Table 1

Risk of Bias Assessment of Randomised Controlled Trials (ROB-2)

StudyDomain 1Domain 2Domain 3Domain 4Domain 5Overall risk of bias
Risk of bias arising from the randomisation processRisk of bias due to deviations from the intended interventions (effect of assignment to intervention)Risk of bias due to deviations from the intended interventions (effect of adhering to intervention)Missing outcome dataRisk of bias in measurement of the outcomeRisk of bias in selection of the reported result
Manz et al18LowLow (unblinded participants)LowLowLowLowLow
Manz et al19LowLow (unblinded participants)LowHigh risk (missing data for secondary outcome)LowLowHigh risk (unpredictable)
Hassoon et al20LowLow (unblinded participants)LowLowLowLowLow
Strömblad et al21LowSome concerns (Hawthorne’s effect and unequal arm size after exclusion postrandomisation)LowLowLowLowSome concerns (unpredictable)
Seok et al31LowLow (unblinded participants)LowLowLowLowLow
Nicolae et al29LowLowLowLowLowLowLow
Nelson et al26LowHigh risk (per-protocol analysis with 13% dropout rate)LowHigh risk (13% missing outcome data)LowLowHigh risk (unpredictable)
  • The risk of bias for each domain of the study is colour-coded. High risk of bias: red; moderate risk of bias: orange and low risk of bias: green.