Consumer and community involvement in preventive health: current insights and considerations for future best practice.

Consumer and community involvement (CCI) in preventive research and health initiatives is not only encouraged but is expected within a rapidly evolving landscape across health policy, practice and research. Here, we summarise the fundamental principles of CCI, as well as outline the barriers and current developments in working towards best practices at organisational and systems levels. CCI stands at a critical juncture. Best practice emphasises meaningful partnerships with consumers and communities to deliver impactful research and prevention activities, yet complex challenges and systematic barriers remain. We need further evidence to demonstrate both 'what' and 'how' CCI should be best implemented in these settings. We present key considerations for researchers, organisations and systems to catalyse the transition of CCI from mere recognition of its importance to pragmatic and optimum implementation and, ultimately, to systemic reform. These include changes to capacity building, funding structures, equitable engagement and transparent evaluation. These must be underpinned by evidence-based approaches, partnership, trust and broad consensus processes to achieve meaningful and impactful CCI in research and healthcare improvement through a lens of inclusivity.

OptimalMe Program: A Mixed Method Investigation into the Engagement and Acceptability of a Preconception Digital Health Lifestyle Intervention with Individual Coaching for Women's Health and Behaviour Change.

Preconception interventions, specifically addressing general health, lifestyle behaviours and weight management, are limited despite their importance in optimising women's health. The objective of this study is to evaluate the engagement and acceptability of OptimalMe, a digital preconception intervention. Participants, (n = 298) Australian women aged 18-44 with private health insurance planning to conceive within 12 months, received a standardised intervention, including access to a digital healthy lifestyle platform (educational materials, behaviour change activities, and self-monitoring resources), ongoing text messaging, and remotely delivered health coaching (two appointments) with randomised delivery methods (telephone/videoconference). Engagement and acceptability were assessed through mixed method analyses. The results show that 76.2% attended both coaching sessions, with similar participation rates for telehealth (75.2%) and videoconferencing (77.2%) (p = 0.469). All participants logged into the digital platform, with 90.6% accessing educational materials and 91.3% using behaviour change tools. Digital platform engagement declined over time, suggesting potential benefits from additional health coaching support for ongoing participation. The post-intervention evaluation (n = 217 participants) demonstrated that approximately 90% found the digital module engaging, meeting information needs, would recommend the program, and were satisfied with the support. OptimalMe demonstrated positive acceptability and engagement; however, further research is warranted to explore strategies for sustaining engagement with the digital interventions.

Translating evidence into practice in primary care management of adolescents and women with polycystic ovary syndrome: a mixed-methods study.

BACKGROUND: The international guideline on polycystic ovary syndrome (PCOS) provides evidence-based recommendations on the management of PCOS. Guideline implementation tools (GItools) were developed for general practitioner (GP) use to aid rapid translation of guidelines into practice. This mixed-methods study aimed to evaluate barriers and enablers of the uptake of PCOS GItools in general practice. DESIGN AND SETTING: A cross-sectional survey was distributed through professional networks and social media to GPs and GPs in training in Australia. Survey respondents were invited to contribute to semi-structured interviews. Interviews were audio-recorded and transcribed verbatim. Qualitative data were thematically analysed and mapped deductively to the Theoretical Domains Framework and Capability, Opportunity, Motivation and Behaviour model. RESULTS: The study engaged 146 GPs through surveys, supplemented by interviews with 14 participants. A key enabler to capability was reflective practice. Barriers relating to opportunity included limited awareness and difficulty locating and using GItools due to length and lack of integration into practice software, while enablers included ensuring recommendations were relevant to GP scope of practice. Enablers relevant to motivation included co-use with patients, and evidence of improved outcomes with the use of GItools. DISCUSSION: This study highlights inherent barriers within the Australian healthcare system that hinder GPs from integrating evidence for PCOS. Findings will underpin behaviour change interventions to assist GPs in effectively utilising guidelines in clinical practice, therefore minimising variations in care. While our findings will have a direct influence on guideline translation initiatives, changes at organisational and policy levels are also needed to address identified barriers.

Evaluating Preconception Health and Behaviour Change in Australian Women Planning a Pregnancy: The OptimalMe Program, a Digital Healthy Lifestyle Intervention with Remotely Delivered Coaching.

OptimalMe is a digital healthy lifestyle intervention for women planning a pregnancy, with remotely delivered coaching. This follow-up study of Australian women, stratified by coaching delivery mode (phone vs. videoconferencing), assessed alignment to preconception care guidelines and self-reported behaviour change. Overall, 298 women enrolled with a mean (SD) age of 31.8 (4.3) years and mean BMI of 25.7 (6.1) kg/m2. Suboptimal preconception behaviours were reported at baseline, including alcohol consumption (57.2%), infrequent weighing (37.2%) and incomplete cervical cancer screening (15.8%) and prenatal supplementation (38.5). At follow-up (4.5 months) (n = 217), a statistically significant shift towards desired behaviours was reported for alcohol consumption (z = -2.6045, p = 0.00932), preconception supplementation (z = -2.7288, p = 0.00634) and frequent weight monitoring (z = -5.2911, p < 0.00001). An insignificant shift towards adherence to cervical cancer screening (z = -1.8679, p = 0.06148) was observed, with a positive trend towards adherence. Results indicate that women who are actively planning a pregnancy require support to optimise health and lifestyle in preparation for pregnancy and general health and lifestyle improvement. Women demonstrated improvement in lifestyle behaviours and self-monitoring, indicating the uptake of low-intensity, non-prescriptive information provision. Supporting the provision of knowledge-enhancing tools and general healthy lifestyle information combines with skilled health coaching as an effective method for behaviour change and self-management. OptimalMe also shows significant improvements in rates of healthcare engagement, which suggests coaching-based digital health interventions may decrease women's barriers for preconception care and improve engagement in clinical settings.

Breaking Boundaries: Toward Consistent Gender-Sensitive Language in Sexual and Reproductive Health Guidelines.

This review assesses gender-sensitive language in sexual and reproductive health (SRH) guidelines, including a guideline for polycystic ovary syndrome. We conducted a systematic search across databases like Medline, EMBASE, and Cochrane until July 31, 2023, using terms related to gender-inclusivity, SRH, and guideline protocols. Criteria for inclusion were gender-sensitive language, SRH focus, and guideline relevance, excluding non-English articles or those without policy considerations. Our search yielded 25 studies, with 6 included for qualitative synthesis. Results showed significant gaps in using gender-sensitive language in SRH guidelines. The debate on this language mirrors broader societal discourse. Recognizing gender diversity is essential for research, clinical practices, and societal norms. While promoting inclusion, drawbacks like unintended erasure or miscommunication should also be addressed. A gender-additive approach balances inclusivity and biological accuracy. Precise and inclusive discourse is crucial. Future research should focus on systemic approaches in the SRH sector.

Prevalence and determinants of mental health related to climate change in Australia.

AIMS: The climate emergency will likely prove this century's greatest threat to public health within which mental health effects need consideration. While studies consistently show the majority of Australians are very concerned about the impacts of climate change, there is limited evidence from nation-wide research linking climate change with mental health burden in sub-populations. This study aimed to understand the impact of climate change on mental health in the Australian population and identify populations who are most at risk of climate-related mental health burden. METHODS: A nation-wide Australian survey conducted between August and November 2020 of adults was approximately representative across sex, age, location, state and area disadvantage. Two-stage recruitment involved unrestricted self-selected community sample through mainstream and social media (N = 4428) and purposeful sampling using an online panel (N = 1055). RESULTS: Most Australians report having a direct experience of a climate change-related event. Young people are experiencing significant rates of eco-anxiety. One in four people with direct experience of a climate change-related event met post-traumatic stress disorder screening criteria. People who have not had a direct experience are showing symptoms of pre-trauma, particularly in younger age groups and women. There were 9.37% (503/5370) of respondents with responses indicating significant eco-anxiety, 15.68% (370/2359) with pre-traumatic stress and 25.60% (727/2840) with post-traumatic stress disorder. Multivariable regressions confirmed that younger people are more affected by eco-anxiety and post-traumatic stress disorder (pre- or post-trauma); women are more affected by post-traumatic stress disorder (pre- or post-trauma) and those from more disadvantaged regions are more affected by eco-anxiety. CONCLUSION: Australia is facing a potential mental health crisis. Individuals with and without direct experience of climate change are reporting significant mental health impacts, with younger age groups being disproportionately affected. There are key roles for clinicians and other health professionals in responding to and preventing climate-related mental health burden.

Assessing the Content and Quality of Digital Tools for Managing Gestational Weight Gain: Systematic Search and Evaluation.

BACKGROUND: Digital health resources have the potential to assist women in optimizing gestational weight gain (GWG) during pregnancy to improve maternal health outcomes. OBJECTIVE: In this study, we aimed to evaluate the quality and behavior change potential of publicly available digital tools (websites and apps) that facilitate GWG tracking. METHODS: Digital tools were identified using key search terms across website search engines and app stores and evaluated using the Mobile App Rating Scale, the App Behavior Change Scale, as well as criteria to evaluate the rigor and safety of GWG information. RESULTS: Overall, 1085 tools were screened for inclusion (162 websites and 923 apps), and 19 were deemed eligible. The mean Mobile App Rating Scale quality score was 3.31 (SD 0.53) out of 5, ranging from 2.26 to 4.39, and the mean App Behavior Change Scale score was 6 (SD 3.4) out of 21, ranging from 19 to 0. Of the 19 items used to evaluate rigor of GWG advice, most tools (n=11, 57.9%) contained ≤3 items. CONCLUSIONS: This review emphasizes the substantial limitations in current digital resources promoting the monitoring and optimization of GWG. Most tools were of low quality, had minimal behavior change potential, and were potentially unsafe, with minimal linkage to evidence-based information or partnership with health care.

OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial.

BACKGROUND: Reproductive-aged women are a high-risk population group for accelerated weight gain and obesity development, with pregnancy recognized as a critical contributory life-phase. Healthy lifestyle interventions during the antenatal period improve maternal and infant health outcomes, yet translation and implementation of such interventions into real-world health care settings remains limited. OBJECTIVE: We aim to generate key implementation learnings to inform the feasibility of future scale up and determine the effectiveness of intervention delivery methods on engagement, experience, acceptability, knowledge, risk perception, health literacy, and modifiable weight-related health behaviors in women during preconception, pregnancy, and postpartum periods. METHODS: This randomized hybrid implementation effectiveness study will evaluate the penetration, reach, feasibility, acceptability, adoption, and fidelity of a healthy lifestyle intervention (OptimalMe) implemented into, and in partnership with, private health care. Individual health outcomes associated with implementation delivery mode, including knowledge, risk perception, health literacy, self-management, and health behaviors, are secondary outcomes. A total of 300 women aged 18 to 44 years, who are not pregnant but wish to conceive within the next 12 months, and with access to the internet will be recruited. All participants will receive the same digital lifestyle intervention, OptimalMe, which is supported by health coaching and text messages during preconception, pregnancy, and postpartum periods. We will use a parallel 2-arm design to compare telephone with videoconference remote delivery methods for health coaching. Methods are theoretically underpinned by the Consolidated Framework for Implementation Research and outcomes based on the Reach, Engagement, Adaptation, Implementation and Maintenance framework. RESULTS: The study was approved on August 16, 2019 and has been registered. Recruitment commenced in July 2020, and data collection is ongoing. Results are expected to be published in 2022. CONCLUSIONS: The study's design aligns with best practice implementation research. Results will inform translation of evidence from randomized controlled trials on healthy lifestyle interventions into practice targeting women across preconception, pregnancy, and postpartum periods. Learnings will target consumers, program facilitators, health professionals, services, and policy makers to inform future scale up to ultimately benefit the health of women across these life-phases. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ACTRN12620001053910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378243&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33625.

Australians report climate change as a bigger concern than COVID-19.

Australia experienced two public health emergencies in 2020 - the catastrophic bushfires and the global coronavirus (COVID-19) pandemic. Whilst these were separate events, both have similar drivers arising from human pressures on the natural environment. Here we report on relative personal concerns of Australians in a survey implemented during the global COVID-19 pandemic. The study design was a cross sectional online survey administered between 11 August and 11 November 2020. The setting was an Australia-wide online population involving 5483 individuals aged ≥18 residing in Australia. Recruitment occurred in two stages: unrestricted self-selected community sample through mainstream and social media (N = 4089); and purposeful sampling using an online panel company (N = 1055). The sample was predominantly female (N = 3187); mean age of 52.7 years; and approximately representative of adults in Australia for age, location, state and area disadvantage (IRSD quintiles). Climate change was very much a problem for 66.3% of the sample, while COVID-19 was ranked at the same level by only 25.3%. Three times as many participants reported that climate change was very much a problem than COVID-19, despite responding at a time when Australians were experiencing Stage 2 through 4 lockdowns. Demographic differences relating to relative personal concerns are discussed. Even in the midst of the uncertainty of a public health pandemic, Australians report that climate change is their most significant personal problem. Australia needs to apply an evidence-based public health approach to climate change, like it did for the pandemic, which will address the climate change concerns of Australians.

A Comprehensive PCOS Research and Guideline Translation Program to Improve Practice.

Polycystic ovary syndrome (PCOS) is a common and complex endocrinopathy affecting reproductive-age women with a reported prevalence of 8 to 13%. To address the knowledge, practice, consumer satisfaction, and research gaps, an international research collaboration was formed to develop the first "International Evidence-Based Guideline for the Assessment and Management of Polycystic Ovary Syndrome (2018)." This article describes an effective research translation program to disseminate the guideline internationally to women and health providers. To date, this had led to 75,197 views and almost 36,000 downloads of the PCOS guideline, and 43,000 views and 10,600 downloads of a suite of PCOS resources. AskPCOS app, the first freely accessible, evidence-based PCOS app, has 9,910 users (between 400 and 800 users per month), 23,447 sessions, and 87,801 screen viewings. Fifty-four percent of returning users are from across 137 countries, with the most users in Australia, the United States, the United Kingdom, the Netherlands, and India. Extensive global uptake of the PCOS guideline and compendium of resources was augmented by extensive formative consumer and health professional consultation, end-user engagement across the evidence-creation spectrum, co-design, and quality improvement.

Support Seeking in the Postpartum Period: Content Analysis of Posts in Web-Based Parenting Discussion Groups.

BACKGROUND: The transition from pregnancy to motherhood is a major developmental phase that can be challenging for both women and their families. For new mothers, the postpartum period is recognized as a critical period for increased risk of both physical and mental health concerns. For this reason, it is imperative that women receive accurate, evidence-based information during this time. OBJECTIVE: This study aims to explore the conversations of new mothers on a web-based parenting forum to investigate what topics or concerns are being discussed. METHODS: A leading Australian web-based support forum for women before and after birth was used to obtain a sample of posts from the mothers of infants aged 0-12 months. Quantitative data (word frequencies and sentiment analysis) and qualitative data (post content) were extracted from discussion threads and examined to determine sentiments and theoretical storylines. RESULTS: In total, 260 posts were sampled. Infant care was the most prominent overarching topic discussed, with feeding and sleep being the most discussed subtopics. Discussions about maternal care were much less frequent but included questions about birth recovery, breastfeeding concerns, and interconception. A pattern of behavior emerged within the posts. This pattern resembled a cycle of learning across five phases: help seeking, solution ideation, testing and skill development, consolidation, and empowerment and improved mental well-being. A dynamic interplay was observed as mothers navigated new concerns or developmental changes. CONCLUSIONS: Engagement in web-based forums to seek help and support during the postpartum period was common, with infant health and well-being being the primary concerns for new mothers during this time. The identification of a maternal learning cycle within the forum underscores the contributory role of web-based communities in maternal peer social support, information seeking, and early parenting practices.

Harmonizing research outcomes for polycystic ovary syndrome (HARP), a marathon not a sprint: current challenges and future research need.

Investing in clinical research and evidence-based medicine has helped to improve the care for women with polycystic ovary syndrome (PCOS). However, several important questions remain unanswered on the optimal prevention and management strategies for PCOS. Addressing this uncertainty is often hindered by suboptimal research conduct leading to inefficient evidence synthesis and research wastage. PCOS research is often practised by varied specialized teams in silo leading to disharmonious and fragmented efforts neglecting the lifelong impact of PCOS on women's wellbeing. Poor engagement among key stakeholders and lay consumers continues to limit the impact and benefits of research to society. Selective reporting on surrogate outcomes with a 'significant' P-value is a common malpractice in PCOS outputs. Effective adoption of the harmonizing research outcomes for PCOS (HARP) core outcome set is needed to minimize heterogeneity in reporting and promote research excellence. Small single-centre studies offer limited value to assess the varied PCOS phenotypes. Efficient large scale data-sharing is needed to address complex research questions and glean the benefits of big data research. We propose a roadmap to address these challenges and remedy future research need by promoting patient and public involvement in PCOS research to guide research efforts and address real patients' needs; engaging all key stakeholder groups to promote a multi-disciplinary lifelong approach to new research; continuously refining research needs and priorities to revise the knowledge gap and allocate resources judiciously; standardizing outcomes definitions and measurement tools to harmonize reporting and promote excellence in research; and by investing in large data-sharing infrastructure to facilitate big data research and govern ethical data sharing.

Perinatal Distress During COVID-19: Thematic Analysis of an Online Parenting Forum.

BACKGROUND: The COVID-19 global pandemic has impacted the whole of society, requiring rapid implementation of individual-, population-, and system-level public health responses to contain and reduce the spread of infection. Women in the perinatal period (pregnant, birthing, and postpartum) have unique and timely needs for directives on health, safety, and risk aversion during periods of isolation and physical distancing for themselves, their child or children, and other family members. In addition, they are a vulnerable group at increased risk of psychological distress that may be exacerbated in the context of social support deprivation and a high-risk external environment. OBJECTIVE: The aim of this study is to examine the public discourse of a perinatal cohort to understand unmet health information and support needs, and the impacts on mothering identity and social dynamics in the context of COVID-19. METHODS: A leading Australian online support forum for women pre- through to postbirth was used to interrogate all posts related to COVID-19 from January 27 to May 12, 2020, inclusive. Key search terms included "COVID," "corona," and "pandemic." A three-phase analysis was conducted, including thematic analysis, sentiment analysis, and word frequency calculations. RESULTS: The search yielded 960 posts, of which 831 were included in our analysis. The qualitative thematic analysis demonstrated reasonable understanding, interpretation, and application of relevant restrictions in place, with five emerging themes identified. These were (1) heightened distress related to a high-risk external environment; (2) despair and anticipatory grief due to deprivation of social and family support, and bonding rituals; (3) altered family and support relationships; (4) guilt-tampered happiness; and (5) family future postponed. Sentiment analysis revealed that the content was predominantly negative (very negative: n=537 and moderately negative: n=443 compared to very positive: n=236 and moderately positive: n=340). Negative words were frequently used in the 831 posts with associated derivatives including "worried" (n=165, 19.9%), "risk" (n=143, 17.2%), "anxiety" (n=98, 11.8%), "concerns" (n=74, 8.8%), and "stress" (n=69, 8.3%). CONCLUSIONS: Women in the perinatal period are uniquely impacted by the current pandemic. General information on COVID-19 safe behaviors did not meet the particular needs of this cohort. The lack of nuanced and timely information may exacerbate the risk of psychological and psychosocial distress in this vulnerable, high-risk group. State and federal public health departments need to provide a central repository of information that is targeted, consistent, accessible, timely, and reassuring. Compensatory social and emotional support should be considered, using alternative measures to mitigate the risk of mental health disorders in this cohort.

The Role of Health Literacy in Postpartum Weight, Diet, and Physical Activity.

BACKGROUND: Postpartum weight retention is a significant contributor to obesity in women, adverse perinatal events in subsequent pregnancies, and chronic disease risk. Health literacy is known to impact health behaviors. The study aimed to identify the health literacy domains utilized in postpartum weight management interventions and to determine their impact on weight, diet and physical activity in postpartum women. METHODS: We searched MEDLINE, CINAHL, EMBASE, PSYCINFO, and EBM databases. We included random control trials of lifestyle intervention in postpartum women (within two years post-delivery) published up to 3 May 2019. Subgroup analyses were performed to determine the effect of health literacy domains on outcomes. RESULTS: Out of 5000 studies, 33 studies (n = 3905) were included in the systematic review and meta-analysis. The health literacy domain self-care (skills and knowledge) was associated with a significant reduction in body weight (mean difference (MD) -2.46 kg; 95% confidence interval (CI) from -3.65 to -1.27) and increase in physical activity (standardized mean difference (SMD) 0.61; 95% CI 0.20 to 1.02). No other health literacy domain was associated with significant outcomes in weight, energy intake, or physical activity. CONCLUSIONS: Health literacy skills such as knowledge of self-care are effective in improving weight and in increasing physical activity in postpartum women. The efficacy of other health domains was not supported.

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.

Adolescent polycystic ovary syndrome according to the international evidence-based guideline.

BACKGROUND: Diagnosing polycystic ovary syndrome (PCOS) during adolescence is challenging because features of normal pubertal development overlap with adult diagnostic criteria. The international evidence-based PCOS Guideline aimed to promote accurate and timely diagnosis, to optimise consistent care, and to improve health outcomes for adolescents and women with PCOS. METHODS: International healthcare professionals, evidence synthesis teams and consumers informed the priorities, reviewed published data and synthesised the recommendations for the Guideline. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied to appraise the evidence quality and the feasibility, acceptability, cost, implementation and strength of the recommendations. RESULTS: This paper focuses on the specific adolescent PCOS Guideline recommendations. Specific criteria to improve diagnostic accuracy and avoid over diagnosis include: (1) irregular menstrual cycles defined according to years post-menarche; > 90 days for any one cycle (> 1 year post-menarche), cycles< 21 or > 45 days (> 1 to < 3 years post-menarche); cycles < 21 or > 35 days (> 3 years post-menarche) and primary amenorrhea by age 15 or > 3 years post-thelarche. Irregular menstrual cycles (< 1 year post-menarche) represent normal pubertal transition. (2) Hyperandrogenism defined as hirsutism, severe acne and/or biochemical hyperandrogenaemia confirmed using validated high-quality assays. (3) Pelvic ultrasound not recommended for diagnosis of PCOS within 8 years post menarche. (4) Anti-Müllerian hormone levels not recommended for PCOS diagnosis; and (5) exclusion of other disorders that mimic PCOS. For adolescents who have features of PCOS but do not meet diagnostic criteria an 'at risk' label can be considered with appropriate symptomatic treatment and regular re-evaluations. Menstrual cycle re-evaluation can occur over 3 years post menarche and where only menstrual irregularity or hyperandrogenism are present initially, evaluation with ultrasound can occur after 8 years post menarche. Screening for anxiety and depression is required and assessment of eating disorders warrants consideration. Available data endorse the benefits of healthy lifestyle interventions to prevent excess weight gain and should be recommended. For symptom management, the combined oral contraceptive pill and/or metformin may be beneficial. CONCLUSIONS: Extensive international engagement accompanied by rigorous processes honed both diagnostic criteria and treatment recommendations for PCOS during adolescence.

Harmonising research outcomes for polycystic ovary syndrome: an international multi-stakeholder core outcome set.

STUDY QUESTION: What are the key core outcomes to be reported in studies on polycystic ovary syndrome (PCOS)? SUMMARY ANSWER: We identified 3 generic and 30 specific core outcomes in 6 specialist domains: metabolic (8), reproductive (7), pregnancy (10), oncological (1), psychological (1) and long-term outcomes (1). WHAT IS KNOWN ALREADY: Research reporting PCOS is heterogeneous with high variation in outcome selection, definition and quality. STUDY DESIGN, SIZE, DURATION: Evidence synthesis and a modified Delphi method with e-surveys were used as well as a consultation meeting. PARTICIPANTS/MATERIALS, SETTING, METHODS: Overall, 71 health professionals and 123 lay consumers (women with lived experience of PCOS and members of advocacy and peer support groups) from 17 high-, middle- and low-income countries were involved in this analysis. MAIN RESULTS AND THE ROLE OF CHANCE: The final core outcome set included 3 generic outcomes (BMI, quality of life, treatment satisfaction) that are applicable to all studies on women with PCOS and 30 specific outcomes that were categorised into six specialist domains: 8 metabolic outcomes (waist circumference, type 2 diabetes, insulin resistance, impaired glucose tolerance, hypertension, coronary heart disease, lipid profile, venous thromboembolic disease); 7 reproductive outcomes [viable pregnancy (confirmed by ultrasound including singleton, twins and higher multiples), clinical and biochemical hyperandrogenism, menstrual regularity, reproductive hormonal profile, chronic anovulation, ovulation stimulation success including the number of stimulated follicles ≥ 12 mm, incidence and severity of ovarian hyperstimulation syndrome]; 10 pregnancy outcomes (live birth, miscarriage, stillbirth, neonatal mortality, gestational weight gain, gestational diabetes, preterm birth, hypertensive disease in pregnancy, baby birth weight, major congenital abnormalities); 3 psychological outcomes (depression, anxiety, eating disorders); 1 oncological (abnormal endometrial proliferation including atypical endometrial hyperplasia and endometrial cancer); and 1 outcome in the long-term domain (long-term offspring metabolic and developmental outcomes). LIMITATIONS, REASONS FOR CAUTION: We involved lay consumers in all stages of study through e-surveys but not through focus groups, thereby limiting our understanding of their choices. We did not address the variations in the definitions and measurement tools for some of the core outcomes. WIDER IMPLICATIONS OF THE FINDINGS: Implementing this core outcome set in future studies on women with PCOS will improve the quality of reporting and aid evidence synthesis. STUDY FUNDING/COMPETING INTEREST(S): Evidence synthesis was funded through the Australian government, National Health and Medical Research Council (NHMRC) Centre for Research Excellence in PCOS, and H.T. is funded through an NHMRC fellowship. B.H.A. is funded through an NIHR lectureship. All authors have no competing interest to declare.

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.

A Review of First Line Infertility Treatments and Supporting Evidence in Women with Polycystic Ovary Syndrome.

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility in women of reproductive age. Lifestyle change is considered the first line treatment for the management of infertile anovulatory women with PCOS, and weight loss for those who are overweight or obese. First line medical ovulation induction therapy to improve fertility outcomes is letrozole, whilst other less efficacious ovulation induction agents, such as clomiphene citrate, metformin, and metformin combined with clomiphene citrate, may also be considered. Metformin combined with clomiphene citrate is more effective than clomiphene citrate alone. In obese women with PCOS, clomiphene citrate could be used in preference to metformin alone whilst clomiphene citrate could be added to metformin alone in order to improve reproductive outcome in all women with PCOS. Gonadotrophins, which are more effective than clomiphene citrate in therapy naïve women with PCOS, can be considered a first line therapy in the presence of ultrasound monitoring, following counselling on the cost and the potential risk of multiple pregnancy.