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


Workshop session 5: Thursday, 14:00-15:30

Workshop category: 

  • Methods for conducting syntheses (including different evidence, searching and information retrieval, statistics, assessing methodological quality)


Date and Location


Thursday 14 September 2017 - 14:00 to 15:30


Contact persons and facilitators

Contact person:


Alexandra McAleenan
Roy Elbers
Ian Shrier
Jonathan Sterne


Higgins J1, The development group for the Cochrane risk of bias tool for non-randomised studies .1
1 School of Social and Community Medicine, University of Bristol, UK
Target audience

Target audience: 

Review authors

Level of difficulty: 

Type of workshop

Type of workshop : 



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.