Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome
Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome
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DOI：
10.1093/humrep/dey256
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发表时间：
2018-09-01
影响因子：
6.1
通讯作者：
Norman, Robert J.
中科院分区：
文献类型：
--
作者：
Teede, Helena J.;Misso, Marie L.;Norman, Robert J.
研究问题：根据现有最佳证据、临床专业知识和消费者偏好，对多囊卵巢综合征 (PCOS) 女性的建议评估和治疗是什么？摘要：国际循证指南，包括 166 条建议和实践要点，解决了优先考虑的问题，以促进一致的、循证的护理，并改善多囊卵巢综合征女性的体验和健康结果。已知信息：以前的指南要么缺乏严格的循证流程，要么没有考虑消费者和国际多学科的观点，要么已经过时。 PCOS 的诊断仍存在争议，评估和治疗也不一致。患有 PCOS 的女性的需求没有得到充分满足，证据实践差距仍然存在。 研究设计、规模、持续时间：国际循证指南的制定吸引了专业协会和消费者组织的多学科专家以及 PCOS 女性在各个阶段的直接参与。遵循研究和评估指南评估 (AGREE) II 合规流程，并进行了广泛的证据综合。建议、评估、制定和评价 (GRADE) 框架的分级适用于证据质量、可行性、可接受性、成本、实施和最终推荐强度。 参与者/材料、背景、方法：治理包括六大洲国际咨询和项目委员会、五个指南制定小组以及消费者和翻译委员会。广泛的卫生专业人士和消费者参与了解了指南的范围和优先事项。参与的国际学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、营养学、运动生理学、公共卫生和其他专家，以及消费者、项目管理、证据综合和翻译专家。共有 71 个国家的 37 个学会和组织参与了这一进程。 15 个月内举行的 20 次面对面会议解决了 60 个优先临床问题，涉及 40 项系统评价和 20 项叙述性评价。基于证据的建议是通过五个指南小组内的共识投票制定和批准的，并根据国际反馈和同行评审进行修改，最终建议在所有小组中获得批准。 主要结果和机会的作用：PCOS 评估和管理中的证据通常为低到中等质量。该指南提供了 31 条基于证据的建议、59 条临床共识建议和 76 条临床实践要点，均与 PCOS 的评估和管理相关。该指南的主要变化包括：（i）大幅细化个体诊断标准，重点提高诊断准确性； (ii) 减少不必要的测试； (iii) 更加关注教育、生活方式改变、情绪健康和生活质量； (iv) 强调基于证据的药物治疗和更便宜、更安全的生育管理。 局限性、注意原因：总体证据质量一般为低至中等，需要对这种被忽视但常见的疾病进行更多的研究，特别是在完善 PCOS 的具体诊断特征方面。承认区域卫生系统的差异，并提供了指南和翻译资源适应的流程。调查结果的更广泛影响：PCOS 评估和管理的国际指南根据最佳可用证据、专家多学科输入和消费者偏好，为临床医生提供了关于最佳实践的明确建议。研究建议已经产生，全面的多方面传播和翻译计划通过综合评估计划支持该指南。 研究经费/竞争利益：该指南主要由澳大利亚国家健康和医学研究委员会 (NHMRC) 资助，并与 ESHRE 和美国生殖医学会合作支持。指南制定小组成员没有收到付款。差旅费由赞助组织承担。利益冲突的披露从一开始就进行了声明，并在整个指南流程中不断更新，与 NHMRC 指南流程保持一致。有关指南制定小组所声明的冲突的完整详细信息，请访问利益披露登记册中的 https://www.monash.edu/medicine/sphpm/mchri/pcos/guideline。在指定作者中，Costello 博士已声明持有 Virtus Health 股份，并曾获得默克雪兰诺 (Merck Serono) 的会议演讲赞助。 Laven 教授宣布获得 Ferring、Euroscreen 的资助以及 Ferring、Euroscreen、Danone 和 Titus Healthcare 的个人费用。诺曼教授已宣布拥有 IVF 部门的小股东权益。其余作者没有需要声明的利益冲突。该指南由我们的合作伙伴、合作协会和消费者组织的特殊利益团体进行了同行评审，根据 AGREE-II 标准进行了独立评估，并接受了方法学审查。本指南得到了指南制定小组所有成员的批准，并提交 NHMRC 最终批准。
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. In total, 37 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 AGREE-II 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.