Detecting Anomalies Among Practice Sites Within Multicenter Trials.

ABSTRACT:

Background

Recent multisite trials reveal striking heterogeneities in results between trial sites. These may be because of population differences indicating different treatment benefits among different types of participants or site anomalies, such as failures to adhere to study protocols that could negatively affect study validity. We sought to determine whether a new data analysis strategy-transportability methods-could suggest site anomalies not readily identified through standard methods.

Methods and results

We applied transportability methods to 2 large, multicenter cardiovascular disease treatment trials: the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist; n=3445) comparing spironolactone to placebo for heart failure (

SUBMITTER: Berkowitz SA 

PROVIDER: S-EPMC6578590 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature