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DOI: 10.1055/s-0039-1688477
Creation of a Multicenter Pediatric Inpatient Data Repository Derived from Electronic Health Records
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.Publikationsverlauf
17. Dezember 2018
19. März 2019
Publikationsdatum:
08. Mai 2019 (online)
![](https://www.thieme-connect.de/media/10.1055-s-00035026/201902/lookinside/thumbnails/10-1055-s-0039-1688477_180262cr-1.jpg)
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 extractionProtection 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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References
- 1 Park HA. President's Statement. Yearb Med Inform 2017; 26 (01) 1-2
- 2 Issa NT, Byers SW, Dakshanamurthy S. Big data: the next frontier for innovation in therapeutics and healthcare. Expert Rev Clin Pharmacol 2014; 7 (03) 293-298
- 3 Margolis R, Derr L, Dunn M. , et al. The National Institutes of Health's Big Data to Knowledge (BD2K) initiative: capitalizing on biomedical big data. J Am Med Inform Assoc 2014; 21 (06) 957-958
- 4 Ross MK, Wei W, Ohno-Machado L. “Big data” and the electronic health record. Yearb Med Inform 2014; 9: 97-104
- 5 Evans RS. Electronic health records: then, now, and in the future. Yearb Med Inform 2016; (Suppl. 01) S48-S61
- 6 Weng C, Kahn MG. Clinical research informatics for big data and precision medicine. Yearb Med Inform 2016; 25 (01) 211-218
- 7 Elliott JH, Grimshaw J, Altman R. , et al. Informatics: make sense of health data. Nature 2015; 527 (7576): 31-32
- 8 Sutherland SM, Kaelber DC, Downing NL, Goel VV, Longhurst CA. Electronic health record-enabled research in children using the electronic health record for clinical discovery. Pediatr Clin North Am 2016; 63 (02) 251-268
- 9 Sward KA, Rubin S, Jenkins TL, Newth CJ, Dean JM. ; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Collaborative Pediatric Critical Care Research Network (CPCCRN). Case study: semantic annotation of a pediatric critical care research study. Comput Inform Nurs 2016; 34 (03) 101-104
- 10 Zhao J, Henriksson A, Asker L, Boström H. Predictive modeling of structured electronic health records for adverse drug event detection. BMC Med Inform Decis Mak 2015; 15 (Suppl. 04) S1
- 11 Silverstein JM, Roe ED, Munir KM. , et al. Use of electronic health records to characterize a rare disease in the U.S.: treatment, comorbidities, and follow-up trends among patients with a confirmed diagnosis of acromegaly. Endocr Pract 2018; 24 (06) 517-526
- 12 Liu F, Jagannatha A, Yu H. Towards drug safety surveillance and pharmacovigilance: current progress in detecting medication and adverse drug events from electronic health records. Drug Saf 2019; 42 (01) 95-97
- 13 Imatoh T, Sai K, Takeyama M. , et al. Identification of risk factors and development of detection algorithm for denosumab-induced hypocalcaemia. J Clin Pharm Ther 2019; 44 (01) 62-68
- 14 Laughon MM, Benjamin Jr DK. Mechanisms to provide safe and effective drugs for children. Pediatrics 2014; 134 (02) e562-e563
- 15 England A, Wade K, Smith PB, Berezny K, Laughon M. ; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee. Optimizing operational efficiencies in early phase trials: the Pediatric Trials Network experience. Contemp Clin Trials 2016; 47: 376-382
- 16 Laughon MM, Benjamin Jr DK, Capparelli EV. , et al. Innovative clinical trial design for pediatric therapeutics. Expert Rev Clin Pharmacol 2011; 4 (05) 643-652
- 17 Hornik CP, Benjamin Jr DK, Smith PB. , et al; Best Pharmaceuticals for Children Act—Pediatric Trials Network. Electronic health records and pharmacokinetic modeling to assess the relationship between ampicillin exposure and seizure risk in neonates. J Pediatr 2016; 178: 125-129.e1
- 18 Hornik CP, Chu PY, Li JS, Clark RH, Smith PB, Hill KD. Comparative effectiveness of digoxin and propranolol for supraventricular tachycardia in infants. Pediatr Crit Care Med 2014; 15 (09) 839-845
- 19 Testoni D, Hornik CP, Neely ML. , et al; Best Pharmaceuticals for Children Act — Pediatric Trials Network Administrative Core Committee. Safety of octreotide in hospitalized infants. Early Hum Dev 2015; 91 (07) 387-392
- 20 Zimmerman KO, Hornik CP, Ku L. , et al. Sedatives and analgesics given to infants in neonatal intensive care units at the end of life. J Pediatr 2015; 167 (02) 299-304
- 21 Autmizguine J, Hornik CP, Benjamin Jr DK. , et al; Best Pharmaceuticals for Children Act—Pediatric Trials Network Administrative Core Committee. Anaerobic antimicrobial therapy after necrotizing enterocolitis in VLBW infants. Pediatrics 2015; 135 (01) e117-e125
- 22 Fiks AG, Grundmeier RW, Steffes J. , et al; Comparative Effectiveness Research Through Collaborative Electronic Reporting (CER2) Consortium. Comparative effectiveness research through a collaborative electronic reporting consortium. Pediatrics 2015; 136 (01) e215-e224
- 23 FHIR R4. A Standard for Health Care Data Exchange. Available at: http://www.hl7.org/fhir/index.html . Accessed February 1, 2019
- 24 HL7 Standards-Section 3: Clinical and Administrative Domains. Available at: http://www.hl7.org/implement/standards/product_section.cfm?section=3 . Accessed February 1, 2019
- 25 CDISC. Biomedical Research Integrated Domain Group (BRIDG) Model. Available at: https://www.cdisc.org/standards/domain-information-module/bridg . Accessed February 1, 2019
- 26 PCORnet Common Data Model (CDM) Specification.Version 2.0. Available at: http://pcornet.org/wp-content/uploads/2015/03/2015-02-27-PCORnet-Common-Data-Model-v2-0-RELEASE.pdf . Accessed February 1, 2019
- 27 U.S. National Library of Medicine. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/resources/download . Accessed February 1, 2019
- 28 Selby JV, Lipstein SH. PCORI at 3 years--progress, lessons, and plans. N Engl J Med 2014; 370 (07) 592-595
- 29 Zhou X, Murugesan S, Bhullar H. , et al. An evaluation of the THIN database in the OMOP Common Data Model for active drug safety surveillance. Drug Saf 2013; 36 (02) 119-134
- 30 Xu Y, Zhou X, Suehs BT. , et al. A comparative assessment of Observational Medical Outcomes Partnership and Mini-Sentinel common data models and analytics: implications for active drug safety surveillance. Drug Saf 2015; 38 (08) 749-765
- 31 Stang PE, Ryan PB, Racoosin JA. , et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010; 153 (09) 600-606
- 32 PCORnet. PCORnet Coordinating Center. Available at: https://pcornet.org/about-pcornet/pcornet-coordinating-center/ . Accessed February 6, 2019
- 33 National Institute of Standards and Technology. Federal Information Security Management Act (FISMA) Implementation Project. Available at: https://www.nist.gov/programs-projects/federal-information-security-management-act-fisma-implementation-project . Accessed February 6, 2019
- 34 Antman EM, Benjamin EJ, Harrington RA. , et al; American Heart Association Data Sharing Summit Attendees. Acquisition, analysis, and sharing of data in 2015 and beyond: a survey of the landscape: a conference report from the American Heart Association Data Summit 2015. J Am Heart Assoc 2015; 4 (11) e002810
- 35 Janke AT, Overbeek DL, Kocher KE, Levy PD. Exploring the potential of predictive analytics and big data in emergency care. Ann Emerg Med 2016; 67 (02) 227-236
- 36 Khoury MJ. Planning for the future of epidemiology in the era of big data and precision medicine. Am J Epidemiol 2015; 182 (12) 977-979
- 37 Kim J. Big data, health informatics, and the future of cardiovascular medicine. J Am Coll Cardiol 2017; 69 (07) 899-902
- 38 Sutherland SM, Goldstein SL, Bagshaw SM. Acute kidney injury and big data. Contrib Nephrol 2018; 193: 55-67
- 39 Deakyne Davies SJ, Grundmeier RW, Campos DA. , et al; Pediatric Emergency Care Applied Research Network. The Pediatric Emergency Care Applied Research Network Registry: a multicenter electronic health record registry of pediatric emergency care. Appl Clin Inform 2018; 9 (02) 366-376
- 40 Deans KJ, Sabihi S, Forrest CB. Learning health systems. Semin Pediatr Surg 2018; 27 (06) 375-378
- 41 Forrest CB, Margolis P, Seid M, Colletti RB. PEDSnet: how a prototype pediatric learning health system is being expanded into a national network. Health Aff (Millwood) 2014; 33 (07) 1171-1177
- 42 Forrest CB, Margolis PA, Bailey LC. , et al. PEDSnet: a national pediatric learning health system. J Am Med Inform Assoc 2014; 21 (04) 602-606
- 43 Khare R, Utidjian L, Ruth BJ. , et al. A longitudinal analysis of data quality in a large pediatric data research network. J Am Med Inform Assoc 2017; 24 (06) 1072-1079
- 44 Hemingway H, Asselbergs FW, Danesh J. , et al; Innovative Medicines Initiative 2nd programme, Big Data for Better Outcomes, BigData@Heart Consortium of 20 academic and industry partners including ESC. Big data from electronic health records for early and late translational cardiovascular research: challenges and potential. Eur Heart J 2018; 39 (16) 1481-1495
- 45 Weng C. Optimizing clinical research participant selection with informatics. Trends Pharmacol Sci 2015; 36 (11) 706-709
- 46 De Moor G, Sundgren M, Kalra D. , et al. Using electronic health records for clinical research: the case of the EHR4CR project. J Biomed Inform 2015; 53: 162-173
- 47 Hernandez AF, Fleurence RL, Rothman RL. The ADAPTABLE Trial and PCORnet: shining light on a new research paradigm. Ann Intern Med 2015; 163 (08) 635-636
- 48 Hsieh EM, Hornik CP, Clark RH, Laughon MM, Benjamin Jr DK, Smith PB. ; Best Pharmaceuticals for Children Act—Pediatric Trials Network. Medication use in the neonatal intensive care unit. Am J Perinatol 2014; 31 (09) 811-821
- 49 Trembath A, Hornik CP, Clark R, Smith PB, Daniels J, Laughon M. ; Best Pharmaceuticals for Children Act—Pediatric Trials Network. Comparative effectiveness of surfactant preparations in premature infants. J Pediatr 2013; 163 (04) 955-60.e1
- 50 Ericson JE, Gostelow M, Autmizguine J. , et al; Pediatric Trials Network Executive Committee and Investigators. Safety of high-dose acyclovir in infants with suspected and confirmed neonatal herpes simplex virus infections. Pediatr Infect Dis J 2017; 36 (04) 369-373
- 51 Hornik CP, Herring AH, Benjamin Jr DK. , et al; Best Pharmaceuticals for Children Act-Pediatric Trials Network. Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants. Pediatr Infect Dis J 2013; 32 (07) 748-753
- 52 Autmizguine J, Benjamin Jr DK, Smith PB. , et al. Pharmacokinetic studies in infants using minimal-risk study designs. Curr Clin Pharmacol 2014; 9 (04) 350-358
- 53 Salerno S, Hornik CP, Cohen-Wolkowiez M. , et al; Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee. Use of population pharmacokinetics and electronic health records to assess piperacillin-tazobactam safety in infants. Pediatr Infect Dis J 2017; 36 (09) 855-859
- 54 Hornik CP, Onufrak NJ, Smith PB. , et al. Association between oral sildenafil dosing, predicted exposure, and systemic hypotension in hospitalised infants. Cardiol Young 2018; 28 (01) 85-92
- 55 Ku LC, Wu H, Greenberg RG. , et al. Use of therapeutic drug monitoring, electronic health record data, and pharmacokinetic modeling to determine the therapeutic index of phenytoin and lamotrigine. Ther Drug Monit 2016; 38 (06) 728-737
- 56 Ge S, Beechinor RJ, Hornik CP. , et al. External evaluation of a gentamicin infant population pharmacokinetic model using data from a national electronic health record database. Antimicrob Agents Chemother 2018; 62 (09) e00669-e18
- 57 Gliklich R, Dreyer N, Leavy M, Velentgas P, Khurana L. Standards in the conduct of registry studies for patient-centered outcomes research. Patient-Centered Outcomes Research Institute;March 15, 2012. Available at: https://www.pcori.org/assets/Standards-in-the-Conduct-of-Registry-Studies-for-Patient-Centered-Outcomes-Research.pdf . Accessed June 6, 2018
- 58 Leavy MB. Multinational registries: challenges and opportunities. Addendum to Registries for Evaluating Patient Outcomes: A User's Guide.3rd ed. Rockville, MD: Agency for Healthcare Research and Quality; 2018
- 59 Mack C, Su Z, Westreich D. Managing missing data in patient registries. Addendum to Registries for Evaluating Patient Outcomes: A User's Guide.3rd ed. Rockville, MD: Agency for Healthcare Research and Quality; 2018
- 60 Velupillai S, Mowery D, South BR, Kvist M, Dalianis H. Recent advances in clinical natural language processing in support of semantic analysis. Yearb Med Inform 2015; 10 (01) 183-193