Abstract
Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2445-2454 |
| Number of pages | 10 |
| Journal | Pain |
| Volume | 165 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 1 2024 |
Funding
This study was supported by the Hospital for Special Surgery Department of Anesthesiology, Critical Care, and Pain Management's Research and Education Fund and by funding from the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION; 1U01FD007702) public\u2013private partnership and by the National Institutes of Health (K24NS126861). The views expressed in this article are those of the authors, and no official endorsement by the Food and Drug Administration (FDA) or the companies that provided support for the ACTTION public-private partnership should be inferred. The ACTTION public\u2013private partnership has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, philanthropy, royalties, and other sources (a list of industry sponsors can be found at https://www.acttion.org/partners ). During the past 3 years, D.J.L. has received funding from the U.S. Food and Drug Administration. D.C.T. has received in the past 5 years research grants and contracts from the U.S. Food and Drug Administration and the U.S. National Institutes of Health, U.S. Patient-Centered Outcome Research Institute, and U.S. National Center for Occupational Health and Safety; received compensation for serving on advisory boards from Eli Lilly, GlaxoSmithKline, Novartis, and Pfizer. He received and honorarium from Wolters Kluwer in his role as editor-in-chief of The Clinical Journal of Pain. P.G.C. is funded in part through the UK National Institute for Health and Care Research (NIHR) Leeds Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. T.J.S. has received grants or contracts from Pfizer, Regeneron, Eli Lilly, Amgen, Grunenthal, Galapagos, Novartis, Techfields, and Paradigm, and consulting fees from PFizer, Lilly, Vertex, GlaxoSmithKline, Biosplice, Collegium, Acadia, Grunenthal, Techfields, Galapagos, Unity. Moebius, Paradigm, Moebius, and Paradigm. R.H.D. has received in the past 5 years research grants and contracts from the U.S. Food and Drug Administration and the U.S. National Institutes of Health, and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, Beckley, Biogen, Biohaven, Biosplice, Boston Scientific, Braeburn, Cardialen, Centrexion, Chiesi, Chromocell, Clexio, Collegium, CoimbiGene, Confo, Decibel, Editas, Eli Lilly, Endo, Ethismos (equity), Eupraxia, Exicure, GlaxoSmithKline, Glenmark, Gloriana, Hope, Kriya, Lotus, Mainstay, Merck, Mind Medicine (also equity), Neumentum, Neurana, NeuroBo, Novaremed, Novartis, OliPass, Orion, Oxford Cannabinoid Technologies, Pfizer, Q-State, Reckitt Benckiser, Regenacy (also equity), Rho, Sangamo, Sanifit, Scilex, Semnur, SIMR Biotech, Sinfonia, SK Biopharmaceuticals, Sollis, SPM Therapeutics, SPRIM Health, Teva, Theranexus, Vertex, Vizuri, and WCG. J.S.G. has received (unrelated to this work) grant support from the NIH and Neurometrix, consulting income from AlgoTX, GW pharmaceuticals, Eikonozo, and Saluda, and shares for consulting from Eisana Corp.
Keywords
- Chronic pain
- Clinical meaningfulness
- Clinical trials
- Patient global assessment
- Within-patient change
ASJC Scopus subject areas
- Neurology
- Clinical Neurology
- Anesthesiology and Pain Medicine