RoB 2 · randomised trials

Risk-of-bias example: RoB 2 traffic light and summary

RoB 2 traffic-light plot and weighted summary bar plot for nine randomised trials, with the five RoB 2 domains and an overall judgement per trial.

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Risk of bias domainsStudyD1D2D3D4D5OverallAdams 2015++++++Baker 2016−+++−−Chen 2017+−×++×Diaz 2018+++−+−Evans 2018×−++−×Fischer 2019++++++Garcia 2020+−+++−Huang 2021−+−++−Ibrahim 2022++++−−Bias arising from the randomisation process+−×Bias due to deviations from intended interventions+−Bias due to missing outcome data+−×Bias in measurement of the outcome+−Bias in selection of the reported result+−Overall risk of bias+−×0%25%50%75%100%Share of total weightD1: Bias arising from the randomisation processD2: Bias due to deviations from intended interventionsD3: Bias due to missing outcome dataD4: Bias in measurement of the outcomeD5: Bias in selection of the reported resultJudgement:+Low−Some concerns×High
RoB 2 judgements for nine trials (top) and the share of meta-analysis weight at each level of risk (bottom). Illustrative data.

About this example

RoB 2 assesses five domains for each result of a randomised trial: the randomisation process, deviations from the intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result. The traffic-light plot shows every judgement, so a reader can see at a glance that the two trials at high risk owe it to different domains.

The summary plot below is weighted by the trials’ meta-analysis weights, as robvis does by default, which shows how much of the pooled evidence is at each level of risk: most of the weight comes from trials at low risk or with some concerns, even though a third of the trials raise concerns in domain 5.

The data

StudyD1D2D3D4D5OverallWeight
Adams 2015LowLowLowLowLowLow14.2
Baker 2016Some concernsLowLowLowSome concernsSome concerns9.8
Chen 2017LowSome concernsHighLowLowHigh6.1
Diaz 2018LowLowLowSome concernsLowSome concerns12.5
Evans 2018HighSome concernsLowLowSome concernsHigh4.3
Fischer 2019LowLowLowLowLowLow18.9
Garcia 2020LowSome concernsLowLowLowSome concerns11
Huang 2021Some concernsLowSome concernsLowLowSome concerns8.7
Ibrahim 2022LowLowLowLowSome concernsSome concerns14.5

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