Intended for healthcare professionals

Research Methods & Reporting

A guide to research partnerships for pragmatic clinical trials

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g6826 (Published 01 December 2014) Cite this as: BMJ 2014;349:g6826
  1. Karin E Johnson, research associate1,
  2. Chris Tachibana, scientific editor and writer1,
  3. Gloria D Coronado, senior investigator2,
  4. Laura M Dember, professor of medicine3,
  5. Russell E Glasgow, associate director4,
  6. Susan S Huang, associate professor and medical director of epidemiology and infection prevention5,
  7. Paul J Martin, medical director6,
  8. Julie Richards, project manager1,
  9. Gary Rosenthal, professor7,
  10. Ed Septimus, medical director infection prevention and epidemiology8,
  11. Gregory E Simon, senior investigator1,
  12. Leif Solberg, associate medical director for care improvement research9,
  13. Jerry Suls, senior scientist10,
  14. Ella Thompson, project manager1,
  15. Eric B Larson, vice president for research1
  1. 1Group Health Research Institute, Seattle, WA 98101, USA
  2. 2Kaiser Permanente Center for Health Research, Portland, OR 97227, USA
  3. 3University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA
  4. 4Colorado Health Outcomes Program, University of Colorado School of Medicine, Aurora, CO 80045, USA
  5. 5University of California Irvine School of Medicine, Irvine, CA 92697, USA
  6. 6Clinical Research Support, Fred Hutchinson Cancer Research Center, Seattle WA 98109, USA
  7. 7Internal Medicine, University of Iowa, Iowa City, IA 52242, USA
  8. 8Clinical Service Group, Hospital Corporation of America, Nashville, TN 374022, USA
  9. 9HealthPartners Institute for Education and Research, Bloomington, MN 55425, USA
  10. 10National Cancer Institute, Bethesda, MD 20892, USA
  1. Correspondence to: K E Johnson johnson.ke{at}ghc.org
  • Accepted 2 September 2014

Summary points

  • Demonstration pragmatic clinical trials supported by the Health Care Systems Research Collaboratory of the US National Institutes of Health highlight the following lessons about building strong research partnerships between health researchers and healthcare systems:

    • • Participating in pragmatic clinical trials can provide healthcare systems with evidence and tools to improve healthcare, and researchers with opportunities to conduct high impact clinical studies

    • • Pragmatic clinical trials answer questions relevant to healthcare systems, so clinicians, healthcare managers, health information technology (IT) staff, and clinical operations staff need to be involved in the study design

    • • A successful pragmatic clinical trial starts with a strong partnership between researcher and healthcare system, goes through a rigorous objective evaluation of the ability of the partner healthcare system(s) to participate, and ends with evidence about sustainable ways to improve care, as well as a long term scientific relationship

Pragmatic clinical trials are comparative effectiveness studies conducted in real-world settings to answer questions relevant to patients, clinicians, and healthcare decision makers. In contrast, explanatory clinical trials study how treatments or interventions work in carefully controlled settings and study populations, often to investigate a biological hypothesis or test a drug or device to meet regulatory requirements. The pragmatic approach requires unique methods to achieve the goal of identifying sustainable, generalizable, evidence based ways to improve healthcare.1 2 3 4 5 While previous authors addressed statistical considerations,6 little guidance is available on the methods for establishing partnerships between researchers and the people and processes in usual care settings that are necessary to conduct a pragmatic clinical trial. Based on insights from an initiative to accelerate pragmatic research,7 this article summarizes best practices for researchers and partners in healthcare systems as they establish collaborative relationships, develop research questions, and implement sustainable pragmatic clinical trials.

Pragmatic trial example

A recent example …

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