Fragility of randomised controlled trials for systemic lupus erythematosus and lupus nephritis therapies.

ABSTRACT:

Objective

We aimed to evaluate the robustness of phase III randomised controlled trials (RCTs) for SLE and lupus nephritis (LN) using the fragility index (FI), the reverse FI (RFI) and the fragility quotient (FQ).

Methods

We searched for phase III RCTs that included patients with active SLE or LN. Data on primary endpoints, total participants and the number of events for each arm were obtained. We calculated the FI score for RCTs with statistically significant results (number of patients required to change from event to non-event to make the study lose statistical significance), the RFI for RCTs without statistically significant results (number of patients required to change from non-event to event to make study gain statistical significance) and the FQ score for both (FI or

SUBMITTER: Figueroa-Parra G 

PROVIDER: S-EPMC10806519 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature