探索哪些研究结果最能反映女性月经大出血体验的定性研究：利益相关者参与核心结局集制定。
Qualitative study exploring which research outcomes best reflect women's experiences of heavy menstrual bleeding: stakeholder involvement in development of a core outcome set.
机构信息
Women's Health Research Unit, Wolfson Institute of Population Health, Queen Mary University London, London, UK
Women's Health Research Unit, Wolfson Institute of Population Health, Queen Mary University London, London, UK.
出版信息
BMJ Open. 2023 Jul 17;13(7):e063637. doi: 10.1136/bmjopen-2022-063637.
OBJECTIVE
This work contributed to the development of a core outcome set (COS) for heavy menstrual bleeding (HMB). The objective was to determine which research outcomes best reflect how HMB affects women's lives and to identify additional research outcomes, not previously reported. It was important to explore and record participants' reasoning for prioritising outcomes and use this information to reinforce the patients' voice during later phases of the COS development.
DESIGN
Patient workshop discussions and telephone interviews.
SETTING
East London teaching hospital.
PARTICIPANTS
Inclusion criteria were that participants must be over 18 years old, that either they or their partner had a history of HMB and that they had a good understanding of written and spoken English.
RESULTS
41 participants were recruited for the study. 8 women and 1 man completed the study. The eight female participants were representative of the different underlying causes and treatments for HMB. Participants ranged in age from their early 20s to their 60s and represented a range of ethnic groups. The five main themes that were identified as being important to patients were: and . We identified eight coding nodes that did not correspond with our list of previously reported outcomes in studies of HMB. These nodes were consolidated and became five new outcomes for potential inclusion in the COS.
CONCLUSIONS
HMB stops women living their lives as they would wish. It affects their relationships, education, careers, reproductive wishes, social life and mental health. This is a condition of girls and women in the prime of their lives, but for many, the constant threat of a heavy period starting means that they sacrifice that freedom. The societal and economic costs of women being incapacitated every month has an effect on everyone.
TRIAL REGISTRATION
The COS study is registered with the COMET (Core Outcome Measures in Effectiveness Trials) Initiative-project reference number 789.
目的
本研究旨在制定一项关于重度月经过多（HMB）的核心结局集（COS）。目的是确定哪些研究结局最能反映 HMB 如何影响女性的生活，并确定以前未报告的其他研究结局。探索和记录参与者优先考虑结局的理由，并在 COS 开发的后期阶段利用这些信息来加强患者的声音，这一点非常重要。
设计
患者研讨会讨论和电话访谈。
地点
东伦敦教学医院。
参与者
纳入标准为参与者必须年满 18 岁，要么自己或其伴侣有 HMB 病史，且对书面和口头英语有很好的理解。
结果
研究共招募了 41 名参与者。有 8 名女性和 1 名男性完成了研究。这 8 名女性参与者代表了 HMB 的不同潜在原因和治疗方法。参与者年龄从 20 多岁到 60 多岁不等，代表了不同的种族群体。被确定为对患者重要的五个主要主题是： 和 。我们确定了 8 个与我们之前在 HMB 研究中报告的结局列表不对应的编码节点。这些节点被整合，并成为潜在纳入 COS 的 5 个新结局。
结论
HMB 使女性无法按照自己的意愿生活。它影响她们的人际关系、教育、职业、生育愿望、社交生活和心理健康。这是一个处于生命黄金期的女孩和女性的疾病，但对许多人来说，每月大量月经开始的持续威胁意味着她们不得不牺牲这种自由。女性每月因身体不适而无法工作所带来的社会和经济成本，对每个人都有影响。
试验注册
COS 研究在 COMET（有效性试验的核心结局测量）倡议中注册，项目参考号为 789。
Zotero 插件