Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
Bias | Author's judgement | Support for judgement |
Randomization |
High |
Quote: "Odd numbers of patients were in the intervention group while even numbers of patients in the control group using a computer-generated allocation order." Comment: It is unclear whether the allocation sequence is random. The authors refer to the study as a "randomized trial' in the title and Methods section, but as a "quasi-experimental study" in the abstract. It is unclear whether the allocation sequence was concealed. The ROB2 algorithm suggests an assessment of "some concerns". However, because of the discrepancy in the authors' reports of the study design, the reviewers assessed the risk of bias for this domain as "high". |
Deviations from intervention |
Some concerns |
Comment: Unblinded study. No information is reported on deviation from the intended intervention that arose because of the trial context’ (i.e., no information on whether any co-interventions were administered). Two participants in each arm dropped out of the study and were excluded from the analysis. The remaining participants were analyzed according to their assigned interventions. |
Missing outcome data |
Low |
Comment: 76 randomized/72 analyzed. Risk assessed to be low for the outcomes: FEV1, FVC, FEV/FVC %, 6MWT, SF36 Physical health section score. |
Measurement of the outcome |
High |
Comment: Unblinded study. FEV1, FVC, and FEV/FVC % are observer-assessed outcomes that do not involve clinical judgment. SF-36 is a patient-reported outcome. 6MWT is an outcome in which participants' performance may be affected by knowledge of intervention receipt. All outcomes are statistically significant in favor of the intervention group. Participants and outcome assessors could have strong beliefs in the efficacy of the rehabilitation intervention compared to the control (no intervention). Risk assessed to be low for the outcomes: FEV1, FVC, FEV/FVC %. Risk assessed to be "high" for the outcomes: 6MWT, SF36 Physical health section score. |
Selection of the reported results |
Some concerns |
Comment: The study registration, the protocol and the statistical analysis plan were not available. Risk assessed to be "some concerns" for the outcomes: FEV1, FVC, FEV/FVC %, 6MWT, SF36 Physical health section score. |
Overall risk of bias |
High |