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Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials.

Publication ,  Journal Article
Langford, DJ; Lou, R; Sheen, S; Amtmann, D; Colloca, L; Edwards, RR; Farrar, JT; Katz, NP; McDermott, MP; Reeve, BB; Wasan, AD; Turk, DC ...
Published in: J Pain
April 2023

Variability in pain-related outcomes can hamper assay sensitivity of chronic pain clinical trials. Expectations of outcome in such trials may account for some of this variability, and thereby impede development of novel pain treatments. Measurement of participants' expectations prior to initiating study treatment (active or placebo) is infrequent, variable, and often unvalidated. Efforts to optimize and standardize measurement, analysis, and management of expectations are needed. In this Focus Article, we provide an overview of research findings on the relationship between baseline expectations and pain-related outcomes in clinical trials of pharmacological and nonpharmacological pain treatments. We highlight the potential benefit of adjusting for participants' expectations in clinical trial analyses and draw on findings from patient interviews to discuss critical issues related to measurement of expectations. We conclude with suggestions regarding future studies focused on better understanding the utility of incorporating these measures into clinical trial analyses. PERSPECTIVE: This focus article provides an overview of the relationship between participants' baseline expectations and pain-related outcomes in the setting of clinical trials of chronic pain treatments. Systematic research focused on the measurement of expectations and the impact of adjusting for expectations in clinical trial analyses may improve assay sensitivity.

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Published In

J Pain

DOI

EISSN

1528-8447

Publication Date

April 2023

Volume

24

Issue

4

Start / End Page

575 / 581

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pain Management
  • Motivation
  • Humans
  • Chronic Pain
  • Anesthesiology
  • 4202 Epidemiology
  • 3202 Clinical sciences
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences
 

Citation

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Langford, D. J., Lou, R., Sheen, S., Amtmann, D., Colloca, L., Edwards, R. R., … Gewandter, J. S. (2023). Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials. J Pain, 24(4), 575–581. https://doi.org/10.1016/j.jpain.2022.12.011
Langford, Dale J., Raissa Lou, Soun Sheen, Dagmar Amtmann, Luana Colloca, Robert R. Edwards, John T. Farrar, et al. “Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials.J Pain 24, no. 4 (April 2023): 575–81. https://doi.org/10.1016/j.jpain.2022.12.011.
Langford DJ, Lou R, Sheen S, Amtmann D, Colloca L, Edwards RR, et al. Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials. J Pain. 2023 Apr;24(4):575–81.
Langford, Dale J., et al. “Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials.J Pain, vol. 24, no. 4, Apr. 2023, pp. 575–81. Pubmed, doi:10.1016/j.jpain.2022.12.011.
Langford DJ, Lou R, Sheen S, Amtmann D, Colloca L, Edwards RR, Farrar JT, Katz NP, McDermott MP, Reeve BB, Wasan AD, Turk DC, Dworkin RH, Gewandter JS. Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials. J Pain. 2023 Apr;24(4):575–581.
Journal cover image

Published In

J Pain

DOI

EISSN

1528-8447

Publication Date

April 2023

Volume

24

Issue

4

Start / End Page

575 / 581

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pain Management
  • Motivation
  • Humans
  • Chronic Pain
  • Anesthesiology
  • 4202 Epidemiology
  • 3202 Clinical sciences
  • 17 Psychology and Cognitive Sciences
  • 11 Medical and Health Sciences