Dongngan Truong1, Leo Lopez2, Peter C Frommelt3, Jessica Stelter3, Brenda Ni4, Meryl S Cohen5, Ashwin Prakash6, Steven D Colan6, Christopher Spurney7, Jonathan Soslow8, Gail D Pearson9, Joseph Mahgerefteh10, Ritu Sachdeva11, Ricardo Pignatelli12, Felicia Trachtenberg4, Mario Stylianou9, Karen Altmann13, Kathleen A Rathge14, Joseph Camarda15, Shahryar Chowdhury16, Andreea Dragulescu17, Michele Frommelt3, Olukayode Garuba12, Brian Soriano18, Shubhika Srivastava19, Poonam Thankavel20, Mary E van der Velde21, L LuAnn Minich1. 1. University of Utah and Primary Children's Hospital, Salt Lake City, UT, USA. 2. Stanford University, Palo Alto, CA, USA. 3. Medical College of Wisconsin, Milwaukee, WI, USA. 4. New England Research Institutes, Watertown, MA, USA. 5. Children's Hospital of Philadelphia, Philadelphia, PA, USA. 6. Boston Children's Hospital, Boston, MA, USA. 7. Children's National Health System, Washington D.C., USA. 8. Vanderbilt University Medical Center, Nashville, TN, USA. 9. National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA. 10. Children's Hospital at Montefiore, Albert Einstein School of Medicine, New York City, NY, USA. 11. Emory University School of Medicine, Atlanta, GA, USA. 12. Texas Children's Hospital/Baylor College of Medicine, Houston, TX, USA. 13. Columbia University Medical Center, New York City, NY, USA. 14. Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. 15. Ann and Robert H. Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 16. Medical University of South Carolina, Charleston, SC, USA. 17. Hospital for Sick Children, Toronto, ON, Canada. 18. Seattle Children's Heart Center, University of Washington School of Medicine, Seattle, WA, USA. 19. Mount Sinai Hospital/Icahn School of Medicine, New York City, NY, USA. 20. UT Southwestern Medical Center, Dallas, TX, USA. 21. Congenital Heart Center, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI, USA.
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.
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.
Authors: Leo Lopez; Steven D Colan; Peter C Frommelt; Gregory J Ensing; Kathleen Kendall; Adel K Younoszai; Wyman W Lai; Tal Geva Journal: J Am Soc Echocardiogr Date: 2010-05 Impact factor: 5.251
Authors: Kathryn E Flynn; Cynthia L Hahn; Judith M Kramer; Devon K Check; Carrie B Dombeck; Soo Bang; Jane Perlmutter; Felix A Khin-Maung-Gyi; Kevin P Weinfurt Journal: PLoS One Date: 2013-01-30 Impact factor: 3.240
Authors: Ritu Sachdeva; Kayla L Stratton; David E Cox; Saro H Armenian; Aarti Bhat; William L Border; Kasey J Leger; Wendy M Leisenring; Lillian R Meacham; Karim T Sadak; Shanti Narasimhan; Eric J Chow; Paul C Nathan Journal: Echocardiography Date: 2021-01-24 Impact factor: 1.724
Authors: Justin T Tretter; Jonathan Windram; Theresa Faulkner; Michelle Hudgens; Skaiste Sendzikaite; Nico A Blom; Katarina Hanseus; Rohit S Loomba; Colin J McMahon; Bistra Zheleva; Raman Krishna Kumar; Jeffrey P Jacobs; Erwin N Oechslin; Gary D Webb; Andrew N Redington Journal: Cardiol Young Date: 2020-04-13 Impact factor: 1.093