International evidence-based guideline for the assessment and management of polycystic ovary syndrome 2018
Objective: To develop and translate rigorous, comprehensive evidence-based diagnosis, assessment and treatment guidelines, to improve the lives of women with polycystic ovary syndrome (PCOS) worldwide.
Participants: Extensive health professional and patient engagement informed guideline priority areas. International Society-nominated panels included consumers, paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, psychiatry, psychology, dietetics, exercise physiology, public health, project management, evidence
synthesis and translation experts.
Evidence: Best practice evidence-based guideline development involved extensive evidence synthesis and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework covered evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength.
Process: Governance included an international advisory board from six continents, a project board, five guideline development groups with 63 members, consumer and translation committees. The Australian Centre for Research Excellence in PCOS, funded by the National Health and Medical Research Council (NHMRC), partnered with
European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine.
Thirty seven organisations across 71 countries collaborated with 23 face to face international meetings over 15 months. Sixty prioritised clinical questions involved 40 systematic and 20 narrative reviews, generating 166 recommendations and practice points. Convened Committees from partner and collaborating organisations provided peer review and the guideline was approved by the NHMRC.
Conclusions: We endorse the Rotterdam PCOS diagnostic criteria in adults (two of clinical or biochemical hyperandrogenism, ovulatory dysfunction, or polycystic ovaries on ultrasound) and where irregular menstrual cycles and hyperandrogenism are present, highlight that ultrasound is not necessary in diagnosis. Within eight years of menarche, both hyperandrogenism and ovulatory dysfunction are required, with ultrasound not recommended. Ultrasound criteria are tightened with advancing technology. Anti-Müllerian hormone levels are not yet adequate for diagnosis. Once diagnosed, assessment and management includes reproductive, metabolic and psychological features. Education, self-empowerment, multidisciplinary care and lifestyle intervention for prevention or management of excess weight are important. Depressive and anxiety symptoms should be screened, assessed and managed with the need for awareness of other impacts on emotional wellbeing. Combined oral contraceptive pills are firstline pharmacological management for menstrual irregularity and hyperandrogenism, with no specific recommended preparations and general preference for lower dose preparations. Metformin is recommended in addition or alone, primarily for metabolic features. Letrozole is first-line pharmacological infertility therapy; with clomiphene and metformin having a role alone and in combination. In women with PCOS and anovulatory infertility, gonadotrophins are second line. In the absence of an absolute indication for IVF, women with PCOS and anovulatory infertility, could be offered IVF third line where other ovulation induction therapies have failed. Overall evidence is low to moderate quality, requiring significant research expansion in this neglected, yet common condition. Guideline translation will be extensive including a multilingual patient mobile application and health professional training.