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

Risk of bias for analysis 1.9 Health‐related quality of life (HRQoL): St George's Respiratory Questionnaire (SGRQ).

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 1.9.1 Symptoms
Beaumont 2018 Low risk of bias Allocation sequence was random, concealed, and baseline characteristics were similar. Low risk of bias ITT analysis was conducted. Low risk of bias Only the data of two participants out of 149 were missing. High risk of bias Participant‐reported outcome and no sham was used. Low risk of bias No differences between the trial register, the conference abstracts, data were reported correctly according to their distribution with no differences with the methods section. High risk of bias HRQoF is a participants‐reported outcome and there are no information about blinding or the use of a sham training.
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 All participants were analysed according to their initial allocation. Low risk of bias No missing data. High risk of bias Participant reported outcome that involves judgements, and participants were not blinded. Some concerns Only the trial register is available. High risk of bias Allocation was probably not concealed, participants were not blinded and only the journal article is available.
Subgroup 1.9.2 Activity
Beaumont 2018 Low risk of bias Allocation sequence was random, concealed, and baseline characteristics were similar. Low risk of bias ITT analysis was conducted. Low risk of bias Only the data of two participants out of 149 were missing. High risk of bias Participant‐reported outcome and no sham was used. Low risk of bias No differences between the trial register, the conference abstracts, data were reported correctly according to their distribution with no differences with the methods section. High risk of bias HRQoF is a participants‐reported outcome and there are no information about blinding or the use of a sham training.
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 All participants were analysed according to their initial allocation. Low risk of bias No missing data. High risk of bias Participant reported outcome that involves judgements, and participants were not blinded. Some concerns Only the trial register is available. High risk of bias Allocation was probably not concealed, participants were not blinded and only the journal article is available.
Subgroup 1.9.3 Impact
Beaumont 2018 Low risk of bias Allocation sequence was random, concealed, and baseline characteristics were similar. Low risk of bias ITT analysis was conducted. Low risk of bias Only the data of two participants out of 149 were missing. High risk of bias Participant‐reported outcome and no sham was used. Low risk of bias No differences between the trial register, the conference abstracts, data were reported correctly according to their distribution with no differences with the methods section. High risk of bias HRQoF is a participants‐reported outcome and there are no information about blinding or the use of a sham training.
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 All participants were analysed according to their initial allocation. Low risk of bias No missing data. High risk of bias Participant reported outcome that involves judgements, and participants were not blinded. Some concerns Only the trial register is available. High risk of bias Allocation was probably not concealed, participants were not blinded and only the journal article is available.
Subgroup 1.9.4 Total
Abedi Yekta 2019 Some concerns No information about allocation concealment. Low risk of bias All participants were analysed according to the initial allocation. Low risk of bias Missing data is balanced between the the four groups. High risk of bias HRQoF is a participant‐reported outcome that involves judgements. Low risk of bias A trial register is available, and no adjusted analysis were conducted. High risk of bias Lack of details about the randomisation process and participants were not blinded.
Beaumont 2018 Low risk of bias Allocation sequence was random, concealed, and baseline characteristics were similar. Low risk of bias ITT analysis was conducted. Low risk of bias Only the data of two participants out of 149 were missing. High risk of bias Participant‐reported outcome and no sham was used. Low risk of bias No differences between the trial register, the conference abstracts, data were reported correctly according to their distribution with no differences with the methods section. High risk of bias HRQoF is a participants‐reported outcome and there are no information about blinding or the use of a sham training.
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. Low risk of bias Participants were blinded. Some concerns Only the journal article is available. Some concerns Lack of details about allocation concealment and only the trial register is available.
Majewska‐Pulsakowska 2016 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. High risk of bias The scale is validated, participants were not blinded, and it is a participant reported‐outcome that do not involve judgements. 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 participants were not blinded.
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 two groups. Low risk of bias Participant‐reported outcome that involves judgements, and a sham was used. Low risk of bias No differences between the trial register, the methods and the results sections. Some concerns Lack of details about allocation concealment.
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 All participants were analysed according to their initial allocation. Low risk of bias No missing data. High risk of bias Participant reported outcome that involves judgements, and participants were not blinded. Some concerns Only the trial register is available. High risk of bias Allocation was probably not concealed, participants were not blinded and only the journal article is available.
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 only 7% of the data were missing, we considered LOCF a valid imputation method for this kind of intervention. High risk of bias Participants were not blinded, and it is an observer reported outcome that involves judgements. Some concerns Only the journal article is available, and both adjusted and unadjusted analysis were reported. High risk of bias Participants were not blinded and only the journal article is available.