VENOUS 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) | 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 | It was unclear if 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 | Quote: "11 patients in the NF group and 10 patients in the PS group were dropped out from the study. The reasons of the discontinuation were hypoalbuminaemia (1), increased bete‐2 microglobulin, social reasons (2), dead (1), unknown reason (5) in NF group, and modality change (2), unknown reason (8). Finally, 15 patients in NF and 14 patients terminated the study, however, 2 patients with the data deficit in each group were excluded." |
Selective reporting (reporting bias) | High risk | Information about the protocol and the statistical analysis plan were not reported. Fatigue 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 | No data were available to assess the possible imbalance between groups. Funding and conflicts of interest were not reported |