Quality Assessment

Randomized Controlled Trials (RoB 2)

Domain	Risk of Bias
Randomization process	(Low / Some concerns / High)
Deviations from intended interventions	(Low / Some concerns / High)
Missing outcome data	(Low / Some concerns / High)
Measurement of the outcome	(Low / Some concerns / High)
Selection of the reported result	(Low / Some concerns / High)
Overall Judgment	(Low / Some concerns / High)

Item	Score (0-2)	Comments
A clearly stated aim
Inclusion of consecutive patients
Prospective data collection
Endpoints appropriate to the aim of the study
Unbiased assessment of the study endpoint
Follow-up period appropriate to the aim of the study
Loss to follow-up less than 5%
Prospective calculation of the study size
Control group (only for comparative studies)
Baseline equivalence of groups (only for comparative studies)
Adequate statistical analyses (only for comparative studies)
Adequate follow-up of control group (only for comparative studies)
Total Score