Abstract
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.
Original language | English |
---|---|
Pages (from-to) | 105-114 |
Number of pages | 10 |
Journal | Journal of Clinical Epidemiology |
Volume | 111 |
Early online date | 9 Feb 2018 |
DOIs | |
Publication status | Published - 1 Jul 2019 |
Bibliographical note
Copyright © 2018 Elsevier Inc. All rights reserved.Keywords
- Certainty of the evidence
- GRADE
- Nonrandomized studies
- Quality of evidence
- Risk of bias
- ROBINS