Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain: results of the INTEGRATE-pain Delphi process

Giulia Bova; Anthony Domenichiello; Janelle E Letzen; Daniela C Rosenberger; Andrew Siddons; Ulrike Kaiser; Adam Anicich; Ralf Baron; Judy Birch; Didier Bouhassira; George Casey; Katie Golden; Smriti Iyengar; Barbara I Karp; Hiltrud Liedgens; Winfried Meissner; Kate Nicholson; Leah Pogorzala; Deirdre Ryan; Rolf-Detlef Treede; Peter Tugwell; Dennis C Turk; Katy Vincent; Jan Vollert; Paula R Williamson; Sarah A Woller; Ruth Zaslansky; Laura D Wandner; Esther M Pogatzki-Zahn

doi:10.1016/j.eclinm.2023.102340

Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain: results of the INTEGRATE-pain Delphi process

EClinicalMedicine. 2023 Dec 2:66:102340. doi: 10.1016/j.eclinm.2023.102340. eCollection 2023 Dec.

Authors

Giulia Bova¹, Anthony Domenichiello^{1

2}, Janelle E Letzen¹, Daniela C Rosenberger³, Andrew Siddons^{1

4}, Ulrike Kaiser⁵, Adam Anicich⁶, Ralf Baron⁷, Judy Birch⁸, Didier Bouhassira⁹, George Casey¹⁰, Katie Golden¹¹, Smriti Iyengar¹, Barbara I Karp¹, Hiltrud Liedgens¹², Winfried Meissner¹³, Kate Nicholson¹⁴, Leah Pogorzala¹, Deirdre Ryan¹⁵, Rolf-Detlef Treede¹⁶, Peter Tugwell¹⁷, Dennis C Turk¹⁸, Katy Vincent¹⁹, Jan Vollert^{3

20}, Paula R Williamson²¹, Sarah A Woller¹, Ruth Zaslansky¹³, Laura D Wandner¹, Esther M Pogatzki-Zahn³

Affiliations

¹ National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), United States.
² Kelly Services Inc, United States.
³ Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany.
⁴ N4 Solutions LLC, United States.
⁵ University Hospital Schleswig-Holstein, Campus Luebeck, Germany.
⁶ National Institutes of Health-Department of Defense-Veterans Affairs (NIH-DoD-VA) Pain Management Collaboratory (PMC), United States.
⁷ Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital of Schleswig-Holstein, Campus Kiel, Germany.
⁸ Pelvic Pain Support Network, United Kingdom.
⁹ Inserm U987, UVSQ, Paris-Saclay University, Ambroise Pare Hospital, 92100, Boulogne-Billancourt, France.
¹⁰ Outcome Measures in Rheumatology (OMERACT), United States.
¹¹ Coalition for Headache and Migraine Patients (CHAMP), United States.
¹² Gruenenthal GmbH, Aachen, Germany.
¹³ University Hospital Jena, Germany.
¹⁴ National Pain Advocacy Center, United States.
¹⁵ Pain Alliance Europe, Ireland.
¹⁶ Department of Neurophysiology, MCTN, Medical Faculty Mannheim of Heidelberg University, Mannheim, Germany.
¹⁷ Dept of Medicine, University of Ottawa, Canada.
¹⁸ University of Washington, United States.
¹⁹ University of Oxford, United Kingdom.
²⁰ Faculty of Health and Life Sciences, Department of Clinical and Biomedical Sciences, University of Exeter, Exeter, UK.
²¹ MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, United Kingdom.

Abstract

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.

Keywords: Acute pain; Chronic pain; Core outcome sets; Delphi method; Recurrent/episodic pain; Transition from acute to chronic pain.