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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.

Publication ,  Journal Article
Kerns, RD; Davis, AF; Fritz, JM; Keefe, FJ; Peduzzi, P; Rhon, DI; Taylor, SL; Vining, R; Yu, Q; Zeliadt, SB; George, SZ
Published in: J Pain
April 2023

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.

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Published In

J Pain

DOI

EISSN

1528-8447

Publication Date

April 2023

Volume

24

Issue

4

Start / End Page

568 / 574

Location

United States

Related Subject Headings

  • Research Design
  • Pain
  • Humans
  • Anesthesiology
  • 4202 Epidemiology
  • 3202 Clinical sciences
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences
 

Citation

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Kerns, R. D., Davis, A. F., Fritz, J. M., Keefe, F. J., Peduzzi, P., Rhon, D. I., … George, S. Z. (2023). Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence. J Pain, 24(4), 568–574. https://doi.org/10.1016/j.jpain.2022.12.008
Kerns, Robert D., Alison F. Davis, Julie M. Fritz, Francis J. Keefe, Peter Peduzzi, Daniel I. Rhon, Stephanie L. Taylor, et al. “Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence.J Pain 24, no. 4 (April 2023): 568–74. https://doi.org/10.1016/j.jpain.2022.12.008.
Kerns, Robert D., et al. “Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence.J Pain, vol. 24, no. 4, Apr. 2023, pp. 568–74. Pubmed, doi:10.1016/j.jpain.2022.12.008.
Kerns RD, Davis AF, Fritz JM, Keefe FJ, Peduzzi P, Rhon DI, Taylor SL, Vining R, Yu Q, Zeliadt SB, George SZ. Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence. J Pain. 2023 Apr;24(4):568–574.
Journal cover image

Published In

J Pain

DOI

EISSN

1528-8447

Publication Date

April 2023

Volume

24

Issue

4

Start / End Page

568 / 574

Location

United States

Related Subject Headings

  • Research Design
  • Pain
  • Humans
  • Anesthesiology
  • 4202 Epidemiology
  • 3202 Clinical sciences
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences