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BMC Med Res Methodol. 2017 Sep 18;17(1):144. doi: 10.1186/s12874-017-0420-7.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

Author information

1
Department of Population Health Sciences, Duke University School of Medicine, 220 W Main St., Suite 720A, Durham, NC, 27705, USA. kevin.weinfurt@duke.edu.
2
Duke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA. kevin.weinfurt@duke.edu.
3
Department of Psychology and Neuroscience, Duke Clinical Research Institute, Durham, NC, 27710, USA. kevin.weinfurt@duke.edu.
4
Duke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA.
5
Duke University School of Medicine, 3115 N. Duke Street, Durham, NC, 27704, USA.
6
Kaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227-1098, USA.
7
Perelman School of MedicineBlockley Hall, Office 920, 423 Guardian Drive, Philadelphia, PA, 19104, USA.
8
Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
9
University of Washington, 325 Ninth Ave, Box 359728, Seattle, WA, 98104-2499, USA.
10
University of California Irvine School of Medicine, 101 The City Drive South, City Tower, Suite 400, Mail Code: 4081, Orange, CA, 92868, USA.
11
Group Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
12
Department of Community Health, Brown University, Box G-S121-2, Providence, RI, 02912, USA.
13
Department of Population Medicine, Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USA.
14
Department of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
15
Hospital Corporation of America Nashville TN, AND Texas A&M College of Medicine, One Park Plaza, Nashville, TN, 37203, USA.
16
CHB Wordsmith, Inc., 22 Bagwell Ave, Raleigh, NC, 27607, USA.
17
Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave., Room 203, Baltimore, MD, 21205, USA.
18
University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX, 75390-8856, USA.
19
University of Washington School of Medicine, 325 9th Ave, Seattle, WA, 98104, USA.

Abstract

BACKGROUND:

The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.

METHODS:

To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.

RESULTS:

In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.

CONCLUSION:

A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

KEYWORDS:

Cluster randomized trials; Embedded clinical trials; Pragmatic clinical research; Pragmatic research; Stakeholder engagement

PMID:
28923013
PMCID:
PMC5604499
DOI:
10.1186/s12874-017-0420-7
[Indexed for MEDLINE]
Free PMC Article

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