目的:在研究子宫腺肌病的保留子宫干预措施的所有研究中,应报告哪些结局?
结论:我们在9个领域中确定了24个特异性结局和26个一般性核心结局。
背景:报道子宫腺肌病治疗的研究不是以患者为中心,结果选择差异很大,定义,质量报告和衡量。
方法:在2021年3月至12月之间进行了国际共识发展过程。第一轮的参与者是150名医疗保健专业人员,17名研究人员和334名患有子宫腺肌病的人或伴侣,中低收入国家。第二轮共有291人参加。
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,以及有子宫腺肌病生活经验的人和他们的伴侣。该过程的核心组成部分是两步改进的Delphi电子调查。指导委员会分析了结果,并在半结构化会议中创建了最终核心成果集(COS)。
结果:共确定了241项结果,并将其提炼成71项潜在结果的长列表。最终的COS包括9个领域的24个特定核心结果和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,提供护理,不良事件和报告项目,所有这些都有指导委员会提供的定义。其中19项结果仅适用于某些研究类型。虽然不包括在COS中,指导委员会建议应记录三项卫生经济成果.
结论:来自欧洲以外大陆的患者在这项调查中代表性不足。调查缺乏翻译可能限制了非英语国家人民的积极参与。只有58%的参与者回到了第二轮,但分析未显示减员偏倚。关于哪些症状是由子宫腺肌病引起的,以及它们何时与子宫内膜异位症等其他共存疾病有关,目前还缺乏科学证据。随着未来的研究提供了更多的清晰度,有必要对COS进行适当的审查和修订。
结论:在未来关于子宫腺肌病治疗的研究中实施这种COS将提高报告的质量并有助于证据合成。
背景:这项工作没有收到具体资金。T.T.在这项工作期间,从挪威东南部卫生局获得了一笔赠款(赠款编号2020083)。T.T.从GeneralElectrics和Medtronic收取超声波讲座的个人费用。E.R.L.是挪威子宫内膜异位症协会的主席。M.G.M.是AbbvieInc和Myovant的顾问,从AbbVie获得研究经费,是妇女健康研究合作的主席。S.-W.G.是亚洲子宫内膜异位症和子宫腺肌病协会的董事会成员,在美国子宫内膜异位症基金会的科学顾问委员会,世界子宫内膜异位症协会前任大会主席,他没有收取个人费用。E.S.从英国国立卫生研究院获得了两项子宫内膜异位症多中心试验的工作资助,玫瑰信托基金,还有Barts和伦敦慈善机构,他是药品和保健产品监管机构(MHRA)的成员,妇女健康药物专家咨询小组,他是世界子宫内膜异位症协会的大使,他收到了Hologic的个人讲座费用,奥林巴斯,美敦力,强生,直觉和卡尔·斯托兹。M.H.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。
背景:不适用。
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.
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.
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.
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.
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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