Bova G, Domenichiello A, Letzen JE, Rosenberger DC, Siddons A, Kaiser U, Anicich A, Baron R, Birch J, Bouhassira D, Casey G, Golden K, Iyengar S, Karp BI, Liedgens H, Meissner W, Nicholson K, Pogorzala L, Ryan D, Treede RD, Tugwell P, Turk DC, Vincent K, Vollert J, Williamson PR, Woller SA, Zaslansky R, Wandner LD, and Pogatzki-Zahn EM
Background: Pain is the leading cause of disability worldwide among adults and effective treatment options remain elusive. Data harmonization efforts, such as through core outcome sets (COS), could improve care by highlighting cross-cutting pain mechanisms and treatments. Existing pain-related COS often focus on specific conditions, which can hamper data harmonization across various pain states., Methods: Our objective was to develop four overarching COS of domains/subdomains (i.e., what to measure) that transcend pain conditions within different pain categories. We hosted a meeting to assess the need for these four COS in pain research and clinical practice. Potential COS domains/subdomains were identified via a systematic literature review (SLR), meeting attendees, and Delphi participants. We conducted an online, three step Delphi process to reach a consensus on domains to be included in the four final COS. Survey respondents were identified from the SLR and pain-related social networks, including multidisciplinary health care professionals, researchers, and people with lived experience (PWLE) of pain. Advisory boards consisting of COS experts and PWLE provided advice throughout the process., Findings: Domains in final COS were generally related to aspects of pain, quality of life, and physical function/activity limitations, with some differences among pain categories. This effort was the first to generate four separate, overarching COS to encourage international data harmonization within and across different pain categories., Interpretation: The adoption of the COS in research and clinical practice will facilitate comparisons and data integration around the world and across pain studies to optimize resources, expedite therapeutic discovery, and improve pain care., Funding: Innovative Medicines Initiative 2 Join Undertaking; European Union Horizon 2020 research innovation program, European Federation of Pharmaceutical Industries and Associations (EFPIA) provided funding for IMI-PainCare. RDT acknowledges grants from Esteve and TEVA., Competing Interests: Giulia Bova has nothing to disclose. Anthony Domenichiello has nothing to disclose. Janelle Letzen has nothing to disclose. Daniela C. Rosenberger has nothing to disclose. Andrew Siddons has nothing to disclose. Ulrike Kaiser is the principal investigator of VAPAIN. Adam Anicich has nothing to disclose. Ralf Baron reports grants from EU Projects: „Europain“ (115,007). DOLORisk (633,491). IMI Paincare (777,500). Ðerman Federal Ministry of Education and Research (BMBF): Verbundprojekt: Frühdetektion von Schmerzchronifizierung (NoChro) (13GW0338C). Ðerman Research Network on Neuropathic Pain (01EM0903). Ðfizer Pharma GmbH, Sanofi Genzyme GmbH, Grünenthal GmbH, Mundipharma Research GmbH und Co. KG., Alnylam Pharmaceuticals Inc., Zambon GmbH, Bayer AG, Sanofi Aventis GmbHÐ personal fees from Pfizer Pharma GmbH, Sanofi Genzyme GmbH, Grünenthal GmbH, Mundipharma, Lilly GmbH, Desitin Arzneimittel GmbH, Teva GmbH, Bayer AG, MSD GmbH, Seqirus Australia Pty. Ltd, Novartis Pharma GmbH, TAD Pharma GmbH, Grünenthal SA Portugal, Grünen¬thal Pharma AG Schweiz, Grünenthal B.V. Niederlande, Evapharma, Takeda Pharmaceuticals International AG Schweiz, Ology Medical Education Netherlands, Ever Pharma GmbH, Amicus Therapeutics GmbH, Novo Nordisk Pharma GmbH, Chiesi GmbH, Stada Mena DWC LLC Dubai, Hexal AG, Viatris, personal fees from Pfizer Pharma GmbH, Sanofi Genzyme GmbH, Grünenthal GmbH, Lilly, Novartis Pharma GmbH, Bristol-Myers Squibb, Biogenidec, AstraZeneca GmbH, Daiichi Sankyo, Glenmark Pharmaceuticals S.A., Seqirus Australia Pty. Ltd, Teva Pharmaceuticals Europe Niederlande, Teva GmbH, Genentech, Mundipharma International Ltd. UK, Galapagos NV, Kyowa Kirin GmbH, Vertex Pharmaceuticals Inc., Biotest AG, Celgene GmbH, Desitin Arzneimittel GmbH, Regeneron Pharmaceuticals Inc. USA, Theranexus DSV CEA Frankreich, Abbott Products Operations AG Schweiz, Bayer AG, Grünenthal Pharma AG Schweiz, Akcea Therapeutics Germany GmbH, Asahi Kasei Pharma Corporation, AbbVie Deutschland GmbH & Co. KG, Air Liquide Sante International Frankreich, Alnylam Germany GmbH, Lateral Pharma Pty Ltd, Hexal AG, Angelini, Janssen, SIMR Biotech Pty Ltd Australien, Confo Therapeutics N. V. Belgium, Merz Pharmaceuticals GmbH, Neumentum Inc., F. Hoffmann-La Roche Ltd. Switzerland, AlgoTherapeutix SAS France, Nanobiotix SA France, AmacaThera Inc. Canada, outside the submitted work. Judy Birch has nothing to disclose. Didier Bouhassira reports personal fees from Grunenthal, personal fees from Bayer, outside the submitted work. George Casey has nothing to disclose. Katie Golden has nothing to disclose. Smriti Iyengar has nothing to disclose. Barbara Karp has nothing to disclose. Hiltrud Liedgens has nothing to disclose. Winfried Meissner reports grants from European Commission, during the conduct of the study; personal fees from Grünenthal, grants from Mundipharma, grants from Pfizer, personal fees from Ethypharm, personal fees from Kyowa, personal fees from Spectrum Therapeutics, outside the submitted work. Kate Nicholson has no conflicts or disclosures. She is employed by the National Pain Advocacy Center, which takes no industry funding and advocates for the health and rights of people living with pain. She was a member on the patient Advisory Committee for this project and received an honorarium for attending early organizational strategic planning for the project. She also received support for attending the European Pain Federation (EFIC) conference to present on concepts from this project. Leah Pogorzala has nothing to disclose. Deidre Ryan has nothing to disclose. Rolf-Detlef Treede reports grants from Innovative Medicines Initiative EU and EFPIA, during the conduct of the study; grants from Deutsche Forschungsgemeinschaft, grants from Esteve, TEVA, personal fees from Bayer, Grünenthal, GSK, Merz, Saluda Medical, Sanofi, Cered, and Vertex outside the submitted work. Peter Tugwell has nothing to disclose. Dennis Turk has received in the past 5 years research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health, U.S. Patient-Centered Outcome Research Institute, and US National Center for Occupational Health and Safety; received compensation for serving on advisory boards from Eli Lilly, GlaxoSmithKline, Novartis, and Pfizer. He received an honorarium from Wolters Kluwer in his role as editor-in-chief of The Clinical Journal of Pain. Katy Vincent reports grants from Innovative Medicines Initiative 2 Joint Undertaking (GA No. 777500) (Horizon 2020 and EFPIA), during the conduct of the study; grants and personal fees from Bayer Healthcare (paid to institution), and personal fees from Reckitts (paid to institution), outside the submitted work. She received payment from Gedeon Richter for consultancy and talks, paid to the institution. Jan Vollert reports personal fees from Vertex Pharmaceuticals, personal fees from Embody Orthopaedics, personal fees from Casquar, outside the submitted work. Paula Williamson chairs the COMET Initiative Management Group. Sarah Woller has nothing to disclose. Ruth Zaslansky has nothing to disclose. Laura Wandner has nothing to disclose. Esther Pogatzki-Zahn reports grants from the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF), the Federal Joint Committee (G-BA) and the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777500. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. All money goes to the institutions (WWU/UKM) EPZ is working for. EPZ received personal fees (money went to her institution) from Gruenenthal, Medtronic and Novartis unrelated to the current work. She received an honorarium in her role as debuty-editor-in-chief of the European Journal of Anaesthesiology., (© 2023 Published by Elsevier Ltd.)