Challenges and lessons learned from the Pediatric Heart Network Normal Echocardiogram Database study.

ABSTRACT:

Background

The Pediatric Heart Network Normal Echocardiogram Database Study had unanticipated challenges. We sought to describe these challenges and lessons learned to improve the design of future studies.

Methods

Challenges were divided into three categories: enrolment, echocardiographic imaging, and protocol violations. Memoranda, Core Lab reports, and adjudication logs were reviewed. A centre-level questionnaire provided information regarding local processes for data collection. Descriptive statistics were used, and chi-square tests determined differences in imaging quality.

Results

For the 19 participating centres, challenges with enrolment included variations in Institutional Review Board definitions of "retrospective" eligibility, overestimation of non-White par

SUBMITTER: Truong D 

PROVIDER: S-EPMC7255408 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature