An expanded national cohort study of transgender people

跨性别者的扩大全国队列研究

• 批准号: 10634687
• 负责人: Michael Goodman
• 金额: $ 64.41万
• 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/10634687
• 关键词: Acute; American; Androgen Antagonists; Area; Benefits and Risks; Birth; Blood; Blood Pressure; Body mass index; Bone Density; California; Cardiovascular Diseases; Cardiovascular system; Clinical; Cohort Studies; Computerized Medical Record; Data; Data Analyses; Data Collection; Dementia; Development; Diagnosis; Disease; Dose; Drug Combinations; Electronics; 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; 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; cis-female; cis-male; cisgender; clinical practice; cohort; dosage; experience; follow-up; gender affirming care; gender affirming hormone therapy; gender affirming therapy; 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.

项目摘要/摘要 该提案的目的是扩展和扩展对过渡，成果和结果的持续纵向研究 性别（强），这是从电子病历中确定的跨性别人群 三个大型综合卫生保健系统：Kaiser Permanente Georgia，Kaiser Permanente Southern 加利福尼亚州和北加利福尼亚州的凯撒（Kaiser Permanente）。该研究现在包括6,459名具有指数的成员 从2006年到2014年的日期（跨性别状态的第一个证据）。跨性别队列与 初始演讲（指数日期）出生年度，种族/种族，场地和会员年，最多10个男性 和10名女性非转变者参与者。截至2016年底，迄今为止的随访一直延伸。 强大的队列已经提供了许多新发现，这些发现将为临床实践提供依据。我们发现 雌激素的使用与静脉血栓栓塞和缺血的风险增加了几倍 经狂女队的中风。我们还发现精神病的患病率要高得多 与匹配相比 控件。尽管这些结果很重要，但由于治疗稀疏，许多分析是不可行的 特定地层和需要更长的后续行动。目前尚不清楚观察到的关联是否可以通过 特定的给药途径，剂量或药物组合。此外，强大的队列提供了 有机会表征广泛的临床健康指标和实验室的分布 跨性别者之间的措施，这可能有助于发展相关参考范围 这些人口。在此应用程序中，我们建议1）在已确定的现有站点上包括其他主题 到2024年，2）在Kaiser Permanente中大西洋州添加一个新地点，以增加地理和 同类人口的人口多样性，以及3）延长跟进至2025年。最终的队列将包括 多达30,000名成员与600,000名参照人相匹配。数据收集方法中描述的数据收集方法 当前的应用程序先前已成功实施。新项目将解决三个领域 重要性：1）与激素治疗的各个方面有关急性心血管事件的发生； 2）跨性别人士的心理健康状况和自杀企图的发生率的变化； 3） 跨性激素治疗的代谢和血液学后果。该项目将由 包括跨性别健康专家，基于电子记录的数据收集，S流行病学和 特别是药物ePidemiology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。