Initial antiretroviral therapy regimen and risk of heart failure.

OBJECTIVES: Heart failure risk is elevated in people with HIV (PWH). We investigated whether initial antiretroviral therapy (ART) regimens influenced heart failure risk. DESIGN: Cohort study. METHODS: PWH who initiated an ART regimen between 2000 and 2016 were identified from three integrated healthcare systems. We evaluated heart failure risk by protease inhibitor, nonnucleoside reverse transcriptase inhibitors (NNRTI), and integrase strand transfer inhibitor (INSTI)-based ART, and comparing two common nucleotide reverse transcriptase inhibitors: tenofovir disoproxil fumarate (tenofovir) and abacavir. Follow-up for each pairwise comparison varied (i.e. 7 years for protease inhibitor vs. NNRTI; 5 years for tenofovir vs. abacavir; 2 years for INSTIs vs. PIs or NNRTIs). Hazard ratios were from working logistic marginal structural models, fitted with inverse probability weighting to adjust for demographics, and traditional cardiovascular risk factors. RESULTS: Thirteen thousand six hundred and thirty-four PWH were included (88% men, median 40 years of age; 34% non-Hispanic white, 24% non-Hispanic black, and 24% Hispanic). The hazard ratio (95% CI) were: 2.5 (1.5-4.3) for protease inhibitor vs. NNRTI-based ART (reference); 0.5 (0.2-1.8) for protease inhibitor vs. INSTI-based ART (reference); 0.1 (0.1-0.8) for NNRTI vs. INSTI-based ART (reference); and 1.7 (0.5-5.7) for tenofovir vs. abacavir (reference). In more complex models of cumulative incidence that accounted for possible nonproportional hazards over time, the only remaining finding was evidence of a higher risk of heart failure for protease inhibitor compared with NNRTI-based regimens (1.8 vs. 0.8%; P  = 0.002). CONCLUSION: PWH initiating protease inhibitors may be at higher risk of heart failure compared with those initiating NNRTIs. Future studies with longer follow-up with INSTI-based and other specific ART are warranted.

Prevalence of self-inflicted injuries among transgender and gender diverse adolescents and young adults compared to their peers: an examination of interaction with mental health morbidity.

PURPOSE: Compare occurrence of self-inflicted injuries among transgender and gender diverse (TGD) youth to that of their cisgender peers while accounting for mental health diagnoses. METHODS: Review of electronic health records from three integrated health care systems identified 1087 transfeminine and 1431 transmasculine adolescents and young adults. Poisson regression was used to calculate prevalence ratios comparing the proportion of TGD participants with at least one self-inflicted injury (a surrogate for suicide attempt) before index date (first evidence of TGD status) to the corresponding proportions in presumed cisgender male and female referents matched on age, race/ethnicity, and health plan. Interactions between gender identities and mental health diagnoses were assessed on multiplicative and additive scales. RESULTS: TGD adolescents and young adults were more likely to have a self-inflicted injury, various mental health diagnoses, and multiple mental health diagnoses than their cisgender peers. The prevalence of self-inflicted injuries among TGD adolescents and young adults was high even in the absence of mental health diagnoses. Results were consistent with positive additive interaction and negative multiplicative interaction. CONCLUSIONS: Universal suicide prevention efforts for all youth, including those with no mental health diagnoses, and more intensive suicide prevention efforts for TGD adolescents and young adults and those with at least one mental health diagnosis are warranted.

Patient Pill Organization Strategies and Adherence Measured in a Cross-Sectional Study of Hypertension.

Background: The strategies patients use to organize medications (eg, pill dispenser) may be reflected in adherence measured at follow-up. We studied whether medication organization strategies patients use at home are associated with adherence measured using pharmacy-fills, self-report, and pill counts. Design: Secondary analysis of data from a prospective randomized clinical trial. Setting: Eleven US safety-net and community primary care clinics. Patients: Of the 960 enrolled self-identified non-Hispanic Black and White patients prescribed antihypertensive medications, 731 patients reported pill organization strategies and were included. Variable: Patients were asked if they use any of the following medication organization strategies: finish previous refills first; use a pill dispenser; combine same prescriptions; or combine dissimilar prescriptions. Outcomes: Adherence to antihypertensive medications using pill counts (range, 0.0-1.0% of the days covered), pharmacy-fill (proportion of days covered >90%), and self-report (adherent/non-adherent). Results: Of the 731 participants, 38.3% were men, 51.7% were age ≥65, 52.9% self-identified as Black or African American. Of the strategies studied, 51.7% finished previous refills first, 46.5% used a pill dispenser, 38.2% combined same prescriptions and 6.0% combined dissimilar prescriptions. Median (IQR) pill count adherence was 0.65 (0.40-0.87), pharmacy-fill adherence was 75.7%, and self-reported adherence was 63.2%. Those who combined same prescriptions had significantly lower measured pill count adherence than those who did not (0.56 (0.26-0.82) vs 0.70 (0.46-0.90), p<0.01) with no significant difference in pharmacy-fill (78.1% vs 74%, p=0.22) or self-reported adherence (63.0% vs 63.3%, p=0.93). Conclusion: Self-reported medication organization strategies were common. Combining same prescriptions was associated with lower adherence as measured using pill counts but not pharmacy-fills or self-report. Clinicians and researchers should identify the pill organization strategies used by their patients to understand how these strategies may influence measures of patient adherence. Trial Registration: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).

Variation in Heart Failure Risk by HIV Severity and Sex in People With HIV Infection.

BACKGROUND: HIV is an independent risk factor for heart failure (HF). However, the association of HIV severity with incident HF and the potential interaction with sex are incompletely understood. SETTING: Integrated health care system. METHODS: We conducted a cohort study of people with HIV (PWH) and matched people without HIV (PWoH), all aged ≥ 21 years and with no previous HF. Poisson regression was used to compare incident HF by HIV status, with PWH stratified by severity of HIV infection [defined by recent (<6 months) CD4 count, nadir CD4 count, or recent HIV RNA level]. Models were adjusted for sociodemographic characteristics, substance use, and HF risk factors. Analyses were conducted for men and women combined, then by sex. RESULTS: The study included 38,868 PWH and 386,569 PWoH (mean baseline age = 41.0 ± 10.8 years; 88% men). Compared with PWoH, incident HF risk was higher among PWH with lower recent CD4 [200-499 cells/µL, adjusted rate ratio (aRR) = 1.82, 95% confidence interval (CI) = 1.50 to 2.21 and <200 cells/µL, aRR = 3.26 (2.47 to 4.30)] and a low nadir CD4 [<200 cells/µL, aRR = 1.56 (1.37 to 1.79)] but not among PWH with normal CD4 [≥500 cells/µL, aRR = 1.14 (0.90 to 1.44)]. Higher incident HF risk was observed among PWH at all HIV RNA levels, with greater HF risk at higher HIV RNA levels. The excess HF risk associated with low CD4 (recent or nadir) and high HIV RNA was stronger among women than men (P interactions=0.05, 0.08, and 0.01, respectively). CONCLUSIONS: Given the association of HIV severity with HF, optimizing HIV treatment and management may be important for HF prevention among PWH.

Cohort profile: pathways to care among people with disorders of sex development (DSD).

PURPOSE: The 'DSD Pathways' study was initiated to assess health status and patterns of care among people enrolled in large integrated healthcare systems and diagnosed with conditions comprising the broad category of disorders (differences) of sex development (DSD). The objectives of this communication are to describe methods of cohort ascertainment for two specific DSD conditions-classic congenital adrenal hyperplasia with 46,XX karyotype (46,XX CAH) and complete androgen insensitivity syndrome (CAIS). PARTICIPANTS: Using electronic health records we developed an algorithm that combined diagnostic codes, clinical notes, laboratory data and pharmacy records to assign each cohort candidate a 'strength-of-evidence' score supporting the diagnosis of interest. A sample of cohort candidates underwent a review of the full medical record to determine the score cutoffs for final cohort validation. FINDINGS TO DATE: Among 5404 classic 46,XX CAH cohort candidates the strength-of-evidence scores ranged between 0 and 10. Based on sample validation, the eligibility cut-off for full review was set at the strength-of-evidence score of ≥7 among children under the age of 8 years and ≥8 among older cohort candidates. The final validation of all cohort candidates who met the cut-off criteria identified 115 persons with classic 46,XX CAH. The strength-of-evidence scores among 648 CAIS cohort candidates ranged from 2 to 10. There were no confirmed CAIS cases among cohort candidates with scores <6. The in-depth medical record review for candidates with scores ≥6 identified 61 confirmed cases of CAIS. FUTURE PLANS: As the first cohort of this type, the DSD Pathways study is well-positioned to fill existing knowledge gaps related to management and outcomes in this heterogeneous population. Analyses will examine diagnostic and referral patterns, adherence to care recommendations and physical and mental health morbidities examined through comparisons of DSD and reference populations and analyses of health status across DSD categories.

Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial.

BACKGROUND: Social vulnerability indicators are associated with health care inequities and may similarly impede ongoing participation in research studies. We evaluated the association of social vulnerability indicators and research participant attrition in a trial focused on reducing health disparities. METHODS: Self-identified White or Black adults enrolled in the HYVALUE trial (Hypertension and VALUEs), a randomized trial testing a values-affirmation intervention on medication adherence, from February 2017 to September 2019 were included. The self-reported measures of social vulnerability indicators included: (1) Black race; (2) female gender; (3) no health insurance; (4) unemployment; (5) a high school diploma or less; and (6) financial-resource strain. Full attrition was defined as not completing at least one 3- or 6-month follow-up study visit. Log-binomial regression models adjusted for age, gender, race, medical comorbidities, and the other social vulnerability indicators to estimate the relative risk of each social vulnerability indicator with study attrition. RESULTS: Among 825 participants, the mean age was 63.3 years (±11.7 years), 60% were women, 54% were Black, and 97% reported at least one social vulnerability. Overall, 21% participants had full attrition after study enrollment. After adjustment for all other social vulnerabilities, only financial-resource strain remained consistently associated with full attrition (relative risk, 1.71 [95% CI, 1.28-2.29]). In a secondary analysis of partial attrition (completed only one follow-up visit), financial-resource strain (relative risk, 1.40 [95% CI, 1.09-1.81]) and being uninsured (relative risk, 1.54 [95% CI, 1.01-2.34]) were associated with partial attrition. CONCLUSIONS: In a trial aimed at reducing disparities in medication adherence, participants who reported financial-resource strain had a higher risk of participant attrition independent of race or gender. Our findings suggest that efforts to retain diverse populations in clinical trials should extend beyond race and gender to consider other social vulnerability indicators. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03028597.

Early Referral, Living Donation, and Preemptive Kidney Transplant.

BACKGROUND: Preemptive kidney transplant (PKT) is recognized as the most beneficial and cost-effective form of renal replacement therapy among patients with end-stage renal disease. Despite optimal outcomes and improved quality of life associated with PKT, its use as a first renal replacement therapy remains low among patients with end-stage renal disease. The goal of this retrospective cohort study was to compare, among adult kidney transplant recipients, characteristics across PKT status. METHODS: We compared the characteristics of patients who did and did not have a PKT over 5 years, from 2010 to 2014, using the electronic health records of Kaiser Permanente Mid-Atlantic States. RESULTS: A total of 233 patients received a kidney-alone transplant, and, of these, 44 patients (19%) were PKT and 189 patients (81%) were non-PKT. Of the patients in the PKT group, 43% received a kidney from a deceased donor. PKT recipients were more often White, had polycystic kidney disease or glomerulonephritis, received a living donor organ, and were transplanted at certain transplant centers. Estimated glomerular filtration rate on listing for those who received a deceased donor transplant was higher in PKT than non-PKT patients listed pre-dialysis. CONCLUSIONS: PKT was associated with having a living kidney donor and with having a higher estimated glomerular filtration rate at listing for deceased donor recipients.

Human Immunodeficiency Virus Infection and Variation in Heart Failure Risk by Age, Sex, and Ethnicity: The HIV HEART Study.

OBJECTIVES: To evaluate the risk of heart failure (HF) linked to human immunodeficiency virus (HIV) infection, how risk varies by demographic characteristics, and whether it is explained by atherosclerotic disease or risk factor treatment. PATIENTS AND METHODS: We performed a retrospective cohort study of persons with HIV (PWHs) from January 1, 2000, through December 31, 2016, frequency-matched 1:10 to persons without HIV on year of entry, age, sex, race/ethnicity, and treating facility. We evaluated the risk of incident HF associated with HIV infection, overall and by left ventricular systolic function, and whether HF risk varied by demographic characteristics. RESULTS: Among 38,868 PWHs and 386,586 matched persons without HIV, mean ± SD age was 41.4±10.8 years, with 12.3% female, 21.1% Black, 20.5% Hispanic, and 3.9% Asian/Pacific Islander. During median follow-up of 3.8 years (interquartile range, 1.4-9.0 years), the rate (per 100 person-years) of incident HF was 0.23 in PWHs vs 0.15 in those without HIV (P<.001). The PWHs had a higher adjusted HF rate (adjusted hazard ratio [aHR], 1.73; 95% confidence interval [CI], 1.57 to 1.91), which was only modestly attenuated after accounting for interim acute coronary syndrome events. Results were similar by systolic function category. The adjusted risk of HF in PWHs was more prominent for those 40 years and younger (aHR, 2.45; 95% CI, 1.92 to 3.03), women (aHR, 2.48; 95% CI, 1.90 to 3.26), and Asian/Pacific Islanders (aHR, 2.46; 95% CI, 1.27 to 4.74). CONCLUSION: HIV infection increases the risk of HF, which varied by demographic characteristics and was not primarily mediated through atherosclerotic disease pathways or differential use of cardiopreventive medications.

Is There a Link Between Hormone Use and Diabetes Incidence in Transgender People? Data From the STRONG Cohort.

BACKGROUND: Risk of type 2 diabetes mellitus (T2DM) in transgender and gender diverse (TGD) persons, especially those receiving gender-affirming hormone therapy (GAHT) is an area of clinical and research importance. METHODS: We used data from an electronic health record-based cohort study of persons 18 years and older enrolled in 3 integrated health care systems. The cohort included 2869 transfeminine members matched to 28 300 cisgender women and 28 258 cisgender men on age, race/ethnicity, calendar year, and site, and 2133 transmasculine members similarly matched to 20 997 cisgender women and 20 964 cisgender men. Cohort ascertainment spanned 9 years from 2006 through 2014 and follow-up extended through 2016. Data on T2DM incidence and prevalence were analyzed using Cox proportional hazards and logistic regression models, respectively. All analyses controlled for body mass index. RESULTS: Both prevalent and incident T2DM was more common in the transfeminine cohort relative to cisgender female referents with odds ratio and hazard ratio (95% CI) estimates of 1.3 (1.1-1.5) and 1.4 (1.1-1.8), respectively. No significant differences in prevalence or incidence of T2DM were observed across the remaining comparison groups, both overall and in TGD persons with evidence of GAHT receipt. CONCLUSION: Although transfeminine people may be at higher risk for T2DM compared with cisgender females, the corresponding difference relative to cisgender males is not discernable. Moreover, there is little evidence that T2DM occurrence in either transfeminine or transmasculine persons is attributable to GAHT use.

Health Behavior Theory and Hypertension Management: Comparisons Among Black, White, and American Indian and Alaska Native Patients.

In the United States, hypertension is more common among individuals from racial and ethnic minority groups. Hypertension control rates are also lower for minority group members compared with White Americans. However, little research has employed well-established theoretical perspectives on health behavior, such as the Theory of Planned Behavior (TPB) and the Model of Goal-Directed Behavior (MGB), to better understand racial differences in rates of hypertension control. The present study examines the psychological processes involved in efforts to control blood pressure, through the lens of the TPB augmented by the MGB, in hypertensive patients of three racial groups: American Indian/Alaska Native, Black/African American, and White. Participants completed measures of past efforts to control blood pressure, attitudes, norms, perceived behavioral control, intentions, and anticipated emotions. Analyses employed confirmatory factor analysis and cross-groups path analysis. Measurement of the theoretical constructs and core putative mediators of blood pressure control intentions were largely similar across racial groups. With regard to the patterns of relationships among the constructs, differences among the groups were most apparent in pathways from past efforts to both cognitive and affective theoretical antecedents of intentions. These findings contribute to the sparse literature on factors involved in racial differences in hypertension control rates and may inform future interventions aimed at increasing hypertension control behaviors. Trial Registration ClinicalTrials.gov, NCT03028597, registered 23 January 2017, https://clinicaltrials.gov/ct2/show/NCT03028597; ClinicalTrials.gov, NCT04414982, registered 4 June 2020 (retrospectively registered), https://www.clinicaltrials.gov/ct2/show/NCT04414982.

Effect of Values Affirmation on Reducing Racial Differences in Adherence to Hypertension Medication: The HYVALUE Randomized Clinical Trial.

Importance: Stereotype threat, or the fear of confirming a negative stereotype about one's social group, may contribute to racial differences in adherence to medications by decreasing patient activation to manage chronic conditions. Objective: To examine whether a values affirmation writing exercise improves medication adherence and whether the effect differs by patient race. Design, Setting, and Participants: The Hypertension and Values trial, a patient-level, blinded randomized clinical trial, compared an intervention and a control writing exercise delivered immediately prior to a clinic appointment. Of 20 777 eligible, self-identified non-Hispanic Black and White patients with uncontrolled hypertension who were taking blood pressure (BP) medications, 3891 were approached and 960 enrolled. Block randomization by self-identified race ensured balanced randomization. Patients enrolled between February 1, 2017, and December 31, 2019, at 11 US safety-net and community primary care clinics, with outcomes assessed at 3 and 6 months. Analysis was performed on an intention-to-treat basis. Interventions: From a list of 11 values, intervention patients wrote about their most important values and control patients wrote about their least important values. Main Outcomes and Measures: The primary outcome of adherence to BP medications was measured using pharmacy fill data (proportion of days covered >90%) at baseline, 3 months, and 6 months. The secondary outcome was systolic and diastolic BP. Patient activation to manage their health was also measured. Results: Of 960 patients, 474 (286 women [60.3%]; 256 Black patients [54.0%]; mean [SD] age, 63.4 [11.9] years) were randomly assigned to the intervention group and 486 (288 women [59.3%]; 272 Black patients [56.0%]; mean [SD] age, 62.8 [12.0] years) to the control group. Baseline medication adherence was lower (318 of 482 [66.0%] vs 331 of 412 [80.3%]) and mean (SE) BP higher among Black patients compared with White patients (systolic BP, 140.6 [18.5] vs 137.3 [17.8] mm Hg; diastolic BP, 83.9 [12.6] vs 79.7 [11.3] mm Hg). Compared with baseline, pharmacy fill adherence did not differ between intervention and control groups at 3 months (odds ratio [OR], 0.91 [95% CI, 0.57-1.43]) or at 6 months (OR, 0.86 [95% CI, 0.53-1.38]). There were also no treatment effect differences in pharmacy fill adherence by patient race (Black patients at 3 months: OR, 1.08 [95% CI, 0.61-1.92]; at 6 months: OR, 1.04 [95% CI, 0.58-1.87]; White patients at 3 months: OR, 0.68 [95% CI, 0.33-1.44]; at 6 months: OR, 0.55 [95% CI, 0.24-1.27]). Immediately after the intervention, the median patient activation was higher in intervention patients than in control patients, but this difference was not statistically significant in an unadjusted comparison (75.0 [IQR, 65.5-84.8] vs 72.5 [IQR, 63.1-80.9]; P = .06). In adjusted models, the Patient Activation Measure score immediately after the intervention was significantly higher in the intervention patients than in control patients (mean difference, 2.3 [95% CI, 0.1-4.5]). Conclusions and Relevance: A values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among Black and White patients with hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03028597.

Implementation of a Plant-Based, Nutrition Program in a Large Integrated Health Care System: Results of a Pilot Program.

INTRODUCTION: Despite the proven efficacy of plant-based diets in the management of cardiometabolic diseases, most healthcare providers do not incorporate them into treatment plans. OBJECTIVE: Conduct a post-hoc evaluation of a novel plant-based nutrition program in a large integrated health care system, including the impact on health care outcomes. METHODS: A large integrated health care system launched an innovative 12-week plant-based nutrition program that included weekly nutrition education, peer mentoring, and support. Plasma cholesterol levels, hemoglobin A1C, blood pressure, body weight, and healthcare utilization parameters were measured before and after the program. The current study is a pre- and post-descriptive analysis of the health metrics of individuals who participated in the program and a matched comparison group. RESULTS: A total of 408 patients, across a wide range of weight categories, demographics, and co-morbidities, participated in a plant-based nutrition program, and program completers experienced mean reductions in total and LDL plasma cholesterol levels of 11.0 and 8.1 mg/dL, respectively, as well as reductions in medication usage, office visits, and body weight. CONCLUSION: Implementation of a novel plant-based, nutrition program in a large integrated health care system was associated with improvements in health outcomes.

Longitudinal Changes in Liver Enzyme Levels Among Transgender People Receiving Gender Affirming Hormone Therapy.

BACKGROUND: The effect of gender affirming hormone therapy (GAHT) on clinical laboratory parameters, including levels of liver enzymes alanine aminotransferase (ALT) and aspartate transaminase (AST), is an area of uncertainty in transgender health. AIM: We sought to estimate the distribution parameters of liver enzyme levels among transmasculine (TM) and transfeminine (TF) persons receiving GAHT relative to the corresponding measures in cisgender reference groups, and to evaluate longitudinal changes in these laboratory measures following GAHT initiation. METHODS: The data for this longitudinal study included 624 TF and 438 transmasculine (TM) people as well as 4,090 cisgender males and 4,797 cisgender females enrolled in 3 integrated health systems. Time under observation was divided into 2 intervals: from the first blood test to the date of the first filled GAHT prescription and from GAHT initiation to the most recent ALT or AST measurement. Linear mixed models were used to compare changes in log-transformed ALT and AST values among transgender cohort members before and after GAHT initiation, and relative to the reference groups. The results were expressed as relative differences (in %) and the ratios of these differences (ratios-of-ratios) along with the 95% confidence intervals (CIs). OUTCOMES: Changes in ALT and AST levels among transgender people over time and relative to the corresponding changes in cisgender referents. RESULTS: Among TM study participants, the post GAHT ratios-of-ratios for AST were 1.61 (95% CI: 1.13, 2.31) and 1.57 (95% CI: 1.06, 2.31) relative to cisgender males and females respectively. For ALT, the corresponding comparisons yielded the ratios-of-ratios (95% CIs) of 2.06 (1.67, 2.54) and 1.90 (1.50, 2.40). No statistically significant changes were observed among TF participants. Other factors associated with higher liver enzyme levels included alcohol use/abuse and obesity. CLINICAL IMPLICATIONS: TM persons may experience modest increases in ALT and AST concentrations following testosterone initiation; however, clinical significance of the observed association remains unclear and requires further investigation. By contrast, feminizing GAHT is unlikely to induce appreciable changes in liver enzyme levels. STRENGTH AND LIMITATIONS: The strengths of this study are the longitudinal design and the ability to assemble an unselected cohort nested within large health systems. The main limitations include the lack of information on hormone levels and the inability to take into account GAHT doses and routes of administration. CONCLUSION: The influence of long-term GAHT on ALT and AST levels appears modest and not likely to reflect clinically meaningful changes in liver function. Hashemi L, Zhang Q, Getahun D, et al. Longitudinal Changes in Liver Enzyme Levels Among Transgender People Receiving Gender Affirming Hormone Therapy. J Sex Med 2021;18:1662-1675.

A Mixed Methods Study Describing the Quality of Healthcare Received by Transgender and Gender Nonconforming Patients at a Large Integrated Health System.

Transgender and gender nonconforming (TGNC) patients have been seeking medical care in higher numbers and have faced unique social, personal, and health issues that affect the quality of care they receive. The purpose of this study was to conduct a mixed-methods study to describe TGNC care at Kaiser Permanente Mid-Atlantic States, a large integrated health system. We used a transgender registry to describe a TGNC patient population and compared healthcare utilization between TGNC patients and non-TGNC patients. Four focus groups were also conducted among 28 patients. Atlas.ti software was used to code and analyze themes for the qualitative analysis. Among the 282 adults TGNC patients, the mean age was 32.6 years. Of the study sample, 59% were White, and 27% were Black. TGNC patients demonstrated an increased use of email/telephone visits and the online patient portal and more cancellations and no-shows compared to non-TGNC controls. Of the 28 TGNC patients who participated in the focus groups, 39% identified as female, 21% as a transman, and 18% as non-binary/genderqueer. Participants were predominantly White (68%), highly educated (74%), and reported use of hormones (89%). Themes that emerged from our qualitative analysis included: limited availability of TGNC information; positive and negative sentiments regarding patient-provider interactions; issues with case management; limited access to care; lack of coordination of care; negative staff experiences. We identified specific areas in a health system to improve the quality of care of TGNC patients, including specific TGNC training for providers and staff, a source of TGNC information/resources, and hiring and training TGNC-specific case managers.

Progression of Gender Dysphoria in Children and Adolescents: A Longitudinal Study.

BACKGROUND AND OBJECTIVES: The progression of gender-expansive behavior to gender dysphoria and to gender-affirming hormonal treatment (GAHT) in children and adolescents is poorly understood. METHODS: A cohort of 958 gender-diverse (GD) children and adolescents who did not have a gender dysphoria-related diagnosis (GDRD) or GAHT at index were identified. Rates of first GDRD and first GAHT prescription were compared across demographic groups. RESULTS: Overall, 29% of participants received a GDRD and 25% were prescribed GAHT during the average follow-up of 3.5 years (maximum 9 years). Compared with youth assigned male sex at birth, those assigned female sex at birth were more likely to receive a diagnosis and initiate GAHT with hazard ratio (95% confidence interval) estimates of 1.3 (1.0-1.7), and 2.5 (1.8-3.3), respectively. A progression to diagnosis was more common among those aged ≥15 years at initial presentation compared with those aged 10 to 14 years and those aged 3 to 9 years (37% vs 28% vs 16%, respectively). By using the youngest group as a reference, the adjusted hazard ratios (95% confidence interval) for a GDRD were 2.0 (1.3-3.0) for age 10 to 14 years and 2.7 (1.8-3.9) for age ≥15 years. Racial and ethnic minorities were less likely to receive a diagnosis or be prescribed GAHT. CONCLUSIONS: This study characterized the progression of GD behavior in children and adolescents. Less than one-third of GD youth receive an eventual GDRD, and approximately one-quarter receive GAHT. Female sex at birth, older age of initial GD presentation to medical care, and non-Hispanic white race and ethnicity increased the likelihood of receiving diagnosis and treatment.

Changes in Size and Demographic Composition of Transgender and Gender Non-Binary Population Receiving Care at Integrated Health Systems.

OBJECTIVE: To examine temporal changes in the number and demographic composition of transgender/gender non-binary (TGNB) population using data from integrated health care systems. METHODS: Electronic health records from Kaiser Permanente health plans in Georgia and Northern and Southern California were used to identify TGNB individuals, who sought care from January 2006 to December 2014, and the data were analyzed by year, site, age, and sex assigned at birth. RESULTS: In 2006, the number of TGNB people (and corresponding 95% CI) per 100 000 population were 3.5 (1.9, 6.3) in Georgia, 5.5 (4.8, 6.4) in Southern California, and 17 (16, 19) in Northern California. In 2014, these frequencies increased to 38 (32, 45), 44 (42, 46), and 75 (72, 78) per 100 000 population, respectively. When analyzed by age, the most rapid increase was observed among persons 18 to 25 years old, and this increase accelerated after 2010. The ratio of transmasculine to transfeminine persons also changed from 1:1.7 in 2006 to 1:1 in 2014 overall and from 1:1 in 2006 to 1.8:1 in 2014 among persons <18 years of age. CONCLUSION: This analysis confirms previous observations that the proportion of TGNB people is growing, especially among young adults. The composition of the TGNB population is also changing from predominantly transfeminine to roughly 1:1 overall and to predominantly transmasculine in children and adolescents.

Human immunodeficiency virus infection and risks of morbidity and death in adults with incident heart failure.

Aims: Human immunodeficiency virus (HIV) increases the risk of heart failure (HF), but whether it influences subsequent morbidity and mortality remains unclear. Methods and results: We investigated the risks of hospitalization for HF, HF-related emergency department (ED) visits, and all-cause death in an observational cohort of incident HF patients with and without HIV using data from three large US integrated healthcare delivery systems. We estimated incidence rates and adjusted hazard ratios (aHRs) by HIV status at the time of HF diagnosis for subsequent outcomes. We identified 448 persons living with HIV (PLWH) and 3429 without HIV who developed HF from a frequency-matched source cohort of 38 868 PLWH and 386 586 without HIV. Mean age was 59.5 ± 11.3 years with 9.8% women and 31.8% Black, 13.1% Hispanic, and 2.2% Asian/Pacific Islander. Compared with persons without HIV, PLWH had similar adjusted rates of HF hospitalization [aHR 1.01, 95% confidence interval (CI): 0.81-1.26] and of HF-related ED visits [aHR 1.22 (95% CI: 0.99-1.50)], but higher adjusted rates of all-cause death [aHR 1.31 (95% CI: 1.08-1.58)]. Adjusted rates of HF-related morbidity and all-cause death were directionally consistent across a wide range of CD4 counts but most pronounced in the subset with a baseline CD4 count <200 or 200-499 cells/µL. Conclusion: In a large, diverse cohort of adults with incident HF receiving care within integrated healthcare delivery systems, PLWH were at an independently higher risk of all-cause death but not HF hospitalizations or HF-related ED visits. Future studies investigating modifiable HIV-specific risk factors may facilitate more personalized care to optimize outcomes for PLWH and HF.

Efficacy and Safety of Direct Oral Anticoagulants for Atrial Fibrillation Across Body Mass Index Categories.

Background Direct-acting oral anticoagulants are now the preferred method of anticoagulation in patients with atrial fibrillation. Limited data on efficacy and safety of these fixed-dose regimens are available in severe obesity where drug pharmacokinetics and pharmacodynamics may be altered. The objectives of this study were to evaluate efficacy and safety in patients with atrial fibrillation taking direct-acting oral anticoagulants across body mass index (BMI) categories in a contemporary, real-world population. Methods and Results We performed a retrospective study of patients with atrial fibrillation at an integrated multisite healthcare system. Patients receiving a direct-acting oral anticoagulant prescription and ≥12 months of follow-up between 2010 and 2017 were included. The primary efficacy and safety outcomes were ischemic stroke or systemic embolism and intracranial hemorrhage. We performed Cox proportional hazards modeling to compute hazard ratios (HRs) adjusted for CHA2DS2-VASc score to examine differences by excess BMI categories relative to normal BMI. Of 7642 patients, mean±SD age was 69±12 years with a median (interquartile range) follow-up of 3.8 (2.2-6.0) years. Approximately 22% had class 1 obesity and 19% had class 2 or 3 obesity. Stroke risks were similar in patients with and without obesity (HR, 1.2; 95% CI, 0.5-2.9; and HR, 0.68; 95% CI, 0.23-2.0 for class 1 and class 2 or 3 obesity compared with normal BMI, respectively). Risk of intracranial hemorrhage was also similar in class 1 and class 2 or 3 obesity compared with normal BMI (HR, 0.64; 95% CI, 0.35-1.2; and HR, 0.66; 95% CI, 0.35-1.2, respectively). Conclusions Direct-acting oral anticoagulants demonstrated similar efficacy and safety across all BMI categories, even at high weight values.