Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

Autor:	Gewandter JS; Department of Anesthesiology, University of Rochester, Rochester, NY, USA., Dworkin RH; Department of Anesthesiology, University of Rochester, Rochester, NY, USA., Turk DC; University of Washington, Seattle, WA, USA., Farrar JT; University of Pennsylvania, Philadelphia, PA, USA., Fillingim RB; University of Florida, Gainesville, FL, USA., Gilron I; Queen's University, Kingston, ON, Canada., Markman JD; Department of Anesthesiology, University of Rochester, Rochester, NY, USA., Oaklander AL; Harvard University, Boston, MS, USA., Polydefkis MJ; Johns Hopkins University, Baltimore, MD, USA., Raja SN; Johns Hopkins University, Baltimore, MD, USA., Robinson JP; University of Washington, Seattle, WA, USA., Woolf CJ; Harvard University, Boston, MS, USA., Ziegler D; German Diabetes Center at Heinrich Heine University, Düsseldorf, Germany., Ashburn MA; University of Pennsylvania, Philadelphia, PA, USA., Burke LB; Lora Group, LLC, Royal Oak, MD, USA., Cowan P; American Chronic Pain Association, Rocklin, CA, USA., George SZ; University of Florida, Gainesville, FL, USA., Goli V; Pfizer and Duke University, Raleigh-Duram, NC, USA., Graff OX; GlaxoSmithKline, London, United Kingdom., Iyengar S; Eli Lilly, Indianapolis, IN, USA., Jay GW; Virtuous Pharma, Inc, Raleigh-Durham, NC, USA., Katz J; York University, Toronto, ON, Canada., Kehlet H; Rigshospitalet, Copenhagen University, Denmark., Kitt RA; Department of Anesthesiology, University of Rochester, Rochester, NY, USA., Kopecky EA; Endo Pharmaceuticals, Inc, Malvern, PA, USA., Malamut R; Teva Pharmaceuticals, North Wales, PA, USA., McDermott MP; Department of Anesthesiology, University of Rochester, Rochester, NY, USA., Palmer P; AcelRx, Redwood City, CA, USA., Rappaport BA; Arlington, VA, USA., Rauschkolb C; Johnson and Johnson, Titusville, NJ, USA., Steigerwald I; Grünenthal GMbH, Aachen, Germany., Tobias J; Jazz Pharmaceuticals, Palo Alto, CA, USA., Walco GA; University of Washington, Seattle, WA, USA.
Jazyk:	angličtina
Zdroj:	Pain reports [Pain Rep] 2021 Jan 21; Vol. 6 (1), pp. e895. Date of Electronic Publication: 2021 Jan 21 (Print Publication: 2021).
DOI:	10.1097/PR9.0000000000000895
Abstrakt:	Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials. Competing Interests: The views expressed in this article are those of the authors, none of whom have financial conflicts of interest specifically related to the issues discussed in this article. At the time of the meeting on which this article is based, several authors were employed by pharmaceutical companies, and others had received consulting fees or honoraria from one or more pharmaceutical or device companies. Authors of this article who were not employed by industry or government at the time of the meeting received travel stipends, hotel accommodations, and meals during the meeting from the University of Rochester Office of Continuing Professional Education with funds from unrestricted grants to support the activities of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) provided by multiple pharmaceutical companies. Preparation of background literature reviews and draft manuscripts was supported by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US FDA, which has received research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, and other sources. No official endorsement by the FDA, US Department of Veterans Affairs, US National Institutes of Health, or the pharmaceutical and device companies that have provided unrestricted grants to support the activities of IMMPACT and ACTTION should be inferred.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.)
Databáze:	MEDLINE
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