No details of the reasons of missingness, but its proportion is small (6%). Low risk of bias Outcome assessors were blinded. Some concerns Only the journal article is available. Some concerns Some issues with ITT analysis, missingness could be dependant on its true value, and only the journal article is available.
Subgroup 2.17.2 Without respiratory muscle weakness
Beckerman 2005 Some concerns No information about allocation concealment, and the two groups had similar baseline characteristics. High risk of bias No reason for drop out were reported for five participants (11%). High risk of bias 11 participants dropped out (6 died). However, No reasons for drop out were reported for the remaining participants. Low risk of bias Outcome assessors were blinded. Some concerns Only the journal article is available. High risk of bias No information about allocation concealment or a trial register. 26% of the participants dropped out of the study with no reason reported for 11%.
Belman 1988 Some concerns Randomisation was reported only as a sentence. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias missing data are due to intercurrent illnessess and pneumothorax. Low risk of bias Observed‐reported outcome that do not involve judgement. Some concerns Only the journal article is available. Some concerns Lack of details about allocation concealment and only the journal article is available.
Berton 2015 Some concerns No information about allocation concealment. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias Missingness is independent on its true value. Low risk of bias Outcome assessors were blinded. Some concerns No information if adjusted analysis were planned in advance. Some concerns No information about allocation concealment and if adjusted analysis were planned in advance.
Bustamante 2007 Some concerns Only a statement about randomisation was reported, the two groups had similar baseline characteristics. Low risk of bias No participants were excluded. Low risk of bias No missing data. Low risk of bias Observer‐reported outcome that do not involve judgements, and the method of measurement was valid. Some concerns Only the journal article is available. Some concerns No details about allocation concealment, randomisation and only the journal article is available.
Covey 2001 Some concerns Randomisation was reported only as a sentence, and the two groups had similar baseline characteristics. Some concerns No ITT analysis were conducted, with no impact on the results. Some concerns Missingness is balanced between the two groups Low risk of bias Observer reported outcome that do not involve judgements, and the method of measurement was valid. Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process, no ITT was conducted, missingness could depend on its true value, and only the journal article is available.
Dacha 2019 Low risk of bias From personal communication with the trialist, the suequence was random, concealed, and the groups had similar baseline characteristics. Low risk of bias From personal communication with the trialist, ITT was conducted. Low risk of bias No missing data. Low risk of bias Outcome assessors were blinded. Some concerns Only the abstract and the trial register are available (study ongoing) Some concerns Only the abstract and the trial register are available (ongoing study).
Hill 2006 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 only two participants (5%) are missing. Low risk of bias Outcome assessors were blinded. Some concerns Only the journal article is available. Some concerns Lack of details about allocation concealment, and only the journal article is available.
Hsiao 2003 Some concerns Randomisation was reported only as a sentence, and the two groups had similar baseline characteristics. High risk of bias 10% of participants were excluded (per protocol analysis). Some concerns Missingness is unlikely to be dependant on its true value. Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available. High risk of bias Lack of details about the randomisation process and only the journal article is available. There are serious issues with ITT and missingness is likely to be dependant on the outcome.
Kim 1993 Some concerns Randomisation was reported only as a sentence, and both groups had similar baseline characteristics. Low risk of bias Participants were analysed according to their initial allocation. Some concerns Missingness is balanced between the two groups. Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process, only the journal article is available and missingness could depend on the outcome.
Koppers 2006 Some concerns Randomisation was reported only as a sentence, the two groups had similar baseline characteristics. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias 7% of the data are missing (3 participants out of 39). Low risk of bias Observer reported outcome that do not involve judgements. Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process and only the journal article is available.
Langer 2018 Low risk of bias Allocation was random, concealed, and baseline characteristics were similar between the groups. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias No missing data. Low risk of bias Outcome assessors were blinded, and the method of measurement was valid. Low risk of bias No differences between the trial register, the abstracts, and the journal article. Low risk of bias No detected issues with the five domains.
Larson 1999 Some concerns Randomisation was reported only as a sentence. Some concerns It is unclear if the reasons of exclusion might have an impact on the results. High risk of bias some of the reasons of missingness are: lack of interest, inability to perform training, poor adherence. Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available. High risk of bias Lack of details about the randomisation process, and only the trial register is available. There is some concern with ITT and missingness is likely to be dependant on the outcome.
Lisboa 1997 Some concerns Randomisation was reported only as a sentence, and the two groups had similar baseline characteristics. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias No missing data. Low risk of bias Outcome assessors were blinded. Some concerns Only the journal article is available. Some concerns Lack of details about allocation concealment and only the journal article is available.
Nikoletou 2016 Some concerns No information about allocation concealment, and the two groups had similar baseline characteristics. Some concerns 3 participants (5%) were excluded due to poor adherence. Some concerns Missingness is balanced between the two groups. Low risk of bias Outcome assessors were blinded. Some concerns Lack of details about the randomisation process, no ITT analysis, important amount of missing data and only the journal article is available. Some concerns Lack of details about the randomisation process, some issues with  ITT analysis, important amount of missing data and only the journal article is available.
Petrovic 2012 Some concerns Randomisation was reported only as a sentence, and the two groups had similar baseline characteristics. Low risk of bias All participants were analysed according to their initial allocation. Low risk of bias No missing data. Low risk of bias Observer reported outcome that do not involve judgements, and the method of measurement is valid. Some concerns No additional information were provided in the trial register. Some concerns Lack of details about the randomisation process and the trial register does not provide supplementary information.
Ramirez Sarmiento 2002 Some concerns Randomisation was reported only as a sentence, and no differences between the groups at visual inspection. High risk of bias 12% of the participants were excluded. Low risk of bias Missingness is independent on its true value. Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available. High risk of bias Lack of details about the randomisation process, only the journal article is available and ITT analysis was not conduted appropriately.
Saka 2021 Some concerns Lack of details about allocation concealment Low risk of bias All participants were analysed according to their initial allocation Low risk of bias Missingness is independent on its true value Low risk of bias The outcome was measured according to international guidelines Some concerns Lack of details in the trial register Some concerns Lack of details about the randomisation process, and the trial register did not provide sufficient information.
Scherer 2000 Some concerns No information about allocation concealment, and both groups had similar baseline characteristics. Low risk of bias One participant excluded due to rip fracture. Some concerns Missingness was balanced between the two groups Low risk of bias Observer reported outcome that do not involve judgement. Some concerns Only the journal article is available. Some concerns Lack of details about the randomisation process, only the journal article is available and missingness could be dependent on its true value.
Xu 2018 Low risk of bias The sequence was random, concealed, and the two groups had similar baseline characteristics. Low risk of bias ITT analysis was conducted. Low risk of bias Missingness is independent on its true value. Low risk of bias Outcome assessors were blinded. Low risk of bias No differences between the trial register, the conference abstracts and the journal article. Low risk of bias No detected issue with the five domains.