TY - JOUR
T1 - International PCOS guideline clinical research priorities roadmap
T2 - A co-designed approach aligned with end-user priorities in a neglected women's health condition
AU - Teede, H J
AU - Gibson, M
AU - Laven, J
AU - Dokras, A
AU - Moran, L J
AU - Piltonin, T
AU - Costello, M
AU - Joham, A E
AU - Mousa, A
AU - Tay, C T
AU - International PCOS Network
AU - Arlt, Wiebke
AU - Azziz, Ricardo
AU - Balen, Adam
AU - Bedson, Lisa
AU - Berry, Lorna
AU - Boivin, Jacky
AU - Boyle, Jacqueline
AU - Brennan, Leah
AU - Brown, Wendy
AU - Burgert, Tania
AU - Busby, Maureen
AU - Ee, Carolyn
AU - Garad, Rhonda M
AU - Harrison, Cheryce
AU - Hart, Roger
AU - Misso, Marie
AU - Morman, Rachel
AU - Hirschberg, Angelica Lindén
AU - Ho, Tuong
AU - Hoeger, Kathleen
AU - Jitpiriyaroj, Sonia
AU - Jordan, Cailin
AU - Legro, Richard S
AU - Li, Rong
AU - Lujan, Marla
AU - Ma, Ronald C
AU - Mansfield, Darren
AU - Marsh, Kate
AU - Mocanu, Edgar
AU - Norman, Robert J
AU - Oberfield, Sharon
AU - Hopkins, Dawn Kimberly
AU - Patel, Malika
AU - Peña, Alexia
AU - Redman, Leanne
AU - Rombauts, Luk
AU - Romualdi, Daniela
AU - Shah, Duru
AU - Spritzer, Poli Mara
AU - Stener-Victorin, Elisabet
AU - Tehrani, Fahimeh Ramezani
AU - Thangaratinam, Shakila
AU - Thondan, Mala
AU - Vanky, Eszter
AU - Al Wattar, Bassel H
AU - Wijeyaratne, Chandrika
AU - Witchel, Selma
AU - Yang, Dongzi
AU - Yildiz, Bulent O
PY - 2024/12
Y1 - 2024/12
N2 - 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).
AB - 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).
KW - Consumer and community involvement
KW - Diabetes mellitus
KW - Evidence-based medicine
KW - Infertility
KW - Polycystic ovary syndrome
KW - Public and patient involvement
KW - Research
UR - http://www.scopus.com/inward/record.url?scp=85209100777&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1078444
UR - http://purl.org/au-research/grants/NHMRC/1171592
U2 - 10.1016/j.eclinm.2024.102927
DO - 10.1016/j.eclinm.2024.102927
M3 - Article
AN - SCOPUS:85209100777
SN - 2589-5370
VL - 78
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 102927
ER -