The Fragility of Landmark Randomized Controlled Trials in the Plastic Surgery Literature.

ABSTRACT

Background: Randomized controlled trials (RCTs) are integral to the progress of evidenced-based medicine and help guide changes in the standards of care. Although results are traditionally evaluated according to their corresponding P value, the universal utility of this statistical metric has been called into question. The fragility index (FI) has been developed as an adjunct method to provide additional statistical perspective. In this study, we aimed to determine the fragility of 25 highly cited RCTs in the plastic surgery literature. Methods: A PubMed search was used to identify the 25 highest cited RCTs with statistically significant dichotomous outcomes across 24 plastic surgery journals. Article characteristics were extracted, and the FI of each article was calculated. Additionally, Altmetric scores were determined for each study to determine article attention across internet platforms. Results: The median FI score across included studies was 4 (2-7.5, interquartile range). The two highest FI scores were 208 and 58, respectively. Four studies (16%) had scores of 0 or 1. Three studies (12%) had scores of 2. All other studies (72%) had FI scores of 3 or higher. The median Altmetric score was 0 (0-3). Conclusion: The FI can provide additional perspective on the robustness of study results, but like the P value, it should be interpreted in the greater context of other study elements.