A systematic literature review on patient-reported outcome domains and measures in nonsurgical efficacy trials related to chronic pain associated with endometriosis: an urgent call to action.

Autor:	Rosenberger DC; Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany., Mennicken E; Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany., Schmieg I; Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany., Medkour T; INSERM U987, UVSQ-Paris-Saclay University, Ambroise Paré Hospital, Boulogne-Billancourt, France., Pechard M; INSERM U987, UVSQ-Paris-Saclay University, Ambroise Paré Hospital, Boulogne-Billancourt, France., Sachau J; Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany., Fuchtmann F; Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany., Birch J; Pelvic Pain Support Network, Poole, United Kingdom., Schnabel K; Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany., Vincent K; Nuffield Department of Women's and Reproductive Health, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, United Kingdom., Baron R; Division of Neurological Pain Research and Therapy, Department of Neurology, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany., Bouhassira D; INSERM U987, UVSQ-Paris-Saclay University, Ambroise Paré Hospital, Boulogne-Billancourt, France., Pogatzki-Zahn EM; Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Muenster, Muenster, Germany.
Jazyk:	angličtina
Zdroj:	Pain [Pain] 2024 Nov 01; Vol. 165 (11), pp. 2419-2444. Date of Electronic Publication: 2024 Jul 02.
DOI:	10.1097/j.pain.0000000000003290
Abstrakt:	Abstract: Endometriosis, a common cause for chronic pelvic pain, significantly affects quality of life, fertility, and overall productivity of those affected. Therapeutic options remain limited, and collating evidence on treatment efficacy is complicated. One reason could be the heterogeneity of assessed outcomes in nonsurgical clinical trials, impeding meaningful result comparisons. This systematic literature review examines outcome domains and patient-reported outcome measures (PROMs) used in clinical trials. Through comprehensive search of Embase, MEDLINE, and CENTRAL up until July 2022, we screened 1286 records, of which 191 were included in our analyses. Methodological quality (GRADE criteria), information about publication, patient population, and intervention were assessed, and domains as well as PROMs were extracted and analyzed. In accordance with IMMPACT domain framework, the domain pain was assessed in almost all studies (98.4%), followed by adverse events (73.8%). By contrast, assessment of physical functioning (29.8%), improvement and satisfaction (14.1%), and emotional functioning (6.8%) occurred less frequently. Studies of a better methodological quality tended to use more different domains. Nevertheless, combinations of more than 2 domains were rare, failing to comprehensively capture the bio-psycho-social aspects of endometriosis-associated pain. The PROMs used showed an even broader heterogeneity across all studies. Our findings underscore the large heterogeneity of assessed domains and PROMs in clinical pain-related endometriosis trials. This highlights the urgent need for a standardized approach to both, assessed domains and high-quality PROMs ideally realized through development and implementation of a core outcome set, encompassing the most pivotal domains and PROMs for both, stakeholders and patients. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu