PBM Module 4a Risk-of-bias-tabel

Publicatiedatum 12-12-2023 | 18:00

Risk of bias table for intervention studies (randomized controlled trials; based on Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University)

Study reference (first author, publication year)	Was the allocation sequence adequately generated? Definitely yes Probably yes Probably no Definitely no	Was the allocation adequately concealed? Definitely yes Probably yes Probably no Definitely no	Blinding: Was knowledge of the allocated interventions adequately prevented? Were patients blinded? Were healthcare providers blinded? Were data collectors blinded? Were outcome assessors blinded? Were data analysts blinded? Definitely yes Probably yes Probably no Definitely no	Was loss to follow-up (missing outcome data) infrequent? Definitely yes Probably yes Probably no Definitely no	Are reports of the study free of selective outcome reporting? Definitely yes Probably yes Probably no Definitely no	Was the study apparently free of other problems that could put it at a risk of bias? Definitely yes Probably yes Probably no Definitely no	Overall risk of bias If applicable/necessary, per outcome measure LOW Some concerns HIGH
Loeb, 2022	Definitely yes Reason: Trial participants were randomly assigned (1:1) to either medical masks or N95 respirators. Participants were randomly assigned centrally by a study statistician who generated the sequence using a computerized random number generator. Randomization was stratified by site in permuted blocks of 4. The randomization scheme was provided by an interactive web response system and performed centrally.	Definitely yes Reason: Investigators were blinded to the group assignment	Definitely no Reason: it was not possible to conceal the identity of the medical mask or N95 respirator assignment to the study staff or participants	Definitely yes Reason: loss to-follow-up was minimal and an ITT-analysis was performed	Definitely yes Reason: All relevant outcomes were reported, and the trial was registered (ClinicalTrials.gov: NCT04296643)	Definitely no Reason: Potential acquisition of SARS-CoV-2 through household and community exposure, heterogeneity between countries, uncertainty in the estimates of effect, differences in self-reported adherence, differences in baseline antibodies, and between-country differences in circulating variants and vaccination.	HIGH