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.
By H. Schünemann, Carlos A. Cuello, Elie A. Akl, R. Mustafa, J. Meerpohl, K. Thayer, R. Morgan, G. Gartlehner, Regina Kunz, S. Katikireddi and 3 more. Journal of Clinical Epidemiology, 2018
718 citations recorded by the source corpus.
OBJECTIVE 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. STUDY DESIGN AND SETTING 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. RESULTS 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. CONCLUSIONS 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.
Subfields: Economics and Econometrics, General Health Professions, Statistics and Probability
View Paper: https://www.semanticscholar.org/paper/cf0d116e848fca50508ac07e082d05e29ba05fcd
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Citations in the corpus
- Quarantine alone or in combination with other public health measures to control COVID‐19: a rapid review (2020, neutral): “Newer GRADE guidelines state that observational studies can also start as high certainty if the 'Risk of bias' assessment tool used was ROBINS-I (Schünemann 2019).”
- A tool to assess risk of bias in non-randomized follow-up studies of exposure effects (ROBINS-E) (2024, positive): “An example of such a framework is the GRADE approach (Guyatt et al., 2011) where users may start at high certainty in the “study limitations” (risk of bias) domain of GRADE and use their ROBINS-E evaluation to determine how many levels to rate down this certainty (Schunemann et al., 2018).”