Table 1 Risk of bias for Randomized Clinical Trials. Version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2)
Gibreel, 2017 | Slot, 2014 | Slot, 2019 | Ibrahim, 2022 | |
|---|---|---|---|---|
Was the allocation sequence random? | Y | Y | Y | Y |
Was the allocation sequence concealed until participants were enrolled and assigned to interventions? | Y | Y | Y | PY |
Did baseline differences between intervention groups suggest a problem with the randomization process? | NI | PN | PN | PN |
Risk of bias judgement | Low Risk | Low Risk | Low Risk | Some concerns |
Were participants aware of their assigned intervention during the trial? | NA | NA | NA | NA |
Were carers and people delivering the interventions aware of participants’ assigned intervention during the trial? | NA | NA | NA | NA |
Were there deviations from the intended intervention that arose because of the trial context? | PY | PN | PN | PN |
Were these deviations likely to have affected the outcome? | PN | PN | PN | PN |
Were these deviations from intended intervention balanced between groups? | NI | NI | NI | NI |
Risk of bias judgement | Some concerns | Low Risk | Low Risk | Low Risk |
Was an appropriate analysis used to estimate the effect of assignment to intervention? | Y | Y | Y | Y |
Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized? | NA | NA | NA | NA |
Risk of bias judgement | Low Risk | Low Risk | Low Risk | Low Risk |
Was an appropriate analysis used to estimate the effect of adhering to intervention? | NI | NI | NI | Y |
Risk of bias judgement | Some concerns | Some concerns | Some concerns | Low Risk |
Were data for this outcome available for all, or nearly all, participants randomized? | NI | NI | NI | NI |
Is there evidence that the result was not biased by missing outcome data? | N | N | N | N |
Could missingness in the outcome depend on its true value? | NI | NI | NI | NI |
Is it likely that missingness in the outcome depended on its true value? | NI | NI | NI | NI |
Risk of bias judgement | High Risk | High Risk | High Risk | High Risk |
Was the method of measuring the outcome inappropriate? | N | N | N | N |
Could measurement or ascertainment of the outcome have differed between intervention groups? | N | N | N | N |
Were outcome assessors aware of the intervention received by study participants? | NA | NA | NA | NA |
Could assessment of the outcome have been influenced by knowledge of intervention received? | PN | PN | PN | PN |
Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | PN | PN | PN | PN |
Risk of bias judgement | Low Risk | Low Risk | Low Risk | Low Risk |
Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | NI | NI | NI | NI |
Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements within the outcome domain? | PN | PN | PN | PN |
Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data? | PN | PN | PN | PN |
Risk of bias judgement | Some concerns | Some concerns | Some concerns | Some concerns |
Overall risk of bias judgement | High Risk | High Risk | High Risk | High Risk |