TY - JOUR
T1 - Pragmatic (trial) informatics
T2 - A perspective from the NIH health care systems research collaboratory
AU - Richesson, Rachel L.
AU - Green, Beverly B.
AU - Laws, Reesa
AU - Puro, Jon
AU - Kahn, Michael G.
AU - Bauck, Alan
AU - Smerek, Michelle
AU - Van Eaton, Erik G.
AU - Zozus, Meredith
AU - Hammond, WEd
AU - Stephens, Kari A.
AU - Simon, Greg E.
N1 - Funding Information:
This publication was made possible by grants 1U54AT007748-01, 1UH2AT007769-01, 1UH2AT007782-01, 1UH2AT007755-01, 1UH2AT007788-01, 1UH2AT007766-01, 1UH2 AT007784-01, and 1UH2AT007797-01 from the National Institutes of Health.
Publisher Copyright:
© The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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.
AB - 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.
KW - Clinical informatics
KW - Demonstration project
KW - Electronic health records
KW - National Institutes of Health
KW - Pragmatic clinical trial
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U2 - 10.1093/jamia/ocx016
DO - 10.1093/jamia/ocx016
M3 - Article
C2 - 28340241
AN - SCOPUS:85029577575
SN - 1067-5027
VL - 24
SP - 996
EP - 1001
JO - Journal of the American Medical Informatics Association : JAMIA
JF - Journal of the American Medical Informatics Association : JAMIA
IS - 5
M1 - ocx016
ER -