Department of Gynecology, Oslo University Hospital, Oslo, Norway.
Institute for Women's Health, University College Hospital, London, UK.
Hum Reprod. 2022 Aug 25;37(9):2012-2031. doi: 10.1093/humrep/deac166.
What outcomes should be reported in all studies investigating uterus-sparing interventions for treating uterine adenomyosis?
We identified 24 specific and 26 generic core outcomes in nine domains.
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.
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.
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.
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在调查治疗子宫腺肌病的保留子宫干预措施的所有研究中，应该报告哪些结果？
我们在九个领域中确定了 24 个特定和 26 个通用核心结果。
研究报告的腺肌病治疗不是以患者为中心的，并且在结果选择、定义、报告和质量测量方面存在广泛的差异。
研究设计、大小、持续时间：2021 年 3 月至 12 月进行了国际共识发展过程。第一轮的参与者包括来自 48 个高、中、低收入国家的 150 名医疗保健专业人员、17 名研究人员和 334 名腺肌病患者或其伴侣。第二轮有 291 名参与者。
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患有腺肌病的个人及其伴侣。该过程的核心部分是一项分两步的改良 Delphi 电子调查。指导委员会分析了结果，并在一次半结构化会议中创建了最终的核心结果集（COS）。
共确定了 241 个结果，并将其提炼为 71 个潜在结果的“长列表”。最终的 COS 包括 24 个特定和 26 个通用核心结果，涵盖疼痛、子宫出血、生殖结果、血液学、泌尿系统、生活影响、护理交付、不良事件和报告项目九个领域，所有这些都由指导委员会提供定义。这 26 个通用核心结果中有 19 个仅适用于某些研究类型。尽管不在 COS 中，但指导委员会建议记录三个健康经济学结果。
局限性、谨慎的原因：该调查中来自欧洲以外大陆的患者代表性不足。调查没有翻译可能限制了非英语国家患者的积极参与。只有 58%的参与者返回第二轮，但分析并未表明存在退出偏差。关于哪些症状是由腺肌病引起的，以及它们何时与其他共存疾病（如子宫内膜异位症）相关，缺乏科学证据。随着未来研究提供更明确的信息，有必要对 COS 进行适当的审查和修订。
在未来关于腺肌病治疗的研究中实施这个 COS 将提高报告质量并有助于证据综合。
研究资助/利益冲突：这项工作没有收到特定的资助。在这项工作期间，T.T. 收到了挪威东南地区卫生当局的一项拨款（拨款号 2020083）。T.T. 因讲座而从通用电气和美敦力获得个人报酬。E.R.L. 是挪威子宫内膜异位症协会的主席。M.G.M. 是 Abbvie Inc 和 Myovant 的顾问，接受 AbbVie 的研究资助，是妇女健康研究合作组织的主席。S.-W.G. 是亚洲子宫内膜异位症和腺肌病学会的董事会成员，是美国子宫内膜异位症基金会的科学顾问委员会成员，是世界子宫内膜异位症协会的前大会主席，他都没有从中获得个人报酬。E.S. 作为这项工作的一部分，他获得了英国国家卫生研究院、罗斯特里茨信托基金和伦敦慈善机构为两项子宫内膜异位症多中心试验提供的资助，他是药品和保健品监管局（MHRA）、妇女健康药品专家咨询小组的成员，是世界子宫内膜异位症协会的大使，他因讲座从 Hologic、Olympus、Medtronic、Johnson & Johnson、Intuitive 和 Karl Storz 获得个人报酬。M.H. 是英国妇科内窥镜学会小组委员会的成员。没有其他利益冲突。
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