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. 2023 Jul 25;2023(7):CD015078. doi: 10.1002/14651858.CD015078

Risk of bias for analysis 1.9 All‐cause mortality up to longest follow‐up.

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
Bohula 2022 (COVID‐PACT) Low risk of bias Due to blockwise electronic randomsation with 2x2 factorial design and almost no baseline differences, we rated low risk of bias in this domain. The minor differences on Baseline were probably due to small sample sizes. High risk of bias Rated high due to imbalanced high rates of crossovers. Additionally, the planned duration of treatment wasn't specified nor in the study registry nor in the publication, so we cannot judge whether there were deviations from intended interventions. Low risk of bias The outcome was reported for all randomised participants. Low risk of bias The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were aware of the intervention received, but it is unlikely that knowledge of intervention received could have affected outcome measurement. Some concerns Rated some concerns, because no SAP was available and mutliple outcome measure possible due to timeframe of follow up that was not prespecified nor reported (deviations from intended interventions potential selection of the reported result). High risk of bias Overall rated high due to many and imbalanced crossovers, unbalanced cointerventions, unclear timeframe of treatment and follow up.