Pragmatic (trial) informatics: A perspective from the NIH health care systems research collaboratory

Rachel L. Richesson, Beverly B. Green, Reesa Laws, Jon Puro, Michael G. Kahn, Alan Bauck, Michelle Smerek, Erik G. Van Eaton, Meredith Zozus, WEd Hammond, Kari A. Stephens, Greg E. Simon

Research output: Contribution to journalArticle

14 Scopus citations

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.

Original languageEnglish (US)
Article numberocx016
Pages (from-to)996-1001
Number of pages6
JournalJournal of the American Medical Informatics Association
Volume24
Issue number5
DOIs
StatePublished - Jan 1 2017
Externally publishedYes

Keywords

  • Clinical informatics
  • Demonstration project
  • Electronic health records
  • National Institutes of Health
  • Pragmatic clinical trial

ASJC Scopus subject areas

  • Health Informatics

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