SWIFT 2020.
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: "The randomisation takes place, on a state‐by‐state basis using the method of minimisation as they agree to participate. The randomisation was stratified based upon location (state), metropolitan or regional, private or public unit or prior or current use of the IPOS‐Renal questionnaire for symptom monitoring within each centre and cluster size." |
Allocation concealment (selection bias) | Low risk | Quote: "The trial statistician concealed until the site initiation visit. Access to the allocations is limited to the CI (RLM), the trial statistician (CB), the CTC trial operations coordinator (PW) and ANZDATA Registry Manager (Ms. Kylie Hurst) to minimise risk of inadvertently influencing sites or prematurely revealing allocation." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Blinding to allocation is not possible within clusters due to the nature of the intervention; however, all staff compiling and analysing outcome data will be blinded to allocation." Comment: 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: "Blinding to allocation is not possible within clusters due to the nature of the intervention; however, all staff compiling and analysing outcome data will be blinded to allocation." Comment: Fatigue was assessed with an appropriate measure. 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. Other subjective outcomes were assessed |
Incomplete outcome data (attrition bias) All outcomes | High risk | Not reported in sufficient detail to perform adjudication |
Selective reporting (reporting bias) | High risk | Information about the protocol were reported. It was not 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 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 | Unclear risk | Quote: "The study sponsor and the study founders (Australian NHMRC, Kidney Health Australia), did not have any role or ultimate authority in study design; collection, management, analysis, interpretation of data, writing of the report, or the decision to submit the report for publication." Comment: Baseline characteristics were not reported. Funding did not influence the data analysis and authors did not have conflicts of interest |