Hostname: page-component-78c5997874-4rdpn Total loading time: 0 Render date: 2024-11-02T18:53:09.687Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Part of: Pediatric Heart Network

Published online by Cambridge University Press:  17 June 2019

Carol J. Prospero ,
Felicia L. Trachtenberg ,
Victoria L. Pemberton ,
Sara K. Pasquali ,
Brett R. Anderson ,
Kathleen E. Ash ,
Jessica Bainton ,
Carolyn Dunbar-Masterson ,
Eric M. Graham  and
Michelle S. Hamstra
...Show all authors
Carol J. Prospero
Affiliation:
Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, DE, USA
Felicia L. Trachtenberg
Affiliation:
New England Research Institutes, Watertown, MA, USA
Victoria L. Pemberton
Affiliation:
National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA
Sara K. Pasquali
Affiliation:
Division of Pediatric Cardiology, Department of Pediatrics, University of Michigan C.S. Mott Children’s Hospital, Ann Arbor, MI, USA
Brett R. Anderson
Affiliation:
Division of Pediatric Cardiology, New York Presbyterian/Morgan Stanley Children’s Hospital, New York, NY, USA
Kathleen E. Ash
Affiliation:
Division of Pediatric Cardiology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
Jessica Bainton
Affiliation:
Division of Pediatric Cardiology, The Hospital for Sick Children, Toronto, ON, Canada
Carolyn Dunbar-Masterson
Affiliation:
Department of Cardiology, Boston Children’s Hospital, Boston, MA, USA
Eric M. Graham
Affiliation:
Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC, USA
Michelle S. Hamstra
Affiliation:
Division of Pediatric Cardiology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA
Danielle Hollenbeck-Pringle
Affiliation:
New England Research Institutes, Watertown, MA, USA
Jeffrey P. Jacobs
Affiliation:
Department of Surgery, Johns Hopkins All Children’s Hospital, Saint Petersburg, FL, USA
Marshall L. Jacobs
Affiliation:
Division of Cardiac Surgery, Johns Hopkins Heart and Vascular Institute, Baltimore, MD, USA
Rija John
Affiliation:
Division of Congenital Heart Surgery, Texas Children’s Hospital, Houston, TX, USA
Linda M. Lambert
Affiliation:
Division of Pediatric Cardiothoracic Surgery, University of Utah, Salt Lake City, UT, USA
Matthew E. Oster
Affiliation:
Division of Pediatric Cardiology, Emory University School of Medicine, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Elizabeth Swan
Affiliation:
Division of Pediatric Cardiology, Riley Hospital for Children, Indianapolis, IN, USA
Abigail Waldron
Affiliation:
Division of Cardiology, Children’s Hospital Philadelphia, Philadelphia, PA, USA
Meena Nathan*
Affiliation:
Department of Cardiac Surgery, Boston Children’s Hospital, Boston, MA, USA
*
Author for correspondence: Meena Nathan MD, MPH, Department of Cardiac Surgery, Bader 273, Boston Children’s Hospital, 300 Longwood Ave, Boston, MA 02115, USA. Tel: +1 617 355 7932; Fax: +1 617 730 0214; E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

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.

Keywords

Research efficiencyprospective studiesregistry data
Type
Original Article
Information
Cardiology in the Young , Volume 29 , Issue 7 , July 2019 , pp. 930 - 938
Copyright
© Cambridge University Press 2019 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Pasquali, SK, Jacobs, JP, Farber, GK, et al. Report of the National Heart, Lung, and Blood Institute working group: an integrated network for congenital heart disease research. Circulation 2016; 133: 1410–1418.CrossRefGoogle Scholar
James, S, Rao, SV, Granger, CB. Registry-based randomized clinical trials – a new clinical trial paradigm. Nat Rev Cardiol 2015; 12: 312–316.CrossRefGoogle ScholarPubMed
Jones, WS, Roe, MT, Antman, EM, et al. The changing landscape of randomized clinical trials in cardiovascular disease. J Am Coll Cardiol 2016; 68: 1898–1907.CrossRefGoogle ScholarPubMed
Roe, MT, Mahaffey, KW, Ezekowitz, JA, et al. The future of cardiovascular clinical research in North America and beyond-addressing challenges and leveraging opportunities through unique academic and grassroots collaborations. Am Heart J 2015; 169: 743–750.CrossRefGoogle ScholarPubMed
Vener, DF, Gaies, M, Jacobs, JP, Pasquali, SK. Clinical databases and registries in congenital and pediatric cardiac surgery, cardiology, critical care, and anesthesiology worldwide. World J Pediatr Congenit Heart Surg 2017; 8: 77–87.CrossRefGoogle ScholarPubMed
Zannad, F, Pfeffer, MA, Bhatt, DL, et al. Streamlining cardiovascular clinical trials to improve efficiency and generalisability. Heart 2017; 103: 1156–1162.CrossRefGoogle ScholarPubMed
Lauer, MS, D’Agostino, RB Sr. The randomized registry trial – the next disruptive technology in clinical research? N Engl J Med 2013; 369: 1579–1581.CrossRefGoogle ScholarPubMed
Jacobs, ML, Jacobs, JP, Hill, KD, et al. The Society of Thoracic Surgeons Congenital Heart Surgery Database: 2017 update on research. Ann Thorac Surg 2017; 104: 731–741.CrossRefGoogle Scholar
Riehle-Colarusso, TJ, Bergersen, L, Broberg, CS, et al. Databases for congenital heart defect public health studies across the lifespan. J Am Heart Assoc 2016; 5.Google Scholar
Frobert, O, Lagerqvist, B, Olivecrona, GK, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013; 369: 1587–1597.CrossRefGoogle ScholarPubMed
Gaies, MG, Jeffries, HE, Niebler, RA, et al. Vasoactive-inotropic score is associated with outcome after infant cardiac surgery: an analysis from the pediatric cardiac critical care consortium and virtual PICU system registries. Pediatr Crit Care Med 2014; 15: 529–537.CrossRefGoogle ScholarPubMed
Rao, SV, Hess, CN, Barham, B, et al. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for women (study of access site for enhancement of PCI for women) trial. JACC Cardiovasc Interv 2014; 7: 857–867.CrossRefGoogle ScholarPubMed
Mahony, L, Sleeper, LA, Anderson, PA, et al. The pediatric heart network: a primer for the conduct of multicenter studies in children with congenital and acquired heart disease. Pediatr Cardiol 2006; 27: 191–198.CrossRefGoogle ScholarPubMed
Nathan, M, Jacobs, ML, Gaynor, JW, et al. Completeness and accuracy of local clinical registry data for children undergoing heart surgery. Ann Thorac Surg 2017; 103: 629–636.CrossRefGoogle ScholarPubMed
Clarke, DR, Breen, LS, Jacobs, ML, et al. Verification of data in congenital cardiac surgery. Cardiol Young 2008; 18: 177–187.CrossRefGoogle ScholarPubMed
Jacobs, JP, Jacobs, ML, Mavroudis, C, et al. Nomenclature and databases for the surgical treatment of congenital cardiac disease – an updated primer and an analysis of opportunities for improvement. Cardiol Young 2008; 18: 38–62.CrossRefGoogle Scholar
The Society for Thoracic Surgeons. STS Congenital Heart Surgery Database Data Specifications Version 3.22. 2013; https://www.sts.org/sites/default/files/documents/CongenitalDataSpecsV3_22.pdf Accessed 18 June, 2018.Google Scholar
Harris, PA, Taylor, R, Thielke, R, Payne, J, Gonzalez, N, Conde, JG. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377–381.CrossRefGoogle ScholarPubMed
Hess, CN, Rao, SV, Kong, DF, et al. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of access site for enhancement of percutaneous coronary intervention for women (SAFE-PCI for women). Am Heart J 2013; 166: 421–428.CrossRefGoogle Scholar
STeroids to REduce Systemic Inflammation after Neonatal Heart Surgery. https://ClinicalTrials.gov/show/NCT03229538. Accessed 8 January, 2018.Google Scholar
Hill, KD, Kannankeril, PJ. Perioperative corticosteroids in children undergoing congenital heart surgery: five decades of clinical equipoise. World J Pediatr Congenit Heart Surg 2018; 9: 294–296.CrossRefGoogle ScholarPubMed
Frobert, O, Lagerqvist, B, Gudnason, T, et al. Thrombus aspiration in ST-elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am Heart J 2010; 160: 1042–1048.CrossRefGoogle ScholarPubMed
Wachtell, K, Lagerqvist, B, Olivecrona, GK, James, SK, Frobert, O. Novel trial designs: lessons learned from thrombus aspiration during ST-segment elevation myocardial infarction in Scandinavia (TASTE) trial. Curr Cardiol Rep 2016; 18: 11.CrossRefGoogle ScholarPubMed
Supplementary material: PDF

Prospero et al. supplementary material

Prospero et al. supplementary material 1

Download Prospero et al. supplementary material(PDF)
PDF 50.6 KB