Application of the Reverse Fragility Index to Statistically Nonsignificant Randomized Clinical Trial Results.

ABSTRACT:

Importance

Interpreting randomized clinical trials (RCTs) and their clinical relevance is challenging when P values are either marginally above or below the P = .05 threshold.

Objective

To use the concept of reverse fragility index (RFI) to provide a measure of confidence in the neutrality of RCT results when assessed from the clinical perspective.

Design, setting, and participants

In this cross-sectional study, a MEDLINE search was conducted for RCTs published from January 1, 2013, to December 31, 2018, in JAMA, the New England Journal of Medicine (NEJM), and The Lancet. Eligible studies were phase 3 and 4 trials with 1:1 randomization and statistically nonsignificant binary primary end points. Data analysis was performed from August 1, 2019, to August 31, 2019.

E

SUBMITTER: Khan MS 

PROVIDER: S-EPMC7407075 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature