Using ROBINS-I to assess risk of bias in non-randomised studies of interventions

McAleenan A1, Elbers R1, Shrier I2, Sterne J3, Higgins J4, The development group for the Cochrane risk of bias tool for non-randomised studies .4
1University of Bristol, 2Centre for Clinical Epidemiology, Lady Davis Institute, McGill University, 3University of Bristol, UK, 4School of Social and Community Medicine, University of Bristol

Objectives: Describe ROBINS-I, a tool to assess risk of bias in non-randomised studies of interventions (NRSI), train participants through completion of an example assessment, and describe recent extensions to different types of study design.

Description: NRSI can provide information about effects of interventions that is not available from randomised trials, but their results may be affected by confounding, selection and misclassification biases. The ROBINS-I tool assesses the risk of bias in NRSI based on the comparison to a hypothetical pragmatic randomised trial that is free of bias. It assesses the risk of bias within seven domains, within which risk of bias judgements are informed by responses to ‘signalling questions’.

This workshop will give a brief overview of the ROBINS-I tool. It will incorporate guided practical sessions in which participants will complete parts of a risk-of-bias assessment for one example study, and there will be opportunities for discussion of the tool and its role in systematic reviews. We will describe recent extensions of ROBINS-I to different types of design and analysis.