Disclosures. Dr. Kleykamp was employed by the health care consulting firm Pinney Associates from 2014 through 2018. During her employment, she provided consulting advice to pharmaceutical companies, the electronic cigarette company NJOY, and the tobacco company RAI Services Company on noncombustible tobacco products including e-cigarettes. Dr. Kleykamp received compensation in 2019 from the health technology assessment company Hayes/TractManager and government contractor Palladian Partners for freelance medical writing on topics unrelated to this systematic review. In the previous 36 months, Dr. Arnold had received research grants from Pfizer , Eli Lilly , Daiichi Sankyo , Teva , Allergan , Aptinyx , Axsome , Swing Therapeutics , Otsuka , Astellas , and Tonix , as well as compensation for consulting on clinical trials from Pfizer, Eli Lilly, Daiichi Sankyo, Zynerba, Astellas, Cinrx, Prismic, Teva, Allergan, Jazz Pharmaceuticals, and Lundbeck. In the previous 36 months, Dr. Fillingim had received research support from the National Institutes of Health . In the previous 36 months, Dr. Grol-Prokopczyk had received research support from the National Institutes of Health. Dr. Ohrbach had received research support from the National Institutes of Health. In the previous 36 months, Dr. Turk had received support from research grants and contracts from US Food and Drug Administration, National Institutes of Health, and the Patient-Centered Outcomes Research Institute and compensation for consulting on research methods and reporting from AccelRx, Eli Lilly, Flexion, GlaxoSmithKline, Novartis, and Pfizer. In the previous 5 years, Dr. Dworkin had received research grants and contracts from the US Food and Drug Administration and the 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, AstraZeneca, Biogen, Biohaven, Boston Scientific, Braeburn, Celgene, Centrexion, Chromocell, Clexio, Concert, Coronado, Daiichi Sankyo, Decibel, Dong-A, Editas, Eli Lilly, Eupraxia, Glenmark, Grace, Hope, Hydra, Immune, Johnson & Johnson, Lotus Clinical Research, Mainstay, Medavante, Merck, Neumentum, Neurana, NeuroBo, Novaremed, Novartis, NSGene, Olatec, Periphagen, Pfizer, Phosphagenics, Quark, Reckitt Benckiser, Regenacy (also equity), Relmada, Sanifit, Scilex, Semnur, SK Life Sciences, Sollis, Spinifex, Syntrix, Teva, Thar, Theranexus, Trevena, Vertex, and Vizuri. Drs. Ferguson, McNicol, Bixho, and Edwards did not report any disclosures.
The preliminary findings associated with the review were presented at Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting XXIII, July 25-26, 2019, Washington, DC, that focused on central sensitization as a potential mechanism.
Preparation of this systematic review was supported by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION). ACTTION has received contracts, grants, or other revenue from the US Food and Drug Administration, multiple pharmaceutical and device companies, royalties, philanthropy, and other sources. The views expressed in this article are those of the authors, and no official endorsement by the US Food and Drug Administration or the pharmaceutical and device companies that provided unrestricted grants to support the activities of the ACTTION public-private partnership should be inferred.
The authors wish to thank Linda Hasman at the School of Medicine and Dentistry at the University of Rochester for her assistance in building the search strategy.