A new instrument to assess Risk of Bias in Non-randomised Studies of Exposures (ROBINS-E): Application to studies of environmental exposure


Workshop session 2: Wednesday, 14:00-15:30

Workshop category: 

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


Date and Location


Wednesday 13 September 2017 - 14:00 to 15:30


Contact persons and facilitators

Contact person:


Rebecca Morgan
Jonathan Sterne


Higgins J1, Thayer K2, Schunemann H3, Rooney A4, Taylor K4
1 University of Bristol, UK
2 Environmental Protection Agency, USA
3 McMaster University, Canada
4 National Institute for Environmental Health Sciences, USA
Target audience

Target audience: 

Review authors, researchers, and guideline developers

Level of difficulty: 

Type of workshop

Type of workshop : 



Objectives: To introduce a new tool for assessing risk of bias in non-randomised studies of exposures, and illustrate its application to studies of environmental and occupational exposure.

Description: Systematic reviews should include rigorous risk-of-bias assessments of included studies. We are adapting the recently published ROBINS-I instrument (for risk of bias in non-randomised studies of interventions) to address non-randomized studies of exposures other than interventions, including environmental and occupational exposures. This workshop will present an overview of the adapted instrument (to be named ROBINS-E), and will explain the proposed changes to ROBINS-I that will make ROBINS-E more suitable for assessing studies of exposures). Key aspects include preliminary consideration of risk of bias within the review protocol, use of signaling questions to inform risk-of-bias judgments, specification of a 'target experiment', detailed assessments of confounding and exposure measurement error, and guidance for interpretation across a body of evidence.
There will be a hands-on exercise to apply the draft ROBINS-E instrument to individual studies of a specific environmental exposure. The workshop will conclude by making a study-level risk-of-bias judgment, and discuss considerations when using ROBINS-E to assess individual studies to inform a systematic review, including making an overall risk-of-bias judgment across a body of evidence for a specific outcome.