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Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence

  • Robert D. Kerns
    Correspondence
    Address reprint requests to Robert D. Kerns, PhD, Departments of Psychiatry, Neurology, and Psychology, Yale University, New Haven, Connecticut; Pain Research, Informatics, Multimorbidities, and Education (PRIME) Center of Innovation, VA Connecticut Healthcare System, West Haven, Connecticut, USA.
    Affiliations
    Departments of Psychiatry, Neurology, and Psychology, Yale University, New Haven, Connecticut, Pain Research, Informatics, Multimorbidities, and Education (PRIME) Center of Innovation, VA Connecticut Healthcare System, West Haven, Connecticut
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  • Alison F. Davis
    Affiliations
    Pain Management Collaboratory, Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut
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  • Julie M. Fritz
    Affiliations
    Department of Physical Therapy & Athletic Training, College of Health, The University of Utah, Salt Lake City, Utah
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  • Francis J. Keefe
    Affiliations
    Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina
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  • Peter Peduzzi
    Affiliations
    Department of Biostatistics, Yale Center for Analytical Sciences, Yale School of Public Health, , New Haven, Connecticut
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  • Daniel I. Rhon
    Affiliations
    Department of Rehabilitation Medicine, School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland
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  • Stephanie L. Taylor
    Affiliations
    Center for the Study of Healthcare Innovation, Implementation and Policy, Veterans Health Administration, Greater Los Angeles VA Health Care System, Los Angeles, California

    Department of Medicine and Department of Health Policy and Management, UCLA, Los Angeles, California
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  • Robert Vining
    Affiliations
    Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, Iowa
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  • Qilu Yu
    Affiliations
    Office of Clinical and Regulatory Affairs, National Institutes of Health, National Center for Complementary and Integrative Health, Bethesda, Maryland
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  • Steven B. Zeliadt
    Affiliations
    Center of Innovation for Veteran-Centered and Value-Driven Care, VA Puget Sound Health Care System, Seattle, Washington

    Department of Health Services, School of Public Health, University of Washington, Seattle, Washington
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  • Steven Z. George
    Affiliations
    Laszlo Ormandy Distinguished Professor, Department of Orthopaedic Surgery and Duke Clinical Research Institute, Duke University, Durham North Carolina
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Published:December 24, 2022DOI:https://doi.org/10.1016/j.jpain.2022.12.008

      Highlights

      • Pragmatic pain trials are important to address clinical practice gaps.
      • Pragmatic trials must ensure that flexibility does not compromise treatment fidelity.
      • Principles for balancing flexibility and fidelity in pragmatic trials are highlighted.

      Abstract

      Nonpharmacological treatments are considered first-line pain management strategies, but they remain clinically underused. For years, pain-focused pragmatic clinical trials (PCTs) have generated evidence for the enhanced use of nonpharmacological interventions in routine clinical settings to help overcome implementation barriers. The Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) framework describes the degree of pragmatism across 9 key domains. Among these, “flexibility in delivery” and “flexibility in adherence,” address a key goal of pragmatic research by tailoring approaches to settings in which people receive routine care. However, to maintain scientific and ethical rigor, PCTs must ensure that flexibility features do not compromise delivery of interventions as designed, such that the results are ethically and scientifically sound. Key principles of achieving this balance include clear definitions of intervention core components, intervention monitoring and documentation that is sufficient but not overly burdensome, provider training that meets the demands of delivering an intervention in real-world settings, and use of an ethical lens to recognize and avoid potential trial futility when necessary and appropriate.

      Perspective

      This article presents nuances to be considered when applying the PRECIS-2 framework to describe pragmatic clinical trials. Trials must ensure that patient-centered treatment flexibility does not compromise delivery of interventions as designed, such that measurement and analysis of treatment effects is reliable.

      Key words

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