Bicer 2022.
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
Cointerventions
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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: "The patient data relating to the questionnaire, VAS pain (measurement of pain level), VAS fatigue, and Piper fatigue scale at the first follow‐up (the first interview before acupressure) were collected by the researcher." Comment: 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: "A total of 150 patients, meeting the inclusion criteria, were reached during the study. Five patients in the intervention group did not agree to participate in the study. Two of these patients experienced local pruritus in the area the device was applied, one patient developed a fistula problem, and two patients left the city during the follow‐up. Additionally, three patients in the placebo group did not want to continue the study since two of these patients were receiving treatment in a hospital out of the city due to coronary angiography. Therefore, the study was completed with 135 patients." Comment: 135/150 participants completed the study (> 5% loss to follow‐up. Some reasons for discontinuation were provided, and some were related to the intervention |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan was not reported. It was 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 data at all time points were reported. 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 did not influence the data analysis and conflicts of interest were not reported. No other source of bias were apparent |