Habilitative Teletherapy for Children with Autism Spectrum Disorder: A Survey of Parents.

OBJECTIVE: The purpose of this study was to investigate whether service losses during the coronavirus disease 2019 (COVID-19) pandemic were associated with worsened parent mental health or child behavioral health among families of children with autism spectrum disorder and to identify factors associated with favorable parent appraisals of habilitative teletherapy (applied behavior analysis; speech, occupational, physical therapy) for their child. METHOD: This web-based survey study was conducted from May to July 2021 with parents whose children were receiving habilitative therapy for autism from an integrated health system. A total of 322 parents responded to the survey (20% response rate). The outcome variables were pandemic-related parent mental health, pandemic-related child behavioral health, and appraisal of habilitative teletherapy. Predictors were COVID-19-related services changes in health care or child care, COVID-19 history (COVID-19 stress, testing positive for COVID-19), and child autism factors (autistic behaviors, caregiving strain). RESULTS: Loss of regular child care was associated with higher odds of worsened parent mental health (odds ratio [OR] = 2.7, 95% confidence interval [CI] = 1.5-4.8); higher levels of caregiving strain were associated with worsened child behavioral health (OR = 2.3, 95% CI = 1.4-3.8). Higher levels of COVID-19 stress were associated with more favorable appraisals of telehealth (ß = 0.4, p < 0.01), whereas higher caregiving strain scores were associated with less favorable appraisals of telehealth (ß = -0.2, p < 0.01). CONCLUSION: During COVID-19, caregiving factors were associated with worsened parent mental health and worsened child behavioral health, and telehealth is not preferred by all families. Policy interventions to support caregivers, such as affordable, high-quality child care and paid family leave, are a high priority.

Prenatal Influenza Vaccination or Influenza Infection and Autism Spectrum Disorder in Offspring.

BACKGROUND: As prenatal vaccinations continue to be given more frequently, it is important to assess long-term safety events. We investigated the association between prenatal influenza vaccination or infection and autism spectrum disorder (ASD) in offspring. METHODS: A retrospective cohort study of mother-child pairs with deliveries between 1 January 2011 and 31 December 2014 at Kaiser Permanente Southern California was performed. Children aged >1 year were followed through 31 December 2018. Maternal influenza vaccination or infection during pregnancy was obtained from electronic health records. ASD was defined by International Classification of Diseases, Ninth or Tenth Revisions, Clinical Modification, codes after age 1 year. Cox proportional hazard models estimated the crude and inverse probability of treatment weighted (IPTW) hazard ratios (HR) for the association between maternal influenza vaccination or infection and ASD. RESULTS: There were 84 739 mother-child pairs included in the final analytic sample. Of the 46 257 women vaccinated, 32.4% were vaccinated during the first trimester, 41.8% during the second trimester, and 25.8% during the third trimester. ASD was diagnosed in 1930 (2.3%) children. The IPTW analyses showed no association between prenatal influenza vaccination or infection and ASD in offspring (HR, 1.04; 95% confidence interval [CI], .95-1.13; HR, 1.12; 95% CI, .66-1.89, respectively). CONCLUSIONS: Prenatal influenza vaccination or infection was not associated with ASD risk in offspring. The findings support recommendations to vaccinate pregnant women to protect themselves and their infants, both of whom are vulnerable to severe morbidity following infection.

Patient Outcomes After Applied Behavior Analysis for Autism Spectrum Disorder.

OBJECTIVES: The purpose of this study was to examine patterns of service receipt and patient outcomes for children receiving applied behavior analysis (ABA) for autism spectrum disorder (ASD) in an integrated health care system in which commercially insured children were covered by a state autism mandate. METHODS: This retrospective, observational study used a random sample of children with ASD (3-17 yrs) who were members of a large integrated health care system in Southern California and referred for ABA between January 2016 and November 2018. From the 4145 children referred, a random stratified sample of 334 was selected to extract data from clinical reports over 24 months of services. The primary outcome measures were time in ABA and child adaptive behavior. RESULTS: Thirteen percent of the sample never received ABA after referral. Of those who were referred for ABA, 66% initiated ABA and remained in services for 12 months, whereas less than half (46%) remained in services for 24 months. Having a history of special education was associated with longer time spent in ABA, whereas having a single parent was associated with discontinuation of ABA. A minority of children received a full ABA dose (28%), but the lowest functioning children still experienced clinically significant adaptive behavior gains after 24 months of ABA (p = 0.02). CONCLUSION: In a health system implementation of ABA for children with ASD, there were high rates of ABA discontinuation and low ABA dosing. These challenges may diminish the potential benefits of ABA, even in a context in which there is mandated commercial insurance coverage.

Real-world evidence of quadrivalent meningococcal conjugate vaccine safety in the United States: a systematic review.

Two quadrivalent meningococcal conjugate vaccines (MenACWY) that prevent invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W have been licensed in the U.S. in the past 10-15 years. We systematically reviewed published studies conducted in the U.S. to evaluate the real-world safety evidence of meningococcal conjugate vaccines. We performed a literature search in PubMed of publications from 01/01/2005 to 02/29/2020 and identified 18 studies meeting inclusion criteria. Populations included high-risk persons aged 2 months to 10 years, adolescents/adults aged ≥11 years, pregnant populations, and hematopoietic cell transplant recipients. We extracted information about study setting, study design, exposure, outcomes, comparison group, follow-up/look back period, study population, sample size, available demographic/indication information, results, key conclusion, and reference. These published studies found no new significant safety concerns related to MenACWY. Consideration for future research includes a post-licensure safety evaluation of a new MenACWY product approved in April 2020.

Suicide Attempts Among a Cohort of Transgender and Gender Diverse People.

INTRODUCTION: Transgender and gender diverse people often face discrimination and may experience disproportionate emotional distress that leads to suicide attempts. Therefore, it is essential to estimate the frequency and potential determinants of suicide attempts among transgender and gender diverse individuals. METHODS: Longitudinal data on 6,327 transgender and gender diverse individuals enrolled in 3 integrated healthcare systems were analyzed to assess suicide attempt rates. Incidence was compared between transmasculine and transfeminine people by age and race/ethnicity and according to mental health status at baseline. Cox proportional hazards models examined rates and predictors of suicide attempts during follow-up. Data were collected in 2016, and analyses were conducted in 2019. RESULTS: During follow-up, 4.8% of transmasculine and 3.0% of transfeminine patients had at least 1 suicide attempt. Suicide attempt rates were more than 7 times higher among patients aged <18 years than among those aged >45 years, more than 3 times higher among patients with previous history of suicide ideation or suicide attempts than among those with no such history, and 2-5 times higher among those with 1-2 mental health diagnoses and more than 2 mental health diagnoses at baseline than among those with none. CONCLUSIONS: Among transgender and gender diverse individuals, younger people, people with previous suicidal ideation or attempts, and people with multiple mental health diagnoses are at a higher risk for suicide attempts. Future research should examine the impact of gender-affirming healthcare use on the risk of suicide attempts and identify targets for suicide prevention interventions among transgender and gender diverse people in clinical settings.

The Association of Prenatal Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination With Attention-Deficit/Hyperactivity Disorder.

As prenatal vaccinations become more prevalent, it is important to assess potential safety events. In a retrospective cohort study of Kaiser Permanente Southern California (Pasadena, California) mother-child pairs with birth dates during January 1, 2011-December 31, 2014, we investigated the association between prenatal tetanus, diphtheria, and acellular pertussis (Tdap) vaccination and risk of attention-deficit/hyperactivity disorder (ADHD) in offspring. Information on Tdap vaccination during pregnancy was obtained from electronic medical records. ADHD was defined by International Classification of Diseases codes (Ninth or Tenth Revision) and dispensed ADHD medication after age 3 years. Children were followed to the date of their first ADHD diagnosis, the end of Kaiser Permanente membership, or the end of follow-up (December 31, 2018). In Cox proportional hazards models, we estimated unadjusted and adjusted hazard ratios for the association between maternal Tdap vaccination and ADHD, with inverse probability of treatment weighting (IPTW) used to adjust for confounding. Of 128,756 eligible mother-child pairs, 85,607 were included in the final sample. The ADHD incidence rate was 3.41 per 1,000 person-years in the Tdap-vaccinated women and 3.93 per 1,000 person-years in the unvaccinated (hazard ratio = 1.01, 95% confidence interval: 0.88, 1.16). The IPTW-adjusted analyses showed no association between prenatal Tdap vaccination and ADHD in offspring (hazard ratio = 1.00, 95% confidence interval: 0.88, 1.14). In this study, prenatal Tdap vaccination was not associated with ADHD risk in offspring, supporting recommendations to vaccinate pregnant women.

Safety of MenACWY-CRM vaccine exposure during pregnancy.

BACKGROUND: Although the meningococcal conjugate MenACWY-CRM vaccine is not approved for use in pregnant women, unintentional exposure during pregnancy can occur, especially during early pregnancy among women of child-bearing age. This study provides safety information about inadvertent MenACWY-CRM vaccination during pregnancy. METHODS: The evaluated population consisted of pregnant female members of Kaiser Permanente Southern California who inadvertently received MenACWY-CRM at 11-21 years of age during 09/30/2011-06/30/2013 within 28 days prior to conception or during pregnancy. Chart abstraction was conducted to identify pregnancy and birth outcomes, including spontaneous and induced abortions, preterm births, low weight births, and major congenital malformations (MCMs). RESULTS: There were 92 women who received MenACWY-CRM during the pregnancy exposure period, mainly during the first trimester (76.1%). Hispanics represented the largest race/ethnicity category (68.5%). Among the known pregnancy outcomes (n = 66; excluding induced abortions and unknown pregnancy outcomes), the prevalence of spontaneous abortions was 18.2% (n = 12). Among live born infants (n = 55; from 54 pregnancies), 14.5% (n = 8) were born preterm (<37 weeks gestation) and 9.1% (n = 5) had a low birthweight (<2500 g). The prevalence rate of MCMs among live born infants (n = 55) was 1.8% (n = 1). CONCLUSIONS: This study provides baseline prevalence estimates of spontaneous abortions, preterm births, low weight births, and MCMs among women inadvertently exposed to MenACWY-CRM during the pregnancy period. These estimates appear to be comparable with U.S. background prevalence estimates.

Safety of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old.

INTRODUCTION: The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is recommended for 2-23 month-old infants/toddlers at increased risk for meningococcal disease. This study adds to the current knowledge of MenACWY-CRM safety among this age group in a clinical care setting. METHODS: Kaiser Permanente Southern California members aged 2-23 months who received MenACWY-CRM between July 2014 and June 2017 were included. Electronic health records were searched for emergency department (ED) and hospitalization encounters, and diagnoses associated with these visits up to 6 months after each dose. RESULTS: There were 138 infants/toddlers who received MenACWY-CRM, with 59.4% being African American and 66.7% receiving only one dose. Most infants either had a high-risk condition (i.e., anatomic/functional asplenia or DiGeorge syndrome) (42.0%), or a travel indication (54.3%). The incidence rate of ED visits was 0.6/person-year (95% confidence interval [CI]: 0.5-0.8), 0.4/person-year (CI: 0.3-0.5) for hospitalizations, and 0.1/person-year (CI: 0.1-0.3) for ED to hospital transfers. Overall, 29.0% of recipients had an incident diagnosis in the ED or hospital setting. Fever and acute upper respiratory infections were the most common diagnoses, with 46 out of 47 diagnoses occurring among infants with high-risk conditions. CONCLUSIONS: Data from this descriptive observational study do not suggest safety concerns associated with MenACWY-CRM when used as part of clinical care of 2-23 month-old infants/toddlers indicated for vaccination.

Modifiable Failures in the Colorectal Cancer Screening Process and Their Association With Risk of Death.

BACKGROUND & AIMS: Colorectal cancer (CRC) deaths occur when patients do not receive screening or have inadequate follow-up of abnormal results or when the screening test fails. We have few data on the contribution of each to CRC-associated deaths or factors associated with these events. METHODS: We performed a retrospective cohort study of patients in the Kaiser Permanente Northern and Southern California systems (55-90 years old) who died of CRC from 2006 through 2012 and had ≥5 years of enrollment before diagnosis. We compared data from patients with those from a matched cohort of cancer-free patients in the same system. Receipt, results, indications, and follow-up of CRC tests in the 10-year period before diagnosis were obtained from electronic databases and chart audits. RESULTS: Of 1750 CRC deaths, 75.9% (n = 1328) occurred in patients who were not up to date in screening and 24.1% (n = 422) occurred in patients who were up to date. Failure to screen was associated with fewer visits to primary care physicians. Of 3486 cancer-free patients, 44.6% were up to date in their screening. Patients who were up to date in their screening had a lower risk of CRC death (odds ratio, 0.38; 95% confidence interval, 0.33-0.44). Failure to screen, or failure to screen at appropriate intervals, occurred in a 67.8% of patients who died of CRC vs 53.2% of cancer-free patients; failure to follow-up on abnormal results occurred in 8.1% of patients who died of CRC vs 2.2% of cancer-free patients. CRC death was associated with higher odds of failure to screen or failure to screen at appropriate intervals (odds ratio, 2.40; 95% confidence interval, 2.07-2.77) and failure to follow-up on abnormal results (odds ratio, 7.26; 95% confidence interval, 5.26-10.03). CONCLUSIONS: Being up to date on screening substantially decreases the risk of CRC death. In 2 health care systems with high rates of screening, most people who died of CRC had failures in the screening process that could be rectified, such as failure to follow-up on abnormal findings; these significantly increased the risk for CRC death.

Prenatal Tetanus, Diphtheria, Acellular Pertussis Vaccination and Autism Spectrum Disorder.

: media-1vid110.1542/5803567555001PEDS-VA_2018-0120Video Abstract BACKGROUND: Increasing vaccination of pregnant women makes it important to assess safety events potentially linked to prenatal vaccination. This study investigates the association between prenatal tetanus, diphtheria, acellular pertussis (Tdap) vaccination and autism spectrum disorder (ASD) risk in offspring. METHODS: This is a retrospective cohort study of mother-child pairs with deliveries January 1, 2011 to December 31, 2014 at Kaiser Permanente Southern California hospitals. Maternal Tdap vaccination from pregnancy start to delivery date was obtained from electronic medical records. A diagnosis of ASD was obtained by using International Classification of Diseases, Ninth and Tenth Revision codes. Children were managed from birth to first ASD diagnosis, end of membership, or end of follow-up (June 30, 2017). Cox proportional hazards models estimated the unadjusted and adjusted hazard ratios (HRs) for the association between maternal Tdap vaccination and ASD, with inverse probability of treatment weighting to adjust for confounding. RESULTS: Women vaccinated were more likely to be Asian American or Pacific Islander, be nulliparous, have a higher education, receive influenza vaccination prenatally, and give birth at term. ASD was diagnosed in 1341 (1.6%) children, and the incidence rate was 3.78 per 1000 person years in the Tdap exposed and 4.05 per 1000 person years in the unexposed group (HR: 0.98, 95% confidence interval: 0.88-1.09). The inverse probability of treatment weighting-adjusted analyses revealed that prenatal Tdap vaccination was not associated with an increased ASD risk (HR: 0.85, 95% confidence interval: 0.77-0.95). CONCLUSIONS: Prenatal Tdap vaccination was not associated with an increased ASD risk. We support recommendations to vaccinate pregnant women to protect infants, who are at highest risk of death after pertussis infection.

Cross-sex Hormones and Acute Cardiovascular Events in Transgender Persons: A Cohort Study.

Background: Venous thromboembolism (VTE), ischemic stroke, and myocardial infarction in transgender persons may be related to hormone use. Objective: To examine the incidence of these events in a cohort of transgender persons. Design: Electronic medical record-based cohort study of transgender members of integrated health care systems who had an index date (first evidence of transgender status) from 2006 through 2014. Ten male and 10 female cisgender enrollees were matched to each transgender participant by year of birth, race/ethnicity, study site, and index date enrollment. Setting: Kaiser Permanente in Georgia and northern and southern California. Patients: 2842 transfeminine and 2118 transmasculine members with a mean follow-up of 4.0 and 3.6 years, respectively, matched to 48 686 cisgender men and 48 775 cisgender women. Measurements: VTE, ischemic stroke, and myocardial infarction events ascertained from diagnostic codes through the end of 2016 in transgender and reference cohorts. Results: Transfeminine participants had a higher incidence of VTE, with 2- and 8-year risk differences of 4.1 (95% CI, 1.6 to 6.7) and 16.7 (CI, 6.4 to 27.5) per 1000 persons relative to cisgender men and 3.4 (CI, 1.1 to 5.6) and 13.7 (CI, 4.1 to 22.7) relative to cisgender women. The overall analyses for ischemic stroke and myocardial infarction demonstrated similar incidence across groups. More pronounced differences for VTE and ischemic stroke were observed among transfeminine participants who initiated hormone therapy during follow-up. The evidence was insufficient to allow conclusions regarding risk among transmasculine participants. Limitation: Inability to determine which transgender members received hormones elsewhere. Conclusion: The patterns of increases in VTE and ischemic stroke rates among transfeminine persons are not consistent with those observed in cisgender women. These results may indicate the need for long-term vigilance in identifying vascular side effects of cross-sex estrogen. Primary Funding Source: Patient-Centered Outcomes Research Institute and Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Parental First Concerns and Timing of Autism Spectrum Disorder Diagnosis.

Specific developmental concerns can distinguish between an early versus later diagnosis of autism spectrum disorder (ASD). Caregiver survey responses of children ≥ 9 years-of-age (2012) with ASD were used to evaluate developmental concerns and associations with age of diagnosis [early (< 3 years: n = 106) vs. later (≥ 3 years: n = 432)] using logistic regression. Concerns arose at mean age 18 and 35-months for children diagnosed early versus later, respectively. Concerns about poor eye contact (aOR 1.81, CI 1.08, 3.05), pointing/gesturing (aOR 2.74, CI 1.60, 4.70), response to own name (aOR 3.03, CI 1.75, 5.23), and babbling/speaking (aOR 1.67, CI 0.98, 2.82) were associated with an early diagnosis. Caregivers and pediatricians are critical in early identification and timely entry into intervention.

Mental Health of Transgender and Gender Nonconforming Youth Compared With Their Peers.

BACKGROUND: Understanding the magnitude of mental health problems, particularly life-threatening ones, experienced by transgender and/or gender nonconforming (TGNC) youth can lead to improved management of these conditions. METHODS: Electronic medical records were used to identify a cohort of 588 transfeminine and 745 transmasculine children (3-9 years old) and adolescents (10-17 years old) enrolled in integrated health care systems in California and Georgia. Ten male and 10 female referent cisgender enrollees were matched to each TGNC individual on year of birth, race and/or ethnicity, study site, and membership year of the index date (first evidence of gender nonconforming status). Prevalence ratios were calculated by dividing the proportion of TGNC individuals with a specific mental health diagnosis or diagnostic category by the corresponding proportion in each reference group by transfeminine and/or transmasculine status, age group, and time period before the index date. RESULTS: Common diagnoses for children and adolescents were attention deficit disorders (transfeminine 15%; transmasculine 16%) and depressive disorders (transfeminine 49%; transmasculine 62%), respectively. For all diagnostic categories, prevalence was severalfold higher among TGNC youth than in matched reference groups. Prevalence ratios (95% confidence intervals [CIs]) for history of self-inflicted injury in adolescents 6 months before the index date ranged from 18 (95% CI 4.4-82) to 144 (95% CI 36-1248). The corresponding range for suicidal ideation was 25 (95% CI 14-45) to 54 (95% CI 18-218). CONCLUSIONS: TGNC youth may present with mental health conditions requiring immediate evaluation and implementation of clinical, social, and educational gender identity support measures.

Association Between Gender Confirmation Treatments and Perceived Gender Congruence, Body Image Satisfaction, and Mental Health in a Cohort of Transgender Individuals.

BACKGROUND: Transgender individuals sometimes seek gender confirmation treatments (GCT), including hormone therapy (HT) and/or surgical change of the chest and genitalia ("top" and "bottom" gender confirmation surgeries). These treatments may ameliorate distress resulting from the incongruence between one's physical appearance and gender identity. AIM: The aim was to examine the degree to which individuals' body-gender congruence, body image satisfaction, depression, and anxiety differed by GCT groups in cohorts of transmasculine (TM) and transfeminine (TF) individuals. METHODS: The Study of Transition, Outcomes, and Gender is a cohort study of transgender individuals recruited from 3 health plans located in Georgia, Northern California, and Southern California; cohort members were recruited to complete a survey between 2015-2017. Participants were asked about: history of GCT; body-gender congruence; body image satisfaction; depression; and anxiety. Participants were categorized as having received: (1) no GCT to date; (2) HT only; (3) top surgery; (4) partial bottom surgery; and (5) definitive bottom surgery. OUTCOMES: Outcomes of interest included body-gender congruence, body image satisfaction, depression, and anxiety. RESULTS: Of the 2,136 individuals invited to participate, 697 subjects (33%) completed the survey, including 347 TM and 350 TF individuals. The proportion of participants with low body-gender congruence scores was significantly higher in the "no treatment" group (prevalence ratio [PR] = 3.96, 95% CI 2.72-5.75) compared to the definitive bottom surgery group. The PR for depression comparing participants who reported no treatment relative to those who had definitive surgery was 1.94 (95% CI 1.42-2.66); the corresponding PR for anxiety was 4.33 (95% CI 1.83-10.54). CLINICAL TRANSLATION: Withholding or delaying GCT until depression or anxiety have been treated may not be the optimal treatment course given the benefits of reduced levels of distress after undergoing these interventions. CONCLUSIONS: Strengths include the well-defined sampling frame, which allowed correcting for non-response, a sample with approximately equal numbers of TF and TM participants, and the ability to combine data on HT and gender confirmation surgeries. Limitations include the cross-sectional design and the fact that participants may not be representative of the transgender population in the United States. Body-gender congruence and body image satisfaction were higher, and depression and anxiety were lower among individuals who had more extensive GCT compared to those who received less treatment or no treatment at all. Owen-Smith AA, Gerth J, Sineath RC, et al. Association Between Gender Confirmation Treatments and Perceived Gender Congruence, Body Image Satisfaction and Mental Health in a Cohort Of Transgender Individuals. J Sex Med 2018;15:591-600.

Patterns and correlates of cervical cancer screening initiation in a large integrated health care system.

BACKGROUND: The latest 2012 US Preventive Services Task Force cervical cancer screening guidelines recommended screening initiation at age 21 years. Little is known about the cervical cancer screening initiation practices in the community and whether there are critical gaps with respect to adherence to current clinical guidelines. Despite an overall decline in cervical cancer incidence across women of all ages, the incidence rate has not declined among 24-25 year olds between 2000 (2.79 per 100,000) and 2013 (2.93 per 100,000). Thus, it is important to understand cervical cancer screening initiation in young women and how woman- and provider-level factors affect the timing of screening initiation to identify areas for improving cervical cancer prevention. OBJECTIVE: We examined patterns and correlates of cervical cancer screening initiation among women turning age 21 years in a large community-based practice. STUDY DESIGN: Female members of Kaiser Permanente Southern California who turned age 21 years (baseline) during 2013-2015 and had not previously received a Papanicolaou test were included. Cervical cancer screening initiation through October 2016 was captured using electronic health records. Incidence rate and cumulative incidence of screening initiation was calculated. Associations between patient and provider characteristics and screening initiation were evaluated using multivariable Cox models. RESULTS: A total of 38,257 women were included and the Papanicolaou screening initiation rate was 44 per 100 person-years during the study period. Approximately 40% initiated screening within 1 year after turning age 21 years. In multivariable analyses, Asian/Pacific Islanders (hazard ratio, 0.91; confidence interval, 0.86-0.96 compared with non-Hispanic whites); Medicaid enrollees (hazard ratio, 0.90; confidence interval, 0.83, 0.97); those whose primary language is not English (hazard ratio, 0.71; confidence interval, 0.67, 0.75); those who have a historical inpatient visit, primary care physician in pediatrics, internal medicine, or another specialty compared with family practice; and have a male rather than female primary care physician (hazard ratio, 0.46; confidence interval, 0.36, 0.57) less often initiated screening. On the other hand, those who used other preventive services such as getting a human papilloma virus and influenza vaccination and those with a history of pregnancy, contraception use, and sexually transmitted infections more often had timely screening initiation. CONCLUSION: Less than half of the women insured for preventative services initiated screening at age 21 years. Strategies to improve adherence to screening initiation guidelines should consider a tailored approach for at-risk subgroups and addressing initiation challenges associated with male physicians.

Cohort profile: Study of Transition, Outcomes and Gender (STRONG) to assess health status of transgender people.

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.