Assessing risk of bias in randomised studies: RoB 2.0

Article type
Authors
Sterne J1, Elbers R2, Higgins J2, Reeves B2, Hróbjartsson A3, Boutron I4
1University of Bristol, UK
2University of Bristol
3Syddansk Universitet
4Paris Descartes University
Abstract
Objectives: To gain experience using the revised Cochrane Risk-of-Bias tool (RoB 2.0) to assess risk of bias in randomised trials.

Description: Randomised trials (RCTs) provide evidence about the effects of healthcare interventions. However, results can be undermined by flaws in design, conduct, analyses and selective reporting. Therefore, systematic reviews typically include assessments of the validity of the included RCTs.
We will present the revised Cochrane Risk-of-Bias tool (RoB 2.0). The tool includes signalling questions and algorithms to help review authors judge the risk of bias arising from the randomisation process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in the measurement of the outcome, and bias in the selection of the reported result.
The workshop will cover:
- The importance of specifying the result of interest to be assessed;
- Guidance on specifying the effect of interest (that of assignment to intervention, or starting and adhering to intervention);
- Signalling questions and algorithms to inform risk-of-bias judgment;
- Guidance on reaching an overall risk-of-bias judgment for the assessed result.
A worked example will be used to provide hands-on training and facilitate discussion. Participants have the option to complete their assessments in a semi-automated Excel template, and are encouraged to bring their own portable device to access detailed guidance from the internet (www.riskofbias.info)