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
N1 - Publisher Copyright:
© 2020 The Author(s). Published by Cambridge University Press.
PY - 2020/4/1
Y1 - 2020/4/1
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
UR - https://www.scopus.com/pages/publications/85082703541
U2 - 10.1017/S1047951120000438
DO - 10.1017/S1047951120000438
M3 - Article
C2 - 32180543
AN - SCOPUS:85082703541
SN - 1047-9511
VL - 30
SP - 456
EP - 461
JO - Cardiology in the Young
JF - Cardiology in the Young
IS - 4
ER -