An expanded national cohort study of transgender people

项目总结/摘要 本提案的目标是扩大和延伸正在进行的关于过渡、成果和 性别（STRONG），这是一个从电子病历中识别的跨性别人群队列， 三个大型综合医疗保健系统：凯撒永久格鲁吉亚，凯撒永久南部 加州和北方加州凯撒永久保险公司。该研究现在包括6，459名成员， 日期（第一次证明变性身份）从2006年到2014年。跨性别人群的匹配是 首次就诊时（索引日期）的出生年份、人种/种族、研究中心和成员年份，最多10名男性 和10名女性非变性者。迄今为止的队列随访持续到2016年底。的 STRONG队列已经提供了许多新的发现，将为临床实践提供信息。我们发现 雌激素使用与静脉血栓栓塞和缺血性中风风险增加几倍有关 在跨女性群体成员中发生中风。我们还发现， 与匹配的患者相比，跨性别参与者的多药治疗和自杀企图发生率更高 对照尽管这些结果很重要，但由于缺乏治疗，许多分析是不可行的- 具体阶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解释为 特定的给药途径、剂量或药物组合。此外，STRONG队列还提供了 有机会描述广泛的临床健康指标和实验室检查的分布 在变性人中采取措施，这可能有助于制定 这些人口。在这项申请中，我们建议：1）在已确定的现有研究中心增加受试者 到2024年，2）在Kaiser Permanente Mid-Atlantic States增加一个新的站点，以增加地理位置， 队列的人口多样性，以及3）将随访延长至2025年。最后一组将包括 多达30 000名成员与600 000份参考资料相匹配。中描述的数据收集方法 目前的申请已经成功地实施了。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企图发生率的变化;以及3） 交叉性激素治疗的代谢和血液学后果。该项目将由一个 该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，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。

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.