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Zil Goldstein,1 Musaub Khan,2 Tamar Reisman,1 Joshua D Safer11Center for Transgender Medicine and Surgery at Mount Sinai, Mount Sinai Health System and Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; 2New York Medical College, Valhalla, NY USAIntroduction: Venous thromboembolism (VTE) is a potential risk of estrogen therapy. However, data show an improvement in the quality of life for transgender people who use feminizing hormone therapy. With few transgender-specific data, guidance may be drawn from cisgender (nontransgender) data, with a focus on hormonal birth control and postmenopausal hormone replacement therapy (HRT). The aim of this review is to examine the degree to which routes of administration, patient comorbidities, and type of hormone utilized affect the safety of estrogen therapy.Methods: We identified 6,349 studies by searching PubMed with the terms “transgender”, “estrogen”, “VTE”, and “HRT”. Of these, there were only 13 studies between 1989 and 2018 that investigated the effects of hormone therapy, including types of estrogens used, in transgender women and men.Results: The data suggest that the route of hormone administration, patient demographics, and patient comorbidities all affect estrogen’s link with VTE. For example, avoiding ethinyl estradiol might make the use of hormone therapy in trans feminine individuals safer than oral birth control. Data from both cis and trans groups suggest additional VTE risk associated with the use of progestins. While transdermal estrogens dosed up to 0.1 mg/day or below appear lower risk for VTE than other forms of estrogen, it is unclear whether this is related to the delivery method or a dose effect. Finally, even if the risk from exogenous estrogen use remains significant statistically, the absolute clinical risk remains low.Conclusion: Clinicians should avoid the use of ethinyl estradiol. Additionally, data suggest that progestins should be avoided for transgender individuals. Further study of the relationship between estrogen use and the risk of VTE will serve to inform the safest care strategies for transgender individuals.Keywords: transgender, estrogen therapy, venous thromboembolism

Presents a procedure for determining the optimal number of observations to use in multivariate-multifacet generalizability designs when costs constraints are imposed. Showing how the procedure easily applies to the univariate case; Illustrative example; Method; Results; Discussion.

Presents a method for determining the optimal number of conditions to use in measurement designs when resource constraints are imposed. The method is illustrated using a multivariate two-facet design, and extensions to other designs are discussed.

Presents an efficient search procedure for determining the optimal number of observations of facets in a design that maximizes generalizability when resource constraints are imposed. Illustrates the procedure for a three- and four-facet, fully crossed design, and extensions are presented for other design configurations.

Sexually transmitted infections (STIs) are steadily increasing in incidence. Marginalized communities across social categories (race, ethnicity, gender, and sexuality) face the heaviest burden, including Black, indigenous, Latino, queer (gay, bisexual), transgender, and nonbinary populations. These disparities persist even when controlled for high-risk sexual behaviors. The laboratory maintains a responsibility to develop and offer appropriate testing for all communities. This review aims to integrate the clinical laboratory's role in building sexual health testing options across genders and sexual behaviors with a focus on molecular, swab-based testing., Competing Interests: Disclosure D.N. Greene received salary from LetsGetChecked and payment for scientific advisory from Abbott Diagnostics., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: The goal of this preliminary study is to describe the vaginal microbiome of transgender and gender nonbinary (TGNB) individuals using nonculture-based techniques. TGNB individuals may undergo gender-affirming surgical procedures, which can include the creation of a neovagina. Little is known about microbial species that comprise this environment in states of health or disease., Methods: In this pilot study, vaginal swabs were self-collected from 15 healthy self-identified TGNB participants (age 26-69 years) and 8 cisgender comparator participants (age 27-50 years) between 2017 and 2018. Next-generation 16S ribosomal RNA sequencing was used to profile individual bacterial communities from all study samples., Results: The TGNB cohort demonstrated significantly higher intraindividual (alpha) diversity than the cisgender group ( p =0.0003). Microbial species commensal to the gut and skin were identified only in specimens from TGNB participants. Although Lactobacillus species were dominant in all cisgender comparator samples, they were found at low relative abundance (≤3%) in TGNB samples., Conclusion: In this study, specimens collected from neovaginas showed increased alpha diversity and substantially different composition compared with natal vaginas. In contrast to natal vaginas, neovaginas were not dominated by Lactobacillus , but were hosts to many microbial species. Studies that help to improve our understanding of the neovaginal microbiome may enable clinicians to differentiate between healthy and diseased neovaginal states., (Copyright 2023, Mary Ann Liebert, Inc., publishers.)

In the United States, it is estimated that 0.3% of Americans aged 65 and older, or almost 172,000 individuals, identify as transgender. Aging comes with a unique set of challenges and experiences for this population, including health care disparities, mental health concerns, and social isolation. It is crucial for clinicians to use a patient-centered and trauma-informed care approach to address their specific needs and provide evidence-based quality health care, including preventive screenings, mental health support, and advocating for legal protections., Competing Interests: Disclosure The authors have no financial disclosures to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: The aims of this study were to ascertain the effectiveness and safety of the off-label use of topical timolol as an adjunct treatment for hard-to-heal (chronic) wounds. Furthermore, to review and analyse the existing literature regarding the use of topical timolol on wounds of varying aetiologies., Method: A systematic review of literature in the English language published between May 1961-May 2021 on the application of topical timolol for hard-to-heal wounds in adults was performed. Each research study was evaluated by two reviewers independently. Studies eligible for inclusion in the review were randomised controlled trials (RCTs), clinical trials, observational studies of at least 4 weeks' duration, case series and case studies. Search strategies were performed according to PRISMA guidelines and included MeSH terms and keyword searches., Results: An initial 878 articles were identified from a search of PubMed, Ovid Medline, Embase, Cochrane, and SCOPUS. Of these, 699 were reviewed for eligibility, 19 were read in full-text, and 12 were selected for inclusion in the review. In total, two RCTs and 10 observational studies, including five case studies, were analysed. All studies demonstrated efficacy and safety of topical timolol; however, statistical analysis remained limited by lack of blinding and small sample sizes., Conclusion: This review concludes with all currently available evidence that topical timolol may be considered as an effective and safe adjunct treatment for refractory wounds, primarily venous leg ulcers and diabetic foot ulcers. Given the overall safety, low cost and ease of application of topical timolol, this review provides evidence in favour of off-label use and should prompt further, more rigorous studies.

Background: Extracorporeal membrane oxygenation (ECMO) provides lifesaving support to critically ill patients who experience refractory cardiopulmonary failure but carries a high risk for acute brain injury. We aimed to identify characteristics reflecting acute brain injury in children requiring ECMO support., Methods: This is a prospective observational study from 2019 to 2022 of pediatric ECMO patients undergoing neuromonitoring, including continuous electroencephalography, cerebral oximetry, and transcranial Doppler ultrasound (TCD). The primary outcome was acute brain injury. Clinical and neuromonitoring characteristics were collected. Multivariate logistic regression was implemented to model odds ratios (ORs) and identify the combined characteristics that best discriminate risk of acute brain injury using the area under the receiver operating characteristic curve., Results: Seventy-five pediatric patients requiring ECMO support were enrolled in this study, and 62 underwent neuroimaging or autopsy evaluations. Of these 62 patients, 19 experienced acute brain injury (30.6%), including seven (36.8%) with arterial ischemic stroke, four (21.1%) with hemorrhagic stroke, seven with hypoxic-ischemic brain injury (36.8%), and one (5.3%) with both arterial ischemic stroke and hypoxic-ischemic brain injury. A univariate analysis demonstrated acute brain injury to be associated with maximum hourly seizure burden (p = 0.021), electroencephalographic suppression percentage (p = 0.022), increased interhemispheric differences in electroencephalographic total power (p = 0.023) and amplitude (p = 0.017), and increased differences in TCD Thrombolysis in Brain Ischemia (TIBI) scores between bilateral middle cerebral arteries (p = 0.023). Best subset model selection identified increased seizure burden (OR = 2.07, partial R 2  = 0.48, p = 0.013), increased quantitative electroencephalographic interhemispheric amplitude differences (OR = 2.41, partial R 2  = 0.48, p = 0.013), and increased interhemispheric TCD TIBI score differences (OR = 4.66, partial R 2  = 0.49, p = 0.006) to be independently associated with acute brain injury (area under the receiver operating characteristic curve = 0.92)., Conclusions: Increased seizure burden and increased interhemispheric differences in both quantitative electroencephalographic amplitude and TCD MCA TIBI scores are independently associated with acute brain injury in children undergoing ECMO support., (© 2023. The Author(s).)

Purpose: Although HIV surveillance contains information on HIV outcomes among transgender persons with HIV (TPWH), it does not include other important data, for example, gender-affirming health care, which may influence viral suppression (VS). We describe TPWH accessing Medicaid and the association of gender-affirming surgery with VS., Methods: Through matching Medicaid claims with HIV registry data, a cohort of previously identified TPWH in Medicaid was compared to cisgender women and men in terms of VS in 2013-2017 in New York City. Medicaid claims were used to identify TPWH who obtained gender-affirming surgery (e.g., chest, genital surgeries). We described the VS of those who had surgery and examined temporal trends in VS pre- and postsurgery and by surgery type., Results: 1730 TPWH were enrolled in Medicaid and in HIV care in 2013-2017. Overall for VS at last laboratory, TPWH in Medicaid had lower VS (76.0%) than cisgender women (80.4%) and men (83.3%). The exception was the 185 TPWH who obtained gender-affirming surgery (86.5%). Among 160 TPWH in Medicaid who obtained gender-affirming surgery and achieved VS, VS increased presurgery (66.3% 2 years prior, 76.9% 1 year prior) and remained high 1 year after (86.3%) and 2 years after (87.7%) (the last percentage is only among those who had surgery before 2017, N =81)., Conclusion: Gender-affirming surgery may be an important motivator to becoming virally suppressed and was associated with sustained high VS, which can lead to improved survival and quality of life. Medicaid and other insurers should consider improving access to gender-affirming surgery among TPWH., Competing Interests: No competing financial interests exist., (Copyright 2023, Mary Ann Liebert, Inc., publishers.)

Objective: Accumulating evidence demonstrates that gender affirming hormone therapy (GAHT) improves mental health outcomes in transgender persons. Data specific to the risks associated with GAHT for transgender persons continue to emerge, allowing for improvements in understanding, predicting, and mitigating adverse outcomes while informing discussion about desired effects. Of particular concern is the risk of venous thromboembolism (VTE) in the context of both longitudinal GAHT and the perioperative setting. Combining what is known about the risk of VTE in cisgender individuals on hormone therapy (HT) with the evidence for transgender persons receiving HT allows for an informed approach to assess underlying risk and improve care in the transgender community., Observations: Hormone formulation, dosing, route, and duration of therapy can impact thromboembolic risk, with transdermal estrogen formulations having the lowest risk. There are no existing risk scores for VTE that consider HT as a possible risk factor. Risk assessment for recurrent VTE and bleeding tendencies using current scores may be helpful when assessing individual risk. Gender affirming surgeries present unique perioperative concerns, and certain procedures include a high likelihood that patients will be on exogenous estrogens at the time of surgery, potentially increasing thromboembolic risk., Conclusions and Relevance: Withholding GAHT due to potential adverse events may cause negative impacts for individual patients. Providers should be knowledgeable about the management of HT in transgender individuals of all ages, as well as in the perioperative setting, to avoid periods in which transgender individuals are off GAHT. Treatment decisions for both anticoagulation and HT should be individualized and tailored to patients' overall goals and desired outcomes, given that the physical and mental health benefits of gender affirming care may outweigh the risk of VTE., (Copyright © 2022 AACE. Published by Elsevier Inc. All rights reserved.)

Purpose: Undercounting of transgender people with HIV (PWH) in New York City (NYC) remains prevalent. We sought to improve our ability to accurately enumerate transgender PWH and address their needs for gender-affirming health care., Methods: We enhance previous algorithms used to identify transgender beneficiaries, using diagnoses, prescriptions, and sex at birth from Medicaid claims in 2013-2017. We then matched beneficiaries to individuals diagnosed with HIV in the HIV surveillance registry to identify transgender PWH., Results: Our algorithm identified 6043 transgender persons who accessed Medicaid in 2013-2017, with 1472 (24%) reported to the HIV registry, 1168 (79%) of whom were accurately identified as transgender in the registry. We found 292 transgender persons in the registry that had accessed Medicaid but were not identified by our algorithm, for a total of 6335 transgender persons accessing Medicaid (0.1% of the NYC Medicaid population), including 1764 transgender PWH (28% of transgender persons accessing Medicaid). From 2013 to 2017, there was a 35% increase in transgender persons identified in Medicaid claims using our algorithm., Conclusion: We identified a large number of transgender persons in Medicaid, many of whom were PWH. We saw a sizeable increase over the 5-year period, likely due, in part, to expansion of Medicaid policy to cover gender-affirming health care. Given the high proportion of transgender PWH accessing Medicaid, Medicaid claims data are a valuable source of health information for the transgender population, a group that is often difficult to identify due to issues of underreporting, stigma, reduced access to appropriate care, and misgendering by health care personnel., Competing Interests: No competing financial interests exist., (Copyright 2022, Mary Ann Liebert, Inc., publishers.)

Pediatric neurocritical care (PNCC) is a rapidly growing field. Challenges posed by the COVID-19 pandemic on trainee exposure to educational opportunities involving direct patient care led to the creative solutions for virtual education supported by guiding organizations such as the Pediatric Neurocritical Care Research Group (PNCRG). Our objective is to describe the creation of an international, peer-reviewed, online PNCC educational series targeting medical trainees and faculty. More than 1600 members of departments such as pediatrics, pediatric critical care, and child neurology hailing from 75 countries across six continents have participated in this series over a 10-month period. We created an online educational channel in PNCC with over 2500 views to date and over 130 followers. This framework could serve as a roadmap for other institutions and specialties seeking to address the ongoing problems of textbook obsolescence relating to the rapid acceleration in knowledge acquisition, as well as those seeking to create new educational content that offers opportunities for an interactive, global audience. Through the creation of a virtual community of practice, we have created an international forum for pediatric healthcare providers to share and learn specialized expertise and best practices to advance global pediatric health.

Objectives: Recently, an estradiol immunoassay manufacturer (Beckman Coulter, USA) issued an 'important product notice' alerting clinical laboratories that their assay (Access Sensitive Estradiol) was not indicated for patients undergoing exogenous estradiol treatment. The objective of this analysis was to evaluate immunoassay bias relative to liquid chromatography tandem mass spectrometry (LC-MS/MS) in transgender women and to examine the influence of unconjugated estrone on measurements., Design: Cross-sectional secondary analysis., Methods: Estradiol concentrations from 89 transgender women were determined by 3 immunoassays (Access Sensitive Estradiol ('New BC') and Access Estradiol assays ('Old BC'), Beckman Coulter; Estradiol III assay ('Roche'), Roche Diagnostics) and LC-MS/MS. Bias was evaluated with and without adjustment for estrone concentrations. The number of participants who shifted between three estradiol concentration ranges for each immunoassay vs LC-MS/MS (>300 pg/mL, 70-300 pg/mL, and <70 pg/mL) was calculated., Results: The New BC assay had the largest magnitude overall bias (median: -34%) and was -40%, -22%, and -10%, among participants receiving tablet, patch, or injection preparations, respectively. Overall bias was -12% and +17% for the Roche and Old BC assays, respectively. When measured with the New BC assay, 18 participants shifted to a lower estradiol concentration range (vs 9 and 10 participants based on Roche or Old BC assays, respectively). Adjustment for estrone did not minimize bias., Conclusions: Immunoassay measurement of estradiol in transgender women may lead to falsely decreased concentrations that have the potential to affect management. A multidisciplinary health care approach is needed to ensure if appropriate analytical methods are available.

Background: Transgender people are at a high risk of suicidal ideation, suicide attempts, and deaths. Among transgender individuals, 77% and 41% engage in suicidal ideation and suicide attempt in their lifetime, respectively, which exceeds the general population rates (9.2% and 2.7%, respectively). Traditionally, suicide risk factors have been studied over a long period between measurements, making it difficult to understand the short-term variability in suicide risk. Mobile phone apps offer an opportunity to understand the immediate precursors of suicidality through the assessment of behaviors and moods in real time. This is the first study to use a mobile phone app (TransLife) to understand the short-term risk factors for suicide among transgender individuals., Objective: This study aims to beta test the usability of an evidence-informed mobile health (mHealth) suicide prevention phone app, TransLife. The primary aims are to obtain preliminary data on user engagement and satisfaction with the app, and to assess the feasibility of completing ecological momentary assessments (mood logs) within the app., Methods: We used qualitative methods and an exploratory research approach that combined naturalistic app use, focus groups, and semistructured phone interviews. The focus group was informed about the development of the prototype. We conducted a 3-week evaluation to determine engagement and obtain detailed user feedback about the app. After participation in the pilot, phone-based, semistructured, and audio-recorded exit interviews were conducted with the research participants., Results: In total, 16 transgender individuals participated in this study. On average, users logged in 4 (SD 2.7) times a week and spent approximately 5 (SD 3.5) minutes on the app per log-in. A total of 6 major themes emerged in this study. These themes focused on the app's functionality, satisfaction with using the app, perceived ease of use, perceived safety of providing personal data within the app, trusting the app enough to share personal feelings, and features that make this app engaging. These themes suggest that TransLife is an engaging, useful, and acceptable mHealth intervention. Participants reported that the app was easy to use and understand, supported mental self-care, promoted self-awareness, and helped them identify triggers of negative moods., Conclusions: The results of this pilot study indicate that TransLife is an engaging, acceptable, and potentially effective mHealth intervention. Transgender participants reported many advantages of using TransLife, such as being able to track their mood, connecting to the community, and accessing local resources. This study provides initial support for the acceptability and usability of TransLife as an mHealth intervention designed for the transgender community., (©Alex Dubov, Liana Fraenkel, Zil Goldstein, Hansel Arroyo, Derek McKellar, Steve Shoptaw. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.03.2021.)

Purpose: Tendon reconstruction is frequently required under conditions of tendon deficiency. The authors sought a technique that could obviate the need for tendon harvest yet meet the minimum load of 45 N required for an early active motion protocol. This study was designed to determine the ideal suture construct utilizing the tendon with Z-lengthening (TWZL) technique., Methods: Sixty fresh-frozen cadaveric flexor digitorum profundus tendons of the index, middle, and ring fingers were randomized into 5 different TWZL construct designs using 3-0 braided polyethylene suture. Constructs were tested on an electromechanical actuator until failure was observed on the load-elongation recording. Data points on maximum yield and load at 8% strain were recorded for each construct., Results: The maximum yield data revealed the construct with a 4-core suture type configuration (construct #4) had the highest overall mean load to failure at 150 N compared with all other constructs. The construct with the highest mean load at 8% strain was that with a 4-core type repair (construct #4) at 59 N. The constructs with Krackow locking sutures (constructs #2, #3, and #4 were found to withstand a significantly higher mean load at 8% strain than those without Krackow sutures (#0 and #1). Comparison among constructs with Krackow locking sutures #2 (56 N), #3 (48 N), and #4 (59 N) did not show a significant difference in mean load at 8% strain. Construct #3, however, had an SD and 95% confidence interval that fell below the 45 N early active motion threshold, whereas both #2 and #4 had 95% confidence intervals that fell no lower than 50 N., Conclusions: This study provides evidence that the TWZL technique utilizing either construct #2 or #4 could provide sufficient strength and reproducibility for tendon reconstruction., Clinical Relevance: The study describes the application of the TWZL technique for utilization in tendon reconstruction and quantifies differences in the yield strengths of the 5 proposed constructs., (Copyright © 2020 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Introduction: Nearly all cervical cancer cases are caused by one of several high-risk strains of the human papillomavirus (hr-HPV). Transmasculine (TM) individuals (persons who have a masculine spectrum gender identity, but were recorded female at birth) have low adherence to standard cervical cancer screening modalities. Introduction of self-collected vaginal swabs for hr-HPV DNA testing may promote initiation and adherence to cervical cancer screening among TM individuals to narrow screening disparities. The purpose of this study was to assess the rate of cervical cancer screening among TM individuals following the introduction of self-collected swabbing for hr-HPV DNA testing in comparison to clinician-administered cervical specimen collection. Methods: Rates of uptake and adherence to cervical cancer screening among TM individuals were assessed before and after the clinical introduction of self-collected swab testing in October 2017. Rates were compared with the rates of cervical cancer screening among cisgender women at a colocated Comprehensive Health Program during the time period of review. Results: Of the 121 TM patients seen for primary care in the 6-month baseline period before the October 2017 introduction of self-collected swabbing for hr-HPV DNA testing, 30 (25%) had cervical cancer screening documented in the electronic medical record. Following the implementation of self-swabbing, of 193 patients, 98 (51%) had a documented cervical cancer screening, a two-fold increase in the rates of adherence to cervical cancer screening ( p <0.001). Conclusion: Self-collected swab testing for hr-HPV can increase rates of adherence to screening recommendations among an otherwise under-screened population., Competing Interests: Dr. Safer served on an advisory panel for Endo Pharmaceuticals in 2018. Other authors have no conflicts of interest to disclose., (© Zil Goldstein et al. 2020; Published by Mary Ann Liebert, Inc.)

Background: The prevalence of paternal perinatal depression (PPD) is approximately 10%. Despite this epidemiology and what is known about the importance of paternal mental health to family functioning, there is limited research on evidence-based interventions for PPD. This systematic review aimed to investigate the literature for randomized-controlled trials (RCT) of interventions for PPD., Methods: This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Databases searched included Medline, EMBASE, EBM Reviews, PubMed, PsycInfo, and CINAHL. Search terms included depression, depressive disorder, fathers, pregnancy, and peripartum period, etc. RESULTS: The search strategy identified 2949 items. A total of 10 interventions over the course of 25 years of research met inclusion criteria. Three of the included studies found a small but significant effect on paternal depression scores. However, none of the included studies exclusively targeted paternal mental health. Instead, they addressed paternal well-being indirectly by focusing on the mother, infant, or couple relationship., Limitations: Studies did not require fathers to meet criteria for depression at baseline. This may have resulted in a selection bias, whereby the included fathers may not have required any treatment. We were also unable to perform additional statistical analyses because of the limited research available as well as the inconsistent outcome measures., Conclusions: There remains limited research on interventions assessing paternal depressive symptomatology, and none have targeted diagnosed PPD. Because of the prevalence and impact of this disorder, it is imperative to identify and offer treatments and interventions specifically tailored towards this population., Competing Interests: Declaration of Competing Interest The authors declare no potential conflict of interest., (Copyright © 2019. Published by Elsevier B.V.)

Objective: The objective of this article is to describe the hormonal pathways required for breast development in cisgender women and to review the current available literature describing breast growth and breast cancer risk in transgender women. Methods: Literature review and discussion. Results: Early mammary tissue development occurs prenatally. This process is hormone-independent and occurs similarly in males and females. Breast tissue is quiescent until puberty, at which time surging estrogen levels in cisgender girls mediate breast development and growth. Adult breast tissue composition further evolves in cisgender women during pregnancy, lactation, and menopause, revealing the ever-changing interplay between breast structure and hormonal environment. Conclusion: Breast growth is a significant physical endpoint in the hormonal treatment of transgender women. Transgender hormone regimens, which typically pair an estrogen with an anti-androgen, can help achieve this goal.