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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Article info
Publication history
Published online: December 24, 2022
Accepted:
December 18,
2022
Received in revised form:
December 5,
2022
Received:
October 12,
2022
Publication stage
In Press Journal Pre-ProofFootnotes
Research reported in this publication was made possible by grant number U24 AT009769 from the National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH), and the NIH Office of Behavioral and Social Sciences Research (OBSSR). Additional support was provided for some authors. For Drs. Fritz and Rhon, support was also provided by the following UG3/UH3 cooperative agreements from NCCIH (AT009761 and AT009763), and the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory - Pragmatic Clinical Trials Demonstration Project Awards (W81XWH-18-2-0003, W81XWH-18-2-0007 and W81XWH-18-2-0008) and the U.S. Department of Veterans Affairs, Health Services Research and Development Service (SDR-17-306). For Dr. George, support was provided by NCCIH (UH3AT00970). For Drs. Taylor and Zeliadt, support was provided by the Veterans Health Administration Office of Research and Development (SDR-17-306). For Dr. Vining, support was provided by NCCIH (UH3AT009761). For Dr. Keefe, support was provided by the National Institute on Aging (R01AG058702, UH3AG067493, R01AG064947), the National Cancer Institute (R01CA237892, R01CA229425, UG1CA189824), NCCIH (UH3AT009790), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (UH3AR077360), the National Institute of Nursing Research (UG3NR019196), the National Institute of Diabetes and Digestive and Kidney Diseases (U01DK123813), and the American Cancer Society (RSG-20-134-01-PCSM).
The authors have no conflicts of interest to declare.
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© 2023 by United States Association for the Study of Pain, Inc.
