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

Risk of bias for analysis 4.2 In‐hospital mortality at up to day 150.

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
Subgroup 4.2.1 No oxygen at baseline
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. Some concerns There was no statistical analysis plan and pre‐defined protocol did not state the form of analysis. Reported analyses are appropriate but could have been selected. Some concerns Overall judged some concerns. 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 appropriate but not pre‐defined with a risk of selective reporting.
Subgroup 4.2.2 Low‐flow or high‐flow oxygen at baseline
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. Some concerns There was no statistical analysis plan and pre‐defined protocol did not state the form of analysis. Reported analyses are appropriate but could have been selected. Some concerns Overall judged some concerns. 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 appropriate but not pre‐defined with a risk of selective reporting.
Subgroup 4.2.3 Mechanical ventilation at baseline
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. Some concerns There was no statistical analysis plan and pre‐defined protocol did not state the form of analysis. Reported analyses are appropriate but could have been selected. Some concerns Overall judged some concerns. 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 appropriate but not pre‐defined with a risk of selective reporting.