Publication details
GRADE concept 4: rating the certainty of evidence when study interventions or comparators differ from PICO targets
| Authors | |
|---|---|
| Year of publication | 2023 |
| Type | Article in Periodical |
| Magazine / Source | Journal of clinical epidemiology |
| MU Faculty or unit | |
| Citation | |
| Web | https://www.sciencedirect.com/science/article/pii/S0895435623001063?via%3Dihub |
| Doi | http://dx.doi.org/10.1016/j.jclinepi.2023.04.018 |
| Keywords | GRADE; Certainty of evidence; Applicability; External validity; Treatment switching; Cross-over |
| Description | Objectives: This Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept article offers systematic reviewers, guideline authors, and other users of evidence assistance in addressing randomized trial situations in which interventions or com-parators differ from those in the target people, interventions, comparators, and outcomes. To clarify what GRADE considers under indi-rectness of interventions and comparators, we focus on a particular example: when comparator arm participants receive some or all aspects of the intervention management strategy (treatment switching).Study Design and Setting: An interdisciplinary panel of the GRADE working group members developed this concept article through an iterative review of examples in multiple teleconferences, small group sessions, and e-mail correspondence. After presentation at a GRADE working group meeting in November 2022, attendees approved the final concept paper, which we support with examples from systematic reviews and individual trials.Results: In the presence of safeguards against risk of bias, trials provide unbiased estimates of the effect of an intervention on the peo-ple as enrolled, the interventions as implemented, the comparators as implemented, and the outcomes as measured. Within the GRADE framework, differences in the people, interventions, comparators, and outcomes elements between the review or guideline recommendation targets and the trials as implemented constitute issues of indirectness. The intervention or comparator group management strategy as im-plemented, when it differs from the target comparator, constitutes one potential source of indirectness: Indirectness of interventions and comparatorsdcomparator group receipt of the intervention constitutes a specific subcategory of said indirectness. The proportion of comparator arm participants that received the intervention and the apparent magnitude of effect bear on whether one should rate down, and if one does, to what extent.Conclusion: Treatment switching and other differences between review or guideline recommendation target interventions and compar-ators vs. interventions and comparators as implemented in otherwise relevant trials are best considered issues of indirectness. & COPY; 2023 Elsevier Inc. All rights reserved. |