Noninferiority Designed Cardiovascular Trials in Highest-Impact Journals.

ABSTRACT:

Background

Noninferiority trials are increasingly being performed. However, little is known about their methodological quality. We sought to characterize noninferiority cardiovascular trials published in the highest-impact journals, features that may bias results toward noninferiority, features related to reporting of noninferiority trials, and the time trends.

Methods

We identified cardiovascular noninferiority trials published in JAMA, Lancet, or New England Journal of Medicine from 1990 to 2016. Two independent reviewers extracted the data. Data elements included the noninferiority margin and the success of studies in achieving noninferiority. The proportion of trials showing major or minor features that may have affected the noninferiority inference was determined. Major

SUBMITTER: Bikdeli B 

PROVIDER: S-EPMC8416048 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature