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

Risk of bias for analysis 1.2 Worsening up to day 28: participants with new need for invasive mechanical ventilation or death.

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
Horby 2021 (RECOVERY) Low risk of bias A web‐based randomisation with allocation concealment was used and the baseline characteristics were balanced between groups. High risk of bias In the intervention group, 10% never obtained the treatment and 31% did not recieve it consistently. There were even 210 (3%) participants in the control group receiving the intervention. Low risk of bias Data for this outcome were available for 99% of the included participants. Low risk of bias The measurement of the outcome was appropriate. We suppose, that the assessment of such an objective outcome could not have been influenced by the knowledge of the intervention. Low risk of bias SAP finalized before assessment. High risk of bias Overall, we rate the risk of bias to be high due to deviations from the intended intervention.
REMAP‐CAP 2022 Low risk of bias Due to platform study design, allocation concealment for randomisation between Cox‐inhibitor and P2Y12 inhibitor was not given, but as we analyzed both interventions together, the impact seems negligible. Any baseline differences are probably due to chance. Some concerns We rate some concerns due to missing information whether there were crossovers or whether the assigned medication was really taken. The rate of withdrewn consent was low among all strata. High risk of bias Rated high due to a huge amount of participants randomized without reported outcome: We found that outcome reported for 60.5% (1.104 out of 1.824 ) of the randomized participants. Low risk of bias We rate low risk of bias in this domain, although there was a lack of information about how concretely the outcome was assessed. Low risk of bias Rated low, as the SAP was finalized before unbliding and the outcome was measured and analyzed as planned. High risk of bias Overall rated high due to a huge amount (>20%) of participants randomized had no reported outcome.