Table A4:
GRADE Evidence Profile for Comparison of MRD-Directed Treatment Reduction Versus Standard Treatment in MRD–Low-Risk Patients
| Number of Studiesa (Design) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| Event-Free Survival | |||||||
| 1 (RCT) | Serious limitations (–1)b | No serious limitations | No serious limitations | No serious limitationsc | Undetected | None | ⊕⊕⊕ Moderate |
| Overall Survival | |||||||
| 1 (RCT) | Serious limitations (–1)b | No serious limitations | No serious limitations | No serious limitationsd | Undetected | None | ⊕⊕⊕ Moderate |
| Relapse | |||||||
| 1 (RCT) | Serious limitations (–1)b | No serious limitations | No serious limitations | No serious limitationsc | Undetected | None | ⊕⊕⊕ Moderate |
Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; MRD, minimal residual disease; RCT, randomized controlled trial.
Based on GRADE assessment for rating quality of evidence detailed in Guyatt et al.52
See Table A3 for risk of bias assessment.
Few events overall; however, target sample size was met and exceeded to achieve planned power to detect differences in primary outcomes, even after accounting for potential attrition. Authors state that ability to rule out a clinically significant 7% reduction in event-free survival was achieved by randomization.
Few deaths during study observation period, adequately powered to rule out a 10% difference in overall survival (OS) between groups but unclear if time was sufficient to adequately evaluate OS.