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 participants, centre categorisation of Hispanic participants that differed from National Institutes of Health definitions, and exclusion of potential participants due to missing demographic data. Institutional Review Board amendments resolved many of these challenges. There was an unanticipated burden imposed on centres due to high numbers of echocardiograms that were reviewed but failed to meet submission criteria. Additionally, image transfer software malfunctions delayed Core Lab image review and feedback. Between the early and late study periods, the proportion of unacceptable echocardiograms submitted to the Core Lab decreased (14 versus 7%, p < 0.01). Most protocol violations were from eligibility violations and inadvertent protected health information disclosure (overall 2.5%). Adjudication committee reviews led to protocol changes.Conclusions:Numerous challenges encountered during the Normal Echocardiogram Database Study prolonged study enrolment. The retrospective design and flaws in image transfer software were key impediments to study completion and should be considered when designing future studies collecting echocardiographic images as a primary outcome.

Challenges associated with retrospective analysis of left ventricular function using clinical echocardiograms from a multicenter research study

“…These studies had been performed for a variety of clinical indications such as murmur, chest pain, and syncope in otherwise healthy children and deemed normal. Nearly 56% of the studies were excluded by the centers due to inadequate or incomplete imaging 18 . Despite extensive screening at each center prior to submitting the studies to the core laboratory, 10% of the submitted studies did not contain all of the required echocardiographic parameters 17,18 .…”

“…Nearly 56% of the studies were excluded by the centers due to inadequate or incomplete imaging. 18 Despite extensive screening at each center prior to submitting the studies to the core laboratory, 10% of the submitted studies did not contain all of the required echocardiographic parameters. 17,18 Our results are similar, in that 66% of our studies had at least one quality issue, many prohibiting comprehensive analysis of cardiac function.…”

Heart University: a new online educational forum in paediatric and adult congenital cardiac care. The future of virtual learning in a post-pandemic world?

“…Another area of collaboration is that Heart University will begin to Cardiology in the Young feature White Papers, Guideline Papers, and Landmark Papers published in Cardiology in the Young. 18,22,23 Approximately every 4 months, Cardiology in the Young will provide Heart University with a new "hot of the press" major paper that is published in Cardiology in the Young. Heart University will post and highlight this paper on the Heart University site.…”