Dy Geolani W, Blasdel Gaines, Dugi Daniel, Butler Christi, Hotaling James M, Myers Jeremy B, Goodwin Isak, Bluebond-Langner Rachel, Zhao Lee C, Agarwal Cori A
Department of Urology, Oregon Health and Science University, Portland, Oregon, USA.
Division of Plastic and Reconstructive Surgery, Department of Surgery, Oregon Health and Science University, Portland, Oregon, USA.
Transgend Health. 2024 Oct 9;9(5):399-412. doi: 10.1089/trgh.2022.0111. eCollection 2024 Oct.
High quality data regarding long-term clinical and patient-reported outcomes (PROs) of genital gender-affirming surgery (GGAS) are lacking, and transgender and non-binary (TGNB) community voices have not historically been included in research development. These factors limit the utility of current research for guiding patients, clinicians, payers, and other GGAS stakeholders in decision-making. The Transgender and Non-Binary Surgery (TRANS) Registry has been developed to meet the needs of GGAS stakeholders and address limitations of traditional GGAS research.
Development of the TRANS Registry occurred over several developmental phases beginning in May 2019 to present. Stakeholder engagement was performed throughout these phases, including: determination of key clinical outcomes and PROs, creation and implementation of data collection tools within the electronic health record (EHR), and development of centralized registry infrastructure.
The TRANS Registry is a prospective observational registry of individuals seeking vaginoplasty and vulvoplasty. The EHR-enabled infrastructure allows patients and clinicians to contribute longitudinal outcomes data to the TRANS Registry. We describe our community engaged approach to designing the TRANS Registry, including lessons learned, challenges, and future directions.
The TRANS Registry is the first multicenter initiative to prospectively track the health of individuals seeking vaginoplasty and vulvoplasty using EHR-enabled methods, engaging TGNB community members and clinicians as partners in the process. This process may be used as a model for registry development in other emerging fields where high-quality longitudinal outcomes data are needed.
缺乏关于生殖器性别确认手术（GGAS）长期临床和患者报告结局（PROs）的高质量数据，而且跨性别者和非二元性别（TGNB）群体的声音在以往的研究开展过程中未被纳入。这些因素限制了当前研究对指导患者、临床医生、支付方及其他GGAS利益相关者进行决策的效用。已设立跨性别和非二元性别手术（TRANS）登记处，以满足GGAS利益相关者的需求并解决传统GGAS研究的局限性。
TRANS登记处的开发始于2019年5月，历经多个发展阶段直至目前。在这些阶段中都开展了利益相关者参与活动，包括：确定关键临床结局和PROs、在电子健康记录（EHR）中创建并实施数据收集工具，以及开发集中式登记处基础设施。
TRANS登记处是一个针对寻求阴道成形术和外阴成形术个体的前瞻性观察登记处。基于EHR的基础设施使患者和临床医生能够为TRANS登记处提供纵向结局数据。我们描述了我们在设计TRANS登记处时采用的社区参与方法，包括经验教训、挑战和未来方向。
TRANS登记处是首个多中心倡议，以前瞻性方式利用基于EHR的方法追踪寻求阴道成形术和外阴成形术个体的健康状况，让TGNB群体成员和临床医生在此过程中成为合作伙伴。这一过程可作为其他需要高质量纵向结局数据的新兴领域登记处开发的典范。
