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

被引：3

作者：

Truong, Dongngan ^{[1
,2
]}

Lopez, Leo ^{[3
]}

Frommelt, Peter C. ^{[4
]}

Stelter, Jessica ^{[4
]}

Ni, Brenda ^{[5
]}

Cohen, Meryl S. ^{[6
]}

Prakash, Ashwin ^{[7
]}

Colan, Steven D. ^{[7
]}

Spurney, Christopher ^{[8
]}

Soslow, Jonathan ^{[9
]}

Pearson, Gail D. ^{[10
]}

Mahgerefteh, Joseph ^{[11
]}

Sachdeva, Ritu ^{[12
]}

Pignatelli, Ricardo ^{[13
]}

Trachtenberg, Felicia ^{[5
]}

Stylianou, Mario ^{[10
]}

Altmann, Karen ^{[14
]}

Rathge, Kathleen A. ^{[15
]}

Camarda, Joseph ^{[16
]}

Chowdhury, Shahryar ^{[17
]}

Dragulescu, Andreea ^{[18
]}

Frommelt, Michele ^{[4
]}

Garuba, Olukayode ^{[13
]}

Soriano, Brian ^{[19
]}

Srivastava, Shubhika ^{[20
]}

Thankavel, Poonam ^{[21
]}

van der Velde, Mary E. ^{[22
]}

Minich, L. LuAnn ^{[1
,2
]}

机构：

[1] Univ Utah, 81 North Mario Capecchi Dr, Salt Lake City, UT 84113 USA

[2] Primary Childrens Med Ctr, 81 North Mario Capecchi Dr, Salt Lake City, UT 84113 USA

[3] Stanford Univ, Palo Alto, CA 94304 USA

[4] Med Coll Wisconsin, Milwaukee, WI 53226 USA

[5] New England Res Inst, 9 Galen St, Watertown, MA 02172 USA

[6] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA

[7] Boston Childrens Hosp, Boston, MA USA

[8] Childrens Natl Hlth Syst, Washington, DC USA

[9] Vanderbilt Univ, Med Ctr, Nashville, TN USA

[10] NHLBI, NIH, Bldg 10, Bethesda, MD 20892 USA

[11] Childrens Hosp Montefiore, Albert Einstein Sch Med, New York, NY USA

[12] Emory Univ, Sch Med, Atlanta, GA USA

[13] Texas Childrens Hosp, Baylor Coll Med, Houston, TX 77030 USA

[14] Columbia Univ, Med Ctr, New York, NY USA

[15] Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH 45229 USA

[16] Northwestern Univ, Ann & Robert H Lurie Childrens Hosp Chicago, Feinberg Sch Med, Chicago, IL USA

[17] Med Univ South Carolina, Charleston, SC 29425 USA

[18] Hosp Sick Children, Toronto, ON, Canada

[19] Univ Washington, Sch Med, Seattle Childrens Heart Ctr, Seattle, WA USA

[20] Mt Sinai Hosp, Icahn Sch Med, New York, NY 10029 USA

[21] UT Southwestern Med Ctr, Dallas, TX USA

[22] Univ Michigan, CS Mott Childrens Hosp, Congenital Heart Ctr, Ann Arbor, MI 48109 USA

来源：

CARDIOLOGY IN THE YOUNG | 2020年 / 30卷 / 04期

关键词：

Echocardiography; paediatric cardiology; Challenges;

D O I：

10.1017/S1047951120000438

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：456 / 461

页数：6

共 6 条

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