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 这项提议的目标是扩大和扩大正在进行的关于过渡、成果和 性别(Strong)，这是从电子医疗记录中识别的一群变性人 三大综合医疗保健系统：Kaiser Permanente佐治亚州、Kaiser Permanente Southern 加利福尼亚州和北加州的凯撒永久。这项研究现在有6459名成员和一个索引 日期(变性人身份的第一个证据)从2006年到2014年。跨性别者队列与 出生年份、种族/民族、地点和会员年度(索引日期)，最多10名男性 和10名女性非变性人注册。到目前为止，队列跟踪一直持续到2016年底。这个 强大的队列已经提供了一些新的发现，这些发现将为临床实践提供信息。我们发现 雌激素的使用与静脉血栓栓塞症和缺血性疾病的风险增加数倍相关 跨女性队列成员中的中风。我们还发现精神疾病的患病率要高得多 与匹配的人相比，变性人参与者服用多种药物和自杀企图的发生率更高 控制。尽管这些结果很重要，但由于稀疏的治疗，许多分析是不可行的。 具体层面和需要更长时间的后续行动。目前还不清楚观察到的关联是否可以用 给药的具体途径、剂量或药物组合。此外，强大的队列提供了一个 有机会确定广泛的临床健康指标和实验室的分布 在变性人中的措施，这可能有助于在#年制定相关的参考范围 这些人口。在本申请中，我们建议1)包括现有地点确定的其他主题 到2024年，2)在中大西洋各州Kaiser Permanente增加一个新地点，以增加地理和 队列的人口多样性，以及3)将后续行动延长到2025年。最终的队列将包括AS 多达3万名成员与60万名推荐人匹配。中描述的数据收集方法 目前的应用已经在以前成功实现。新项目将涉及三个领域 重要：1)与激素治疗的各个方面有关的急性心血管事件的发生； 2)跨性别者的心理健康状况和自杀企图发生率的变化；以及3) 跨性别激素治疗的代谢和血液学后果。该项目将由一名 该团队包括变性人健康、基于电子记录的数据收集、S流行病学和 特别是药物流行病学方法，先进的纵向数据分析，心理健康， 心血管疾病、神经科学和内分泌学。