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

Published:December 25, 2022DOI:https://doi.org/10.1016/j.jpain.2022.12.011

      Highlights

      • Participants’ outcome expectations may contribute to clinical trial outcome variability.
      • Outcome expectations are influenced by a number of factors.
      • A brief, content-valid measure of outcome expectations is needed.
      • Adjusting for expectations in clinical trial analyses may improve assay sensitivity.

      Abstract

      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.

      Key Words

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