GRADE guidelines: 18. How ROBINS-I and other tools to assess risk of bias in nonrandomized studies should be used to rate the certainty of a body of evidence

To provide guidance on how systematic review authors, guideline developers, and health technology assessment practitioners should approach the use of the risk of bias in nonrandomized studies of interventions (ROBINS-I) tool as a part of GRADE's certainty rating process. The study design and se...

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Bibliographic Details
Published in:Journal of clinical epidemiology Vol. 111; pp. 105 - 114
Main Authors: Schünemann, Holger J., Cuello, Carlos, Akl, Elie A., Mustafa, Reem A., Meerpohl, Jörg J., Thayer, Kris, Morgan, Rebecca L., Gartlehner, Gerald, Kunz, Regina, Katikireddi, S Vittal, Sterne, Jonathan, Higgins, Julian PT, Guyatt, Gordon
Format: Journal Article
Language:English
Published: United States Elsevier Inc 01.07.2019
Elsevier Limited
Subjects:
Bias
Certainty of the evidence
Clinical trials
Clinical Trials as Topic - standards
Decision making
Design
Domains
Dose-response effects
Epidemiology
Evidence-Based Medicine - methods
Evidence-Based Medicine - standards
GRADE
Humans
Internal Medicine
Nonrandomized studies
Observational Studies as Topic - standards
Practice Guidelines as Topic - standards
Quality
Quality of evidence
Risk Assessment
Risk Factors
Risk of bias
ROBINS
Studies
Systematic Reviews as Topic
Technology assessment
Uncertainty
Working groups
GRADE
Risk of bias
ROBINS
Quality of evidence
Nonrandomized studies
Certainty of the evidence
ISSN:0895-4356, 1878-5921, 1878-5921
Online Access:Get full text
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Summary:To provide guidance on how systematic review authors, guideline developers, and health technology assessment practitioners should approach the use of the risk of bias in nonrandomized studies of interventions (ROBINS-I) tool as a part of GRADE's certainty rating process. The study design and setting comprised iterative discussions, testing in systematic reviews, and presentation at GRADE working group meetings with feedback from the GRADE working group. We describe where to start the initial assessment of a body of evidence with the use of ROBINS-I and where one would anticipate the final rating would end up. The GRADE accounted for issues that mitigate concerns about confounding and selection bias by introducing the upgrading domains: large effects, dose-effect relations, and when plausible residual confounders or other biases increase certainty. They will need to be considered in an assessment of a body of evidence when using ROBINS-I. The use of ROBINS-I in GRADE assessments may allow for a better comparison of evidence from randomized controlled trials (RCTs) and nonrandomized studies (NRSs) because they are placed on a common metric for risk of bias. Challenges remain, including appropriate presentation of evidence from RCTs and NRSs for decision-making and how to optimally integrate RCTs and NRSs in an evidence assessment.
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ISSN:0895-4356
1878-5921
1878-5921
DOI:10.1016/j.jclinepi.2018.01.012