Clinical outcome assessment in clinical trials of chronic pain treatments

Kushang V Patel, Dagmar Amtmann, Mark P Jensen, Shannon M Smith, Christin Veasley, Dennis C Turk, Kushang V Patel, Dagmar Amtmann, Mark P Jensen, Shannon M Smith, Christin Veasley, Dennis C Turk

Abstract

Clinical outcome assessments (COAs) measure outcomes that are meaningful to patients in clinical trials and are critical for determining whether a treatment is effective. The objectives of this study are to (1) describe the different types of COAs and provide an overview of key considerations for evaluating COAs, (2) review COAs and other outcome measures for chronic pain treatments that are recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) or other expert groups, and (3) review advances in understanding pain-related COAs that are relevant to clinical trials. The authors reviewed relevant articles, chapters, and guidance documents from the European Medicines Agency and U.S. Food and Drug Administration. Since the original core set of outcome measures were recommended by IMMPACT 14 years ago, several new advancements and publications relevant to the measurement or interpretation of COAs for chronic pain trials have emerged, presenting new research opportunities. Despite progress in the quality of measurement of several outcome domains for clinical trials of chronic pain, there remain some measurement challenges that require further methodological investigation.

Keywords: Chronic pain; Clinical trials; Outcome assessment; Patient-reported outcomes.

Conflict of interest statement

D. Amtmann and M.P. Jensen participated in the development of the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference measure, but did not receive any royalty payments for that work. M.P. Jensen codeveloped the Pain Quality Assessment Scale (PQAS) that is reviewed in this article, and receives royalties from licensing fees paid by funded researchers who use the measure (clinicians and unfunded researchers can use the PQAS without paying a licensing fee). D.C. Turk codeveloped the Multidimensional Pain Inventory (MPI) and the second short-form McGill Pain Questionnaire (SF-MPQ-2), but does not receive any royalty payments for the use of these measures. The remaining authors have no conflict of interest to declare.Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The International Association for the Study of Pain.

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