Creation of a Multicenter Pediatric Inpatient Data Repository Derived from Electronic Health Records (original) (raw)

Appl Clin Inform 2019; 10(02): 307-315
DOI: 10.1055/s-0039-1688477

Georg Thieme Verlag KG Stuttgart · New York

Authors

• Christoph P. Hornik
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States
• Andrew M. Atz
  2Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, United States
• Catherine Bendel
  3Department of Pediatrics, University of Minnesota Medical School, Minneapolis, Minnesota, United States
• Francis Chan
  4Department of Pediatrics, Loma Linda University School of Medicine, Loma Linda, California, United States
• Kevin Downes
  5Department of Pediatrics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
• Robert Grundmeier
  5Department of Pediatrics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
• Ben Fogel
  6Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
• Debbie Gipson
  7Department of Pediatrics and Communicable Disease, University of Michigan, Ann Arbor, Michigan, United States
• Matthew Laughon
  8Department of Pediatrics, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
• Michael Miller
  9Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
• Michael Smith
  10Department of Pediatrics, University of Louisville School of Medicine, Louisville, Kentucky, United States
  11Division of Pediatric Infectious Diseases, Duke University School of Medicine, Durham North Carolina, United States
• Chad Livingston
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States
• Cindy Kluchar
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States
• Anne Heath
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States
• Chanda Jarrett
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States
• Brian McKerlie
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States
• Hetalkumar Patel
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States
• Christina Hunter
  1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States on behalf of the Best Pharmaceuticals for Children Act–Pediatric Trials Network

Funding This work was funded under National Institute for Child Health and Human Development (NICHD) contract HHSN27520100–003I for the Pediatric Trials Network (PI: Danny Benjamin). C.P.H. receives support for research from NICHD grant K23HD090239. M.L. receives funding from FDA grant RO1 5R01FD005101–03.

Further Information

Publication History

17 December 2018

19 March 2019

Publication Date:
08 May 2019 (online)

Abstract

Background Integration of electronic health records (EHRs) data across sites and access to that data remain limited.

Objective We developed an EHR-based pediatric inpatient repository using nine U.S. centers from the National Institute of Child Health and Human Development Pediatric Trials Network.

Methods A data model encompassing 147 mandatory and 99 optional elements was developed to provide an EHR data extract of all inpatient encounters from patients <17 years of age discharged between January 6, 2013 and June 30, 2017. Sites received instructions on extractions, transformation, testing, and transmission to the coordinating center.

Results We generated 177 staging reports to process all nine sites' 147 mandatory and 99 optional data elements to the repository. Based on 520 prespecified criteria, all sites achieved 0% errors and <2% warnings. The repository includes 386,159 inpatient encounters from 264,709 children to support study design and conduct of future trials in children.

Conclusion Our EHR-based data repository of pediatric inpatient encounters utilized a customized data model heavily influenced by the PCORnet format, site-based data mapping, a comprehensive set of data testing rules, and an iterative process of data submission. The common data model, site-based extraction, and technical expertise were key to our success. Data from this repository will be used in support of Pediatric Trials Network studies and the labeling of drugs and devices for children.

Keywords

pediatric clinical trials - electronic heath record reuse - NICHD Pediatric Trials Network - inpatient repository - data extraction

Protection of Human and Animal Subjects

This study was approved by institutional review boards of Duke University (coordinating center) and each participating site.

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