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2023 年多囊卵巢综合征评估和管理国际循证指南推荐意见。

Recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome.

机构信息

Monash Centre for Health Research and Implementation, Monash University and Monash Health, Melbourne, Victoria, Australia.

National Health and Medical Research Council Centre for Research Excellence in Women's Health in Reproductive Life, Australia.

出版信息

Eur J Endocrinol. 2023 Aug 2;189(2):G43-G64. doi: 10.1093/ejendo/lvad096.

Abstract

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.

摘要

研究问题

基于现有最佳证据、临床专业知识和消费者偏好,对于多囊卵巢综合征(PCOS)患者,应如何进行评估和管理?

总结答案

国际循证指南针对优先问题和结果进行了探讨,并包含 254 条建议和实践要点,以促进一致的、基于证据的治疗并改善 PCOS 患者的体验和健康结局。

已知情况

2018 年国际 PCOS 指南经过独立评估,质量很高,并整合了来自六大洲的多学科和消费者观点;目前已在 196 个国家使用,并被广泛引用。该指南基于现有但通常质量较低或极低的证据。它采用了严格的方法学流程,并解决了共同关注的问题。该指南从基于共识的诊断标准转变为基于证据的诊断标准,提高了诊断的准确性,同时促进了治疗的一致性。然而,诊断仍然延迟,PCOS 患者的需求未得到充分满足,证据质量仍然较低,证据与实践之间的差距仍然存在。

研究设计、规模和持续时间:2023 年国际循证指南更新再次与专业协会和消费者组织的 2018 年网络合作,涉及多学科专家和 PCOS 患者直接参与各个阶段。完成了广泛的证据综合评估。遵循指南研究与评估 II(AGREE II)的认可流程。应用分级推荐评估、制定、评价(GRADE)框架评估证据质量、可行性、可接受性、成本、实施以及最终建议强度,并在整个过程中考虑多样性和包容性。

参与者/材料、设置和方法:应结合全文阅读本摘要,以了解详细的参与者和方法。治理包括一个由 6 大洲的国际顾问和管理委员会、5 个指南制定小组以及儿科、消费者和翻译委员会组成的组织。广泛的消费者参与和指南专家为更新范围和重点提供了信息。参与的国际社会提名小组包括儿科、内分泌学、妇科、初级保健、生殖内分泌学、产科、精神病学、心理学、饮食学、运动生理学、肥胖护理、公共卫生和其他专家,以及消费者、项目管理、证据综合、统计学家和翻译专家。涵盖 71 个国家的 39 个专业和消费者组织参与了这一过程。20 次会议和 5 次面对面论坛历时 12 个月,解决了 58 个优先临床问题,涉及 52 项系统综述和 3 项叙述性综述。通过 5 个指南小组的共识制定和批准了循证建议,并根据国际反馈和同行评审进行了修改,方法学严谨性由独立审查进行评估,并得到澳大利亚政府国家卫生和医学研究委员会的批准。

主要结果和机会的作用

过去 5 年来,PCOS 评估和管理方面的证据质量普遍有所提高,但仍处于低至中等水平。技术证据报告和分析(约 6000 页)为 77 条循证建议和 54 条共识建议以及 123 个实践要点提供了依据。主要更新内容包括以下几点:(1)进一步细化了个别诊断标准,简化了诊断算法,并将抗苗勒氏管激素水平纳入成年人的超声检查替代方法;(2)加强了对 PCOS 更广泛特征的认识,包括代谢危险因素、心血管疾病、睡眠呼吸暂停、非常高的心理特征患病率以及妊娠期间不良结局的高风险状态;(3)强调了鲜为人知的、多样化的疾病负担以及需要加强医疗专业人员教育、基于证据的患者信息、改善的护理模式和共同决策,以改善患者体验,同时开展更多研究;(4)保持对健康生活方式、情绪健康和生活质量的重视,同时意识到和考虑体重耻辱;(5)强调基于证据的医学治疗和更便宜、更安全的生育管理。

局限性和谨慎的原因

总体而言,建议得到了加强,证据得到了改善,但仍然普遍处于低至中等质量水平。目前,在这一被忽视但常见的疾病中,需要开展更多的研究。考虑到区域卫生系统的差异,并提供了指南和翻译资源改编的进一步流程。

研究结果的更广泛意义

2023 年国际 PCOS 评估和管理指南为临床医生和患者提供了基于现有最佳证据、多学科专业知识和消费者偏好的最佳实践建议。已经提出了研究建议,并通过综合评估计划支持指南和翻译资源,同时提供了一个全面的多方面传播和翻译计划。

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