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

Publication ,  Journal Article
Weinfurt, KP; Hernandez, AF; Coronado, GD; DeBar, LL; Dember, LM; Green, BB; Heagerty, PJ; Huang, SS; James, KT; Jarvik, JG; Larson, EB ...
Published in: BMC Med Res Methodol
September 18, 2017

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.

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Published In

BMC Med Res Methodol

DOI

EISSN

1471-2288

Publication Date

September 18, 2017

Volume

17

Issue

1

Start / End Page

144

Location

England

Related Subject Headings

  • United States
  • Research Report
  • Research Design
  • Pragmatic Clinical Trials as Topic
  • National Institutes of Health (U.S.)
  • Humans
  • General & Internal Medicine
  • Electronic Health Records
  • Delivery of Health Care
  • Decision Making
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Weinfurt, K. P., Hernandez, A. F., Coronado, G. D., DeBar, L. L., Dember, L. M., Green, B. B., … Curtis, L. H. (2017). Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory. BMC Med Res Methodol, 17(1), 144. https://doi.org/10.1186/s12874-017-0420-7
Weinfurt, Kevin P., Adrian F. Hernandez, Gloria D. Coronado, Lynn L. DeBar, Laura M. Dember, Beverly B. Green, Patrick J. Heagerty, et al. “Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.BMC Med Res Methodol 17, no. 1 (September 18, 2017): 144. https://doi.org/10.1186/s12874-017-0420-7.
Weinfurt KP, Hernandez AF, Coronado GD, DeBar LL, Dember LM, Green BB, et al. Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory. BMC Med Res Methodol. 2017 Sep 18;17(1):144.
Weinfurt, Kevin P., et al. “Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.BMC Med Res Methodol, vol. 17, no. 1, Sept. 2017, p. 144. Pubmed, doi:10.1186/s12874-017-0420-7.
Weinfurt KP, Hernandez AF, Coronado GD, DeBar LL, Dember LM, Green BB, Heagerty PJ, Huang SS, James KT, Jarvik JG, Larson EB, Mor V, Platt R, Rosenthal GE, Septimus EJ, Simon GE, Staman KL, Sugarman J, Vazquez M, Zatzick D, Curtis LH. Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory. BMC Med Res Methodol. 2017 Sep 18;17(1):144.
Journal cover image

Published In

BMC Med Res Methodol

DOI

EISSN

1471-2288

Publication Date

September 18, 2017

Volume

17

Issue

1

Start / End Page

144

Location

England

Related Subject Headings

  • United States
  • Research Report
  • Research Design
  • Pragmatic Clinical Trials as Topic
  • National Institutes of Health (U.S.)
  • Humans
  • General & Internal Medicine
  • Electronic Health Records
  • Delivery of Health Care
  • Decision Making