Background: Observational epidemiologic studies provide critical data for the evaluation of the potential effects of environmental, occupational and behavioural exposures on human health. Systematic reviews of these studies play a key role in informing policy and practice. Systematic reviews should incorporate assessments of the risk of bias in results of the included studies.
Objective: To develop a new tool, Risk Of Bias In Non-randomized Studies - of Exposures (ROBINS-E) to assess risk of bias in estimates from cohort studies of the causal effect of an exposure on an outcome.
Methods and Results: ROBINS-E was developed by a large group of researchers from diverse research and public health disciplines through a series of working groups, in-person meetings and pilot testing phases. The tool aims to assess the risk of bias in a specific result (exposure effect estimate) from an individual observational study that examines the effect of an exposure on an outcome. A series of preliminary considerations informs the core ROBINS-E assessment, including details of the result being assessed and the causal effect being estimated. The assessment addresses bias within seven domains, through a series of 'signalling questions'. Domain-level judgements about risk of bias are derived from the answers to these questions, then combined to produce an overall risk of bias judgement for the result, together with judgements about the direction of bias.
Conclusion: ROBINS-E provides a standardized framework for examining potential biases in results from cohort studies. Future work will produce variants of the tool for other epidemiologic study designs (e.g. case-control studies). We believe that ROBINS-E represents an important development in the integration of exposure assessment, evidence synthesis and causal inference.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Judy LaKind reports receipt of support for research on systematic reviews and assessments of review processes from NCASI, the American Petroleum Institute and the National Institute of Environmental Health Sciences and served on the GRADE panel for assessing the certainty of modeled evidence. Annette O’Connor reports funding from the US National Pork Board and the United Soybean Board that includes: consulting or advisory. Jelena Savović reports a relationship with JEMMDx Limited that includes: consulting or advisory. Jelena Savović reports a relationship with Core Models Limited that includes: teaching. Kate Tilling reports a relationship with CHDI Foundation that includes: consulting or advisory. Kate Tilling reports a relationship with UK MHRA that includes: paid expert testimony. Jos Verbeek reports a relationship with World Health Organization that includes: consulting or advisory. The remaining authors report no financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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