Lessons learned in the use of clinical registry data in a multi-centre prospective study: the Pediatric Heart Network Residual Lesion Score Study

• Type of Material: Article
• Authors: Carol J. Prospero, Alfred I. duPont Hospital for Children; Felicia L. Trachtenberg, New England Research Institutes; Victoria L. Pemberton, National Heart, Lung, and Blood Institute; Sara K. Pasquali, University of Michigan; Brett R. Anderson, New York Presbyterian Morgan Stanley Children's Hospital; Kathleen E. Ash, Cincinnati Children's Hospital Medical Center; Jessica Bainton, Hospital for Sick Children; Carolyn Dunbar-Masterson, Boston Children's Hospital; Eric M. Graham, Medical University of South Carolina; Michelle S. Hamstra, Cincinnati Children's Hospital Medical Center; Danielle Hollenbeck-Pringle, New England Research Institutes; Jeffrey P. Jacobs, Johns Hopkins All Children's Hospital; Marshall L. Jacobs, Johns Hopkins Heart and Vascular Institute; Rija John, Texas Children's Hospital; Linda M. Lambert, University of Utah; Matthew Oster, Emory University; Elizabeth Swan, Riley Hospital for Children; Abigail Waldron, Children's Hospital of Philadelphia; Meena Nathan, Boston Children's Hospital
• Language: English
• Date: 2019-07-01
• Publisher: CAMBRIDGE UNIV PRESS
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © Cambridge University Press 2019.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1017/S1047951119001148
• Title of Journal or Parent Work: CARDIOLOGY IN THE YOUNG
• Volume: 29
• Issue: 7
• Start Page: 930
• End Page: 938
• Grant/Funding Information: The study was supported by grants (U24HL135691, U10HL068270, HL109818, HL109778, HL109816, HL109743, HL109741, HL109673, HL068270, HL109781, HL135665 and HL135680) from the National Heart, Lung, and Blood Institute, National Institutes of Health. Meena Nathan was supported by a K23 grant (NHLBI/NIH HL119600). Brett Anderson was supported by a K23 grant (NHLBI/NIH HL133454). The contents of this work are solely the responsibility of the authors and do not necessarily represent the official views of the National Heart, Lung, and Blood Institute.
• Keywords: PERCUTANEOUS CORONARY INTERVENTION; Life Sciences & Biomedicine; ACCESS SITE; Pediatrics; TRIAL; THROMBUS ASPIRATION; CRITICAL-CARE; Cardiac & Cardiovascular Systems; registry data; Science & Technology; ENHANCEMENT; CHILDREN; SAFE-PCI; prospective studies; CARDIAC-SURGERY; Research efficiency; Cardiovascular System & Cardiology; OPPORTUNITIES
• Research Categories: Health Sciences, Health Care Management; Biology, Anatomy; Health Sciences, Medicine and Surgery

Abstract

Background: Using existing data from clinical registries to support clinical trials and other prospective studies has the potential to improve research efficiency. However, little has been reported about staff experiences and lessons learned from implementation of this method in pediatric cardiology.Objectives: We describe the process of using existing registry data in the Pediatric Heart Network Residual Lesion Score Study, report stakeholders' perspectives, and provide recommendations to guide future studies using this methodology.Methods: The Residual Lesion Score Study, a 17-site prospective, observational study, piloted the use of existing local surgical registry data (collected for submission to the Society of Thoracic Surgeons-Congenital Heart Surgery Database) to supplement manual data collection. A survey regarding processes and perceptions was administered to study site and data coordinating center staff.Results: Survey response rate was 98% (54/55). Overall, 57% perceived that using registry data saved research staff time in the current study, and 74% perceived that it would save time in future studies; 55% noted significant upfront time in developing a methodology for extracting registry data. Survey recommendations included simplifying data extraction processes and tailoring to the needs of the study, understanding registry characteristics to maximise data quality and security, and involving all stakeholders in design and implementation processes.Conclusions: Use of existing registry data was perceived to save time and promote efficiency. Consideration must be given to the upfront investment of time and resources needed. Ongoing efforts focussed on automating and centralising data management may aid in further optimising this methodology for future studies.