STUDY QUESTION What outcomes should be reported in all studies investigating uterus-sparing interventions for treating uterine adenomyosis? SUMMARY ANSWER We identified 24 specific and 26 generic core outcomes in nine domains. WHAT IS KNOWN ALREADY Research reporting adenomyosis treatment is not patient-centred and shows wide variation in outcome selection, definition, reporting and measurement of quality. STUDY DESIGN, SIZE, DURATION An international consensus development process was performed between March and December 2021. Participants in round one were 150 healthcare professionals, 17 researchers and 334 individuals or partners with lived experience of adenomyosis from 48 high-, middle- and low-income countries. There were 291 participants in the second round. PARTICIPANTS/MATERIALS, SETTING, METHODS Stakeholders included active researchers in the field, healthcare professionals involved in diagnosis and treatment, and people and their partners with lived experience of adenomyosis. The core component of the process was a 2-step modified Delphi electronic survey. The Steering Committee analysed the results and created the final core outcome set (COS) in a semi-structured meeting. MAIN RESULTS AND THE ROLE OF CHANCE A total of 241 outcomes was identified and distilled into a ‘long list’ of 71 potential outcomes. The final COS comprises 24 specific and 26 generic core outcomes across nine domains, including pain, uterine bleeding, reproductive outcomes, haematology, urinary system, life impact, delivery of care, adverse events and reporting items, all with definitions provided by the Steering Committee. Nineteen of these outcomes will apply only to certain study types. Although not included in the COS, the Steering Committee recommended that three health economic outcomes should be recorded. LIMITATIONS, REASONS FOR CAUTION Patients from continents other than Europe were under-represented in this survey. A lack of translation of the survey might have limited the active participation of people in non-English speaking countries. Only 58% of participants returned to round two, but analysis did not indicate attrition bias. There is a significant lack of scientific evidence regarding which symptoms are caused by adenomyosis and when they are related to other co-existent disorders such as endometriosis. As future research provides more clarity, the appropriate review and revision of the COS will be necessary. WIDER IMPLICATIONS OF THE FINDINGS Implementing this COS in future studies on the treatment of adenomyosis will improve the quality of reporting and aid evidence synthesis. STUDY FUNDING/COMPETING INTEREST(S) No specific funding was received for this work. T.T. received a grant (grant number 2020083) from the South Eastern Norwegian Health Authority during the course of this work. T.T. receives personal fees from General Electrics and Medtronic for lectures on ultrasound. E.R.L. is the chairman of the Norwegian Endometriosis Association. M.G.M. is a consultant for Abbvie Inc and Myovant, receives research funding from AbbVie and is Chair of the Women’s Health Research Collaborative. S.-W.G. is a board member of the Asian Society of Endometriosis and Adenomyosis, on the scientific advisory board of the endometriosis foundation of America, previous congress chair for the World Endometriosis Society, for none of which he received personal fees. E.S. received outside of this work grants for two multicentre trials on endometriosis from the National Institute for Health Research UK, the Rosetrees Trust, and the Barts and the London Charity, he is a member of the Medicines and Healthcare Products Regulatory Agency (MHRA), Medicines for Women’s Health Expert Advisory Group, he is an ambassador for the World Endometriosis Society, and he received personal fees for lectures from Hologic, Olympus, Medtronic, Johnson & Johnson, Intuitive and Karl Storz. M.H. is member of the British Society for Gynaecological Endoscopy subcommittee. No other conflict of interest was declared. TRIAL REGISTRATION NUMBER N/A.

中文翻译：

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为保留子宫的子宫腺肌病治疗 (COSAR) 研究制定核心结果集和结果定义：一项国际多方利益相关者修改的德尔福共识研究

研究问题 在所有调查保留子宫干预措施治疗子宫腺肌病的研究中，应报告哪些结果？总结答案 我们确定了 9 个领域的 24 个特定和 26 个通用核心结果。已知情况 报告子宫腺肌病治疗的研究并非以患者为中心，并且在结果选择、定义、报告和质量测量方面存在很大差异。研究设收入国家。第二轮共有291人参加。参与者/材料，设置，方法 利益相关者包括该领域的活跃研究人员、参与诊断和治疗的医疗保健专业人员以及具有子宫腺肌病生活经验的人及其合作伙伴。该过程的核心组成部分是一个两步修改的德尔福电子调查。指导委员会在半结构化会议上分析了结果并创建了最终的核心成果集 (COS)。主要结果和机会的作用 总共确定了 241 个结果并将其提炼成一个包含 71 个潜在结果的“长列表”。最终的 COS 包括 9 个领域的 24 个特定和 26 个通用核心结果，包括疼痛、子宫出血、生殖结果、血液学、泌尿系统、生活影响、护理提供、不良事件和报告项目，所有定义均由指导委员会提供. 其中 19 个结果仅适用于某些研究类型。尽管未包含在 COS 中，但指导委员会建议应记录三个卫生经济结果。局限性、谨慎的原因 来自欧洲以外大陆的患者在本次调查中的代表性不足。调查缺乏翻译可能会限制非英语国家的人们的积极参与。只有 58% 的参与者返回到第二轮，但分析并未表明流失偏差。关于哪些症状是由子宫腺肌病引起的，以及它们何时与其他共存疾病（如子宫内膜异位症）有关，目前还缺乏科学证据。由于未来的研究提供了更多的清晰度，因此有必要对 COS 进行适当的审查和修订。研究结果的更广泛意义 在未来的子宫腺肌病治疗研究中实施此 COS 将提高报告质量并有助于证据合成。研究资金/竞争兴趣没有收到这项工作的具体资金。TT 在这项工作期间收到了来自挪威东南部卫生局的赠款（赠款编号 2020083）。TT 从通用电气和美敦力收取个人费用，用于超声波讲座。ERL 是挪威子宫内膜异位症协会的主席。MGM 是 Abbvie Inc 和 Myovant 的顾问，接受 AbbVie 的研究资助，并且是女性健康研究合作组织的主席。S.-WG 是亚洲子宫内膜异位症和子宫腺肌症协会的董事会成员，也是美国子宫内膜异位症基金会科学顾问委员会的成员，前世界子宫内膜异位症协会大会主席，他没有收到任何个人费用。ES 在这项工作之外获得了来自英国国家健康研究所、Rosetrees Trust 以及 Barts 和伦敦慈善机构的两项关于子宫内膜异位症的多中心试验的资助，他是药品和保健产品监管机构 (MHRA) 的成员， Medicines for Women's Health Expert Advisory Group，他是世界子宫内膜异位症协会的大使，并为 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 的讲座收取个人费用。MH 是英国妇科内窥镜学会小组委员会的成员。没有宣布其他利益冲突。试用注册号 不适用。他没有收到任何个人费用。ES 在这项工作之外获得了来自英国国家健康研究所、Rosetrees Trust 以及 Barts 和伦敦慈善机构的两项关于子宫内膜异位症的多中心试验的资助，他是药品和保健产品监管机构 (MHRA) 的成员， Medicines for Women's Health Expert Advisory Group，他是世界子宫内膜异位症协会的大使，并为 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 的讲座收取个人费用。MH 是英国妇科内窥镜学会小组委员会的成员。没有宣布其他利益冲突。试用注册号 不适用。他没有收到任何个人费用。ES 在这项工作之外获得了来自英国国家健康研究所、Rosetrees Trust 以及 Barts 和伦敦慈善机构的两项关于子宫内膜异位症的多中心试验的资助，他是药品和保健产品监管机构 (MHRA) 的成员， Medicines for Women's Health Expert Advisory Group，他是世界子宫内膜异位症协会的大使，并为 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 的讲座收取个人费用。MH 是英国妇科内窥镜学会小组委员会的成员。没有宣布其他利益冲突。试用注册号 不适用。在这项工作之外，他获得了来自英国国家健康研究所、Rosetrees 信托基金以及 Barts 和伦敦慈善机构的两项关于子宫内膜异位症的多中心试验的资助，他是药品和保健产品监管机构 (MHRA) 的成员对于女性健康专家咨询小组，他是世界子宫内膜异位症协会的大使，并为 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 的讲座收取个人费用。MH 是英国妇科内窥镜学会小组委员会的成员。没有宣布其他利益冲突。试用注册号 不适用。在这项工作之外，他获得了来自英国国家健康研究所、Rosetrees 信托基金以及 Barts 和伦敦慈善机构的两项关于子宫内膜异位症的多中心试验的资助，他是药品和保健产品监管机构 (MHRA) 的成员对于女性健康专家咨询小组，他是世界子宫内膜异位症协会的大使，并为 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 的讲座收取个人费用。MH 是英国妇科内窥镜学会小组委员会的成员。没有宣布其他利益冲突。试用注册号 不适用。Medicines for Women's Health Expert Advisory Group，他是世界子宫内膜异位症协会的大使，并为 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 的讲座收取个人费用。MH 是英国妇科内窥镜学会小组委员会的成员。没有宣布其他利益冲突。试用注册号 不适用。Medicines for Women's Health Expert Advisory Group，他是世界子宫内膜异位症协会的大使，并为 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 的讲座收取个人费用。MH 是英国妇科内窥镜学会小组委员会的成员。没有宣布其他利益冲突。试用注册号 不适用。