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Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory

Year: 2017
Type: article
Abstract: Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. The Health Care Systems Research Collaboratory, initiated by the National Institutes of Health Common Fund in 2010, is a pioneering cooperative aimed at identifying and overcoming operational challenges to pragmatic research. Drawing from our experience, we present 4 broad categories of informatics-related challenges: (1) using clinical data for research, (2) integrating data from heterogeneous systems, (3) using electronic health records to support intervention delivery or health system change, and (4) assessing and improving data capture to define study populations and outcomes. These challenges impact the validity, reliability, and integrity of PCTs. Achieving the full potential of PCTs and a learning health system will require meaningful partnerships between health system leadership and operations, and federally driven standards and policies to ensure that future electronic health record systems have the flexibility to support research.
DOI: 10.1093/jamia/ocx016
Authors: Rachel L Richesson, Beverly B Green, Reesa Laws, Jon Puro, Michael G Kahn, Alan Bauck, Michelle Smerek, Erik G Van Eaton, Meredith Zozus, W Ed Hammond, Kari A Stephens, Greg E Simon
Institutions: Duke University, Kaiser Permanente Washington Health Research Institute, Kaiser Permanente Center for Health Research, Ochin, University of Colorado Denver, University of Washington, University of Arkansas for Medical Sciences
Language: English
Open Access status: green
Awards: Pragmatic trial of population-based programs to prevent suicide attempt, G1544754352, Collaborative Care for Chronic Pain in Primary Care, Nighttime Dosing of Anti-Hypertensive Medications: A Pragmatic Clinical Trial, G3907841409, G3989836571, G4350769723, G452087023, A Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE), Pragmatic Trials in Maintenance Hemodialysis, G5593765148, Health Care Systems Research Collaboratory - Coordinating Center, Strategies and Opportunities to Stop Colon Cancer in Priority Populations, Decreasing Bioburden to Reduce Healthcare-Associated Infections and Readmissions, Strategies and Opportunities to Stop Colon Cancer in Priority Populations
OpenAlex ID: W2631386570
FWCI: 7.11
Cites: 22
Cited by: 39
Related to: 10