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.
Bibliographical noteFunding Information:
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.
K.D. has received research support from Merck, Inc. and Pfizer, Inc. M.L. has received research support from United Therapeutics. The remaining authors have nothing to disclose.
© 2019 Georg Thieme. All rights reserved.
- NICHD Pediatric Trials Network
- data extraction
- electronic heath record reuse
- inpatient repository
- pediatric clinical trials