EClinicalMedicine (Dec 2024)

International PCOS guideline clinical research priorities roadmap: a co-designed approach aligned with end-user priorities in a neglected women’s health conditionResearch in context

  • H.J. Teede,
  • M. Gibson,
  • J. Laven,
  • A. Dokras,
  • L.J. Moran,
  • T. Piltonin,
  • M. Costello,
  • A. Mousa,
  • A.E. Joham,
  • C.T. Tay,
  • Wiebke Arlt,
  • Ricardo Azziz,
  • Adam Balen,
  • Lisa Bedson,
  • Lorna Berry,
  • Jacky Boivin,
  • Jacqueline Boyle,
  • Leah Brennan,
  • Wendy Brown,
  • Tania Burgert,
  • Maureen Busby,
  • Carolyn Ee,
  • Rhonda M. Garad,
  • Cheryce Harrison,
  • Roger Hart,
  • Marie Misso,
  • Rachel Morman,
  • Angelica Lindén Hirschberg,
  • Tuong Ho,
  • Kathleen Hoeger,
  • Sonia Jitpiriyaroj,
  • Cailin Jordan,
  • Richard S. Legro,
  • Rong Li,
  • Marla Lujan,
  • Ronald C. Ma,
  • Darren Mansfield,
  • Kate Marsh,
  • Edgar Mocanu,
  • Robert J. Norman,
  • Sharon Oberfield,
  • Dawn Kimberly Hopkins,
  • Malika Patel,
  • Alexia Peña,
  • Leanne Redman,
  • Luk Rombauts,
  • Daniela Romualdi,
  • Duru Shah,
  • Poli Mara Spritzer,
  • Elisabet Stener-Victorin,
  • Fahimeh Ramezani Tehrani,
  • Shakila Thangaratinam,
  • Mala Thondan,
  • Eszter Vanky,
  • Bassel H. Al Wattar,
  • Chandrika Wijeyaratne,
  • Selma Witchel,
  • Dongzi Yang,
  • Bulent O. Yildiz

Journal volume & issue
Vol. 78
p. 102927

Abstract

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Summary: Background: Polycystic ovary syndrome (PCOS) is a common endocrinopathy with significant reproductive, metabolic, and psychological complications. Consensus on PCOS clinical research priorities across end-users is fundamental and necessitates a robust co-development of a clinical research roadmap to guide international research efforts. Methods: A multistage process included: i) international surveys of women and healthcare providers to identify research priorities and unmet needs; ii) interrogation of systematic reviews conducted for the International PCOS Guideline to identify research gaps; iii) International PCOS Guideline Network consensus generated clinical research roadmap; and iv) international peer review for external validation. Findings: A codesigned survey engaging 1278 women with PCOS and 1474 healthcare providers found general concordance on research priorities. International PCOS Guideline development processes identified gaps in the literature and coproduced over 150 research priorities throughout the women’s life course, affirmed in international peer review. Key themes included: 1) Optimizing PCOS diagnosis; understanding natural history across diverse populations and life stages; detecting and preventing complications, and integrating and interrogating large data assets; 2) developing evidence-based resources, exploring optimal modes for information provision and models of care; 3) exploring effective lifestyle and weight management strategies; minimising weight stigma; 4) exploring intervention effects (including treatment efficacy, safety, cost-effectiveness, and long-term follow-up) on diverse features of PCOS across subgroups; and 5) optimising preconception care and fertility treatments in PCOS. Interpretation: This rigorously coproduced International PCOS Guideline clinical research roadmap addresses stakeholder priorities to guide future clinical research in this common yet neglected condition. The roadmap complements the established PCOS Core Outcome Set to enhance research quality, and tackles evidence-practice gaps to improve health outcomes for women with PCOS throughout their life course. Funding: The survey, International PCOS Guideline Network and 2018 and 2023 International PCOS Guidelines were funded by the Australian National Health and Medical Research Council (NHMRC) Centres of Research excellence in PCOS (APP1078444) and in Women’s Health in Reproductive life (APP1171592). Guideline partners, American Society for Reproductive Medicine (ASRM), Endocrine Society, European Society of Human Reproduction and Embryology (ESHRE), and European Society of Endocrinology (ESE), provided additional funding and assisted in guideline development. HT and AM are NHMRC Research Fellows. LM was funded by a Heart Foundation Future Leader and Veski Fellowship and CTT by the NHMRC Centres of Research excellence in Women’s Health in Reproductive life. All disclosures of interest were declared before commencing GDG involvement and updated before all major milestones and are available alongside the PCOS Guideline (https://www.monash.edu/__data/assets/pdf_file/0009/3371292/Register-of-disclosures-of-interest.pdf).

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