SOCIABLE 2017.
Study characteristics | ||
Methods | Study design
Study dates
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Participants |
Baseline characteristics
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Interventions | Intervention classification
Intervention group
Control group
Cointerventions
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Outcomes | Outcomes reported
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Notes | Additional information
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation methods were not reported in sufficient detail to permit judgement. No imbalance between intervention groups was apparent |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported in sufficient detail to permit judgement. No imbalance between intervention groups was apparent |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from the study suggested by authors: "Single blind study". Comment: A single blind is considered as high risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote from the study suggested by authors: "Our outcome assessor was masked to randomisation assignment." Comment: Fatigue was not clearly reported, although the therapy helped people in addressing fatigue during their activities. However, subjective measures were used. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely |
Incomplete outcome data (attrition bias) All outcomes | High risk | 9/12 participants completed the study (> 5% loss to follow‐up). Reasons were not provided |
Selective reporting (reporting bias) | High risk | Information about the protocol were reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was not reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported |
Other bias | Low risk | There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding did not influence the data analysis and authors did not have conflicts of interest |