Surgical clinical trials with non-inferiority design: a cross-sectional bibliometric analysis.

ABSTRACT:

Background

Wide-spread concerns have been raised about possible bias in published surgical non-inferiority trials. Therefore, we performed a comprehensive bibliometric analysis to identify the existence of bias, and provided recommendations for future non-inferiority trials.

Methods

Databases including MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched (last update on 27 April 2020) to include published phase II and phase III non-inferiority surgical trials. We collected general information and parameters associated with trial design. The association between extracted factors and establishment of non-inferiority was then analyzed.

Results

A total of 347 trials were included in this study. Only 13 (3.7%) trials reported

SUBMITTER: Shu C 

PROVIDER: S-EPMC8422099 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature