Cecen 2021.
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
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) | High risk | Since the study was a quasi‐experimental trial, no random element was used in generating the allocation sequence or the sequence was predictable |
Allocation concealment (selection bias) | High risk | Method of allocation concealment was not reported in sufficient detail to permit judgement. However, since the study was a quasi‐experimental trial, there was a reason to suspect that the enrolling investigator or the participant had knowledge of the forthcoming allocation. 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 participants and/or investigators 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/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. However, objective and subjective outcomes were assessed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The patients involved in the preliminary application were included in the number of samples and new patients who met the criteria in each group of 28 patients were included in the groups by computerized randomisation and a total of 84 patients was reached. Since one patient from the hand massage group left the dialysis canter temporarily after the fifth massage session, and one patient from the foot massage group died after being taken to the intensive care prior to the fourth session, one patient from each group was excluded from the research. As a result, a total of 82 patients, including 27 patients in each of the hand massage and foot massage groups, and 28 patients in the control group, formed the sample of the research." Comment: 54/56 participants in the intervention groups and 28/28 in the control group completed the study (< 5% loss to follow‐up). Differences between subgroups were reported. Reasons for discontinuation were reported |
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 | Low risk | There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. The study seemed to be free from other source of bias |