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Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome

Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome
Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome

Study question: what is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? 

Summary answer: international evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. 

What is known already: the 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from 6 continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low-to low-quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus-based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, the evidence quality was low, and evidence-practice gaps persist. 

Study design, size, and duration: the 2023 International Evidence-based Guideline update re-engaged the 2018 network across professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation, and ultimately recommendation strength, and diversity and inclusion were considered throughout. 

Participants/materials, setting, and methods: this summary should be read in conjunction with the full guideline for detailed participants and methods. Governance included a 6-continent international advisory and management committee, 5 guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health, and other experts, alongside consumers, project management, evidence synthesis, statisticians, and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and 5 face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across 5 guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council. 

Main results and the role of chance: the evidence in the assessment and management of PCOS has generally improved in the past 5 years but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpin 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include the following: (1) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm, and inclusion of anti-Müllerian hormone levels as an alternative to ultrasound in adults only; (2) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnoea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; (3) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care, and shared decision-making to improve patient experience, alongside greater research; (4) maintained emphasis on healthy lifestyle, emotional well-being, and quality of life, with awareness and consideration of weight stigma; and (5) emphasizing evidence-based medical therapy and cheaper and safer fertility management. 

Limitations and reasons for caution: overall, recommendations are strengthened and evidence is improved but remains generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. 

Wider implications of the findings: the 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input, and consumer preferences. Research recommendations have been generated, and a comprehensive multifaceted dissemination and translation programme supports the guideline with an integrated evaluation programme.

assessment, evidence based, GRADE, guideline, management, polycystic ovary syndrome
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Teede, Helena J., Tay, Chau Thien, Laven, Joop J.E., Dokras, Anuja, Moran, Lisa J., Piltonen, Terhi T., Costello, Michael F., Boivin, Jacky, Redman, Leanne M., Boyle, Jacqueline A., Norman, Robert J., Mousa, Aya and Joham, Anju E. , the International PCOS Network (2023) Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome. European journal of endocrinology, 189 (2), G43-G64. (doi:10.1093/ejendo/lvad096).

Record type: Article

Abstract

Study question: what is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? 

Summary answer: international evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. 

What is known already: the 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from 6 continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low-to low-quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus-based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, the evidence quality was low, and evidence-practice gaps persist. 

Study design, size, and duration: the 2023 International Evidence-based Guideline update re-engaged the 2018 network across professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation, and ultimately recommendation strength, and diversity and inclusion were considered throughout. 

Participants/materials, setting, and methods: this summary should be read in conjunction with the full guideline for detailed participants and methods. Governance included a 6-continent international advisory and management committee, 5 guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health, and other experts, alongside consumers, project management, evidence synthesis, statisticians, and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and 5 face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across 5 guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council. 

Main results and the role of chance: the evidence in the assessment and management of PCOS has generally improved in the past 5 years but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpin 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include the following: (1) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm, and inclusion of anti-Müllerian hormone levels as an alternative to ultrasound in adults only; (2) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnoea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; (3) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care, and shared decision-making to improve patient experience, alongside greater research; (4) maintained emphasis on healthy lifestyle, emotional well-being, and quality of life, with awareness and consideration of weight stigma; and (5) emphasizing evidence-based medical therapy and cheaper and safer fertility management. 

Limitations and reasons for caution: overall, recommendations are strengthened and evidence is improved but remains generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. 

Wider implications of the findings: the 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input, and consumer preferences. Research recommendations have been generated, and a comprehensive multifaceted dissemination and translation programme supports the guideline with an integrated evaluation programme.

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Accepted/In Press date: 28 July 2023
Published date: 15 August 2023
Additional Information: Funding Information: This effort was primarily funded by the Australian Government via the National Health Medical Research Council (NHMRC) (APP1171592), supported by a partnership with American Society for Reproductive Medicine, Endocrine Society, European Society for Human Reproduction and Embryology, and the European Society for Endocrinology. Collaborating organizations provided in-kind support. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). H.J.T. and A.M. are funded by NHMRC fellowships. C.T.T. is funded by a Royal Australasian College of Physicians (RACP) fellowship. Guideline development group members were volunteers. Travel expenses were covered by the partnering organizations. Funding Information: This effort was primarily funded by the Australian Government via the National Health Medical Research Council (NHMRC) (APP1171592), supported by a partnership with American Society for Reproductive Medicine, Endocrine Society, European Society for Human Reproduction and Embryology, and the European Society for Endocrinology. Collaborating organizations provided in-kind support. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). H.J.T. and A.M. are funded by NHMRC fellowships. C.T.T. is funded by a Funding Information: Conflict of interest: Disclosures of interest were declared at the outset and updated throughout the guideline process, aligned with National Health Medical Research Council (NHMRC) guideline processes. These are available online (www.monash.edu/medicine/mchri/pcos). Of named authors H.J.T., C.T.T., A.D., L.M., L.R., J. Boyle, and A.M. have no conflicts of interest to declare. J.L. declares grant from Ferring and Merck; consulting fees from Ferring and Titus Health Care; speaker’s fees from Ferring; unpaid consultancy for Ferring, Roche Diagnostics and Ansh Labs; and sits on ad - visory boards for Ferring, Roche Diagnostics, Ansh Labs, and Gedeon Richter. T.P. declares a grant from Roche; consulting fees from Gedeon Richter and Organon; speaker’s fees from Gedeon Richter and Exeltis; travel support from Gedeon Richter and Exeltis; unpaid consultancy for Roche Diagnostics; and sits on advisory boards for Roche Diagnostics. M.C. declares travels support from Merck; and sits on an advisory board for Merck. J. Boivin declares grants from Merck Serono Ltd.; consulting fees from Ferring B.V; speaker’s fees from Ferring Arzneimittell GmbH; travel support from Organon; and sits on an advisory board for the Office of Health Economics. R.J.N. has received speaker’s fees from Merck and sits on an advisory board for Ferring. A.J. has received speaker’s fees from Novo Nordisk and Boehringer Ingelheim. The guideline was peer reviewed by special interest groups across our 39 partner and collaborating organizations, was independently methodologically assessed against AGREEII criteria and was approved by all members of the guideline development groups and by the NHMRC.
Keywords: assessment, evidence based, GRADE, guideline, management, polycystic ovary syndrome

Identifiers

Local EPrints ID: 484750
URI: http://eprints.soton.ac.uk/id/eprint/484750
ISSN: 0804-4643
PURE UUID: f3d8a935-c153-4a96-8ce3-4e4b74e81e53
ORCID for Ying Cheong: ORCID iD orcid.org/0000-0001-7687-4597

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Date deposited: 21 Nov 2023 17:32
Last modified: 12 Jul 2024 01:45

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Contributors

Author: Helena J. Teede
Author: Chau Thien Tay
Author: Joop J.E. Laven
Author: Anuja Dokras
Author: Lisa J. Moran
Author: Terhi T. Piltonen
Author: Michael F. Costello
Author: Jacky Boivin
Author: Leanne M. Redman
Author: Jacqueline A. Boyle
Author: Robert J. Norman
Author: Aya Mousa
Author: Anju E. Joham
Author: Wiebke Arlt
Author: Ricardo Azziz
Author: Adam Balen
Author: Lisa Bedson
Author: Lorna Berry
Author: Jacky Boivin
Author: Jacqueline Boyle
Author: Leah Brennan
Author: Wendy Brown
Author: Tania Burgert
Author: Maureen Busby
Author: Carolyn Ee
Author: Rhonda M. Garad
Author: Melanie Gibson-Helm
Author: Cheryce Harrison
Author: Roger Hart
Author: Kim Hopkins
Author: Angelica Lindén Hirschberg
Author: Tuong Ho
Author: Kathleen Hoeger
Author: Cailin Jordan
Author: Richard S. Legro
Author: Rong Li
Author: Marla Lujan
Author: Ronald Ma
Author: Darren Mansfield
Author: Kate Marsh
Author: Edgar Mocanu
Author: Ben Mol
Author: Rachel Mormon
Author: Robert Norman
Author: Sharon Oberfield
Author: Malika Patel
Author: Loyal Pattuwage
Author: Alexia Peña
Author: Leanne Redman
Author: Luk Rombauts
Author: Ying Cheong ORCID iD
Corporate Author: the International PCOS Network

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