Balouchi 2016.
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 1
Intervention group 2
Co‐interventions
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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 |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported in sufficient detail to permit judgement |
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: "Data were collected using a demographic questionnaire and the Multi‐dimensional Fatigue Inventory (MFI‐20)." 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 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 | The number of patients who completed the study was not clearly stated for the first phase. It was unclear if there was evidence that the results were not biased by missing outcome data |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were not 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 (cross‐over study: data related to the first period were not reported). All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported |
Other bias | Unclear risk | No data were available to assess the possible imbalance between groups. Funding was unlikely to influence the data analysis and conflicts of interest were not reported |