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

Published online by Cambridge University Press:  17 March 2020

Dongngan Truong
Affiliation:
University of Utah and Primary Children’s Hospital, Salt Lake City, UT, USA
Leo Lopez
Affiliation:
Stanford University, Palo Alto, CA, USA
Peter C. Frommelt
Affiliation:
Medical College of Wisconsin, Milwaukee, WI, USA
Jessica Stelter
Affiliation:
Medical College of Wisconsin, Milwaukee, WI, USA
Brenda Ni
Affiliation:
New England Research Institutes, Watertown, MA, USA
Meryl S. Cohen
Affiliation:
Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Ashwin Prakash
Affiliation:
Boston Children’s Hospital, Boston, MA, USA
Steven D. Colan
Affiliation:
Boston Children’s Hospital, Boston, MA, USA
Christopher Spurney
Affiliation:
Children’s National Health System, Washington D.C., USA
Jonathan Soslow
Affiliation:
Vanderbilt University Medical Center, Nashville, TN, USA
Gail D. Pearson
Affiliation:
National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA
Joseph Mahgerefteh
Affiliation:
Children’s Hospital at Montefiore, Albert Einstein School of Medicine, New York City, NY, USA
Ritu Sachdeva
Affiliation:
Emory University School of Medicine, Atlanta, GA, USA
Ricardo Pignatelli
Affiliation:
Texas Children’s Hospital/Baylor College of Medicine, Houston, TX, USA
Felicia Trachtenberg
Affiliation:
New England Research Institutes, Watertown, MA, USA
Mario Stylianou
Affiliation:
National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA
Karen Altmann
Affiliation:
Columbia University Medical Center, New York City, NY, USA
Kathleen A. Rathge
Affiliation:
Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
Joseph Camarda
Affiliation:
Ann and Robert H. Lurie Children’s Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
Shahryar Chowdhury
Affiliation:
Medical University of South Carolina, Charleston, SC, USA
Andreea Dragulescu
Affiliation:
Hospital for Sick Children, Toronto, ON, Canada
Michele Frommelt
Affiliation:
Medical College of Wisconsin, Milwaukee, WI, USA
Olukayode Garuba
Affiliation:
Texas Children’s Hospital/Baylor College of Medicine, Houston, TX, USA
Brian Soriano
Affiliation:
Seattle Children’s Heart Center, University of Washington School of Medicine, Seattle, WA, USA
Shubhika Srivastava
Affiliation:
Mount Sinai Hospital/Icahn School of Medicine, New York City, NY, USA
Poonam Thankavel
Affiliation:
UT Southwestern Medical Center, Dallas, TX, USA
Mary E. van der Velde
Affiliation:
Congenital Heart Center, C.S. Mott Children’s Hospital, University of Michigan, Ann Arbor, MI, USA
L. LuAnn Minich
Affiliation:
University of Utah and Primary Children’s Hospital, Salt Lake City, UT, USA
Corresponding

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.

Type
Original Article
Copyright
© The Author(s), 2020. Published by Cambridge University Press

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Footnotes

*

A list of all Pediatric Heart Network Investigators is provided (Online Supplement 1, S1).

References

Lopez, L, Colan, S, Stylianou, M, et al. Relationship of echocardiographic Z scores adjusted for body surface area to age, sex, race, and ethnicity: the pediatric heart network normal echocardiogram database. Circ Cardiovasc Imaging 2017; 10: e006979.CrossRefGoogle Scholar
Wagner, TH, Murray, C, Goldberg, J, Adler, JM, Abrams, J. Costs and benefits of the National Cancer Institute Central Institutional Review Board. J Clin Oncol 2010; 28: 662666.CrossRefGoogle ScholarPubMed
Flynn, KE, Hahn, CL, Kramer, JM, et al.Using central IRBs for multicenter clinical trials in the United States. PLoS One 2013; 8: 811.CrossRefGoogle ScholarPubMed
Lopez, L, Colan, SD, Frommelt, PC, et al.Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the pediatric measurements writing group of the american society of echocardiography pediatric and congenital heart disease council. J Am Soc Echocardiogr [Internet]. Elsevier Inc; 2010; 23: 465495. Available from: http://dx.doi.org/10.1016/j.echo.2010.03.019CrossRefGoogle ScholarPubMed
NOT-OD-01–053 : NIH Policy on Reporting Race and Ethnicity Data : Subjects in Clinic Research, Release Date August 8, 2001 110.Google Scholar
Gonzalez-Barrera, A, Hugo Lopez, M.Is being Hispanic a matter of race, ethnicity or both? Pew Res Cent 2015; 20142016.Google Scholar
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