Study Question:
What is the recommended assessment and management of women with polycystic ovary syndrome
(PCOS), based on the best available evidence, clinical expertise, and consumer preference?
Summary Answer:
International evidence-based guidelines including 166 recommendations and practice
points, addressed prioritized questions to promote consistent, evidence-based care
and improve the experience and health outcomes of women with PCOS.
What Is Known Already:
Previous guidelines either lacked rigorous evidence-based processes, did not engage
consumer and international multidisciplinary perspectives, or were outdated. Diagnosis
of PCOS remains controversial and assessment and management are inconsistent. The
needs of women with PCOS are not being adequately met and evidence practice gaps persist.
Study Design, Size, Duration:
International evidence-based guideline development engaged professional societies
and consumer organizations with multidisciplinary experts and women with PCOS directly
involved at all stages. Appraisal of Guidelines for Research and Evaluation (AGREE)
II-compliant processes were followed, with extensive evidence synthesis. The Grading
of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was
applied across evidence quality, feasibility, acceptability, cost, implementation
and ultimately recommendation strength.
Participants/Materials, Setting, Methods:
Governance included a six continent international advisory and a project board, five
guideline development groups, and consumer and translation committees. Extensive health
professional and consumer engagement informed guideline scope and priorities. Engaged
international society-nominated panels included pediatrics, endocrinology, gynecology,
primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics,
exercise physiology, public health and other experts, alongside consumers, project
management, evidence synthesis, and translation experts. Thirty-seven societies and
organizations covering 71 countries engaged in the process. Twenty face-to-face meetings
over 15 months addressed 60 prioritized clinical questions involving 40 systematic
and 20 narrative reviews. Evidence-based recommendations were developed and approved
via consensus voting within the five guideline panels, modified based on international
feedback and peer review, with final recommendations approved across all panels.
Main Results and the Role of Chance:
The evidence in the assessment and management of PCOS is generally of low to moderate
quality. The guideline provides 31 evidence based recommendations, 59 clinical consensus
recommendations and 76 clinical practice points all related to assessment and management
of PCOS. Key changes in this guideline include: i) considerable refinement of individual
diagnostic criteria with a focus on improving accuracy of diagnosis; ii) reducing
unnecessary testing; iii) increasing focus on education, lifestyle modification, emotional
wellbeing and quality of life; and iv) emphasizing evidence based medical therapy
and cheaper and safer fertility management.
Limitations, Reasons for Caution:
Overall evidence is generally low to moderate quality, requiring significantly greater
research in this neglected, yet common condition, especially around refining specific
diagnostic features in PCOS. Regional health system variation is acknowledged and
a process for guideline and translation resource adaptation is provided.
Wider Implications of the Findings:
The international guideline for the assessment and management of PCOS provides clinicians
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 program supports the guideline
with an integrated evaluation program.
Study Funding/Competing Interest(S):
The guideline was primarily funded by the Australian National Health and Medical Research
Council of Australia (NHMRC) supported by a partnership with ESHRE and the American
Society for Reproductive Medicine. Guideline development group members did not receive
payment. Travel expenses were covered by the sponsoring organizations. Disclosures
of conflicts of interest were declared at the outset and updated throughout the guideline
process, aligned with NHMRC guideline processes. Full details of conflicts declared
across the guideline development groups are available at https://www.monash.edu/medicine/sphpm/mchri/pcos/guideline
in the Register of disclosures of interest. Of named authors, Dr Costello has declared
shares in Virtus Health and past sponsorship from Merck Serono for conference presentations.
Prof. Laven declared grants from Ferring, Euroscreen and personal fees from Ferring,
Euroscreen, Danone and Titus Healthcare. Prof. Norman has declared a minor shareholder
interest in an IVF unit. The remaining authors have no conflicts of interest to declare.
The guideline was peer reviewed by special interest groups across our partner and
collaborating societies and consumer organizations, was independently assessed against
AGREEII criteria and underwent methodological review. This guideline was approved
by all members of the guideline development groups and was submitted for final approval
by the NHMRC