Comparative Effectiveness Research Through a Collaborative Electronic Reporting Consortium

Abstract

The United States lacks a system to use routinely collected electronic health record (EHR) clinical data to conduct comparative effectiveness research (CER) on pediatric drug therapeutics and other child health topics. This Special Article describes the creation and details of a network of EHR networks devised to use clinical data in EHRs for conducting CER, led by the American Academy of Pediatrics Pediatric Research in Office Settings (PROS). To achieve this goal, PROS has linked data from its own EHR-based “ePROS” network with data from independent practices and health systems across the United States. Beginning with 4 of proof-of-concept retrospective CER studies on psychotropic and asthma medication use and side effects with a planned full-scale prospective CER study on treatment of pediatric hypertension, the Comparative Effectiveness Research Through Collaborative Electronic Reporting (CER2) collaborators are developing a platform to advance the methodology of pediatric pharmacoepidemiology. CER2 will provide a resource for future CER studies in pediatric drug therapeutics and other child health topics. This article outlines the vision for and present composition of this network, governance, and challenges and opportunities for using the network to advance child health and health care. The goal of this network is to engage child health researchers from around the United States in participating in collaborative research using the CER2 database.

Electronic health record (EHR) based postmarketing surveillance of adverse events associated with pediatric off‐label medication use: A case study of short‐acting beta‐2 agonists and arrhythmias

“…This was a retrospective cohort study of pediatric patients, aged 0 to 18 years, who received care within 1 of 2 health care systems within the Comparative Effectiveness Research through Collaborative Electronic Reporting (CER 2 ) Consortium . These 2 health systems were selected for this study given their relatively large sample sizes for analyzing a rare outcome and the diversity of their practices, underlying populations and referral patterns.…”

“…As described previously, the AAP governs the use of data contributed to the CER 2 Consortium and oversees all research conducted . Children's Hospital of Philadelphia serves as the contracted data coordinating center for the centralized data.…”

“…However, while advantageous in sample size, these data sources often do not contain nuanced clinical codes, clinical data, and in many cases, lack longitudinal follow‐up. To address these limitations, the American Academy of Pediatrics (AAP) created a research network of pediatric centers to study medication use in the pediatric population . Because the data for this network are obtained from the electronic health record (EHR), researchers have access to rich clinical data such as vital signs, growth parameters, and laboratory studies in addition to the data commonly found in other data sources such as diagnoses and prescriptions.…”

Identifying the “Blip on the Radar Screen”: Leveraging Big Data in Defining Drug Safety and Efficacy in Pediatric Practice

“…Examples of databases (Table ) available for clinical research in children include institutional EHR data (hospitals and clinics), aggregated EHR data (ie, Cerner Health Facts ® ), and administrative claims data (ie, Market Scan ® , QuintilesIMS™). There are also pediatric‐specific databases such as the Pediatric Health Information System ® (PHIS, Children's Hospital Association), Kids’ Inpatient Database (KID) that is part of the Healthcare Cost and Utilization Project (HCUP, AHRQ) and Pediatric Research in Office Settings (PROS, AAP) . There are specific population databases such as neonatal databases (Vermont Oxford Network databases, Kaiser Permanente Neonatal data set), critically ill children databases, disease‐specific registries (ie, Cystic Fibrosis Foundation Registry, Children's Oncology Group Registry, Pediatric Heart Failure Registry), and pediatric learning health systems (Pedsnet, ImproveCareNow, and Comparative Effectiveness Research Through Collaborative Electronic Reporting) …”

“…It may be possible to evaluate the effect of polypharmacy on response to therapy that is not possible under the highly restrictive RCT. Electronic health care data have been leveraged to support large‐scale pharmacoepidemiologic research to study medication use, efficacy, and safety . EHRs are useful for evaluating health care resource use, adoption of new therapies, and the effect of policy and guidelines on medication use .…”