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. 2023 Jan 25;2023(1):CD014962. doi: 10.1002/14651858.CD014962.pub2

Risk of bias for analysis 1.4 All‐cause mortality (time‐to‐event).

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Beigel 2020 Low risk of bias Randomisation was stratified by study site and disease severity in a 1:1 ratio and the allocation sequence was probably concealed. There were no baseline imbalances that would suggest a problem with randomisation. Low risk of bias Participants and care takers were adequately blinded. The analysis was appropriate (intention‐to‐treat population). Low risk of bias Outcome available for all participants. Low risk of bias Measuring of the outcome was appropriate. The outcome was assessed using standardised methods and assessors were unaware of the treatment assignments. Low risk of bias The data was analysed in accordance with a pre‐specified protocol. Low risk of bias Overall judged low risk of bias. The method of the randomisation process was not provided, but there were no baseline imbalances that would suggest a problem with randomisation. Blinding was appropriate, and outcome measurement was according to a pre‐specified protocol.
WHO Solidarity Trial Consortium 2022 Low risk of bias Patients were randomised by a study website, which probably concealed the allocation sequence. There were no baseline imbalances that would suggest a problem with randomisation Low risk of bias Participants and care takers were aware of the assigned intervention, but there were no deviations from intended interventions and the analysis was appropriate (intention‐to‐treat population). Low risk of bias Data was available for nearly all participants (<5% missing) randomised. Low risk of bias Outcome assessors were aware of the intervention received. Knowledge of intervention received could not have affected the outcome measurement. Low risk of bias The data was analysed in accordance with a pre‐specified protocol. Multiple analyses were reported according to a pre‐defined protocol. Low risk of bias Overall judged low risk of bias. Details about randomisation and missing data were provided. It was an open‐label study, but this could not have affected the outcome measurement. Outcome measurement and analyses were carried out according to a pre‐defined study protocol.