Purpose The Study of Transition, Outcomes and Gender (STRONG) was initiated to assess the health status of transgender people in general and following gender-affirming treatments at Kaiser Permanente health plans in Georgia, Northern California and Southern California. The objectives of this communication are to describe methods of cohort ascertainment and data collection and to characterise the study population.
Participants A stepwise methodology involving computerised searches of electronic medical records and free-text validation of eligibility and gender identity was used to identify a cohort of 6456 members with first evidence of transgender status (index date) between 2006 and 2014. The cohort included 3475 (54%) transfeminine (TF), 2892 (45%) transmasculine (TM) and 89 (1%) members whose natal sex and gender identity remained undetermined from the records. The cohort was matched to 127 608 enrollees with no transgender evidence (63 825 women and 63 783 men) on year of birth, race/ethnicity, study site and membership year of the index date. Cohort follow-up extends through the end of 2016.
Findings to date About 58% of TF and 52% of TM cohort members received hormonal therapy at Kaiser Permanente. Chest surgery was more common among TM participants (12% vs 0.3%). The proportions of transgender participants who underwent genital reconstruction surgeries were similar (4%–5%) in the two transgender groups. Results indicate that there are sufficient numbers of events in the TF and TM cohorts to further examine mental health status, cardiovascular events, diabetes, HIV and most common cancers.
Future plans STRONG is well positioned to fill existing knowledge gaps through comparisons of transgender and reference populations and through analyses of health status before and after gender affirmation treatment. Analyses will include incidence of cardiovascular disease, mental health, HIV and diabetes, as well as changes in laboratory-based endpoints (eg, polycythemia and bone density), overall and in relation to gender affirmation therapy.
- electronic medical records
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Contributors VPQ and MG prepared the original draft of the manuscript. RN conducted data analyses and put together tables and figures. RC and LC were responsible for the preparation and application of data collection programs and ascertainment of study variables. EH, VPQ, DG, MJS and DT led study implementation at participating sites and were actively involved in study planning and design. TAB-C, AM and BR were responsible for the day-to-day project management at each site. DR and TLL provided methodological input on various aspects of study design, including identification of sources of bias and ways of addressing threats to validity. VT and JS provided input on clinical aspects of the study and were responsible for adjudication of study eligibility, gender identity and gender affirmation. KW developed, pilot-tested and supervised the cohort validation and gender identity ascertainment review protocols and programming. SG, CV and SW are members of the Stakeholder Advisory Group who assisted with the development of inclusion and exclusion criteria, assessment of gender identity and interpretation of the data. All authors provided critical review of the manuscript for important intellectual content and approved the final version.
Funding This research was supported by the Contract AD-12-11-4532 from the Patient Centered Outcome Research Institute and by the Grant R21HD076387 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Competing interests None declared.
Ethics approval Emory University IRB.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Once the initial data analyses are complete, we will be open to collaborations with outside investigators as permitted by the IRBs of participating sites as well as by local, state and federal laws and regulations. In particular, we will encourage collaborations with researchers whose expertise is under-represented on our research team. To become a collaborator, a researcher will be required to submit an application, which will undergo both a scientific and an IRB review. In view of the complexity of the database, interested investigators will be asked to form a collaborative arrangement with the STRONG investigators rather than simply receive the data themselves. No additional data are available.
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