Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory.
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.
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- United States
- Research Design
- Pragmatic Clinical Trials as Topic
- National Institutes of Health (U.S.)
- Medical Informatics
- Medical Informatics
- Humans
- Electronic Health Records
- 46 Information and computing sciences
- 42 Health sciences
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- United States
- Research Design
- Pragmatic Clinical Trials as Topic
- National Institutes of Health (U.S.)
- Medical Informatics
- Medical Informatics
- Humans
- Electronic Health Records
- 46 Information and computing sciences
- 42 Health sciences