An expanded national cohort study of transgender people

跨性别者的扩大全国队列研究

• 批准号: 10298761
• 负责人: Michael Goodman
• 金额: $ 72.76万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10298761
• 关键词: Acute; Address; American; Androgen Antagonists; Area; Benefits and Risks; Birth; Blood; Blood Pressure; Body mass index; Bone Density; California; Cardiovascular Diseases; Cardiovascular system; Caring; Clinical; Cohort Studies; Computerized Medical Record; Data; Data Analyses; Data Collection; Dementia; Development; Diagnosis; Disease; Dose; Drug Combinations; Endocrine; Endocrinology; Enrollment; Enzymes; Epidemiology; Estrogens; Ethnic Origin; Event; Feeling suicidal; Female; Gender; General Population; Geography; Goals; Gonadal Steroid Hormones; Guidelines; Health; Health Status; Healthcare; Hematocrit procedure; Hematology; High Prevalence; Hormones; Hospitalization; Incidence; Individual; Integrated Health Care Systems; Internal Medicine; Ischemic Stroke; Journals; Knowledge; Laboratories; Lipids; Liver; Longitudinal Studies; Longitudinal cohort; Masculine; Measures; Mental Health; Metabolic; Methods; Monitor; NIH Program Announcements; Neurosciences; Oral; Outcome; Participant; Pattern; Persons; Pharmaceutical Preparations; Pharmacoepidemiology; Polypharmacy; Population; Preventive Medicine; Progesterone; Publications; Publishing; Race; Recommendation; Recording of previous events; Reference Values; Reporting; Research; Resources; Risk; Route; Schedule; Self-Injurious Behavior; Serum; Site; Societies; Suicide attempt; Testosterone; Woman; age group; age related; base; cis-female; cis-male; cisgender; clinical practice; cohort; dosage; experience; follow-up; gender nonconforming; hormone therapy; indexing; male; member; men; transfeminine; transgender; transmasculine; venous thromboembolism

PROJECT SUMMARY/ABSTRACT The goal of this proposal is to expand and extend the ongoing longitudinal Study of Transition, Outcomes & Gender (STRONG), which is a cohort of transgender people identified from the electronic medical records of three large integrated health care systems: Kaiser Permanente Georgia, Kaiser Permanente Southern California, and Kaiser Permanente Northern California. The study now includes 6,459 members with an index date (first evidence of transgender status) from 2006 through 2014. The transgender cohort is matched on year of birth, race/ethnicity, site, and membership year at initial presentation (index date) with up to 10 male and 10 female non-transgender enrollees. To-date cohort follow up extends through the end of 2016. The STRONG cohort has already provided a number of new findings that will inform clinical practice. We found that estrogen use is associated with several-fold increase in risk for venous thromboembolism and ischemic stroke among transfeminine cohort members. We also found a much higher prevalence of psychiatric polypharmacy and higher incidence of suicide attempts among transgender participants compared to matched controls. Despite the importance of these results, many analyses were not feasible due to sparse treatment- specific strata and the need for longer follow up. It is unclear if the observed associations can be explained by a specific route of administration, dosage, or drug combinations. In addition, the STRONG cohort offers an opportunity to characterize the distributions of a wide range of clinical health indicators and laboratory measures among transgender people, which may help with the development of relevant reference ranges in these population. In this application, we propose 1) including additional subjects at existing sites identified through 2024, 2) adding a new site at Kaiser Permanente Mid-Atlantic States to increase geographic and demographic diversity of the cohort, and 3) extending follow up through 2025. The final cohort will include as many as 30,000 members matched to 600,000 referents. The methods of data collection described in the current application have been successfully implemented previously. The new project will address three areas of importance: 1) occurrence of acute cardiovascular events in relation to various aspects of hormone therapy; 2) changes in mental health status and incidence of suicide attempts among transgender people; and 3) metabolic and hematologic consequences of cross-sex hormone therapy. The project will be carried out by a team that includes experts in transgender health, electronic record-based data collection, s epidemiology and specifically pharmacoepidemiology methods, advanced longitudinal data analyses, mental health, cardiovascular disease, neuroscience and endocrinology.

项目概要/摘要 该提案的目标是扩大和扩展正在进行的转型、成果和 性别（STRONG），这是从电子病历中识别出的一组跨性别者 三大综合医疗保健系统：Kaiser Permanente Georgia、Kaiser Permanente Southern 加利福尼亚州和北加利福尼亚州凯撒医疗机构。该研究目前包括 6,459 名成员，并有一个指数 日期（跨性别身份的第一个证据）从 2006 年到 2014 年。跨性别队列匹配 出生年份、种族/族裔、地点和初次介绍时的会员年份（索引日期），最多 10 名男性 和 10 名女性非跨性别参与者。迄今为止的队列随访一直持续到 2016 年底。 STRONG 队列已经提供了许多可为临床实践提供信息的新发现。我们发现 雌激素的使用与静脉血栓栓塞和缺血性风险增加数倍有关 跨性别群体成员中的中风。我们还发现精神病患病率要高得多 与匹配的参与者相比，跨性别参与者的多重用药和自杀企图发生率更高 控制。尽管这些结果很重要，但由于处理稀疏，许多分析并不可行 - 特定阶层以及需要更长时间的跟进。目前还不清楚观察到的关联是否可以用以下方式解释： 特定的给药途径、剂量或药物组合。此外，STRONG 队列还提供 有机会描述各种临床健康指标和实验室的分布特征 跨性别者的测量，这可能有助于制定相关参考范围 这些人口。在本申请中，我们建议 1) 在已确定的现有地点包括额外的主题 到 2024 年，2) 在 Kaiser Permanente 大西洋中部各州增加一个新地点，以扩大地理和 该队列的人口多样性，以及 3) 将随访时间延长至 2025 年。最终队列将包括： 多达 30,000 名会员与 600,000 名推荐人相匹配。中描述的数据收集方法 当前的应用程序之前已成功实施。新项目将涉及三个领域 重要性：1）与激素治疗的各个方面相关的急性心血管事件的发生； 2）跨性别者心理健康状况和自杀未遂发生率的变化；和 3) 跨性别激素治疗的代谢和血液学后果。该项目将由一个 团队包括跨性别健康、基于电子记录的数据收集、流行病学和 特别是药物流行病学方法、高级纵向数据分析、心理健康、 心血管疾病、神经科学和内分泌学。