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. 2020 Jan 29;5(1):37–45. doi: 10.1302/2058-5241.5.190017

Table 3.

The risk of bias in non-randomized studies of interventions (ROBINS-I) assessment tool

Authors, year Risk of bias within each domain Overall risk of bias across domains Overall risk of bias across studies
Confounding Participant
selection
Intervention
classification
Departure from intended interventions Missing data Measurement of outcomes Selection of reported results
Barbosa et al, 201328 Critical Critical Serious Moderate Moderate Critical Moderate Critical High
Lee et al, 201431 Critical Serious Serious Moderate Moderate Serious Moderate Critical

Judgement (within a study): Low risk of bias (comparable to a well performed randomized controlled trial: RCT), Moderate risk of bias (sound, but not comparable to a well performed RCT), Serious risk of bias (important problems), Critical risk of bias (too problematic to provide useful evidence), No information.

(Across studies) Low risk of bias: Most information is from studies at low risk of bias

Unclear risk of bias: Most information is from studies at low or unclear risk of bias

High risk of bias: The proportion of information from studies at high risk of bias is sufficient to affect the interpretation of results