1. World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonization Project: V. Physical examination standards in endometriosis research.
- Author
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Lin T, Allaire C, As-Sanie S, Stratton P, Vincent K, Adamson GD, Arendt-Nielsen L, Bush D, Jansen F, Longpre J, Rombauts L, Shah J, Toussaint A, Hummelshoj L, Missmer SA, and Yong PJ
- Subjects
- Humans, Female, Pelvic Pain diagnosis, Pelvic Pain etiology, Pelvic Pain pathology, Endometriosis pathology, Endometriosis diagnosis, Phenotype, Physical Examination standards, Biomedical Research standards, Biological Specimen Banks standards
- Abstract
Objective: The World Endometriosis Research Foundation established the Endometriosis Phenome and Biobanking Harmonisation Project (EPHect) to create standardized documentation tools (with common data elements) to facilitate the comparison and combination of data across different research sites and studies. In 2014, 4 data research standards were published: clinician-reported surgical data, patient-reported clinical data, and fluid and tissue biospecimen collection. Our current objective is to create an EPHect standard for the clinician-reported physical examination (EPHect-PE) for research studies., Design: An international consortium involving 26 clinical and academic experts and patient partners from 11 countries representing 25 institutions and organizations. Two virtual workshops, followed by the development of the physical examination standards underwent multiple rounds of iterations and revisions., Subjects: N/A MAIN OUTCOME MEASURE(S): N/A RESULT(S): The EPHect-PE tool provides standardized assessment of physical examination characteristics and pain phenotyping. Data elements involve examination of back and pelvic girdle; abdomen including allodynia and trigger points; vulva including provoked vestibulodynia; pelvic floor muscle tone and tenderness; tenderness on unidigital pelvic examination; presence of pelvic nodularity; uterine size and mobility; presence of adnexal masses; presence of incisional masses; speculum examination; tenderness and allodynia at an extra-pelvic site (e.g., forearm); and recording of anthropometrics., Conclusion(s): The EPHect-PE standards will facilitate the standardized documentation of the physical examination, including the assessment and documentation of examination phenotyping of endometriosis-associated pelvic pain., Competing Interests: Declaration of Interests T.L. has nothing to disclose. C.A. reports consultancy fees from AbbVie and Pfizer. S.A.-S reports consultancy fees from Myovant-Pfizer, Organon, and Bayer. P.S. has received royalties from UpToDate for a section about acute pelvic pain and from Frontiers in Reproductive Health as Specialty Editor for Gynecology, and participated in an AbbVie advisory board and is part of a team that received botulinum toxin and funds for monitoring a clinical trial that were provided by Allergan, Inc. through a Clinical Trials Agreement with the National Institutes of Health (NIH). K.V. has received research funding from Bayer AG and honoraria for consultancy from Bayer AG, Eli Lilly, AbbVie, and Reckitts. G.D.A. reports consultancy fees from Organon, Labcorp, and Cooper, and is the CEO of and has equity in ARC Fertility. L.A.-N. has nothing to disclose. D.B. is the owner of EPP Coaching and Consulting and has received travel expenses and speaking fees from Myovant and Guerbet. F.J., J.L and L.R., have nothing to disclose. J.S. is part of a team that received botulinum toxin and funds for monitoring a clinical trial that was provided by Allergan, Inc. through a Clinical Trials Agreement with the NIH. A.T. has nothing to disclose. L.H. is remunerated by WERF as the EPHect-PE project manager. S.A.M. reports consultancy and grant funding from AbbVie for population-based research unrelated to this project and from Frontiers in Reproductive Health as Field Chief Editor. P.J.Y. has nothing to disclose. The WERF EPHect Working Group (not listed in the author list): E.A. has nothing to disclose. J.C. is the IPPS vice-president and a consultant for SoLa Therapy, AbbVie, and Myovant; E.C. is an employee of Endometriosis UK; H.C.G has nothing to disclose. A.W.H.’s institution (University of Edinburgh) has received payment for consultancy and grant funding from Roche Diagnostics to assist in the early development of a possible blood diagnostic biomarker for endometriosis, consultancy fees from Gesynta and Joii, and grant funding from the UKRI, NIHR, CSO, and Wellbeing of Women for endometriosis research. A.W.H. has received payment for a lecture from Theramex, is president-elect of the World Endometriosis Society, co-editor in chief of Reproduction and Fertility, was a member of the NICE and ESHRE Endometriosis Guideline Groups, and is a trustee and medical advisor to Endometriosis UK; A.J. has nothing to disclose. G.L. is an employee of the US Veterans Health Administration, reports research funding from the NIH and Department of Defence, and has served as a consultant for Myovant, AbbVie, and Pelvic Sola Therapy. D.C.M. and O.C.N. have nothing to disclose. F.F.T. has royalties from Wolters Kluwer, has consulted for Bayer and Tremeau Pharmaceuticals, and received research support from Dot Laboratories., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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