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

Dongngan Truong; Leo Lopez; Peter C. Frommelt; Jessica Stelter; Brenda Ni; Meryl S. Cohen; Ashwin Prakash; Steven D. Colan; Christopher Spurney; Jonathan Soslow; Gail D. Pearson; Joseph Mahgerefteh; Ritu Sachdeva; Ricardo Pignatelli; Felicia Trachtenberg; Mario Stylianou; Karen Altmann; Kathleen A. Rathge; Joseph Camarda; Shahryar Chowdhury; Andreea Dragulescu; Michele Frommelt; Olukayode Garuba; Brian Soriano; Shubhika Srivastava; Poonam Thankavel; Mary E. Van Der Velde; L. Luann Minich

doi:10.1017/S1047951120000438

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

Dongngan Truong, Leo Lopez, Peter C. Frommelt, Jessica Stelter, Brenda Ni, Meryl S. Cohen, Ashwin Prakash, Steven D. Colan, Christopher Spurney, Jonathan Soslow, Gail D. Pearson, Joseph Mahgerefteh, Ritu Sachdeva, Ricardo Pignatelli, Felicia Trachtenberg, Mario Stylianou, Karen Altmann, Kathleen A. Rathge, Joseph Camarda, Shahryar ChowdhuryAndreea Dragulescu, Michele Frommelt, Olukayode Garuba, Brian Soriano, Shubhika Srivastava, Poonam Thankavel, Mary E. Van Der Velde, L. Luann Minich

Research output: Contribution to journal › Review article › peer-review

3 Scopus citations

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.

Original language	English (US)
Journal	Cardiology in the Young
DOIs	https://doi.org/10.1017/S1047951120000438
State	Accepted/In press - 2020

Keywords

Challenges
Echocardiography
paediatric cardiology

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health
Cardiology and Cardiovascular Medicine

Access to Document

10.1017/S1047951120000438

Cite this

Truong, D., Lopez, L., Frommelt, P. C., Stelter, J., Ni, B., Cohen, M. S., Prakash, A., Colan, S. D., Spurney, C., Soslow, J., Pearson, G. D., Mahgerefteh, J., Sachdeva, R., Pignatelli, R., Trachtenberg, F., Stylianou, M., Altmann, K., Rathge, K. A., Camarda, J., ... Minich, L. L. (Accepted/In press). Challenges and lessons learned from the Pediatric Heart Network Normal Echocardiogram Database study. Cardiology in the Young. https://doi.org/10.1017/S1047951120000438

Truong, D, Lopez, L, Frommelt, PC, Stelter, J, Ni, B, Cohen, MS, Prakash, A, Colan, SD, Spurney, C, Soslow, J, Pearson, GD, Mahgerefteh, J, Sachdeva, R, Pignatelli, R, Trachtenberg, F, Stylianou, M, Altmann, K, Rathge, KA, Camarda, J, Chowdhury, S, Dragulescu, A, Frommelt, M, Garuba, O, Soriano, B, Srivastava, S, Thankavel, P, Van Der Velde, ME & Minich, LL 2020, 'Challenges and lessons learned from the Pediatric Heart Network Normal Echocardiogram Database study', Cardiology in the Young. https://doi.org/10.1017/S1047951120000438

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title = "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.",

keywords = "Challenges, Echocardiography, paediatric cardiology",

author = "Dongngan Truong and Leo Lopez and Frommelt, {Peter C.} and Jessica Stelter and Brenda Ni and Cohen, {Meryl S.} and Ashwin Prakash and Colan, {Steven D.} and Christopher Spurney and Jonathan Soslow and Pearson, {Gail D.} and Joseph Mahgerefteh and Ritu Sachdeva and Ricardo Pignatelli and Felicia Trachtenberg and Mario Stylianou and Karen Altmann and Rathge, {Kathleen A.} and Joseph Camarda and Shahryar Chowdhury and Andreea Dragulescu and Michele Frommelt and Olukayode Garuba and Brian Soriano and Shubhika Srivastava and Poonam Thankavel and {Van Der Velde}, {Mary E.} and Minich, {L. Luann}",

note = "Publisher Copyright: {\textcopyright} 2020 The Author(s). Published by Cambridge University Press.",

year = "2020",

doi = "10.1017/S1047951120000438",

language = "English (US)",

journal = "Cardiology in the Young",

issn = "1047-9511",

publisher = "Cambridge University Press",

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TY - JOUR

T1 - Challenges and lessons learned from the Pediatric Heart Network Normal Echocardiogram Database study

AU - Truong, Dongngan

AU - Lopez, Leo

AU - Frommelt, Peter C.

AU - Stelter, Jessica

AU - Ni, Brenda

AU - Cohen, Meryl S.

AU - Prakash, Ashwin

AU - Colan, Steven D.

AU - Spurney, Christopher

AU - Soslow, Jonathan

AU - Pearson, Gail D.

AU - Mahgerefteh, Joseph

AU - Sachdeva, Ritu

AU - Pignatelli, Ricardo

AU - Trachtenberg, Felicia

AU - Stylianou, Mario

AU - Altmann, Karen

AU - Rathge, Kathleen A.

AU - Camarda, Joseph

AU - Chowdhury, Shahryar

AU - Dragulescu, Andreea

AU - Frommelt, Michele

AU - Garuba, Olukayode

AU - Soriano, Brian

AU - Srivastava, Shubhika

AU - Thankavel, Poonam

AU - Van Der Velde, Mary E.

AU - Minich, L. Luann

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Challenges

KW - Echocardiography

KW - paediatric cardiology

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UR - http://www.scopus.com/inward/citedby.url?scp=85082703541&partnerID=8YFLogxK

U2 - 10.1017/S1047951120000438

DO - 10.1017/S1047951120000438

M3 - Review article

C2 - 32180543

AN - SCOPUS:85082703541

SN - 1047-9511

JO - Cardiology in the Young

JF - Cardiology in the Young

ER -

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

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