Cited by 248Meta-analysis and systematic reviewsStatistical Methods in EpidemiologyAdvanced Causal Inference Techniques

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A risk of bias instrument for non-randomized studies of exposures: A users' guide to its application in the context of GRADE

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Morgan, Rebecca L., Thayer, Kristina A., Santesso, Nancy, Holloway, Alison C., Blain, Robyn, Eftim, Sorina E., Goldstone, Alexandra E., Ross, Pam, Ansari, Mohammed, Akl, Elie A, Filippini, Tommaso, Hansell, Anna, Meerpohl, Joerg J., Mustafa, Reem A., Verbeek, Jos, Vinceti, Marco, Whaley, Paul, Schünemann, Holger J.·2019·Environment International

DOI 10.1016/j.envint.2018.11.004PMC PMC8221004

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Abstract

The objective of this paper is to explain how to apply, interpret, and present the results of a new instrument to assess the risk of bias (RoB) in non-randomized studies (NRS) dealing with effects of environmental exposures on health outcomes. This instrument is modeled on the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) instrument. The RoB instrument for NRS of exposures assesses RoB along a standardized comparison to a randomized target experiment, instead of the study-design directed RoB approach. We provide specific guidance for the integral steps of developing a research question and target experiment, distinguishing issues of indirectness from RoB, making individual-study judgments, and performing and interpreting sensitivity analyses for RoB judgments across a body of evidence. Also, we present an approach for integrating the RoB assessments within the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework to assess the certainty of the evidence in the systematic review. Finally, we guide the reader through an overall assessment to support the rating of all domains that determine the certainty of a body of evidence using the GRADE approach.

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GRADE guidelines: 3. Rating the quality of evidence
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GRADE guidelines: 8. Rating the quality of evidence—indirectness
Guyatt, G. H., Oxman, A. D., Kunz, R., Woodcock, J., Brozek, J., Helfand, M., Alonso-Coello, P., Falck-Ytter, Y., Jaeschke, R., Vist, G., et al. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.04.014 · Cited by 1,843
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Identifying the PECO: A framework for formulating good questions to explore the association of environmental and other exposures with health outcomes
Morgan, R. L., Whaley, P., Thayer, K. A., & Schünemann, H. J. (2018) · Environment International · doi:10.1016/j.envint.2018.07.015 · Cited by 1,424
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GRADE guidelines: 9. Rating up the quality of evidence
Guyatt, G. H., Oxman, A. D., Sultan, S., Glasziou, P., Akl, E. A., Alonso-Coello, P., Atkins, D., Kunz, R., Brozek, J., Montori, V., et al. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.06.004 · Cited by 1,336 · cited 6×
“These latter two domains contribute to increasing the CoE in a body of evidence of NRS in GRADE; however, within the RoB instrument for NRS of exposures they may also influence the study-level judgments (Guyatt et al., 2011c).”
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Thayer, 2013, Draft protocol for systematic review to evaluate the evidence for an association between bisphenol A (BPA) exposure and obesity, Natl. Toxicol. Program

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Authors: Morgan, R. L., Thayer, K. A., Santesso, N., Holloway, A. C., Blain, R., Eftim, S. E., Goldstone, A. E., Ross, P., Ansari, M., Akl, E. A., Filippini, T., Hansell, A., Meerpohl, J. J., Mustafa, R. A., Verbeek, J., Vinceti, M., Whaley, P., & Schünemann, H. J.
Affiliations: McMaster University (CA)
Environmental Protection Agency (US)
ICF International (United States) (US)
University of Ottawa (CA)
University of Modena and Reggio Emilia (IT)
Imperial College Healthcare NHS Trust (GB)
University of Freiburg (DE)
University of Kansas Medical Center (US)
Finnish Institute of Occupational Health (FI)
Boston University (US)
Lancaster University (GB)
Corresponding author: Schünemann, Holger J.
ORCID: Morgan, Rebecca L.
Thayer, Kristina A.
Santesso, Nancy
Holloway, Alison C.
Blain, Robyn
Eftim, Sorina E.
Akl, Elie A
Filippini, Tommaso
Hansell, Anna
Meerpohl, Joerg J.
Mustafa, Reem A.
Verbeek, Jos
Vinceti, Marco
Whaley, Paul
Schünemann, Holger J.
Venue: Environment International
Publisher: Elsevier BV
Published: 2019-01
Volume: 122
Pages: 168-184
ISSN: 0160-4120 (ISSN-L)
DOI: 10.1016/j.envint.2018.11.004
PMC: PMC8221004
OpenAlex: W2901788566
Cited by: 248
References: 33
Citations by year: 2026: 20 · 2025: 34 · 2024: 31 · 2023: 45 · 2022: 45 · 2021: 41 · 2020: 25 · 2019: 7
FWCI: 13.92
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Environment International (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Lancaster EPrints (Lancaster University) (acceptedVersion)
PubMed Central (acceptedVersion, cc-by-nc-nd)
IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by-nc-nd)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Figshare (submittedVersion, cc-by)
Leicester Research Archive (University of Leicester) (submittedVersion, other-oa)
Funders: Intramural Research Program of the National Institute of Environmental Health Sciences
MacGRADE Centre at the McMaster University
Topics: Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: risk of bias, non-randomized studies, environmental exposure, ROBINS-I, GRADE, quality of evidence, indirectness, sensitivity analysis, systematic reviews
MeSH terms: Environmental Exposure, Humans, Random Allocation, Research Design, Bias, Risk Assessment

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A risk of bias instrument for non-randomized studies of exposures: A users' guide to its application in the context of GRADE

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