Fragility in cardiovascular randomized controlled trials with primary continuous outcomes (2018-2022) from multi-perspectives assessment: a cross-sectional survey.

ABSTRACT:

Objective

This study aims to assess the robustness of cardiovascular disease randomized controlled trials (RCTs) with primary continuous outcomes from a clinical perspective, utilizing the concepts of continuous fragility index (CFI), reverse continuous fragility index (RCFI) and their corresponding quotients (CFQ, RCFQ).

Methods

A cross-sectional study was conducted, searching PubMed for cardiovascular RCTs published between January 1, 2018, to December 31, 2022, in eight high-impact journals. Inclusion criteria were phase III or IV trials with 1:1 randomization, reporting at least one primary continuous outcome. Data analysis involved altering each outcome until achieving the reversal of significance (ɑ = 0.05) to determine the CFI or RCFI. The fragility quotients were the

SUBMITTER: Zhou X 

PROVIDER: S-EPMC11616752 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature