Hadadian 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
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: "Fifty six patients who had undergone haemodialysis and meeting the inclusion criteria, were divided into two groups by simple random sampling." Comment: 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 | Quote: "This study was done as a single‐blind clinical trial. [...] TEAS group treated by acupuncture in real points, while, in the TEAS‐Sham patients, based on the acupuncture expert opinion, the procedure was implemented for them in the false points, so that the patients were not aware of their grouping and blinded about it." Comment: A single‐blind study is considered as high risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The questionnaires were filled up by the researcher before and after 10th session of intervention." 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. It was not stated if the interviewer was blinded to the treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "In this study 95 patients were screened, 72 patients met the inclusion criteria and 60 patients agreed and consented to the study. Four patients were excluded over the intervention: 2 in the TEAS group and 2 in the sham group. Finally, 56 cases including 28 cases in the TEAS group and 28 cases in the Sham group completed the research." Comment: 28/30 participants in the intervention group and 28/30 participants in the control group completed the study (> 5% lost to follow‐up, without differences between groups). Reasons for discontinuations were not reported |
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 | 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 |