25 research outputs found
Health literacy driving health engagement in the pluralist context of migrant health in Australia
Migrants have a range of unrecognised health literacy skills that are not adequately understood or addressed within the Australian health sector. This study has shown that migrants have effective compensatory mechanisms that, if supported, may optimise health literacy and engagement and ultimately, may improve health outcomes.<br /
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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 45 days (> 1 to  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
Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome
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
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
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 six 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, evidence quality was low and evidence-practice gaps persist.
STUDY DESIGN, SIZE, DURATION
The 2023 International Evidence-based Guideline update reengaged 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, METHODS
This summary should be read in conjunction with the full Guideline for detailed participants and methods. Governance included a six-continent international advisory and management committee, five 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 five 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 five 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 (NHMRC).
MAIN RESULTS AND THE ROLE OF CHANCE
The evidence in the assessment and management of PCOS has generally improved in the past five years, but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpins 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include: i) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm and inclusion of anti-Müllerian hormone (AMH) levels as an alternative to ultrasound in adults only; ii) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; iii) 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; iv) maintained emphasis on healthy lifestyle, emotional wellbeing and quality of life, with awareness and consideration of weight stigma; and v) emphasizing evidence-based medical therapy and cheaper and safer fertility management.
LIMITATIONS, 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 program supports the Guideline with an integrated evaluation program.
STUDY FUNDING/COMPETING INTEREST(S)
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 European Society for Endocrinology. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). HJT and AM are funded by NHMRC fellowships. JT 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. Disclosures of interest were strictly managed according to NHMRC policy and are available with the full guideline, technical evidence report, peer review and responses (www.monash.edu/medicine/mchri/pcos). Of named authors HJT, CTT, AD, LM, LR, JBoyle, AM have no conflicts of interest to declare. JL 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 advisory boards for Ferring, Roche Diagnostics, Ansh Labs, and Gedeon Richter. TP 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. MC declares travels support from Merck; and sits on an advisory board for Merck. JBoivin 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. RJN has received speaker’s fees from Merck and sits on an advisory board for Ferring. AJoham 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
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
OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial
BackgroundReproductive-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.
ObjectiveWe 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.
MethodsThis 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.
ResultsThe 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.
ConclusionsThe 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 RegistrationAustralian 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)DERR1-10.2196/3362
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
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