Cho 2004.
Study characteristics | ||
Methods | Study design
Study dates
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Participants | Study characteristics
Baseline characteristics
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Interventions | Intervention classificaiton
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 | Quote: "Patients were then assigned randomly to either experimental or the control group. [...] There were no differences in demographic data between the groups (p > 0.05). However, a significant difference in age (p < 0.05) was found between groups." Comment: Sequence generation methods were not reported in sufficient detail to permit judgement |
Allocation concealment (selection bias) | Unclear risk | It was not stated if the enrolling investigator (project director) had knowledge of the forthcoming allocation. Although there were some differences between groups, these differences did not suggest a problem with the randomisation process |
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 | 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. However, other subjective outcomes were reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "62 cases were recruited to this study and 3 cases in the experimental and 1 case in the control group dropped out. [...] The reasons for dropping out were relocation or being transferred to other dialysis centre." Comment: 28/31 participants in the intervention group and 30/31 participants in the control group completed the study (> 5% lost to follow‐up, with differences between group). Reasons for discontinuations seemed to be not related to the treatment allocation |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan was 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 | Although there were some differences between groups, there was no substantial evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding and conflicts of interest were not reported |