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

  • Dongngan Truong (a1), Leo Lopez (a2), Peter C. Frommelt (a3), Jessica Stelter (a3), Brenda Ni (a4), Meryl S. Cohen (a5), Ashwin Prakash (a6), Steven D. Colan (a6), Christopher Spurney (a7), Jonathan Soslow (a8), Gail D. Pearson (a9), Joseph Mahgerefteh (a10), Ritu Sachdeva (a11), Ricardo Pignatelli (a12), Felicia Trachtenberg (a4), Mario Stylianou (a9), Karen Altmann (a13), Kathleen A. Rathge (a14), Joseph Camarda (a15), Shahryar Chowdhury (a16), Andreea Dragulescu (a17), Michele Frommelt (a3), Olukayode Garuba (a12), Brian Soriano (a18), Shubhika Srivastava (a19), Poonam Thankavel (a20), Mary E. van der Velde (a21), L. LuAnn Minich (a1) and For the Pediatric Heart Network Investigators...

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.

Copyright

Corresponding author

Author for correspondence: Dongngan Truong, 81 North Mario Capecchi Drive, University of Utah and Primary Children’s Hospital, Salt Lake City, UT84113, USA. Tel: 801-213-3599. E-mail: Dongngan.truong@hsc.utah.edu

Footnotes

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

Footnotes

References

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1.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.
2.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.
3.Flynn, KE, Hahn, CL, Kramer, JM, et al.Using central IRBs for multicenter clinical trials in the United States. PLoS One 2013; 8: 811.
4.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.2010.03.019
5.NOT-OD-01–053 : NIH Policy on Reporting Race and Ethnicity Data : Subjects in Clinic Research, Release Date August 8, 2001 110.
6.Gonzalez-Barrera, A, Hugo Lopez, M.Is being Hispanic a matter of race, ethnicity or both? Pew Res Cent 2015; 20142016.

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

  • Dongngan Truong (a1), Leo Lopez (a2), Peter C. Frommelt (a3), Jessica Stelter (a3), Brenda Ni (a4), Meryl S. Cohen (a5), Ashwin Prakash (a6), Steven D. Colan (a6), Christopher Spurney (a7), Jonathan Soslow (a8), Gail D. Pearson (a9), Joseph Mahgerefteh (a10), Ritu Sachdeva (a11), Ricardo Pignatelli (a12), Felicia Trachtenberg (a4), Mario Stylianou (a9), Karen Altmann (a13), Kathleen A. Rathge (a14), Joseph Camarda (a15), Shahryar Chowdhury (a16), Andreea Dragulescu (a17), Michele Frommelt (a3), Olukayode Garuba (a12), Brian Soriano (a18), Shubhika Srivastava (a19), Poonam Thankavel (a20), Mary E. van der Velde (a21), L. LuAnn Minich (a1) and For the Pediatric Heart Network Investigators...

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