ROB 2

# https://methods.cochrane.org/risk-bias-2

# https://www.bmj.com/content/366/bmj.l4898

# [Risk-of-bias assessment using Cochrane's revised tool for randomized trials (RoB 2) was useful but challenging and resource-intensive: observations from a systematic review 23](https://www.sciencedirect.com/science/article/pii/S0895435623001634)

1.1 Was the allocation sequence random?

1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?

1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?

2.1. Were participants aware of their assigned intervention during the trial?

2.2. Were carers and people delivering the interventions aware of participants' assigned

intervention during the trial?

2.3. Were important non-protocol interventions balanced across intervention groups?

2.4. Were there failures in implementing the intervention that could have affected the outcome?

2.5. Was there non-adherence to the assigned intervention regimen that could have affected participants' outcomes?

2.6. Was an appropriate analysis used to estimate the effect of adhering to intervention?

3.1 Were data for this outcome available for all, or nearly all, participants randomized?

3.2 Is there evidence that the result was not biased by missing outcome data?

3.3 Could missingness in the outcome depend on its true value?

3.4 Is it likely that missingness

in the outcome depended on its true value?

4.1 Was the method of measuring the outcome inappropriate?

4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?

4.3 Were outcome assessors aware of the intervention received by study participants?

4.4 Could assessment of the outcome have been influenced by knowledge of intervention received?

4.5 Is it likely that assessment of the outcome was influenced by knowledge of intervention received?

5.1 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?

5.2.... multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?

5.3... multiple eligible analyses of the data?