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

Risk of bias for analysis 6.4 Serious adverse events.

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
Gottlieb 2021 Low risk of bias Judged low risk of bias. Randomly assigned in a 1:1 ratio, stratified according to residence in a skilled nursing facility, age (< 60 years, >= 60 years), location (US or outside US). There are only baseline differences that arose by chance and do not indicate a problem in the randomisation process. Low risk of bias Judged low risk of bias. Participants and trial personnel were blinded. The analysis was appropriate. Low risk of bias Judged low risk if bias. Data were available for all participants (ITT). Low risk of bias There is only one way to measure the outcome. Double blinding was maintained until finalisation of the data. Low risk of bias Judged low risk of bias. Analysis was performed in accordance to the pre‐specified analysis plan (Section 8 of Trial Protocol). There is only one way to measure the outcome. SAEs are defined in study protocol. Low risk of bias Overall judged low risk of bias. Randomly assigned in a 1:1 ratio, stratified according to residence in a skilled nursing facility, age (< 60 years, >= 60 years), location (US or outside US). There are only baseline differences that arose by chance and do not indicate a problem in the randomisation process. The analysis was appropriate. Data were available for all participants (ITT). There is only one way to measure the outcome. Double blinding was maintained until finalisation of the data. Analysis was performed in accordance to the pre‐specified analysis plan (Section 8 of Trial Protocol). There is only one way to measure the outcome. SAEs are defined in study protocol.