Evidence summaries and recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome: Lifestyle management.

Lifestyle is fundamental in chronic disease prevention and management, and it has been recommended as a first-line treatment in the Australian polycystic ovary syndrome (PCOS) guideline 2011. The first international evidence-based guideline on PCOS was developed in 2018, which expanded the scope and evidence in the Australian guideline. This paper summarizes the lifestyle recommendations and evidence summaries from the guideline. International multidisciplinary guideline development groups delivered the International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome 2018. The process followed the Appraisal of Guidelines for Research and Evaluation II and The Grading of Recommendations, Assessment, Development and Evaluation framework. Extensive communication and meetings addressed six prioritized clinical questions through five reviews. Evidence-based recommendations were formulated before consensus voting within the panel. Evidence shows the benefits of multicomponent lifestyle intervention, efficacy of exercise and weight gain prevention with no specific diet recommended. Lifestyle management is the first-line management in the intervention hierarchy in PCOS. Multicomponent lifestyle intervention including diet, exercise and behavioural strategies is central to PCOS management with a focus on weight and healthy lifestyle behaviours. The translation programme optimizes reach and dissemination for health professionals and consumers.

A brief update on the evidence supporting the treatment of infertility in polycystic ovary syndrome.

BACKGROUND: Polycystic ovary syndrome (PCOS) is complex with reproductive, metabolic and psychological features. Infertility is a prevalent presenting feature of PCOS with approximately 75% of these women suffering infertility due to anovulation, making PCOS by far the most common cause of anovulatory infertility. Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated. AIMS: This review paper aims to provide a brief update on the best available and most current research evidence supporting the treatment of PCOS which informed the recommendations in the assessment and treatment of infertility section of the international evidence-based guideline on PCOS 2018. MATERIALS AND METHODS: International evidence-based guideline development engaged professional societies and consumer organisations with multidisciplinary experts and women with PCOS directly involved at all stages. RESULTS: Lifestyle change alone is considered the first-line treatment for the management of infertile anovulatory PCOS women who are overweight or obese. Letrozole should now be considered first-line pharmacological treatment for ovulation induction to improve fertility outcomes. Clomiphene citrate alone and metformin alone could also be used as first-line pharmacological therapy, although both are less effective than letrozole and metformin is less effective than clomiphene citrate in obese women. Gonadotrophins or laparoscopic ovarian surgery are usually second-line ovulation induction therapies. In the absence of an absolute indication for in vitro fertilisation (IVF) / intracytoplasmic sperm injection, women with PCOS and anovulatory infertility could be offered IVF as third-line therapy where first- or second-line ovulation induction therapies have failed. CONCLUSION: This review provides the best available evidence informing recommendations (along with clinical expertise and consumer preference) which provide clinicians with clear advice on best practice for the management of infertile women with PCOS.

Exercise Recommendations for Women with Polycystic Ovary Syndrome: Is the Evidence Enough?

In this opinion piece, we summarize, discuss implications of implementation, and critically evaluate our 2018 evidence-based guideline recommendations for exercise and physical activity in women with polycystic ovary syndrome (PCOS). We developed recommendations as part of a larger international guideline development project. The overall guideline scope and priorities were informed by extensive health professional and consumer engagement. The lifestyle guideline development group responsible for the exercise recommendations included experts in endocrinology, exercise physiology, gynecology, dietetics, and obstetrics, alongside consumers. Extensive online communications and two face-to-face meetings addressed five prioritized clinical questions related to lifestyle, including the role of exercise as therapy for women with PCOS. The guideline recommendations were formulated based on one narrative and two evidence-based reviews, before consensus voting within the guideline panel. The development process was in accordance with the Appraisal of Guidelines for Research and Evaluation (AGREE) II, and used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework to assess evidence quality, desirable and undesirable consequences, feasibility, acceptability, cost, implementation, and recommendation strength. Given the evidence for exercise as therapy in PCOS being of low quality, a consensus recommendation was made based on current exercise guidelines for the general population. Women with PCOS and clinicians are forced to adopt generic approaches when recommending exercise therapy that perpetuates clinical management with pharmacological solutions. The current status of evidence highlights the need for greater international co-operation between researchers and funding agencies to address key clinical knowledge gaps around exercise therapy in PCOS to generate evidence for appropriate, scalable, and sustainable best practice approaches.

Anti-Müllerian Hormone in PCOS: A Review Informing International Guidelines.

Polycystic ovary syndrome (PCOS) affects 8-13% of women. The Rotterdam diagnostic criteria include polycystic ovarian morphology (PCOM) on ultrasound, but given recognized challenges, serum anti-Müllerian hormone (AMH) is proposed as an alternative. To inform international PCOS guidelines, a systematic review was completed. Key identified gaps include large international studies in well-defined populations across the lifespan, clustering of AMH with PCOS features, relationships to long-term health outcomes, and improved quality, assay standardization, and sample handling, all needed to determine cut offs. Here we identify research priorities to address these gaps and enhance AMH utility in PCOS. Once issues are addressed, AMH levels could replace more costly and less accessible ultrasound in PCOS diagnosis.

Effect of the combined oral contraceptive pill and/or metformin in the management of polycystic ovary syndrome: A systematic review with meta-analyses.

BACKGROUND: Polycystic ovary syndrome (PCOS) has a prevalence of 8%-13%. Given the prevalence, diverse health impacts and variation in care, rigorous evidence-based guidelines are needed in PCOS management. This systematic review with meta-analyses aimed to investigate the effect of the combined oral contraceptive pill (COCP) and/or metformin in the management of hormonal and clinical features of PCOS, to inform international guidelines. METHODS: Electronic databases were searched systematically from inception until 11 January 2017 to inform the guideline process. Eligible studies were randomized controlled trials which investigated the effect of COCPs and/or metformin alone or combined on hormonal and clinical features in women with PCOS. Outcomes were prioritized as critical for informing a decision about an intervention or important or not important, according to GRADE. Articles were assessed by one author against selection criteria, in consultation with a second author. Data were double extracted independently by four authors, and data quality appraisal was completed. Meta-analyses were conducted, where appropriate. RESULTS: Fifty-six studies were eligible for inclusion. Outcomes prioritized by women and health professionals included the following: irregular cycles, insulin resistance, weight, BMI, thromboembolic events and gastrointestinal effects. In low-quality evidence in adolescents, meta-analyses demonstrated that metformin was better than COCP for BMI (mean difference [MD] -4.02 [-5.23, -2.81], P < 0.001); COCP was better than metformin for menstrual regulation (MD -0.19 [-0.25, -0.13], P < 0.00001). In low-quality evidence in adults, meta-analyses demonstrated that metformin was better than placebo for BMI (MD -0.48 [-0.94, -0.02], P = 0.04); metformin was better than COCP for fasting insulin (MD 4.00 [2.59, 5.41], P = 0.00001), whereas COCP was better than metformin for irregular cycles (MD 12.49 [1.34, 116.62], P = 0.03). Combined oral contraceptive pill alone was better than the combination with an anti-androgen for BMI (MD -3.04 [-5.45, -0.64], P = 0.01). Metformin was associated with generally mild gastrointestinal adverse events. Differences in statistical significance were observed when outcomes were subgrouped by BMI. CONCLUSIONS: This review identified that COCP therapy has benefits for management of hyperandrogenism and menstrual regulation. Metformin combined with the COCP may be useful for management of metabolic features. There is minimal evidence of benefits of adding an anti-androgen to COCP therapy. Metformin alone has benefits for adult women for management of weight, hormonal and metabolic outcomes, especially for women with BMI ≥ 25 kg/m2 . There is inadequate evidence to suggest the optimal COCP formulation, or dosing regimen and formulation of metformin.

Large-Scale Evidence-Based Guideline Development Engaging the International PCOS Community.

The evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS) integrates the best available evidence with international, multidisciplinary clinical expertise and consumer preferences to provide health professionals, consumers, and policy makers with high-quality, comprehensive guidance about diagnosing and managing PCOS. Here, we outline the rigorous and systematic process, defined a priori and documented to be reproducible, to minimize bias and maintain transparency, in alignment with the Appraisal of Guidelines for Research and Evaluation (AGREE II) criteria and incorporating the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework that render this PCOS evidence-based guideline credible, trustworthy, reliable, and useable.

The Needs of Women and Healthcare Providers regarding Polycystic Ovary Syndrome Information, Resources, and Education: A Systematic Search and Narrative Review.

This article aims to identify and summarize the information, resource, and education needs of women with polycystic ovary syndrome (PCOS) and their healthcare providers. A systematic search of peer-reviewed, primary research literature was conducted. A total of 4,230 articles were identified, duplicates were removed, as well as the title and abstract of 2,819 studies and the full texts of 123 studies were screened against predetermined inclusion criteria. Findings from 35 included studies are described narratively. Main outcome measures include women's perceived needs for, and experiences of, PCOS care and information; healthcare providers' delivery of PCOS care and information; and healthcare providers' perceived needs for PCOS information, education programs, or professional development. There is a wealth of literature informing how PCOS information, education, and resources can better meet the needs of women, and about the role women expect healthcare providers to play in providing information within optimal PCOS care. However, few studies evaluate how well existing resources meet women's diverse needs. There is growing indirect evidence about the information and education needed by healthcare providers to provide best-practice PCOS care. However, little research has directly investigated healthcare providers' information needs or efficacy of PCOS-specific educational programs for healthcare providers. PCOS resources for women should be comprehensive, evidence-based, include the bio-psychosocial dimensions of the condition, and available through a variety of modes. The range of healthcare providers that women may seek care from need resources to support consistent use of the recommended diagnostic criteria, effective recommendation of lifestyle management, and early detection and treatment of symptoms and complications.

Engaging a disadvantaged community with a fruit and vegetable box scheme.

ISSUE ADDRESSED: Interventions which target the determinants of unhealthy diets are required to promote healthy eating and reduce the burdens of diet-related diseases such as cardiovascular disease, diabetes and some cancers. METHODS: Qualitative interviews (n = 12) were conducted to explore the perspectives and experiences of local stakeholders regarding the implementation and uptake of a healthy eating initiative (a fruit and vegetable box scheme) in a disadvantaged, regional community. RESULTS: Factors affecting the community's engagement included marketing strategies, customer experiences, a community-centred approach, partnerships and logistics. CONCLUSIONS: Community engagement is often essential for an intervention to be effective. The factors which influence community engagement should be considered during planning, especially when targeting disadvantaged groups. SO WHAT?: Behavioural change interventions may continue to be met with limited success if community engagement and the overarching structural barriers to healthy eating are not addressed.

Weight Management Interventions in Women with and without PCOS: A Systematic Review.

Polycystic ovary syndrome (PCOS) is a common endocrinopathy among women associated with reproductive, metabolic and psychological features. While weight management is recommended as first-line treatment, it is unclear if women with PCOS achieve similar benefits as women without PCOS. This systematic review thus aimed to compare the efficacy of weight management interventions in women with and without PCOS. Databases were searched until May 2017. The primary outcome was weight and anthropometric, reproductive, metabolic and psychological measures were secondary outcomes. Of 3264 articles identified, 14 studies involving n = 933 (n = 9 high and n = 5 moderate risk of bias) met the inclusion criteria. No statistically significant differences in weight or weight loss following the intervention were found between women with and without PCOS in five studies, with the remaining studies not comparing the difference in weight or weight loss between these groups. Secondary outcomes did not differ significantly between the two groups. This review identified that there is a paucity of high quality research in this area and that more rigorous research is needed.