Statistical fragility of outcomes in acellular dermal matrix literature: A systematic review of randomized controlled trials

Background: Acellular dermal matrix (ADM ) is commonly used in plastic and re - constructive surgery. With the abundance of randomized controlled trials (RCTs ) reporting Pvalues for ADM outcomes, this study used the fragility index (FI ), reverse fragility index (rFI ), and fragility quotient (FQ ) to evaluate the statistical stability of the outcomes in ADM RCTs. Methods: PubMed, Embase, SCOPUS, Medline, and Cochrane databases were reviewed for ADM RCTs (2003 -present ) reporting a dichotomous, categorical outcome. FI and rFI (event reversals influencing outcome significance ) and FQ (standardized fragility ) were calculated and reported as median. Subgroup analysis was performed based on intervention types. Results: Among the 127 studies screened, 56 RCTs with 579 outcomes were included. The median FI stood at 4 ( 3- 5) and FQ was 0.04 (0.03 -0.07 ). Only 101 outcomes were statistically significant with a median FI of 3 ( 1- 6) and FQ of 0.04 (0.02 -0.08 ). The nonsignificant outcomes had a median FI of 4 ( 3- 5) and FQ of 0.04 (0.03 -0.07 ). Notably, 26% of the outcomes had several patients lost to follow up equal to or surpassing the FI. Based on the intervention type, the median FIs showed minor fluctuations but remained low. Conclusions: Outcomes from ADM -related RCTs were statistically fragile. Slight outcome re - versals or maintenance of patient follow -up can alter the significance of results. Therefore, future researchers are recommended to jointly report FI, FQ, and Pvalues to offer a com - prehensive view of the robustness in ADM literature. (c) 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.