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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - A risk of bias instrument for non-randomized studies of exposures
T2 - A users' guide to its application in the context of GRADE
AU - Morgan, Rebecca L.
AU - Thayer, Kristina A.
AU - Santesso, Nancy
AU - Holloway, Alison C.
AU - Blain, Robyn
AU - Eftim, Sorina E.
AU - Goldstone, Alexandra E.
AU - Ross, Pam
AU - Ansari, Mohammed
AU - Akl, Elie
AU - Filippini, Tommaso
AU - Hansell, Anna
AU - Meerpohl, Joerg J.
AU - Mustafa, Reem A.
AU - Verbeek, Jos
AU - Vinceti, Marco
AU - Whaley, Paul Alexander
AU - Schunemann, Holger J.
AU - GRADE Working Group
PY - 2019/1
Y1 - 2019/1
N2 - 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.
AB - 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.
KW - Risk of bias
KW - Environmental health
KW - GRADE
KW - Non-randomized studies
KW - Study limitations
KW - ROBINS
U2 - 10.1016/j.envint.2018.11.004
DO - 10.1016/j.envint.2018.11.004
M3 - Journal article
VL - 122
SP - 168
EP - 184
JO - Environment International
JF - Environment International
SN - 0160-4120
ER -