Hostname: page-component-586b7cd67f-gb8f7 Total loading time: 0 Render date: 2024-11-22T20:42:52.319Z Has data issue: false hasContentIssue false
  • English
  • Français

Enhancing efficiency and scientific impact of a clinical trials network: the Pediatric Heart Network Integrated CARdiac Data and Outcomes (iCARD) Collaborative

Part of: Pediatric Heart Network

Published online by Cambridge University Press:  06 August 2019

Sara K. Pasquali Open the ORCID record for Sara K. Pasquali [Opens in a new window] ,
Jonathan R. Kaltman ,
J. William Gaynor ,
Brian W. McCrindle ,
Jane W. Newburger ,
Brett R. Anderson ,
Mark A. Scheurer ,
Nelangi M. Pinto ,
Jeffrey B. Anderson  and
Matthew E. Oster
...Show all authors
Sara K. Pasquali*
Affiliation:
Department of Pediatrics, University of Michigan C.S. Mott Children’s Hospital, Ann Arbor, MI, USA
Jonathan R. Kaltman
Affiliation:
Division of Cardiovascular Sciences, The National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA
J. William Gaynor
Affiliation:
Department of Surgery, Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Brian W. McCrindle
Affiliation:
Department of Pediatrics, University of Toronto, Labatt Family Heart Centre, The Hospital for Sick Children, Toronto, Ontario, Canada
Jane W. Newburger
Affiliation:
Department of Cardiology, Boston Children’s Hospital, Department of Pediatrics, Harvard Medical School, Boston, MA, USA
Brett R. Anderson
Affiliation:
Division of Pediatric Cardiology, New York-Presbyterian/Morgan Stanley Children’s Hospital, Columbia University Irving Medical Center, New York, NY, USA
Mark A. Scheurer
Affiliation:
Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA
Nelangi M. Pinto
Affiliation:
Department of Pediatrics, University of Utah, Salt Lake City, UT, USA
Jeffrey B. Anderson
Affiliation:
Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
Matthew E. Oster
Affiliation:
Emory University School of Medicine, Children’s Healthcare of Atlanta, Atlanta, GA, USA
Jeffrey P. Jacobs
Affiliation:
Department of Surgery, Johns Hopkins All Children’s Heart Institute, St. Petersburg, FL, USA
Bradley S. Marino
Affiliation:
Department of Pediatrics, Northwestern University Feinberg School of Medicine, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL, USA
Carlos M. Mery
Affiliation:
Texas Center for Pediatric and Congenital Heart Disease, University of Texas Dell Medical School / Dell Children’s Medical Center, Austin, TX, USA
Gail D. Pearson
Affiliation:
Division of Cardiovascular Sciences, The National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA
*
Author for correspondence: S. Pasquali, MD, University of Michigan C.S. Mott Children’s Hospital, 1540 E. Hospital Drive, Ann Arbor, MI 48105, USA. Tel: 734-232-8594; Fax: 734-936-9470; E-mail: [email protected]
Get access Rights & Permissions [Opens in a new window]

Abstract

Recent years have seen an exponential increase in the variety of healthcare data captured across numerous sources. However, mechanisms to leverage these data sources to support scientific investigation have remained limited. In 2013 the Pediatric Heart Network (PHN), funded by the National Heart, Lung, and Blood Institute, developed the Integrated CARdiac Data and Outcomes (iCARD) Collaborative with the goals of leveraging available data sources to aid in efficiently planning and conducting PHN studies; supporting integration of PHN data with other sources to foster novel research otherwise not possible; and mentoring young investigators in these areas. This review describes lessons learned through the development of iCARD, initial efforts and scientific output, challenges, and future directions. This information can aid in the use and optimisation of data integration methodologies across other research networks and organisations.

Keywords

CHDoutcomesdatabase
Type
Review Article
Information
Cardiology in the Young , Volume 29 , Issue 9 , September 2019 , pp. 1121 - 1126
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

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
Vener, DF, Gaies, MG, Jacobs, JP, Pasquali, SK. Clinical databases and registries in congenital cardiac surgery, critical care, and anesthesiology worldwide. World J Pediatr Congenit Heart Surg 2017; 8: 77–87.CrossRefGoogle ScholarPubMed
Gaies, M, Anderson, J, Kipps, A, et al. Cardiac Networks United: an integrated pediatric and congenital cardiovascular research and improvement network. Cardiol Young 2018. doi: 10.1017/S1047951118001683. [Epub ahead of print].CrossRefGoogle Scholar
Pasquali, SK, Schumacher, KR, Davies, RR. Can linking databases answer questions about paediatric heart failure? Cardiology in the young 2015; 2: 160–166.CrossRefGoogle Scholar
Pasquali, SK, Jacobs, ML, Jacobs, JP. Linking databases. In: Barach, PR, Jacobs, JP, Lipshultz, SE, Laussen, PC (eds). Pediatric and Congenital Cardiac Care. Volume 1: Outcomes Analysis. New York, NY: Springer, 2015: 395–399.Google Scholar
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
Merelli, I, Perez-Sanchez, H, Gesing, S, D’Agostino, D. Managing, analyzing, and integrating big data in medical bioinformatics: open problems and future perspectives. Biomed Res Int 2014; 2014: 134023. doi: 10.1155/2014/134023. [Epub 2014 Sep 1].CrossRefGoogle Scholar
Alberts, B, Kirschner, MW, Tilghman, S, Varmus, H. Rescuing US biomedical research from its systemic flaws. Proc Natl Acad Sci USA 2014; 111: 5773–5777.CrossRefGoogle ScholarPubMed
Franklin, RC, Jacobs, JP, Krogmann, ON, et al. Nomenclature for congenital and paediatric cardiac disease: historical perspectives and The International Pediatric and Congenital Cardiac Code. Cardiol Young 2008; 2: 70–80.CrossRefGoogle Scholar
Jacobs, JP. Introduction – databases and the assessment of complications associated with the treatment of patients with congenital cardiac disease. Cardiol Young 2008; 2: 1–37.Google Scholar
Gaies, M, Pasquali, SK, Nicolson, SC, et al. Sustainability of infant cardiac surgery early extubation practices after implementation and study. Ann Thorac Surg 2019; 107(5): 1427–1433. doi: 10.1016/j.athoracsur.2018.09.024.CrossRefGoogle ScholarPubMed
Bates, KE, Mahle, WT, Bush, L, et al. Variation in implementation and outcomes of early extubation practices after infant cardiac surgery. Ann Thorac Surg 2019; 107(5):1434–1440. doi: 10.1016/j.athoracsur.2018.11.031.CrossRefGoogle ScholarPubMed
McHugh, KE, Mahle, WT, Hall, MA, et al. Hospital costs related to early extubation after infant cardiac surgery. Ann Thorac Surg 2019; 107(5):1421–1426. doi: 10.1016/j.athoracsur.2018.10.019.CrossRefGoogle ScholarPubMed
McHugh, KE, Pasquali, SK, Hall, MA, Scheurer, MA. Cost variation across centers for the Norwood operation. Ann Thorac Surg 2018; 105: 851–856.CrossRefGoogle ScholarPubMed
Nathan, M, Jacobs, ML, Gaynor, JW, et al. Completeness and reliability of perioperative variables in local clinical registry data vs. research coordinator chart review for children undergoing heart surgery. Ann Thorac Surg 2017; 103: 629–636.CrossRefGoogle Scholar
McHugh, KE, Pasquali, SK, Hall, MA, Scheurer, MA. Impact of post-operative complications on hospital costs following the Norwood Operation. Cardiol Young 2016; 26(7):1303–1309.CrossRefGoogle ScholarPubMed
Minich, LL, Pemberton, VL, Shekerdemian, LS, et al. The PHN Scholar Award programme: a unique mentored award embedded within a multicenter Network. Cardiol Young 2018;28(6):854–861. doi: 10.1017/S1047951118000483.CrossRefGoogle Scholar
Li, JS, Colan, SD, Sleeper, LA, et al. Lessons learned from a pediatric clinical trial: the Pediatric Heart Network angiotensin-converting enzyme inhibition in mitral regurgitation study. Am Heart J 2011; 161: 233–240.CrossRefGoogle ScholarPubMed
Gaies, M, Cooper, DS, Tabbutt, S, et al. Collaborative quality improvement in the cardiac intensive care unit: development of the Paediatric Cardiac Critical Care Consortium (PC4). Cardiol Young 2015; 25: 951–957.CrossRefGoogle Scholar
Lauer, MS, D’Agostino, RB. The randomized registry trial-the next disruptive technology in clinical research? N Engl J Med 2013; 369: 1579–1581.CrossRefGoogle ScholarPubMed
Frobert, O, Lagerqvist, B, Olivecrona, GK, et al. Thormbus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013; 369: 1587–1597.CrossRefGoogle ScholarPubMed
STeroids to REduce Systemic Inflammation after Neonatal Heart Surgery (STRESS). Retrieved February 19, 2019, from https://clinicaltrials.gov/ct2/show/NCT03229538?recrs=a&titles=stress&age0&rank1.Google Scholar
Porter, ME. What is value in health care? N Engl J Med 2010; 363: 2477–2481.CrossRefGoogle ScholarPubMed
Pasquali, SK, Jacobs, JP, Shook, GJ, et al. Linking clinical registry data with administrative data using indirect identifiers: implementation and validation in the congenital heart surgery population. Am Heart J 2010; 160: 1099–1104.CrossRefGoogle ScholarPubMed
Ohye, RG, Sleeper, LA, Mahony, L, et al. Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med 2010; 362: 1980–1992.CrossRefGoogle ScholarPubMed
Mahle, WT, Nicolson, SC, Hollenbeck-Pringle, D, et al. Utilizing a collaborative learning model to promote early extubation following infant heart surgery. Pediatr Crit Care Med 2016; 17: 939–947.CrossRefGoogle ScholarPubMed
NIH Collaboratory. Retrieved February 19, 2019, from https://rethinkingclinicaltrials.org/ Google Scholar
Patient-centered Outcomes Research Institute. Retrieved February 19, 2019, from https://www.pcori.org/ Google Scholar
The Institute for Precision Cardiovascular Medicine. Retrieved February 19, 2019, from https://precision.heart.org/ Google Scholar
Pasquali, SK, Ravishankar, C, Romano, JC, et al. Design and initial results of a programme for routine standardised longitudinal follow-up after congenital heart surgery. Cardiol Young 2016; 26: 1590–1596.CrossRefGoogle ScholarPubMed