A tool to assess risk of bias in non-randomized follow-up studies of exposure effects (ROBINS-E)

•ROBINS-E is a new tool to assess risk of bias in an observational study.•The tool addresses an estimate of the effect of an exposure on an outcome.•An assessment covers potential biases in seven bias domains.•A judgement on risk of bias and a predicted direction of bias are produced. Observational...

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Veröffentlicht in:Environment international Jg. 186; S. 108602
Hauptverfasser: Higgins, Julian P.T., Morgan, Rebecca L., Rooney, Andrew A., Taylor, Kyla W., Thayer, Kristina A., Silva, Raquel A., Lemeris, Courtney, Akl, Elie A., Bateson, Thomas F., Berkman, Nancy D., Glenn, Barbara S., Hróbjartsson, Asbjørn, LaKind, Judy S., McAleenan, Alexandra, Meerpohl, Joerg J., Nachman, Rebecca M., Obbagy, Julie E., O'Connor, Annette, Radke, Elizabeth G., Savović, Jelena, Schünemann, Holger J., Shea, Beverley, Tilling, Kate, Verbeek, Jos, Viswanathan, Meera, Sterne, Jonathan A.C.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Netherlands Elsevier Ltd 01.04.2024
Elsevier
Schlagworte:
Bias
Cohort Studies
Confounding
environment
Environmental
Environmental Exposure - statistics & numerical data
Epidemiologic Studies
epidemiological studies
Epidemiology
Exposure
exposure assessment
Follow-Up Studies
human health
Humans
issues and policy
Misclassification/measurement bias
observational studies
Observational Studies as Topic
public health
risk
Risk Assessment - methods
Risk of bias
Selection bias
Environmental
Risk of bias
Misclassification/measurement bias
Confounding
Selection bias
Exposure
Epidemiology
ISSN:0160-4120, 1873-6750, 1873-6750
Online-Zugang:Volltext
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Zusammenfassung:•ROBINS-E is a new tool to assess risk of bias in an observational study.•The tool addresses an estimate of the effect of an exposure on an outcome.•An assessment covers potential biases in seven bias domains.•A judgement on risk of bias and a predicted direction of bias are produced. 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. 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. 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. 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.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
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content type line 23
ISSN:0160-4120
1873-6750
1873-6750
DOI:10.1016/j.envint.2024.108602