Table A5:
GRADE Evidence Profile for Comparison of MRD-Directed Treatment Augmentation Versus Standard Treatment in MRD–High-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 | Serious limitations (–1)d | Undetected | None | ⊕⊕ Low |
| 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 and technically underpowered to detect effect sizes found; however, target sample size for > 80% power to detect a 10% difference between groups after accounting for potential attrition was met, and between-group differences are clinically important and statistically significant.
Few deaths during study observation period yielded imprecision around the estimate and lack of power to adequately evaluate a clinically meaningful difference between treatment groups in overall survival.