Assessing risk of bias in randomised studies: RoB 2.0


Workshop session 3: Wednesday, 16:00-17:30

Workshop category: 

  • Real world evidence (pragmatic trials, big data)


Date and Location


Wednesday 13 September 2017 - 16:00 to 17:30


Contact persons and facilitators

Contact person:


Jonathan Sterne
Roy Elbers


Higgins J1, Reeves B1, Hróbjartsson A2, Boutron I3
1 University of Bristol, United Kingdom
2 Syddansk Universitet, Denmark
3 Paris Descartes University, France
Target audience

Target audience: 

Systematic review authors, Clinical trialists

Level of difficulty: 

Type of workshop

Type of workshop : 



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 (