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Original research article, male-to-female gender-affirming surgery: 20-year review of technique and surgical results.

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  • 1 Serviço de Urologia, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
  • 2 Serviço de Psiquiatria, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
  • 3 Serviço de Psiquiatria, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, Brazil

Purpose: Gender dysphoria (GD) is an incompatibility between biological sex and personal gender identity; individuals harbor an unalterable conviction that they were born in the wrong body, which causes personal suffering. In this context, surgery is imperative to achieve a successful gender transition and plays a key role in alleviating the associated psychological discomfort. In the current study, a retrospective cohort, we report the 20-years outcomes of the gender-affirming surgery performed at a single Brazilian university center, examining demographic data, intra and postoperative complications. During this period, 214 patients underwent penile inversion vaginoplasty.

Results: Results demonstrate that the average age at the time of surgery was 32.2 years (range, 18–61 years); the average of operative time was 3.3 h (range 2–5 h); the average duration of hormone therapy before surgery was 12 years (range 1–39). The most commons minor postoperative complications were granulation tissue (20.5 percent) and introital stricture of the neovagina (15.4 percent) and the major complications included urethral meatus stenosis (20.5 percent) and hematoma/excessive bleeding (8.9 percent). A total of 36 patients (16.8 percent) underwent some form of reoperation. One hundred eighty-one (85 percent) patients in our series were able to have regular sexual intercourse, and no individual regretted having undergone GAS.

Conclusions: Findings confirm that it is a safety procedure, with a low incidence of serious complications. Otherwise, in our series, there were a high level of functionality of the neovagina, as well as subjective personal satisfaction.

Introduction

Transsexualism (ICD-10) or Gender Dysphoria (GD) (DSM-5) is characterized by intense and persistent cross-gender identification which influences several aspects of behavior ( 1 ). The terms describe a situation where an individual's gender identity differs from external sexual anatomy at birth ( 1 ). Gender identity-affirming care, for those who desire, can include hormone therapy and affirming surgeries, as well as other procedures such as hair removal or speech therapy ( 1 ).

Since 1998, the Gender Identity Program (PROTIG) of the Hospital de Clínicas de Porto Alegre (HCPA), Universidade Federal do Rio Grande do Sul, Brazil has provided public assistance to transsexual people, is the first one in Brazil and one of the pioneers in South America. Our program offers psychosocial support, health care, and guidance to families, and refers individuals for gender-affirming surgery (GAS) when indicated. To be eligible for this surgery, transsexual individuals must have been adherent to multidisciplinary follow-up for at least 2 years, have a minimum age of 21 years (required for surgical procedures of this nature), have a positive psychiatric or psychological report, and have a diagnosis of GD.

Gender-affirming surgery (GAS) is increasingly recognized as a therapeutic intervention and a medical necessity, with growing societal acceptance ( 2 ). At our institution, we perform the classic penile inversion vaginoplasty (PIV), with an inverted penis skin flap used as the lining for the neovagina. Studies have demonstrated that GAS for the management of GD can promote improvements in mental health and social relationships for these patients ( 2 – 5 ). It is therefore imperative to understand and establish best practice techniques for this patient population ( 2 ). Although there are several studies reporting the safety and efficacy of gender-affirming surgery by penile inversion vaginoplasty, we present the largest South-American cohort to date, examining demographic data, intra and postoperative complications.

Patients and Methods

Subjects and study setup.

This is a retrospective cohort study of Brazilian transgender women who underwent penile inversion vaginoplasty between January of 2000 and March of 2020 at the Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. The study was approved by our institutional medical and research ethics committee.

At our institution, gender-affirming surgery is indicated for transgender women who are under assistance by our program for transsexual individuals. All transsexual women included in this study had at least 2 years of experience as a woman and met WPATH standards for GAS ( 1 ). Patients were submitted to biweekly group meetings and monthly individual therapy.

Between January of 2000 and March of 2020, a total of 214 patients underwent penile inversion vaginoplasty. The surgical procedures were performed by two separate staff members, mostly assisted by residents. A retrospective chart review was conducted recording patient demographics, intraoperative and postoperative complications, reoperations, and secondary surgical procedures. Informed consent was obtained from all individual participants included in the study.

Hormonal Therapy

The goal of feminizing hormone therapy is the development of female secondary sex characteristics, and suppression/minimization of male secondary sex characteristics.

Our general therapy approach is to combine an estrogen with an androgen blocker. The usual estrogen is the oral preparation of estradiol (17-beta estradiol), starting at a dose of 2 mg/day until the maximum dosage of 8 mg/day. The preferred androgen blocker is spironolactone at a dose of 200 mg twice a day.

Operative Technique

At our institution, we perform the classic penile inversion vaginoplasty, with an inverted penis skin flap used as the lining for the neovagina. For more details, we have previously published our technique with a step-by-step procedure video ( 6 ). All individuals underwent intestinal cleansing the evening before the surgery. A first-generation cephalosporin was used as preoperative prophylaxis. The procedure was performed with the patient in a dorsal lithotomy position. A Foley catheter was placed for bladder catheterization. A inverted-V incision was made 4 cm above the anus and a flap was created. A neovaginal cavity was created between the prostate and the rectum with blunt dissection, in the Denonvilliers space, until the peritoneal fold, usually measuring 12 cm in extension and 6 cm in width. The incision was then extended vertically to expose the testicles and the spermatic cords, which were removed at the level of the external inguinal rings. A circumferential subcoronal incision was made ( Figure 1 ), the penis was de-gloved and a skin flap was created, with the de-gloved penis being passed through the scrotal opening ( Figure 2 ). The dorsal part of the glans and its neurovascular bundle were bluntly dissected away from the penile shaft ( Figure 3 ) as well as the urethra, which included a portion of the bulbospongious muscle ( Figure 4 ). The corpora cavernosa was excised up to their attachments at the symphysis pubis and ligated. The neoclitoris was shaped and positioned in the midline at the level of the symphysis pubis and sutured using interrupted 5-0 absorbable suture. The corpus spongiosum was reduced and the urethra was shortened, spatulated, and placed 1 cm below the neoclitoris in the midline and sutured using interrupted 4-0 absorbable suture. The penile skin flap was inverted and pulled into the neovaginal cavity to become its walls ( Figure 5 ). The excess of skin was then removed, and the subcutaneous tissue and the skin were closed using continuous 3-0 non-absorbable suture ( Figure 6 ). A neo mons pubis was created using a 0 absorbable suture between the skin and the pubic bone. The skin flap was fixed to the pubic bone using a 0 absorbable suture. A gauze impregnated with Vaseline and antibiotic ointment was left inside the neovagina, and a customized compressive bandage was applied ( Figure 7 —shows the final appearance after the completion of the procedures).

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Figure 1 . The initial circumferential subcoronal incision.

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Figure 2 . The de-gloved penis being passed through the scrotal opening.

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Figure 3 . The dorsal part of the glans and its neurovascular bundle dissected away from the penile shaft.

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Figure 4 . The urethra dissected including a portion of the bulbospongious muscle. The grey arrow shows the penile shaft and the white arrow shows the dissected urethra.

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Figure 5 . The inverted penile skin flap.

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Figure 6 . The neoclitoris and the urethra sutured in the midline and the neovaginal cavity.

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Figure 7 . The final appearance after the completion of the procedures.

Postoperative Care and Follow-Up

The patients were usually discharged within 2 days after surgery with the Foley catheter and vaginal gauze packing in place, which were removed after 7 days in an ambulatorial attendance.

Our vaginal dilation protocol starts seven days after surgery: a kit of 6 silicone dilators with progressive diameter (1.1–4 cm) and length (6.5–14.5 cm) is used; dilation is done progressively from the smallest dilator; each size should be kept in place for 5 min until the largest possible size, which is kept for 3 h during the day and during the night (sleep), if possible. The process is performed daily for the first 3 months and continued until the patient has regular sexual intercourse.

The follow-up visits were performed 7 days, 1, 2, 3, 6, and 12 months after surgery ( Figure 8 ), and included physical examination and a quality-of-life questionnaire.

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Figure 8 . Appearance after 1 month of the procedure.

Statistical Analysis

The statistical analysis was conducted using Statistical Product and Service Solutions Version 18.0 (SPSS). Outcome measures were intra-operative and postoperative complications, re-operations. Descriptive statistics were used to evaluate the study outcomes. Mean values and standard deviations or median values and ranges are presented as continuous variables. Frequencies and percentages are reported for dichotomous and ordinal variables.

Patient Demographics

During the period of the study, 214 patients underwent penile inversion vaginoplasty, performed by two staff surgeons, mostly assisted by residents ( Table 1 ). The average age at the time of surgery was 32.2 years (range 18–61 years). There was no significant increase or decrease in the ages of patients who underwent SRS over the study period (Fisher's exact test: P = 0.065; chi-square test: X 2 = 5.15; GL = 6; P = 0.525). The average of operative time was 3.3 h (range 2–5 h). The average duration of hormone therapy before surgery was 12 years (range 1–39). The majority of patients were white (88.3 percent). The most prevalent patient comorbidities were history of tobacco use (15 percent), human immunodeficiency virus infection (13 percent) and hypertension (10.7 percent). Other comorbidities are listed in Table 1 .

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Table 1 . Patient demographics.

Multidisciplinary follow-up was comprised of 93.45% of patients following up with a urologist and 59.06% of patients continuing psychiatric follow-up, median follow-up time of 16 and 9.3 months after surgery, respectively.

Postoperative Results

The complications were classified according to the Clavien-Dindo score ( Table 2 ). The most common minor postoperative complications (Grade I) were granulation tissue (20.5 percent), introital stricture of the neovagina (15.4 percent) and wound dehiscence (12.6 percent). The major complications (Grade III-IV) included urethral stenosis (20.5 percent), urethral fistula (1.9 percent), intraoperative rectal injury (1.9 percent), necrosis (primarily along the wound edges) (1.4 percent), and rectovaginal fistula (0.9 percent). A total of 17 patients required blood transfusion (7.9 percent).

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Table 2 . Complications after penile inversion vaginoplasty.

A total of 36 patients (16.8 percent) underwent some form of reoperation.

One hundred eighty-one (85 percent) patients in our series were able to have regular sexual vaginal intercourse, and no individual regretted having undergone GAS.

Penile inversion vaginoplasty is the gold-standard in gender-affirming surgery. It has good functional outcomes, and studies have demonstrated adequate vaginal depths ( 3 ). It is recognized not only as a cosmetic procedure, but as a therapeutic intervention and a medical necessity ( 2 ). We present the largest South-American cohort to date, examining demographic data, intra and postoperative complications.

The mean age of transsexual women who underwent GAS in our study was 32.2 years (range 18–61 years), which is lower than the mean age of patients in studies found in the literature. Two studies indicated that the mean ages of patients at time of GAS were 36.7 years and 41 years, respectively ( 4 , 5 ). Another study reported a mean age at time of GAS of 36 years and found there was a significant decrease in age at the time of GAS from 41 years in 1994 to 35 years in 2015 ( 7 ). According to the authors, this decrease in age is associated with greater tolerance and societal approval regarding individuals with GD ( 7 ).

There was no grade IV or grade V complications. Excessive bleeding noticed postoperatively occurred in 19 patients (8.9 percent) and blood transfusion was required in 17 cases (7.9 percent); all patients who required blood transfusions were operated until July 2011, and the reason for this rate of blood transfusion was not identified.

The most common intraoperative complication was rectal injury, occurring in 4 patients (1.9 percent); in all patients the lesion was promptly identified and corrected in 2 layers absorbable sutures. In 2 of these patients, a rectovaginal fistula became evident, requiring fistulectomy and colonic transit deviation. This is consistent with current literature, in which rectal injury is reported in 0.4–4.5 percent of patients ( 4 , 5 , 8 – 13 ). Goddard et al. suggested carefully checking for enterotomy after prostate and bladder mobilization by digital rectal examination ( 4 ). Gaither et al. ( 14 ) commented that careful dissection that closely follows the urethra along its track from the central tendon of the perineum up through the lower pole of the prostate is critical and only blunt dissection is encouraged after Denonvilliers' fascia is reached. Alternatively, a robotic-assisted approach to penile inversion vaginoplasty may aid in minimizing these complications. The proposed advantages of a robotic-assisted vaginoplasty include safer dissection to minimize the risk of rectal injury and better proximal vaginal fixation. Dy et al. ( 15 ) has had no rectal injuries or fistulae to date in his series of 15 patients, with a mean follow-up of 12 months.

In our series, we observed 44 cases (20.5 percent) of urethral meatus strictures. We credit this complication to the technique used in the initial 5 years of our experience, in which the urethra was shortened and sutured in a circular fashion without spatulation. All cases were treated with meatal dilatation and 11 patients required surgical correction, being performed a Y-V plastic reconstruction of the urethral meatus. In the literature, meatal strictures are relatively rare in male-to-female (MtF) GAS due to the spatulation of the urethra and a simple anastomosis to the external genitalia. Recent systematic reviews show an incidence of five percent in this complication ( 16 , 17 ). Other studies report a wide incidence of meatal stenosis ranging from 1.1 to 39.8 percent ( 4 , 8 , 11 ).

Neovagina introital stricture was observed in 33 patients (15.4 percent) in our study and impedes the possibility of neovaginal penetration and/or adversely affects sexual life quality. In the literature, the reported incidence of introital stenosis range from 6.7 to 14.5 percent ( 4 , 5 , 8 , 9 , 11 – 13 ). According to Hadj-Moussa et al. ( 18 ) a regimen of postoperative prophylactic dilation is crucial to minimize the development of this outcome. At our institution, our protocol for vaginal dilation started seven days after surgery and was performed three to four times a day during the first 3 months and was continued until the individual had regular sexual intercourse. We treated stenosis initially with dilation. In case of no response, we propose a surgical revision with diamond-shaped introitoplasty with relaxing incisions. In recalcitrant cases, we proposed to the patient a secondary vaginoplasty using a full-thickness skin graft of the lower abdomen.

One hundred eighty-one (85 percent) patients were classified as having a “functional vagina,” characterized as the capacity to maintain satisfactory sexual vaginal intercourse, since the mean neovaginal depth was not measured. In a review article, the mean neovaginal depth ranged from 10 to 13.5 cm, with the shallowest neovagina depth at 2.5 cm and the deepest at 18 cm ( 17 ). According to Salim et al. ( 19 ), in terms of postoperative functional outcomes after penile inversion vaginoplasty, a mean percentage of 75 percent (range from 33 to 87 percent) patients were having vaginal intercourse. Hess et al. found that 91.4% of patients who responded to a questionnaire were very satisfied (34.4%), satisfied (37.6%), or mostly satisfied (19.4%) with their sexual function after penile inversion vaginoplasty ( 20 ).

Poor cosmetic appearance of the vulva is common. Amend et al. reported that the most common reason for reoperation was cosmetic correction in the form of mons pubis and mucosa reduction in 50% of patients ( 16 ). We had no patient regrets about performing GAS, although 36 patients (16.8 percent) were reoperated due to cosmetic issues. Gaither et al. propose in order to minimize scarring to use a one-stage surgical approach and the lateralization of surgical scars to the groin ( 14 ). Frequently, cosmetic issues outcomes are often patient driven and preoperative patient education is necessary ( 14 ).

Analyzing the quality of life, in 2016, our health care group (PROTIG) published a study assessing quality of life before and after gender-affirming surgery in 47 patients using the diagnostic tool 100-item WHO Quality of Life Assessment (WHOQOL-100) ( 21 ). The authors found that GAS promotes the improvement of psychological aspects and social relations. However, even 1 year after GAS, MtF persons continue to report problems in physical and difficulty in recovering their independence. In a systematic review and meta-analysis of QOL and psychosocial outcomes in transsexual people, researchers verified that sex reassignment with hormonal interventions more likely corrects gender dysphoria, psychological functioning and comorbidities, sexual function, and overall QOL compared with sex reassignment without hormonal interventions, although there is a low level of evidence for this ( 22 ). Recently, Castellano et al. assessed QOL in 60 Italian transsexuals (46 transwomen and 14 transmen) at least 2 years after SRS using the WHOQOL-100 (general QOL score and quality of sexual life and quality of body image scores) to focus on the effects of hormonal therapy. Overall satisfaction improved after SRS, and QOL was similar to the controls ( 23 ). Bartolucci et al. evaluated the perception of quality of sexual life using four questions evaluating the sexual facet in individuals with gender dysphoria before SRS and the possible factors associated with this perception. The study showed that approximately half the subjects with gender dysphoria perceived their sexual life as “poor/dissatisfied” or “very poor/very dissatisfied” before SRS ( 24 ).

Our study has some limitations. The total number of operated patients is restricted within the long follow-up period. This is due to a limitation in our health system, which allows only 1 sexual reassignment surgery to be performed per month at our institution. Neovagin depth measurement was not performed routinely in the follow-up of operated patients.

Conclusions

The definitive treatment for patients with gender dysphoria is gender-affirming surgery. Our series demonstrates that GAS is a feasible surgery with low rates of serious complications. We emphasize the high level of functionality of the vagina after the procedure, as well as subjective personal satisfaction. Complications, especially minor ones, are probably underestimated due to the nature of the study, and since this is a surgical population, the results may not be generalizable for all transgender MTF individuals.

Data Availability Statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Ethics Statement

The studies involving human participants were reviewed and approved by Hospital de Clínicas de Porto Alegre. The patients/participants provided their written informed consent to participate in this study.

Author Contributions

GM: conception and design, data acquisition, data analysis, interpretation, drafting the manuscript, review of the literature, critical revision of the manuscript and factual content, and statistical analysis. ML and TR: conception and design, data interpretation, drafting the manuscript, critical revision of the manuscript and factual content, and statistical analysis. DS, KS, AF, AC, PT, AG, and RC: conception and design, data acquisition and data analysis, interpretation, drafting the manuscript, and review of the literature. All authors contributed to the article and approved the submitted version.

This study was supported by the Fundo de Incentivo à Pesquisa e Eventos (FIPE - Fundo de Incentivo à Pesquisa e Eventos) of Hospital de Clínicas de Porto Alegre.

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Keywords: transsexualism, gender dysphoria, gender-affirming genital surgery, penile inversion vaginoplasty, surgical outcome

Citation: Moisés da Silva GV, Lobato MIR, Silva DC, Schwarz K, Fontanari AMV, Costa AB, Tavares PM, Gorgen ARH, Cabral RD and Rosito TE (2021) Male-to-Female Gender-Affirming Surgery: 20-Year Review of Technique and Surgical Results. Front. Surg. 8:639430. doi: 10.3389/fsurg.2021.639430

Received: 17 December 2020; Accepted: 22 March 2021; Published: 05 May 2021.

Reviewed by:

Copyright © 2021 Moisés da Silva, Lobato, Silva, Schwarz, Fontanari, Costa, Tavares, Gorgen, Cabral and Rosito. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Gabriel Veber Moisés da Silva, veber.gabriel@gmail.com

This article is part of the Research Topic

Gender Dysphoria: Diagnostic Issues, Clinical Aspects and Health Promotion

Nigel Barber Ph.D.

The Gender Reassignment Controversy

When people opt for surgery, are they satisfied with the outcome.

Posted March 16, 2018 | Reviewed by Ekua Hagan

In an age of increasing gender fluidity, it is surprising that so many find it difficult to accept the gender of their birth and take the drastic step of changing it through surgery. What are their motives? Are they satisfied with the outcome?

Gender may be the most important dimension of human variation, whether that is either desirable, or inevitable. In every society, male and female children are raised differently and acquire different expectations, and aspirations, for their work lives, emotional experiences, and leisure pursuits.

These differences may be shaped by how children are raised but gender reassignment, even early in life, is difficult, and problematic. Reassignment in adulthood is even more difficult.

Such efforts are of interest not just for medical reasons but also for the light they shed on gender differences.

The first effort at reassignment, by John Money, involved David Reimer whose penis was accidentally damaged at eight months due to a botched circumcision.

The Money Perspective

Money believed that while children are mostly born with unambiguous genitalia, their gender identity is neutral. He felt that which gender a child identifies with is determined primarily by how parents treat it and that parental views are shaped by the appearance of the genitals.

Accordingly, Money advised the parents to have the child surgically altered to resemble a female and raise it as “Brenda.” For many years, Money claimed that the reassignment had been a complete success. Such was his influence as a well-known Johns Hopkins gender researcher that his views came to be widely accepted by scholars and the general public.

Unfortunately for Brenda, the outcome was far from happy. When he was 14, Reimer began the process of reassignment to being a male. As an adult, he married a woman but depression and drug abuse ensued, culminating in suicide at the age of 38 (1).

Money's ideas about gender identity were forcefully challenged by Paul McHugh (2), a leading psychiatrist at the same institution as Money. The brunt of this challenge came from an analysis of gender reassignment cases in terms of both motivation and outcomes.

Adult Reassignment Surgery Motivation

Why do people (predominantly men) seek surgical reassignment (as a woman)? In a controversial take, McHugh argued that there are two main motives.

In one category fall homosexual men who are morally uncomfortable about their orientation and see reassignment as a way of solving the problem. If they are actually women, sexual interactions with men get redefined as heterosexual.

McHugh argued that many of the others seeking reassignment are cross-dressers. These are heterosexual men who derive sexual pleasure from wearing women's clothing. According to McHugh, surgery is the logical extreme of identifying with a female identity through cross-dressing.

If his thesis is correct, McHugh denies that reassignment surgery is ever either medically necessary or ethically defensible. He feels that the surgeon is merely cooperating with delusional thinking. It is analogous to providing liposuction treatment for an anorexic who is extremely slender but believes themselves to be overweight.

To bolster his case, McHugh looked at the clinical outcomes for gender reassignment surgeries.

Adult Reassignment Results

Anecdotally, the first hurdle for reassignment is how the result is perceived by others. This problem is familiar to anyone who looked at Dustin Hoffman's depiction of a woman ( Tootsie ). Diligent as the actor was in his preparation, his character looked masculine.

For male-to-female transsexuals, the toughest audience to convince is women. As McHugh reported, one of his female colleagues said: “Gals know gals, and that's a guy.”

According to McHugh, although transsexuals did not regret their surgery, there were little or no psychological benefits:

“They had much the same problems with relationships, work, and emotions, as before. The hope that they would emerge now from their emotional difficulties to flourish psychologically had not been fulfilled (2)”.

gender reassignment and transgender

Thanks to McHugh's influence, gender reassignment surgeries were halted at Johns Hopkins. The surgeries were resumed, however, and are now carried out in many hospitals here and around the world.

What changed? One likely influence was the rise of the gay rights movement that now includes transgender people under its umbrella and has made many political strides in work and family.

McHugh's views are associated with the religious right-wing that has lost ground in this area.

Transgender surgery is now covered by medical insurance reflecting more positive views of the psychological benefits.

Aspirational Surgery

Why do people who are born as males want to be women? Why do females want to be men? There seems to be no easy biological explanation for the transgender phenomenon (2).

Transgender people commonly report a lifelong sense that they feel different from their biological category and express satisfaction after surgery (now called gender affirmation) that permits them to be who they really are.

The motivation for surgical change is thus aspirational rather than medical, as is true of most cosmetic surgery also. Following surgery, patients report lower gender dysphoria and improved sexual relationships (3).

All surgeries have potential costs, however. According to a Swedish study of 324 patients (3, 41 percent of whom were born female) surgery was associated with “considerably higher risks for mortality, suicidal behavior, and psychiatric morbidity than the general population.”

1 Blumberg, M. S. (2005). Basic instinct: The genesis of behavior. New York: Thunder's Mouth Press.

2 McHugh, P. R. (1995). Witches, multiple personalities, and other psychiatric artifacts. Nature Medicine, 1, 110-114.

3 Dhejne, S., Lichtenstein, P., Boman, M., et al. (2011). Long-term follow-up of transsexual persons undergoing sex reassignment surgery: Cohort study of Sweden . Plos One.

Nigel Barber Ph.D.

Nigel Barber, Ph.D., is an evolutionary psychologist as well as the author of Why Parents Matter and The Science of Romance , among other books.

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Outcomes are estimated from bivariate and multivariable generalized estimating equation models. aOR, indicates adjusted odds ratio; GAD-7, Generalized Anxiety Disorder 7-item scale; PHQ-9, Patient Health Questionnaire 9-item scale; whiskers, 95% CIs.

eTable 1. Survey Instruments

eTable 2. Prevalence of Exposure Over Time

eTable 3. Prevalence of Outcomes Over Time by Exposure Group

eTable 4. E-Value Calculation for Association Between Puberty Blockers or Gender-Affirming Hormones and Mental Health Outcomes

eTable 5. Examining Association Between Puberty Blockers or Gender-Affirming Hormones and Mental Health Outcomes Separately

eTable 6. Bivariate Model Restricted to Youths Ages 13 to 17 Years

eTable 7. Multivariable Model Restricted to 90 Youths Ages 13 to 17 Years

eTable 8. Sensitivity Analyses using Patient Health Questionnaire 8-item Scale Score of 10 or Greater for Moderate to Severe Depression

eFigure 1. Schematic of Generalized Estimating Equation Model

eFigure 2. Association Between Receipt of Gender-Affirming Hormones or Puberty Blockers and Mental Health Outcomes

eReferences

  • Medical Groups Defend Patient-Physician Relationship and Access to Adolescent Gender-Affirming Care JAMA Medical News & Perspectives April 19, 2022 This Medical News article discusses physicians’ advocacy to protect patients and the patient-physician relationship amid efforts by politicians to limit access or criminalize gender-affirming care. Bridget M. Kuehn, MSJ
  • As Laws Restricting Health Care Surge, Some US Physicians Choose Between Fight or Flight JAMA Medical News & Perspectives June 13, 2023 In this Medical News article, 13 physicians and health care experts spoke with JAMA about the increasing efforts to criminalize evidence-based medical care in the US. Melissa Suran, PhD, MSJ
  • Data Errors in eTables 2 and 3 JAMA Network Open Correction July 26, 2022
  • Improving Mental Health Among Transgender and Gender-Diverse Youth JAMA Network Open Invited Commentary February 25, 2022 Brett Dolotina, BS; Jack L. Turban, MD, MHS

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Tordoff DM , Wanta JW , Collin A , Stepney C , Inwards-Breland DJ , Ahrens K. Mental Health Outcomes in Transgender and Nonbinary Youths Receiving Gender-Affirming Care. JAMA Netw Open. 2022;5(2):e220978. doi:10.1001/jamanetworkopen.2022.0978

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Mental Health Outcomes in Transgender and Nonbinary Youths Receiving Gender-Affirming Care

  • 1 Department of Epidemiology, University of Washington, Seattle
  • 2 Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle
  • 3 School of Medicine, University of Washington, Seattle
  • 4 Department of Psychiatry and Behavioral Medicine, Department of Adolescent and Young Adult Medicine, Seattle Children’s Hospital, Seattle, Washington
  • 5 University of California, San Diego School of Medicine, Rady Children's Hospital
  • 6 Division of Adolescent Medicine, Department of Pediatrics, Seattle Children’s Hospital, Seattle, Washington
  • Invited Commentary Improving Mental Health Among Transgender and Gender-Diverse Youth Brett Dolotina, BS; Jack L. Turban, MD, MHS JAMA Network Open
  • Medical News & Perspectives Medical Groups Defend Patient-Physician Relationship and Access to Adolescent Gender-Affirming Care Bridget M. Kuehn, MSJ JAMA
  • Medical News & Perspectives As Laws Restricting Health Care Surge, Some US Physicians Choose Between Fight or Flight Melissa Suran, PhD, MSJ JAMA
  • Correction Data Errors in eTables 2 and 3 JAMA Network Open

Question   Is gender-affirming care for transgender and nonbinary (TNB) youths associated with changes in depression, anxiety, and suicidality?

Findings   In this prospective cohort of 104 TNB youths aged 13 to 20 years, receipt of gender-affirming care, including puberty blockers and gender-affirming hormones, was associated with 60% lower odds of moderate or severe depression and 73% lower odds of suicidality over a 12-month follow-up.

Meaning   This study found that access to gender-affirming care was associated with mitigation of mental health disparities among TNB youths over 1 year; given this population's high rates of adverse mental health outcomes, these data suggest that access to pharmacological interventions may be associated with improved mental health among TNB youths over a short period.

Importance   Transgender and nonbinary (TNB) youths are disproportionately burdened by poor mental health outcomes owing to decreased social support and increased stigma and discrimination. Although gender-affirming care is associated with decreased long-term adverse mental health outcomes among these youths, less is known about its association with mental health immediately after initiation of care.

Objective   To investigate changes in mental health over the first year of receiving gender-affirming care and whether initiation of puberty blockers (PBs) and gender-affirming hormones (GAHs) was associated with changes in depression, anxiety, and suicidality.

Design, Setting, and Participants   This prospective observational cohort study was conducted at an urban multidisciplinary gender clinic among TNB adolescents and young adults seeking gender-affirming care from August 2017 to June 2018. Data were analyzed from August 2020 through November 2021.

Exposures   Time since enrollment and receipt of PBs or GAHs.

Main Outcomes and Measures   Mental health outcomes of interest were assessed via the Patient Health Questionnaire 9-item (PHQ-9) and Generalized Anxiety Disorder 7-item (GAD-7) scales, which were dichotomized into measures of moderate or severe depression and anxiety (ie, scores ≥10), respectively. Any self-report of self-harm or suicidal thoughts over the previous 2 weeks was assessed using PHQ-9 question 9. Generalized estimating equations were used to assess change from baseline in each outcome at 3, 6, and 12 months of follow-up. Bivariate and multivariable logistic models were estimated to examine temporal trends and investigate associations between receipt of PBs or GAHs and each outcome.

Results   Among 104 youths aged 13 to 20 years (mean [SD] age, 15.8 [1.6] years) who participated in the study, there were 63 transmasculine individuals (60.6%), 27 transfeminine individuals (26.0%), 10 nonbinary or gender fluid individuals (9.6%), and 4 youths who responded “I don’t know” or did not respond to the gender identity question (3.8%). At baseline, 59 individuals (56.7%) had moderate to severe depression, 52 individuals (50.0%) had moderate to severe anxiety, and 45 individuals (43.3%) reported self-harm or suicidal thoughts. By the end of the study, 69 youths (66.3%) had received PBs, GAHs, or both interventions, while 35 youths had not received either intervention (33.7%). After adjustment for temporal trends and potential confounders, we observed 60% lower odds of depression (adjusted odds ratio [aOR], 0.40; 95% CI, 0.17-0.95) and 73% lower odds of suicidality (aOR, 0.27; 95% CI, 0.11-0.65) among youths who had initiated PBs or GAHs compared with youths who had not. There was no association between PBs or GAHs and anxiety (aOR, 1.01; 95% CI, 0.41, 2.51).

Conclusions and Relevance   This study found that gender-affirming medical interventions were associated with lower odds of depression and suicidality over 12 months. These data add to existing evidence suggesting that gender-affirming care may be associated with improved well-being among TNB youths over a short period, which is important given mental health disparities experienced by this population, particularly the high levels of self-harm and suicide.

Transgender and nonbinary (TNB) youths are disproportionately burdened by poor mental health outcomes, including depression, anxiety, and suicidal ideation and attempts. 1 - 5 These disparities are likely owing to high levels of social rejection, such as a lack of support from parents 6 , 7 and bullying, 6 , 8 , 9 and increased stigma and discrimination experienced by TNB youths. Multidisciplinary care centers have emerged across the country to address the health care needs of TNB youths, which include access to medical gender-affirming interventions, such as puberty blockers (PBs) and gender-affirming hormones (GAHs). 10 These centers coordinate care and help youths and their families address barriers to care, such as lack of insurance coverage 11 and travel times. 12 Gender-affirming care is associated with decreased rates of long-term adverse outcomes among TNB youths. Specifically, PBs, GAHs, and gender-affirming surgeries have all been found to be independently associated with decreased rates of depression, anxiety, and other adverse mental health outcomes. 13 - 16 Access to these interventions is also associated with a decreased lifetime incidence of suicidal ideation among adults who had access to PBs during adolescence. 17 Conversely, TNB youths who present to care later in adolescence or young adulthood experience more adverse mental health outcomes. 18 Despite this robust evidence base, legislation criminalizing and thus limiting access to gender-affirming medical care for minors is increasing. 19 , 20

Less is known about the association of gender-affirming care with mental health outcomes immediately after initiation of care. Several studies published from 2015 to 2020 found that receipt of PBs or GAHs was associated with improved psychological functioning 21 and body satisfaction, 22 as well as decreased depression 23 and suicidality 24 within a 1-year period. Initiation of gender-affirming care may be associated with improved short-term mental health owing to validation of gender identity and clinical staff support. Conversely, prerequisite mental health evaluations, often perceived as pathologizing by TNB youths, and initiation of GAHs may present new stressors that may be associated with exacerbation of mental health symptoms early in care, such as experiences of discrimination associated with more frequent points of engagement in a largely cisnormative health care system (eg, interactions with nonaffirming pharmacists to obtain laboratory tests, syringes, and medications). 25 Given the high risk of suicidality among TNB adolescents, there is a pressing need to better characterize mental health trends for TNB youths early in gender-affirming care. This study aimed to investigate changes in mental health among TNB youths enrolled in an urban multidisciplinary gender clinic over the first 12 months of receiving care. We also sought to investigate whether initiation of PBs or GAHs was associated with depression, anxiety, and suicidality.

This cohort study received approval from the Seattle Children’s Hospital Institutional Review Board. For youths younger than age 18 years, caregiver consent and youth assent was obtained. For youths ages 18 years and older, youth consent alone was obtained. The 12-month assessment was funded via a different mechanism than other survey time points; thus, participants were reconsented for the 12-month survey. The study follows the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guideline.

We conducted a prospective observational cohort study of TNB youths seeking care at Seattle Children’s Gender Clinic, an urban multidisciplinary gender clinic. After a referral is placed or a patient self-refers, new patients, their caregivers, or patients with their caregivers are scheduled for a 1-hour phone intake with a care navigator who is a licensed clinical social worker. Patients are then scheduled for an appointment at the clinic with a medical provider.

All patients who completed the phone intake and in-person appointment between August 2017 and June 2018 were recruited for this study. Participants completed baseline surveys within 24 hours of their first appointment and were invited to complete follow-up surveys at 3, 6, and 12 months. Youth surveys were used to assess most variables in this study; caregiver surveys were used to assess caregiver income. Participation and completion of study surveys had no bearing on prescribing of PBs or GAHs.

We assessed 3 internalizing mental health outcomes: depression, generalized anxiety, and suicidality. Depression was assessed using the Patient Health Questionnaire 9-item scale (PHQ-9), and anxiety was assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). We dichotomized PHQ-9 and GAD-7 scores into measures of moderate or severe depression and anxiety (ie, scores ≥10). 26 , 27 Self-harm and suicidal thoughts were assessed using PHQ-9 question 9 (eTable 1 in the Supplement ).

Participants self-reported if they had ever received GAHs, including estrogen or testosterone, or PBs (eg, gonadotropin-releasing hormone analogues) on each survey. We conducted a medical record review to capture prescription of androgen blockers (eg, spironolactone) and medications for menstrual suppression or contraception (ie, medroxyprogesterone acetate or levonorgestrel-releasing intrauterine device) during the study period.

We a priori considered potential confounders hypothesized to be associated with our exposures and outcomes of interest based on theory and prior research. Self-reported gender was ascertained on each survey using a 2-step question that asked participants about their current gender and their sex assigned at birth. If a participant’s self-reported gender changed across surveys, we used the gender reported most frequently by a participant (3 individuals identified as transmasculine at baseline and as nonbinary on all follow-up surveys). We collected data on self-reported race and ethnicity (available response options were Arab or Middle Eastern; Asian; Black or African American; Latinx; Native American, American Indian, or Alaskan Native or Native Hawaiian; Pacific Islander; and White), age, caregiver income, and insurance type. Race and ethnicity were assessed as potential covariates owing to known barriers to accessing gender-affirming care among transgender youth who are members of minority racial and ethnic groups. For descriptive statistics, Asian and Pacific Islander groups were combined owing to small population numbers. We included a baseline variable reflecting receipt of ongoing mental health therapy other than for the purpose of a mental health assessment to receive a gender dysphoria diagnosis. We included a self-report variable reflecting whether youths felt their gender identity or expression was a source of tension with their parents or guardians. Substance use included any alcohol, marijuana, or other drug use in the past year. Resilience was measured by the Connor-Davidson Resilience Scale (CD-RISC) 10-item score developed to measure change in an individual’s state resilience over time. 28 Resilience scores were dichotomized into high (ie, ≥median) and low (ie, <median). Prior studies of young adults in the US reported mean CD-RISC scores ranging from 27.2 to 30.1. 29 , 30

We used generalized estimating equations to assess change in outcomes from baseline at each follow-up point (eFigure 1 in the Supplement ). We used a logit link function to estimate adjusted odds ratio (aOR) for the association between variables and each mental health outcome. We initially estimated bivariate associations between potential confounders and mental health outcomes. Multivariable models included variables that were statistically significant in bivariate models. For all outcomes and models, statistical significance was defined as 95% CIs that did not contain 1.00. Reported P values are based on 2-sided Wald test statistics.

Model 1 examined temporal trends in mental health outcomes, with time (ie, baseline, 3, 6, and 12 months) modeled as a categorical variable. Model 2 estimated the association between receipt of PBs or GAHs and mental health outcomes adjusted for temporal trends and potential confounders. Receipt of PBs or GAHs was modeled as a composite binary time-varying exposure that compared mean outcomes between participants who had initiated PBs or GAHs and those who had not across all time points (eTable 2 in the Supplement ). All models used an independent working correlation structure and robust standard errors to account for the time-varying exposure variable.

We performed several sensitivity analyses. Because our data were from an observational cohort, we first considered the degree to which they were sensitive to unmeasured confounding. To do this, we calculated the E-value for the association between PBs or GAHs and mental health outcomes in model 2. The E-value is defined as the minimum strength of association that a confounder would need to have with both exposure and outcome to completely explain away their association (eTable 4 in the Supplement ). 31 Second, we performed sensitivity analyses on several subsets of youths. We separately examined the association of PBs and GAHs with outcomes of interest, although we a priori did not anticipate being powered to detect statistically significant outcomes owing to our small sample size and the relatively low proportion of youths who accessed PBs. We also conducted sensitivity analyses using the Patient Health Questionnaire 8-item scale (PHQ-8), in which the PHQ-9 question 9 regarding self-harm or suicidal thoughts was removed, given that we analyzed this item as a separate outcome. Lastly, we restricted our analysis to minor youths ages 13 to 17 years because they were subject to different laws and policies related to consent and prerequisite mental health assessments. We used R statistical software version 3.6.2 (R Project for Statistical Computing) to conduct all analyses. Data were analyzed from August 2020 through November 2021.

A total of 169 youths were screened for eligibility during the study period, among whom 161 eligible youths were approached. Nine youths or caregivers declined participation, and 39 youths did not complete consent or assent or did not complete the baseline survey, leaving a sample of 113 youths (70.2% of approached youths). We excluded 9 youths aged younger than 13 years from the analysis because they received different depression and anxiety screeners. Our final sample included 104 youths ages 13 to 20 years (mean [SD] age, 15.8 [1.6] years). Of these individuals, 84 youths (80.8%), 84 youths, and 65 youths (62.5%) completed surveys at 3, 6, and 12 months, respectively.

Our cohort included 63 transmasculine youths (60.6%), 27 transfeminine youths (26.0%), 10 nonbinary or gender fluid youths (9.6%), and 4 youths who responded “I don’t know” or did not respond to the gender identity question on all completed questionnaires (3.8%) ( Table 1 ). There were 4 Asian or Pacific Islander youths (3.8%), 3 Black or African American youths (2.9%); 9 Latinx youths (8.7%); 6 Native American, American Indian, or Alaskan Native or Native Hawaiian youths (5.8%); 67 White youths (64.4%); and 9 youths who reported more than 1 race or ethnicity (8.7%). Race and ethnicity data were missing for 6 youth (5.8%).

At baseline, 7 youths had ever received PBs or GAHs (including 1 youth who received PBs, 4 youths who received GAHs, and 2 youths who received both PBs and GAHs). By the end of the study, 69 youths (66.3%) had received PBs or GAHs (including 50 youths who received GAHs only [48.1%], 5 youths who received PBs only [4.8%], and 14 youths who received PBs and GAHs [13.5%]), while 35 youths had not received either PBs or GAHs (33.7%) (eTable 3 in the Supplement ). Among 33 participants assigned male sex at birth, 17 individuals (51.5%) had received androgen blockers, and among 71 participants assigned female sex at birth, 25 individuals (35.2%) had received menstrual suppression or contraceptives by the end of the study.

A large proportion of youths reported depressive and anxious symptoms at baseline. Specifically, 59 individuals (56.7%) had baseline PHQ-9 scores of 10 or more, suggesting moderate to severe depression; there were 22 participants (21.2%) scoring in the moderate range, 11 participants (10.6%) in the moderately severe range, and 26 participants (25.0%) in the severe range. Similarly, half of participants had a GAD-7 score suggestive of moderate to severe anxiety at baseline (52 individuals [50.0%]), including 20 participants (19.2%) scored in the moderate range, and 32 participants (30.8%) scored in the severe range. There were 45 youths (43.3%) who reported self-harm or suicidal thoughts in the prior 2 weeks. At baseline, 65 youths (62.5%) were receiving ongoing mental health therapy, 36 youths (34.6%) reported tension with their caregivers about their gender identity or expression, and 34 youths (32.7%) reported any substance use in the prior year. Lastly, we observed a wide range of resilience scores (median [range], 22.5 [1-38], with higher scores equaling more resiliency). There were no statistically significant differences in baseline characteristics by gender.

In bivariate models, substance use was associated with all mental health outcomes ( Table 2 ). Youths who reported any substance use were 4-fold as likely to have PHQ-9 scores of moderate to severe depression (aOR, 4.38; 95% CI, 2.10-9.16) and 2-fold as likely to have GAD-7 scores of moderate to severe anxiety (aOR, 2.07; 95% CI, 1.04-4.11) or report thoughts of self-harm or suicide in the prior 2 weeks (aOR, 2.06; 95% CI, 1.08-3.93). High resilience scores (ie, ≥median), compared with low resilience scores (ie, <median), were associated with lower odds of moderate or severe anxiety (aOR, 0.51; 95% CI, 0.26-0.999).

There were no statistically significant temporal trends in the bivariate model or model 1 ( Table 2 and Table 3 ). However, among all participants, odds of moderate to severe depression increased at 3 months of follow-up relative to baseline (aOR, 2.12; 95% CI, 0.98-4.60), which was not a significant increase, and returned to baseline levels at months 6 and 12 ( Figure ) prior to adjusting for receipt of PBs or GAHs.

We also examined the association between receipt of PBs or GAHs and mental health outcomes in bivariate and multivariable models (eFigure 2 in the Supplement ). After adjusting for temporal trends and potential confounders ( Table 4 ), we observed that youths who had initiated PBs or GAHs had 60% lower odds of moderate to severe depression (aOR, 0.40; 95% CI, 0.17-0.95) and 73% lower odds of self-harm or suicidal thoughts (aOR, 0.27; 95% CI, 0.11-0.65) compared with youths who had not yet initiated PBs or GAHs. There was no association between receipt of PBs or GAHs and moderate to severe anxiety (aOR, 1.01; 95% CI, 0.41-2.51). After adjusting for time-varying exposure of PBs or GAHs in model 2 ( Table 4 ), we observed statistically significant increases in moderate to severe depression among youths who had not received PBs or GAHs by 3 months of follow-up (aOR, 3.22; 95% CI, 1.37-7.56). A similar trend was observed for self-harm or suicidal thoughts among youths who had not received PBs or GAHs by 6 months of follow-up (aOR, 2.76; 95% CI, 1.22-6.26). Lastly, we estimated E-values of 2.56 and 3.25 for the association between receiving PGs or GAHs and moderate to severe depression and suicidality, respectively (eTable 4 in the Supplement ). Sensitivity analyses obtained comparable results and are presented in eTables 5 through 8 in the Supplement .

In this prospective clinical cohort study of TNB youths, we observed high rates of moderate to severe depression and anxiety, as well as suicidal thoughts. Receipt of gender-affirming interventions, specifically PBs or GAHs, was associated with 60% lower odds of moderate to severe depressive symptoms and 73% lower odds of self-harm or suicidal thoughts during the first year of multidisciplinary gender care. Among youths who did not initiate PBs or GAHs, we observed that depressive symptoms and suicidality were 2-fold to 3-fold higher than baseline levels at 3 and 6 months of follow-up, respectively. Our study results suggest that risks of depression and suicidality may be mitigated with receipt of gender-affirming medications in the context of a multidisciplinary care clinic over the relatively short time frame of 1 year.

Our findings are consistent with those of prior studies finding that TNB adolescents are at increased risk of depression, anxiety, and suicidality 1 , 11 , 32 and studies finding long-term and short-term improvements in mental health outcomes among TNB individuals who receive gender-affirming medical interventions. 14 , 21 - 24 , 33 , 34 Surprisingly, we observed no association with anxiety scores. A recent cohort study of TNB youths in Dallas, Texas, found that total anxiety symptoms improved over a longer follow-up of 11 to 18 months; however, similar to our study, the authors did not observe statistically significant improvements in generalized anxiety. 22 This suggests that anxiety symptoms may take longer to improve after the initiation of gender-affirming care. In addition, Olson et al 35 found that prepubertal TNB children who socially transitioned did not have increased rates of depression symptoms but did have increased rates of anxiety symptoms compared with children who were cisgender. Although social transition and access to gender-affirming medical care do not always go hand in hand, it is noteworthy that access to gender-affirming medical care and supported social transition appear to be associated with decreased depression and suicidality more than anxiety symptoms.

Time trends were not significant in our study; however, it is important to note that we observed a transient and nonsignificant worsening in mental health outcomes in the first several months of care among all participants and that these outcomes subsequently returned to baseline by 12 months. This is consistent with findings from a 2020 study 36 in an academic medical center in the northwestern US that observed no change in TNB adolescents’ GAD-7 or PHQ-9 scores from intake to first follow-up appointment, which occurred a mean of 4.7 months apart. Given that receipt of PBs or GAHs was associated with protection against depression and suicidality in our study, it could be that delays in receipt of medications is associated with initially exacerbated mental health symptoms that subsequently improve. It is also possible that mental health improvements associated with receiving these interventions may have a delayed onset, given the delay in physical changes after starting GAHs.

Few of our hypothesized confounders were associated with mental health outcomes in this sample, most notably receipt of ongoing mental health therapy and caregiver support; however, this is not surprising given that these variables were colinear with baseline mental health, which we adjusted for in all models. Substance use was the only variable associated with all mental health outcomes. In addition, youths with high baseline resilience scores were half as likely to experience moderate to severe anxiety as those with low scores. This finding suggests that substance use and resilience may be additional modifiable factors that could be addressed through multidisciplinary gender-affirming care. We recommend more granular assessment of substance use and resilience to better understand support needs (for substance use) and effective support strategies (for resilience) for TNB youths in future research.

This study has a number of strengths. This is one of the first studies to quantify a short-term transient increase in depressive symptoms experienced by TNB youths after initiating gender-affirming care, a phenomenon observed clinically by some of the authors and described in qualitative research. 37 Although we are unable to make causal statements owing to the observational design of the study, the strength of associations between gender-affirming medications and depression and suicidality, with large aOR values, and sensitivity analyses that suggest that these findings are robust to moderate levels of unmeasured confounding. Specifically, E-values calculated for this study suggest that the observed associations could be explained away only by an unmeasured confounder that was associated with both PBs and GAHs and the outcomes of interest by a risk ratio of 2-fold to 3-fold each, above and beyond the measured confounders, but that weaker confounding could not do so. 31

Our findings should be interpreted in light of the following limitations. This was a clinical sample of TNB youths, and there was likely selection bias toward youths with supportive caregivers who had resources to access a gender-affirming care clinic. Family support and access to care are associated with protection against poor mental health outcomes, and thus actual rates of depression, anxiety, and suicidality in nonclinical samples of TNB youths may differ. Youths who are unable to access gender-affirming care owing to a lack of family support or resources require particular emphasis in future research and advocacy. Our sample also primarily included White and transmasculine youths, limiting the generalizability of our findings. In addition, the need to reapproach participants for consent and assent for the 12-month survey likely contributed to attrition at this time point. There may also be residual confounding because we were unable to include a variable reflecting receipt of psychotropic medications that could be associated with depression, anxiety, and self-harm and suicidal thought outcomes. Additionally, we used symptom-based measures of depression, anxiety, and suicidality; further studies should include diagnostic evaluations by mental health practitioners to track depression, anxiety, gender dysphoria, suicidal ideation, and suicide attempts during gender care. 2

Our study provides quantitative evidence that access to PBs or GAHs in a multidisciplinary gender-affirming setting was associated with mental health improvements among TNB youths over a relatively short time frame of 1 year. The associations with the highest aORs were with decreased suicidality, which is important given the mental health disparities experienced by this population, particularly the high levels of self-harm and suicide. Our findings have important policy implications, suggesting that the recent wave of legislation restricting access to gender-affirming care 19 may have significant negative outcomes in the well-being of TNB youths. 20 Beyond the need to address antitransgender legislation, there is an additional need for medical systems and insurance providers to decrease barriers and expand access to gender-affirming care.

Accepted for Publication: January 10, 2022.

Published: February 25, 2022. doi:10.1001/jamanetworkopen.2022.0978

Correction: This article was corrected on July 26, 2022, to fix minor errors in the numbers of patients in eTables 2 and 3 in the Supplement.

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2022 Tordoff DM et al. JAMA Network Open .

Corresponding Author: Diana M. Tordoff, MPH, Department of Epidemiology, University of Washington, UW Box 351619, Seattle, WA 98195 ( [email protected] ).

Author Contributions : Diana Tordoff had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Diana Tordoff and Dr Wanta are joint first authors. Drs Inwards-Breland and Ahrens are joint senior authors.

Concept and design: Collin, Stepney, Inwards-Breland, Ahrens.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Tordoff, Wanta, Collin, Stepney, Inwards-Breland.

Critical revision of the manuscript for important intellectual content: Wanta, Collin, Stepney, Inwards-Breland, Ahrens.

Statistical analysis: Tordoff.

Obtained funding: Inwards-Breland, Ahrens.

Administrative, technical, or material support: Ahrens.

Supervision: Wanta, Inwards-Breland, Ahrens.

Conflict of Interest Disclosures: Diana Tordoff reported receiving grants from the National Institutes of Health National Institute of Allergy and Infectious Diseases unrelated to the present work and outside the submitted work. No other disclosures were reported.

Funding/Support: This study was supported Seattle Children’s Center for Diversity and Health Equity and the Pacific Hospital Preservation Development Authority.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

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Outlawing Trans Youth: State Legislatures and the Battle over Gender-Affirming Healthcare for Minors

Chapter One

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As soon as I realized that I was not happy in my body, I went up to my parents to fix it. And it felt as natural as going up and being like, “Hey, I’m hungry.” I was just kind of like, “Hey, when’s the girl thing happening? ”

— Nicole Maines, actress and transgender activist, on coming out as transgender as a child 1

More than one-third of transgender high school students attempt suicide in a given year. 2 This alarming statistic underscores the importance of providing transgender youth 3 with access to medically necessary healthcare to bring their bodies into alignment with their gender identities. 4 Fortunately, medical science and understanding have advanced such that trans youth can safely and effectively transition under the supervision of medical professionals. 5 Obstacles remain, to be sure. 6 But information about, and access to, gender-affirming care for trans youth is more widespread than ever before. 7

Over the last few years, however, a growing political tide has threatened to reverse this progress. Gender-affirming healthcare 8 for minors has become a new frontier in the culture war. In the first months of 2020 alone, legislators in at least fifteen states introduced bills that would have prohibited and, in many cases, criminalized providing gender-affirming healthcare services to minors. 9 None of these bills became law. 10 But the fight over gender-affirming healthcare for minors is far from over; as of January 2021, at least nine states were considering gender-affirming care bans, 11 with more sure to follow, and a recent court decision in the United Kingdom effectively banning hormone treatments for trans youth under sixteen is likely to embolden the stateside opposition even further. 12 This Chapter shines light on attempts to outlaw necessary gender-affirming medical treatment for minors, drawing on scientific evidence and legal doctrine to show why such legislative efforts are harmful, prejudiced, and unconstitutional. Section A will outline the current medical standard of care for trans youth and argue that access to gender-affirming care provides critical and empirically demonstrable psychological, social, and legal benefits for trans youth. Section B will describe the 2020 bills, 13 critique their foundational premises, and analyze how their paternalistic narratives represent new rhetorical strategies of opposition to trans youth. Section C will offer two constitutional arguments against the bans, one based in the Equal Protection Clause and one based in parental due process rights.

The Importance of Gender-Affirming Healthcare for Trans Youth

The prevalence and availability of gender-affirming healthcare for trans youth have increased considerably since the 1990s, when transitioning before adulthood was quite rare. 14 A 2017 survey found that almost two percent of American public high school students in ten states and nine large urban school districts identified as transgender, 15 and although not all trans youth seek out gender-affirming healthcare, exponentially greater numbers of trans youth are pursuing this care. 16 This section describes the current medical standard of gender-affirming healthcare for trans youth and explains the importance of gender-affirming healthcare to the mental and social well-being and legal recognition of trans youth.

1. The Current Standard of Care.

The purpose of gender-affirming healthcare is usually to treat gender dysphoria (“dysphoria”), or “discomfort or distress that is caused by a discrepancy between a person’s gender identity and that person’s sex assigned at birth.” 17 Physical and social transition through the use of gender-affirming healthcare is clinically shown to reduce dysphoria by aligning a transgender person’s physical body and gender presentation with their gender identity. 18 Thus, every major U.S. medical association recognizes that gender-affirming healthcare is medically necessary treatment for dysphoria. 19

Gender-affirming healthcare for trans youth is typically admin-istered pursuant to Standards of Care published by the World Professional Association for Transgender Health (WPATH SOC), an international body of experts in transgender healthcare. 20 The WPATH SOC represent the authoritative medical consensus on treatment for dysphoria in transgender people. 21

The first step in gender-affirming treatment for trans youth is therapy and counseling. The WPATH SOC recommend that trans youth be diagnosed with gender dysphoria and referred by a gender therapist before they begin physical transition. 22 After the initial diagnosis, gender-affirming therapists help trans youth process their gender identities and cope with distress associated with dysphoria and coexisting sources of stress, and support them in taking future steps in physical and social transition. 23

Trans youth who are diagnosed with dysphoria sometimes begin hormone treatments, depending on their age and stage of physical development. Trans youth who have reached the early stages of puberty may be prescribed puberty blockers, which prevent the further progression of assigned-sex puberty and the development of associated secondary sex characteristics. 24 Halting puberty is typically done to give trans youth more time to process their identity and decide whether to pursue further steps in transition, 25 and to prevent irreversible physical changes that conflict with their desired gender presentation and increase dysphoria. 26

Beginning at around age sixteen, 27 trans youth can be prescribed hormone replacement therapy (HRT), which causes development of secondary sex characteristics associated with the trans youth’s identified gender. 28 For trans girls, HRT involves suppressing endogenous testosterone and taking estrogen, 29 a regimen that typically causes breast growth, softer skin, and reduction in body hair, 30 while for trans boys, it involves taking testosterone, 31 which typically causes muscle growth, an increase in body and facial hair, and a deeper voice. 32 Some nonbinary youth also seek HRT, but there are currently no formal standards of care for nonbinary people and there is little research as to clinical outcomes outside the binary context. 33 The WPATH SOC and Endocrine Society typically require parental consent before doctors may prescribe HRT to minors. 34

Gender confirmation surgery (GCS), which involves changing a transgender person’s reproductive anatomy to the anatomy usually associated with their identified gender, is rarely performed for trans youth because the WPATH SOC require the patient to have attained the age of majority to be eligible for surgery. 35 Additionally, insurance coverage usually requires GCS patients to be eighteen or older. 36 However, GCS is not the only type of gender-affirming surgery. Transgender men may undergo surgery to remove breast tissue (“top surgery”), and the WPATH SOC allow this surgery to be performed on patients under eighteen on a case-by-case basis. 37

2. Why Trans Youth Need Access to Gender-Affirming Healthcare .

Access to these gender-affirming healthcare services is essential — even lifesaving — for trans youth. There is a vast disparity in traditional measures of quality of life between trans youth with untreated dysphoria and their cisgender peers. A wealth of empirical research confirms that, although it does not erase this gap, medical transition narrows it considerably. This section summarizes the benefits of gender-affirming care for trans youth in three spheres: mental health, social acceptance, and legal rights. Although they are categorized separately for organizational purposes, these spheres often intersect and complement one another in practice.

(a) Mental Health. — Untreated dysphoria in trans youth is associated with severe mental health problems, including depression, social anxiety, and suicidal thoughts and behavior. 38 A study of baseline (pre-transition) psychological characteristics of trans youth revealed that twenty percent had “moderate to extreme” depressive symptoms, and that their reported rate of suicidal thoughts and attempts was at least three times higher than that of the general youth population. 39 Over half reported having thought about suicide, and a third reported at least one attempt. 40

Conversely, a large body of research demonstrates that trans youth who receive gender-affirming healthcare to treat their dysphoria show decreased anxiety, depression, suicidal behavior, and psychological distress, 41 and increased quality of life. 42 Trans children who are allowed to socially transition before puberty have relatively normal rates of depression and anxiety, “in striking contrast” with nontransitioned trans children. 43 A longitudinal study of trans adolescents before and after they received gender-affirming care found that psychological functioning steadily improved throughout treatment and that overall well-being after treatment was “comparable to [that of] same-age peers.” 44 And a study of transgender adults found that subjects who had received puberty blockers in childhood had a significantly lower incidence of suicidal ideation than did those who had wanted puberty blockers but did not receive them. 45 Of course, gender dysphoria is not the sole cause of psychological distress and mental health problems in trans youth, nor is access to gender-affirming healthcare a panacea. But, in the words of the preeminent professional association of pediatric psychiatry in the United States, “[r]esearch consistently demonstrates that gender diverse youth . . . have better mental health outcomes” when they have access to gender-affirming healthcare. 46

(b) Social Integration. — Middle school and high school are stressful for many young people, but they are often particularly difficult social environments for trans youth. Not only are trans students disproportionately bullied and alienated by their peers, 47 but they may also have problems fitting in due to the frequent mental health issues associated with untreated dysphoria 48 and feelings of not “belonging” with cisgender students. 49 This trauma only intensifies with the onset of assigned-sex puberty, which causes trans youth to develop secondary sex characteristics (such as breasts in trans boys and facial hair in trans girls) that are inconsistent with their gender identities. 50 Because of this process, trans youth who undergo assigned-sex puberty often experience decreased self-esteem and increased body image issues, which can cause further social and educational impairment. 51 Physical changes from puberty may also make it harder for trans youth to “pass” as the gender with which they identify, 52 meaning they are more likely to experience psychological problems 53 and to face discrimination and abuse. 54

Puberty blockers and HRT allow trans youth to avoid many of these challenges. Trans youth who start puberty blockers or HRT in childhood or adolescence are spared the hardships of navigating school and peer relationships while presenting as a gender with which they do not identify. Because of this relief, medically transitioned trans youth are often more confident and socially well-adjusted than their nontransitioned peers. 55 Undergoing medical transition at an earlier age also allows many trans youth to “pass” more easily as their identified gender, 56 and avoid many of the challenges associated with being visibly transgender. 57

(c) Legal Status. — Gender-affirming medical care often mediates the availability of legal rights and protections for trans youth. Most notably, many states require medical evidence like a diagnosis of gender dysphoria, HRT, or GCS to change a transgender person’s gender on identity documents such as driver’s licenses and birth certificates. 58 Misalignment between a trans youth’s gender presentation and their gender on identity documents is not an isolated indignity; it can have serious collateral consequences. For example, many colleges and universities do not allow students to use their preferred names or genders in school records if they have not legally changed them on identity documents. 59

Access to gender-affirming care is also critical for many trans youth to participate in competitive school sports. The National Collegiate Athletic Association and some state high school athletic associations allow trans girls to play on girls’ sports teams only after they have taken HRT for a certain period, out of concern that their assigned sex gives them an “unfair” advantage. 60 Trans boys typically do not have to meet specific medical criteria in order to play on boys’ teams, 61 but in practice it will often be difficult for trans boys to compete with other boys without the physiological benefits of testosterone. 62

Finally, lack of access to gender-affirming care continues to mitigate trans youths’ access to sex-segregated school bathrooms and locker rooms. The Biden Administration is expected to reinstate the Obama Administration’s 2016 Title IX guidance that required schools to allow students to use facilities consistent with their gender identities. 63 Even so, there are reasons to think access to gender-affirming medical care is still relevant to determining trans youths’ access to such facilities. First, trans youth may be less comfortable coming out as transgender to their peers and school officials if they have not started medical transition. Second, school districts and courts may be more willing to accept in practice a trans student’s use of facilities consistent with their identified gender if they have provided evidence of being diagnosed with dysphoria or undergoing gender-affirming medical treatment. 64

Proposed State Legislation Banning Gender-Affirming Healthcare for Trans Youth

1. background and legislative context..

A custody battle in a Dallas suburb is an unlikely spark for a political brushfire. But in October 2019, a dispute in Texas family court over parental rights for a seven-year-old transgender girl ignited outrage in conservative circles. 65 The girl’s father, Jeffrey Younger, petitioned for full custody based on his disagreement with her mother’s gender-affirming parenting approach, accusing the mother of “emotional abuse” for allowing the girl to express her gender identity. 66 Unfolding amid a frenzy of media coverage and vocal opposition to the mother’s gender-affirming stance from conservatives, 67 the Younger case shined a national spotlight on the issue of gender-affirming medical care for minors and prompted calls for legislative action from Texas Republicans. 68

In truth, the Younger case and the ensuing media controversy did not begin the political movement against gender-affirming healthcare for minors so much as add fuel to a campaign already broiling within conservative lobbying groups. The Heritage Foundation, one of the most influential conservative think tanks in the United States, 69 hosted a series of events on the “medical risks” of gender-affirming healthcare for trans youth at its DC headquarters throughout 2019. 70 These events proved foundational to later legislative efforts; attendees at the conferences authored several of the bans, 71 and a policy manager at Family Policy Alliance, a Christian conservative lobbying group that cohosted one of the Heritage events, confirmed that her organization “work[ed] with legislators all over the country” to distribute “model” gender-affirming care bans to be introduced during states’ 2020 legislative sessions. 72

With help from these groups, legislators in fifteen states introduced bills between January and March 2020 banning medical professionals from providing gender-affirming healthcare to minors. 73 The bills are tellingly similar in substance and language. 74 Almost every bill (with some minor deviations 75 ) bans all medical professionals in the state from administering puberty blockers or HRT to, or performing gender-affirming surgery on, anyone under the age of eighteen, with notable exceptions for minors with “medically verifiable” developmental disorders or intersex conditions. 76 Most of the proposals make providing gender-affirming care a crime; on the extreme end, violation of Idaho’s prohibition is a felony punishable by a life sentence. 77 Because they would prevent any state-licensed medical providers from administering gender-affirming care, the bans would effectively prohibit trans youth from accessing that care unless they were able to travel out of state. Thus, they would disproportionately burden trans youth from disadvantaged socioeconomic backgrounds and communities of color, who are less likely to have the resources to travel across state lines or to relocate for care. 78

None of the fifteen bills introduced in early 2020 became law, 79 al-though bills in Alabama and South Dakota passed by large margins in individual state houses. 80 But the fact that no bills passed during the 2020 legislative session may not be a meaningful indication of whether they will pass in the future. The COVID-19 lockdowns in the United States in March 2020 forced many state legislatures to adjourn regular sessions before important committee votes on the bills. 81 Additionally, a wave of early failures does not necessarily rule out future success; “bathroom bills” banning trans people from using public bathrooms and changing facilities consistent with their identified genders failed in at least ten states between 2013 and 2015 82 before North Carolina infamously passed House Bill 2 in March 2016. 83 Finally, a recent High Court decision in the United Kingdom severely inhibiting administration of puberty blockers to trans youth under age sixteen is likely to invigorate opponents of gender-affirming care for trans youth in the United States. 84

2. Explaining Gender-Affirming Healthcare Bans.

Legal and political battles over gender-affirming healthcare have persisted for decades, 85 and are somewhat ubiquitous today. 86 Nevertheless, the gender-affirming care bans deserve particular attention because they mark a subtle yet important rhetorical pivot in the broader political opposition to trans youth. To understand the larger sociopolitical significance of the gender-affirming care bans, as well as to lay the foundation for constitutional arguments against them, this section deconstructs the bans’ underlying purposes and rationales.

Some of the bills included statements of legislative purpose that provide useful starting points. For example, the Mississippi Senate bill’s “Legislative findings and intent” section states in part that “the decision to pursue [gender-affirming care] should not be presented to or determined for minors who are incapable of comprehending the negative implications and life-altering difficulties attending to these interventions.” 87 Similar language subsists throughout the proposals, revealing a consistent, surface-level legislative intent to “protect” trans youth from gender-affirming medical interventions. 88

This paternalistic rhetoric represents a narrative shift that has surfaced in the wake of widespread rejection of preexisting justifications for discrimination against trans youth. The most prominent political crusade against trans youth, the bathroom scare of the mid-to-late 2010s, portrayed trans youth as predatory, deviant, and mentally unstable, 89 and their rights to use sex-segregated spaces as intrusions on the privacy and safety of cisgender children. 90 These strategies have largely failed both in courts of law 91 and in the court of public opinion. 92 Even many conservatives have cautioned that overt fearmongering about trans people intruding on others in public spaces is not a winning political strategy. 93

But prejudice dies hard. When one justification for negative treatment of a disfavored group falls out of favor with the public or the legal system, opponents of that group often translate their prejudice into new rhetorical forms that are more palatable. 94 The shift from the stigmatization and vilification of trans youth in the bathroom bills to the victimization narrative embodied in the gender-affirming care bans illustrates how opponents of trans identity are adapting their rhetoric in response to changing legal and social attitudes towards transgender children. Courts, media, and the public should not be fooled. The paternalistic arguments underlying gender-affirming care bans reflect the same underlying prejudices arising from the same individuals and groups, 95 and are directed towards the same ends — erasing trans youth by stigmatizing transgender identity and fortifying the gender binary 96 — as bathroom bills and similar transparently vindictive campaigns. In translating their hostility to trans youth into a more socially acceptable language of “protecting” trans youth from the supposedly fraught choice of whether to transition, 97 cultural conservatives play both sides of the ball. They moderate their image by appealing to fundamental paternalistic impulses while continuing to work toward eradication of transgender identity in children by blocking access to medical services that make transition possible. 98

Their pretextual nature does not — as the UK case illustrated 99 — mean the paternalistic justifications can be ignored. The argument that trans youth should not receive gender-affirming medical care must be vigorously discredited on its own terms as a fallacious rationalization of ingrained prejudices that contradicts both empirical data and the experiences of thousands of children. For one thing, the bills’ central justification, that trans youth lack the capacity for self-reflection necessary to accurately perceive their gender identities, 100 is flatly untrue. Trans youth are quite secure in their gender identities by the time hormonal interventions become physiologically appropriate. 101 A related claim, that trans youth should have to wait until adulthood to transition because many young children who display gender nonconforming behavior “desist,” or do not grow up to be transgender, 102 has questionable empirical support 103 and, more fundamentally, equivocates gender expression with gender identity. There is a meaningful difference between a child who exhibits gender-atypical behavior and a child who persistently identifies as another gender, and the fact that the former child may not be transgender does nothing to invalidate the latter child’s entitlement to access medically necessary gender-affirming care. And gender nonconforming children who later “desist” from expressing the binary gender opposite to their assigned sex may not necessarily identify as cisgender; they may be nonbinary or possess another gender identity. Presuming that all of these persons are cisgender thus erases nonbinary experiences. 104 Second, the implied premise that trans youth have unilateral control over whether and when they transition is empirically untrue because the current standards of care recommend both parental consent and a medical diagnosis of gender dysphoria before a minor can receive puberty blockers or HRT. 105 This “gatekeeping” model, far from uncritically acceding to trans youths’ wishes, privileges caution and deliberation over ease of access. 106 Finally, even if one accepts that a certain number of cisgender youth will mistakenly transition if gender-affirming healthcare is available (which is itself a dubious proposition), that number is likely dwarfed by the number of trans youth who will suffer the opposite, equivalent harm — being unable to transition even though transition is right for them — if gender-affirming healthcare is not available.

Constitutional Arguments Against Gender-Affirming Care Bans

Gender-affirming care bans are not only harmful and founded on false premises, they are also unconstitutional. This section sketches two constitutional arguments against these proposed bans: one based in the Equal Protection Clause of the Fourteenth Amendment, and one based in the parental rights strand of substantive due process jurisprudence.

1. Equal Protection.

The Equal Protection Clause ensures the right of all citizens to enjoy “the equal protection of the laws,” 107 or to be free from unjustified, government-imposed discrimination. 108 An equal protection challenge against a facially discriminatory law usually proceeds in two stages: First, the plaintiff must show that the law discriminates or classifies based on the plaintiff’s membership in a protected class. 109 Second, the burden shifts to the government to show that the classification is justified by an adequate government interest, and the extent of the government’s burden depends on the tier of scrutiny applied to the type of classification at issue. 110

(a) Protected Class. — In the last few years, a growing number of courts of appeals have found that discrimination against transgender people violates equal protection. 111 Some courts have held that transgender status is a protected class in its own right, 112 while others have found that antitransgender discrimination is sex discrimination. 113 Across-the-board bans on gender-affirming healthcare for trans youth would likely receive heightened scrutiny under either framing. Gender-affirming care bans discriminate based on transgender status because they prohibit providing HRT and GCS to minors for the specific purpose of affirming a trans youth’s gender identity, thus facially discriminating against transgender identity, and because in most cases they include exceptions allowing that same care to be provided to cisgender minors for the purpose of treating intersex conditions or “disorder[s] of sexual development.” 114 It may be argued that the bans do not facially discriminate based on transgender status, because they simply bar conduct associated with being transgender . But this formalistic status/conduct distinction was hardly convincing in the context of sexual orientation discrimination and is similarly unpersuasive in the context of antitransgender discrimination. 115

The per se transgender status argument may no longer be necessary, however, in light of the Supreme Court’s recent decision in Bostock v. Clayton County , 116 which held that discrimination against transgender people is sex discrimination under Title VII. 117 Justice Gorsuch’s majority opinion applied a but-for causation standard to find that “discrimination based on . . . transgender status necessarily entails discrimination based on sex.” 118 Although Bostock ’s holding formally reached only Title VII, Justice Alito’s dissent and several courts of appeals recognized that its analysis applies just as clearly to equal protection claims. 119 Just as an employer discriminates “because of sex” when it “intentionally penalizes a person [assigned] male at birth for traits or actions that it tolerates in an employee [assigned] female at birth,” 120 bans on gender-affirming care for minors discriminate because of sex when they deny minors assigned one sex at birth access to certain medical procedures for gender-affirming purposes, but allow those same procedures to be performed for minors assigned the other sex at birth for non-gender-affirming purposes. 121

(b) Government Interest. — To survive heightened scrutiny, the government’s interest must at least be “important” and the law must be “substantially related” to the advancement of the interest. 122 Gender-affirming care bans fail this means-ends inquiry along both dimensions. First, the alleged purpose of the bans — to protect children from receiving gender-affirming healthcare — is fundamentally inconsistent with the empirical evidence and the lived experiences of many trans youth showing the efficacy and safety of these treatments, 123 and is based in faulty logic. 124 It is hard to argue that “protecting” children from medically necessary healthcare that is endorsed by nearly every professional medical association in the country 125 and validated by a near-unanimous consensus in peer-reviewed literature 126 is an interest sufficiently “legitimate” to pass rational basis review, much less one “important” enough to satisfy heightened scrutiny. 127 Second, the bans fail the “substantially related” test because they are considerably underinclusive: even as they identify gender-affirming medical interventions as “dangerous and uncontrolled human medical experiment[s],” 128 they allow the same procedures to be performed on children who have “medically verifiable disorder[s] of sex development.” 129 If the bans are actually motivated by concern over the supposed dangers of puberty blockers, HRT, and GCS, providing an exception allowing those treatments to be performed for practically any medical condition other than gender dysphoria 130 is hardly “substantially related” to abating these alleged harms.

If their purposes are taken at face value, the gender-affirming care bans cannot survive heightened scrutiny. But they also fail under rational basis review, since, as section A explained, their real purpose is preventing transgender children from expressing their transgender identity, 131 an expression of animus against transgender people that cannot be a legitimate government interest in the first place. 132 Animus can be demonstrated in a number of ways: based on inference from the structure of the law and through direct evidence that the law was motivated by prejudice. 133 As the Supreme Court held in City of Cleburne v. Cleburne Living Center, Inc ., 134 the structure of a classification can provide inferential evidence of animus when the alleged government interest does not support targeting the particular group over and above other similarly situated groups. 135 Thus, when state governments profess that bans on gender-affirming medical treatments are meant to protect children from invasive and life-changing medical procedures, but only ban procedures that are performed for the purpose of affirming a trans youth’s gender identity, the arbitrariness of the classification suggests the stated interests are pretext for animus. 136

Ultimately, however, this structural analysis is probably unneeded because there is abundant direct evidence of animus against transgender people surrounding the bans. 137 For example, during a private meeting, the Florida bill’s sponsor told a nonbinary opponent of the bill that transgender people “manufacture” their identities. 138 The author of the South Dakota legislation labeled medical transition in minors a “crime against humanity” and analogized it to medical experimentation at Auschwitz. 139 The lead sponsor of the Colorado bill admitted he was “not concerned” about the potential impact of the bill on the mental health of trans youth in the state, but was disturbed by “a progression of acceptance of young kids being sterilized.” 140 The organizations that promoted these bills also demonstrate clear animus towards transgender identity. YouTube removed the video of the October 2019 Heritage Foundation event that inspired many of the bills after determining that the Heritage panelists’ incendiary comments violated the YouTube hate speech policy. 141 And the Family Policy Alliance, which helped draft many of the bills, declares prominently on its website that it “oppose[s] . . . attempts to normalize” being transgender, “especially amongst impressionable children.” 142

2. Due Process and Parental Rights.

The gender-affirming care bans also arguably violate the Fourteenth Amendment’s due process guarantee of parents ’ rights to make decisions about the upbringing of their children. The due process right to freedom in child rearing is one of the foundational rights protected under substantive due process doctrine, dating back to the early twentieth century 143 and consistently reaffirmed since then. 144 It protects parents’ ability to make important decisions about “the care, custody, and control of their children” free from government interference, 145 based on the presumption that a parent, not the state, is in the best position to determine their child’s best interests. 146 The Supreme Court has never explicitly held that the due process right to freedom in child rearing encompasses the right to direct a child’s medical care, but has implied as much in at least one case. 147 Many other courts and commentators have presumed that parents’ common law right to supervise their children’s healthcare is constitutionally protected. 148 Gender-affirming care bans would likely violate this right. Prohibiting parents from authorizing medically necessary treatment for their children when they believe this care is in their children’s best interests is just the kind of intrusive government conduct that parental due process rights guard against.

Of course, parental rights are not absolute. The state can limit parental autonomy in medical decisionmaking in order to prevent injury to children’s health and well-being. 149 For example, many states have passed bans on conversion therapy for minors based on the nearly unanimous medical consensus that such treatment is harmful and dangerous. 150 Courts have upheld these bans against due process challenges on the ground that “the fundamental rights of parents do not include the right to choose . . . a specific medical or mental health treatment that the state has reasonably deemed harmful.” 151

The test is whether the treatment is actually harmful or reasonably believed to be harmful, which depends on the weight of scientific evidence for the legislature’s judgment. Conversion therapy bans do not violate due process because a considerable scientific consensus views conversion therapy as harmful and senseless. 152 The crucial difference in the case of gender-affirming care bans is that the weight of the scientific supermajority, 153 along with a growing canon of empirical research 154 and the lived experiences of thousands of trans youth who benefit from gender-affirming care, is against the legislatures’ judgments that gender-affirming care is harmful.

None of this is to say that challenges to gender-affirming healthcare bans on due process grounds are certain to prevail. Courts often fail to interrogate the factual underpinnings of a legislature’s judgment because their focus is more directly trained on rooting out the motivations of the legislature than on checking the lawmakers’ work in an empirical sense, 155 or because they are distracted by their moral preconceptions of an issue. 156 This failure is unfortunately commonplace in transgender rights cases, 157 though recent decisions have shown improvement in this regard. 158 There is also a risk that parental due process arguments could be turned against trans youth who seek to use state resources to obtain access to gender-affirming care against the wishes of unaccepting parents. Detailed exploration of this question is not possible here, but it is doubtful that the best-interests presumption applies if the parent’s decision not to accept their child’s transgender identity or desire to transition is motivated by prejudice, to which “the law cannot, directly or indirectly, give . . . effect.” 159

Anxiety about gender-affirming medical interventions for trans youth is understandable in many respects. Puberty blockers, HRT, and GCS are dramatic and life-changing decisions. However, a failure to intervene can be equally consequential. In other words, foregoing gender-affirming care “is not a neutral option” 160 for trans youth: it is a choice that imposes significant risks of physical, mental, social, and legal harms. Even so, this Chapter does not argue that every trans youth must transition before adulthood. Although evidence suggests this is the best option in many cases, every trans youth is different, and many transgender people live happy and healthy lives after transitioning as adults. Nor does this Chapter have the scope to opine on the ideal distribution of agency in these decisions between doctors, parents, and trans youth, beyond the observation that parents’ animus or prejudice against transgender people should not inhibit a youth’s access to care. 161 Ultimately, “protecting” trans youth requires allowing them to access medical care that permits them to live according to their own definitions of themselves, rather than the definitions ascribed to them by politicians whose goal is not protection, but suppression of children whose identities threaten their worldview. Perhaps lawmakers will one day realize this. But for now, the issue of gender-affirming healthcare for trans youth remains a heated battleground in the culture war, with the rights of thousands of children once again subject to political will.

^ Pam O’Brien, How Nicole Maines Is Paving the Way for the Next Generation of LGBTQ Youth , Shape (Aug. 15, 2019), <a href=" https://www.shape.com/celebrities/interviews/nicole-maines-transgender-activist-supergirl ">https://www.shape.com/celebrities/interviews/nicole-maines-transgender-activist-supergirl">https://www.shape.com/celebrities/interviews/nicole-maines-transgender-activist-supergirl [ https://perma.cc/5QET-8948 ].

^ See Michelle M. Johns et al., Transgender Identity and Experiences of Violence Victimization, Substance Use, Suicide Risk, and Sexual Risk Behaviors Among High School Students — 19 States and Large Urban School Districts, 2017 , 68 Morbidity & Mortality Wkly. Rep . 67, 70 (2019).

^ Hereinafter “trans youth,” which this Chapter defines as transgender children and adolescents between roughly twelve and eighteen years of age.

^ This Chapter assumes basic familiarity with terms like “transgender” and “cisgender” and with the difference between assigned sex at birth and gender identity. For an introductory explanation of these concepts, see Understanding Gender , Gender Spectrum , <a href=" https://genderspectrum.org/articles/understanding-gender ">https://genderspectrum.org/articles/understanding-gender">https://genderspectrum.org/articles/understanding-gender [ https://perma.cc/U635-823E ].

^ See Jason Rafferty, Ensuring Comprehensive Care and Support for Transgender and Gender-Diverse Children and Adolescents , Pediatrics , Oct. 2018, at 1, 4–5.

^ See generally, e.g ., Emily Ikuta, Note, Overcoming the Parental Veto: How Transgender Adolescents Can Access Puberty-Suppressing Hormone Treatment in the Absence of Parental Consent Under the Mature Minor Doctrine , 25 S. Cal. Interdisc. L.J. 179 (2016) (describing the problems that arise when the parent of a trans youth refuses to provide consent to gender-affirming treatment for their child, and how minors can argue for the right to consent).

^ See, e.g ., Diane Ehrensaft, Gender Nonconforming Youth: Current Perspectives , 8 Adolescent Health Med. & Therapeutics 57, 57–58 (2017). This increased research and attention has largely centered on the experiences of youth who transition from one binary gender to the other, and has neglected the experiences of nonbinary youth. Abbie E. Goldberg et al., Health Care Experiences of Transgender Binary and Nonbinary University Students , 47 Counseling Psych . 59, 86 (2019). For more on the experiences of nonbinary youth in transgender healthcare, see, for example, Gary E. Butler, Child and Adolescent Endocrinology , in Genderqueer and Non-binary Genders 171, 177–79 (Christina Richards, Walter Pierre Bouman & Meg-John Barker eds., 2017); and Goldberg et al., supra , at 86–90.

^ This Chapter uses the umbrella term “gender-affirming healthcare” to describe the range of medical services that trans youth use to bring their bodies and lived experiences into alignment with their gender identities (“transition”).

^ See Past Legislation Affecting LGBT Rights Across the Country , ACLU (Mar. 20, 2020), https://www.aclu.org/past-legislation-affecting-lgbt-rights-across-country-2020 [ https://perma.cc/KQ6T-KDR2 ] [hereinafter ACLU Legislation Tracker ]; H.B. 3515, 101st Gen. Assemb., Reg. Sess. (Ill. 2019). The Illinois bill was originally introduced in 2019, but changed sponsors in 2020. See Bill Status of HB 3515 , Ill. Gen. Assembly , https://www.ilga.gov/legislation/BillStatus.asp?DocNum=3515&GAID=15&DocTypeID=HB&SessionID=108&GA=101 [ https://perma.cc/6S5R-6SX9 ].

^ See ACLU Legislation Tracker , supra note 9; Bill Status of HB 3515 , supra note 9.

^ See H.B. 1, 2021 Leg., Reg. Sess. (Ala. 2021); S.B. 224, 122d Gen. Assemb., 1st Reg. Sess. (Ind. 2021); H. File 193, 89th Gen. Assemb., Reg. Sess. (Iowa 2021); H.B. 33, 101st Gen. Assemb., 1st Reg. Sess. (Mo. 2021); H.B. 113, 67th Leg., Reg. Sess. (Mont. 2021); H.B. 68, 167th Gen. Ct., Reg. Sess. (N.H. 2021); S.B. 676, 58th Leg., 1st Reg. Sess. (Okla. 2021); H.B. 92, 64th Leg., Gen. Sess. (Utah 2021); H.B. 68, 87th Leg., Reg. Sess. (Tex. 2020). For an up-to-date list of gender-affirming care bans filed in 2021, see Legislative Tracker: Anti-transgender Medical Care Bans , Freedom for All Ams ., <a href=" https://freedomforallamericans.org/legislative-tracker/medical-care-bans ">https://freedomforallamericans.org/legislative-tracker/medical-care-bans/">https://freedomforallamericans.org/legislative-tracker/medical-care-bans [ https://perma.cc/JX3V-J3US ].

^ See Bell v. Tavistock [2020] EWHC (Admin) 3274 [151] (Eng.).

^ Because the rationales and legal errors underlying the 2021 bills were substantially the same as the 2020 bills, and because the 2021 bills were rapidly evolving and changing at the time of publication, this Chapter focuses its critique on the 2020 bills rather than the 2021 bills.

^ See, e.g ., Hallie Horowitz, Introduction to Just Evelyn, Mom, I Need to Be a Girl 4, 4 (1998), <a href=" https://ai.eecs.umich.edu/people/conway/TS/Evelyn/Mom_I_need_to_be_a_girl.pdf ">http://ai.eecs.umich.edu/people/conway/TS/Evelyn/Mom_I_need_to_be_a_girl.pdf">https://ai.eecs.umich.edu/people/conway/TS/Evelyn/Mom_I_need_to_be_a_girl.pdf [ https://perma.cc/LD34-7MYX ] (describing “one of the first” adolescent transitions in the mid-1990s).

^ Johns et al., supra note 2, at 68. 1.6 percent said they were “not sure.” Id .

^ See Ehrensaft, supra note 7, at 57–58.

^ World Pro. Ass’n for Transgender Health, Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People 5 (7th ed. 2012) [hereinafter WPATH SOC]. Importantly, dysphoria is a psychological condition that results from a difference between gender identity and assigned sex at birth; transgender identity is not itself a psychological condition or mental illness. See id . at 5–6.

^ See id . at 8.

^ Kellan E. Baker, The Future of Transgender Coverage , 376 New Eng. J. Med. 1801 , 1801 (2017); see Professional Organization Statements Supporting Transgender People in Health Care , Lambda Legal (Sept. 17, 2018), https://www.lambdalegal.org/sites/default/files/publications/downloads/resource_trans-professional-statements_09-18-2018.pdf [ https://perma.cc/5HTA-PUHR ] (collecting statements of medical necessity). “Medically necessary” — and the closely related term “medical necessity” — is a term of art used to describe “[h]ealth care services or supplies needed to diagnose or treat an illness, injury, condition, disease or its symptoms and that meet accepted standards of medicine.” Medically Necessary , HealthCare.gov , <a href=" https://www.healthcare.gov/glossary/medically-necessary ">https://www.healthcare.gov/glossary/medically-necessary/">https://www.healthcare.gov/glossary/medically-necessary [ https://perma.cc/Y6K7-HAKL ].

^ See WPATH SOC, supra note 17, at 1–2; Rafferty, supra note 5, at 6. Other medical associations also provide guidance to clinicians in specific areas of care such as hormone treatment. See, e.g ., Wylie C. Hembree et al., Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline , 102 J . Clinical Endocrinology & Metabology 3869, 3874 (2017).

^ See Am. Med. Ass’n House of Delegates, Resolution: 122, Subject: Removing Financial Barriers to Care for Transgender Patients 1 (2008), <a href=" https://www.imatyfa.org/assets/ama122.pdf ">http://www.imatyfa.org/assets/ama122.pdf">https://www.imatyfa.org/assets/ama122.pdf [ https://perma.cc/T6RY-7LZN ]; Edmo v. Corizon, Inc., 935 F.3d 757, 769 (9th Cir. 2019) (citing case law and medical authority recognizing the WPATH SOC as the prevailing medical standard).

^ See WPATH SOC, supra note 17, at 14, 18–19.

^ See Johanna Olson, Catherine Forbes & Marvin Belzer, Management of the Transgender Adolescent , 165 Archives Pediatric & Adolescent Med . 171, 174 (2011) (stating that the majority of gender specialists follow this affirming approach); Leigh A. Spivey & Laura Edwards-Leeper, Future Directions in Affirmative Psychological Interventions with Transgender Children and Adolescents , 48 J. Clinical Child & Adolescent Psych . 343, 347–48 (2019).

^ See Simone Mahfouda et al., Review, Puberty Suppression in Transgender Children and Adolescents , 5 Lancet Diabetes & Endocrinology 816, 817–18 (2017).

^ Id . at 816; see WPATH SOC, supra note 17, at 19.

^ See WPATH SOC, supra note 17, at 19; Mahfouda et al., supra note 24, at 817–18.

^ See Hembree et al., supra note 20, at 3884–85.

^ See WPATH SOC, supra note 17, at 33–34.

^ Id . at 48.

^ Id . at 38 tbl.1B.

^ Id . at 49.

^ Id . at 37 tbl.1A.

^ See Butler, supra note 7, at 179; Anna Martha Vaitses Fontanari et al., Gender Affirmation Is Associated with Transgender and Gender Nonbinary Youth Mental Health Improvement , 7 LGBT Health 237, 243 (2020).

^ See WPATH SOC, supra note 17, at 20; Hembree et al., supra note 20, at 3878 tbl.5. But see generally Ikuta, supra note 6 (describing a strategy for minors in the United States to obtain HRT without parental consent).

^ See WPATH SOC, supra note 17, at 21, 54–55; see also Olson, Forbes & Belzer, supra note 23, at 176.

^ See, e.g ., Clinical Policy Bulletin, Gender Affirming Surgery , Aetna (Jan. 12, 2021), <a href="https://www.aetna.com/cpb/medical/data/600_699/0615.html ">https://www.aetna.com/cpb/medical/data/600_699/0615.html [ https://perma.cc/C5ZK-VZAR ].

^ WPATH SOC, supra note 17, at 21; see also Masculinizing Chest Reconstruction (“Top Surgery”) , UCSF Transgender Care , <a href=" https://transcare.ucsf.edu/masculinizing-chest-reconstruction-top-surgery ">https://transcare.ucsf.edu/masculinizing-chest-reconstruction-top-surgery/">https://transcare.ucsf.edu/masculinizing-chest-reconstruction-top-surgery [ https://perma.cc/6HM2-UV5W ].

^ See, e.g ., Trevor Project, National Survey on LGBTQ Youth Mental Health 2020 , at 3 (2020), <a href=" https://www.thetrevorproject.org/wp-content/uploads/2020/07/The-Trevor-Project-National-Survey-Results-2020.pdf ">https://www.thetrevorproject.org/wp-content/uploads/2020/07/The-Trevor-Project-National-Survey-Results-2020.pdf">https://www.thetrevorproject.org/wp-content/uploads/2020/07/The-Trevor-Project-National-Survey-Results-2020.pdf [ https://perma.cc/WXM5-JVG6 ]; Johanna Olson et al., Baseline Physiologic and Psychosocial Characteristics of Transgender Youth Seeking Care for Gender Dysphoria , 57 J. Adolescent Health 374, 375, 378 tbl.5 (2015).

^ Olson et al., supra note 38, at 379.

^ Id .; see also Johns et al., supra note 2, at 69 tbl.2 (finding that 43.9% of transgender high school students considered attempting and 34.6% attempted).

^ See, e.g ., Rosalia Costa et al., Psychological Support, Puberty Suppression, and Psychosocial Functioning in Adolescents with Gender Dysphoria , 12 J. Sexual Med . 2206, 2212 (2015); Annelou L.C. de Vries et al., Young Adult Psychological Outcome After Puberty Suppression and Gender Reassignment , Pediatrics , Oct. 2014, at 1, 6–7; Fontanari et al., supra note 33, at 243; Kristina R. Olson et al., Mental Health of Transgender Children Who Are Supported in Their Identities , Pediatrics , Mar. 2016, at 1, 5; Jack L. Turban et al., Pubertal Suppression for Transgender Youth and Risk of Suicidal Ideation , Pediatrics , Feb. 2020, at 1, 5; Anna I.R. van der Miesen et al., Psychological Functioning in Transgender Adolescents Before and After Gender-Affirmative Care Compared with Cisgender General Population Peers , 66 J. Adolescent Health 699, 703 (2020).

^ See de Vries et al., supra note 41, at 7. See generally What Does the Scholarly Research Say About the Effect of Gender Transition on Transgender Well-Being? , Cornell Univ.: What We Know Project , <a href=" https://whatweknow.inequality.cornell.edu/topics/lgbt-equality/what-does-the-scholarly-research-say-about-the-well-being-of-transgender-people ">https://whatweknow.inequality.cornell.edu/topics/lgbt-equality/what-does-the-scholarly-research-say-about-the-well-being-of-transgender-people">https://whatweknow.inequality.cornell.edu/topics/lgbt-equality/what-does-the-scholarly-research-say-about-the-well-being-of-transgender-people [ https://perma.cc/RZ6H-4JC8 ] [hereinafter What We Know Project ] (collecting over fifty studies showing improvements in quality of life for transgender people after gender-affirming care).

^ Lily Durwood, Katie A. McLaughlin & Kristina R. Olson, Mental Health and Self-Worth in Socially Transitioned Transgender Youth , 56 J. Am. Acad. Child & Adolescent Psychiatry 116, 116 (2017).

^ de Vries et al., supra note 41, at 7 (finding that transitioned youth exhibited “quality of life, satisfaction with life, and subjective happiness” scores similar to those of cisgender youth).

^ See Turban et al., supra note 41, at 5.

^ AACAP Statement Responding to Efforts to Ban Evidence-Based Care for Transgender and Gender Diverse Youth , Am. Acad. Child & Adolescent Psychiatry (Nov. 8, 2019), <a href=" https://www.aacap.org/AACAP/Latest_News/AACAP_Statement_Responding_to_Efforts-to_ban_Evidence-Based_Care_for_Transgender_and_Gender_Diverse.aspx ">https://www.aacap.org/AACAP/Latest_News/AACAP_Statement_Responding_to_Efforts-to_ban_Evidence-Based_Care_for_Transgender_and_Gender_Diverse.aspx">https://www.aacap.org/AACAP/Latest_News/AACAP_Statement_Responding_to_Efforts-to_ban_Evidence-Based_Care_for_Transgender_and_Gender_Diverse.aspx [ https://perma.cc/WXH9-5AKY ] [hereinafter AACAP Statement ]; see also Endocrine Soc’y & Pediatric Endocrine Soc’y, Transgender Health Position Statement (2020), <a href=" https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/position_statement_transgender_health_pes.pdf ">https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/position_statement_transgender_health_pes.pdf">https://www.endocrine.org/-/media/endocrine/files/advocacy/position-statement/position_statement_transgender_health_pes.pdf [ https://perma.cc/JQ9S-TAQ2 ].

^ See, e.g ., Johns et al., supra note 2, at 69 tbl.2 (showing significantly higher rates of in-person and online bullying and feelings of unsafety at school compared to cisgender students); cf . Trevor Project , supra note 38, at 7 (showing high levels of violence and discrimination against transgender youth).

^ See sources cited supra notes 38–40 and accompanying text.

^ See Goldberg et al., supra note 7, at 7.

^ See Hembree et al., supra note 20, at 3880–81 (listing various “[i]rreversible and . . . undesirable sex characteristics” that develop during assigned-sex puberty, id . at 3881); Turban et al., supra note 41, at 6.

^ See Jenifer K. McGuire et al., Body Image in Transgender Young People: Findings from a Qualitative, Community Based Study , 18 Body Image 96, 103 (2016) (noting that transgender young people feel social stress when they exhibit physical characteristics associated with their assigned sexes); Developments in the Law — Sexual Orientation & Gender Identity , 127 Harv. L. Rev . 1680, 1726 (2014) (noting the “severe negative impact” of discrimination on trans students’ educational outcomes and that socially transitioned trans youth “report a healthier sense of belonging than their peers who are not able to express and embrace their transgender identities”).

^ See, e.g ., Laura Kuper , IMPACT LGBT Health & Dev. Program , Puberty Blocking Medications 8 (2014), <a href=" https://www.impactprogram.org/wp-content/uploads/2014/12/Kuper-2014-Puberty-Blockers-Clinical-Research-Review.pdf ">https://www.impactprogram.org/wp-content/uploads/2014/12/Kuper-2014-Puberty-Blockers-Clinical-Research-Review.pdf">https://www.impactprogram.org/wp-content/uploads/2014/12/Kuper-2014-Puberty-Blockers-Clinical-Research-Review.pdf [ https://perma.cc/78G8-PAZW ] (“[I]t is more difficult to align the body with one’s affirmed gender once physical changes in [puberty] occur . . . .”). It should be noted, however, that the concept of “passing” as one’s identified gender may not apply to nonbinary individuals, whose gender identities may not align with a binary mode of gender presentation. Cf . Christina Richards, Psychology , in Genderqueer and Non-binary Genders , supra note 7, at 141, 147 (noting that the genders of nonbinary people may be “socially unintelligible” such that they “find themselves in the trap of either seeming to be what they aren’t and so being accepted, or seeming to be what they are and so facing opprobrium”).

^ See Margaret To et al., Visual Conformity with Affirmed Gender or “Passing”: Its Distribution and Association with Depression and Anxiety in a Cohort of Transgender People , 17 J. Sexual Med . 2084, 2088 (2020).

^ See id . at 2089; Brynn Tannehill, For Many Trans People, Not Passing Is Not an Option , Slate (June 27, 2018, 11:54 AM), <a href=" https://slate.com/human-interest/2018/06/not-passing-or-blending-is-dangerous-for-many-trans-people.html ">https://slate.com/human-interest/2018/06/not-passing-or-blending-is-dangerous-for-many-trans-people.html">https://slate.com/human-interest/2018/06/not-passing-or-blending-is-dangerous-for-many-trans-people.html [ https://perma.cc/3EPP-6ZNS ].

^ See Costa et al., supra note 41, at 2212 (stating that use of puberty blockers results in “improvement in many aspects of . . . psychosocial functioning, such as mood improvement and school integration”); McGuire et al., supra note 51, at 105 (reporting increased confidence, self-acceptance, and social adjustment in trans youth who transition).

^ See, e.g ., Kuper , supra note 52, at 8; Ikuta, supra note 6, at 213.

^ See To et al., supra note 53, at 2089; Tannehill, supra note 54.

^ See Nat’l Ctr. for Transgender Equal., Summary of State Birth Certificate Gender Change Laws (2020), <a href=" https://transequality.org/sites/default/files/docs/resources/Summary of State Birth Certificate Laws Jan 2020.pdf"><a href="https://transequality.org/sites/default/files/docs/resources/Summary%20of%20State%20Birth%20Certificate%20Laws%20Jan%202020.pdf ">https://transequality.org/sites/default/files/docs/resources/Summary%20of%20State%20Birth%20Certificate%20Laws%20Jan%202020.pdf [ https://perma.cc/PP39-SYZ2 ]; Identity Document Laws and Policies , Movement Advancement Project (Feb. 11, 2021), <a href=" https://www.lgbtmap.org/equality-maps/identity_document_laws ">https://www.lgbtmap.org/equality-maps/identity_document_laws">https://www.lgbtmap.org/equality-maps/identity_document_laws [ https://perma.cc/E2BP-4HB7 ].

^ See Abbie E. Goldberg, Genny Beemyn & JuliAnna Z. Smith, What Is Needed, What Is Valued: Trans Students’ Perspectives on Trans-Inclusive Policies and Practices in Higher Education , 29 J. Educ. & Psych. Consultation 27, 31–32 (2019).

^ Jacob Gershman, States Weigh Measures to Stop Transgender Athletes from Competing in Women’s Sports , Wall St. J . (Jan. 7, 2020, 5:30 AM), <a href=" https://www.wsj.com/articles/states-weigh-measures-to-stop-transgender-athletes-from-competing-in-womens-sports-11578393001 ">https://www.wsj.com/articles/states-weigh-measures-to-stop-transgender-athletes-from-competing-in-womens-sports-11578393001">https://www.wsj.com/articles/states-weigh-measures-to-stop-transgender-athletes-from-competing-in-womens-sports-11578393001 [ https://perma.cc/SX58-6ERN ]; see NCAA Off. of Inclusion, NCAA Inclusion of Transgender Student-Athletes 13 ( 2011) , <a href=" https://www.ncaa.org/sites/default/files/Transgender_Handbook_2011_Final.pdf ">http://www.ncaa.org/sites/default/files/Transgender_Handbook_2011_Final.pdf">https://www.ncaa.org/sites/default/files/Transgender_Handbook_2011_Final.pdf [ https://perma.cc/RG7X-HHJ2 ]. Along with their campaigns against gender-affirming healthcare, see infra section B.1, pp. 2172–75, state legislatures have launched a parallel nationwide offensive against trans girls’ participation in women’s sports, see Gershman, supra ; see also , e.g ., Hecox v. Little, No. 20-cv-00184, 2020 WL 4760138, at *15, *39 (D. Idaho Aug. 17, 2020) (granting preliminary injunction against one such athletics ban on trans girls).

^ See, e.g ., NCAA Off. of Inclusion , supra note 60, at 13 (“A trans male (FTM) student-athlete who is not taking testosterone related to gender transition may participate on a men’s or women’s team.”).

^ Cf . David J. Handelsman, Angelica L. Hirschberg & Stephanie Bermon, Circulating Testosterone as the Hormonal Basis of Sex Differences in Athletic Performance , 39  Endocrine Revs . 803, 823 (2018) (finding that higher testosterone explains “most, if not all, the sex differences in sporting performance”).

^ See The Biden Plan to Advance LGBTQ+ Equality in America and Around the World , Biden for President , <a href=" https://joebiden.com/lgbtq-policy ">https://joebiden.com/lgbtq-policy/">https://joebiden.com/lgbtq-policy [ https://perma.cc/8TDP-C4UD ]; Dear Colleague Letter on Transgender Students from Catherine E. Lhamon, Assistant Sec’y for C.R., U.S. Dep’t of Educ. & Vanita Gupta, Principal Deputy Assistant Att’y Gen. for C.R., U.S. Dep’t of Just. 3 (May 13, 2016), https://www2.ed.gov/about/offices/list/ocr/letters/colleague-201605-title-ix-transgender.pdf [ https://perma.cc/85P9-GFHP ].

^ Cf., e.g ., Adams ex rel . Kasper v. Sch. Bd., 318 F. Supp. 3d 1293, 1326 (M.D. Fla. 2018), aff’d , 968 F.3d 1286 (11th Cir. 2020) (crediting evidence of the plaintiff’s “social, medical, and legal transitions” in determining he had a right to use the boys’ restroom at school).

^ See Teo Armus, A Texas Man Says His 7-Year-Old Isn’t Transgender. Now His Custody Fight Has Reached the Governor’s Office ., Wash. Post (Oct. 24, 2019, 6:13 AM), <a href=" https://www.washingtonpost.com/nation/2019/10/24/james-younger-luna-transgender-greg-abbott ">https://www.washingtonpost.com/nation/2019/10/24/james-younger-luna-transgender-greg-abbott/">https://www.washingtonpost.com/nation/2019/10/24/james-younger-luna-transgender-greg-abbott [ https://perma.cc/WSH8-BDJF ].

^ See, e.g ., Senator Ted Cruz (@SenTedCruz), Twitter (Oct. 23, 2019, 7:01 PM), <a lang="en"" href=" https://twitter.com/sentedcruz/status/1187157024888496128 ">https://twitter.com/sentedcruz/status/1187157024888496128?lang=en">https://twitter.com/sentedcruz/status/1187157024888496128 [ https://perma.cc/X67V-3LQZ ] (accusing the mother of “child abuse”).

^ María Méndez, Could Transgender Kids’ Care Be Next “Bathroom Bill” for Texas Republicans? , Dall. Morning News (Oct. 25, 2019, 11:57 AM), <a href=" https://www.dallasnews.com/news/politics/2019/10/25/could-transgender-kids-care-be-next-bathroom-bill-for-texas-republicans ">https://www.dallasnews.com/news/politics/2019/10/25/could-transgender-kids-care-be-next-bathroom-bill-for-texas-republicans/">https://www.dallasnews.com/news/politics/2019/10/25/could-transgender-kids-care-be-next-bathroom-bill-for-texas-republicans [ https://perma.cc/7MCJ-DWYA ].

^ See About Heritage , Heritage Found ., <a href=" https://www.heritage.org/about-heritage/impact ">https://www.heritage.org/about-heritage/impact">https://www.heritage.org/about-heritage/impact [ https://perma.cc/TPW2-KYPQ ].

^ See, e.g ., Summit on Protecting Children from Sexualization , Heritage Found ., at 2:12:28 (Oct. 9, 2019), <a href=" https://www.heritage.org/marriage-and-family/event/summit-protecting-children-sexualization ">https://www.heritage.org/marriage-and-family/event/summit-protecting-children-sexualization">https://www.heritage.org/marriage-and-family/event/summit-protecting-children-sexualization [ https://perma.cc/DN2P-RRXZ ] [hereinafter Summit ]; see also Brianna January, Anti-LGBTQ Group Heritage Foundation Has Hosted Four Anti-trans Panels So Far in 2019 , Media Matters for Am . (Apr. 18, 2019, 9:18 AM), <a href=" https://www.mediamatters.org/heritage-foundation/anti-lgbtq-group-heritage-foundation-has-hosted-four-anti-trans-panels-so-far ">https://www.mediamatters.org/heritage-foundation/anti-lgbtq-group-heritage-foundation-has-hosted-four-anti-trans-panels-so-far">https://www.mediamatters.org/heritage-foundation/anti-lgbtq-group-heritage-foundation-has-hosted-four-anti-trans-panels-so-far [ https://perma.cc/Q7SK-D5DT ].

^ See Sydney Bauer, The New Anti-trans Culture War Hiding in Plain Sight , New Republic (Feb. 11, 2020), <a href=" https://newrepublic.com/article/156539/new-anti-trans-culture-war-hiding-plain-sight ">https://newrepublic.com/article/156539/new-anti-trans-culture-war-hiding-plain-sight">https://newrepublic.com/article/156539/new-anti-trans-culture-war-hiding-plain-sight [ https://perma.cc/ZC7X-JK3E ]; Chris Johnson, Advocates Prepare for Fight as Anti-trans Youth Legislation Advances in S.D ., Wash. Blade (Jan. 31, 2020, 2:22 PM), <a href=" https://www.washingtonblade.com/2020/01/31/advocates-prepare-for-fight-as-anti-trans-youth-legislation-advances-in-s-d ">https://www.washingtonblade.com/2020/01/31/advocates-prepare-for-fight-as-anti-trans-youth-legislation-advances-in-s-d/">https://www.washingtonblade.com/2020/01/31/advocates-prepare-for-fight-as-anti-trans-youth-legislation-advances-in-s-d [ https://perma.cc/85YF-JHX3 ].

^ See Bauer, supra note 71; Summit , supra note 70. Model legislation is often a symptom of pervasive interest group influence in state legislatures. See Rob O’Dell & Nick Penzenstadler, You Elected Them to Write New Laws. They’re Letting Corporations Do It Instead ., USA Today (June 19, 2019, 5:56 PM), <a href=" https://www.usatoday.com/in-depth/news/investigations/2019/04/03/abortion-gun-laws-stand-your-ground-model-bills-conservatives-liberal-corporate-influence-lobbyists/3162173002 ">https://www.usatoday.com/in-depth/news/investigations/2019/04/03/abortion-gun-laws-stand-your-ground-model-bills-conservatives-liberal-corporate-influence-lobbyists/3162173002/">https://www.usatoday.com/in-depth/news/investigations/2019/04/03/abortion-gun-laws-stand-your-ground-model-bills-conservatives-liberal-corporate-influence-lobbyists/3162173002 [ https://perma.cc/3ACT-WP3W ].

^ See sources cited supra note 9. Although a Utah Representative was considering a bill to ban HRT and GCS, he changed course and drafted a bill geared toward exploratory research into gender-affirming healthcare. See Connor Richards, Utah House Rejects Bill to Study Effects of Hormone Therapy on Transgender Minors , Daily Herald (Mar. 10, 2020), https://www.heraldextra.com/news/local/govt-and-politics/legislature/utah-house-rejects-bill-to-study-effects-of-hormone-therapy-on-transgender-minors/article_2fc144a0-9573-50fc-a6e7-60841a6d8632.html [ https://perma.cc/M4CH-44DC ]. The fifteen-state count thus does not include the Utah bill.

^ For a database containing links to the text, sponsors, and status of the 2020 bills, see ACLU Legislation Tracker , supra note 9. For the bills introduced so far in 2021, see sources cited supra note 11; Legislation Affecting LGBT Rights Across the Country , ACLU (Feb. 11, 2021), https://www.aclu.org/legislation-affecting-lgbt-rights-across-country [ https://perma.cc/RD96-UXDP ].

^ Tennessee’s bill banned all gender-affirming care for minors who have not started puberty, but allowed minors who have begun puberty to receive gender-affirming care upon the recommendation of three physicians. See H.B. 2576, 111th Gen. Assemb., Reg. Sess. § 1(b) (Tenn. 2020). In addition, Missouri’s, Oklahoma’s, and South Carolina’s bills did not contain a “medically verifiable” exception, see H.B. 1721, 100th Gen. Assemb., 2d Reg. Sess. (Mo. 2020); S.B. 1819, 57th Leg., 2d Reg. Sess. (Okla. 2020); H.B. 4716, 123d Gen. Assemb, Reg. Sess. (S.C. 2020), and Mississippi’s and South Dakota’s bills did not follow the eighteen-year cutoff, see S.B. 2490, 2020 Leg., Reg. Sess. § 3(b) (Miss. 2020) (defining minors as below age twenty-one); H.B. 1057, 95th Gen. Assemb., Reg. Sess. (S.D. 2020) (defining minors as below age sixteen).

^ See, e.g ., S. File 2213, 88th Gen. Assemb., Reg. Sess. § 1 (3) (Iowa 2020); H.B. 513, 133d Gen. Assemb., Reg. Sess. § 1, sec. 5128.03(C)(1) (Ohio 2020).

^ See H.B. 465, 65th Leg., 2d Reg. Sess. (Idaho 2020). The law would have defined gender-affirming care as “genital mutilation of a child,” which carries a maximum life sentence under the state criminal code. See id .; Idaho Code § 18-1506B(6) (2020).

^ Cf . Annamarie Forestiere, America’s War on Black Trans Women , Harv. C.R.-C.L. L. Rev. Amicus Blog (Sept. 23, 2020), <a href=" https://harvardcrcl.org/americas-war-on-black-trans-women ">https://harvardcrcl.org/americas-war-on-black-trans-women/">https://harvardcrcl.org/americas-war-on-black-trans-women [ https://perma.cc/DRD4-RHXY ] (noting that high poverty and homelessness rates among Black trans women affect their ability to travel); La’Tasha D. Mayes, Black Women Are Dying from a Lack of Access to Reproductive Health Services , TIME (Jan. 19, 2018, 11:53 AM), <a href=" https://time.com/5109797/black-women-dying-reproductive-health ">https://time.com/5109797/black-women-dying-reproductive-health/">https://time.com/5109797/black-women-dying-reproductive-health [ https://perma.cc/LY33-M8JL ] (showing how similar laws restricting reproductive healthcare access disparately affect people of color).

^ See ACLU Legislation Tracker , supra note 9.

^ See Bauer, supra note 71; Nico Lang, Alabama Moves Closer to Transgender Health Care Ban for Minors , NBC News (Mar. 10, 2020, 4:21 PM), <a href=" https://www.nbcnews.com/feature/nbc-out/alabama-moves-closer-transgender-health-care-ban-minors-n1154791 ">https://www.nbcnews.com/feature/nbc-out/alabama-moves-closer-transgender-health-care-ban-minors-n1154791">https://www.nbcnews.com/feature/nbc-out/alabama-moves-closer-transgender-health-care-ban-minors-n1154791 [ https://perma.cc/3KDX-HYYE ].

^ See Changes to State Legislative Session Dates in Response to the Coronavirus (COVID-19) Pandemic, 2020 , Ballotpedia (Jan. 21, 2021), https://ballotpedia.org/Changes_to_state_legislative_session_dates_in_response_to_the_coronavirus_(COVID-19)_pandemic,_2020 [ https://perma.cc/JK26-WYNM ]; ACLU Legislation Tracker , supra note 9 (showing that several bills died in committee in mid-March).

^ See Joellen Kralik, “ Bathroom Bill” Legislative Tracking , Nat’l Conf. of State Legislatures (Oct. 24, 2019), <a href=" https://www.ncsl.org/research/education/-bathroom-bill-legislative-tracking635951130.aspx ">https://www.ncsl.org/research/education/-bathroom-bill-legislative-tracking635951130.aspx">https://www.ncsl.org/research/education/-bathroom-bill-legislative-tracking635951130.aspx [ https://perma.cc/5JH4-QPZA ] (listing the states).

^ See Elena Schneider, The Bathroom Bill that Ate North Carolina , Politico Mag . (Mar. 23, 2017), <a href=" https://www.politico.com/magazine/story/2017/03/the-bathroom-bill-that-ate-north-carolina-214944 ">https://www.politico.com/magazine/story/2017/03/the-bathroom-bill-that-ate-north-carolina-214944">https://www.politico.com/magazine/story/2017/03/the-bathroom-bill-that-ate-north-carolina-214944 [ https://perma.cc/5E4M-VHQC ]; see also N.C. Gen. Stat . § 143-760(b), (d) (repealed 2017).

^ See Bell v. Tavistock [2020] EWHC (Admin) 3274 (Eng.). The court ruled that puberty blockers are presumptively inappropriate for adolescents under sixteen, id . at [151], and that court authorization may be necessary for sixteen- and seventeen-year-olds, id . at [152].

^ See, e.g ., G.B. v. Lackner, 145 Cal. Rptr. 555, 556, 559 (Ct. App. 1978) (reversing state health department’s denial of insurance coverage for GCS).

^ See, e.g ., Whitman-Walker Clinic, Inc. v. U.S. Dep’t of Health & Hum. Servs., No. CV 20-1630, 2020 WL 5232076, at *1 (D.D.C. Sept. 2, 2020) (challenging the Trump Administration’s rescission of an Obama Administration policy banning discrimination against transgender people in healthcare). For an overview of other legal battles surrounding gender-affirming healthcare, see generally Judson Adams et al., Transgender Rights and Issues , 21 Geo. J. Gender & L . 479, 494–507 (2020).

^ S.B. 2490, 2020 Leg., Reg. Sess. § 2(1)(a) (Miss. 2020).

^ See, e.g ., id . § 2(2); H.B. 3515, 101st Gen. Assemb., Reg. Sess. § 10 (Ill. 2019). Indeed, many of the bills even share a version of the same title: “Vulnerable Child Protection Act.” See, e.g ., H.B. 303, 2020 Leg., Reg. Sess. § 1 (Ala. 2020); H.B. 1365, 2020 Leg., Reg. Sess. (Fla. 2020); H.B. 513, 133d Gen. Assemb., Reg. Sess. § 2 (Ohio 2020).

^ See Amy L. Stone, Gender Panics About Transgender Children in Religious Right Discourse , 15 J. LGBT Youth 1, 1–3 (2018).

^ See, e.g ., Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d 586, 613–14 (4th Cir. 2020); id . at 626 (Wynn, J., concurring); Doe ex rel . Doe v. Boyertown Area Sch. Dist., 897 F.3d 518, 526 (3d Cir. 2018); see also Note, Constitutional Privacy and the Fight Over Access to Sex-Segregated Spaces , 133 Harv. L. Rev . 1684, 1685 (2020).

^ See, e.g ., Grimm , 972 F.3d at 620; Doe , 897 F.3d at 538.

^ See Gabby Orr, The Wedge Issue That’s Dividing Trumpworld , Politico Mag . (Aug. 7, 2020, 7:08 AM), <a href=" https://www.politico.com/news/magazine/2020/08/07/wedge-issue-dividing-trumpworld-392323# ">https://www.politico.com/news/magazine/2020/08/07/wedge-issue-dividing-trumpworld-392323">https://www.politico.com/news/magazine/2020/08/07/wedge-issue-dividing-trumpworld-392323# [ https://perma.cc/M2H2-JTBL ] (noting that “public opinion [is] moving dramatically in favor” of transgender rights); Schneider, supra note 83 (detailing the backlash to House Bill 2 in North Carolina).

^ See, e.g ., Orr, supra note 92 (detailing a sharply divided opinion within the Trump reelection campaign concerning whether to embrace an explicitly antitransgender platform).

^ Professor Reva Siegel has termed this phenomenon “preservation-through-transformation.” Reva B. Siegel, “ The Rule of Love”: Wife Beating as Prerogative and Privacy , 105 Yale L.J . 2117, 2180 (1996); see id . at 2179 (“[T]he manner in which a legal system enforces social stratification . . . evolve[s] over time, changing shape as it is contested.”).

^ See Editorial, Lawmakers Reach New Low with Latest Transgender Bill , Argus Leader (Jan. 27, 2020, 10:14 AM), <a href=" https://www.argusleader.com/story/opinion/editorials/2020/01/23/south-dakota-legislature-transgender-bill-fred-deutsch/4551350002 ">https://www.argusleader.com/story/opinion/editorials/2020/01/23/south-dakota-legislature-transgender-bill-fred-deutsch/4551350002/">https://www.argusleader.com/story/opinion/editorials/2020/01/23/south-dakota-legislature-transgender-bill-fred-deutsch/4551350002 [ https://perma.cc/EHA6-QVMU ] (noting that the chief sponsor of the 2020 South Dakota gender-affirming care ban also introduced the state’s failed bathroom bill in 2016); Chase Strangio, Conservative Legislators Want Transgender Kids’ Lives as the New Battlefield in Their Culture War , NBC News (Jan. 17, 2021, 3:30 AM), <a href=" https://www.nbcnews.com/think/opinion/conservative-legislators-want-transgender-kids-lives-new-battlefield-their-culture-ncna1254483 ">https://www.nbcnews.com/think/opinion/conservative-legislators-want-transgender-kids-lives-new-battlefield-their-culture-ncna1254483">https://www.nbcnews.com/think/opinion/conservative-legislators-want-transgender-kids-lives-new-battlefield-their-culture-ncna1254483 [ https://perma.cc/8AXG-39EJ ].

^ See Nancy J. Knauer, The Politics of Eradication and the Future of LGBT Rights , 21 Geo. J. Gender & L . 615, 655 (2020); Strangio, supra note 95.

^ See Clifford J. Rosky, Fear of the Queer Child , 61 Buff. L. Rev . 607, 638–39 (2013) (noting that paternalistic justifications for opposing LGBTQ youth are “more appealing to a wide audience and more challenging for LGBT advocates to rebut,” id . at 639).

^ See Strangio, supra note 95; see also Knauer, supra note 96, at 637 (“By focusing on the element of choice and the ability to change, anti-LGBT advocates . . . attempt to not only destabilize LGBT identities, but to eradicate them completely because they believe that being LGBT is not a choice that anyone should make.”).

^ See Bell v. Tavistock [2020] EWHC (Admin) 3274 (Eng.). Immediately after the High Court upheld a challenge to the National Health Service (NHS) gender-affirming treatment protocol for minors, framing the decision as an exercise of “the protective role of the court,” id . at [149], the defendant NHS trust announced a moratorium on new referrals for puberty blockers, see Owen Bowcott, Puberty Blockers: Under-16s “Unlikely to Be Able to Give Informed Consent ,” The Guardian (Dec. 1, 2020, 12:18 AM), <a href=" https://www.theguardian.com/world/2020/dec/01/children-who-want-puberty-blockers-must-understand-effects-high-court-rules ">https://www.theguardian.com/world/2020/dec/01/children-who-want-puberty-blockers-must-understand-effects-high-court-rules">https://www.theguardian.com/world/2020/dec/01/children-who-want-puberty-blockers-must-understand-effects-high-court-rules [ https://perma.cc/L4CR-4KJ7 ].

^ See supra p. 2175.

^ See Rafferty, supra note 5, at 4 (“[C]hildren who are prepubertal and assert [a trans identity] know their gender as clearly and as consistently as their developmentally equivalent peers who identify as cisgender . . . .”); see also Anne A. Fast & Kristina R. Olson, Gender Development in Transgender Preschool Children , 89 Child Dev . 620, 631–32 (2018) (finding that “[a]cross all measures of preference, behavior, stereotyping, and identity . . . preschool-age socially transitioned transgender children never significantly differed from their [cisgender] peers,” id . at 631).

^ See Jesse Singal, When Children Say They’re Trans , The Atlantic (July/Aug. 2018), <a href=" https://www.theatlantic.com/magazine/archive/2018/07/when-a-child-says-shes-trans/561749 ">https://www.theatlantic.com/magazine/archive/2018/07/when-a-child-says-shes-trans/561749/">https://www.theatlantic.com/magazine/archive/2018/07/when-a-child-says-shes-trans/561749 [ https://perma.cc/P7RZ-CH57 ].

^ See Julia Temple Newhook et al., A Critical Commentary on Follow-Up Studies and “Desistance” Theories About Transgender and Gender-Nonconforming Children , 19 Int’l J. Transgenderism 212, 212–13 (2018) (claiming that the studies showing “desistance” of gender dysphoria are methodologically flawed).

^ See id . at 218 (noting that “desistance” arguments concerning gender nonconforming youth “reinforce [a] limited binary perspective on gender and sexuality” and that “if we find that people do not fit our categories, then it is the categories that must change”); see also Goldberg et al., supra note 7, at 92.

^ See WPATH SOC , supra note 17, at 14, 18–19.

^ See Singal, supra note 102; see also WPATH SOC, supra note 17, at 18 (“Before any physical interventions are considered for adolescents, extensive exploration of psychological, family, and social issues should be undertaken . . . .”).

^ U.S. Const . amend . XIV , § 1.

^ See City of Cleburne v. Cleburne Living Ctr., Inc., 473 U.S. 432, 439–40 (1985).

^ See, e.g ., Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d 586, 607 (4th Cir. 2020).

^ See, e.g ., Cleburne , 473 U.S. at 440–42; Grimm , 972 F.3d at 608; see also Ashutosh Bhagwat, Purpose Scrutiny in Constitutional Analysis , 85 Calif. L. Rev . 297, 303–04 (1997).

^ See, e.g ., Grimm , 972 F.3d at 607; Adams ex rel . Kasper v. Sch. Bd., 968 F.3d 1286, 1296, 1304 (11th Cir. 2020); Whitaker ex rel . Whitaker v. Kenosha Unified Sch. Dist. No. 1 Bd. of Educ., 858 F.3d 1034, 1051–52 (7th Cir. 2017).

^ See, e.g ., Grimm , 972 F.3d at 610; Karnoski v. Trump, 926 F.3d 1180, 1201 (9th Cir. 2019); see also Kevin M. Barry et al., A Bare Desire to Harm: Transgender People and the Equal Protection Clause , 57 B.C. L. Rev . 507, 551–67 (2016) (arguing that transgender status satisfies the four-factor test for whether a group should receive protected status).

^ See, e.g ., Whitaker , 858 F.3d at 1051; Glenn v. Brumby, 663 F.3d 1312, 1317 (11th Cir. 2011); Smith v. City of Salem, 378 F.3d 566, 568, 577 (6th Cir. 2004).

^ H.B. 321, 2020 Gen. Assemb., Reg. Sess. § 1(3) (Ky. 2020); see, e.g ., id . § 1(2); H.B. 303, 2020 Leg., Reg. Sess. § 4 (Ala. 2020). Even the bills that do not specifically except treatment of intersex or developmental conditions from the prohibitions imply through their language that the bans only apply to use of the prohibited services as gender-affirming medical treatment. See, e.g ., H.B. 2210, 100th Gen. Assemb., 2d Reg. Sess. § A(1) (Mo. 2020) (prohibiting medical providers from “administering any hormonal treatment or performing any surgical treatment for the purpose of gender reassignment ” (emphasis added)); see also S.B. 1819, 57th Leg., 2d Reg. Sess. § 1(C) (Okla. 2020).

^ See, e.g ., Christian Legal Soc’y Chapter of the Univ. of Cal., Hastings Coll. of the Law v. Martinez, 561 U.S. 661, 689 (2010) (“A tax on wearing yarmulkes is a tax on Jews.” (quoting Bray v. Alexandria Women’s Health Clinic, 506 U.S. 263, 270 (1993))).

^ 140 S. Ct. 1731 (2020).

^ See id . at 1754.

^ Id . at 1747.

^ See id . at 1783 (Alito, J., dissenting) (“By equating discrimination because of sexual orientation or gender identity with discrimination because of sex, the Court’s decision will be cited as a ground for subjecting all three forms of discrimination to [heightened scrutiny].”); see also, e.g ., Adams ex rel . Kasper v. Sch. Bd., 968 F.3d 1286, 1296 (11th Cir. 2020) (applying Bostock to find that a school board policy discriminating against transgender students was sex discrimination warranting heightened scrutiny).

^ Bostock , 140 S. Ct. at 1741.

^ See Flack v. Wis. Dep’t of Health Servs., 328 F. Supp. 3d 931, 948 (W.D. Wis. 2018) (observing that a Medicaid exclusion for gender-affirming healthcare was “a straightforward case of sex discrimination” because “if plaintiffs’ natally assigned sexes had matched their gender identities, their requested, medically necessary surgeries to reconstruct their genitalia or breasts would be covered”).

^ United States v. Virginia, 518 U.S. 515, 524 (1996) (citations omitted); see Bhagwat, supra note 110, at 304. While this test for “intermediate scrutiny” has been used for gender-based classifications, courts apply a more searching “strict scrutiny” test for certain other classifications. See id .

^ See supra section A.2, pp. 2167–72.

^ See supra section B.2, pp. 2175–78.

^ See sources cited supra note 19.

^ See, e.g ., What We Know Project , supra note 42 (stating that, of more than fifty studies published between 1991 and 2017, ninety-three percent “found that gender transition improves the overall well-being of transgender people,” and that there were “no studies concluding that gender transition causes overall harm”) ; see also sources cited supra notes 41–42. But see infra pp. 2184–85 (describing concerns with judicial analysis of scientific evidence).

^ See Bhagwat, supra note 110, at 303 (discussing rational basis review).

^ H.B. 303, 2020 Leg., Reg. Sess. § 2(1) (Ala. 2020).

^ Id . § 4(b). The Alabama bill defines “medically verifiable” conditions to include “external biological sex characteristics that are irresolvably ambiguous . . . , [such as] having both ovarian and testicular tissue,” and “[ab]normal sex chromosome structure, sex steroid hormone production, or sex steroid hormone action.” Id .

^ See, e.g ., Romer v. Evans, 517 U.S. 620, 634 (1996) (explaining that “a bare . . . desire to harm a politically unpopular group cannot constitute a legitimate government interest” (citation omitted)); City of Cleburne v. Cleburne Living Ctr., Inc., 473 U.S. 432, 446–47 (1985); Susannah W. Pollvogt, Unconstitutional Animus , 81 Fordham L. Rev . 887, 888 (2012).

^ See Pollvogt, supra note 132, at 926–27.

^ 473 U.S. 432.

^ See id . at 447–50. In Cleburne , the Court held that a city’s denial of a special zoning permit to a group home for people with intellectual disabilities violated equal protection because it was founded on “irrational prejudice” against such people. Id . at 450. The Court inferred prejudice in part because the city imposed special permitting requirements on the group home for reasons such as density, traffic congestion, and exposure to litigation risk that applied equally to other high-density residential uses, such as nursing homes and dormitories, for which special permits were not required. See id . at 447–50.

^ Cf . Romer , 517 U.S. at 635; Cleburne , 473 U.S. at 450.

^ See Jessica A. Clarke, Explicit Bias , 113 Nw. U. L. Rev . 505, 511 (2018) (defending the probative value of explicit statements of bias as evidence of discriminatory intent); Pollvogt, supra note 132, at 927.

^ Jeff Taylor, Florida Lawmaker Told Nonbinary Candidate He’s “Manufacturing” His Identity , NewNowNext (Feb. 4, 2020), <a href=" https://www.newnownext.com/florida-republican-sabatini-gender-nonbinary-manufacturing-identity/02/2020 ">http://www.newnownext.com/florida-republican-sabatini-gender-nonbinary-manufacturing-identity/02/2020/">https://www.newnownext.com/florida-republican-sabatini-gender-nonbinary-manufacturing-identity/02/2020 [ https://perma.cc/3NTT-LSBB ].

^ Katie Shepherd, A GOP Lawmaker, the Son of an Auschwitz Survivor, Compared Doctors Treating Transgender Children to Nazis. He Regrets It ., Wash. Post (Jan. 28, 2020, 11:45 AM), <a href=" https://www.washingtonpost.com/nation/2020/01/28/deutsch-transgender-doctors-nazi ">https://www.washingtonpost.com/nation/2020/01/28/deutsch-transgender-doctors-nazi/">https://www.washingtonpost.com/nation/2020/01/28/deutsch-transgender-doctors-nazi [ https://perma.cc/7AJH-AMJX ]. To his credit, Rep. Deutsch later apologized. Id .

^ John Herrick, Anti-LGBTQ Bills Doomed to Die. Advocates Say They Still Take a Toll ., Colo. Indep . (Feb. 13, 2020), <a href=" https://www.coloradoindependent.com/2020/02/13/gop-anti-lgbtq-transgender-youth ">https://www.coloradoindependent.com/2020/02/13/gop-anti-lgbtq-transgender-youth/">https://www.coloradoindependent.com/2020/02/13/gop-anti-lgbtq-transgender-youth [ https://perma.cc/GQP4-8AJP ].

^ See Emily Jashinsky, Exclusive: Man Tried to Share His Regrets About Transgender Life. YouTube Censored It , Federalist (June 19, 2020), https://thefederalist.com/2020/06/19/exclusive-man-tried-to-share-his-regrets-about-transgender-life-youtube-censored-it [ https://perma.cc/9JEM-M7NJ ]; see also, e.g ., Summit , supra note 70, at 2:15:20 (panelist describing the pioneers of gender-affirming treatment for minors as “pedophile activist[s]”).

^ Transgenderism & Gender Dysphoria , Fam. Pol’y All . (internal quotation marks omitted), <a href=" https://familypolicyalliance.com/issues/sexuality/transgender ">https://familypolicyalliance.com/issues/sexuality/transgender/">https://familypolicyalliance.com/issues/sexuality/transgender [ https://perma.cc/77QD-7FMA ]; see Bauer, supra note 71.

^ See Pierce v. Soc’y of Sisters, 268 U.S. 510, 534–35 (1925); Meyer v. Nebraska, 262 U.S. 390, 399 (1923).

^ See, e.g ., Troxel v. Granville, 530 U.S. 57, 65–66 (2000); Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 851 (1992); Moore v. City of East Cleveland, 431 U.S. 494, 499 (1977); Stanley v. Illinois, 405 U.S. 645, 651 (1972).

^ Troxel , 530 U.S. at 65.

^ See id . at 69–70.

^ See Parham v. J.R., 442 U.S. 584, 603–04 (1979) (recognizing “parents’ authority to decide what is best for the[ir] child” in the medical context, id . at 604); see also Kanuszewski v. Mich. Dep’t of Health & Hum. Servs., 927 F.3d 396, 418–19 (6th Cir. 2019).

^ See, e.g ., Kanuszewski , 927 F.3d at 418–19; PJ ex rel . Jensen v. Wagner, 603 F.3d 1182, 1197 (10th Cir. 2010); Restatement of the Law, Children and the Law § 2.30 (Am. L. Inst ., Tentative Draft No. 1, 2018) ; Alicia Ouellette, Shaping Parental Authority over Children’s Bodies , 85 Ind. L.J . 955, 966–68 (2010).

^ See Prince v. Massachusetts, 321 U.S. 158, 166–67 (1944).

^ See, e.g ., Cal. Bus. & Prof. Code § 865.1 (West 2021); Editorial, A Nationwide Ban Is Needed for “Anti-gay Therapy ,” Sci. Am . (Jan. 1, 2020), <a href=" https://www.scientificamerican.com/article/a-nationwide-ban-is-needed-for-anti-gay-therapy ">https://www.scientificamerican.com/article/a-nationwide-ban-is-needed-for-anti-gay-therapy/">https://www.scientificamerican.com/article/a-nationwide-ban-is-needed-for-anti-gay-therapy [ https://perma.cc/BV37-ZYVH ].

^ Pickup v. Brown, 740 F.3d 1208, 1236 (9th Cir. 2014); see also, e.g ., Doe ex rel . Doe v. Governor of N.J., 783 F.3d 150, 156 (3d Cir. 2015) (same).

^ See Doe , 783 F.3d at 152–53; Pickup , 740 F.3d at 1231–32.

^ Compare, e.g ., Policy Statement, Conversion Therapy , Am. Acad. Child & Adolescent Psychiatry (2018), <a href=" https://www.aacap.org/AACAP/Policy_Statements/2018/Conversion_Therapy.aspx ">https://www.aacap.org/AACAP/Policy_Statements/2018/Conversion_Therapy.aspx">https://www.aacap.org/AACAP/Policy_Statements/2018/Conversion_Therapy.aspx [ https://perma.cc/LV4U-SV3P ] (confirming that conversion therapy “lack[s] scientific credibility and clinical utility”), and Editorial, supra note 150 (noting that various medical associations characterize conversion therapy as “useless and injurious”), with, e.g ., AACAP Statement , supra note 46 (stating that “AACAP strongly opposes any efforts . . . to block access” to “evidence-based [gender-affirming] care”), and Endocrine Soc’y & Pediatric Endocrine Soc’y, supra note 46, at 2 (describing gender-affirming care for minors as “effective, relatively safe when appropriately monitored, and . . . the standard of care” (parentheses omitted)).

^ See Joseph Landau, Broken Records: Reconceptualizing Rational Basis Review to Address “Alternative Facts” in the Legislative Process , 73 Vand. L. Rev . 425, 443–44 (2020) (noting that the doctrinal framework for judicial review of legislative purposes is ill-equipped to protect marginalized groups from “distorted legislative records” based on “alternative facts,” id . at 443).

^ See, e.g ., Gonzales v. Carhart, 550 U.S. 124, 179–82 (2007) (Ginsburg, J., dissenting) (describing the majority’s “bewildering,” id . at 179, rejection of the “significant medical authority,” id . at 180 (quoting Stenberg v. Carhart, 530 U.S. 914, 932 (2000)), supporting the use of a late-term abortion procedure to protect the patient’s health in some circumstances); id . at 182 (“Ultimately, the Court admits that moral concerns are at work . . . .” (quotation marks omitted)).

^ See, e.g ., Gibson v. Collier, 920 F.3d 212, 223 (5th Cir. 2019) (“There is no medical consensus that sex reassignment surgery is a necessary or even effective treatment for gender dysphoria.”).

^ See, e.g ., Edmo v. Corizon, Inc., 935 F.3d 757, 803 (9th Cir. 2019) (holding that prison officials’ denial of medically necessary gender-affirming medical care violated the Eighth Amendment).

^ Palmore v. Sidoti, 466 U.S. 429, 433 (1984).

^ WPATH SOC, supra note 17, at 21.

^ See Ikuta, supra note 6, at 227–28.

  • Health Care Law
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April 12, 2021

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Reframing the harm: religious exemptions and third-party harm after little sisters.

Chapter Two

The Legal Infrastructure of Childbirth

Chapter Three

Conditions of Confinement, COVID-19, and the CDC

Chapter Four

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  • Gender reassignment discrimination

Published: 22 December 2021

Last updated: 23 February 2023

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What the equality act says about gender reassignment discrimination, different types of gender reassignment discrimination, circumstances when being treated differently due to gender reassignment is lawful, pages in this guide.

  • Your rights under the Equality Act 2010
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What countries does this apply to?

On this page we have used plain English to help explain legal terms. This does not change the meaning of the law.

The Equality Act 2010 uses the term ‘transsexual’ for individuals who have the protected characteristic of gender reassignment. We recognise that some people consider this term outdated, so we have used the term ‘trans’ to refer to a person who has the protected characteristic of gender reassignment. However, we note that some people who identify as trans may not fall within the legal definition.

This page is subject to updates due to the evolving nature of some of the issues highlighted. 

This is when you are treated differently because you are trans in one of the  situations covered by the Equality Act . The treatment could be a one-off action or as a result of a rule or policy. It doesn’t have to be intentional to be unlawful.

There are some circumstances when being treated differently due to being trans is lawful. These are explained below.

The Equality Act 2010 says that you must not be discriminated against because of gender reassignment.

In the Equality Act, gender reassignment means proposing to undergo, undergoing or having undergone a process to reassign your sex.

To be protected from gender reassignment discrimination, you do not need to have undergone any medical treatment or surgery to change from your birth sex to your preferred gender.

You can be at any stage in the transition process, from proposing to reassign your sex, undergoing a process of reassignment, or having completed it. It does not matter whether or not you have applied for or obtained a Gender Recognition Certificate, which is the document that confirms the change of a person's legal sex. 

For example, a person who was born female and decides to spend the rest of their life as a man, and a person who was born male and has been living as a woman for some time and obtained a Gender Recognition Certificate, both have the protected characteristic of gender reassignment. 

There are four types of gender reassignment discrimination.

Direct discrimination

Direct discrimination happens when someone treats you worse than another person in a similar situation because you are trans.

You inform your employer that you intend to spend the rest of your life living as the opposite sex. If your employer alters your role against your wishes to avoid you having contact with clients, this would be direct gender reassignment discrimination.

The Equality Act says that you must not be directly discriminated against because:

  • you  have  the protected characteristic of gender reassignment. A wide range of people identify as trans. However, you are not protected under the Equality Act unless you have proposed, started or completed a process to change your sex.
  • someone  thinks   you   have  the protected characteristic of gender reassignment. For example, because you occasionally cross-dress or do not conform to gender stereotypes (this is known as discrimination by perception).
  • you are  connected   to  a person who has the protected characteristic of gender reassignment, or someone wrongly thought to have this protected characteristic (this is known as discrimination by association).

Absences from work

If you are absent from work because of your gender reassignment, your employer cannot treat you worse than you would be treated if you were absent:

  • due to an illness or injury.

Example –  

Your employer cannot pay you less than you would have received if you were off sick.

  • due to some other reason - however, in this case it is only discrimination if your employer is acting unreasonably.

If your employer would agree to a request for time off for someone to attend their child’s graduation ceremony, then it may be unreasonable to refuse you time off for part of a gender reassignment process. This would include, for example, time off for counselling.

Indirect discrimination

Indirect discrimination happens when an organisation has a particular policy or way of working that puts people with the protected characteristic of gender reassignment at a disadvantage. Sometimes indirect gender reassignment discrimination can be permitted if the organisation or employer is able to show that there is a good reason for the discrimination. This is known as  objective justification .

An employer has a practice of starting induction sessions for new staff with an ice-breaker designed to introduce everyone in the room to each other. Each worker is required to provide a picture of themselves as a toddler. One worker is a trans woman who does not wish her colleagues to know that she was brought up as a boy, so she does not bring her photo and is criticised by the employer in front of the group for not joining in. The same approach is taken for all new staff, but it puts people with the protected characteristic of gender reassignment at a particular disadvantage.  This would be unlawful indirect discrimination unless the employer could show that the practice was justified.

Harassment is when someone makes you feel humiliated, offended or degraded for reasons related to gender reassignment.

A person who has undergone male-to-female gender reassignment is having a drink in a pub with friends and the landlord keeps calling her ‘sir’ or ‘he’ when serving drinks, despite her complaining about it.

Harassment can never be justified. However, if an organisation or employer can show it did everything it could to prevent people who work for it from harassing you, you will not be able to make a claim for harassment against the organisation, only against the harasser.

Victimisation

Victimisation is when you are treated badly because you have made a complaint of gender reassignment discrimination under the Equality Act. It can also occur if you are supporting someone who has made a complaint of gender reassignment discrimination.

A person proposing to undergo gender reassignment is being harassed by a colleague at work. He makes a complaint about the way his colleague is treating him and is sacked.

A difference in treatment may sometimes be lawful. This will be the case where the circumstances fall under one of the exceptions in the Equality Act that allow organisations to provide different treatment or services on the basis of gender reassignment.

Examples –    

The organisers of a women’s triathlon event decide to exclude a trans woman with a Gender Recognition Certificate as they think her strength or stamina gives her an unfair advantage. However, the organisers would need to be able to show that this was necessary to make the event fair or safe for everyone.

A service provider provides single-sex services. The Equality Act allows a lawfully established separate or single-sex service provider to prevent, limit or modify people’s access on the basis of gender reassignment in some circumstances. However, limiting or modifying access to, or excluding a trans person from, the separate or single-sex service of the gender in which they present will be unlawful if you cannot show such action is a proportionate means of achieving a legitimate aim. This applies whether or not the person has a Gender Recognition Certificate.

Updated: 23 Feb 2023

  • Removed paragraph on language recommendations made by Women and Equalities Committee (WEC) in 2016
  • Removed the term ‘transsexual’ as per WEC 2016 recommendations
  • Added paragraph explaining use of plain English in the guidance
  • Removed a paragraph on intersex people not being explicitly protected from discrimination by the Equality Act

Page updates

22 December 2021

Last updated:

23 February 2023

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If you think you might have been treated unfairly and want further advice, you can contact the  Equality Advisory and Support Service (EASS) .

The EASS is an independent advice service, not operated by the Equality and Human Rights Commission.

Phone: 0808 800 0082  

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Trends in suicide death risk in transgender people: results from the Amsterdam Cohort of Gender Dysphoria study (1972–2017)

C. m. wiepjes.

1 Department of Endocrinology, Amsterdam UMC, VU University Medical Center, Amsterdam the Netherlands

2 Center of Expertise on Gender Dysphoria, Amsterdam UMC, VU University Medical Center, Amsterdam the Netherlands

M. den Heijer

M. a. bremmer.

3 Department of Psychiatry, Amsterdam UMC, VU University Medical Center, Amsterdam the Netherlands

C. J. M. de Blok

B. j. g. coumou.

4 Department of Medical Psychology, Amsterdam UMC, VU University Medical Center, Amsterdam the Netherlands

T. D. Steensma

Associated data.

Author elects to not share data.

This study explored the overall suicide death rate, the incidence over time, and the stage in transition where suicide deaths were observed in transgender people.

A chart study, including all 8263 referrals to our clinic since 1972. Information on death occurrence, time, and cause of death was obtained from multiple sources.

Out of 5107 trans women (median age at first visit 28 years, median follow‐up time 10 years) and 3156 trans men (median age at first visit 20 years, median follow‐up time 5 years), 41 trans women and 8 trans men died by suicide. In trans women, suicide deaths decreased over time, while it did not change in trans men. Of all suicide deaths, 14 people were no longer in treatment, 35 were in treatment in the previous two years. The mean number of suicides in the years 2013–2017 was higher in the trans population compared with the Dutch population.

Conclusions

We observed no increase in suicide death risk over time and even a decrease in suicide death risk in trans women. However, the suicide risk in transgender people is higher than in the general population and seems to occur during every stage of transitioning. It is important to have specific attention for suicide risk in the counseling of this population and in providing suicide prevention programs.

Significant outcomes

  • Suicide death risk in trans people did not increase over time.
  • Suicide deaths occurred during every stage of transitioning.
  • Suicide death risk is higher in trans people than in the general population.

Limitations

  • Psychological comorbidity was not known.
  • No data were available for people on the waiting list for their first appointment.

Introduction

Gender dysphoria (GD) refers to the distress related to a marked incongruence between one’s assigned gender at birth and the experienced gender ( 1) . Trans people are diverse in the intensity of experienced GD ( 2) , their needs for medical transition ( 3) , and the impairment that GD can have on their life. Studies focusing on the wellbeing of trans people show a greater vulnerability for experiencing mental health problems compared with the non‐trans (cis) population ( 4) . Most prevalent are affective and anxiety problems ( 5 , 6 , 7 , often accompanied by feelings, thoughts, or behaviours linked to suicidality ( 8 , 9 .

The prevalence of suicidality in trans people in suicidal ideation, suicidal attempts, and suicide death rates is studied in varying degrees and shows high variability in findings. A systematic review by McNeil et al ( 9) . reported suicidal ideation rates across 17 identified studies, ranging from 37% ( 10) up to 83% ( 11) . Prevalence rates on suicidal attempts in trans people, which are generally observed to be lower than suicidal ideation, showed to be lower but also with a wide variation in reported rates, ranging from 9.8% ( 12) up to 44% ( 13) . Since structured prevalence studies on suicide deaths are lacking in the transgender literature, an estimation comes from a limited number of studies reporting on suicide death rates in small study samples. Derived from a systematic review on suicidality in trans people by Marshall et al. ( 8) , suicide death rates varied from 0% ( 14) to 4.2% in a sample of 24 post‐treatment trans people from Sweden ( 15) . Six of these studies only included postsurgical people ( 14 , 15 , 16 , 17 , 18 , 19 , whereas two studies also included trans people who were only using hormones without surgery ( 20 , 21 . However, studies differentiating the treatment stage during which death by suicide occurred are lacking. In addition, studies differentiating between suicide in trans women and trans men are scarce. While some studies found that trans men have a higher risk of suicide attempts than trans women ( 22 , 23 , other studies reported no differences in suicide attempts between trans women and trans men ( 24 , 25 . Only one cohort distinguished suicide death risk in trans women and trans men and found that trans women had an increased risk of suicide death compared with trans men ( 20 , 21 .

Aims of the study

The aim of the current study is to explore the overall suicide death rate in trans women and trans men in the largest clinical cohort of gender‐referred people seen at the Center of Expertise on Gender Dysphoria of the Amsterdam University Medical Centers between 1972 and 2017 the Netherlands ( 26) . In addition, the change in incidence of suicide death rate over time and at what stage in transition (pretreatment, during hormonal treatment and/or surgical phase, or post‐treatment) suicide deaths were observed was explored. The relevance of such information is to get a greater understanding of how large the risk is in clinically referred transgender people and whether suicide prevention interventions should focus on specific stages in transition or not.

Material and methods

Study design.

A retrospective chart study was performed, including all people who once visited the Center of Expertise on Gender Dysphoria of the Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands, between 1972 and 2017. The selection of the study population is described previously ( 26) . A total of 8263 adults, adolescents, and children were included, with a median age at first visit of 25 years (range 4 to 81 years) and a median follow‐up time of 7.5 years (range 0.0 to 45.5 years). Information on death occurrence, time, and cause of death was obtained by cross‐checking multiple sources: the National Civil Record Registry ( 21) , which contains date of birth and date of death of all inhabitants of the Netherlands, and the hospital registration system, medical, and psychological files for cause of death.

The Medical Ethics Review Committee of the Amsterdam UMC, Vrije Universiteit Amsterdam, reviewed this study and determined that the Medical Research Involving Human Subjects Act (WMO) did not apply to this study. Therefore, and because of the retrospective design, necessity for informed consent was waived.

After an initial visit to the endocrinologist (for adults) or child psychiatrist (for children and adolescents), all people were referred to the psychology department for the diagnostic phase. In this phase, people were seen to gain insight into their experienced gender identity, to verify whether they fulfill the diagnosis gender dysphoria, to explore their treatment desires, and to prepare them for possible medical interventions. After this phase, people may start with hormonal treatment. Trans women received treatment with anti‐androgens and estrogens. Trans men were treated with testosterone. In adolescents, treatment first started with a period of puberty suppression, followed by estrogens of testosterone around the age of 16 years ( 27) .

Surgical interventions can be offered to people aged 18 years or older. Depending on the desired treatment, the surgery is preceded after at least one year of hormonal treatment (genital surgery) or can be offered after the diagnostic phase (e.g., breast removal). After surgery, all people were usually seen every 2 years for medical check‐up.

Statistical analyses

Characteristics of the population were shown as median with range due to the non‐normal distribution. The total number of people seen at our center and the total number of suicide deaths were counted and were expressed as percentages as well as incidence per 100 000 person years. For each year, the number of people at risk and the number of people who died by suicide were calculated. Cox regression analyses were performed to calculate hazard ratios (HR) with corresponding 95% confidence intervals (95% CI). Date of first visit was used as start date of follow‐up. The end date of follow‐up was either date of death or date of closing the database (December 31, 2017). Suicide death was analyzed as event. To analyze whether the incidence of suicide deaths changed over time, the year of first visit was added as determinant to the analyses. Analyses were adjusted for age at first visit as age might be related to suicide death risk. Time between date of suicide death and first visit, and between date of suicide death and start of hormonal treatment, if applicable, were calculated. All analyses were performed for the total population and were stratified for trans women and trans men.

All analyses were performed using STATA Statistical software (Statacorp, College Station, TX, USA), version 15.1.

The characteristics of the study population are shown in Table  1 . In total, 8263 people attended the gender identity clinic, of which 5107 were trans women (median age at first visit 28 years, range 4 to 81 years) and 3156 were trans men (median age at first visit 20 years, range 4 to 73 years). The median follow‐up time was 7.5 years (range 0.0–45.5 years), which was longer in trans women (10.2 years, range 0.0–45.5 years) than in trans men (4.8 years, range 0.0–45.5 years). The total follow‐up time was 92 227 person years (64 287 in trans women and 27 940 in trans men).

Characteristics of the study population (A) and the people who died by suicide (B)

 TotalTrans womenTrans men
(A)
Number of people826351073156
Age at first visit, year25 (4–81)28 (4–81)20 (4–73)
Follow‐up time, year7.5 (0.0–45.5)10.2 (0.0–45.5)4.8 (0.0–45.5)
(B)
Number of suicides49 (0.6%)41 (0.8%)8 (0.3%)
Age at first visit, year31 (15–59)31 (15–58)21 (16–59)
Age at time of suicide, year41 (18–66)41 (18–66)36 (21–60)
Follow‐up time, year6.7 (0.6–32.7)6.7 (0.6–32.7)6.7 (0.6–23.1)
Time between start hormones and suicide, year6.4 (0.4–32.5) 6.1 (0.4–32.5) 6.9 (3.7–23.1)

Data are shown as number or median (range).

Forty‐nine people died by suicide: 41 trans women (0.8%) and 8 trans men (0.3%), which is 64 per 100 000 person years in trans women and 29 per 100 000 person years in trans men. The median follow‐up time between first visit and suicide death was 6.7 years (range 0.6 to 32.7 years) in trans women and 6.7 years (range 0.6 to 23.1 years) in trans men. Trans women had a higher overall suicide death risk than trans men (per year: HR 2.26, 95% CI 1.06–4.82). Four suicide deaths occurred in individuals who were referred to the clinic before the age of 18 (0.2%), which is a lower risk than in adults (0.7%, P  = 0.010).

The course of number of people at risk and the number of people who died by suicide over the years is shown in Fig.  1 . Overall suicide deaths did not increase over the years: HR per year 0.97 (95% CI 0.94–1.00). In trans women, suicide death rates decreased slightly over time (per year: HR 0.96, 95% CI 0.93–0.99), while it did not change in trans men (per year: HR 1.10, 95% CI 0.97–1.25). Adjustment for age at the first visit did not change these numbers.

An external file that holds a picture, illustration, etc.
Object name is ACPS-141-486-g001.jpg

Number of people at risk (left y ‐axis) and the number of suicides (right y ‐axis), between 1972 and 2017.

As the median follow‐up time between first visit and suicide death was 6.7 years, subgroup analyses were performed in those who had their first visit before 2011. This did not change the outcomes: trans women ( n  = 3115) HR 0.94, 95% CI 0.91–0.98; trans men ( n  = 1269) HR 1.02, 95% CI 0.90–1.16).

Of the 49 people who died by suicide, 35 had a face‐to‐face contact with the endocrinologist or psychologist of the gender identity clinic in the previous two years, while the other 14 people were no longer in active counseling with the clinic. Sixteen of the 35 people who recently had visited the clinic, only came for a medical check‐up, as they were postsurgery (vaginoplasty or phalloplasty). Two people were in the surgery trajectory, and 17 were still in the diagnostic or hormonal phase at time of suicide. The transition phases separately for trans women and trans men who died by suicide are shown in Table  2 .

The occurrence of suicide deaths distinguished for transition stage, and trans women or trans men

 Total (  = 49)Trans women (  = 41)Trans men (  = 8)
In active counseling35296
In diagnostic or hormonal phase17161
In surgical phase202
Only medical follow‐up care16133
No active counseling14122

Data are shown as number. In active counseling is defined as a face‐to‐face contact with the endocrinologist or psychologist of the gender identity clinic in the previous two years.

The mean number of suicides in the years 2013–2017 was higher in the trans population (40 per 100 000 person years; 43 per 100 000 trans women and 34 per 100 000 trans men) compared with the Dutch population in this time frame (11 per 100 000 person years; 15 per 100 00 registered men and 7 per 100 000 registered women) ( 28) .

The current study investigated the suicide death risk in the largest clinical cohort of gender‐referred individuals to the Center of Expertise on Gender Dysphoria at the Amsterdam UMC, the Netherlands, between 1972 and 2017. Findings from the chart reviews showed us a decrease in suicide death risk over time in trans women and no change in suicide death risk in trans men. Trans women, however, showed a higher suicide death risk than trans men. Between 2013 and 2017, the suicide risk in Dutch referred transgender people (40 per 100 000 person years) showed to be three to four times higher than the general Dutch population (11 per 100 000 person years) ( 28) . Evaluation of transition stage in relation to suicide deaths showed that approximately two‐third of the observed suicides occurred in those who were still in active treatment (diagnostic, hormonal, or surgical phase). The incidence of suicide deaths and transition stage was similar in trans women and trans men.

Suicidal behaviour is a complex phenomenon that is a result of many individual (age, male sex assigned at birth, previous suicide attempts, mental health history, substance abuse) as well as more distant environmental factors. A recent literature review clearly demonstrates the specific risk factors for suicide in sexual minority youth, which includes negative social environments, inadequate support within the closest social network, and an absence of lesbian, gay, bisexual, and transgender (LGBT) movements in communities ( 29) . In our cohort, both trans women and trans men show a three‐ to four‐fold elevated risk of suicide compared with the population rate in the Netherlands and can therefore be considered a high‐risk group. Although the Netherlands is known for its tolerance toward sexual minority groups in comparison to most countries in the world ( 30) , the societal position of trans people is generally less favorable compared with the lesbian, gay, bisexual, and cis‐gender population. Furthermore, compared with trans men, the societal position of trans women is lower ( 31 , 32 .

In the Netherlands, between 1972 and 2017 suicide rates showed a fluctuating course. Our finding of a slightly decreasing suicide risk in Dutch trans women may confer some hope. Recent studies showed an increase in societal acceptance toward lesbian, gay, bisexual, and transgender people ( 31) , and indications of an increase in social‐economic status over the years ( 33) . Although specific information on trans men and trans women is unavailable, it is conceivable that the improvement of societal position may have effect on the psychological functioning and the prevention of suicidal risk in trans women. The cause of this increase in tolerance seems largely to be the effect of a national and international increase in visibility and attention for trans people in media and society. Another explanation may be that, with the increase in attention and acceptance, the threshold for transgender people to seek treatment or professional help has become lower over the years. This is also reflected by the increase in referrals each year ( 26) . Lastly, with the increase of knowledge in this field and the literature about the vulnerability of the transgender population for suicidal ideation, suicidal attempts, and suicide death rates, it is conceivable to assume that the attention to these risks has increased in clinical counseling and may have its effect on prevention of suicide deaths over the years.

Although the incidence of suicide deaths in trans women decreased over the years, the overall incidence still showed to be higher in trans women compared with trans men. Conflicting results in literature are reported about the risk of suicide attempts between trans women and trans men. Some studies reported that trans men had a higher risk of suicide attempts than trans women ( 22 , 23 , while in other studies no differences in suicide attempts between trans women and trans men were found ( 24 , 25 . Only two studies looked at the differences in the risk of death by suicide between trans women and trans men and found that trans women had an increased risk compared with trans men ( 20 , 21 . However, these two studies were earlier studies performed in our center and therefore include a smaller part of our current study population.

An important finding was that the incidence for observed suicide deaths was almost equally distributed over the different stages of treatment. Although the distribution showed that one‐third of the suicides occurred in people who were no longer in active treatment in our center, the other two‐third of the people who died by suicide still visited our center in the previous two years. About half of these last two‐third people were still in active diagnostic or medical treatment, while the other half completed their transition and only came for a medical check‐up. This indicates that vulnerability for suicide occurs similarly in the different stages of transition. Although the literature on suicide risk factors is comprehensive, and particular suicidal risk factors like verbal victimization, physical and sexual violence, and the absence of social support ( 9 , 34 , may apply for transgender people in all stages of transitioning, it seems clinically highly relevant to understand and explore possible differences in motives and risk factors in the different stages of treatment. Therefore, future research on suicide deaths and suicide risk factors in transgender people should have a greater focus on transition status in relation to these motives and risk factors.

This study is performed in the largest cohort of gender‐referred people from the Netherlands, consisting of a large population of both adult and adolescent trans women and trans men at different stages of their transition with a long follow‐up time. However, this study has also some limitations. First, this study is a retrospective chart study. Although we used multiple strategies to obtain data about date of death, it is possible that we missed some data. Second, we did not have information about psychological comorbidities or other psychological information, such as social support. Third, we only had information about people who actually visited our gender identity clinic. Information about people on the waiting list for their first appointment was lacking.

To conclude, in our clinic we observed no increase in suicide death risk over time and even a decrease over time in suicide death risk in trans women was found. Since the suicide risk in the transgender population is higher than the general population and seems to occur during every stage of transitioning, it is important that (mental) health practitioners pay attention to this risk and create a safe environment in which these feelings can be discussed at all stages of treatment and counseling. Further research is necessary to investigate the motives behind the suicides, as input in the development of adequate suicide prevention programs.

Conflicts of interests

Wiepjes CM, den Heijer M, Bremmer MA, Nota NM, de Blok CJM, Coumou BJG, Steensma TD. Trends in suicide death risk in transgender people: results from the Amsterdam Cohort of Gender Dysphoria study (1972–2017) . [ PMC free article ] [ PubMed ]

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Youth Access to Gender Affirming Care: The Federal and State Policy Landscape

Lindsey Dawson , Jennifer Kates , and MaryBeth Musumeci Published: Jun 01, 2022

This analysis reflects the policy environment as of June 2020. Our newer tracker , provides a regularly updated overview of state policy restrictions on youth access to gender affirming care.

Numerous states have implemented or considered actions aimed at limiting LGBTQ+ youth access to gender affirming health care. Four states (Alabama, Arkansas, Texas, and Arizona) have recently enacted such restrictions (though the AL, AR, and TX laws all have been temporarily blocked by court rulings) and in 2022, 15 states are considering 25 similar pieces of legislation. At the same time, other states have adopted broad nondiscrimination health protections based on gender identity and sexual orientation. Separately, the Biden administration, which has been working to eliminate barriers and expand access to health care for LGBTQ+ people more generally, has come out against restrictive state policies. This analysis explores the current state and federal policy landscape regarding gender affirming services for youth and the implications of restrictive state laws.

Table 1: Key Terms
Gender Identity Gender identity is one’s internal sense of being male, female, some combination, or another gender. Gender identity may or may not align with sex or gender assigned at birth.
Transgender Somebody who is transgender has a gender identity different from that traditionally associated with sex assigned at birth.
Gender Dysphoria Gender dysphoria “a concept [and clinical diagnosis] designated in the DSM-5 as clinically significant distress or impairment related to a strong desire to be of another gender, which may include desire to change primary and/or secondary sex characteristics. Not all transgender or gender diverse people experience dysphoria.”
Gender Affirming Care Gender-affirming care is a model of care which a spectrum of “social, psychological, behavioral or medical (including hormonal treatment or surgery) interventions designed to support and affirm an individual’s gender identity.”

What is the status of state policy restrictions aimed at limiting youth access to gender affirming care?

Four states (Alabama, Arkansas, Texas, and Arizona) recently enacted laws or policies restricting youth access to gender affirming care and, in some cases, imposing penalties on adults facilitating access. Alabama, Arkansas, and Texas have been temporarily blocked from enforcing these laws and policies by court order.

  • Alabama. In April 2022, the Alabama governor signed a bill into law that prevents transgender minors from receiving gender affirming care, including puberty blockers, hormone therapy, and surgical intervention. The bill makes it a felony for any person to “engage in or cause” a transgender minor to receive any of these treatments, punishable by up to 10 years in prison or a fine up to $15,000. The bill additionally states that nurses, counselors, teachers, principals, and other administrative school officials shall not withhold from a minor’s parents or guardian that their child’s “perception of his or her gender or sex is inconsistent with the minor’s sex” assigned at birth and shall not encourage a minor to do so. Shortly after enactment, a federal lawsuit challenging the law was filed by four Alabama families with transgender children, two healthcare providers, and a clergy member. Subsequently, the U.S. Department of Justice (DOJ) joined the case as an additional plaintiff challenging the law. This case has been consolidated with another lawsuit filed by two other Alabama families with transgender children, which raises similar challenges. In May 2022, a federal district court entered a preliminary injunction, blocking enforcement of several sections of the Alabama law while the litigation is pending. Specifically, the preliminary injunction applies to the sections of the law that prohibit puberty blockers and hormone therapy. Other sections of the law remain in effect, including the prohibition on surgical intervention and the prohibition on school officials keeping secret or encouraging or compelling children to keep secret certain gender-identity information from children’s parents. When deciding to grant the preliminary injunction, the district court found that the plaintiffs were substantially likely to succeed on their claim that the sections of the law that prohibit puberty blockers and hormone therapy unconstitutionally violate parents’ fundamental right to autonomy under the 14 th Amendment’s due process clause by prohibiting parents from obtaining medical treatment for their children subject to medically accepted standards. The court also fond that the plaintiffs were substantially likely to succeed on their claim that these sections of the law are unconstitutional sex discrimination in violation of the 14 th Amendment’s equal protection clause because the law denies medically necessary services only to transgender minors, while allowing those services for cisgender minors. Additionally, the court found that the plaintiffs were likely to suffer irreparable harm, in the form of “severe physical and/or psychological harm” and “significant deterioration in their familial relationships and educational performance,” if the law was not blocked. The state has appealed the district court’s decision to the 11 th Circuit.
  • Arkansas . In 2021, on override of Governor Hutchinson’s veto, Arkansas lawmakers passed legislation prohibiting gender-affirming treatment for minors, including puberty blockers, hormone therapy, and gender affirming surgery. The law also prohibits medical providers from making referrals to other providers for minors seeking these procedures. Under the law, medical providers offering gender affirming care or providing referrals for such care to minors may be subject to discipline by relevant licensing entities. The legislation additionally includes a prohibition on private insurance coverage of gender affirming services for minors and a prohibition on the use of public funds, including through Medicaid, for coverage of these services for minors. In May 2021, four families of transgender youth and two physicians challenged the Arkansas law in federal court, arguing that the law is illegal sex discrimination under the 14 th Amendment’s equal protection clause. They also argue that the law violates parents’ right to autonomy protected by the 14 th Amendment’s due process clause and violates the families and physicians’ right to free speech under the 1 st Amendment. The U.S. Department of Justice (DOJ) filed a statement of interest in support of the plaintiffs’ motion for a preliminary injunction in the Arkansas case. DOJ  argued that the Arkansas law  violates the Equal Protection Clause of the 14 th Amendment because the state law “singles out transgender minors. . . specifically and discriminatorily den[ies] their access to medically necessary care based solely on their sex assigned at birth.” A preliminary injunction was granted in July 2021, temporarily blocking the state from enforcing the law while the case is pending. The court found that the plaintiffs were likely to succeed on all three of their Constitutional claims, and that the law was not substantially related to the state’s interest in protecting children or regulating physicians’ ethics because the law allows the same medical treatments for cisgender minors. The court also found that the plaintiffs will suffer irreparable physical and psychological harm if the law is not blocked. The court also denied the state’s motion to dismiss the case. The state has appealed both of those decisions to the 8 th Circuit, where a decision is currently pending. A group of 19 states filed an amicus brief in support of the state’s appeal. 1 They argue that states have “broad authority” to regulate gender affirming services, because they allege this area is “fraught with medical uncertainties,” contrary to the evidence from the American Academy of Pediatrics and the American Medical Association on which the lower court relied. Another group of 20 states and the District of Columbia filed an amicus brief in support of the plaintiffs. 2 They argue that they and their residents are economically, physically, and mentally harmed by discrimination against transgender people. They also argue that their states “protect access to gender-affirming healthcare based on well-accepted medical standards” and that Arkansas’ law is unconstitutional sex discrimination and “ignores medical consensus as well as decisions made between doctors and their patients.” Litigation in the case continues in the district court, where the case is scheduled for trial during the week of July 25, 2022.
  • Texas . In February 2022, Governor Abbott of Texas issued a directive defining certain gender affirming services for youth as child abuse, and calling for investigation of and penalties for parents who support their children in taking certain medications or undertaking certain procedures, which could include the removal of their children. In addition, under the directive, health care professionals who facilitate access to these services could also face penalties and a range of professionals in the state would be mandated to report known use of the specified gender affirming services. While other states with proposed policies to limit youth access to gender affirming care include penalties for parents who facilitate access to these services (see below), no implemented policy ties the parental role to child abuse as the Texas directive does. In the wake of litigation , a state court entered a temporary injunction preventing the state from enforcing the directive while the case is pending. The court found that the governor acted outside his statutory legal authority in issuing the directive, and the plaintiffs will suffer immediate and irreparable injuries, including loss of employment, deprivation of constitutional rights, and loss of medically necessary care. However, the Texas Supreme Court subsequently modified the temporary injunction, finding that the courts lack authority to prevent enforcement of the directive statewide. Instead, the state is prohibited from enforcing the directive only against the plaintiffs involved in the lawsuit while the case is pending. The case is scheduled for trial on July 11, 2022.
  • Arizona . In March 2022, Arizona Governor Ducey signed legislation into law that bans physicians from providing gender-affirming surgical treatment to minors. The legislation does not address hormone therapy or puberty blockers.

In addition, since January 2022 15 states introduced a total of 25 bills that would restrict access to gender-affirming care for youth. Provisions in these bills varied considerably and include those that would:

  • criminalize or impose/permit professional disciplinary action (e.g. revoking or suspending licensure) on health professionals providing gender-affirming care to minors, in some cases labeling such services as child abuse
  • penalize parents aiding in youth accessing gender-affirming care
  • permit individuals to file for damages against providers who violate such laws
  • limit insurance coverage or payment for gender affirming services or prohibit the use of state funds for such services

Beyond these policies, states have also passed or considered other policies restricting access, including so called “bathroom bills” which restrict access to bathrooms or locker rooms based on sex assigned at birth, the recent Florida “don’t say gay” bill that would prohibit classroom discussion on sexual orientation or gender identity, and laws that limit transgender students’ access to sports. While these policies are not directly tied to health or health care access, their attempts to limit access to social spaces and services and present non-affirming sentiments could negatively impact LGBTQ+ people’s mental health and well-being. For instance, one recent study found that state laws permitting the denial of services to same-sex couples “are associated with increases in mental distress among sexual minority adults.” In addition, and directly related to health care, Florida recently released non-biding guidance recommending against gender affirming care for youth.

What states have introduced protections related to sexual orientation and gender identity in health care?

Though not specific to youth access to gender affirming care, some states have adopted policies that provide health care protections to LGBTQ+ people, including:

  • prohibitions on health insurance discrimination based on sexual orientation and/or
  • requirements that state Medicaid programs explicitly cover health services related to gender transition

What is federal policy regarding gender-affirming services?

The Biden administration has taken multiple steps to promote access to health care for LGBTQ+ people and to prohibit discrimination on the basis of sexual orientation and gender identity, including:

  • On his first day in office, President Biden signed an executive order directing federal agencies to review existing regulations and policies in order to “prevent and combat discrimination” based on gender identity and sexual orientation. The order states that “people should be able to access healthcare…without being subjected to sex discrimination” and views sex nondiscrimination protections as encompassing sexual orientation and gender identity, following the Supreme Court’s Bostock
  • On May 10, 2021, also in light of the Bostock ruling, the Biden Administration announced that the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) would include gender identity and sexual orientation in its interpretation and enforcement of Section 1557’s prohibition against sex discrimination. Section 1557 of the Affordable Care Act (ACA) contains the law’s primary nondiscrimination provisions, including a prohibition on discrimination on the basis of sex by a range of health care entities and programs that receive federal funding. The May 2021 announcement marked both a reversal of Trump Administration policy, which eliminated gender identity and sex stereotyping from the regulations, and an expansion of Obama Administration policy, which included gender identity and sex stereotyping in the definition of sex discrimination but omitted sexual orientation. Following the  Bostock  ruling, two federal district courts issued nationwide preliminary injunctions, blocking implementation of several provisions of the Trump Administration’s regulations related to Section 1557. Biden Administration implementing regulations on Section 1557 are expected to expand on the May announcement.

In addition to establishing a foundation of nondiscrimination policies for LGBTQ+ people, and participating in the Alabama and Arkansas cases as noted above, the administration has responded specifically to the Texas directive, denouncing it as discriminatory and stating that gender affirming care for youth should be supported as follows:

  • Statement from President Biden: The statement from the president states that the administration is “putting the state of Texas on notice that their discriminatory actions put children’s lives at risk. These announcements make clear that rather than weaponizing child protective services against loving families, child welfare agencies should instead expand access to gender-affirming care for transgender children.”
  • Statement from Dept. of Health and Human Services (HHS) Sec. Becerra : Becerra’s statement reaffirms “HHS’s commitment to supporting and protecting transgender youth and their parents, caretakers and families” and details action items the administration is taking in response to the Texas directive including those that follow below.
  • Following the actions in Texas, HHS’s Administration on Children, Youth and Families issued an Information Memorandum to state child welfare agencies writing that child welfare systems should advance safety and support for LGBTQI+ youth, including though access to gender affirming care.
  • Specifically, the guidance states that categorically refusing treatment based on gender identity is prohibited discrimination under Section 1557. The guidance also states that Section 1557’s prohibition against sex-based discrimination is likely violated if a provider reports parents seeking medically necessary gender affirming care for their child to state authorities, if the provider or facility is receiving federal funding. The guidance further states that restricting a provider from providing gender affirming care may violate Section 1557.
  • The guidance states that in cases where gender dysphoria qualifies as a disability, restrictions that prevent individuals from receiving medically necessary care based on a diagnosis or perception of gender dysphoria may also violate Section 504 and the ADA.
  • It also articulates requirements under the Health Insurance Portability and Accountability Act (HIPAA) that prohibit health plans and providers from disclosing protected health information, such as use of gender affirming physical or mental health care without patient consent, except in limited circumstances.

OCR enforces each of these federal laws, and the guidance states that parents or caregivers who believe their child has been denied health care, including gender affirming care, and health care providers who believe they have been unlawfully restricted from providing such care, may file an administrative complaint for OCR to investigate.

What do major medical societies say about gender affirming services?

Most major U.S. medical associations, including those in the fields of pediatrics, endocrinology, psychiatry, and psychology, have issued statements recognizing the medical necessity and appropriateness of gender affirming care for youth, typically noting harmful effects of denying access to these services. These include statements from the American Medical Association , American Academy of Pediatrics , the Endocrine Society , American Psychological Association , American Psychiatric Association , and the World Professional Association for Transgender Health , among others , which in some cases were specifically issued in response to the Arkansas legislation and Texas directive. Further, 23 medical associations or societies, including those named above, together filed an amicus brief in the case filed against Texas Gov. Abbott opposing the state directive. The brief states that denying gender affirming treatment to adolescents who need them would irreparably harm their health and that enforcing the directive would irreparably harm providers who are forced to choose between potentially facing civil and criminal penalties or endangering their patients. A similar amicus brief was filed in the Arkansas case.

Additionally, the Endocrine Society supports gender affirming care for young people in their clinical practice guidelines , as does the World Professional Association for Transgender Health’s standards of care . Together these guidelines form the standard of care for treatment of gender dysphoria.

What are the implications of access restrictions?

State policies restricting youth access to gender affirming care could have significant health and other implications for LGBTQ+ youth, their parents, health care providers, and, in some cases, other community members:

LGBTQ+ youth : LGBTQ+ youth experience higher rates of depression, anxiety, and suicidality than their non-LGBTQ+ peers. In one CDC study of youth in 10 states and 9 urban school districts, a higher share of transgender students reported suicide risk outcomes across a range of metrics than cisgender students. These include, in the past 12 months: having felt sad or hopeless, considered attempting suicide, made a suicide plan, attempted suicide, or had a suicide attempt treated by a doctor or nurse. Inability to access gender affirming care, such as puberty suppressors and hormone therapy , has been linked to worse mental health outcomes for transgender youth, including with respect to suicidal ideation, potentially exacerbating the already existing disparities. Conversely, access to this care is associated with improved outcomes in these domains. Policies that aim to prohibit or interrupt access to gender affirming care for youth can therefore have negative implications for health in potentially life-threatening ways.

In addition, LGBTQ people report higher rates of negative experiences with medical providers, so creating barriers to gender affirming care could further challenge transgender people’s relationship with the healthcare system.

Finally, with the Texas directive specifically, and in several other states with bills under consideration, youth are vulnerable to secondary trauma, knowing that if they seek such care, their families and providers could be subject to penalties, and, in the case of Texas, children could be separated from their parents.

Parents : In several states with bills under consideration, parents who facilitate access to evidence-based and potentially lifesaving gender affirming services for their children could face penalties. Under the Texas directive, because it is defined as child abuse, parents who facilitate access to gender affirming care for their children, could be subject to penalties, including losing custody of their children. This may place parents in the position of either supporting their children in accessing care supported by medical evidence and facing penalties or denying their children access in an effort not to make their family vulnerable to investigation and potential separation. Each option for parents in this scenario has the potential to be traumatic for the family, and for youth in particular.

Providers: Like parents, providers may be torn between what the medical literature supports is in the best interest of their patients or facing potential sanctions, including violating professional ethics around confidentiality, as in the case of Texas. The American Psychological Association said in a statement that a requirement such as the Texas directive is a violation of both patient confidentiality and professional ethics. Under such circumstances, providers may be forced to decide whether they will provide the highest standard of care for their patients and potentially face sanctions, or obey the state directive but withhold care and potentially violate patient confidentiality and professional ethics. Further, as noted above, the Biden Admiration has stated that HIPAA requirements prohibit providers from disclosing use of gender affirming care without patient consent, except as in narrow circumstances. However, following HIPPA requirements in this case may make providers vulnerable to state sanction under the directive.

Teachers and others : In Texas, in addition to health care providers, other mandated reporters, such as teachers, could also face penalties for failure to report youth known to be accessing gender affirming care. The directive also states that ”there are similar reporting requirements and criminal penalties for members of the general public,” extending the policy’s reach to practically anyone with knowledge of youth accessing these services.

Looking forward

The legal and policy landscape regarding youth access to gender affirming care is shifting across the country, with an increasing number of states seeking to limit such access and impose penalties. Such policies may have significant, negative implications for the health of young people. At the same time, these states are at odds with federal law and policy, and in two recent cases courts have temporarily blocked enforcement of such restrictions. Moving ahead, it will be important to watch how state bills still under consideration unfold and the final outcome of cases in Alabama, Arkansas, and Texas. Decisions in these cases could determine how such policies intersect with existing federal policies — including Section 1557’s prohibition on sex based discrimination in health care, federal disability non-discrimination protections, and HIPAA patient privacy protections — as well as providers’ professional ethics standards.

These states include Alabama, Alaska, Arizona, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, South Carolina, South Dakota, Tennessee, Texas, Utah, and West Virginia.

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These states include California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Rhode Island, Vermont, and Washington.

Also of Interest

  • LGBT+ People’s Health and Experiences Accessing Care
  • The Health System Appears To Be Selling LGBT+ People Short
  • The Impact of the COVID-19 Pandemic on LGBT+ People’s Mental Health

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CMS.gov Centers for Medicare & Medicaid Services

Gender Dysphoria and Gender Reassignment Surgery

Decision summary.

Currently, the local Medicare Administrative Contractors (MACs) determine coverage of gender reassignment surgery on a case-by-case basis. We received a complete, formal request to make a national coverage determination on surgical remedies for gender identity disorder (GID), now known as gender dysphoria. The Centers for Medicare & Medicaid Services (CMS) is not issuing a National Coverage Determination (NCD) at this time on gender reassignment surgery for Medicare beneficiaries with gender dysphoria because the clinical evidence is inconclusive for the Medicare population.

In the absence of a NCD, coverage determinations for gender reassignment surgery, under section 1862(a)(1)(A) of the Social Security Act (the Act) and any other relevant statutory requirements, will continue to be made by the local MACs on a case-by-case basis. To clarify further, the result of this decision is not national non-coverage rather it is that no national policy will be put in place for the Medicare program. In the absence of a national policy, MACs will make the determination of whether or not to cover gender reassignment surgery based on whether gender reassignment surgery is reasonable and necessary for the individual beneficiary after considering the individual’s specific circumstances. For Medicare beneficiaries enrolled in Medicare Advantage (MA) plans, the initial determination of whether or not surgery is reasonable and necessary will be made by the MA plans.

Consistent with the request CMS received, the focus of this National Coverage Analysis (NCA) was gender reassignment surgery. Specific types of surgeries were not individually assessed. We did not analyze the clinical evidence for counseling or hormone therapy treatments for gender dysphoria. As requested by several public commenters, we have modified our final decision memorandum to remove language that was beyond the scope of the specific request. We are not making a national coverage determination related to counseling, hormone therapy treatments, or any other potential treatment for gender dysphoria.

While we are not issuing a NCD, CMS encourages robust clinical studies that will fill the evidence gaps and help inform which patients are most likely to achieve improved health outcomes with gender reassignment surgery, which types of surgery are most appropriate, and what types of physician criteria and care setting(s) are needed to ensure that patients achieve improved health outcomes.

Proposed Decision Memo

I. decision, ii. background.

Below is a list of acronyms used throughout this document.

AHRQ - Agency for Healthcare Research and Quality AIDS - Acquired Immune Deficiency Syndrome ANOVA - Analysis of Variance APA - American Psychiatric Association APGAR - Adaptability, Partnership Growth, Affection, and Resolve test BIQ - Body Image Questionnaire BSRI - Bem Sex Role Inventory CCEI - Crown Crips Experimental Index CDC – Centers for Disease Control CHIS - California Health Interview Survey CI - Confidence Interval CMS - Centers for Medicare & Medicaid Services DAB - Departmental Appeals Board DSM - Diagnostic and Statistical Manual of Mental Disorders EMBASE - Exerpta Medica dataBASE FBeK - Fragebogen zur Beurteilung des eigenen Korpers FDA - Food and Drug Administration FPI-R - Freiburg Personality Inventory FSFI - Female Sexual Function Index GAF - Global Assessment of Functioning GID - Gender Identity Disorder GIS - Gender Identity Trait Scale GRS - Gender Reassignment Surgery GSI - Global Severity Indices HADS - Hospital Anxiety Depression Scale HHS - U.S. Department of Health and Human Services HIV - Human Immunodeficiency Virus IIP - Inventory of Interpersonal Problems IOM - Institute of Medicine KHQ - King’s Health Questionnaire LGB - Lesbian, Gay, and Bisexual LGBT - Lesbian, Gay, Bisexual, and Transgender MAC - Medicare Administrative Contractor MMPI - Minnesota Multiphasic Personality Inventory NCA - National Coverage Analysis NCD - National Coverage Determination NICE - National Institute for Health Care Excellence NIH - National Institutes of Health NZHTA - New Zealand Health Technology Assessment PIT - Psychological Integration of Trans-sexuals QOL - Quality of Life S.D. - Standard Deviation SADS - Social Anxiety Depression Scale SCL-90R - Symptom Check List 90-Revised SDPE - Scale for Depersonalization Experiences SES - Self Esteem Scale SF - Short Form SMR - Standardized Mortality Ratio SOC – Standards of Care STAI-X1 - Spielberger State and Trait Anxiety Questionnaire STAI-X2 - Spielberger State and Trait Anxiety Questionnaire TSCS - Tennessee Self-Concept Scale U.S. - United States VAS - Visual Analog Scale WHOQOL-BREF - World Health Organization Quality of Life - Abbreviated version of the WHOQOL-100 WPATH - World Professional Association for Transgender Health

A. Diagnostic Criteria

The criteria for gender dysphoria or spectrum of related conditions as defined by the American Psychiatric Association (APA) in the Diagnostic and Statistical Manual of Mental Disorders (DSM) has changed over time (See Appendix A).

Gender dysphoria (previously known as gender identity disorder) is a classification used to describe persons who experience significant discontent with their biological sex and/or gender assigned at birth. Although there are other therapeutic options for gender dysphoria, consistent with the NCA request, this decision only focuses on gender reassignment surgery.

B. Prevalence of Transgender Individuals

For estimates of transgender individuals in the U.S., we looked at several studies.

The Massachusetts Behavior Risk Factor Surveillance Survey (via telephone) (2007 and 2009) identified 0.5% individuals as transgender (Conron et al., 2012).

Derivative data obtained from the 2004 California Lesbian Gay Bisexual and Transgender (LGBT) Tobacco Survey (via telephone) and the 2009 California Health Interview Survey (CHIS) (via telephone) suggested the LGB population constitutes 3.2% of the California population and that transgender subjects constitute approximately 2% of the California LGBT population and 0.06% of the overall California population (Bye et al., 2005; CHIS 2009; Gates, 2011).

Most recently, the Williams Institute published a report that utilized data from the Centers for Disease Control’s (CDC) Behavioral Risk Factor Surveillance System (BRFSS). Overall, they found that 0.6% or 1.4 million U.S. adults identify as transgender. The report further estimated 0.7% of adults between the ages of 18-25 identify as transgender, 0.6% of adults between the ages of 25-65 identify as transgender, and 0.5% of adults age 65 or older identify as transgender (Flores et al., 2016).

In a recent review of Medicare claims data, CMS estimated that in calendar year 2013 there were at least 4,098 transgender beneficiaries (less than 1% of the Medicare population) who utilized services paid for by Medicare, of which 90% had confirmatory diagnosis, billing codes, or evidence of a hormone therapy prescription. The Medicare transgender population is racially and ethnically diverse (e.g., 74% White, 15% African American) and spans the entire country. Nearly 80% of transgender beneficiaries are under age 65, including approximately 23% ages 45-54. (CMS Office of Minority Health 2015).

For international comparison purposes, recent estimates of transgender populations in other countries are similar to those in the United States. New Zealand researchers, using passport data, reported a prevalence of 0.0275% for male-to-female adults and 0.0044% female-to-male adults (6:1 ratio) (Veale, 2008). Researchers from a centers of transgender treatment and reassignment surgery in Belgium conducted a survey of regional plastic surgeons and reported a prevalence of 0.008% male-to-female and 0.003% female-to-male (ratio 2.7:1) surgically reassigned transsexuals in Belgium (De Cuypere et al., 2007). Swedish researchers, using national mandatory reporting data on those requesting reassignment surgery, reported secular changes over time in that the number of completed reassignment surgeries per application increased markedly in the 1990s; the male-to- female/female-to-male sex ratio changed from 1:1 to 2:1; the age of male-to-female and female-to-male applicants was initially similar, but increased by eight years for male-to-female applicants; and the proportion of foreign born applicants increased (Olsson and Moller 2003).

III. History of Medicare Coverage

Date Action
August 1, 1989 CMS published the initial NCD, titled “140.3, Transsexual Surgery" in the Federal Register. (54 Fed. Reg. 34,555, 34,572)
May 30, 2014The HHS Departmental Appeals Board (DAB) determined that the NCD denying coverage for all transsexual surgery was not valid. As a result, MACs determined coverage on a case-by-case basis.

CMS does not currently have a NCD on gender reassignment surgery.

A. Current Request

On December 3, 2015, CMS accepted a formal complete request from a beneficiary to initiate a NCA for gender reassignment surgery.

CMS opened this National Coverage Analysis (NCA) to thoroughly review the evidence to determine whether or not gender reassignment surgery may be covered nationally under the Medicare program.

B. Benefit Category

Medicare is a defined benefit program. For an item or service to be covered by the Medicare program, it must fall within one of the statutorily defined benefit categories as outlined in the Act. For gender reassignment surgery, the following are statutes are applicable to coverage:

Under §1812 (Scope of Part A) Under §1832 (Scope of Part B) Under §1861(s) (Definition of Medical and Other Health Services) Under §1861(s)(1) (Physicians’ Services)

This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

IV. Timeline of Recent Activities

Timeline of Medicare Coverage Policy Actions for Gender Reassignment Surgery

Date Action
December 3, 2015 CMS accepts an external request to open a NCD. A tracking sheet was posted on the web site and the initial 30 day public comment period commenced.
January 2, 2016Initial comment period closed. CMS received 103 comments.
June 2, 2016Proposed Decision Memorandum posted on the web site and the final 30 day public comment period commenced.
July 2, 2016Final comment period closed. CMS received 45 comments.

V. FDA Status

Surgical procedures per se are not subject to the Food and Drug Administration’s (FDA) approval.

Inflatable penile prosthetic devices, rigid penile implants, testicular prosthetic implants, and breast implants have been approved and/or cleared by the FDA.

VI. General Methodological Principles

In general, when making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. (§ 1862 (a)(1)(A)). The evidence may consist of external technology assessments, internal review of published and unpublished studies, recommendations from the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), evidence-based guidelines, professional society position statements, expert opinion, and public comments.

The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: 1) specific clinical question relevant to the coverage request can be answered conclusively; and 2) the extent to which we are confident that the intervention will improve health outcomes for patients.

A detailed account of the methodological principles of study design the agency staff utilizes to assess the relevant literature on a therapeutic or diagnostic item or service for specific conditions can be found in Appendix B. In general, features of clinical studies that improve quality and decrease bias include the selection of a clinically relevant cohort, the consistent use of a single good reference standard, blinding of readers of the index test, and reference test results.

VII. Evidence

A. Introduction

Below is a summary of the evidence we considered during our review, primarily articles about clinical trials published in peer- reviewed medical journals. We also considered articles cited by the requestor, articles identified in public comments, as well as those found by a CMS literature review. Citations are detailed below.

B. Literature Search Methods

CMS staff extensively searched for primary studies for gender dysphoria. The emphasis focused less on specific surgical techniques and more on functional outcomes unless specific techniques altered those types of outcomes.

The reviewed evidence included articles obtained by searching literature databases and technology review databases from PubMed (1965 to current date), EMBASE, the Agency for Healthcare Research and Quality (AHRQ), the Blue Cross/Blue Shield Technology Evaluation Center, the Cochrane Collection, the Institute of Medicine, and the National Institute for Health and Care Excellence (NICE) as well as the source material for commentary, guidelines, and formal evidence-based documents published by professional societies. Systematic reviews were used to help locate some of the more obscure publications and abstracts.

Keywords used in the search included: Trans-sexual, transgender, gender identity disorder (syndrome), gender dysphoria and/or hormone therapy, gender surgery, genital surgery, gender reassignment (surgery), sex reassignment (surgery) and/or quality of life, satisfaction-regret, psychological function (diagnosis of mood disorders, psychopathology, personality disorders), suicide (attempts), mortality, and adverse events-reoperations. After the identification of germane publications, CMS also conducted searches on the specific psychometric instruments used by investigators.

Psychometric instruments are scientific tools used to measure individuals' mental capabilities and behavioral style. They are usually in the form of questionnaires that numerically capture responses. These tools are used to create a psychological profile that can address questions about a person’s knowledge, abilities, attitudes and personality traits. In the evaluation of patients with gender dysphoria, it is important that both validity and reliability be assured in the construction of the tool (validity refers to how well the tool actually measures what it was designed to measure, or how well it reflects the reality it claims to represent, while reliability refers to how accurately results of the tool would be replicated in a second identical piece of research). Reliability and validity are important because when evaluating patients with gender dysphoria most of the variables of interest (e.g., satisfaction, anxiety, depression) are latent in nature (not directly observed but are rather inferred) and difficult to quantify objectively.

Studies with robust study designs and larger, defined patient populations assessed with objective endpoints or validated test instruments were given greater weight than small, pilot studies. Reduced consideration was given to studies that were underpowered for the assessment of differences or changes known to be clinically important. Studies with fewer than 30 patients were reviewed and delineated, but excluded from the major analytic framework. Oral presentations, unpublished white papers, and case reports were excluded. Publications in languages other than English were excluded. The CMS initial internal search for the proposed decision memorandum was limited to articles published prior to March 21, 2016. The CMS internal search for the final decision memorandum continued through articles published prior to July 22, 2016.

Included studies were limited to those with adult subjects. Review and discussion of the management of children and adolescents with the additional considerations of induced pubertal delay are outside the scope of this NCD. In cases where the same population was studied for multiple reasons or where the patient population was expanded over time, the latest and/or most germane sections of the publications were analyzed. The excluded duplicative publications are delineated.

CMS also searched Clinicaltrials.gov to identify relevant clinical trials. CMS looked at trial status including early termination, completed, ongoing with sponsor update, and ongoing with estimated date of completion. Publications on completed trials were sought. For this final decision, CMS also reviewed all evidence submitted via public comment.

C. Discussion of Evidence

The development of an assessment in support of Medicare coverage determinations is based on the same general question for almost all national coverage analyses (NCAs): "Is the evidence sufficient to conclude that the application of the item or service under study will improve health outcomes for Medicare patients?" For this specific NCA, CMS is interested in answering the following question:

Is there sufficient evidence to conclude that gender reassignment surgery improves health outcomes for Medicare beneficiaries with gender dysphoria?

The evidence reviewed is directed towards answering this question.

1. Internal Technology Assessment

CMS conducted an extensive literature search on gender reassignment related surgical procedures and on facets of gender dysphoria that provide context for this analysis. The latter includes medical and environmental conditions.

CMS identified numerous publications related to gender reassignment surgery. A large number of these were case reports, case series with or without descriptive statistics, or studies with population sizes too small to conduct standard parametric statistical analyses. Others addressed issues of surgical technique.

CMS identified and described 36 publications on gender reassignment surgery that included health outcomes. Because the various investigators at a site sometimes conducted serial studies on ever-enlarging cohort populations, studied sub-populations, studied different outcomes, or used different tools to study the same outcomes, not all study populations were unique. To reduce bias from over-lapping populations, only the latest or most germane publication(s) were described. Subsumed publications were delineated.

Of these 36 publications, two publications used different assessment tools on the same population, and, so for the purposes of evaluation, were classified as one study (Udeze et al., 2008; Megeri and Khoosal, 2007). A total of 33 studies were reviewed (See Figure 1). Appendices C, D, and F include more detail of each study. The publications covered a time span from 1979 to 2015. Over half of the studies were published after 2005.

Figure 1. Studies of Gender Reassignment Surgery (GRS)

ANOVA=Analysis of Variance Normative=Psychometric Tests with known normative for large populations

Figure 1 Legend: The studies in Figure 1 are categorized into three groups. The first group, depicted by the colored boxes (red, blue, and green), had explicit controls. There was a single randomized study. The remainder in the first group were observational studies. These were subdivided into longitudinal studies and cross-sectional studies. The second group, depicted by black boxes (starting with the surgery only population box) consisted of surgical series. The third group, depicted by black boxes (starting with mixed population), was composed of patients whose treatment could involve a variety of therapeutic interventions, but who were not stratified by that treatment.

When looking at the totality of studies, the 33 studies could be characterized by the following research design groups:

a. Observational, mixed population of surgical and non-surgical patients without stratification

Asscheman H, Giltay EJ, Megens JA, de Ronde WP, van Trotsenburg MA, Gooren LJ. A long-term follow-up study of mortality in transsexuals receiving treatment with cross-sex hormones. Eur J Endocrinol. 2011 Apr;164(4):635-42. Epub 2011 Jan 25.

Asscheman et al. conducted a retrospective, non-blinded, observational study of mortality using a longitudinal design to assess a mixed population treated with hormones, as well as, reassignment surgery in comparison to a population-based cohort. The study was not designed to assess the specific impact of gender reassignment surgery on clinical outcomes.

The investigators assessed mortality in patients who (a) were from a single-center, unspecified, Dutch university specialty clinic, (b) had initiated cross-sex hormone treatment prior to July 1, 1997, and (c) had been followed (with or without continued hormone treatment) by the clinic for at least one year or had expired during the first year of treatment. The National Civil Record Registry (Gemeentelijke Basis Administratie) was used to identify/confirm deaths of clinic patients. Information on the types or hormones used was extracted from clinic records, and information on the causation of death was extracted from medical records or obtained from family physicians. Mortality data for the general population were obtained through the Central Bureau of Statistics of the Netherlands (Centraal Bureau voor Statistiek). Mortality data from Acquired Immune Deficiency Syndrome (AIDS) and substance abuse were extracted from selected Statistics Netherlands reports. The gender of the general Dutch population comparator group was the natal sex of the respective gender dysphoric patient groups.

A total of 1,331 patients who met the hormone treatment requirements were identified (365 female-to-male [27.4%]; 966 male- to-female [72.6%]; ratio 1:2.6). Of these, 1,177 (88.4%) underwent reassignment surgery (343 [94.0% of female-to-male entrants]; 834 [86.3% of male-to-female entrants]; ratio difference 1:2.4 with a p-value p<0.0001). Later calculations did not distinguish between those with hormone therapy alone versus those with hormone therapy plus reassignment surgery. The mean age at the time of hormone initiation in female-to-male and male-to-female patients was 26.1±7.6 (range 16–56) years and 31.4±11.4 (range 16–76) years respectively, although the male-to-female subjects were relatively older (p<0.001). The mean duration of hormone therapy in female-to-male and male-to-female patients was 18.8±6.3 and 19.4±7.7 years respectively.

There were a total of 134 deaths in the clinic population using hormone therapy with or without surgical reassignment. Of these patients, 12 (3.3%) of the 365 female-to-male patients and 122 (12.6%) of the 966 male-to-female patients died. All-cause mortality for this mixed population was 51% higher and statistically significant (Standardized Mortality Ratio [SMR] 95% confidence interval [CI]) 1.47-1.55) for males-to-females when compared to males in the general Dutch population. The increase in all-cause mortality (12%) for females-to-males when compared to females in the general Dutch population was not statistically significant (95% CI 0.87-1.42).

Ischemic heart disease was a major disparate contributor to excess mortality in male-to-female patients but only in older patients (n=18, SMR 1.64 [95% CI 1.43-1.87]), mean age [range]: 59.7 [42-79] years. Current use of a particular type of estrogen, ethinyl estradiol, was found to contribute to death from myocardial infarction or stroke (Adjusted Hazard Ratio 3.12 [95% CI 1.28-7.63], p=0.01). There was a small, but statistically significant increase in lung cancer that was thought to possibly be related to higher rates of smoking in this cohort.

Other contributors to the mortality difference between male-to-female patients and the Dutch population at large were completed suicide (n=17, SMR 5.70 [95% CI 4.93-6.54]), AIDS (n=16, SMR 30.20 [95% CI 26.0-34.7]), and illicit drug use (n=5, SMR 13.20 [95% CI 9.70-17.6]). An additional major contributor was “unknown cause” (n=21, SMR 4.00 [95% CI 3.52-4.51]). Of the 17 male-to-female hormone treated patients who committed suicide, 13 (76.5%) had received prior psychiatric treatment and six (35.3%) had not undergone reassignment surgery because of concerns about mental health stability.

Overall mortality, and specifically breast cancer and cardiovascular disease, were not increased in the hormone-treated female-to-male patients. Asscheman et al. reported an elevated SMR for illicit drug use (n=1, SMR 25 [6.00-32.5]). This was the cause of one of the 12 deaths in the cohort.

This study subsumes earlier publications on mortality (Asscheman et al. 1989 [n=425]; Van Kesteren et al. 1997 [n=816]).

Gómez-Gil E, Zubiaurre-Elorza L, Esteva I, Guillamon A, Godás T, Cruz Almaraz M, Halperin I, Salamero M. Hormone- treated transsexuals report less social distress, anxiety and depression. Psychoneuroendocrinology. 2012 May;37(5):662-70. Epub 2011 Sep 19.

Gómez-Gil et al. conducted a prospective, non-blinded observational study using a cross-sectional design and non-specific psychiatric distress tools in Spain. The investigators assessed anxiety and depression in patients with gender dysphoria who attended a single-center specialty clinic with comprehensive endocrine, psychological, psychiatric, and surgical care. The clinic employed World Professional Association for Transgender Health (WPATH) guidelines. Patients were required to have met diagnostic criteria during evaluations by 2 experts. Investigators used the Hospital Anxiety and Depression Scale (HADS) and the Social Anxiety and Distress Scale (SADS) instruments. The SADS total score ranges from 0 to 28, with higher scores indicative of more anxiety. English language normative values are 9.1±8.0. HAD-anxiety and HAD-depression total score ranges from 0 to 21, with higher scores indicative of more pathology. Scores less than 8 are normal. ANOVA was used to explore effects of hormone and surgical treatment.

Of the 200 consecutively selected patients recruited, 187 (93.5% of recruited) were included in the final study population. Of the final study population, 74 (39.6%) were female-to-male patients; 113 (60.4%) were male-to-female patients (ratio 1:1.5); and 120 (64.2%) were using hormones. Of those using hormones, 36 (30.0%) were female-to-male; 84 (70.0%) were male-to-female (ratio 1:2.3). The mean age was 29.87±9.15 years (range 15-61). The current age of patients using hormones was 33.6±9.1 years (n=120) and older than the age of patients without hormone treatment (25.9±7.5) (p=0.001). The age at hormone initiation, however, was 24.6±8.1 years.

Of those who had undergone reassignment surgery, 29 (36.7%) were female-to-male; 50 (63.3%) were male-to-female (ratio 1:1.7). The number of patients not on hormones and who had undergone at least one gender-related surgical procedure (genital or non-genital) was small (n=2). The number of female-to-male patients on hormones who had undergone such surgery (mastectomy, hysterectomy, and/or phalloplasty) was 28 (77.8%). The number of male-to-female patients on hormones who had undergone such surgery (mammoplasty, facial feminization, buttock feminization, vaginoplasty, orchiectomy, and/or vocal feminization (thyroid chondroplasty) was 49 (58.3%).

Analysis of the data revealed that although the mean scores HAD-Anxiety, HAD-Depression, and SADS were statistically lower (better) in those on hormone therapy than in those not on hormone therapy, the mean scores for HAD-Depression and SADS were in the normal range for gender dysphoric patients not using hormones. The HAD-Anxiety score was 9 in transsexuals without hormone treatment and 6.4 in transsexuals with hormone treatment. The mean scores for HAD-Anxiety, HAD- Depression, and SADS were in the normal range for gender dysphoric patients using hormones. ANOVA revealed that results did not differ by whether the patient had undergone a gender related surgical procedure or not.

Gómez-Gil E, Zubiaurre-Elorza L, de Antonio I, Guillamon A, Salamero M. Determinants of quality of life in Spanish transsexuals attending a gender unit before genital sex reassignment surgery. Qual Life Res. 2014 Mar;23(2):669-76. Epub 2013 Aug 13.

Gómez-Gil et al. conducted a prospective, non-blinded observational study using a non-specific quality of life tool. There were no formal controls for this mixed population ± non-genital reassignment surgery undergoing various stages of treatment.

The investigators assessed quality of life in the context of culture in patients with gender dysphoria who were from a single-center (Barcelona, Spain), specialty and gender identity clinic. The clinic used WPATH guidelines. Patients were required to have met diagnostic criteria during evaluations by both a psychologist and psychiatrist. Patients could have undergone non-genital surgeries, but not genital reassignment surgeries (e.g., orchiectomy, vaginoplasty, or phalloplasty). The Spanish version of the World Health Organization Quality of Life-Abbreviated version of the WHOQOL-100 (WHOQOL- BREF) was used to evaluate quality of life, which has 4 domains (environmental, physical, psychological, and social) and 2 general questions. Family dynamics were assessed with the Spanish version of the Family Adaptability, Partnership Growth, Affection, and Resolve (APGAR) test. Regression analysis was used to explore effects of surgical treatment.

All consecutive patients presenting at the clinic (277) were recruited and, 260 (93.9%) agreed to participate. Of this number, 59 of these were excluded for incomplete questionnaires, 8 were excluded for prior genital reassignment surgery, and 193 were included in the study (the mean age of this group was 31.2±9.9 years (range 16-67). Of these, 74 (38.3%) were female-to-male patients; 119 (61.7%) were male-to-female patients (ratio1:1.6). Of these, 120 (62.2%) were on hormone therapy; 29 (39.2%) of female-to-male patients had undergone at least 1 non-genital, surgical procedure (hysterectomy n=19 (25.7%); mastectomy n=29 (39.2%)); 51 (42.9%) of male-to-female patients had undergone at least one non-genital surgical procedure with mammoplasty augmentation being the most common procedure, n=47 (39.5%), followed by facial feminization, n=11 (9.2%), buttocks feminization, n=9 (7.6%), and vocal feminization (thyroid chondroplasty), n=2 (1.7%).

WHOQOL-BREF domain scores for gender dysphoric patients with and without non-genital surgery were: “Environmental” 58.81±14.89 (range 12.50-96.88), “Physical” 63.51±17.79 (range 14.29-100), “Psychological” 56.09+16.27 (range 16.67- 56.09), “Social” 60.35±21.88 (range 8.33-100), and “Global QOL and Health” 55.44+27.18 (range 0-100 with higher score representing better QOL). The mean APGAR family score was 7.23±2.86 (range 0-10 with a score of 7 or greater indicative of family functionality).

Regression analysis, which was used to assess the relative importance of various factors to WHOQOL-BREF domains and general questions, revealed that family support was an important element for all four domains and the general health and quality- of-life questions. Hormone therapy was an important element for the general questions and for all of the domains except “Environmental.” Having undergone non-genital reassignment surgery, age, educational levels, and partnership status, did not impact domain and general question results related to quality of life.

Hepp U, Kraemer B, Schnyder U, Miller N, Delsignore A. Psychiatric comorbidity in gender identity disorder. J Psychosom Res. 2005 Mar;58(3):259-61.

Hepp et al. conducted a single-site (Zurich, Switzerland) prospective, non-blinded, observational study using a cross-sectional design. There was some acquisition of retrospective data. The investigators assessed current and lifetime psychiatry co-morbidity using structured interviews for diagnosis of Axis 1 disorders (clinical syndromes) and Axis 2 disorders (developmental or personality disorders) and HADS for dimensional evaluation of anxiety and depression. Statistical description of the cohort and intra-group comparisons was performed. Continuous variables were compared using t-tests and ANOVA.

A total of 31 patients with gender dysphoria participated in the study: 11 (35.5%) female-to-male; 20 (64.5%) male-to-female (ratio 1:1.8). The overall mean age was 32.2±10.3 years. Of the participants, seven had undergone reassignment surgery, 10 pre- surgical patients had been prescribed hormone therapy, and 14 pre-surgical patients had not been prescribed hormone therapy. Forty five and one half percent of female-to-male and 20% of male-to-female patients did not carry a lifetime diagnosis of an Axis 1 condition. Sixty three and six tenths percent of female-to-male and 60% of male-to-female patients did not carry a current diagnosis of an Axis 1 condition. Lifetime diagnosis of substance abuse and mood disorder were more common in male-to-female patients (50% and 55% respectively) than female-to-male patients (36.4% and 27.3% respectively). Current diagnosis of substance abuse and mood disorder were present in male-to-female patients (15% and 20% respectively) and absent in female-to-male patients. One or more personality disorders were identified 41.9%, but whether this was a current or lifetime condition was not specified. Of the patients, five (16.1%) had a Cluster A personality disorder (paranoid-schizoid), seven (22.6%) had a Cluster B personality disorder (borderline, anti-social, histrionic, narcissistic), six (19.4%) had a Cluster C personality disorder (avoidant, dependent, obsessive-compulsive), and two (6.5%) were not otherwise classified.

HADS scores were missing for at least one person. The HADS test revealed non-pathologic results for depression (female-to-male: 6.64±5.03; male-to-female: 6.58±4.21) and borderline results for anxiety (female-to-male: 7.09±5.11; male-to-female: 7.74±6.13, where a result of 7-10 = possible disorder). There were no differences by natal gender. The investigators reported a trend for less anxiety and depression as measured by HADS in the patients who had undergone surgery.

Johansson A, Sundbom E, Höjerback T, Bodlund O. A five-year follow-up study of Swedish adults with gender identity disorder. Arch Sex Behav. 2010 Dec;39(6):1429-37. Epub 2009 Oct 9.

Johansson et al. conducted a two center (Lund and Umeå, Sweden) non-blinded, observational study using a semi-cross-sectional design (albeit over an extended time interval) using a self-designed tool and Axis V assessment. The study was prospective except for the acquisition of baseline Axis V data. There were no formal controls in this mixed population with and without surgery.

The investigators assessed satisfaction with the reassignment process, employment, partnership, sexual function, mental health, and global satisfaction in gender-reassigned persons from two disparate geographic regions. Surgical candidates were required to have met National Board of Health and Welfare criteria including initial and periodic psychiatric assessment, ≥1 year of real-life experience in preferred gender, and ≥1 year of subsequent hormone treatment. In addition, participants were required to have been approved for reassignment five or more years prior and/or to have completed surgical reassignment (e.g., sterilization, genital surgery) two or more years prior. The investigators employed semi-structured interviews covering a self-designed list of 55 pre-formulated questions with a three or five point ordinal scale. Clinician assessment of Global Assessment of Functioning (GAF; Axis V) was also conducted and compared to initial finding during the study. Changes or differences considered to be biologically significant were not pre- specified except for GAF, which pre-specified a difference to mean change ≥5 points. Statistical corrections for multiple comparisons were not included. There was no stratification by treatment.

Of the pool of 60 eligible patients, 42 (70.0% of eligible) (17 [40.5 %] female-to-male; 25 [59.5%] male-to-female; ratio 1:1.5) were available for follow-up. Of these, 32 (53.3% of eligible) (14 [43.8%] female-to-male; 18 [56.2%] male-to-female [ratio 1:1.3]) had completed genital gender reassignment surgery (not including one post mastectomy), five were still in the process of completing surgery, and five (one female-to-male; four male- to-female; ratio 1:4) had discontinued the surgical process prior to castration and genital surgery.

The age (ranges) of the patients at entry into the program, reassignment surgery, and follow-up were 27.8 (18-46), 31.4 (22- 49), and 38.9 (28-53) years in the female-to-male group respectively and 37.3 (21-60), 38.2 (22-57), and 46.0 (25.0-69.0) years in the male- to-female group respectively. The differences in age by cohort group were statistically significant. Of participants, 88.2% of all enrolled female-to-male versus 44.0% of all enrolled female-to-male patients had cross-gender identification in childhood (versus during or after puberty) (p<0.01).

Although 95.2% of all enrolled patients self-reported improvement in GAF, in contrast, clinicians determined GAF improved in 61.9% of patients. Clinicians observed improvement in 47% of female-to-male patients and 72% of male-to- female patients. A ≥5 point improvement in the GAF score was present in 18 (42.9%). Of note, three of the five patients who were in the process of reassignment and five of the five who had discontinued the process were rated by clinicians as having improved.

Of all enrolled 95.2% (with and without surgery) reported satisfaction with the reassignment process. Of these 42 patients, 33 (79%) identified themselves by their preferred gender and nine (21%) identified themselves as transgender. None of these nine (eight male-to-female) had completed reassignment surgery because of ambivalence secondary to lack of acceptance by others and dissatisfaction with their appearance. Of the patients who underwent genital surgery (n=32) and mastectomy only (n=one), 22 (66.7%) were satisfied while four (three female-to-male) were dissatisfied with the surgical treatment.

Regarding relationships after surgery, 16 (38.1%) (41.2% of female- to-male; 36.0% of male-to-female patients) were reported to have a partner. Yet more than that number commented on partner relationships: (a) 62.2 % of the 37 who answered (50.0% of female- to- male; 69.6% of male-to-female patients) reported improved partner relationships (five [11.9%] declined to answer.); (b) 70.0% of the 40 who answered (75.0% of female-to-male; 66.7% of male-to-female patients) reported an improved sex life. Investigators observed that reported post-operative satisfaction with sex life was statistically more likely in those with early rather than late cross-gender identification. In addition 55.4% self-reported improved general health; 16.1% reported impaired general health; 11.9% were currently being treated with anti-depressants or tranquilizers.

This study subsumes earlier work by Bodlund et al. (1994, 1996). The nationwide mortality studies by Dhejne et al. (2011) may include all or part of this patient population.

Leinung M, Urizar M, Patel N, Sood S. Endocrine treatment of transsexual persons: extensive personal experience. Endocr Pract. 2013 Jul-Aug;19(4):644-50. (United States study)

Leinung et al. conducted a single-center (Albany, New York) a partially prospective, non-blinded, observational study using a cross-sectional design and descriptive statistics. There were no formal controls. The investigators assessed employment, substance abuse, psychiatric disease, mood disorders, Human Immunodeficiency Virus (HIV) status in patients who had met WPATH guidelines for therapy, and who had initiated cross-sex hormone treatment.

A total of 242 patients treated for gender identity disorder in the clinic from 1992 through 2009 inclusive were identified. The number of those presenting for therapy almost tripled over time. Of these patients, 50 (20.7%) were female-to-male; 192 (79.3%) male-to-female (ratio 1:3.8).

The age of female-to-male and male-to-female patients with gender dysphoria at the time of clinic presentation was 29.0 and 38.0 years respectively.

The female-to-male and male-to-female patients with gender dysphoria at the time of hormone initiation were young: 27.5 and 35.5 years old respectively (p<0.5). Of the male-to-female cohort, 19 (7.8%) had received hormone therapy in the absence of physician supervision; Of the patient population, 91 (37.6%) had undergone gender-reassignment surgery (32 female-to-male [64.0% of all female-to- male; 35.2% of all surgical patients]; 59 male-to-female [30.7% of all male-to-female; 64.8% of all surgical patients]; ratio 1:1.8).

Psychiatric disease was more common in those who initiated hormone therapy at an older age (>32 years) 63.9% versus 48.9% at a younger age and by natal gender (48.0% of female-to-male; 58.3% male-to-female). Mood disorders were more common in those who initiated hormone therapy at an older age (>32 years) 52.1% versus 36.0% at a younger age and this finding did not differ by natal gender (40.0% of female-to-male; 44.8% male-to- female). The presence of mood disorders increased the time to reassignment surgery in male-to-female patients.

Motmans J , Meier P, Ponnet K, T'Sjoen G. Female and male transgender quality of life: socioeconomic and medical differences. J Sex Med. 2012 Mar;9(3):743-50. Epub 2011 Dec 21.

Motmans et al., conducted a prospective, non-blinded, observational study using a cross-sectional design and a non-specific quality of life tool. No concurrent controls were used in this study. Quality of life in this Dutch-speaking population was assessed using the Dutch version of a SF-36 (normative data was used). Participants included subjects who were living in accordance with the preferred gender and who were from a single Belgian university specialty clinic at Ghent. The Dutch version of the SF-36 questionnaire along with its normative data were used. Variables explored included employment, pension status, ability to work, being involved in a relationship. Also explored, was surgical reassignment surgery and the types of surgical interventions. Intragroup comparisons by transgender category were conducted, and the relationships between variables were assessed by analysis of variance (ANOVA) and correlations.

The age of the entire cohort (n=140) was 39.89±10.21 years (female-to-male: 37.03±8.51; male-to-female: 42.26±10.39). Results of the analysis revealed that not all female-to-male patients underwent surgical reassignment surgery and, of those who did, not all underwent complete surgical reassignment. The numbers of female-to-male surgical interventions were: mastectomy 55, hysterectomy 55, metaoidplasty eight (with five of these later having phalloplasty), phalloplasty 40, and implantation of a prosthetic erectile device 20. The frequencies of various male-to-female surgical interventions were: vaginoplasty 48, breast augmentation 39, thyroid cartilage reduction 17, facial feminization 14, and hair transplantation three.

The final number of subjects with SF-36 scores was 103 (49 [47.6%] female-to-male; 54 [52.4%] male-to-female; ratio 1:1.1). For this measure, the scores for the vitality and mental health domains for the final female-to-male cohort (n= 49 and not limited to those having undergone some element of reassignment surgery) were statistically lower: 60.61±18.16 versus 71.9±18.31 and 71.51±16.40 versus 79.3±16.4 respectively. Scores were not different from the normative data for Dutch women: vitality: 64.3±19.7 or mental health 73.7±18.2. None of the domains of the SF-36 for the final male-to-female cohort (n=54 and not limited to those having undergone some element of reassignment surgery) were statistically different from the normative data for Dutch women.

Analysis of variance indicated that quality of life as measured by the SF-36 did not differ by whether female-to-male patients had undergone genital surgery (metaoidoplasty or phalloplasty) or not. Also, ANOVA indicated that quality of life as measured by the SF-36 did not differ by whether male-to-female patients had undergone either breast augmentation or genital surgery (vaginoplasty) or not.

Whether there is overlap with the Ghent populations studied by Heylens et al. or Weyers et al. is unknown.

Newfield E, Hart S, Dibble S, Kohler L. Female-to-male transgender quality of life. Qual Life Res. 2006 Nov;15(9):1447-57. Epub 2006 Jun 7. (United States study)

Newfield et al. conducted a prospective, observational internet self-report survey of unknown blinding status using a cross- sectional design and a non-specific quality of life tool in a mixed population with and without hormone therapy and/or reassignment surgery. There were no formal controls.

The investigators recruited natal female participants identifying as male using email, internet bulletin boards, and flyers/postcards distributed in the San Francisco Bay Area. Reduction of duplicate entries by the same participant was limited to the use of a unique user name and password.

The investigators employed the Short-Form 36 (SF-36) Version 2 using U.S. normative data. They reported using both male and female normative data for the comparator SF-36 cohort. Data for the eight domains were expressed as normative scoring. The Bonferroni correction was used to adjust for the risk of a Type 1 error with analyses using multiple comparisons.

A total of 379 U.S. respondents classified themselves as males-or-females to males with or without therapeutic intervention. The mean age of the respondents who classified themselves as male or female-to-male was 32.6±10.8 years. Of these 89% were Caucasian, 3.6% Latino, 1.8% African American, 1.8% Asian, and 3.8% other. Of these, 254 (67.0%) reported prior or current testosterone use while 242 (63.8%) reported current testosterone use. In addition, 136 (36.7%) reported having had “top” surgery and 11 (2.9%) reported having “bottom” surgery.

Complete SF-36 data were available for 376 U.S. respondents. For the complete, non-stratified U.S. cohort the Physical Summary Score (53.45±9.42) was statistically higher (better) than the natal gender unspecified SF-36 normative score (50±10) (p=<0.001), but was within one standard deviation of the normative mean. The Mental Summary Score (39.63±12.2) was statistically lower (worse) than the natal gender unspecified SF-36 normative score (50±10) (p<0.001), but was well within two standard deviations of the normative mean. Subcomponents of this score: Mental Health (42.12±10.2), Role Emotional (42.42±11.6), Social Functioning (43.14±10.9), and Vitality (46.22±9.9) were statistically lower (worse) than the SF-36 normative sub-scores, but well within one standard deviation of the normative sub- score means. Interpretive information for these small biologic differences in a proprietary assessment tool was not provided.

Additional intragroup analyses were conducted, although the data were not stratified by type of therapeutic intervention (hormonal, as well as, surgical). Outcomes of hormone therapy were considered separately and dichotomously from reassignment surgery. The Mental Summary Score was statistically higher (better) in those who had “Ever Received Testosterone” (41.22±11.9) than those with “No Testosterone Usage” (36.08±12.6) (p=0.001). The Mental Summary Scores showed a trend towards statistical difference between those who “Ever Received Top Surgery” (41.21±11.6) and those without “Top Surgery” (38.01±12.5) (p=0.067). These differences were well within one standard deviation of the normative mean. Interpretive information for these small biologic differences in a proprietary assessment tool was not provided.

b. Observational, surgical series, without concurrent controls

Blanchard R, Steiner BW, Clemmensen LH. Gender dysphoria, gender reorientation, and the clinical management of transsexualism. J Consult Clin Psychol. 1985 Jun; 53(3):295-304.

Blanchard et al. conducted a single-center (Ontario, Canada), prospective, non-blinded, cross-sectional study using a self-designed questionnaire and a non- specific psychological symptom assessment with normative data. The investigators assessed social adjustment and psychopathology in patients with gender dysphoria and who were at least one year post gender reassignment surgery. Reassignment surgery was defined as either vaginoplasty or mastectomy/construction of male chest contour with or without nipple transplants, but did not preclude additional procedures. Partner preference was determined using Blanchard’s Modified Androphilia-Gynephilia Index, and the nature and extent of any psychopathology was determined with the Symptom Check List 90-Revised (SCL-90R). Differences in test scores considered to be biologically significant were not pre-specified in the methods.

Of the 294 patients (111 natal females and 183 natal males, ratio: 1:1.65) initially evaluated, 263 were diagnosed with gender dysphoria. Of these 79 patients participated in the study (38 female-to-male; 32 male-to-female with male partner preference; 9 male-to-female with female partner preference). The respective mean ages for these 3 groups were 32.6, 33.2, and 47.7 years with the last group being older statistically (p=0.01).

Additional surgical procedures in female-to-male patients included: oophorectomy/hysterectomy (92.1%) and phalloplasty (7.9%). Additional surgical procedures in male-to-female patients with male partner preference included facial hair electrolysis 62.5% and breast implantation (53.1%). Additional procedures in male-to-female patients with female partner preference included facial hair electrolysis (100%) and breast implantation (33.3%). The time between reassignment surgery and questionnaire completion did not differ by group.

Psychopathology as measured by the Global Severity Index of the SCL-90R was absent in all three patient groups. Interpretation did not differ by the sex of the normative cohort.

Of participants, 63.2% of female-to-male patients cohabitated with partners of their natal gender; 46.9% of male-to-female patients with male partner preference cohabitated with partners of their natal gender; and no male-to-female patients with female partner preference cohabitated with partners of their natal gender.

Of participants, 93.7% reported that they would definitely undergo reassignment surgery again. The remaining 6.3% (one female-to-male; one male-to-female with male partner preference; three male-to-female with female partner preference) indicated that they probably would undertake the surgery again. Post hoc analysis suggested that the more ambivalent responders had more recently undergone surgery. Of responders, 98.7% indicated that they preferred life in the reassigned gender. The one ambivalent subject was a skilled and well compensated tradesperson who was unable to return to work in her male dominated occupation.

Eldh J, Berg A, Gustafsson M. Long-term follow up after sex reassignment surgery. Scand J Plast Reconstr Surg Hand Surg. 1997 Mar;31(1):39-45.

Eldh et al. conducted a non-blinded, observational study using a prospective cross-sectional design with an investigator designed questionnaire and retrospective acquisition of pre-operative data. The investigators assessed economic circumstances, family status, satisfaction with surgical results, and sexual function in patients who had undergone gender reassignment surgery.

Of the 175 patients who underwent reassignment surgery in Sweden, 90 responded. Of this number, 50 were female-to-male and 40 were male-to-female (ratio: 1:0.8). Patients reportedly were generally satisfied with the appearance of the reconstructed genitalia (no numbers provided). Of the patients who had undergone surgery prior to 1986, seven (14%) were dissatisfied with shape or size of the neo-phallus; eight (16%) declined comment. There were 14 (35%), with 12 having surgery prior to 1986 and two between 1986 and 1995 inclusive, were moderately satisfied because of insufficient vaginal volume; 8 (20%) declined comment. A neo-clitoris was not constructed until the later surgical cohort. Three of 33 reported no sensation or no sexual sensation. Eight had difficulties comprehending the question and did not respond.

A total of nine (18%) patients had doubts about their sexual orientation; 13 (26%) declined to answer the question. The study found that two female-to- male patients and two male-to-female patients regretted their reassignment surgery and continued to live as the natal gender, and two patients attempted suicide.

Hess J, Rossi Neto R, Panic L, Rübben H, Senf W. Satisfaction with male-to-female gender reassignment surgery. Dtsch Arztebl Int. 2014 Nov 21;111(47):795-801.

Hess at al. conducted a prospective, blinded, observational study using a cross-sectional design and a self-designed anonymous questionnaire. The investigators assessed post-operative satisfaction in male-to-female patients with gender dysphoria who were followed in a urology specialty clinic (Essen, Germany). Patients had met the ICD-10 diagnostic criteria, undergone gender reassignment surgeries including penile inversion vaginoplasty, and a Likert-style questionnaire with 11 elements. Descriptive statistics were provided.

There were 254 consecutive eligible patients who had undergone surgery between 2004 and 2010 identified and sent surveys, of whom 119 (46.9%) responded anonymously. Of the participants, 13 (10.9%) reported dissatisfaction with outward appearance and 16 (13.4%) did not respond; three (2.5%) reported dissatisfaction with surgical aesthetics and 25 (21.0%) did not respond; eight (6.7%) reported dissatisfaction with functional outcomes of the surgery and 26 (21.8%) did not respond; 16 (13.4%) reported they could not achieve orgasm and 28 (23.5%) did not respond; four (3.4%) reported feeling completely male/more male than female and 28 (23.5%) did not respond; six (5.0%) reported not feeling accepted as a woman, two (1.7%) did not understand the question, and 17 (14.3%) did not respond; and 16 (13.4%) reported that life was harder and 24 (20.2%) did not respond.

Lawrence A. Patient-reported complications and functional outcomes of male-to-female sex reassignment surgery. Arch Sex Behav. 2006 Dec;35(6):717-27. Epub 2006 Nov 16. (United States study)

Lawrence conducted a prospective, blinded observational study using a cross-sectional design and a partially self-designed quality of life tool using yes/no questions or Likert scales. The investigator assessed sexual function, urinary function, and other pre/post-operative complications in patients who underwent male-to-female gender reassignment surgery. Questions addressed core reassignment surgery (neo-vagina and sensate neo-clitoris) and related reassignment surgery (labiaplasty, urethral meatus revision, vaginal deepening/widening, and other procedures), use of electrolysis, and use of hormones.

Questionnaires were designed to be completed anonymously and mailed to 727 eligible patients. Of those eligible, 232 (32%) returned valid questionnaires. The age at the time reassignment surgery was 44±9 (range 18-70) years and mean duration after surgery was 3±1 (range 1-7) years.

Happiness with sexual function and the reassignment surgery was reported to be lower when permanent vaginal stenosis, clitoral necrosis, pain in the vagina or genitals, or other complications such as infection, bleeding, poor healing, other tissue loss, other tissue necrosis, urinary incontinence, and genital numbness were present. Quality of life was impaired when pain in the vagina or genitals was present.

Satisfaction with sexual function, gender reassignment surgery, and overall QOL was lower when genital sensation was impaired and when vaginal architecture and lubrication were perceived to be unsatisfactory. Intermittent regret regarding reassignment surgery was associated with vaginal hair and clitoral pain. Vaginal stenosis was associated with surgeries performed in the more distant past; whereas, more satisfaction with vaginal depth and width was present in more recent surgical treatment.

Salvador J, Massuda R, Andreazza T, Koff WJ, Silveira E, Kreische F, de Souza L, de Oliveira MH, Rosito T, Fernandes BS, Lobato MI. Minimum 2-year follow up of sex reassignment surgery in Brazilian male-to-female transsexuals. Psychiatry Clin Neurosci. 2012 Jun; 66(4):371-2. PMID: 22624747.

Salvador et al. conducted a single center (Port Alegre, Brazil) prospective, non-blinded, observational study using a cross-sectional design (albeit over an extended time interval) and a self-designed quality of life tool. The investigators assessed regret, sexual function, partnerships, and family relationships in patients who had undergone gender reassignment surgery at least 24 months prior.

Out of the 243 enrolled in the clinic over a 10 year interval, 82 underwent sex reassignment surgery. There were 69 participants with a minimum 2-year follow up, of whom 52 patients agreed to participate in the study. The age at follow-up was 36.3±8.9 (range 15-58) years with the time to follow-up being 3.8±1.7 (2-7) years. A total of 46 participants reported pleasurable neo-vaginal sex and post-surgical improvement in the quality of their sexual experience. The quality of sexual intercourse was rated as satisfactory to excellent, average, unsatisfactory, or not applicable in the absence of sexual contact by 84.6%, 9.6%, 1.9%, and 3.8% respectively. Of the participants, 78.8% reported greater ease in initiating and maintaining relationships; 65.4% reported having a partner; 67.3% reported increased frequency of intercourse; 36.8% reported improved familial relationships. No patient reported regret over reassignment surgery. The authors did not provide information about incomplete questionnaires.

Tsoi WF. Follow-up study of transsexuals after sex-reassignment surgery. Singapore Med J. 1993 Dec; 34(6):515-7.

Tsoi conducted a single-center (Singapore) prospective, non-blinded, observational study using a cross-sectional design and a self-designed quality of life tool. The investigator assessed overall life satisfaction, employment, partner status, and sexual function in gender-reassigned persons who had undergone gender reassignment surgery between 1972 and 1988 inclusive and who were approximately 2 to 5 years post-surgery. Acceptance criteria for surgery included good physical health, good mental health, absence of heterosexual tendencies, willingness to undergo hormonal therapy for ≥6 months, and willingness to function in the life of the desired gender for ≥6 months. Tsoi also undertook retrospective identification of variables that could predict outcomes.

The size of the pool of available patients was not identified. Of the 81 participants, 36 (44.4%) were female-to-male and 45 (55.6%) were male-to-female (ratio 1:1.25).

The mean ages at the time of the initial visit and operation were: female-to-male 25.4±4.4 (range 14-36) and 27.4 ±4.0; (range 14-36); male-to-female 22.9±4.6 (range 14-36) and 24.7±4.3 (14-36) years respectively. Of all participants, 14.8% were under age 20 at the time of the initial visit. All were at least 20 at the time of gender reassignment surgery. The reported age of onset was 8.6 years for female-to-male patients and 8.7 years for male-to-female patients.

All participants reported dressing without difficulty in the reassigned gender; 95% of patients reported good or satisfactory adjustment in employment and income status; 72% reported good or satisfactory adjustment in relationships with partners. Although the quality of life tool was self-designed, 81% reported good or satisfactory adjustment to their new gender, and 63% reported good or acceptable satisfaction with sexual activity. Of the female-to-male patients, 39% reported good or acceptable satisfaction with sex organ function in comparison to 91% of male-to-female patients (p<0.001). (The author reported that a fully functioning neo-phallus could not be constructed at the time.) The age of non-intercourse sexual activity was the only predictor of an improved outcome.

Weyers S, Elaut E, De Sutter P, Gerris J, T'Sjoen G, Heylens G, De Cuypere G, Verstraelen H. Long-term assessment of the physical, mental, and sexual health among transsexual women. J Sex Med. 2009 Mar;6(3):752-60. Epub 2008 Nov 17.

Weyers at al. (2009) conducted a prospective, non-blinded, observational study using a cross-sectional design and several measurement instruments including a non-specific quality of life tool and a semi-specific quality of life tool (using normative data) along with two self-designed tools.

The investigators assessed general quality of life, sexual function, and body image from the prior four weeks in Dutch-speaking male-to-female patients with gender dysphoria who attended a single-center (Ghent, Belgium), specialized, comprehensive care university clinic. Investigators used the Dutch version of the SF-36 and results were compared to normative data from Dutch women and U.S. women. The 19 items of the Dutch version of the Female Sexual Function Index (FSFI) were used to measure sexual desire, function, and satisfaction. A self-designed seven question visual analog scale (VAS) was used to measure satisfaction with gender related body traits and appearance perception by self and others. A self-designed survey measured a broad variety of questions regarding personal medical history, familial medical history, relationships, importance of sex, sexual orientation, gynecologic care, level of regret, and other health concerns. For this study, hormone levels were also obtained.

The study consisted of 50 (71.5% of the eligible recruits) participants. Analysis of the data revealed that the patient’s average age was 43.1 ±10.4 years, and all of the patients had vaginoplasty. This same population also had undergone additional feminization surgical procedures (breast augmentation 96.0%, facial feminization 36.0%, vocal cord surgery 40.0%, and cricoid cartilage reduction 30.0%). A total of two (4.0%) participants reported “sometimes” regretting reassignment surgery and 23 (46.0%) were not in a relationship. For the cohort, estradiol, testosterone, and sex hormone binding globulin levels were in the expected range for the reassigned gender. The SF-36 survey revealed that the subscale scores of the participants did not differ substantively from those of Dutch and U.S. women. VAS scores of body image were highest for self-image, appearance to others, breasts, and vulva/vagina (approximately 7 to 8 of 10). Scores were lowest for body hair, facial hair, and voice characteristics (approximately 6 to 7 of 10).

The total FSFI score was 16.95±10.04 out of a maximal 36. The FSFI scores averaged 2.8 (6 point maximum): satisfaction 3.46±1.57, desire 3.12+1.47, arousal 2.95±2.17, lubrication 2.39±2.29, orgasm 2.82±2.29, and pain 2.21±2.46. Though these numbers were reported in the study, data on test population controls were not provided.

A post hoc exploration of the data suggested the following: perceived improvement in general health status was greater in the subset that had undergone reassignment surgery within the last year; sexual orientation impacted the likelihood of being in a relationship; SF-36 scores for vitality, social functioning, and mental health were nominally better for those in relationships, but that overall SF-36 scores did not differ by relationship status; sexual orientation and being in a relationship impacted FSFI scores; and reported sexual function was higher in those with higher satisfaction with regards to their appearance.

Wierckx K, Van Caenegem E, Elaut E, Dedecker D, Van de Peer F, Toye K, Weyers S, Hoebeke P, Monstrey S, De Cuypere G, T'Sjoen G. Quality of life and sexual health after sex reassignment surgery in transsexual men. J Sex Med. 2011 Dec;8 (12):3379-88. Epub 2011 Jun 23.

Wierckx at al. conducted a prospective, non-blinded, observational study using a cross-sectional design and several measurement instruments (a non-specific quality of life tool with reported normative data along with three self-designed tools). The investigators assessed general quality of life, sexual relationships, and surgical complications in Dutch-speaking female-to-male patients with gender dysphoria who attended a single-center, specialized, comprehensive care, university clinic (Ghent, Belgium). Investigators used the Dutch version of the SF-36 with 36 questions, eight subscales, and two domains evaluating physical and mental health. Results were compared to normative data from Dutch women and Dutch men. Self -designed questionnaires to evaluate aspects of medical history, sexual functioning (there were separate versions for those with and without partners), and surgical results were also used. The Likert-style format was used for many of the questions.

A total of 79 female-to-male patients with gender dysphoria had undergone reassignment surgery were recruited; ultimately, 47 (59.5%) chose to participate. Three additional patients were recruited by other patients. One of the 50 participants was later excluded for undergoing reassignment surgery within the one year window. The age of patients was: 30±8.2 years (range 16 to 49) at the time of reassignment surgery and 37.1 ±8.2 years (range 22 to 54) at the time of follow-up. The time since hysterectomy, oopherectomy, and mastectomy was 8 years (range 2 to 22). The patient population had undergone additional surgical procedures: metaidoiplasty (n=9; 18.4%), phalloplasty (n=8 after metaidoiplasty, 38 directly; 93.9% total), and implantation of erectile prosthetic device (n=32; 65.3%). All had started hormonal therapy at least two years prior to surgery and continued to use androgens.

The SF-36 survey was completed by 47 (95.9%) participants. The “Vitality” and the “Mental Health” scales were lower than the Dutch male population: 62.1±20.7 versus 71.9±18.3 and 72.6±19.2 versus 79.3±16.4 respectively. These subscale scores were equivalent to the mean scores of the Dutch women.

None of the participants were dissatisfied with their hysterectomy-oopherectomy procedures; 4.1% were dissatisfied with their mastectomies because of extensive scarring; and 2.2% were dissatisfied with their phalloplasties. Of the participants, 17.9% were dissatisfied with the implantation of an erectile prosthetic device; 25 (51.0%) reported at least one post-operative complication associated with phalloplasty (e.g., infection, urethrostenosis, or fistula formation); 16 (50.0% of the 32 with an erectile prosthetic device) reported at least one post-operative complication associated with implantation of an erectile prosthetic (e.g., infection, leakage, incorrect positioning, or lack of function).

A total of 18 (36.7%) participants were not in a relationship; 12.2% reported the inability to achieve orgasm with self-stimulation less than half the time; 12.2% did not respond to the question. Of those participants with partners, 28.5% reported the inability to achieve orgasm with intercourse less than half the time and 9.7% did not respond to this question. Also, 61.3% of those with partners reported (a) no sexual activities (19.4%) or (b) activities once or twice monthly (41.9%), and there were 12.9% who declined to answer.

c. Observational, surgical patients, cross-sectional, with controls

Ainsworth TA, Spiegel JH. Quality of life of individuals with and without facial feminization surgery or gender reassignment surgery. Qual Life Res. 2010 Sep;19(7):1019-24.

Ainsworth and Spiegel conducted a prospective, observational study using a cross-sectional design and a partially self-designed survey tool. The blind status is unknown. Treatment types served as the basis for controls.

The investigators, head and neck surgeons who provided facial feminization services, assessed perception of appearance and quality of life in male-to-female subjects with self-reported gender dysphoria. Patients could have received no therapeutic intervention, hormone therapy, reassignment surgery, and/or facial feminization surgery and an unrestricted length of transition. (Transition refers to the time when a transgender person begins to live as the gender with which they identify rather than the gender assigned at birth.) Criteria for the various types of interventions were not available because of the survey design of the study. Patients were recruited via website or at a 2007 health conference. Pre-specified controls to eliminate duplicate responders were not provided. The investigators employed a self-designed Likert-style facial feminization outcomes evaluation questionnaire and a “San Francisco 36” health questionnaire. No citations were provided for the latter. It appears to be the Short-form (SF) 36-version 2. Changes or differences considered to be biologically significant were not pre-specified. Power corrections for multiple comparisons were not provided.

The investigators reported that there were 247 participants. (The numbers of incomplete questionnaires was not reported.) Of the 247 participants, 25 (10.1%) received only primary sex trait reassignment surgery, 28 (11.3%) received facial surgery without primary sex trait reassignment surgery, 47 (19.0%) received both facial and primary sex trait reassignment surgery, and 147 (59.5%) received neither facial nor reassignment surgery.

The mean age for each of these cohorts was: 50 years (no standard deviation [S.D.]) only reassignment surgery, 51 years (no S.D.) only facial surgery, 49 years (no S.D.) both types of surgery, and 46 years (no S.D.) (neither surgery). Of the surgical cohorts: 100% of those who had undergone primary sex trait reassignment surgery alone used hormone therapy, 86% of those who had undergone facial feminization used hormone therapy, and 98% of those who had undergone both primary sex trait reassignment surgery and facial feminization used hormone therapy. In contrast to the surgical cohorts, 66% of the “no surgery” cohort used hormonal therapy, and a large proportion (27%) had been in transition for less than one year.

The investigators reported higher scores on the facial outcomes evaluation in those who had undergone facial feminization. Scores of the surgical cohorts for the presumptive SF-36 comprehensive mental health domain did not differ from the general U.S. female population. Scores of the “no surgery” cohort for the comprehensive mental health domain were statistically lower than those of the general U.S. female population, but within one standard deviation of the normative mean. Mean scores of all the gender dysphoric cohorts for the comprehensive physical domain were statistically higher than those of the general female U.S. population, but were well within one standard deviation of the normative mean. Analyses of inter-cohort differences for the SF-36 results were not conducted. Although the investigators commented on the potential disproportionate impact of hormone therapy on outcomes and differences in the time in “transition”, they did not conduct any statistical analyses to correct for putative confounding variables.

Kraemer B, Delsignore A, Schnyder U, Hepp U. Body image and transsexualism. Psychopathology. 2008;41(2):96-100. Epub 2007 Nov 23.

Kraemer et al. conducted a single center (Zurich, Switzerland) prospective, non-blinded, observational study using a cross-sectional design comparing pre-and post- surgical cohorts. Patients were required to meet DSM III or DSM IV criteria as applicable to the time of entry into the clinic. Post-surgical patients were from a long-term study group (Hepp et al., 2002). Pre-surgical patients were recent consecutive referrals. The assessment tool was the Fragebogen zur Beurteilung des eigenen Korpers (FBeK) which contained three domains.

There were 23 pre-operative patients: 7 (30.4%) female-to-male and 16 (69.6%) male-to-female (ratio 1:2.3). There were 22 post-operative patients: 8 (36.4 %) female-to-male and 14 (63.6%) male-to-female (ratio 1:1.8). The mean ages of the cohorts were as follows: pre-operative 33.0±11.3 years; post-operative 38.2±9.0 years. The mean duration after reassignment surgery was 51±25 months (range 5-96).

The pre-operative groups had statistically higher insecurity scores compared to normative data for the natal sex: female-to-male 9.0±3.8 versus 5.1±3.7; male-to-female 8.1±4.5 versus 4.7±3.1 as well as statistically lower self-confidence in one’s attractiveness: female-to-male 3.1±2.9 versus 8.9±3.1; male-to-female 7.0±2.9 vs 9.5±2.6.

Mate-Kole C, Freschi M, Robin A. Aspects of psychiatric symptoms at different stages in the treatment of transsexualism. Br J Psychiatry. 1988 Apr;152: 550-3.

Mate-Kole at al. conducted a single site (London, United Kingdom) prospective non-blinded, observational study using a cross-sectional design and two psychological tests (one with some normative data). Concurrent controls were used in this study design. The investigators assessed neuroticism and sex role in natal males with gender dysphoria. Patients at various stages of management, (i.e., under evaluation, using cross-sex hormones, or post reassignment surgery [6 months to 2 years]) were matched by age of cross-dressing onset, childhood neuroticism, personal psychiatric history, and family psychiatric history. Both a psychologist and psychiatrist conducted assessments. The instruments used were the Crown Crisp Experiential Index (CCEI) for psychoneurotic symptoms and the Bem Sex Role Inventory. ANOVA was used to identify differences between the three treatment cohorts.

For each cohort, investigators recruited 50 male-to-female patients from Charing Cross Hospital. The mean ages of the three cohorts were as follows: 34 years for patients undergoing evaluation; 35 years for wait-listed patients; and 37 years for post-operative patients. For the cohorts, 22% of those under evaluation, 24% of those on hormone treatment only, and 30% of those post-surgery had prior psychiatric histories, and 24%, 24%, while 14% in each cohort, respectively, had a history of attempted suicide. More than 30% of patients in each cohort had a first degree relative with a history of psychiatric disease.

The scores for the individual CCEI domains for depression and somatic anxiety were statistically higher (worse) for patients under evaluation than those on hormone treatment alone. The scores for all of the individual CCEI domains (free floating anxiety, phobic anxiety, somatic anxiety, depression, hysteria, and obsessionality) were statistically lower in the post-operative cohort than in the other two cohorts.

The Bem Sex Role Inventory masculinity score for the combined cohorts was lower than for North American norms for either men or women. The Bem Sex Role Inventory femininity score for the combined cohorts was higher than for North American norms for either men or women. Those who were undergoing evaluation had the most divergent scores from North American norms and from the other treatment cohorts. Absolute differences were small. All scores of gender dysphoric patients averaged between 3.95 and 5.33 on a 7 point scale while the normative scores averaged between 4.59 and 5.12.

Wolfradt U, Neumann K. Depersonalization, self-esteem and body image in male-to-female transsexuals compared to male and female controls. Arch Sex Behav. 2001 Jun;30(3):301-10.

Wolfradt and Neumann conducted a controlled, prospective, non-blinded, observational study using a cross-sectional design. The investigators assessed aspects of personality in male-to-female patients who had undergone vocal cord surgery for voice feminization and in healthy non-transgender volunteers from the region. The patients had undergone gender reassignment surgery 1 to 5 years prior to voice surgery. The volunteers were matched by age and occupation.

The primary hypothesis was that depersonalization, with the sense of being detached from one’s body or mental processes, would be more common in male-to- female patients with gender dysphoria. German versions of the Scale for Depersonalization Experiences (SDPE), the Body Image Questionnaire (BIQ), a Gender Identity Trait Scale (GIS), and the Self-Esteem Scale (SES) were used in addition to a question regarding global satisfaction. Three of the assessments used a 5 point scale (BIQ, GIS, and SDPE) for questions. One used a 4 point scale (SES). Another used a 7 point scale (global satisfaction). The study consisted of 30 male-to-female patients, 30 healthy female volunteers, and 30 healthy male volunteers. The mean age of study participants was 43 years (range 29- 67).

Results of the study revealed that there were no differences between the three groups for the mean scores of measures assessing depersonalization, global satisfaction, the integration of masculine traits, and body-image-rejected (subset). Also, the sense of femininity was equivalent for male-to-female patients and female controls and higher than that in male controls. The levels of self-esteem and body image-dynamic (subset) were equivalent for male-to-female patients and male controls and higher than that in female controls, and none of the numeric differences between means exceeded 0.61 units.

Kuhn A, Bodmer C, Stadlmayr W, Kuhn P, Mueller M, Birkhäuser M. Quality of life 15 years after sex reassignment surgery for transsexualism. Fertil Steril. 2009 Nov;92(5):1685-1689.e3. Epub 2008 Nov 6.

Kuhn et al. conducted a prospective, non-blinded, observational study using a cross-sectional design and semi-matched control cohort. The investigators assessed global satisfaction in patients who were from gynecology and endocrinology clinic (Bern, Switzerland), and who had undergone some aspect of gender reassignment surgery in the distant past, but were still receiving cross-sex hormones from the clinic. The quality of life assessment tools included a VAS and the King’s Health Questionnaire (KHQ), which consists of eight domains with scores between zero and five or one and five, with lower scores indicating higher preference. The KHQ and the numerical change/difference required for clinical significance (≥5 points in a given domain, with higher scores being more pathologic) were included in the publication. Twenty healthy female controls from the medical staff who had previously undergone an abdominal or pelvic surgery were partially matched by age and body mass index (BMI), but not sex. No corroborative gynecologic or urologic evaluations were undertaken.

Of the 55 participants, three (5.4%) were female-to-male and 52 (94.5%) were male-to-female (ratio 1:17.3). Reassignment surgery had been conducted 8 to 23 years earlier (median 15 years). The median age of the patients at the time of this study was 51 years (range 39-62 years). The patients had undergone a median of nine surgical procedures in comparison to the two undergone by controls. Reassignment patients were less likely to be married (23.6% versus 65%; p=0.002); partnership status was unknown in five patients. The scores of VAS global satisfaction (maximal score eight) were lower for surgically reassigned patients (4.49±0.1 SEM) than controls (7.35±0.26 SEM) (p<0.0001).

The abstract stated that quality of life was lower in reassignment patients 15 years after surgery relative to controls. One table in the study, Table 2, delineated statistically and biologically significant differences for four of the eight KHQ domains between the patients and controls: physical limitation: 37.6±2.3 versus 20.9±1.9 (p<0.0001), personal limitation: 20.9±1.9 versus 11.6±0.4 (p<0.001), role limitation: 27.8+2.4 versus 34.6+1.7 (p=0.046), and general health: 31.7±2.2 versus 41.0±2.3 (p<0.02). There is a related paper by Kuhn et al. 2006.

Haraldsen IR, Dahl AA. Symptom profiles of gender dysphoric patients of transsexual type compared to patients with personality disorders and healthy adults. Acta Psychiatr Scand. 2000 Oct;102(4):276-81.

Haraldsen and Dahl conducted a single-center (Oslo, Norway) partially prospective, non-blinded, observational study using a cross-sectional design and a non-specific psychometric test. There was a control group, but it was not concurrent.

In the germane sub-study, the investigator assessed psychopathology in patients with gender dysphoria. Patients, who were independently evaluated by two senior psychiatrists, were required to meet DSM III-R or DSM IV diagnostic criteria and the Swedish criteria for reassignment surgery. The Norwegian version of the SCL-90 was used. The testing was conducted from 1987 to 1989 for those who had undergone reassignment surgery between 1963 and 1987 and from 1996 to 1998 for pre- surgical patients who had applied for reassignment surgery between 1996 and 1998. In addition, Axis I, Axis II, and Axis V (Global Functioning) was assessed.

Of 65 post–surgical and 34 pre-surgical patients, 59 post-surgical and 27 pre-surgical patients ultimately entered the study. The combined cohorts consisted of 35 (40.7%) female-to-male patients and 51 (59.3%) male-to-female patients (ratio 1:1.5). The ages were female-to-male 34±9.5 years and female-to-male 33.3±10.0 years. The other control group consisted of patients with personality disorder. Of these, 101 (27 men (33.9±7.3 years) and 74 women (31.6±8.2) were tested during a treatment program. One year later, 98% were evaluated. A total of 28 (32.5%) of the pre- and post- reassignment surgery patients had an Axis I diagnosis compared to 100 (99.0%) of those with personality disorders. Depression and anxiety were the most common diagnoses in both groups, but were approximately three to four times more common in the personality disorder cohort. Seventeen (19.8%) of the pre- and post-reassignment surgery patients had an Axis II diagnosis whereas the mean number of personality disorders in the personality disorder cohort was 1.7±1. The Global Assessment of Function was higher (better) in the gender dysphoric groups (78.0±8.9) than in the personality disorder cohort (53.0±9.0).

Global Severity Indices (GSI) were highest for those with personality disorder regardless of gender and exceeded the cut-point score of 1.0. The GSI scores for females-to-males and males-to-females were 0.67±57 and 0.56±0.45. Although they were nominally higher than the healthy normative controls (males: 0.32±0.36 and females 0.41±0.43), they were well within the non- pathologic range. The same was true for the subscales.

SCL-90 GSI scores did not differ substantively between pre- and post-surgical patients, nor did the SCI subscale scores differ substantively between pre- and post-surgical patients. Any small non-significant differences tracked with the age and sex differences.

Beatrice J. A psychological comparison of heterosexuals, transvestites, preoperative transsexuals, and postoperative transsexuals. J Nerv Ment Dis. 1985 Jun;173(6):358-65. (United States study)

Beatrice conducted a prospective, non-blinded, observational study using a cross-sectional design and control cohorts in the U.S. The investigator assessed psychological adjustment and functioning (self-acceptance) in male-to-female patients with gender dysphoria (with and without GRS), transvestites from two university specialty clinics, and self-identified heterosexual males recruited from the same two universities. The criteria to qualify for the study included being known to the clinic for at least one year, cross-dressing for at least one year without arrest, attendance at 10 or more therapy sessions, emotionally self-supporting, and financially capable of payment for reassignment surgery, and all of these criteria were met by the pre-operative cohort as well as the post-operative cohort. The cohorts were matched to the post-operative cohort (age, educational level, income, ethnicity, and prior heterosexual object choice). The post-operative cohort was selected not on the basis of population representation, but on the basis of demographic feasibility for a small study. The instruments used were the Minnesota Multiphasic Personality Inventory (MMPI) and the Tennessee Self-Concept Scale (TSCS). Changes or differences considered to be biologically significant were not pre-specified.

Of the initial 54 recruits, ten subjects were left in each of the cohorts because of exclusions identified due to demographic factors. The mean age of each cohort were as follows: pre-operative gender dysphoric patients 32.5 (range 27-42) years, postoperative patients 35.1 (30-43) years old, transvestite 32.5 (29-37) years old, and heterosexual male 32.9 (28-38) years old. All were Caucasian. The mean age for cross-dressing in pre-operative patients (6.4 years) and post-operative patients (5.8 years) was significantly lower than for transvestites (11.8 years).

The scores for self-acceptance did not differ by diagnostic category or surgical status as measured by the TSCS instrument. As measured by the T-scored MMPI instrument (50±10), levels of paranoia and schizophrenia were higher for post-operative (GRS) patients (63.0 and 68.8) than transvestites (55.6 and 59.6) and heterosexual males (56.2 and 51.6). Levels of schizophrenia were higher for pre-operative patients (65.1) than heterosexual males (51.6). There were no differences between patients with gender dysphoria. Scores for the Masculine-Feminine domain were equivalent in those with transvestitism and gender dysphoria with or without surgery, but higher than in heterosexual males. The analysis revealed that despite the high level of socio-economic functioning in these highly selected subjects, the MMPI profiles based on the categories with the highest scores were notable for antisocial personality, emotionally unstable personality, and possible manic psychosis in the pre-operative GRS patients and for paranoid personality, paranoid schizophrenia, and schizoid personality in the post-operative GRS patients. By contrast, the same MMPI profiling in heterosexual males and transvestites was notable for the absence of psychological dysfunction.

d. Observational, surgical patients, longitudinal, with controls

Dhejne C, Lichtenstein P, Boman M, Johansson A, Långström N, Landén M. Long-term follow-up of transsexual persons undergoing sex reassignment surgery: cohort study in Sweden. PLoS One. 2011;6(2):e16885. Epub 2011 Feb 22.

Dhejne et al. conducted a retrospective, non-blinded, observational study of nation-wide mortality using a longitudinal and a population-based matched cohort. The investigators assessed conditions such as, but not limited to, mortality, suicide attempts, psychiatric hospitalization, and substance abuse in gender-reassigned persons and randomly selected unexposed controls matched by birth year and natal sex (1:10) as well as by birth year and the reassigned gender (1:10). Data were extracted from national databases including the Total Population Register (Statistics Sweden), the Medical Birth Register, the Cause of Death Register (Statistics Sweden), the Hospital Discharge Register (National Board of Health and Welfare), the Crime Register (National Council of Crime), and those from the Register of Education for highest educational level. The criteria required to obtain the initial certificate for reassignment surgery and change in legal status from the National Board of Health and Welfare were the 2002 WPATH criteria and included evaluation and treatment by one of six specialized teams, name change, a new national identity number indicative of gender, continued use of hormones, and sterilization/castration. Descriptive statistics with hazard ratios were provided.

Investigators identified 804 patients with gender identity disorder (or some other disorder) in Sweden during the period from 1973 to 2003 inclusive. Of these patients, 324 (40.3%) underwent gender-reassignment surgery (133 female-to-male [41.0%]; 191 male-to-female [59.0%]; ratio 1:1.4). The average follow-up time for all-cause mortality was 11.4 years (median 9.1). The average follow-up time for psychiatric hospitalization was 10.4 years (median 8.1).

The mean ages in female-to-male and male-to-female reassigned patients were: 33.3±8.7 (range 20–62) and 36.3± 10.1 (range 21–69) years, respectively. Immigrant status was two times higher in reassigned patients (n=70, 21.6%) than in either type of control (birth [natal] sex matched n=294 [9.1%] or reassigned gender matched n=264 [8.1%]). Educational attainment (10 or more years) was somewhat lower for reassigned patients (n=151 [57.8%]) than in either type of control (birth sex matched n=1,725 [61.5%] or reassigned gender matched n=1804 [64.3%]) (cohort data were incomplete). The biggest discordance in educational attainment was for female-to-male reassigned patients regardless of the control used. Prior psychiatric morbidity (which did not include hospitalization for gender dysphoria) was more than four times higher in reassigned patients (n=58, 17.9%) than in either type of control (birth sex matched n=123 [3.8%] or reassigned gender matched n=114 [3.5%]).

All-cause mortality was higher for patients who underwent gender reassignment surgery (n=27 [8.3%]) than in controls (hazard ratio 2.8 [CI 1.8-4.3]) even after adjustment for covariants (prior psychiatric morbidity and immigration status). Divergence in the survival curves began at 10 years. Survival rates at 20 year follow-up (as derived from figure 1) were: female control 97%, male controls 94%, female-to-male patients 88%, and male-to-female patients 82%. The major contributor to this mortality difference was completed suicide (n=10 [3.1%]; adjusted hazard ratio 19.1 [CI 5.8-62.9]). Mortality due to cardiovascular disease was modestly higher for reassigned patients (n=9 [2.8%]) than in controls (hazard ratio 2.5 [CI 1.2-5.3]).

Suicide attempts were more common in patients who underwent gender reassignment surgery (n= 29 [9.0%] than in controls (adjusted hazard ratio 4.9 [CI 2.9–8.5]). Male-to-female patients were at higher adjusted risk for attempted suicide than either control whereas female-to-male patients were at higher adjusted risk compared to only male controls and maintained the female pattern of higher attempted suicide risk. Hospitalizations for psychiatric conditions (not related to gender dysphoria) were more common in reassigned persons n= 64 [20.0%] than in controls (hazard ratio 2.8 [CI 2.0–3.9]) even after adjusting for prior psychiatric morbidity. Hospitalization for substance abuse was not greater than either type of control.

The nationwide mortality studies by Dhejne et al. (2011) includes much, if not all, of the Landén (1998) patient population and much of the Dhejne et al. (2014) population.

Dhejne C, Öberg K, Arver S, Landén M. An analysis of all applications for sex reassignment surgery in Sweden, 1960-2010: prevalence, incidence, and regrets. Arch Sex Behav. 2014 Nov;43(8):1535-45. Epub 2014 May 29 and Landén M, Wålinder J, Hambert G, Lundström B. Factors predictive of regret in sex reassignment. Acta Psychiatr Scand. 1998 Apr;97(4):284 (Dhejne et al., 2014; Landén et al., 1998) Sweden-All

Dhejne et al. conducted a non-blinded, observational study that was longitudinal for the capture of patients with “regret” in a national database. This same group (Landén et al., 1998) conducted a similar study along with retrospective acquisition of clinical data to explore the differences between the cohorts with and without regret. There were no external controls; only intra- group comparisons for this surgical series.

The investigators assessed the frequency of regret for gender reassignment surgery. Data were extracted from registries at the National Board of Health and Welfare to which patients seeking reassignment surgery or reversal of reassignment surgery make a formal application and which has maintained such records since a 1972 law regulating surgical and legal sex reassignment. The investigators reviewed application files from 1960 through 2010. The specific criteria to qualify for gender surgery were not delineated. Patients typically underwent diagnostic evaluation for at least one year. Diagnostic evaluation was typically followed by the initiation of gender confirmation treatment including hormonal therapy and real-life experience. After two years of evaluation and treatment, patients could make applications to the national board. Until recently sterilization or castration were the required minimal surgical procedures (Dhejne et al., 2011). Secular changes in this program included consolidation of care to limited sites, changes in accepted diagnostic criteria, and provision of non-genital surgery, e.g., mastectomy during the real- life experience phase, and family support.

There were 767 applicants for legal and surgical reassignment (289 [37.7%] female-to-male and 478 [62.3%] male-to-female; ratio 1:1.6). The number of applicants doubled each ten year interval starting in 1981.

Of the applicants, 88.8% or 681 (252 [37.0%] female-to-male and 429 [63.0%] male-to-female; ratio 1:1.7] had undergone surgery and changed legal status by June 30, 2011. This number included eight (four [50.0%] female-to-male and four [50.0%] male to female; ratio 1:1) people who underwent surgery prior to the 1972 law. This number appears to include 41 (two [4.9%] female-to-male and 39 [95.1%] male-to-female; ratio 1:19.5) people who underwent surgery abroad at their own expense (usually in Thailand or the U.S.). This cohort (6% of 681) includes one person who was denied reassignment surgery by Sweden.

Twenty-five (3.3%) of the applications were denied with the two most common reasons being an incomplete application or not meeting the diagnostic criteria. An additional 61(8.0%) withdrew their application, were wait-listed for surgery, postponed surgery (perhaps in hopes of the later revocation of the sterilization requirement), or were granted partial treatment.

The formal application for reversal of the legal gender status, the “regret rate”, was 2.2%. No one who underwent sex- reassignment surgery outside of Sweden (36 of these 41 had surgery after 1991) has requested reversal. The authors noted, however, that this preliminary number may be low because the median time interval to reversal request was eight years-only three of which had elapsed by publication submission- and because it was the largest serial cohort. This number did not include other possible expressions of regret including suicide (Dhejne et al., 2011).

Dhejne et al. in 2014 reported that the female-to-male (n=5): male-to-female (n=10) ratio among those who made formal applications for reversal was 1:2. The investigators also reported that the female-to-male applicants for reversal were younger at the time of initial surgical application (median age 22 years) than the complete female-to-male cohort at the time of surgical application (median age 27 years). By contrast the male-to-female applicants for reversal were older at the time of initial surgical application (median age 35 years) than the complete male-to-female cohort at the time of initial surgical application (median age 32 years). Other clinical data to explore the differences between the cohorts with and without regret were not presented in this update publication.

In their earlier publication, in addition to determining a regret rate (3.8%), Landén et al. extracted data from medical records and government verdicts. Pearson Chi-square testing with Yates’ correction for small sample sizes was used to identify candidate variables predictive of regret. They observed that: (a) 25.0% of the cohort with regrets and 11.4% of the cohort without regrets were unemployed, (b) 16.7% of the cohort with regrets and 15.4% of the cohort without regrets were on “sick benefit”, (c) 15.4% of the cohort with regrets and 13.9% of the cohort without regrets had problems with substance abuse, (d) 69.2% of the cohort with regrets and 34.6% of the cohort without regrets had undergone psychiatric treatment, (e) 15.4% of the cohort with regrets and 8.8% of the cohort without regrets had a mood disorder, and (f) 15.4% of the cohort with regrets and 1.5% of the cohort without regrets had a psychotic disorder.

The putative prognostic factors that were statistically different between the cohorts with and without regret included prior psychiatric treatment, a history of psychotic disorder, atypical features of gender identity, and poor family support. Factors that trended towards statistical difference included having an unstable personality, sexual orientation and transvestitism. Univariate regression analyses further clarified the most important variables. These variables were tested with logistic regression. Initial modeling included the variable “history of psychotic disorder”. Although this variable was predictive, it was excluded from future analyses because it was already a contraindication to reassignment surgery. Additional multivariate regression analyses identified poor family support as the most predictive variable and atypical features of gender identity as the second most important variable. Presence of both variables had a more than additive effect.

The nationwide mortality studies by Dhejne et al. (2011) includes much, if not all, of the Landén (1998) patient population and most of the Dhejne (2014) population. There is a related paper by Landén et al. 1998b that included the criteria to qualify for surgical intervention at that time.

Heylens G, Verroken C, De Cock S, T'Sjoen G, De Cuypere G. Effects of different steps in gender reassignment therapy on psychopathology: a prospective study of persons with a gender identity disorder. J Sex Med. 2014 Jan;11(1):119-26. Epub 2013 Oct 28.

Heylens et al. conducted a prospective, non-blinded observational study using a longitudinal design in which patients served as their own controls. They used a non-specific psychiatric test with normative data along with two self-designed questionnaires. The investigators assessed psychosocial adjustment and psychopathology in patients with gender identity disorders. Patients were to be sequentially evaluated prior to institution of hormonal therapy, then 3 to 6 months after the start of cross-sex hormone treatment, and then again one to 12 months after reassignment surgery. The Dutch version of the SCL-90R with eight subscales (agoraphobia, anxiety, depression, hostility, interpersonal sensitivity, paranoid ideation/psychoticism, and sleeping problems) and a global score (psycho-neuroticism) was used serially. A seven parameter questionnaire was used serially to assess changes in social function. Another cross-sectional survey assessed emotional state. The cohorts at each time point consisted of patients who were in the treatment cohort at the time and who had submitted survey responses.

Ninety of the patients who applied for reassignment surgery between June 2005 and March 2009 were recruited. Fifty seven entered the study. Forty-six (51.1% of the recruited population) underwent reassignment surgery. Baseline questionnaire information was missing for 3 patients. Baseline SCL-90 scores were missing for 1 patient but included SCL-90 scores from some of the 11 recruits who had not yet undergone reassignment surgery. Time point 2 (after hormone therapy) SCL-90 information was missing for 10, but included SCL-90 scores from some of the 11 recruits who had not yet undergone reassignment surgery. At time point 3, 42 (91.3% of those who underwent reassignment surgery) patients completed some part of the SCL-90 survey and the psychosocial questionnaires. Some questionnaires were incomplete. The investigators reported response rates of 73.7% for the psychosocial questionnaires and 82.5% for the SCL-90.

Of those who responded at follow-up after surgery, 88.1% reported having good friends; 52.4% reported the absence of a relationship; 47.6% had no sexual contacts; 42.9% lived alone; 40.5% were unemployed, retired, students, or otherwise not working; 2.4% reported alcohol abuse; and 9.3% had attempted suicide. The frequency of these parameters reportedly did not change statistically during the study interval, but there was no adjustment for the inclusion of patients who did not undergo surgery.

In a cross-sectional, self-report mood survey, of the 42 study entrants who completed the entire treatment regimen including reassignment surgery and the final assessment (refers to the initial 57) reported improved body-related experience (97.6%), happiness (92.9%), mood (95.2%), and self-confidence (78.6%) and reduced anxiety (81.0%). Of participants, 16.7% reported thoughts of suicide. Patients also reported on the intervention phase that they believed was most helpful: hormone initiation (57.9%), reassignment surgery (31.6%), and diagnostic-psychotherapy phase (10.5%).

The global “psycho-neuroticism” SCL-90R score, along with scores of 7 of the 8 subscales, at baseline were statistically more pathologic than the general population. After hormone therapy, the score for global “psycho-neuroticism” normalized and remained normal after reassignment surgery. More specifically the range for the global score is 90 to 450 with higher scores being more pathologic. The score for the general population was 118.3±32.4. The respective scores for the various gender dysphoric cohorts were 157.7±49.8 at initial presentation, 119.7±32.1 after hormone therapy, and 127.9±37.2 after surgery. The scores for the general population and the scores after either hormone treatment or surgical treatment did not differ.

Kockott G, Fahrner EM. Transsexuals who have not undergone surgery: a follow-up study. Arch Sex Behav. 1987 Dec;16 (6):511-22.

Kockott and Fahrner conducted a single center (Munich, Germany) prospective, observational study using a longitudinal design. Treatment cohorts were used as controls, and patients served as their own controls. The investigators assessed psychosocial adjustment in patients with gender identity issues. Patients were to have met DSM III criteria. Trans-sexuality, transvestitism, and homosexuality were differentiated. The criteria required for patients to receive hormone therapy and/or reassignment surgery were not delineated. After receiving hormone therapy, patients were later classified by surgical reassignment status (pre-operative and post-operative) and desire for surgery (unchanged desire, hesitant, and no longer desired).

The first investigative tool was a semi-structured in-person interview consisting of 125 questions. The second investigative tool was a scale that organized the clinical material into nine domains which were then scored on a scale. The Psychological Integration of Trans-sexuals (PIT) instrument developed according to the scale used by Hunt and Hampson (1980) for assessment of 17 post-operative patients. There were 15 interviews and two separate interviewers. There were 80 patients identified, but 58 (72.5%) patients (26 pre-operative; 32 post-operative) were ultimately included in the analysis. The duration of follow-up was longer for post-operative patients (6.5 years) than for pre-operative patients (4.6 years) (including time for one patient subsequently excluded). The mean age of the post-operative patients was 35.5±13.1 years, and the age of the patients who maintained a continued desire for surgery was 31.7±10.2 years. The age of the patients who hesitated about surgery was somewhat older, 40.3±9.4 years. The age of the patients who were no longer interested in surgery was 31.8±6.5 years. All were employed or in school at baseline. Patients with hesitation were financially better-off, had longer-standing relationships even if unhappy, and had a statistical tendency to place less value on sex than those with an unchanged wish for surgery.

Post-operative patients more frequently reported contentment with the desired gender and the success of adaption to the gender role than the pre-operative patients with a persistent desire for surgery. Post-operative patients more frequently reported sexual satisfaction than pre-operative patients with a continuing desire for surgery. Post-operative patients also more frequently reported financial sufficiency and employment than pre-operative patients with a persistent desire for surgery. Suicide attempts were stated to be statistically less frequent in the post-surgical cohort.

Psychosocial adjustment scores were in the low end of the range with “distinct difficulties” (19-27) at the initial evaluation for the post-operative patients (19.7), the pre-operative patients with a persistent wish for surgery (20.2), and the hesitant patients (19.7). At initial evaluation, psychosocial adjustment scores for patients no longer wanting surgery were at the high end of the range with “few difficulties” (10-18). At the final evaluation, Psychosocial adjustment scores were at the high end of the range “few difficulties” (10-18) for the post-operative patients (13.2) and the patients no longer wanting surgery (16.5). Psychosocial adjustment scores at the final evaluation were in the borderline range between “few difficulties” (10-18) and “distinct difficulties” (19-27) for both the pre-operative patients with a persistent desire for surgery (18.7), and the hesitant patients (19.1).

The changes in the initial score and the final follow-up score within each group were tracked and reported to be statistically significant for the post-operative group, but not for the other groups. Statistical differences between groups were not presented. Moreover, the post-operative patients had an additional test immediately prior to surgery. The first baseline score (19.7) would have characterized the patients as having “distinct difficulties” in psychosocial adjustment while the second baseline score (16.7) would have categorized the patients as having “few difficulties” in psychosocial adjustment despite the absence of any intervention except the prospect of having imminent reassignment surgery. No statistics reporting on the change between scores of the initial test and the test immediately prior to surgery and the change between scores of the test immediately prior to surgery and the final follow-up were provided.

Meyer JK, Reter DJ. Sex reassignment. Follow-up. Arch Gen Psychiatry. 1979 Aug;36(9):1010-5. (United States study)

Meyer and Reter conducted a single-center (Baltimore, Maryland, U.S.) prospective, non-blinded, observational study using a longitudinal design and retrospective baseline data. Interview data were scored with a self-designed tool. There were treatment control cohorts, and patients served as their own controls. The investigators assessed patients with gender dysphoria. The 1971 criteria for surgery required documented cross-sex hormone use as well as living and working in the desired gender for at least one year in patients subsequently applying for surgery. Clinical data including initial interviews were used for baseline data. In follow-up, the investigators used extensive two to four hour interviews to collect information on (a) objective criteria of adaptation, (b) familial relationships and coping with life milestones, and (c) sexual activities and fantasies. The objective criteria, which were the subject of the publication, included employment status (Hollingshead job level), cohabitation patterns, and need for psychiatric intervention. The investigators designed a scoring mechanism for these criteria and used it to determine a global adjustment score. The score value or the change score that was considered to be biologically significant was not pre-specified in the methods.

The clinic opened with 100 patients, but when the follow-up was completed, 52 patients were interviewed and 50 gave consent for publication. Of these, 15 (four female-to-male, 11 male-to-female; ratio 1:2.8) were part of the initial operative cohort, 14 (one female-to-male; 13 male-to-female; ratio 1:13) later underwent reassignment surgery at the institution or elsewhere, and 21 (five female-to-male; 16 male-to-female; ratio 1:3.2) did not undergo surgery. The mean ages of these cohorts were 30.1, 30.9, and 26.7 years respectively. The mean follow-up time was 62 months (range 19-142) for those who underwent surgery and 25 months (range 15-48) for those who did not. Socioeconomic status was lowest in those who subsequently underwent reassignment surgery.

Of patients initially receiving surgery, 33% had some type of psychiatric contact prior to the initial clinic evaluation and 8% had psychiatric contact during the follow-up. Of the patients who had not under gone surgery or who had done so later, 72% had some type of psychiatric contact prior to the initial clinic evaluation and 28% had psychiatric contact during follow-up. There was a single female-to-male patient with multiple surgical complications who sought partial reassignment surgery reversal.

The adjustment scores improved over time with borderline statistical significance for the initial operative group and with statistical significance for the never operated group. The absolute score value at follow-up was the same for both groups (1.07+1.53 and 1.10+1.97 respectively). By contrast, the adjustment scores did not improve for those who were not in the cohort initially approved for surgery, but who subsequently underwent surgery later. This was particularly true if the surgery was performed elsewhere. The absolute score value at follow-up was 0.21+1.89.

Related papers include Meyer et al. (1971), Meyer et al. (1974a-d), and Derogatis et al. (1978) along with commentary response by Fleming et al. (1980).

Rakic Z, Starcevic V, Maric J, Kelin K. The outcome of sex reassignment surgery in Belgrade: 32 patients of both sexes. Arch Sex Behav. 1996 Oct;25(5):515-25.

Rakic et al. single-center (Belgrade, Yugoslavia) conducted a prospective, non-blinded, observational study using a cross-sectional design and an investigator- designed quality of life tool that asked longitudinal (pre- and post-treatment) questions. Patients served as their own controls. The authors state that the study was not designed to assess the predictors of poor outcomes.

The investigators assessed global satisfaction, body image, relationships, employment status, and sexual function in patients with gender dysphoria who underwent reassignment surgery between 1989 and 1993 and were at least six months post-operative. The criteria to qualify for gender surgery were delineated (1985 standards from the Harry Benjamin International Gender Dysphoria Association) and included cross-gender behavior for at least one year and sexual orientation to non-natal sex. The questionnaire consisted of 10 questions using yes/no answers or Likert-type scales. Findings were descriptive without statistical analysis. As such, changes or differences considered to be biologically significant were not pre-specified, and there were no adjustments for multiple comparisons.

Of the 38 patients who had undergone reassignment surgery, 34 were eligible for the study and 32 participated in the study (two were lost to follow-up and four were in the peri-operative period) - 10 (31.2%) female-to-male and 22 (68.8%) male-to-female (ratio 1:2.2). The duration of follow-up was 21.8 ±13.4 months (range 6 months to 4 years). The age was female-to-male 27.8±5.2 (range 23-37) and male-to-female 26.4±7.8 (range 19-47).

Using an investigator-designed quality of life tool, all patients reported satisfaction with having undergone the surgery. Of the total participants, four (12.5%) (all male-to-female) and eight (25%) (87.5% male-to-female) reported complete dissatisfaction or partial satisfaction with their appearance. Regarding relationships, 80% of female-to-male and 100% of male-to-female patients were dissatisfied with their relationships with others prior to surgery; whereas, no female-to-male patients and 18.1% of male-to-female patients were dissatisfied with relationships after surgery. Regarding sexual partners, 60% of female-to-male and 72.7% of male-to-female patients reported not having a sexual partner prior to surgery; whereas, 20% of female-to-male patients and 27.3% of male-to-female patients did not have a sexual partner after surgery. Of those with partners at each time interval, 100% of female-to-male and 50% of male-to-female patients reported not experiencing orgasm prior to surgery; whereas, 75% of female-to-male and 37.5% of male-to-female patients reported not experiencing orgasm after surgery.

Ruppin U, Pfäfflin F. Long-term follow-up of adults with gender identity disorder. Arch Sex Behav. 2015 Jul;44(5):1321-9. Epub 2015 Feb 18.

Ruppin and Pfafflin conducted a single-center (Ulm, Germany) partially prospective, non-blinded, observational study using a longitudinal design and non-specific psychometric tests and a self-designed interview tool and questionnaire. Patients served as their own controls.

The investigators assessed psychological symptoms, interpersonal difficulties, gender role stereotypes, personality characteristics, societal function, sexual function, and satisfaction with new gender role in patients with gender dysphoria. Patients were required to have met the ICD-10 criteria for trans-sexualism, been seen by the clinic by prior to 2001, and completed an official change in gender including name change prior to 2001. Assessment tools included German versions of standardized surveys with normative data: the SCL 90R, the Inventory of Interpersonal Problems (IIP), Bem Sex Role Inventory (BSRI), and the Freiburg Personality Inventory (FPI-R), along with semi-structured interviews with self-designed questionnaires. The prospective survey results were compared to retrospective survey results. Changes or inter-group differences considered to be biologically significant were not pre-specified. Diagnostic cut points were not provided. Statistical corrections for multiple comparisons were not included.

Overall, 140 patients received recruitment letters and then 71 (50.7%) agreed to participate. Of these participants, 36 (50.7%) were female-to-male; 35 (49.3%) were male-to-female (ratio 1:0.97). The ages of the patients were: 41.2±5.78 years (female-to-male) and 52.9±10.82 years (male-to-female). The intervals for follow-up were 14.1±1.97 years and 13.7±2.17 years, respectively.

All female-to-male patients had undergone mastectomy; 91.7% had undergone oopherectomy and/or hysterectomy; 61.1% had undergone radial forearm flap phalloplasty or metaoidioplasty. Of male-to-female patients, 94.3% had undergone vaginoplasty and perhaps an additional procedure (breast augmentation, larynx surgery, or vocal cord surgery). Two male-to-female patients had not undergone any reassignment surgery, but were still included in the analyses.

A total of 68 patients ranked their well-being as 4.35±0.86 out of five (three patients did not respond to this question). Of respondents, 40% reported not being in a steady relationship. Regular sexual relationships were reported by 57.1% of 35 female- to-male respondents and 39.4% of 33 male-to-female respondents (three patients did not respond to this question). A total of 11 patients reported receiving out-patient psychotherapy; 69 did not express a desire for gender role reversal (two did not respond to this question). The response rate was less than 100% for most of the self-designed survey questions.

Changes from the initial visit to the follow-up visit were assessed for the SCL-90R in 62 of 71 patients. The effect size was statistically significant and large only for the “Interpersonal Sensitivity” scale (one of 10 parameters). The absolute magnitude of mean change was small: from 0.70±0.67 to 0.26±0.34 (scale range 0-4). The duration of follow-up did not correlate with the magnitude of change on the various scales. Differences in baseline SCL-90R scores of 62 participants were compared with the score of 63 of the 69 eligible recruits who declined to enter the study and were notable for higher “Depression” scores for the latter.

Changes from the initial visit to the follow-up visit were assessed for the IIP in 55 of 71 patients. The effect size was statistically significant and large only for the “Overly Accommodating” scale (one of eight parameters). The absolute magnitude of mean change was small: from 11.64±5.99 to 7.04±4.73 (scale range 0-32). The duration of follow-up did not correlate with the magnitude of change on the various scales.

Changes from the initial visit to the follow-up visit were assessed for the FPI-R in 58 of 71 patients. The effect size was statistically significant and large only for the “Life Satisfaction” scale (one of 12 parameters). The absolute magnitude of mean change was substantive: from 4.43±2.99 to 8.31±2.63 (scale range 0-12). The duration of follow-up did not correlate with the magnitude of change on the various scales.

Changes from the initial visit to the follow-up visit were assessed for the BSRI in 16 of 36 female to male patients and 19 of 35 male to female patients. The “Social Desirability” score increased for the female-to-male respondents. At endpoint, both categories of respondents reported androgynous self-images.

This current report is an update of prior publications by Pfafflin including work with Junge which was published in a variety of formats and initially in German.

Smith YL, Van Goozen SH, Kuiper AJ, Cohen-Kettenis PT. Sex reassignment: outcomes and predictors of treatment for adolescent and adult transsexuals. Psychol Med. 2005 Jan;35(1):89-99.

Smith et al. conducted a single-center (Amsterdam, Netherlands) prospective, non-blinded, observational study using a longitudinal design and psychological function tools. Patients served as their own control prior to and after reassignment surgery. The investigators assessed gender dysphoria, body dissatisfaction, physical appearance, psychopathology, personality traits, and post-operative function in patients with gender dysphoria. Patients underwent some aspect of reassignment surgery. The test instruments included the Utrecht Gender Dysphoria Scale (12 items), the Body Image Scale adapted for a Dutch population (30 items), Appraisal of Appearance Inventory (3 observers, 14 items), the Dutch Short MMPI (83 items), the Dutch version of the Symptom Checklist (SCL)(90 items), and clinic-developed or modified questionnaires. Pre-treatment data was obtained shortly after the initial interview. Post- surgery data were acquired at least one year post reassignment surgery.

Three hundred twenty five consecutive adolescents and adults were screened for the study. One-hundred three (29 [28.2%] female-to-male patients and 74 [71.8%] male-to-female patients [ratio 1:2.6]) never started hormone therapy; 222 (76 [34.2%] female-to-male patients and 146 [65.8%] male-to-female patients [ratio 1:1.9]) initiated hormone therapy. Of the patients who started hormone therapy, 34 (5 [14.7%] female-to-male patients and 29 [85.3%] male-to-female patients [ratio 1:5.8]) discontinued hormone therapy.

Subsequently, the study analysis was limited to adults. One hundred sixty-two (58 [35.8%] female-to-male and 104 [64.2%] male-to-female [ratio 1:1.8]) were eligible and provided pre-surgical test data, and 126 (77.8% of eligible adults) (49 [38.9%] female-to-male and 77 [61.1%] male-to-female [ratio 1:1.6]) provided post-surgical data. For those patients who completed reassignment, the mean age at the time of surgical request was 30.9 years (range 17.7-68.1) and 35.2 years (range 21.3-71.9) years at the time of follow-up. The intervals between hormone treatment initiation and surgery and surgery and follow-up were 20.4 months (range 12 to 73) and 21.3 months (range 12 to 47) respectively.

Of the 126 adults who provided post-surgical data, 50 (40.0%) reported having a steady sexual partner, three (2.3%) were retired, and 58 (46.0%) were unemployed. Regarding regret, six patients expressed some regret regarding surgery, but did not want to resume their natal gender role, and one male-to-female had significant regret and would not make the same decision.

Post-surgery Utrecht dysphoria scores dropped substantially and approached reportedly normal values. The patients’ appearance better matched their new gender. No one was dissatisfied with his/her overall appearance at follow-up. Satisfaction with primary sexual, secondary sexual, and non-sexual body traits improved over time. Male-to-female patients, however, were more dissatisfied with the appearance of primary sex traits than female-to-male patients. Regarding mastectomy, 27 of 38 (71.1%) female-to-male respondents (not including 11 non-respondents) reported incomplete satisfaction with their mastectomy procedure. For five of these patients, the incomplete satisfaction was because of scarring. Regarding vaginoplasty, 20 of 67 (29.8%) male-to-female respondents (not including 10 non-respondents) reported incomplete satisfaction with their vaginoplasty.

Most of the MMPI scales were already in the normal range at the time of initial testing and remained in the normal range after surgery. SCL global scores for psycho- neuroticism were minimally elevated before surgery 143.0±40.7 (scoring range 90 to 450) and normalized after surgery 120.3±31.4. (An analysis using patient level data for only the completers was not conducted.)

Udeze B, Abdelmawla N, Khoosal D, Terry T. Psychological functions in male-to- female people before and after surgery. Sexual and Relationship Therapy. 2008 May; 23(2):141-5. (Not in PubMed) and Megeri D, Khoosal D. Anxiety and depression in males experiencing gender dysphoria. Sexual and Relationship Therapy. 2007 Feb; 22(1):77-81. (Not in PubMed)

Udeze et al. conducted a single-center (Leicester, United Kingdom) prospective, non-blinded, longitudinal study assessing a randomized subset of patients who had completed a non-specific psychological function tool prior to and after male-to-female reassignment surgery. Patients served as their own controls. The investigators used the WPATH criteria for patient selection. Psychiatric evaluations were routine. All patients selected for treatment were routinely asked to complete the self-administered SCL-90R voluntarily on admission to the program and post-operatively. A post-operative evaluations (psychiatric and SCL-90R assessment) were conducted within six months to minimize previously determined loss rates. The patient pool was domestic and international. There were 546 gender dysphoric patients from all over the United Kingdom and abroad, of whom 318 (58.2%) progressed to surgery. Of these, 127 were from the local Leicester area in the United Kingdom and 38 (29.9%) progressed to surgery. The mean age for the selected male-to-female patients at the time of study was 47.33±13.26 years (range 25 to 80) and reflected an average wait time for surgery of 14 months (range 2 months to 6 years). For this investigation, 40 male-to-female subjects were prospectively selected.

The raw SCL-90 global scores for psycho-neuroticism were unchanged over time: 48.33 prior to surgery and 49.15 after surgery. If the scale was consistent with T-scoring, the results were non-pathologic. No psychiatric disorders were otherwise identified prior to or after surgery.

Investigators from the same clinical group (Megeri, Khoosal, 2007) conducted additional testing to specifically address anxiety and depression with the Beck Depression Inventory, General Health Questionnaire (with 4 subscales), HADS, and Spielberger State and Trait Anxiety Questionnaire (STAI-X1 and STA-X2). The test population and study design appear to be the same. No absolute data were presented. Only changes in scores were presented. There were no statistically significant changes.

e. Randomized, surgical patients, longitudinal, with controls

Mate-Kole C, Freschi M, Robin A. A controlled study of psychological and social change after surgical gender reassignment in selected male transsexuals. Br J Psychiatry. 1990 Aug;157:261-4.

Mate-Kole at al. conducted a prospective, non-blinded, controlled, randomized, longitudinal study using investigator-designed patient self-report questionnaires and non-specific psychological tests with some normative data. The investigators assessed neuroticism and sex role in natal males with gender dysphoria who had qualified for male-to-female reassignment surgery at a single-center specialty clinic (London, United Kingdom). Forty sequential patients were alternately assigned to early reassignment surgery or to standard wait times for reassignment surgery. Patients were evaluated after acceptance and 2 years later. The criteria used to qualify for gender surgery were the 1985 standards from the Harry Benjamin International Gender Dysphoria Association. These included a ≥2 year desire to change gender, a ≥1 year demonstrable ability to live and be self-supporting in the chosen gender, and psychiatric assessment for diagnosis and reassessment at six months for diagnostic confirmation and exclusion of psychosis.

Reassignment surgery was defined as orchidectomy, penectomy, and construction of a neo-vagina. The instruments used were the CCEI for psychoneurotic symptoms and the Bem Sex Role Inventory along with an incompletely described investigator- designed survey with questions about social life and sexual activity.

The mean age and range of the entire cohort was 32.5 years (21-53). Members of the early surgery cohort had a history of attempted suicide (one patient), psychiatric treatment for non-gender issues (six patients), and first degree relatives with psychiatric histories (four patients). Members of the standard surgery cohort were similar, with a history of attempted suicide (two patients), psychiatric treatment for non-gender issues (five patients), and first degree relatives with psychiatric histories (six patients). The early surgery group had surgery approximately 1.75 years prior to the follow-up evaluation. In both groups, cross-dressing began at about age 6.

At baseline, the Bem Sex Role Inventory femininity scores were slightly higher than masculinity scores for both cohorts and were similar to Bem North American female normative scores. The scores did not change in either group over time.

At baseline, the scores for the CCEI individual domains (free floating anxiety, phobic anxiety, somatic anxiety, depression, hysteria, and obsessionality) were similar for the cohorts. The total CCEI scores for the two cohorts were consistent with moderate symptoms (Birchnell et al. 1988). Over the two year interval, total CCEI scores increased for standard wait group and approached the relatively severe symptom category. During the same interval, scores dropped into the asymptomatic rage for the post-operative patients.

The investigator-designed survey assessed changes in social and sexual activity of the prior two years, but the authors only compared patients in a given cohort to themselves. Though the researchers did not conduct statistical studies to compare the differences between the two cohorts, they did report increased participation in some, but not all, types of social activities such as sports (solo or group), dancing, dining out, visiting pubs, and visiting others. Sexual interest also increased. By contrast, pre-operative patients did not increase their participation in these activities.

2. External Technology Assessments

  • CMS did not request an external technology assessment (TA) on this issue.
  • There were no AHRQ reviews on this topic.
  • There are no Blue Cross/Blue Shield Health Technology Assessments written on this topic within the last three years.

“Findings supported that LGBT issues have been neglected by public health research and that research unrelated to sexually transmitted diseases is lacking.”

A systematic review of lesbian, gay, bisexual and transgender health in the West Midlands region of the UK compared to published UK research. West Midlands Health Technology Assessment Collaboration. Health Technology Assessment Database. Meads, et al., 2009. No.3.

“Further research is needed but must use more sophisticated designs with comparison groups. This systematic review demonstrated that there are so many gaps in knowledge around LGBT health that a wide variety of studies are needed.”

  • There were no National Institute for Health and Care Excellence (NICE) reviews/guidance documents on this topic.

Tech Brief Series: Transgender Re-assignment Surgery Day P. NZHTA Report. February 2002;1(1). http://nzhta.chmeds.ac.nz/publications/trans_gender.pdf

The research questions included the following: 1. Are there particular subgroups of people with transsexualism who have met eligibility criteria for gender reassignment surgery (GRS) where evidence of effectiveness of that surgery exists?

2. If there is evidence of effectiveness, what subgroups would benefit from GRS?”

The authors concluded that there was not enough evidence to answer either of the research questions.

3. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Meeting

CMS did not convene a MEDCAC meeting.

4. Evidence-Based Guidelines

a. American College of Obstetricians and Gynecologists (ACOG)

Though ACOG did not have any evidence-based guidelines on this topic, they did have the following document: Health Care for Transgender Individuals: Committee Opinion Committee on Health Care for Underserved Women; The American College of Obstetricians and Gynecologists. Dec 2011, No. 512. Obstet Gyncol. 2011;118:1454-8.

“Questions [on patient visit records] should be framed in ways that do not make assumptions about gender identity, sexual orientation, or behavior. It is more appropriate for clinicians to ask their patients which terms they prefer. Language should be inclusive, allowing the patient to decide when and what to disclose. The adoption and posting of a nondiscrimination policy can also signal health care providers and patients alike that all persons will be treated with dignity and respect. Assurance of confidentiality can allow for a more open discussion, and confidentiality must be ensured if a patient is being referred to a different health care provider. Training staff to increase their knowledge and sensitivity toward transgender patients will also help facilitate a positive experience for the patient.”

b. American Psychiatric Association

Report of the American Psychiatric Association Task Force on Treatment of Gender Identity Disorder. Byne, W, Bradley SJ, Coleman E, Eyler AE, Green R, Menvielle EJ, Meyer-Bahlburg HFL, Richard R. Pleak RR, Tompkins DA. Arch Sex Behav. 2012; 41:759–96.

The American Psychiatric Association (APA) was unable to identify any Randomized Controlled Trials (RTCs) regarding mental health issues for transgender individuals.

"There are some level B studies examining satisfaction/regret following sex reassignment (longitudinal follow-up after an intervention, without a control group); however, many of these studies obtained data retrospectively and without a control group (APA level G). Overall, the evidence suggests that sex reassignment is associated with an improved sense of well-being in the majority of cases, and also indicates correlates of satisfaction and regret. No studies have directly compared various levels of mental health screening prior to hormonal and surgical treatments on outcome variables; however, existing studies suggest that comprehensive mental health screening may be successful in identifying those individuals most likely to experience regrets."

Relevant Descriptions of APA Evidence Coding System/Levels:

[B] Clinical trial. A prospective study in which an intervention is made and the results of that intervention are tracked longitudinally. Does not meet standards for a randomized clinical trial.”

[G] Other. Opinion-like essays, case reports, and other reports not categorized above.”

c. Endocrine Society

Endocrine Treatment of Transsexual Persons: an Endocrine Society Clinical Practice Guideline.

Hembree WC, Cohen-Kettenis P, Delemarre-van de Waal HA, Gooren LJ, Meyer WJ 3rd, Spack NP, Tangpricha V, Montori VM; Endocrine Society. J Clin Endocrinol Metab. 2009; 94:3132-54.

This guideline primarily addressed hormone management and surveillance for complications of that management. A small section addressed surgery and found the quality of evidence to be low.

“This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe the strength of recommendations and the quality of evidence, which was low or very low.”

d. World Professional Association for Transgender Health (WPATH)

Standards of Care for the Health of Transsexual, Transgender, and Gender-Nonconforming People (Version 7). Coleman E, Bockting W, Botzer M, Cohen-Kettenis P, DeCuypere G, Feldman J, Fraser L, Green J, Knudson G, Meyer WJ, Monstrey S, Adler RK, Brown GR, Devor AH, Ehrbar R, Ettner R, Eyler E, Garofalo R, Karasic DH, Lev AI, Mayer G, Meyer-Bahlburg H, Hall BP, Pfäfflin F, Rachlin K, Robinson B, Schechter LS, Tangpricha V, van Trotsenburg M, Vitale A, Winter S, Whittle S, Kevan R. Wylie KR, Zucker K. www.wpath.org/_files/140/files/Standards%20of%20Care,%20V7%20Full%20Book.pdf Int J Transgend. 2011;13:165–232.

The WPATH is “an international, multidisciplinary, professional association whose mission is to promote evidence-based care, education, research, advocacy, public policy, and respect in transsexual and transgender health.”

WPATH reported, “The standards of care are intended to be flexible in order to meet the diverse health care needs of transsexual, transgender, and gender-nonconforming people. While flexible, they offer standards for promoting optimal health care and guiding the treatment of people experiencing gender dysphoria—broadly defined as discomfort or distress that is caused by a discrepancy between a person’s gender identity and that person’s sex assigned at birth (and the associated gender role and/or primary and secondary sex characteristics) (Fisk, 1974; Knudson, De Cuypere, & Bockting, 2010b).”

The WPATH standards of care (SOC) “acknowledge the role of making informed choices and the value of harm-reduction approaches.”

The SOC noted, “For individuals seeking care for gender dysphoria, a variety of therapeutic options can be considered. The number and type of interventions applied and the order in which these take place may differ from person to person (e.g., Bockting, Knudson, & Goldberg, 2006; Bolin, 1994; Rachlin, 1999; Rachlin, Green, & Lombardi, 2008; Rachlin, Hansbury, & Pardo, 2010). Treatment options include the following:

  • Changes in gender expression and role (which may involve living part time or full time in another gender role, consistent with one’s gender identity);
  • Hormone therapy to feminize or masculinize the body;
  • Surgery to change primary and/or secondary sex characteristics (e.g., breasts/chest, external and/or internal genitalia, facial features, body contouring);
  • Psychotherapy (individual, couple, family, or group) for purposes such as exploring gender identity, role, and expression; addressing the negative impact of gender dysphoria and stigma on mental health; alleviating internalized transphobia; enhancing social and peer support; improving body image; or promoting resilience.”

e. American Psychological Association

Suggested citation until formally published in the American Psychologist: American Psychological Association. (2015): Guidelines for Psychological Practice with Transgender and Gender Nonconforming People Adopted by the Council of Representatives, August 5 & 7, 2015. www.apa.org/practice/guidelines/transgender.pdf

“The purpose of the Guidelines for Psychological Practice with Transgender and Gender Nonconforming People (hereafter Guidelines) is to assist psychologists in the provision of culturally competent, developmentally appropriate, and trans-affirmative psychological practice with TGNC people.”

“These Guidelines refer to psychological practice (e.g., clinical work, consultation, education, research, training) rather than treatment.”

5. Other Reviews

a. Institute of Medicine (IOM)

The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. Robert Graham (Chair); Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. (Study Sponsor: The National Institutes of Health). Issued March 31, 2011. http://www.nationalacademies.org/hmd/Reports/2011/The-Health-of-Lesbian-Gay-Bisexual-and- Transgender-People.aspx

“To advance understanding of the health needs of all LGBT individuals, researchers need more data about the demographics of these populations, improved methods for collecting and analyzing data, and an increased participation of sexual and gender minorities in research. Building a more solid evidence base for LGBT health concerns will not only benefit LGBT individuals, but also add to the repository of health information we have that pertains to all people.”

“Best practices for research on the health status of LGBT populations include scientific rigor and respectful involvement of individuals who represent the target population. Scientific rigor includes incorporating and monitoring culturally competent study designs, such as the use of appropriate measures to identify participants and implementation processes adapted to the unique characteristics of the target population. Respectful involvement refers to the involvement of LGBT individuals and those who represent the larger LGBT community in the research process, from design through data collection to dissemination.”

b. National Institutes of Health (NIH)

National Institutes of Health Lesbian, Gay, Bisexual, and Transgender (LGBT) Research Coordinating Committee. Consideration of the Institute of Medicine (IOM) report on the health of lesbian, gay, bisexual, and transgender (LGBT) individuals. Bethesda, MD: National Institutes of Health; 2013. http://report.nih.gov/UploadDocs/LGBT%20Health%20Report_FINAL_2013-01-03-508%20compliant.pdf

In response to the IOM report, the NIH LBGT research Coordinating Committee noted that most of the health research for this set of populations is “focused in the areas of Behavioral and Social Sciences, HIV (human immunodeficiency virus)/AIDS, Mental Health, and Substance Abuse. Relatively little research has been done in several key health areas for LGBT populations including the impact of smoking on health, depression, suicide, cancer, aging, obesity, and alcoholism.”

6. Pending Clinical Trials

ClinicalTrials.gov There is one currently listed and recently active trial directed at assessment of the clinical outcomes pertaining to individuals who have had gender reassignment surgery. The study appears to be a continuation of work conducted by investigators cited in the internal technology assessment.

NCT01072825 (Ghent, Belgium sponsor) European Network for the Investigation of Gender Incongruence (ENIGI) is assessing the physical and psychological effects of the hormonal treatment of transgender subjects in two years prior to reassignment surgery and subsequent to surgery. This observational cohort study started in 2010 and is still in progress.

7. Consultation with Outside Experts

Consistent with the authority at 1862(l)(4) of the Act, CMS consulted with outside experts on the topic of treatment for gender dysphoria and gender reassignment surgery.

Given that the majority of the clinical research was conducted outside of the United States, and some studies either took place in or a suggested continuity-of-care and coordination-of-care were beneficial to health outcomes, we conducted expert interviews with centers across the U.S. that provided some form of specialty-focused or coordinated care for transgender patients. These interviews informed our knowledge about the current healthcare options for transgender people, the qualifications of the professionals involved, and the uniqueness of treatment options. We are very grateful to the organizations that made time to discuss treatment for gender dysphoria with us.

From our discussions with the all of the experts we spoke with, we noted the following practices in some centers: (1) specialized training for all staff about transgender healthcare and transgender cultural issues; (2) use of an intake assessment by either a social worker or health care provider that addressed physical health, mental health, and other life factors such as housing, relationship, and employment status; (3) offering primary care services for transgender people in addition to services related to gender-affirming therapy/treatments; (4) navigators who connected patients with name-change information or other legal needs related to gender; (5) counseling for individuals, groups, and families; (6) an informed-consent model whereby individuals were often referred to as “clients” instead of “patients,” and (7) an awareness of depression among transgender people (often measured with tools such as the Adult Outcomes Questionnaire and the Patient Health Questionnaire).

8. Public Comments

We appreciate the thoughtful public comments we received on the proposed decision memorandum. In CMS’ experience, public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum. All comments that were submitted without personal health information may be viewed in their entirety by using the following link: https://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=282&ExpandComments=n#Results

a. Initial Comment Period: December 3, 2015 – January 2, 2016

During the initial comment period, we received 103 comments. Of those, 78% supported coverage of gender reassignment surgery, 15% opposed, and 7% were neutral. The majority of comments supporting coverage were from individuals and advocacy groups.

b. Second Comment Period: June 2, 2016 – July 2, 2016

During the second 30-day public comment period, we received a total of 45 public comments, 7 of which were not posted on the web due to personal health information content. Overall, 82% supported coverage of gender reassignment surgery, 11% opposed, and 7% were neutral or silent in their comment whether they supported or opposed coverage. Half of the comments were submitted by individuals who expressed support for coverage of gender reassignment surgery (51%). We also received comments from physicians, providers, and other health professionals who specialize in healthcare for transgender individuals (17%). We received one comment from a municipality, the San Francisco Department of Public Health. Associations (American Medical Association, American College of Physicians, American Academy of Nursing, American Psychological Association, and LBGT PA Caucus) and advocates (Center for American Progress with many other signatories, Jamison Green & Associates) also submitted comments.

Below is a summary of the comments CMS received. In some instances, commenters identified typographical errors, context missed, and opportunities for CMS to clarify wording and classify articles for ease of reading in the memorandum. As noted earlier, when appropriate and to the extent possible, we updated the decision memorandum to reflect those corrections, improved the context, and clarified the language. In light of public comments, we re-evaluated the evidence and our summaries. We updated our summaries of the studies and clarified the language when appropriate.

1. Contractor Discretion and National Coverage Determination

Comment : Some commenters, including advocates, associations, and providers, supported CMS’ decision for MAC contractor discretion/case-by-case determination for gender reassignment surgery. One stakeholder stated, “We agree with the conclusion that a NCD is not warranted at this time.”

Response : We appreciate the support and understanding among stakeholders for our proposed decision to have the MACs determine coverage on a case-by-case basis. We have clarified in this final decision memorandum that coverage is available for gender reassignment surgery when determined reasonable and necessary and not otherwise excluded by any other relevant statutory requirements by the MAC on a case-by-case basis. “The case-by-case model affords more flexibility to consider a particular individual’s medical condition than is possible when the agency establishes a generally applicable rule.” (78 Fed. Reg. 48165 (August 7, 2013)).

Comment : Some commenters cautioned that CMS’ choice to not issue a NCD at this time must not be interpreted as a national non-coverage determination or used in any way to inappropriately restrict access to coverage for transgender Medicare beneficiaries or other transgender individuals. Multiple commenters indicated their disappointment that CMS did not propose a National Coverage Determination (NCD) and, instead, chose to continue to have local MACs make the coverage decisions on a case-by-case basis. Commenters stated this could result in variability in coverage.

Response : We appreciate the comments. We are not issuing a NCD at this time because the available evidence for gender reassignment surgery provides limited data on specific health outcomes and the characteristics of specific patient populations that might benefit from surgery. In the absence of a NCD, the MAC’s use the same statutory authority as NCDs, section 1862(a)(1)(A) of the Social Security Act (the Act). Under section 1862(a)(1)(A) an item or service must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. While CMS did not have enough evidence to issue a NCD, we believe the MACs will be able to make appropriate coverage decisions on a case-by-case basis taking into account individual characteristics of the Medicare beneficiary.

Comment: Some commenters sought a NCD that would establish guidelines for coverage and include elements such as a prescribed set of surgeries and a shared decision making element.

Response: For the reasons stated above, we are not issuing a NCD at this time and, therefore, are not establishing specific gender reassignment surgery coverage guidelines for the Medicare program. We generally agree that shared decision-making is a fundamental approach to patient-centered health care decisions and strongly encourage providers to use these types of evidence based decision aids. We have not found a shared decision aid on GRS and encourage the development of this necessary element to conduct formal shared-decision making.

Comment : Some commenters expressed concern that there is a misunderstanding of transgender individuals as having a disorder or being abnormal. Some commenters indicated a history of bias and discrimination within society as a whole that has occurred when transgender individuals have sought health care services from the medical community. Some commenters are concerned that the decision not to make a NCD will subject individuals seeking these services to corporate bias by Medicare contractors.

Response : We acknowledge the public comments and that there has been a transformation in the treatment of individuals with gender dysphoria over time. In this NCA, we acknowledge that gender dysphoria is a recognized Diagnostic and Statistical Manual of Mental Disorders (DSM) condition. With respect to the concern about potential bias by Medicare contractors, we have no reason to expect that the judgments made on specific claims will be influenced by an overriding bias, hostility to patients with gender dysphoria, or discrimination. Moreover, the Medicare statue and our regulations provide a mechanism to appeal an adverse initial decision if a claim is denied and those rights may include the opportunity for judicial review. We believe the Medicare appeals process would provide an opportunity to correct any adverse decision that was perceived to have been influenced by bias.

Comment : Commenters mentioned the cost of gender reassignment surgery could influence MAC decision making.

Response : The decisions on whether to cover gender reassignment surgery in a particular case are made on the basis of the statutory language in section 1862 of the Social Security Act that establish exclusions from coverage and would not depend on the cost of the procedure.

2. Coverage with Evidence Development and Research

Comment : In our proposed decision memorandum, we specifically invited comments on whether a study could be developed that would support coverage with evidence development (CED). One organization commented, “We strongly caution against instituting a CED protocol.” Commenters were opposed to coverage limited in clinical trials, suggesting that such coverage would restrict access to care. Several commenters provided suggested topics for clinical research studies for the transgender population. For example, one commenter suggested a study of non-surgical treatment for transgender children prior to puberty.

Response : While we appreciate the comments supporting further research, in general, for gender reassignment surgery, we agree that CED is not the appropriate coverage pathway at this time. While CED is an important mechanism to support research and has the potential to be used to help address gaps in the current evidence, we are not aware of any available, appropriate studies, ongoing or in development, on gender reassignment surgery for individuals with gender dysphoria that could be used to support a CED decision.

3. Gender Reassignment Surgery as Treatment

Comment : One group of commenters requested that CMS consider that, “The established medical consensus is that GRS is a safe, effective, and medically necessary treatment for many individuals with gender dysphoria, and for some individuals with severe dysphoria, it is the only effective treatment.”

Response : We acknowledge that GRS may be a reasonable and necessary service for certain beneficiaries with gender dysphoria. The current scientific information is not complete for CMS to make a NCD that identifies the precise patient population for whom the service would be reasonable and necessary.

4. Physician Recommendations

Comment : Several commenters stated that gender reassignment surgery should be covered as long as it was determined to be necessary, or medically necessary by a beneficiary’s physician.

Response : Physician recommendation is one of many potential factors that the local MAC may consider when determining whether the documentation is sufficient to pay a claim.

5. WPATH Standards of Care

Comment : Several commenters suggested that CMS should recommend the WPATH Standards of Care (WPATH) as the controlling guideline for gender reassignment surgery. They asserted it could satisfy Medicare's reasonable and necessary criteria for determining coverage on a case-by-case basis.

Response : Based on our review of the evidence and conversations with the experts and patient advocates, we are aware some providers consult the WPATH Standards of Care, while others have created their own criteria and requirements for surgery, which they think best suit the needs of their patients. As such, and given that WPATH acknowledges the guidelines should be flexible, we are not in the position to endorse exclusive use of WPATH for coverage. The MACs, Medicare Advantage plans, and Medicare providers can use clinical guidelines they determine useful to inform their determination of whether an item or service is reasonable and necessary. When making this determination, local MACs may take into account physician’s recommendations, the individual’s clinical characteristics, and available clinical evidence relevant to that individual.

6. Scope of the NCA Request

Comment : One commenter stated that CMS did not address the full scope of the NCA request.

Response : The formal request for a NCD is publicly available on our tracking sheet. ( https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id282.pdf ) The letter did not explicitly seek a national coverage determination related to counseling or hormone therapies, but focused on surgical remedies. CMS is aware that beneficiaries with gender dysphoria use a variety of therapies.

Comment : Other commenters stated the scope of the proposed decision is unnecessarily broad because it discussed therapies other than surgery. They suggested this discussion could lead to the unintended consequence of restricting access to those services for transgender Medicare beneficiaries and other transgender individuals.

Response : As we noted in our proposed decision, our decision focused only on gender reassignment surgery. In the course of reviewing studies related to those surgeries, occasionally authors discussed other therapies that were mentioned in our summaries of the evidence. To the extent possible, we have modified our decision to eliminate the discussion of other therapies which were not fully evaluated in this NCA.

7. NCA Question

Comment : Some commenters expressed concern about the phrasing of the question in this NCA.

Response : The phrasing of the research question is consistent with most NCAs and we believe it is appropriate.

8. Evidence Summary and Analysis

Comment : Several commenters disagreed with our summary of the clinical evidence and analysis. A few commenters contended that the overall tone of the review was not neutral and seemed biased or flawed. One commenter noted that the Barrett publication was available on the Internet.

Response : We appreciate the comments that identified technical errors, and we made the necessary revisions to this document. However, we disagree with the contention that our evidence review was not neutral and seemed biased or flawed. We believe that the summary and analysis of the clinical evidence are objective. As with previous NCAs, our review of the evidence was rigorous and methodical. Additionally, we reviewed the Barrett publication, but it did not meet our inclusion criteria to be included in the Evidence section.

9. Evidence Review with Transgender Experts

Comment : Several commenters requested that CMS re-review the clinical evidence discussed in the proposed decision memorandum with outside experts in the field of transgender health and transition/gender reassignment-related surgeries. Several offered the expertise within their organization to assist in this effort.

Response : We appreciate these comments and the transgender health community’s willingness to participate. For this NCA we discussed gender reassignment surgery protocols with experts, primarily in coordinated care settings. Additionally, the public comment periods provide opportunities for expert stakeholder input. According to our process for all NCAs, we do not jointly review evidence with external stakeholders but have carefully reviewed the very detailed comments submitted by a number of outside experts in transgender health care.

10. Previous Non-Coverage NCD

Comment : One commenter noted that they thought research studies for gender reassignment surgery could not take place when the old NCD that prohibited coverage for gender reassignment surgery was in effect.

Response : CMS does not directly conduct clinical studies or pay for research grants. Some medical services are non-covered by Medicare; however, national non-coverage does not preclude research via a number of avenues and other funding entities such as the National Institutes of Health. In this instance, the previous NCD did not preclude interested parties from funding research for gender reassignment surgery that could have been generalizable to the Medicare population.

11. How the Medicare Population Differs from the General Population

Comment : One commenter questioned how the Medicare population differed from the general population, and why any differences would be important in our decision-making.

Response : The Medicare population is different from the general population in age (65 years and older) and/or disability as defined by the Social Security Administration. Due to the biology of aging, older adults may respond to health care treatments differently than younger adults. These differences can be due to, for example, multiple health conditions or co-morbidities, longer duration needed for healing, metabolic variances, and impact of reduced mobility. All of these factors can impact health outcomes. The disabled Medicare population, who are younger than age 65, is different from the general population and typical study populations due to the presence of the causes of disability such as psychiatric disorders, musculoskeletal health issues, and cardiovascular issues.

12. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)

Comment : One commenter suggested CMS should have convened a MEDCAC for this topic.

Response : We appreciate the comment. Given the limited evidence, we did not believe a MEDCAC was warranted according to our guidance document entitled "Factors CMS Considers in Referring Topics to the Medicare Evidence Development & Coverage Advisory Committee" ( https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEDCAC.html ).

13. §1557 of the Affordable Care Act (ACA)

Comment : Some commenters asserted that by not explicitly covering gender reassignment surgery at the national level, CMS was discriminating against transgender beneficiaries in conflict with Section 1557 of the Accountable Care Act (ACA).

Response : This decision does not affect the independent obligation of covered entities, including the Medicare program and MACs, to comply with Section 1557 in making individual coverage decisions. In accordance with Section 1557, MACs will apply neutral nondiscriminatory criteria when making case-by-case coverage determinations related to gender reassignment surgery.

14. Medicaid

Comment : Some commenters observed that some states cover gender reassignment surgery through Medicaid or require commercial insurers operating in the state to cover the surgery.

Response : We appreciate the information about Medicaid and state requirements; however, State decisions are separate from Medicare coverage determinations. We make evidence-based determinations based on our statutory standards and processes.

15. Commercial Insurers

Comment : In several instances, commenters told us that the healthcare industry looks to CMS coverage determinations to guide commercial policy coverage.

Response : CMS makes evidence-based national coverage determinations based on our statutory standards and processes as defined in the Social Security Act, which may not be the same standards that are used in commercial insurance policies or by other health care programs. In addition as noted above, the Medicare population is different (e.g., Medicare covers 95% of adults 65 and older) than the typical population under commercial insurers. We do not issue coverage decisions to drive policy for other health organizations’ coverage in one way or the other.

16. Healthcare for Transgender Individuals

Comment : Numerous professional associations wrote to CMS to explain their support for access to healthcare for transgender individuals.

Response : CMS recognizes that transgender beneficiaries have specific healthcare needs. Many health care treatments are available. We encourage all beneficiaries to utilize their Medicare benefits to help them achieve their best health.

17. Intended Use of the Decision Memorandum

Comment : Several commenters expressed concern that the analysis provided in the proposed and final decision memorandums may be used by individuals, entities, or payers for purposes unrelated to Medicare such as denial of coverage for transgender-related surgeries.

Response : The purpose of the decision memoranda is to memorialize CMS’ analysis of the evidence, provide responses to the public comments received, and to make available the clinical evidence and other data used in making our decision consistent with our obligations under the § 1862 of the Act. The NCD process is open and transparent and our decisions are publicly available. Congress requires that we provide a clear statement of the basis for our determinations. The decision memoranda are an important part of the record of the NCD. Our focus is the Medicare population which, as noted above, is different than the general population in a number of ways. Other entities may conduct separate evidence reviews and analyses that are suited for their specific populations.

18. Cost Barriers to Care and Effects

Comment : A few commenters stated that without Medicare coverage, surgery is difficult to afford and there may be a risk of negative consequences for the individual. One commenter suggested that CMS should consider prior-authorization for these surgeries.

Response : CMS is aware that paying out-of-pocket for medical care is a strain on a beneficiary’s finances. We are also aware of beneficiaries’ hesitancy to undergo surgery prior to knowing whether or not Medicare will pay the claim. Gender reassignment surgeries are not the only procedures whereby payment is not determined until after the provider submits the claim to Medicare. Importantly, documentation for the claims need to be explicit about what procedures were performed and include the appropriate information in the documentation to justify using the code or codes for surgery. Of note, CMS has claims data that indicate Medicare has paid for gender reassignment surgeries in the recent past. Determining which services are designated for prior-authorization is outside of the scope of the NCA process.

19. Surgical Risks and Benefits

Comment : A number of commenters conveyed the benefits of gender reassignment surgery, while other commenters expressed concern that gender reassignment surgery was harmful.

Response : We appreciate these comments.

20. Expenditure of Federal Funds

Comment : Some commenters opposed spending Medicare program funds on gender reassignment surgery for a variety of reasons. For example, some commenters believe it is an “elective” procedure. Other commenters suggested that funds should first be spent on other priorities such as durable medical equipment (DME) or mobility items such as power chairs; increasing reimbursement to providers; or that spending should be limited to the proportion to the transgender adult population in the Medicare program.

Response : The purpose of this NCA is to determine whether or not CMS should issue a NCD to cover surgery for patients who have gender dysphoria. NCAs do not establish payment amounts or spending priorities and, therefore, these comments are outside the scope of this consideration.

VIII. CMS Analysis

National coverage determinations are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under § 1862(l)(6) of the Act. In general, in order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B and must not be otherwise excluded from coverage.

Moreover, in most circumstances, the item or service must be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (§1862(a)(1)(A)). The Supreme Court has recognized that “[t]he Secretary’s decision as to whether a particular medical service is ‘reasonable and necessary’ and the means by which she implements her decision, whether by promulgating a generally applicable rule or by allowing individual adjudication, are clearly discretionary decisions.” Heckler v. Ringer, 466 U.S. 602, 617 (1984). See also, 78 Fed. Reg. 48,164, 48,165 (August 7, 2013)

When making national coverage determinations, we consider whether the evidence is relevant to the Medicare beneficiary population. In considering the generalizability of the results of the body of evidence to the Medicare population, we carefully consider the demographic characteristics and comorbidities of study participants as well as the provider training and experience. This section provides an analysis of the evidence, which included the published medical literature and guidelines pertaining to gender dysphoria, that we considered during our review to answer the question:

CMS carefully considered all the studies listed in this decision memorandum to determine whether they answered the question posed in this NCA. While there appears to be many publications regarding gender reassignment surgery, it became clear that many of the publications did not meet our inclusion/exclusion criteria as explained earlier in the decision memorandum.

Thirty-three papers were eligible based on our inclusion/exclusion criteria for the subsequent review (Figure 1). All studies reviewed had potential methodological flaws which we describe below.

A. Quality of the Studies Reviewed

Overall, the quality and strength of evidence were low due to mostly observational study designs with no comparison groups, subjective endpoints, potential confounding (a situation where the association between the intervention and outcome is influenced by another factor such as a co-intervention), small sample sizes, lack of validated assessment tools, and considerable lost to follow-up (Appendices C and F). The impact of a specific therapeutic intervention can be difficult to determine when there are multiple serial treatments such as psychotherapy, hormone treatment and surgery. To reduce confounding, outcome assessment just prior to and after surgery such as in a longitudinal study would be helpful. The objective endpoints included psychiatric treatment, attempted suicide, requests for surgical reversal, morbidity (direct and indirect adverse events), and mortality (Appendix F). CMS agrees with the utility of these objective endpoints. Quality of life, while important, is more difficult to measure objectively (Appendix E).

Of the 33 studies reviewed, published results were conflicting – some were positive; others were negative. Collectively, the evidence is inconclusive for the Medicare population. The majority of studies were non-longitudinal, exploratory type studies (i.e., in a preliminary state of investigation or hypothesis generating), or did not include concurrent controls or testing prior to and after surgery. Several reported positive results but the potential issues noted above reduced strength and confidence. After careful assessment, we identified six studies that could provide useful information (Figure 1). Of these, the four best designed and conducted studies that assessed quality of life before and after surgery using validated (albeit non-specific) psychometric studies did not demonstrate clinically significant changes or differences in psychometric test results after GRS. (Heylens et al., 2014; Ruppin, Pfafflin, 2015; Smith et al., 2005; Udeze et al., 2008) (Appendix C Panel A and Appendix G.)

Two studies (three articles) assessed functional endpoints (request for surgical reassignment reversal and morbidity/mortality) (Dhejne et al., 2011; Dhejne et al., 2014 along with Landén et al., 1998) (Figure 1 and Appendix C, Panel A and Appendix G). Although the data are observational, they are robust because the Swedish national database is comprehensive (including all patients for which the government had paid for surgical services) and is notable for uniform criteria to qualify for treatment and financial coverage by the government. Dhejne et al. (2014) and Landén et al. (1998) reported cumulative rates of requests for surgical reassignment reversal or change in legal status of 3.3% while Dhejne et al. (2014) reported 2.2%. The authors indicated that the later updated calculation had the potential to be an underestimate because the most recent surgical cohorts were larger in size and had shorter periods of follow-up.

Dhejne et al., (2011) tracked all patients who had undergone reassignment surgery (mean age 35.1 years) over a 30 year interval and compared them to 6,480 matched controls. The study identified increased mortality and psychiatric hospitalization compared to the matched controls. The mortality was primarily due to completed suicides (19.1-fold greater than in control Swedes), but death due to neoplasm and cardiovascular disease was increased 2 to 2.5 times as well. We note, mortality from this patient population did not become apparent until after 10 years. The risk for psychiatric hospitalization was 2.8 times greater than in controls even after adjustment for prior psychiatric disease (18%). The risk for attempted suicide was greater in male-to-female patients regardless of the gender of the control. Further, we cannot exclude therapeutic interventions as a cause of the observed excess morbidity and mortality. The study, however, was not constructed to assess the impact of gender reassignment surgery per se.

We believe at minimum study designs should have a pre-test/post-test longitudinal design accompanied by characterization of all patients lost to follow-up over the entire treatment series as well as those patients who did not complete questionnaires, and the use of psychometric quality-of-life tools which are well validated with linkage to “hard” (objective) patient outcomes in this particular patient population (Trentacosti 2007, PRO 2009) (Appendices C and D).

Patient Care

Clinical evidentiary questions regarding the care of patients with gender dysphoria remain. Many of the publications focused on aspects of surgical technique as opposed to long-term patient outcomes. The specific type(s) of gender/sex reassignment surgery (e.g., genital, non-genital) that could improve health outcomes in adults remain(s) uncertain because most studies included patients who had undertaken one or more of a spectrum of surgical procedures or did not define the specific types of surgical procedures under study. Furthermore, surgical techniques have changed significantly over the last 60 years and may not reflect current practice (Bjerrome Ahlin et al., 2014; Doornaert, 2011; Green, 1998; Pauly, 1968; Selvaggi et al., 2007; Selvaggi, Bellringer, 2011; Tugnet et al., 2007; Doornaert, 2011).

The WPATH care recommendations present a general framework and guidance on the care of the transgender individual. The standards of care are often cited by entities that perform gender reassignment surgery. WPATH notes, “More studies are needed that focus on the outcomes of current assessment and treatment approaches for gender dysphoria.” Appendix D in the WPATH Standards of Care briefly describes their evidence base and acknowledges the historical problems with evidentiary standards, the preponderance of retrospective data, and the confounding impact of multiple interventions, specifically distinguishing the impact of hormone therapy from surgical intervention.

Additionally, CMS met with several stakeholders and conducted several interviews with centers that focus on healthcare for transgender individuals in the U.S. Primary care rather than gender reassignment surgery was often the main focus. Few of the U.S.-based reassignment surgeons we could identify work as part of an integrated practice, and few provide the most complex procedures.

Psychometric Tools

CMS reviewed psychometric endpoints because gender dysphoria (inclusive of prior nomenclature) describes an incongruence between the gender assigned at birth and the gender(s) with which the person identifies.

The psychometric tools used to assess outcomes have limitations. Most instruments that were specific for gender dysphoria were designed by the investigators themselves or by other investigators within the field using limited populations and lacked well documented test characterization. (Appendices E and F) By contrast, test instruments with validation in large populations were non-specific and lacked validation in the gender dysphoric patient populations. (Appendices E and F). In addition, the presentation of psychometric results must be accompanied by enough information about the test itself to permit adequate interpretation of test results. The relevant diagnostic cut-points for scores and changes in scores that are clinically significant should also be scientifically delineated for interpretation.

Generalizability

It is difficult to generalize these study results to the current Medicare population. Many of the studies are old given they were conducted more than 10 years ago. Most of these studies were conducted outside of the U.S. in very different medical systems for treatment and follow-up. Many of the programs were single-site centers without replication elsewhere. The study populations were young and without significant physical or psychiatric co-morbidity (Appendix D). As noted earlier, psychiatric co-morbidity may portend poor outcomes (Asscheman et al., 2011; Landén et al., 1998).

Knowledge Gaps

This patient population faces complex and unique challenges. The medical science in this area is evolving. This review has identified gaps in the evidentiary base as well as recommendations for good study designs. The Institute of Medicine, the National Institutes of Health, and others also identified many of the gaps in the data. (Boehmer, 2002; HHS-HP, 2011; IOM, 2011; Kreukels-ENIGI, 2012; Lancet, 2011; Murad et al., 2010; NIH-LGBT, 2013) The current or completed studies listed in ClinicalTrials.gov are not structured to assess these gaps. These gaps have been delineated as they represent areas in which patient care can be optimized and are opportunities for much needed research.

B. Health Disparities

Four studies included information on racial or ethnic background. The participants in the three U.S. based studies were predominantly Caucasian (Beatrice, 1985; Meyer, Reter, 1979; Newfield et al., 2006). All of the participants in the single Asian study were Chinese (Tsoi, 1993). Additional research is needed in this area.

Based on an extensive assessment of the clinical evidence as described above, there is not enough high quality evidence to determine whether gender reassignment surgery improves health outcomes for Medicare beneficiaries with gender dysphoria and whether patients most likely to benefit from these types of surgical intervention can be identified prospectively.

The knowledge on gender reassignment surgery for individuals with gender dysphoria is evolving. Much of the available research has been conducted in highly vetted patients at select care programs integrating psychotherapy, endocrinology, and various surgical disciplines. Additional research of contemporary practice is needed. To assess long-term quality of life and other psychometric outcomes, it will be necessary to develop and validate standardized psychometric tools in patients with gender dysphoria. Further, patient preference is an important aspect of any treatment. As study designs are completed, it is important to include patient-centered outcomes.

Because CMS is mindful of the unique and complex needs of this patient population and because CMS seeks sound data to guide proper care of the Medicare subset of this patient population, CMS strongly encourages robust clinical studies with adequate patient protections that will fill the evidence gaps delineated in this decision memorandum. As the Institute of Medicine (IOM, 2011) importantly noted: “Best practices for research on the health status of LGBT populations include scientific rigor and respectful involvement of individuals who represent the target population. Scientific rigor includes incorporating and monitoring culturally competent study designs, such as the use of appropriate measures to identify participants and implementation processes adapted to the unique characteristics of the target population. Respectful involvement refers to the involvement of LGBT individuals and those who represent the larger LGBT community in the research process, from design through data collection to dissemination.”

IX. Decision

Currently, the local Medicare Administrative Contractors (MACs) determine coverage of gender reassignment surgery on a case-by-case basis. We have a received a complete, formal request to make a national coverage determination on surgical remedies for gender identity disorder (GID), now known as gender dysphoria. The Centers for Medicare & Medicaid Services (CMS) is not issuing a National Coverage Determination (NCD) at this time on gender reassignment surgery for Medicare beneficiaries with gender dysphoria because the clinical evidence is inconclusive for the Medicare population.

In the absence of a NCD, coverage determinations for gender reassignment surgery, under section 1862(a)(1)(A) of the Social Security Act (the Act) and any other relevant statutory requirements, will continue to be made by the local MACs on a case-by-case basis. To clarify further, the result of this decision is not national non-coverage rather it is that no national policy will be put in place for the Medicare program. In the absence of a national policy, MACs will make the determination on whether or not to cover gender reassignment surgery based on whether gender reassignment surgery is reasonable and necessary for the individual beneficiary after considering the individual’s specific circumstances. For Medicare beneficiaries enrolled in Medicare Advantage (MA) plans, the initial determination of whether or not surgery would be reasonable and necessary will be made by the MA plans.

Consistent with the request CMS received, the focus of this National Coverage Analysis (NCA) was gender reassignment surgery. Specific types of surgeries were not individually assessed. We did not analyze the clinical evidence for counseling or hormone therapy treatments for gender dysphoria. As requested by several public commenters, we have modified our final decision memorandum to remove language that was beyond the scope of the specific request. We are not making a national coverage determination relating to counseling, hormone therapy treatments, or any other potential treatment for gender dysphoria.

A. Appendix A

Diagnostic & Statistical Manual of Mental Disorders (DSM) Criteria for Disorders of Gender Identity since 1980

DSM Version Condition Name Criteria Criteria Comments
DSM III
1980
302.5x [Gender Identity Disorder of Child-hood (302.6)] Required A (cross-gender identification) and B (aversion to one’s natal gender) criteria
Dx excluded by physical intersex condition
Dx excluded by another mental disorder, e.g., schizophrenia
Sense of discomfort and inappropriateness about one’s anatomic sex. Wish to be rid of one’s own genitals and to live as a member of the other sex. The disturbance has been continuous (not limited to periods of stress) for at least 2 years. Further characterization by sexual orientation
Distinguished from Atypical Gender Identity Disorder 302.85

(TS) (302.50) [GID of C] Required A and B criteria Persistent discomfort and sense of inappropriateness about one’s assigned sex. Persistent preoccupation for at least 2 years with getting rid of one’s 1 and 2 sex characteristics and acquiring the sex characteristics of the other sex. Has reached puberty Further characterization by sexual orientation
Distinguished from Gender Identity Disorder of Adolescence or Adulthood, Non-trans-sexual Type
  , non-trans-sexual type, added      


in Adolescents and Adults
(302.85)
(Separate criteria & code for children, but same name)
Required A and B criteria
Dx excluded by physical intersex condition
Cross-gender identification
and 2 sex characteristics &/or acquiring sexual traits of the other sex
Further characterization by sexual orientation
Distinguished from Gender Identity Disorder Not Otherwise Specified 302.6



(Term trans-sexual-ism eliminated)
Required A & B criteria
Dx excluded by physical intersex condition
Cross-gender identification
and 2 sex characteristics &/or acquiring sexual traits of the other sex
Clinically significant distress or impairment in social, occupational, or other important areas of functioning
Outcome may depend on time of onset
Further characterization by sexual orientation
Distinguished from Gender Identity Disorder Not Otherwise Specified 302.6



Gender nonconformity itself not considered to be a mental disorder

The dysphoria associated with the gender incongruence is

Eliminates A & B criteria

Considers gender incongruence to be a spectrum

Considers intersex/ “disorders of sex development” to be a subsidiary and not exclusionary to dx of GD
and 2 sex characteristics* and experienced/expressed gender
and 2 sex characteristics**
and 2 sex characteristics of the other sex (or some alternative gender)
Clinically significant distress or impairment in social, occupational, or other important areas of functioning

* or in young adolescents, the anticipated 2 sex characteristics
** or in young adolescents, prevent the development of the anticipated 2 sex characteristics

≥ 6 month marked discordance between natal gender & experienced/expressed gender as demonstrated by ≥ 6 criteria:
Includes diagnosis for post transition state to permit continued treatment access

Includes disorders of sexual development such as congenital hyperplasia and androgen insensitivity syndromes
 
(302.6) (F64.9)
  This category applies to presentations in which sx c/w gender dysphoria that cause clinically significant distress or impairment, but do not meet the full criteria for gender dysphoria & the reason for not meeting the criteria is not provided.  
 
302.6 (F64.8)
  If the reason that the presentation does not meet the full criteria is provided then this dx should be used  

B. Appendix B

1. General Methodological Principles of Study Design

When making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary. The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve health outcomes for patients.

We divide the assessment of clinical evidence into three stages: 1) the quality of the individual studies; 2) the generalizability of findings from individual studies to the Medicare population; and 3) overarching conclusions that can be drawn from the body of the evidence on the direction and magnitude of the intervention’s potential risks and benefits.

The methodological principles described below represent a broad discussion of the issues we consider when reviewing clinical evidence. However, it should be noted that each coverage determination has its unique methodological aspects.

Assessing Individual Studies

Methodologists have developed criteria to determine weaknesses and strengths of clinical research. Strength of evidence generally refers to: 1) the scientific validity underlying study findings regarding causal relationships between health care interventions and health outcomes; and 2) the reduction of bias. In general, some of the methodological attributes associated with stronger evidence include those listed below:

  • Use of randomization (allocation of patients to either intervention or control group) in order to minimize bias.
  • Use of contemporaneous control groups (rather than historical controls) in order to ensure comparability between the intervention and control groups.
  • Prospective (rather than retrospective) studies to ensure a more thorough and systematical assessment of factors related to outcomes.
  • Larger sample sizes in studies to demonstrate both statistically significant as well as clinically significant outcomes that can be extrapolated to the Medicare population. Sample size should be large enough to make chance an unlikely explanation for what was found.
  • Masking (blinding) to ensure patients and investigators do not know to which group patients were assigned (intervention or control). This is important especially in subjective outcomes, such as pain or quality of life, where enthusiasm and psychological factors may lead to an improved perceived outcome by either the patient or assessor.

Regardless of whether the design of a study is a randomized controlled trial, a non-randomized controlled trial, a cohort study or a case-control study, the primary criterion for methodological strength or quality is the extent to which differences between intervention and control groups can be attributed to the intervention studied. This is known as internal validity. Various types of bias can undermine internal validity. These include:

  • Different characteristics between patients participating and those theoretically eligible for study but not participating (selection bias).
  • Co-interventions or provision of care apart from the intervention under evaluation (performance bias).
  • Differential assessment of outcome (detection bias).
  • Occurrence and reporting of patients who do not complete the study (attrition bias).

In principle, rankings of research design have been based on the ability of each study design category to minimize these biases. A randomized controlled trial minimizes systematic bias (in theory) by selecting a sample of participants from a particular population and allocating them randomly to the intervention and control groups. Thus, in general, randomized controlled studies have been typically assigned the greatest strength, followed by non-randomized clinical trials and controlled observational studies. The design, conduct and analysis of trials are important factors as well. For example, a well-designed and conducted observational study with a large sample size may provide stronger evidence than a poorly designed and conducted randomized controlled trial with a small sample size. The following is a representative list of study designs (some of which have alternative names) ranked from most to least methodologically rigorous in their potential ability to minimize systematic bias:

Randomized controlled trials Non-randomized controlled trials Prospective cohort studies Retrospective case control studies Cross-sectional studies Surveillance studies (e.g., using registries or surveys) Consecutive case series Single case reports

When there are merely associations but not causal relationships between a study’s variables and outcomes, it is important not to draw causal inferences. Confounding refers to independent variables that systematically vary with the causal variable. This distorts measurement of the outcome of interest because its effect size is mixed with the effects of other extraneous factors. For observational, and in some cases randomized controlled trials, the method in which confounding factors are handled (either through stratification or appropriate statistical modeling) are of particular concern. For example, in order to interpret and generalize conclusions to our population of Medicare patients, it may be necessary for studies to match or stratify their intervention and control groups by patient age or co-morbidities.

Methodological strength is, therefore, a multidimensional concept that relates to the design, implementation and analysis of a clinical study. In addition, thorough documentation of the conduct of the research, particularly study selection criteria, rate of attrition and process for data collection, is essential for CMS to adequately assess and consider the evidence.

Generalizability of Clinical Evidence to the Medicare Population

The applicability of the results of a study to other populations, settings, treatment regimens and outcomes assessed is known as external validity. Even well-designed and well-conducted trials may not supply the evidence needed if the results of a study are not applicable to the Medicare population. Evidence that provides accurate information about a population or setting not well represented in the Medicare program would be considered but would suffer from limited generalizability.

The extent to which the results of a trial are applicable to other circumstances is often a matter of judgment that depends on specific study characteristics, primarily the patient population studied (age, sex, severity of disease and presence of co-morbidities) and the care setting (primary to tertiary level of care, as well as the experience and specialization of the care provider). Additional relevant variables are treatment regimens (dosage, timing and route of administration), co-interventions or concomitant therapies, and type of outcome and length of follow-up.

The level of care and the experience of the providers in the study are other crucial elements in assessing a study’s external validity. Trial participants in an academic medical center may receive more or different attention than is typically available in non-tertiary settings. For example, an investigator’s lengthy and detailed explanations of the potential benefits of the intervention and/or the use of new equipment provided to the academic center by the study sponsor may raise doubts about the applicability of study findings to community practice.

Given the evidence available in the research literature, some degree of generalization about an intervention’s potential benefits and harms is invariably required in making coverage determinations for the Medicare population. Conditions that assist us in making reasonable generalizations are biologic plausibility, similarities between the populations studied and Medicare patients (age, sex, ethnicity and clinical presentation) and similarities of the intervention studied to those that would be routinely available in community practice.

A study’s selected outcomes are an important consideration in generalizing available clinical evidence to Medicare coverage determinations. One of the goals of our determination process is to assess health outcomes. These outcomes include resultant risks and benefits such as increased or decreased morbidity and mortality. In order to make this determination, it is often necessary to evaluate whether the strength of the evidence is adequate to draw conclusions about the direction and magnitude of each individual outcome relevant to the intervention under study. In addition, it is important that an intervention’s benefits are clinically significant and durable, rather than marginal or short-lived. Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits.

If key health outcomes have not been studied or the direction of clinical effect is inconclusive, we may also evaluate the strength and adequacy of indirect evidence linking intermediate or surrogate outcomes to our outcomes of interest.

Assessing the Relative Magnitude of Risks and Benefits

Generally, an intervention is not reasonable and necessary if its risks outweigh its benefits. Health outcomes are one of several considerations in determining whether an item or service is reasonable and necessary. CMS places greater emphasis on health outcomes actually experienced by patients, such as quality of life, functional status, duration of disability, morbidity and mortality, and less emphasis on outcomes that patients do not directly experience, such as intermediate outcomes, surrogate outcomes, and laboratory or radiographic responses. The direction, magnitude, and consistency of the risks and benefits across studies are also important considerations. Based on the analysis of the strength of the evidence, CMS assesses the relative magnitude of an intervention or technology’s benefits and risk of harm to Medicare beneficiaries.

Patient Population: Enrolled & Treated with Sex Reassignment Surgery Loss of Patients & Missing Data

Panel A (Controlled Studies)

Author Study Type Recruitment Pool Enrolled % GRS Completion
Dhejne
2011
Longitudinal
Controlled
804 w GD 324 324 (100%) -
Dhejne 2014
Landén
Longitudinal for test variable
Controlled
767 applied for SRS
25 applications denied.
61 not granted full legal status
15 formal applications for surgical reversal
681 681 (100%) NA: Clinical data extracted retrospectively in earlier paper
Heylens Longitudinal
Controlled
90 applicants for SRS
33 excluded
11 later excluded had not yet received SRS by study close.
57 (→46) 46 (80.7%)
Only those w SRS evaluated
Psycho-social survey missing data for 3 at baseline & 4 after SRS.
SCL90 not completed by 1 at baseline, 10 after hormone tx, & 4 after SRS
→missing data for another 1.1% to 11.1%.
Kockott Longitudinal
Controlled
80 applicants for SRS
21 excluded
59 32 (54.2%) went to surgery 1 preoperative patient was later excluded b/c lived completely in aspired gender w/o SRS.
Questions on financial sufficiency not answered by 1 surgical pt.
Questions on sexual satisfaction & gender contentment not answered by 1 & 2 patients awaiting surgery respectively.
Mate-Kole 1990 Longitudinal
Controlled
40 sequential patients of accepted patients.
The number in the available patient pool was not specified.
40 20 (50%) went to surgery -
Meyer Longitudinal
Controlled
Recruitment pool: 100
50 were excluded.
50 15 (30%) had undergone surgery
14 (28%) underwent surgery later
The assessments of all were complete
Rakic Longitudinal
Controlled
92 were evaluated
54 were excluded from surgery
2 post SRS were lost to follow-up
2 post SRS were excluded for being in the peri-operative period
32 32 (100%) Questionnaire completed by all.
Ruppin Longitudinal
Controlled
The number in the available patient pool was not specified.
140 received recruitment letters.
69 were excluded
71 69 (97.2%) The SCL-90, BSRI, FPI-R, & IPP tests were not completed by 9, 34,
13, &16 respectively.
Questions about romantic relationships, sexual relationships, friendships, & family relationships were not answered by 1, 3, 2, & 23 respectively.
Questions regarding gender security & regret & were not answered by 1& 2 respectively.
Smith Longitudinal
Controlled
The number in the available adult patient pool was not specified.
325 adult & adolescent applicants for SRS were recruited.
103 were excluded from additional tx
162 162 (100%) 36 to 61 (22.2%-37.6% of those adults w pre-SRS data) did not complete various post-SRS tests.
Udeze Megeri Longitudinal
Controlled
International patient w GD 546 & post SRS 318.
40 M to F subjects were prospectively selected.
40 40 (100%) -
Ainsworth Internet/convention Survey
Cross-sectional
Controlled
Number of incomplete questionnaires not reported 247 72 (29.1%)
75 (30.6%) facial
147 (59.5%) had received neither facial nor reassignment surgery
-
Beatrice Cross-sectional
Controlled
14 excluded for demographic matching reasons 40 10 (25%) The assessments were completed by all
Haraldsen Cross-sectional
Controlled
Recruitment pool: 99 86 59 (68.6%) -
Kraemer Cross-sectional
Controlled
The number in the available patient pool was not specified. 45 22 (48.9%) -
Kuhn Cross-sectional
Controlled
The number in the available patient pool was not specified. 75 55 (73.3%) -
Mate-Kole 1988 Cross-sectional
Controlled
150 in 3 cohorts. Matched on select traits. The number in the available patient pool was not specified. 150 50 (66.7%) -
Wolfradt Cross-sectional
Controlled
The number in the available patient pool was not specified. 90 30 (33.3%) -

Panel B (Surgical Series: No Concurrent Controls)

Author Study Type Recruitment Pool Enrolled % GRS Completion
Blanchard et al. Cross-sectional
Control: Normative test data
294 clinic patients w GD had completed study questionnaire
116 authorized for GRS.
103 completed GRS & 1 yr post-operative.
24 excluded
79 79(100%) -
Weyers et al. Cross-sectional
Control: Normative test data
>300 M to F patients had undergone GRS
70 eligible patients recruited
20 excluded
50 50 (100%) SF-26 not completed by 1
Wierckx et al. Cross-sectional except for recall questions
Control: Normative test data
79 F to M patients had undergone GRS & were recruited.

3 additional non-clinic patients were recruited by other patients.
32 excluded initially; 1 later.
49 49 (100%) SF-36 test not completed by 2.
Questions regarding sexual re-lationship, sex function, & surgical satisfaction were answered by as few as 27, 28, 32 respectively.
Eldh et al. Cross-sectional except for 1 variable
Control: Self for 1 variable-employ-ment
136 were identified.
46 excluded
90 90 (100%) Questions regarding gender iden-tity, sex life, acceptance, & overall satisfaction were not answered by 13, 14, 14 & 16 respectively.
Employment data missing for 11.
Hess et al. Cross-sectional

No control
254 consecutive eligible patients post GRS identified & sent surveys.
135 excluded.
119 119 (100%) Questions regarding the esthetics, functional, and social outcomes of GRS were not answered by 16 to 28 patients.
Lawrence Cross-sectional
No control
727 eligible patients were recruited.
495 were excluded
232 232 (100%) -
Salvador et al. Cross-sectional
No control
243 had enrolled in the clinic
82 completed GRS
69 eligible patients were identified.
17 excluded.
52 52 (100%) -
Tsoi Cross-sectional
No control
The number in the available patient pool was not specified. 81 81 (100%) -

Panel C (Mixed Treatment Series: No Direct Control Groups)

Author Study Type Recruitment Pool Enrolled % GRS Completion
Gómez-Gil et al. 2012 Cross-sectional
No direct control: Analysis of variance
200 consecutive patients were recruited.
13 declined participation or were excluded for incomplete questionnaires.
187 79 (42.2%) See prior box.
Hepp et al. Cross-sectional
No direct control: Analysis of variance
The number in the available patient pool was not specified. 31 7 (22.6%) HADS test not completed by 1
Motmans et al. Cross-sectional
No direct control: Analysis of variance & regression
255 with GD were identified.
77 were excluded.
148 (→140) Not clearly stated. At least 103 underwent some form of GRS. 8 later excluded for incomplete SF-36 tests.
37 w recent GRS or hormone initiation were excluded from analysis of SF-36 results→103.
Newfield et al. Internet survey
Cross-sectional
No direct control: Analysis of variance
Number of incomplete questionnaires not reported
446 respondents; 384 U.S respondents
62 non-U.S. respondents excluded from SF-36 test results
8 U.S. respondents excluded
376 (U.S.) 139 to 150 (37.0-39.9%) in U.S. -
Gomez-Gil et al. 2014 Cross-sectional
No direct control: Analysis w regression
The number in the available patient pool was not specified.
277 were recruited.
25 excluded
252(→193) 80 (41.4%) non-genital surgery 59 were excluded for incomplete questionnaires. See prior box.
Asscherman Longitudinal
No analysis by tx status
The number in the available patient pool was not specified. 1331 1177 (88.4%) -
Johansson et al. Cross-sectional except for 1 variable No analysis by tx status except for 1 question 60 eligible patients
18 excluded.
42 32 (76.2% of enrolled & 53.3% of eligible) (genital surgery) -
Leinung et al. Cross-sectional

No analysis by tx status
242 total clinic patients 242 91 (37.6%) Employment status data missing for 81 of all patients

*Data obtained via a survey on a website and distributed at a conference B/C=because BSRI=Bem Sex Role Inventory F=Female FP-R=Freiberg Personality Inventory GD=Gender dysphoria GID=Gender identity disorder HADS=Hospital Anxiety & Depression Scale IPP=Inventory of Interpersonal Problems M=Male NA=Not applicable SCL-90=Symptom Checklist-90 SF-36=Short Form 36 GRS=Sex reassignment surgery Tx=Treatment W/o=without

Demographic Features of Study Populations

Author Age (years; mean, S.D., range) Gender Race
Ainsworth Only reassignment surgery:50 (no S.D.)
Only facial surgery: 51 (no S.D.)
Both types of surgery: 49 (no S.D.)
Neither surgery: 46 (no S.D.)
247 M to F -
Beatrice Pre-SRS M to F: 32.5 (27-42), Post-SRS: 35.1 (30-43) 20 M to F plus 20 M controls 100% Caucasian
Dehjne
2011
Post-SRS: all 35.1±9.7 (20-69), F to M 33.3+8.7 (20–62), M to F 36.3+ 10.1(21–69) 133 (41.0%) F to M, 191 (59.0%) M to F; ratio 1:1.4 -
Dhejne 2014
Landén
F to M SRS cohort: median age 27
M to F SRS cohort: median age 32
F to M applicants for reversal: median age 22
M to F applicants for reversal: median age 35
767 applicants for legal/surgical reassignment
289 (37.7%) F to M, 478 (62.3%) M to F; ratio 1:1.6
681 post SRS & legal change
252 (37.0%) F to M, 429 (63.0%) M to F; ratio 1:1.7
15 applicants for reversal
5 (33.3%) F to M, 10 (66.7%) M to F; ratio 1:2
-
Haraldsen Pre-SRS & Post-SRS: F to M 34±9.5, F to M 33.3±10.0
Post-SRS cohort reportedly older. No direct data provided.
Pre & Post SRS 35 (40.7%) F to M, 51 (59.3%) M to F; ratio 1:1.5 -
Heylens - 11 (19.3% of 57) F to M, 46 (80.7%); ratio 1:4.2
(80.7% underwent surgery)
-
Kockott Pre-SRS (continued wish for surgery): 31.7±10.2
Post-SRS: 35.5±13.1
Pre-SRS (continued wish for surgery) 3 (25%) F to M,
9 (75%) M to F; ratio 1:3
Post SRS: 14 (43.8%) F to M, 18 (56.2%) M to F; ratio 1:1.3
-
Kraemer Pre-SRS: 33.0±11.3, Post-SRS: 38.2±9.0 Pre-SRS 7 F to M (30.4%), 16 M to F (69.6%); ratio 1:2.3
Post-SRS 8 F to M (36.4%), 14 M to F (63.6%); ratio 1:1.8
-
Kuhn All post SRS: median (range): 51 ( 39-62) (long-term follow-up) 3 (5.4%) F to M, 52 (94.5%) M to F; ratio 1:17.3. -
Mate-Kole 1988 Initial evaluation: 34, Pre-SRS: 35, Post-SRS: 37 150 M to F -
Mate-Kole 1990 Early & Usual wait SRS: 32.5 years (21-53) 40 M to F -
Meyer Pre-SRS: 26.7
Delayed, but completed SRS: 30.9
Post-SRS: 30.1
Pre-SRS: 5 (23.8%) F to M, 16 (76.2%) M to F; ratio 1:3.2
Delayed, but completed SRS: 1 (7.1%) F to M, 13 (92.9%) M to F; ratio 1:13
Post-SRS: 4 (26.7%) F to M, 11 (73.3%) M to F; ratio 1:2.8
86% Caucasian
Rakic All: 26.8±6.9 (median 25.5, range 19-47),
F to M: 27.8±5.2 (median 27, range 23-37), M to F: 26.4±7.8 (median 24, range 19-47).
10 (31.2%) F to M, 22 (68.8%) M to F; ratio 1:2.2 -
Ruppin All: 47.0±10.42 (but 2 w/o SRS) (13.8±2.8 yrs post legal name change) (long-term follow-up)
F to M: 41.2±5.78, M to F 52.9±10.82
36 (50.7%) F to M, 35 (49.3%) M to F; ratio 1:0.97 -
Smith Time of surgical request for post-SRS: 30.9 (range 17.7-68.1)
Time of follow-up for post-SRS: 35.2 (range 21.3-71.9)
Pre-SRS: 162: 58 (35.8%) F to M, 104 [64.2%] M to F; ratio 1:1.8
Post-SRS: 126: 49 (38.9%) F to M, 77 (61.1%) M to F; ratio 1:1.6
-
Udeze Megeri M to F: 47.33±13.26 (range 25-80). 40 M to F -
Wolfradt Patients & controls: 43 (range 29-67). 30 M to F plus 30 F controls plus 30 M controls. -

*Data obtained via a survey on a website and distributed at a conference SD=Standard deviation

Author Age (years; mean, S.D., range) Gender Caucasian
Blanchard et al. F to M: 32.6, M to F w M partner preference: 33.2, F to M w F partner preference: 47.7 years Post-GRS: 47 (45.6%) F to M, 56 (54.4%) M to F; ratio 1:1.19.
In study: 38 (48.1%) F to M, 32 (40.5%) M to F w M partner preference, 9 (11.4%)
M to F w F partner preference; ratio 1:0.8: 0.2
-
Weyers et al. Post-GRS M to F: 43.1 ±10.4 (long-term follow-up) 50 M to F -
Wierckx et al. Time of GRS: 30±8.2 years (range 16 to 49)
Time of follow-up: 37.1 ±8.2.4 years (range 22 to 54)
49 M to F -
Eldh et al. - 50 (55.6%) F to M, 40 (44.4%) M to F; ratio 1:0.8
There is 1 inconsistency in the text suggesting that these should be reversed.
-
Hess et al. - 119 M to F -
Lawrence Time of GRS: 44±9 (range 18-70) 232 M to F -
Salvador et al. Time of follow-up for post-GRS: 36.28±8.94 (range 18-58)
(Duration of follow-up: 3.8±1.7 [2-7])
52 M to F -
Tsoi Time of initial visit: All: 24.0±4.5, F to M: 25.4±4.4 (14-36), M to F: 22.9±4.6 (14-36).
Time of GRS: All: 25.9±4.14, F to M: 27.4±4.0 (20-36), M to F: 24.7+4.3 (20-36).
36 (44.4%) F to M, 45 (55.6%) M to F; ratio 1:1.25 0%
100% Asian
Author Age (years; mean, S.D., range) Gender Caucasian
Gómez-Gil et al. 2012 W & W/O GRS: All: 29.87±9.15 (range 15-61), W/O hormone tx: 25.9±7.5, W current hormone tx: 33.6±9.1. (At hormone initiation: 24.6±8.1). W/O hormone tx: 38 (56.7%) F to M, 29 (43.3%) M to F; ratio 1:0.8.
W hormone tx: 36 (30.0%) F to M, 84 (70.0%) M to F; ratio 1:2.3.
Post-GRS: 29 (36.7%) F to M, 50 (63.3%) M to F; ratio 1:1.7.
-
Hepp et al. W & W/O GRS: 32.2±10.3 W & W/O GRS: 11 (35.5%) F to M; 20 (64.5%) M to F; ratio 1:1.8. -
Motmans et al. W & W/O GRS: All (n=140) : 39.9±10.2, F to M: 37.0±8.5, M to F: 42.3±10.4 W & W/O GRS: N=140 63(45.0%) F to M, 77 (55.0%) M to F; ratio 1:1.2 N=103 49 (47.6%) F to M; 54 (52.4%) M toF; ratio 1:1.1 -
Newfield et al. W & W/O GRS: U.S.+ non-U.S. : 32.8±11.2, U.S. 32.6±10.8 W & W/O GRS: U.S.+ non-U.S.: F to M, 438, U.S.: F to M: 376 89% of 336 respondents Caucasian
Gomez-Gil, et al. 2014 W & W/O Non-genital GRS: 31.2±9.9 (range 16-67). W & W/O Non-genital GRS: 74 (38.3%) F to M, 119 (61.7%) M to F; ratio1:1.6. -
Asscherman Time of hormone tx: F to M: 26.1±7.6 (16–56), M to F: 31.4±11.4 (16–76) Met hormone tx requirements: 365 (27.4%) F to M, 966 (72.6%) M to F; ratio 1:2.6. Post-GRS: 343 (29.1%) F to M, 834 (70.9%) M to F; ratio 1:2.4. -
Johanssen Time of initial evaluation: F toM: 27.8 (18-46), M to F 37.3 (21-60). Time of GRS: F to M: 31.4 (22-49), M to F 38.2 (22-57). Time of follow-up for post-GRS: F to M: 38.9 (28-53), M to F 46.0 (25-69) (Long-term follow-up) Approved for GRS: 21 (35%) F to M, 39 (65%) M to F; ratio 1:1.9)
Post GRS: 14 (43.8%) F to M; 18 (56.2%) M to F; ratio 1:1.3)
-
Leinung et al. Time of hormone initiation : F to M: 27.5, M to F 35.5 W & W/O GRS: 50 (20.7%) F to M, 192 M to F (79.3%); ratio 1:3.8. Post-GRS: 32 F to M (35.2%); 59 (64.8%) M to F; ratio 1:1.8. -

Psychometric and Satisfaction Survey Instruments

Instrument Name and Developer Development and Validation Information

Published in 1978
Initial data: 152 families in the U.S.
A “friends” component was added in 1983.
Utility has challenged by many including Gardner 2001

Published initially in 1961 with subsequent revisions
It was initially evaluated in psychiatric patients in the U.S.A.
Salkind (1969) evaluated its use in 80 general outpatients in the UK.
Itis copyrighted and requires a fee for use

Published 1974
Initial data: 100 Stanford Undergraduates
1973 update: male 444; female 279
1978 update: 470; female 340

Validity study published 1996 (German)
Population: 405 psychosomatic patients, 141 medical students, 208 sports students


1975
Initial data: 16 male and 16 female transsexual patients in Oregon

(formerly Middlesex Hospital Questionnaire)
Developed circa 1966
Manual published 1970
Initial data: 52 nursing students while in class in the UK
) European Quality of Life Survey Published in 2007
The pilot survey was tested in the UK and Holland with 200 interviews. The survey was revised especially for non-response questions. Another version was tested in 25 persons of each of the 31 countries to be surveyed. Sampling methods were devised. 35,634 Europeans were ultimately surveyed.
Additional updates


Published in 2000
Initial data: 131 normal controls & 128 age-matched subjects with female sexual arousal disorder from 5 U.S. research centers.
Updated 2005: the addition of those with hypoactive sexual desire disorder, female sexual orgasm disorder, dyspareunia/vaginismus, & multiple sexual dysfunctions (n=568), plus more controls (n=261).

Published 1996 (German)

7 edition published 2001, 8 edition in 2009
(Not in PubMed)
German equivalent of MMPI

11 items derived from the Biographical Questionnaire for Trans-sexuals (Verschoor Poortinga 1988)
(Modified by authors of the Smith study)

Published 1989 (German)


Initial publication 1970
Manual published ?1978, 1988 (Not in PubMed)
Initial data: 553 consecutive adult patients in a single UK primary care practice were assessed. Sample of 200 underwent standardized psychiatric interview. Developed to screen for hidden psychological morbidity.
Proprietary test. Now 4 versions.

Published in 1983
Initial data: Patients between 16 & 65 in outpatient clinics in the UK
>100 patients; 2 refusals. 1 50 compared to 2 50.


Published 1988
Initial data: 103 patients about to undergo psychotherapy; some patients post psycho-therapy (Kaiser Permanente-San Francisco)
Proprietary test

1997
Initial data: 293 consecutive women referred for urinary incontinence evaluation in London
Comparison to SF-36


Published in 1941
Updated in 1989 with new, larger, more diverse sample.
MMPI-2: 1,138 men & 462 women from diverse communities & several geographic regions in the U.S.A.
The test is copyrighted.

Neither the underlying version or the Blanchard modified version could be located in PubMed
(Designed by the author of the Blanchard et al. study)


Published 1996 (Dutch) (Not in PubMed)
(Designed by 1 of the authors of the Smith study)

Published 1996 (Dutch) (Not in PubMed)
(Designed by 1 of the authors of the Smith study)

Unpublished manuscript 1998 (University of Halle)
(Designed by 1 of the authors of the Wolfradt study)

Published 1997
Assessed in 22 adolescents
(Designed by 1 of the authors of the Smith Study)

Published 1965 (Not in PubMed)
Initial data: 5,024 high-school juniors & seniors from 10 randomly selected New York schools



Originally derived from the Rand Medical Outcomes Study (n=2471 in version 1; 6742 in version 2 1989).
The earliest test version is free.
Alternative scoring has been developed.
There is a commercial version with a manual.

Initial publication in1969
Requires permission for use

Published 1988 (Dutch) (Not in PubMed)

Current format published in 1983
Proprietary test


Published in 1973 & 1977
Reportedly with normative data for psychiatric patients (in- & out-patient) & normal subjects in the U.S.
Has undergone a revision
Requires qualification for use

In use prior to 1988 publication.
Initial data: 131 psychiatric day care patients.
Updated manual published 1996.
Update population >3000 with age stratification. No other innformation available.
Requires qualification for use

Published in 1997
Initial population: 22 transgender adolescents who underwent reassignment surgery.
(Designed by 1 of the authors of the Smith study)
(abbreviated version)
Field trial version released 1996
Tested in multiple countries. The Seattle site consisted of 192 of the 8294 subjects tested). Population not otherwise described.
The minimal clinically important difference has not been determined.
Permission required

Althof et al., 1983; Greenberg, Frank, 1965; Gurtman, 1996; Lang, Vernon, 1977; Paap et al., 2012; Salkind et al., 1969; Vacchiano, Strauss, 1968.

Endpoint Data Types and Sources

Author National Data Instrument w Substantive Normative Data Instrument w/o Substantive &/or Accessible Normative Data Investigator-designed Other Other
Dhejne
2011
Yes - - - - Mortality (Suicide, Cardiovascular Disease [possible adverse events from Hormone Tx], Cancer), Psych hx & hospitalization, Suicide attempts
Dhejne
Landén
Yes - - - Includes demographics* Education, Employment, Formal application for reversal of status, Psych dx & tx, Substance abuse**
More elements in earlier paper
Beatrice - MMPI form R, TSCS - - Demographic Education, Income, Relationships
Haraldsen - SCL-90/90R - - Demographic DSM Axis 1, II, V (GAF),
Substance abuse
Heylens - SCL-90 - Yes-2 Demographic Employment, Relationships, Substance abuse, Suicide attempts
Ainsworth - Likely SF-36v2* - Yes-1 Demographic -
Ruppin - SCL-90R BSRI, FPI-R, IIP Yes-2 Demographic Adverse events from surgery, Employment, Psych tx, Relationships, Substance abuse
Smith - MMPI-short, SCL-90?R BIS, UGDS,
? Cohen-Kettenis’, Doorn’s x2, (Gid-c, SSS)
Yes-1 or 2 Demographic Adverse events from surgery, Employment, Relationships
Udeze
Megeri
- SCL-90R BDI, GHQ, HADS,STAI-X1, STAI-X2 - - Psych eval & ICD-10 dx
Kuhn - - KHQ Yes-1 Demographic Relationships
Mate-Kole 1990 - - BSRI, CCEI Yes-1 Demographic Employment (relative change), Psych hx, Suicide hx
Wolfradt - - BIQ, GITS, SDE, SES Yes-1 - -
Kraemer - - FBeK - Demographic -
Mate-Kole 1988 - - BSRI, CCEI - Demographic Employment, Psych hx, Suicide hx,
Kockott - - - Yes-1 Demographic Employment, Income, Relationships, Suicide attempts
Meyer - - - Yes-1 Demographic Education, Employment, Income, Psych tx, Phallus removal request
Rakic - - - Yes-1 Demographic Employment, Relationships
Author National Data Instrument w Substantive Normative Data Instrument w/o Sub-stantive &/or Accessible Normative Data Investigator-designed Other Other
Weyers - SF-36 FSFI Yes-2 Demographic Hormone levels, Adverse events from surgery, Relationships
Blanchard - SCL-90R (AG) Yes-1 Demographic Education, Employment, Income, Relationships, Suicide (Incidental finding)
Wierckx - SF-36 - Yes-3 Demographic Hormone levels, Adverse events from surgery, Relationships
Eldh - - - Yes-1 - Adverse events from surgery, Employment, Relationships, Suicide attempts
Hess - - - Yes-1 - -
Lawrence - - - Yes-4 Demographic Adverse events from surgery
Salvador - - - Yes-1 Demographic Relationships
Tsoi - - - Yes-1 Demographic Education, Employment, Relationships (relative change)
Author National Data Instrument w Substantive Normative Data Instrument w/o Sub-stantive &/or Accessible Normative Data Investigator-designed Other Other
Asscheman et al. Yes - - - Demographic Mortality (HIV, Possible adverse events from Hormone Tx, Substance abuse, Suicide)
Motmans et al. - SF36 EQOLS (2 ) - - Demographic Education, Employment, Income, Relationships
Newfield et al. - SF-36v2 - - Demographic Income
Gómez-Gil et al. 2014 - WHOQOL-BREF APGAR Yes-1 Demographic Education, Employment, Relationships
Gómez-Gil et al. 2012 - - HADS, SADS - Demographic Education, Employment, Living arrangements
Hepp et al. - - HADS - Demographic DSM Axis 1& II Psych dx
Johansson et al. - - - Yes-1 Demographic Axis V change (Pt & Clinician) Employment (relative change) Relationship (relative change)
Leinung et al. - - - - Demographic Employment, Disability, DVT, HIV status, Psych dx

Appendix G.

Longitudinal Studies Which Used Patients as Their Own Controls and Which Used Psychometric Tests with Extensive Normative Data or Longitudinal Studies Which Used National Data Sets

Author   Test Patient and Data Loss Results
  Psychometric Test
Heylens et al.
Belgium
2014

SCL-90R 90 applicants for SRS were recruited.
57 (63.3% of recruited) entered the study. → →
At t=0, the mean global “psychoneuroticism” SCL-90R score, along with scores of 7 of 8 subscales, were statistically more pathologic than the general population.

After hormone tx, the mean score for global “psychoneuroticism” normalized & remained normal after reassignment surgery.
Ruppin,Pfafflin,
Germany
2015
  SCL-90R The number in the available patient pool was not specified.
140 received recruitment letters.

At t=0, the “global severity index “SCL-90R score was 0.53±0.49. At post-SRS follow-up the score had decreased to 0.28±0.36.

The scores were statistically different from one another, but are of limited biologic significance given the range of the score for this scale: 0-4.

In the same way, all of the subscale scores were statistically different, but the effect size was reported as large only for “interpersonal sensitivity”: 0.70±0.67 at t=0 and 0.26±0.34 post-SRS.
Smith et al.
Holland
2005
  MMPI
SCL-90
The number in the available adult patient pool was not specified.
325 adult & adolescent applicants for SRS were recruited.
162 (an unknown percentage of the initial recruitment) provided pre-SRS test data.
Most of the MMPI scales were already in the normal range at the time of initial testing.

At t=0, the global “psychoneuroticism” SCL-90 score, which included the drop-outs, was 143.0±40.7.
At post SRS-follow-up, the score had decreased to 120.3±31.4.

The scores were statistically different from one another, but are of limited biologic significance given the range of the score for this scale: 90 to 450, with higher scores consistent with more psychological instability.
Udeze, et al.
2008
Megeri, Khoosal
2007
UK
  SCL-90R The number in the available patient pool was not specified.
40 subjects were prospectively selected.

At t=0, the mean raw global score was 48.33. At post-SRS follow-up, the mean score was 49.15.

There were no statistically significant changes in the global score or for any of the subscales.

 
Dehjne
Sweden
2011
  Swedish
National Records
804 with GID in Sweden 1973 to 2003 were identified.
3240 controls of the natal sex and 3240 controls of the reassigned gender were randomly selected from national records
All cause mortality was higher (n=27[8%]) than in controls (H.R 2.8 [1.8-4.3]) even after adjustment for covariants. Divergence in survival curves was observed after 10 years. The major contributor was completed suicide (n=10 [3%]; adjusted H.R. 19.1 [5.8-62.9]).

Suicide attempts were more common ( n= 29 [9%]) than in controls (adjusted H.R. 4.9 [2.9–8.5]).

Hospitalizations for psychiatric conditions (not related to gender dysphoria) were more common n= 64 [20%] than in controls (H.R. 2.8 [2.0–3.9]) even after adjusting for prior psychiatric morbidity.
Dhejne et al.
2014
Landén et al.
1998
Sweden
  Swedish National Registry 767 applied for SRS/legal status (1960-2010)
681 (88.7%) underwent SRS.
15 formal applications for reversal to natal/original gender (2.2% of the SRS population) were identified thus far (preliminary number). (Does not reflect other manifestations of regret such as suicide.)

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B-Weyers S, Decaestecker K, Verstraelen H, Monstrey S, T'Sjoen G, Gerris J, Hoebeke P, Villeirs G. Clinical and transvaginal sonographic evaluation of the prostate in transsexual women. Urology. 2009 Jul;74(1):191-6. Epub 2009 Apr 23. PMID: 19395005.

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WHO 2014: Chris Beyrer C, Kamarulzaman A (co-chairs.) World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment, and care for key populations . July 2014. www.who.int/hiv/pub/guidelines/keypopulations/en/.

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A-Wierckx K, Elaut E, Van Caenegem E, Van De Peer F, Dedecker D, Van Houdenhove E, T'Sjoen G. Sexual desire in female-to-male transsexual persons: exploration of the role of testosterone administration. Eur J Endocrinol . 2011 Aug;165(2):331-7. Epub 2011 May 20. PMID: 21602316.

B-Wierckx K, Van Caenegem E, Elaut E, Dedecker D, Van de Peer F, Toye K, Weyers S, Hoebeke P, Monstrey S, De Cuypere G, T'Sjoen G. Quality of life and sexual health after sex reassignment surgery in transsexual men. J Sex Med . 2011 Dec;8(12):3379-88. Epub 2011 Jun 23. PMID: 21699661.

Wylie K, Knudson G, Khan S, Bonierbale M, Watanyusakul S, Baral S.  Serving transgender people: clinical care considerations and service delivery models in transgender health. Lancet . Epub 16 June 2016.  http://dx.doi.org/10.1016/S0140-6736(16)00682-6

A-Wierckx K, Van Caenegem E, Pennings G, Elaut E, Dedecker D, Van de Peer F, Weyers S, De Sutter P, T'Sjoen G. Reproductive wish in transsexual men. Hum Reprod. 2012 Feb;27(2):483-7. Epub 2011 Nov 28. PMID: 22128292.

B-Wierckx K, Mueller S, Weyers S, Van Caenegem E, Roef G, Heylens G, T'Sjoen G. Long-term evaluation of cross-sex hormone treatment in transsexual persons. J Sex Med. 2012 Oct;9(10):2641- 51. Epub 2012 Aug 20.  PMID: 22906135.

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Wilson CA, Davies DC. The control of sexual differentiation of the reproductive system and brain. Reproduction. 2007 Feb;133(2):331-59. PMID: 17307903.

Wilson EC, Garofalo R, Harris DR, Belzer M. Sexual risk taking among transgender male-to-female youths with different partner types. Am J Public Health . 2010 Aug;100(8):1500-5. Epub 2009 Nov 12. PMID: 20622176.

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Wilson RC, Nimkarn S, Dumic M, Obeid J, Azar MR, Najmabadi H, Saffari F, New MI. Ethnic- specific distribution of mutations in 716 patients with congenital adrenal hyperplasia owing to 21- hydroxylase deficiency. Mol Genet Metab. 2007 Apr;90(4):414-21. Epub 2007 Feb 1. Erratum in: Mol Genet Metab . 2008 Feb;93(2):219. Azar, Maryam [corrected to Azar, Maryam Razzaghy]. PMID: 17275379.

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B-Wise LA, Titus-Ernstoff L, Palmer JR, Hoover RN, Hatch EE, Perez KM, Strohsnitter WC, Kaufman R, Anderson D, Troisi R. Time to pregnancy and secondary sex ratio in men exposed prenatally to diethylstilbestrol. Am J Epidemiol. 2007 Oct 1;166(7):765-74. Epub 2007 Jun 27. PMID: 17596265.

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Wolfradt U, Neumann K. Depersonalization, self-esteem and body image in male-to-female transsexuals compared to male and female controls. Arch Sex Behav. 2001 Jun;30(3):301-10 PMID: 11330119.

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WPATH 2012 Coleman E, Bockting W, Botzer M, Cohen-Kettenis P, DeCuypere G, Feldman J, Fraser L, Green J, Knudson G, Meyer WJ, Monstrey S, Adler RK, Brown GR, Devor AH, Ehrbar R, Ettner R, Eyler E, Garofalo R, Karasic DH, Istar Lev A, Mayer G, Meyer-Bahlburg H, Paxton Hall B, Pfäfflin F, Rachlin K, Robinson B, Schechter LS, Tangpricha V, van Trotsenburg M, Vitale A, Winter S, Whittle S, Wylie KR, Zucker K. Standards of care for the health of transsexual, transgender, and gender-nonconforming people . (7th version) 2012. http://www.wpath.org/site_page.cfm? pk_association_webpage_menu=1351&pk_association_webpage=3926 .

Wroblewski P, Gustafsson J, Selvaggi G. Sex reassignment surgery for transsexuals. Curr Opin Endocrinol Diabetes Obes. 2013 Dec;20(6):570-4. PMID: 24468760.

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Yik Koon, T. (2002). The Mak Nyahs: Malaysian Male to Female Transsexuals . (Chapter 4) Eastern Universities Press.

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.  PMID: 6880820.

Zimmermann A, Zimmer R, Kovacs L, Einödshofer S, Herschbach P, Henrich G, Tunner W, Biemer E, Papadopulos N. [Transsexuals' life satisfaction after gender transformation operations]. Chirurg . 2006 May;77(5):432-8. German. Erratum in Chirurg . 2006 Jun;77(6):530. PMID: 16437228.

Zoni AC, González MA, Sjögren HW. Syphilis in the most at-risk populations in Latin America and the Caribbean: a systematic review. Int J Infect Dis . 2013 Feb;17(2):e84-92. Epub 2012 Oct 12. PMID: 23063547.

Zucker KJ, Bradley SJ, Hughes HE. Gender dysphoria in a child with true hermaphroditism. Can J Psychiatry. 1987 Oct;32(7):602-9. PMID: 3676994.

A-Zucker KJ, Bradley SJ, Kuksis M, Pecore K, Birkenfeld-Adams A, Doering RW, Mitchell JN, Wild J. Gender constancy judgments in children with gender identity disorder: evidence for a developmental lag . Arch Sex Behav . 1999 Dec;28(6):475-502. PMID: 10650437.

B-Zucker KJ. Intersexuality and gender identity differentiation. Annu Rev Sex Res. 1999;10:1-69. PMID: 10895247.

Zucker K, Cohen-Kettenis P, Drescher J, Meyer-Bahlburg H, Pfäfflin F, Womack W. Memo outlining evidence for change for gender identity disorder in the DSM-5. Arch Sex Behav . 2013 Jul;42(5):901- 14.  PMID: 23868018.

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Page help for nca - gender dysphoria and gender reassignment surgery (cag-00446n) - decision memo, decision memo.

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Who can provide hormone therapy for transgender adults?

Who can provide hormone therapy for transgender adults?

Worldwide, physicians from different specialties offer hormone therapy for transgender adults, including endocrinology, family medicine, primary care, internal medicine, obstetrics and gynecology.

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Gender-affirming care for transgender people.

Transgender people are diverse in their need for gender transition‑related services ; not all transgender people want to affirm their bodies through gender-affirming medical procedures. Procedures include gender-affirming hormone therapy (GAHT); gender-affirming surgery (GAS) – procedures of the face, breast, chest, body, or genitals; and facial hair removal and voice and communication therapy. WPATH recommends that healthcare systems should provide medically necessary gender-affirming health care for transgender people.

According to the medical necessity statement issued by the World Professional Association for Transgender Health (WPATH): “ Sex reassignment plays an undisputed role in contributing toward favourable outcomes, and comprises real life experience, legal name and sex change on identity documents, as well as medically necessary hormone treatment, counselling, psychotherapy, and other medical procedures .”

For many transgender people, hormone therapy is part of the affirmation of their gender identity, so providing this service may assist them to realize their sexual and gender rights.

29 May 2024

gender reassignment and transgender

Sex reassignment plays an undisputed role in contributing toward favourable outcomes, and comprises real life experience, legal name and sex change on identity documents, as well as medically necessary hormone treatment, counselling, psychotherapy, and other medical procedures. (World Professional Association for Transgender Health)

gender reassignment and transgender

Who can provide hormone therapy for transgender adults?  

Worldwide, physicians from different specialties offer hormone therapy for transgender adults, including endocrinology, family medicine, primary care, internal medicine, obstetrics and gynecology, and psychiatry. The WPATH’s Global Education Institute offers training in GAHT.

Depending on comfort level and experience, primary care providers may initiate hormone therapy or maintain hormone therapy started by an endocrinologist or other experienced physician; at a minimum, they should be able to provide information on hormone therapy and referrals to health care professionals who are experienced in providing hormone therapy. Primary care providers may already have experience in the use of estrogens (for contraception and estrogen replacement in post‑menopausal women), testosterone (for hypogonadism and androgen‑deficient states), and testosterone‑blocking medications (for hirsutism and prostatic disease). This knowledge and experience can be used to initiate and maintain hormone therapy among transgender clients who do not have co‑morbid conditions.

The goal of GAHT is to align the body’s external appearance with the experienced gender. In addition to physical changes, psychological benefits occur in the form of improved quality of life, regardless of whether they have undergone GAS, as being on GAHT can help affirm gender identity.

Current standards of care for gender-affirming hormone therapy (GAHT) for transgender adults

For a clinician, a practical target for hormone therapy for testosterone is to increase and maintain the testosterone blood levels to the normal range for a biological male (300–1000 ng/dl) by administering testosterone in similar doses as is used for treatment of hypogonadism (injections, tablets, or skin patches). Similarly, a practical target for hormone therapy for estrogen is to decrease and maintain testosterone levels to 30–100 ng/dl) without supraphysiological levels of estradiol (<200 pg/ml). This is achieved by administering estrogens similar to that in post-surgical menopause (under 50) and in menopause (over 50) and providing anti ‑ androgens (e.g. spironolactone, cyproterone acetate).

In general, hormones are initiated at a low dose and gradually increased to achieve the desired physical effects and/or testosterone levels. Once the maximal physical impact is reached (usually two to three years), a maintenance dose is used. Dosage is also adjusted according to age and associated health conditions (for example, hypertension and diabetes). After surgical removal of gonads, hormone replacement with estrogen or testosterone is life-long and needs to be adapted to the individual.

Self‑administration of hormones among transgender people is quite common. Often it is due to the lack of trans‑competent qualified health professionals or unwillingness among health professionals to prescribe hormones to transgender people. Fear of litigation is a concern in some settings. Therefore, clinicians must take a history of previous and current self‑administration of hormones before prescribing hormone therapy. Information on the type and dosage of self‑administered hormone tablets or injections is primarily gained through peer networks or the internet, both of which can be fallible. Even if the information they receive is correct, transgender people may take higher and/or more frequent doses to speed up their feminization or masculinization process. Unsupervised hormone use can adversely affect the functioning of the liver or heart and increase the risk of thromboembolism. The chances of adverse effects are higher if there is associated problematic alcohol use.

Transgender people must receive accurate and comprehensive information about the benefits and risks of hormone therapy, including information on reversible and permanent physical effects. Informed consent is fundamental for the provision of GAHT. It is good practice to provide a written consent form that sets out the risks and benefits of the treatment before it is initiated. As long‑term GAHT affects fertility (the ability to produce viable sperm or ova), WPATH recommends that decisions about fertility always be discussed with the client. For example, they can be informed about sperm banking, oocyte (egg), or embryo freezing.

Expected time course of physical changes in response to hormone therapy (estrogens or testosterone)

What is puberty suppression?

Puberty suppression prevents the development of secondary sexual characteristics of the gender assigned to them at birth. Before beginning puberty suppression, a mental health professional should diagnose and confirm that the person has gender dysphoria; the initiation of puberty suppression, usually using gonadotropin analogues (GnRH agonist analogues), needs to be managed by an endocrinologist. GnRH agonist analogues have been shown to be safe, and puberty can resume as usual once they are stopped. If the decision is made to start hormone therapy, this would be possible once the GnRH treatment has been discontinued.

The WPATH Standards of Care guidelines (version 7) specify the following minimum criteria for puberty suppression treatment:

1) the adolescent has demonstrated a long‑lasting and intense pattern of gender non‑conformity or dysphoria;

2) gender dysphoria emerged or worsened with the onset of puberty;

3) any coexisting psychological, medical or social problems that could interfere with treatment have been addressed; and

4) the adolescent or parents/carers have given informed consent (depending on the legal age of medical consent) while supporting the adolescent throughout the treatment.

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Imap statement on hormone therapy for transgender and gender diverse persons.

This statement is intended to update Member Associations on Hormone Therapy for Transgender and Gender Diverse Persons.

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Society of Hospital Medicine

Aiming for Equitable Care for Transgender Patients

  • Vanessa Caceres

gender reassignment and transgender

At the same time, survey results presented at SHM Converge in 2021 found that 51% of 259 respondents did not feel clinically competent in providing care to transgender patients and 78% wanted to learn more about LGBTQIA+ healthcare. 1

The 2022 U.S. Transgender survey from the National Center for Transgender Equality, which included more than 92,000 transgender people, found that among those who had seen a healthcare practitioner in the previous 12 months, 48% had at least one negative experience because they were transgender. This included being refused healthcare, being misgendered, having a clinician use harsh language with them, or having a practitioner be physically rough or abusive when treating them. 2

Among those with health insurance in the survey, 26% had at least one issue with their insurance company in the previous year, such as being denied coverage for hormone therapy, surgery, or another type of healthcare issue linked to their gender identity or transition.2

Challenges for equitable care

Oklahoma, South Carolina, Missouri, and Tennessee are the four states with the largest number of anti-trans bills under consideration this year, according to the website Trans Legislation Tracker. In Oklahoma alone, 60 anti-trans bills had been introduced as of mid-April. 3

The number of anti-trans bills across the U.S. has increased rapidly since 2021; in that year, 143 bills were introduced and 18 passed. By 2023, 600 bills were introduced around the U.S., and 87 passed. Pertinent legislation around the U.S. relates to topics such as diversity, equity, and inclusion (DEI); trans individuals participating in sports; teaching about LGBTQIA+ youth; and other topics. 

Dr. Bishop

Laura Bishop, MD (she/her), an associate professor in internal medicine and pediatrics and the med-peds associate program director at the University of Louisville in Kentucky, has observed that out of fear, some patients have been less inclined to disclose their gender identities to treatment teams or their families. Among young patients, changes to gender-affirming care in Kentucky have led to an abrupt discontinuation of hormones. This also has led to an increase in mental health crises among patients who are already impacted by financial insecurities and are not typically able to travel to other states for care.

This fear trickles down to other members of the LGBTQIA+ community.

The anti-trans legislative climate in many states creates a catch-22, says Anthony Dao, MD (he/him), an assistant professor of medicine at Washington University School of Medicine in St. Louis, Mo., and director of OUTmed, a group for LGBTQIA+ trainees, faculty, and staff at WashUMed. Anti-trans or anti-LGBTQIA+ legislation may lead people in these population groups to move elsewhere. At the same time, this lessens overall diversity, perhaps continuing to limit views from others.

Dr. Dao

“I don’t know a single queer person who hasn’t thought about leaving Missouri,” said Dr. Dao, who is gay. “Part of my decision to stay was knowing that I’ve committed to creating a difference for my community. Things won’t be better in Missouri if I leave. Each person in our community matters.” Restrictions to the practice of evidence-based medicine have repercussions that go further than intended, says Dr. Bishop, a point that she has shared in recent talks with legislators. “When pediatric endocrinologists are less inclined to train in a state that restricts their full practice, it affects many more patients than those who are transgender,” she said.

Dr. Khanijow

Dr. Khanijow

Although many hospitalists may want to learn more about transgender care, there’s also a lack of sufficient education. This can turn into “transgender broken arm syndrome,” said Keshav Khanijow, MD (he/him), who’s an assistant professor at the Johns Hopkins University School of Medicine in Baltimore, and chair of the SHM Diversity, Equity, Inclusion, and Justice Special Interest Group. “One pitfall for clinicians is becoming overwhelmed and hyper-concentrated on a patient’s transgender identity because of their presenting concern and misattributing causes of their hospitalization to gender-affirming hormones as opposed to other reasons,” he said.

Another pitfall Dr. Khanijow has seen is the use of the wrong terms when referring to trans patients, such as “transsexual,” “gender reassignment” surgery or hormones, and “a transgender,” which can be offensive.

“Unfortunately, ICD-10 codes may not have caught up to this and still use some of this offensive terminology in coding,” said Dr. Khanijow, who is also a member of the SHM Diversity, Equity, and Inclusion Committee.

Appropriate terminology would be what the patient states their gender identity is, though commonly “the patient is a trans woman” (or man) is okay, Dr. Dao says. Another example is “The patient identifies as a non-binary individual and uses they/them pronouns.”

Dr. Wright

Similarly, electronic health records (EHRs) may not have caught up with appropriate terminology and may not have a clear, consistent way to collect pronouns. This means that trans patients may be asked repeatedly for their pronouns, Dr. Dao says.

Deficiencies in education about transgender health basics are common among even well-meaning practitioners, particularly those who graduated before 2015, says Masina Wright, MD (they/themme), a locum hospitalist in New Mexico. “Let’s take perioperative medicine, for example,” they said. “For those practicing hospital medicine, have you ever taken a CME course on perioperative management of a transgender woman on gender-affirming hormones? What does the evidence say? Is this discussed in Grand Rounds at your hospital?”

Improving transgender care at the administrative level

Although equitable care for transgender patients faces obstacles, there are still initiatives that hospitalists can take to improve care. Here are some strategies to implement at the administrative level.

Aim for a diverse clinical team . “Administrators are high-level people who care about various perspectives and care for different patients. They should be thoughtful in curating their team to have various opinions and diversity,” Dr. Dao said. Having various perspectives increases the chance that someone on the team will be thinking about building trust with different groups of people, including transgender patients.

Advocate for more education about transgender care and LGBTQIA+ care in general. This education can take place at the hospital level (including asking about pronouns) as well as at conferences. SHM has modules on its learning portal that are updated with appropriate documentation and recommended language, and it released a module on transgender healthcare in 2021, Dr. Khanijow says. On a more global level, the World Professional Association for Transgender Health will take place this September in Portugal, Dr. Wright says. There’s also a U.S. Professional Association for Transgender Health every other year, with the last one held in 2023. However, Dr. Wright would like to see trans health integrated into a variety of conferences so it becomes normalized. “Once the appropriate language and basic foundational understanding of gender diversity become just a regular part of the human experience, trans folks can be seen like every other human in the medical system—depoliticized,” they said.

Use EHRs that allow staff to easily list pronouns and remind staff to list those pronouns. “An EHR that easily identifies pronouns/names and actually prints them to a daily list can prevent damaging misgendering or dead-naming,” Dr. Bishop said. Dead-naming is the use of a name given to someone at birth that they no longer use due to a gender transition.

Participate in DEI committees. This can assist with better care for transgender as well as all other patients. “Hospitalists should collaborate with members of their DEI committees,” Dr. Dao said. “Many DEI committees feel like the ‘minorities’ are there to teach the majority. The truth is that all hospitalists are responsible for the advancement of all people.” 

Be a leader and set the tone. “In hospital medicine, a lot of the care is driven by the hospitalist,” Dr. Dao said. “You really set the tone for your team when you’re there. When you have a trans patient, as the leader of the time, you’re setting that positive tone for the patient and making sure [fellow staff] know that the patient is trans and has preferred pronouns.” He also reminds staff of the importance of not misgendering the patient or unnecessarily exposing them. If they have questions about the patient, they can ask a team member or review the chart rather than asking the patient. “Creating a safe environment for your staff to ask you questions has allowed me to have meaningful conversations with my nurses and staff, especially because most intent is that of curiosity rather than of harm,” he said. “Sometimes, it may involve focusing on what everyone can do to best help the patient move forward with their chief health concern.”

Improving transgender care at the patient level

There are also specific approaches and strategies that hospitalists can take directly with transgender patients to improve their care:

gender reassignment and transgender

Focus on their chief health concern . Avoid “transgender broken arm syndrome,” Dr. Khanijow cautions.

Aim for equitable care, not just equal care , Dr. Khanijow advises. Because of the prejudice faced by transgender patients, this may mean taking extra steps to keep these patients safe and comfortable, such as receiving a private room or a room with someone of the same gender identity and setting up reasonable post-discharge follow-up with clinics known for culturally competent care. This also can mean supporting the patient’s identity while they are at the hospital with the use of makeup, prostheses, clothing, or jewelry of their choice. Although hospitalists are bound by local laws, they still can empathize with the patient about how unfair a legal situation might be and try to come up with creative solutions to help patients achieve their goals despite a hostile legal environment, Dr. Khanijow says.

Acknowledge their partners . It’s typical for providers to ask patients if they have a partner to be inclusive, but also be aware that patients may sometimes refer to their partners as their “friends,” Dr. Dao said. “While it’s unnecessary to bully your patient into telling you who is actually with them, it’s important to take a moment and thank them for being there for the patient,” he said. This also includes asking partners what their pronouns are or asking the patient if they can share their partner’s pronouns.

Encourage the use of gender-affirming hormones, PrEP, or other related medications unless there’s a clear contraindication, Dr. Dao says. This is yet another area that’s ripe for more education geared toward hospitalists and other providers. In the 2022 U.S. Transgender Survey, 98% of respondents receiving hormone treatment reported that hormones for their gender identity or transition made them a lot more satisfied (84%) or a little more satisfied (14%) with their life. 

Vanessa Caceres is a medical writer in Bradenton, Fla. 

  • Khanijow K, Rosendale N, et al. Quantifying Hospitalist Education and Awareness of LGBTQ Topics in Health: The Q-Health Project: Abstract 40 published at SHM Converge 2021. Society of Hospital Medicine website. https://shmabstracts.org/abstract/quantifying-hospitalist-education-and-awareness-of-lgbtq-topics-in-health-the-q-health-project/ . Accessed April 23, 2024.
  • James SE, Herman JL, et al. Early Insights: A Report of the 2022 Transgender Survey. Washington, DC: National Center for Transgender Equality; 2024. Available at: https://transequality.org/sites/default/files/2024-02/2022%20USTS%20Early%20Insights%20Report_FINAL.pdf . Accessed April 23, 2024.
  • Oklahoma. Trans Legislation Tracker website. https://translegislation.com/bills/2024/OK . Accessed April 23, 2024.

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Republicans Are ‘Running Out of States’ to Pass New Transgender Restrictions

In an election year, efforts to pass limits on transgender rights have slowed in Republican-led legislatures.

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A group of people stand, looking up toward a television screen.

By Amy Harmon

State legislatures are ending their sessions this spring with only a handful of new restrictions for transgender people on the books, a departure from the previous two years when passing such legislation became a major focus in Republican-dominated state capitols.

In interviews, conservative strategists and transgender rights advocates offered several reasons for the sudden slowdown. In part, they said, Republican state lawmakers had such a high success rate for bills limiting transgender rights in the earlier years that they had covered a lot of ground already. “We’re running out of states to pass things in,” said Terry Schilling, president of the American Principles Project, a national conservative advocacy group.

The smaller number may reflect an election-year recognition among Republican lawmakers that voters may rank gender identity issues below the economy, inflation and jobs. Republican leaders in the Georgia House of Representatives told reporters this spring that they had chosen to focus on “kitchen table” issues, such as an income-tax cut and funding for prekindergarten programs.

Of 28 states where Republicans control the legislature , 24 now prohibit or restrict medical professionals from providing hormone therapies for gender transition to minors ; 24 bar transgender students from participating in sports that align with their gender identity; and 12 bar students from using school bathrooms that do not match their sex assigned at birth , according to the Movement Advancement Project, an L.G.B.T.Q. advocacy group that tracks state-level legislation. Most of those laws were passed before this year’s legislative sessions.

In some Republican-led states where such measures had not already passed, lawmakers pushed for them in this year’s sessions. Bans on transition treatments for minors were enacted this year in Wyoming and South Carolina , and Ohio lawmakers overrode Gov. Mike DeWine’s veto of a ban they had passed late last year.

In Idaho, lawmakers made it illegal for school districts to require that teachers use pronouns consistent with a student’s gender identity. A new Tennessee law requires schools to alert parents if their child requests to go by a name or pronoun different from those entered on school forms. And the governors of Louisiana and Idaho signed legislation specifying that the term “sex” in state code refers to “an individual’s biological sex, either male or female ” and that “gender identity” should not be considered a synonym for it.

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Column: Lynn Conway, leading computer scientist and transgender pioneer, dies at 86

Lynn Conway

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Lynn Conway was the bravest person I ever knew.

It wasn’t merely her struggle to make her way in the male-dominated computer engineering world of the 1960s and 1970s. It was that she did so, with spectacular success, while contending with her own psyche, her family and her bosses at IBM to complete her transgender transition.

Conway died Sunday, according to her husband, Charles Rogers, at home in Jackson, Mich., of a heart condition.

As I recounted in 2020 , I first met Conway when I was working on my 1999 book about Xerox PARC, “Dealers of Lightning,” for which she was a uniquely valuable source. In 2000, when she decided to come out as transgender, she allowed me to chronicle her life in a cover story for the Los Angeles Times Magazine titled “Through the Gender Labyrinth.”

Thanks to your courage, your example, and all the people who followed in your footsteps, as a society we are now in a better place.

— IBM apologizes for firing Lynn Conway for her gender transition in 1968

That article traced her journey from childhood as a male in New York’s strait-laced Westchester County to her decision to transition. Years of emotional and psychological turmoil followed, even as he excelled in academic studies.

He won admission to MIT, but flunked out due to a lack of social or medical support. What would have been Conway’s MIT graduation day found Conway in San Francisco, living on the fringes of the gay community, searching for how to fit in as a male. But he did not see himself as a gay man attracted to other men, but as a woman attracted to other men.

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In 1961 he enrolled at Columbia University, acquiring bachelor’s and master’s degrees in electrical engineering in only two years. That led to a position on a team at IBM secretly designing the world’s fastest supercomputer, a pet project of IBM President Thomas Watson Jr. Conway moved with the team to Menlo Park, Calif., in the years before the surrounding landscape was dubbed Silicon Valley.

By then Conway had gotten married and was raising two daughters. But family life intensified his inner turmoil, and in 1968 he decided to undertake gender reassignment surgery.

Conway at PARC in the 1970s, in front of her Alto, the lab's innovative personal computer.

As I wrote in 2000, Conway had visualized a nearly seamless transition. IBM was supportive, at least at first. It was willing to change the name on company records and execute a transfer to another lab, giving the employee henceforth known as Lynn Conway a fresh start.

But even as the $4,000 operation was still in the planning stage, it became clear that IBM executives could not understand how a transgender employee could fit into a corporate culture that was “still white shirt, blue serge suits and wingtip shoes,” as Conway’s IBM supervisor told me. “This simply wasn’t the IBM image.” The company fired him.

Decades later, Conway was philosophical and nonjudgmental about IBM’s decision. Gender transition and sex reassignment surgery were alien concepts at the time.

“Christine Jorgensen was the last time anything had come out about stuff like this,” Conway told me in 2020. Jorgensen’s transition, which had made front-page news in 1951, had been reduced to a historical curiosity nearly two decades later. T.J. Watson Jr., the president of IBM, “was thinking there would be endless publicity, and I can understand that.”

Lynn Conway

Column: IBM apologizes for firing a transgender pioneer, 52 years late

Lynn Conway’s brilliant contributions to computer science didn’t stop IBM from firing her during her gender transition. Now it has apologized.

Nov. 23, 2020

The family went on welfare for three months. Conway’s wife barred her from contact with her daughters. She would not see them again for 14 years.

Beyond the financial implications, the stigma of banishment from one of the world’s most respected corporations felt like an excommunication.

She sought jobs in the burgeoning electrical engineering community around Stanford, working her way up through start-ups, and in 1973 she was invited to join Xerox’s brand new Palo Alto Research Center, or PARC.

In partnership with Caltech engineering professor Carver Mead, Conway established the design rules for the new technology of “very large-scale integrated circuits” (or, in computer shorthand, VLSI). The pair laid down the rules in a 1979 textbook that a generation of computer and engineering students knew as “Mead-Conway.”

VLSI fostered a revolution in computer microprocessor design that included the Pentium chip, which would power millions of PCs. Conway spread the VLSI gospel by creating a system in which students taking courses at MIT and other technical institutions could get their sample designs rendered in silicon.

Conway’s life journey gave her a unique perspective on the internal dynamics of Xerox’s unique lab, which would invent the personal computer, the laser printer, Ethernet, and other innovations that have become fully integrated into our daily lives. She could see it from the vantage point of an insider, thanks to her experience working on IBM’s supercomputer, and an outsider, thanks to her personal history.

After PARC, she was recruited to head a supercomputer program at the Defense Department’s Advanced Research Projects Agency, or DARPA — sailing through her FBI background check so easily that she became convinced that the Pentagon must have already encountered transgender people in its workforce. A figure of undisputed authority in some of the most abstruse corners of computing, Conway was elected to the National Academy of Engineering in 1989.

She joined the University of Michigan as a professor and associate dean in the College of Engineering. In 2002 she married a fellow engineer, Charles Rogers, and with him lived active life — with a shared passion for white-water canoeing, motocross racing and other adventures — on a 24-acre homestead not far from Ann Arbor, Mich.

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In 2020, she received an unexpected gift: A formal apology from IBM for firing her 52 years earlier. At an emotional ceremony witnessed by 1,200 IBM employees signed on to a company website, Diane Gherson, an IBM senior vice president, told her, “Thanks to your courage, your example, and all the people who followed in your footsteps, as a society we are now in a better place.... But that doesn’t help you, Lynn, probably our very first employee to come out. And for that, we deeply regret what you went through — and know I speak for all of us.”

At Michigan, she is remembered for her “positive outlook, warm encouragement, creativity and ‘singular vision,’” the university observed in a retrospective posted Tuesday . “Conway described herself in 2014 as a perennial beginner, never afraid to take on learning how to do new things.”

Her role as a leader in the transgender community may be even more important than her role in the extraordinary advances of the technology revolution of the late 20th century. She fought not a few battles over anti-transgender discrimination and what she called “the systemic psychological pathologization of gender variance.”

On her personal website she reflected with well-deserved pride of having used the website to offer “gender transitioners ... information, encouragement and hope for a better future.” When she began to do so in 2000, she recalled, “trans women especially were considered sexually-deviant and mentally-ill by prejudiced psychiatrists and psychologists. By compiling stories of those who went on to fulfilling lives after transition,” she wrote, she tried to provide “role models and hope for the many people then in transition.”

She added , “Fortunately, those dark days have receded. Nowadays many tens of thousands of transitioners have not only moved on into happy and fulfilling lives, but are also open and proud about their life accomplishments.”

It’s a reproach to our society and our politics that Lynn’s confidence that the “dark days” of transgender discrimination and prejudice were past has proven to be premature. I hope that she didn’t allow herself to be too discouraged by the cynicism and hypocrisy of the political leadership in some of our most benighted states, and that she never forgot the extraordinarily positive impact she had on all the communities, professional and personal, of which she was a member.

Lynn Conway faced more challenges in her life than most of us can contemplate. She should be remembered as someone who, to paraphrase William Faulkner, not only faced them, but prevailed over them. And in doing so she enriched us all.

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WASHINGTON, D.C., FEBRUARY 22: A candle light vigil if held at As You Are Bar, a safe place for the LGBTQ+ community, in Washington, D.C., February 22, 2024, for Nex Benedict. Nex was a 16-year-old student from Oklahoma who died February 7 after a fight with other students in the bathroom at Owasso High School, which is located in a suburb northeast of Tulsa. Nex used the pronouns they and them and didn't identify themselves as male or female. They were often bullied by other students. (Astrid Riecken For The Washington Post via Getty Images)

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Pulitzer Prize-winning journalist Michael Hiltzik has written for the Los Angeles Times for more than 40 years. His business column appears in print every Sunday and Wednesday, and occasionally on other days. Hiltzik and colleague Chuck Philips shared the 1999 Pulitzer Prize for articles exposing corruption in the entertainment industry. His seventh book, “Iron Empires: Robber Barons, Railroads, and the Making of Modern America,” was published in 2020. His forthcoming book, “The Golden State,” is a history of California. Follow him on Twitter at twitter.com/hiltzikm and on Facebook at facebook.com/hiltzik.

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A Florida law blocking treatment for transgender children is thrown out by a federal judge

FILE - Florida Gov. Ron DeSantis gives his State of the State address during a joint session of the Senate and House of Representatives in Tallahassee, Fla., Jan. 9, 2024. A federal judge on Tuesday, June 11, 2024, struck down a 2023 Florida law that blocked gender-affirming care for transgender minors and severely restricted such treatment for adults. (AP Photo/Gary McCullough, File)

FILE - Florida Gov. Ron DeSantis gives his State of the State address during a joint session of the Senate and House of Representatives in Tallahassee, Fla., Jan. 9, 2024. A federal judge on Tuesday, June 11, 2024, struck down a 2023 Florida law that blocked gender-affirming care for transgender minors and severely restricted such treatment for adults. (AP Photo/Gary McCullough, File)

Terry Spencer, Tuesday, Sept. 6, 2022, in Miami. (AP Photo/Lynne Sladky)

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FORT LAUDERDALE, Fla. (AP) — A federal judge on Tuesday struck down a 2023 Florida law that blocked gender-affirming care for transgender minors and severely restricted such treatment for adults, calling the statute unconstitutional.

Senior Judge Robert Hinkle said the state went too far when it barred transgender minors from being prescribed puberty blockers and hormonal treatments with their parents’ permission. He also stopped the state from requiring that transgender adults only receive treatment from a doctor and not from a registered nurse or other qualified medical practitioner. And he barred a ban on online treatment for transgender adults.

Hinkle said transgender people are constitutionally entitled to the legitimate treatment they need and, quoting the late Rev. Martin Luther King Jr., compared those who oppose it to those who were once against equality for minorities and women.

“Some transgender opponents invoke religion to support their position, just as some once invoked religion to support their racism or misogyny,” Hinkle wrote in his 105-page decision. “Transgender opponents are of course free to hold their beliefs. But they are not free to discriminate against transgender individuals just for being transgender.

FILE - Lawmakers listen as parents speak about the prospect of their children competing against transgender girls in school sports at the Utah State Capitol on March 25, 2022, in Salt Lake City. A federal judge on Monday, June 17, 2024 temporarily blocked the Biden administration’s new Title IX rule expanding protections for LGBTQ+ students in six additional states, dealing another setback for a new policy that has been under legal attack by Republican attorneys general. (AP Photo/Samuel Metz, File)

“In time, discrimination against transgender individuals will diminish, just as racism and misogyny have diminished,” he continued. “To paraphrase a civil-rights advocate from an earlier time, the arc of the moral universe is long, but it bends toward justice.”

Republican Gov. Ron DeSantis’ office blasted Hinkle’s ruling, issuing a statement calling it “erroneous,” and vowing to appeal.

“Through their elected representatives, the people of Florida acted to protect children in this state, and the Court was wrong to override their wishes,” the statement said. “As we’ve seen here in Florida, the United Kingdom, and across Europe, there is no quality evidence to support the chemical and physical mutilation of children. These procedures do permanent, life-altering damage to children, and history will look back on this fad in horror.”

But those who sued the state celebrated the decision.

Lucien Hamel, a transgender adult, issued a statement saying, “I’m so relieved the court saw there is no medical basis for this law — it was passed just to target transgender people like me and try to push us out of Florida.”

“This is my home. I’ve lived here my entire life,” he said. “This is my son’s home. I can’t just uproot my family and move across the country. The state has no place interfering in people’s private medical decisions, and I’m relieved that I can once again get the healthcare that I need here in Florida.”

A mother of one of the children who sued said, “This ruling means I won’t have to watch my daughter needlessly suffer because I can’t get her the care she needs.”

“Seeing Susan’s fear about this ban has been one of the hardest experiences we’ve endured as parents,” said the woman. She was identified in court documents only as Jane Doe and her daughter as Susan Doe to protect their privacy. “All we’ve wanted is to take that fear away and help her continue to be the happy, confident child she is now.”

DeSantis had signed the law last year as he was gearing up for a presidential campaign that was highly based on culture wars.

“We never did this through all of human history until like, what, two weeks ago? Now this is something?” he told cheering supporters as he signed the bill. “They’re having third graders declare pronouns? We’re not doing the pronoun Olympics in Florida.”

At trial, Florida’s attorneys had conceded that the state cannot stop someone from pursuing a transgender identity, but said it can regulate medical care.

For minors, the only treatments at issue are puberty blocking treatments and cross-sex hormones — giving testosterone to someone assigned female at birth, for example. Those who were undergoing treatment when the law was adopted in May 2023 were allowed to continue. Surgery, which is rare for minors, was still blocked.

For adults, treatment was still allowed but could only be done by a physician instead of an advanced practice registered nurse or other professional. It required the patient to sign a consent form in person while in the same room with the doctor, meaning the treatment couldn’t be done on a video call or otherwise online — something not normally required with other medical procedures. Violators could be charged criminally and medical providers could lose their licenses.

Hinkle wrote that Florida had long allowed treatment for gender dysphoria, the feeling that one’s gender identity does not match one’s sex as registered at birth.

“But then the political winds changed,” Hinkle wrote. He was appointed to the bench by Democratic President Bill Clinton in 1996.

For 99% of people, Hinkle wrote, their biological sex and their gender identity are the same. But for a few, they differ. Hinkle said the state admitted that during the trial, even if some won’t believe it and think transgender people are making a choice like “whether to read Shakespeare or Grisham.”

“Many people with this view tend to disapprove of all things transgender and so oppose medical care that supports (it),” he said.

He said even though the state concedes it cannot constitutionally block people from identifying as transgender and presenting themselves as they wish, several legislators made it clear in their comments that this was their goal.

At least 25 states have adopted laws restricting or banning gender-affirming medical care for transgender minors, and most of those states face lawsuits.

The only other one to be struck down so far as unconstitutional is the ban in Arkansas, which the state has appealed to the 8th U.S. Circuit Court of Appeals.

Advocates are asking the U.S. Supreme Court to block Tennessee’s ban on gender-affirming care for minors.

Judges’ orders are in place temporarily blocking enforcement of a ban in Montana and aspects of the ban in Georgia.

TERRY SPENCER

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    When he was 14, Reimer began the process of reassignment to being a male. As an adult, he married a woman but depression and drug abuse ensued, culminating in suicide at the age of 38 (1). Money's ...

  15. Medicare and gender reassignment: Coverage, options, and costs

    In 2024, the monthly premium for Part A is $505. If a person goes to the hospital, they have a $1,632 deductible for every benefit period. There is no coinsurance if a person is discharged within ...

  16. Mental Health Outcomes in Transgender and Nonbinary Youths Receiving

    Young adult psychological outcome after puberty suppression and gender reassignment. Pediatrics, 134(4), 696-704. 14. de Vries et al. (2011). Puberty suppression in adolescents with gender identity disorder: A prospective follow‐up study. ... Building a pediatric patient registry to study health outcomes among transgender and gender expansive ...

  17. Regret after Gender-affirmation Surgery: A Systematic Review and Meta

    There is an unknown percentage of transgender and gender non-confirming individuals who undergo gender-affirmation surgeries (GAS) that experiences regret. ... Adolescents with gender identity disorder who were accepted or rejected for sex reassignment surgery: a prospective follow-up study. J Am Acad Child Adolesc Psychiatry. 2001; 40:472 ...

  18. Outlawing Trans Youth: State Legislatures and the Battle over Gender

    ^ AACAP Statement Responding to Efforts to Ban Evidence-Based Care for Transgender and Gender Diverse Youth, ... Collier, 920 F.3d 212, 223 (5th Cir. 2019) ("There is no medical consensus that sex reassignment surgery is a necessary or even effective treatment for gender dysphoria."). Return to citation ^

  19. Transgender health care coverage

    Plans with transgender exclusions. Many health plans are still using exclusions such as "services related to sex change" or "sex reassignment surgery" to deny coverage to transgender people for certain health care services. Coverage varies by state. Before you enroll in a plan, you should always look at the complete terms of coverage ...

  20. Gender reassignment discrimination

    What the Equality Act says about gender reassignment discrimination. The Equality Act 2010 says that you must not be discriminated against because of gender reassignment. In the Equality Act, gender reassignment means proposing to undergo, undergoing or having undergone a process to reassign your sex. To be protected from gender reassignment ...

  21. Trends in suicide death risk in transgender people: results from the

    Introduction. Gender dysphoria (GD) refers to the distress related to a marked incongruence between one's assigned gender at birth and the experienced gender (1).Trans people are diverse in the intensity of experienced GD (2), their needs for medical transition (3), and the impairment that GD can have on their life.Studies focusing on the wellbeing of trans people show a greater ...

  22. Youth Access to Gender Affirming Care: The Federal and State Policy

    Somebody who is transgender has a gender identity different from that traditionally associated with sex assigned at birth. Gender Dysphoria: Gender dysphoria refers to "a concept [and clinical ...

  23. Gender Dysphoria and Gender Reassignment Surgery

    Smith YL, Van Goozen SH, Kuiper AJ, Cohen-Kettenis PT. Sex reassignment: outcomes and predictors of treatment for adolescent and adult transsexuals. Psychol Med. 2005 Jan;35(1):89-99. ... American Psychological Association. (2015): Guidelines for Psychological Practice with Transgender and Gender Nonconforming People Adopted by the Council of ...

  24. Who can provide hormone therapy for transgender adults?

    Gender-affirming care for transgender people . Transgender people are diverse in their need for gender transition‑related services; not all transgender people want to affirm their bodies through gender-affirming medical procedures.Procedures include gender-affirming hormone therapy (GAHT); gender-affirming surgery (GAS) - procedures of the face, breast, chest, body, or genitals; and facial ...

  25. Aiming for Equitable Care for Transgender Patients

    Although many hospitalists may want to learn more about transgender care, there's also a lack of sufficient education. This can turn into "transgender broken arm syndrome," said Keshav Khanijow, MD (he/him), who's an assistant professor at the Johns Hopkins University School of Medicine in Baltimore, and chair of the SHM Diversity, Equity, Inclusion, and Justice Special Interest Group.

  26. Leader of gender-affirming care at Equitas has personal stake in work

    Vaughn, 31, credits her work at Equitas as "life changing," and said she feels privileged to help some of the group's 6,000 or so transgender patients.

  27. Judge Strikes Down Florida's Ban on Transgender Care for Minors

    A federal judge ruled that Florida could not "prohibit transgender minors from receiving specific kinds of widely accepted gender-affirming medical care." By Patricia Mazzei Reporting from ...

  28. Republicans Are 'Running Out of States' to Pass New Transgender

    Of 28 states where Republicans control the legislature, 24 now prohibit or restrict medical professionals from providing hormone therapies for gender transition to minors; 24 bar transgender ...

  29. Hiltzik: Lynn Conway made life better for millions of people

    Gender transition and sex reassignment surgery were alien concepts at the time. "Christine Jorgensen was the last time anything had come out about stuff like this," Conway told me in 2020.

  30. Florida law blocking treatment for transgender children thrown out

    FORT LAUDERDALE, Fla. (AP) — A federal judge on Tuesday struck down a 2023 Florida law that blocked gender-affirming care for transgender minors and severely restricted such treatment for adults, calling the statute unconstitutional.. Senior Judge Robert Hinkle said the state went too far when it barred transgender minors from being prescribed puberty blockers and hormonal treatments with ...