Soliman 2015.
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
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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 | Not reported. However, interventions were different and investigators/participants could be aware of the treatment assigned |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Fatigue was 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. However, objective and subjective outcomes were assessed |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "40 met the inclusion criteria and agreed to participate within the proposed study, 10 patients were excluded from the study due to death, transplantation or refusing to try to do exercise regularly due to fatigue. Of those, 30 patients completed the study, 18 in experimental group and twelve in control group." Comment: 18/23 participants in the intervention group and 12/17 participants in the control group completed the study (> 5% lost to follow‐up). There were differences between groups. Reasons for discontinuation were provided |
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 was not reported |