Background

The revised tool for assessing risk of bias in randomised trials (RoB 2) was published in late 2019, building on the established Cochrane risk-of-bias tool first released through the Cochrane Handbook in 2008. This session will introduce the RoB 2 tool.

Aim

To introduce the RoB 2 tool, describe the risk-of-bias domains it considers, provide an overview of how the tool should be applied, and support the application of the tool.  

Learning outcomes

In this course, participants will be enabled to:

• Describe the key concepts of the RoB2 tool

• Apply the revised RoB 2 in their reviews

Teaching strategies

The workshop will consist of a mixture of presentations and practical sessions, along with a protected period for Q&A at the end. The practical sessions will be built around a practical “hands-on” risk-of-bias assessment.

Places

30 available for individuals who are resident in Ireland & Northern Ireland

Facilitator

Luke McGuinness (National College of Ireland)

Course content/timetable

Day 1

10:00-11:00 Session I

• Define “bias” in the context of RoB 2
• Introduce the new RoB 2 tool and highlight differences from the established tool
• Provide a summary how the tool is applied (preliminary considerations, signalling questions and judgement algorithms)
• Introduce Domain 1 (Bias arising from the randomisation process), and walkthrough the domains Signalling Questions and algorithm

11:00-11:30 Practical I

• Familiarise attendees with the preliminary steps of the RoB 2 tool
• Give participants an opportunity to apply Domain 1 to an example study

11:30-11:45 Coffee Break

11:45-12:15 Session II

• Discuss effects of interest
• Introduce Domain 2 (Bias due to deviations from the intended interventions), and walkthrough the domains Signalling Questions and algorithm

12:15-12:45 Practical II

• Provide participants with an opportunity to apply Domain 2 to an example study

12:45-13:00 Q&A Session

Day 2

10:00-11:00 Session III

• Introduce Domain 3 (Bias due to missing outcome data), and walkthrough the domains Signalling Questions and algorithm
• Introduce Domain 4 (Bias in measurement of the outcome), and walk through the domains Signalling Questions and algorithm

11:00-11:30 Practical III

• Provide participants with an opportunity to apply Domains 3 & 4 to an example study

11:30-11:45 Coffee Break

11:45-12:15 Session IV

• Introduce Domain 5 (Bias due in selection of the reported result), and walkthrough the domains Signalling Questions and algorithm
• Describe considerations when reaching an overall judgement
• Discuss how results of ROB2 assessments should be used/presented in the review
• Introduce tools to support users in applying and visualising the results of RoB 2

12:15-12:45 Practical IV

• Provide participants with an opportunity to apply Domain 5 to an example study
• Encourage users to consider how the results of the example assessment could be used in a systematic review.
• Allow attendees to practice with some of the tools described in Session IV

12:45-13:00 Q&A Session