Lin 2011.
Study characteristics | ||
Methods | Study design
Study dates
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Participants | Study characteristics
Baseline characteristics
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Interventions | Intervention classification
Intervention group
Control group
Co‐interventions: not reported |
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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) | Low risk | Quote: "Prior to the intervention process, the selected patients were randomly divided by computer into two groups." Comment: The study was a quasi‐experimental study. Computer generation is considered as low risk of bias. No imbalance between intervention groups was apparent |
Allocation concealment (selection bias) | High risk | Method of allocation concealment was not reported in sufficient detail to permit judgement. However the study used a quasi‐experimental design |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported. However, interventions were different and participants and/or investigators could be aware of the treatment assigned |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "To minimize participants’ misunderstanding of the Brief Fatigue Inventory‐Taiwan Form (BFI‐T), the data were collected mainly via a face‐to‐face survey interview. The participants were allowed to ask any questions about the study at any stage." Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant/investigators 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. Other outcomes were objective |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study and were included into the analyses |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were not reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was 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 | Unclear risk | There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding and conflicts of interest were not reported |