Schardong 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
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) | Low risk | Quote: "Randomization occurred through the www.random.org website." |
Allocation concealment (selection bias) | Low risk | Quote: "The sequence of numbers was generated by a researcher “blinded” to the study, and it was kept confidential until the beginning of the intervention to guarantee the concealment of the allocation." |
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 | Low risk | Quote: "All analyses were conducted by a researcher blind to the study procedures (randomisation, evaluations, and intervention)." 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, subjective and objective outcomes were assessed |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Thirty‐six patients with CKF on HD were evaluated for eligibility and possible admission into the study. Twenty‐eight met the inclusion criteria and finalized the protocol." Comment: 14/17 participants in the intervention group and 14/16 participants in the control group completed the study (> 5% lost to follow‐up). There were differences between groups. Reasons for discontinuation were reported |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were reported. Fatigue was assessed using multiple eligible outcome measurements (scales and time points). Fatigue at the end of treatment was reported in a format that was not 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 data analysis and interpretation. No other source of bias were apparent |