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

• Type of Material: Article
• Authors: Dongngan Truong, University of Utah; Leo Lopez, Stanford University; Peter C. Frommelt, Medical College of Wisconsin; Jessica Stelter, Medical College of Wisconsin; Brenda Ni, New England Research Institutes; Meryl S. Cohen, Childrens Hospital of Philadelphia; Ashwin Prakash, Boston Children's Hospital; Steven D. Colan, Boston Children's Hospital; Christopher Spurney, Childrens National Health System; Jonathan Soslow, Vanderbilt University; Gail D. Pearson, National Heart, Lung, and Blood Institute; Joseph Mahgerefteh, Childrens Hospital of Montefiore; Ritu Sachdeva, Emory University; Ricardo Pignatelli, Texas Children's Hospital; Felicia Trachtenberg, New England Research Institutes; Mario Stylianou, National Heart, Lung, and Blood Institute; Karen Altmann, Columbia University; Kathleen A. Rathge, Cincinnati Childrens Hospital Medical Center; Joseph Camarda, Northwestern University; Shahryar Chowdhury, Medical University of South Carolina; Andreea Dragulescu, Hosp Sick Children; Michele Frommelt, Medical College of Wisconsin; Olukayode Garuba, Texas Children's Hospital; Brian Soriano, University of Washington; Shubhika Srivastava, Mt Sinai Hospital; Poonam Thankavel, University of Texas Southwestern; Mary E. van der Velde, University of Michigan; L. LuAnn Minich, University of Utah
• Language: English
• Date: 2020-04-01
• Publisher: CAMBRIDGE UNIV PRESS
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2020, Cambridge University Press
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1017/S1047951120000438
• Title of Journal or Parent Work: CARDIOLOGY IN THE YOUNG
• Volume: 30
• Issue: 4
• Start Page: 456
• End Page: 461
• Grant/Funding Information: Funded by NHLBI/DHHS U01 Grant #HL68270. The study was supported by grants (5UG1HL135685-02, 5UG1HL135682-02, 5UG1Hl135683-02, 5UG1HL135665-02, 5UG1HL135689-02, 5U24HL135691-02, 5UG1HL135678-02, 5UG1HL135680-02, 5UG1HL135666-02, and 5UG1HL135646-02) from the National Heart, Lung, and Blood Institute, NIH.
• Keywords: Life Sciences & Biomedicine; Pediatrics; Challenges; Science & Technology; Echocardiography; Cardiac & Cardiovascular Systems; paediatric cardiology; Cardiovascular System & Cardiology

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.