Carol J Prospero1, Felicia L Trachtenberg2, Victoria L Pemberton3, Sara K Pasquali4, Brett R Anderson5, Kathleen E Ash6, Jessica Bainton7, Carolyn Dunbar-Masterson8, Eric M Graham9, Michelle S Hamstra6, Danielle Hollenbeck-Pringle2, Jeffrey P Jacobs10, Marshall L Jacobs11, Rija John12, Linda M Lambert13, Matthew E Oster14, Elizabeth Swan15, Abigail Waldron16, Meena Nathan17. 1. Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, DE, USA. 2. New England Research Institutes, Watertown, MA, USA. 3. National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA. 4. Division of Pediatric Cardiology, Department of Pediatrics, University of Michigan C.S. Mott Children's Hospital, Ann Arbor, MI, USA. 5. Division of Pediatric Cardiology, New York Presbyterian/Morgan Stanley Children's Hospital, New York, NY, USA. 6. Division of Pediatric Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. 7. Division of Pediatric Cardiology, The Hospital for Sick Children, Toronto, ON, Canada. 8. Department of Cardiology, Boston Children's Hospital, Boston, MA, USA. 9. Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC, USA. 10. Department of Surgery, Johns Hopkins All Children's Hospital, Saint Petersburg, FL, USA. 11. Division of Cardiac Surgery, Johns Hopkins Heart and Vascular Institute, Baltimore, MD, USA. 12. Division of Congenital Heart Surgery, Texas Children's Hospital, Houston, TX, USA. 13. Division of Pediatric Cardiothoracic Surgery, University of Utah, Salt Lake City, UT, USA. 14. Division of Pediatric Cardiology, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, USA. 15. Division of Pediatric Cardiology, Riley Hospital for Children, Indianapolis, IN, USA. 16. Division of Cardiology, Children's Hospital Philadelphia, Philadelphia, PA, USA. 17. Department of Cardiac Surgery, Boston Children's Hospital, Boston, MA, USA.
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.
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.
Entities:
Keywords:
Research efficiency; prospective studies; registry data
Authors: Ole Fröbert; Bo Lagerqvist; Göran K Olivecrona; Elmir Omerovic; Thorarinn Gudnason; Michael Maeng; Mikael Aasa; Oskar Angerås; Fredrik Calais; Mikael Danielewicz; David Erlinge; Lars Hellsten; Ulf Jensen; Agneta C Johansson; Amra Kåregren; Johan Nilsson; Lotta Robertson; Lennart Sandhall; Iwar Sjögren; Ollie Ostlund; Jan Harnek; Stefan K James Journal: N Engl J Med Date: 2013-08-31 Impact factor: 91.245
Authors: Paul A Harris; Robert Taylor; Robert Thielke; Jonathon Payne; Nathaniel Gonzalez; Jose G Conde Journal: J Biomed Inform Date: 2008-09-30 Impact factor: 6.317
Authors: Connie N Hess; Sunil V Rao; David F Kong; Laura H Aberle; Kevin J Anstrom; C Michael Gibson; Ian C Gilchrist; Alice K Jacobs; Sanjit S Jolly; Roxana Mehran; John C Messenger; L Kristin Newby; Ron Waksman; Mitchell W Krucoff Journal: Am Heart J Date: 2013-07-23 Impact factor: 4.749
Authors: Sunil V Rao; Connie N Hess; Britt Barham; Laura H Aberle; Kevin J Anstrom; Tejan B Patel; Jesse P Jorgensen; Ernest L Mazzaferri; Sanjit S Jolly; Alice Jacobs; L Kristin Newby; C Michael Gibson; David F Kong; Roxana Mehran; Ron Waksman; Ian C Gilchrist; Brian J McCourt; John C Messenger; Eric D Peterson; Robert A Harrington; Mitchell W Krucoff Journal: JACC Cardiovasc Interv Date: 2014-08 Impact factor: 11.195
Authors: Ole Fröbert; Bo Lagerqvist; Thórarinn Gudnason; Leif Thuesen; Roger Svensson; Göran K Olivecrona; Stefan K James Journal: Am Heart J Date: 2010-12 Impact factor: 4.749
Authors: L Mahony; L A Sleeper; P A W Anderson; W M Gersony; B W McCrindle; L L Minich; J W Newburger; J P Saul; V L Vetter; G D Pearson Journal: Pediatr Cardiol Date: 2006 Mar-Apr Impact factor: 1.655
Authors: Michael G Gaies; Howard E Jeffries; Robert A Niebler; Sara K Pasquali; Janet E Donohue; Sunkyung Yu; Christine Gall; Tom B Rice; Ravi R Thiagarajan Journal: Pediatr Crit Care Med Date: 2014-07 Impact factor: 3.624
Authors: Jeffrey Phillip Jacobs; Marshall Lewis Jacobs; Constantine Mavroudis; Carl Lewis Backer; Francois G Lacour-Gayet; Christo I Tchervenkov; Rodney C G Franklin; Marie J Béland; Kathy J Jenkins; Hal Walters; Emile A Bacha; Bohdan Maruszewski; Hiromi Kurosawa; David Robinson Clarke; J William Gaynor; Thomas L Spray; Giovanni Stellin; Tjark Ebels; Otto N Krogmann; Vera D Aiello; Steven D Colan; Paul Weinberg; Jorge M Giroud; Allen Everett; Gil Wernovsky; Martin J Elliott; Fred H Edwards Journal: Cardiol Young Date: 2008-12 Impact factor: 1.093
Authors: David R Clarke; Linda S Breen; Marshall L Jacobs; Rodney C G Franklin; Zdzislaw Tobota; Bohdan Maruszewski; Jeffrey P Jacobs Journal: Cardiol Young Date: 2008-12 Impact factor: 1.093
Authors: Marshall L Jacobs; Jeffrey P Jacobs; Kevin D Hill; Sean M O'Brien; Sara K Pasquali; David Vener; S Ram Kumar; Karen Chiswell; James D St Louis; John E Mayer; Robert H Habib; David M Shahian; Felix G Fernandez Journal: Ann Thorac Surg Date: 2019-07-20 Impact factor: 4.330