Summary of Evidence

Transgender healthcare is a rapidly evolving interdisciplinary field. In the last decade, there has been an unprecedented increase in the number and visibility of transgender and gender diverse (TGD) people seeking support and gender-affirming medical treatment in parallel with a significant rise in the scientific literature in this area. The World Professional Association for Transgender Health (WPATH) is an international, multidisciplinary, professional association whose mission is to promote evidence-based care, education, research, public policy, and respect in transgender health. One of the main functions of WPATH is to promote the highest standards of health care for TGD people through the Standards of Care (SOC). The SOC was initially developed in 1979 and the previous version (SOC-7) was published in 2012. In view of the increasing scientific evidence, WPATH commissioned a new version of the Standards of Care, the SOC-8, published in 2022. Revised standards of care in the field of gender care are aimed at improving safe and effective pathways to enhance access of care throughout the lifespan.

Rationale

In 2021, Valentine and Shipherd reported a systematic review of 77 studies published which reported mental health outcomes to (a) characterize what is known about mental health outcomes and (b) describe what gaps persist in this literature. In general, depressive symptoms, suicidality, interpersonal trauma exposure, substance use disorders, anxiety, and general distress have been consistently elevated among Transgender and gender non-conforming (TGNC) adults. This study emphasizes that “depressive symptoms, suicidality, interpersonal trauma exposure, substance use disorders, anxiety, and general distress have been consistently elevated among transgender and gender non-conforming (TGNC) population…Findings suggest that TGNC people are exposed to a variety of social stressors, including stigma, discrimination, and bias events that contribute to mental health problems.” Additional study is necessary to emphasize changes in mental health problems across studies using similar measurements across models to evaluate the growing evidence as a whole.

Ainsworth and Spiegel (2010) published a study that assessed quality of life outcomes of transgender patients who underwent facial gender confirming surgery in combination with genital or breast surgery. Included in the study were 247 transgender females. Mental health quality of life was assessed in transgendered women without surgical intervention compared to the general female population, and transgendered women who had gender reassignment surgery (GRS), facial feminization surgery (FFS), or both. Mental health-related quality of life was statistically diminished (P < 0.05) in transgendered women without surgical intervention compared to the general female population and transwomen who had gender reassignment surgery (GRS), facial feminization surgery (FFS), or both. Investigators concluded that transgender women have diminished mental health-related quality-of-life compared with the general female population. However, surgical treatments (e.g., FFS, GRS, or both) are associated with improved mental health-related quality of life. 

Wernick, et al (2019), in acknowledging that a paucity of research exists related to the effect of surgical intervention on individuals with gender dysphoria, despite the disproportionate mental health risks, undertook a review of the evidence surrounding quality of life and gender-confirmation surgery. Investigators’ aim was to examine existing literature for an understanding of the impact of gender affirming surgery, and to understand to what extent the surgical intervention could improve psychological well-being. 17 studies were identified. Investigators found that “most studies included in this review found that many GAS [gender affirming surgeries] have a significant, positive impact on several constructs associated with psychological well-being. Findings from this review suggest that individuals with gender dysphoria who undergo facial feminization or masculinization, vocal feminization, breast augmentation, mastectomy, chest reconstruction, metoidioplasty, orchiectomy, salpingooophorectomy, vaginoplasty, or phalloplasty may experience significant improvements in quality of life, body image/satisfaction, and overall psychiatric functioning.” Future research should be focused on understanding how specific GAS affect mental health status over time. 

Morrison et al (2020) published a prospective, international, multicenter, cohort study with adult gender-diverse patients with gender dysphoria (n=66). Authors noted that facial feminization surgery plays a critical role in gender affirmation; as the face is one of the most visible external indicators of gender, typically masculine features make it difficult for transfeminine individuals to be perceived as their correct gender. This study set out to determine the effects of facial feminization surgery on quality-of-life outcomes.

Facial feminization outcome score was calculated preoperatively and postoperatively (1-week to 1-month and >6 months). Patients noted that their brows, jaws, and chins were the most masculine aspects of their faces (54.5 percent, 33.3 percent, and 30.3 percent, respectively). Following surgery, median facial feminization  outcome score increased from 47.2 preoperative to 80.6 at 6 months or more postoperatively (p < 0.0001). Mean satisfaction was excellent (3.0 at both 1-month and ≥6-month follow-up; p = 0.46). Cephalometric values were significantly more feminine following surgery. Investigators concluded that facial feminization achieved improved quality of life, feminized cephalometries, feminine gender appearance, good overall aesthetics, and high satisfaction that were present at 1 month and stable at more than 6 months.

The findings that current smokers have a higher risk of wound infection and wound disruption can be explained by the pathophysiological mechanisms related to the toxic effects and oxidative destruction induced by smoking and nicotine. Smoking impedes the innate defense system of the lung, including damaging mucus transport, aggravating mucus production, and diminishing macrophage function, resulting in increased risk of pulmonary complications. While NRT contains nicotine, it contains lower amounts without other carcinogens, and the impact on the body is more gradual. Plasma nicotine levels provided by NRT vary according to dose and delivery method but in general are lower than those maintained during active smoking. The exclusion of NRT will remove barriers to accessing surgical care and promote overall smoking cessation, while promoting consistency with clinical guidelines.   

In 2022, Chiang et al published results on a retrospective, cohort study of 1,156,002 patients, utilizing files of the American College of Surgeons National Surgical Quality Improvement Program database. Multivariable logistic regression was used to calculate the odds ratios (ORs) with 95% confidence intervals (CIs) for postoperative wound complications, pulmonary complications, and in-hospital mortality associated with smokers. Smoking was associated with a significantly increased risk of postoperative wound disruption (OR 1.65, 95% CI 1.56-1.75), surgical site infection (OR 1.31, 95% CI 1.28-1.34), reintubation (OR 1.47, 95% CI 1.40-1.54), and in-hospital mortality (OR 1.13, 95% CI 1.07-1.19) compared with nonsmoking. The length of hospital stay was significantly increased in smokers compared with non-smokers. They found that current smokers who underwent surgery had approximately 30% increased odds of developing surgical site infection (SSI) and 65% increased odds of developing wound disruption. Study conclusions state smoking status is related to increased perioperative risk for wound complications following major surgical procedures. The current literature review has shown that smoking harms wound healing. The study adds to existing evidence and improves understanding of healing complications in smoking surgical cases. Wound complications are associated with other adverse outcomes and have a significant impact on patient quality of life and health care budgets. Therefore, patients who smoke should be informed about the potentially increased risks of complications before surgery. 

In 2022, Liu et al published a meta-analysis on the effect of preoperative smoking and smoking cessation on wound healing and infection in post-surgery subjects. This analysis incorporated 11 trials involving 218,567 patients following surgery; 176,670 were previous or non-smokers, and 41,897 were smokers. Never smokers or those who had ceased smoking had significantly lower postoperative wound healing problems (odds ratio 0.74; 95% CI 0.63-0.87, p < .001) compared with smokers. Non-smokers had significantly lower postoperative wound healing problems and surgical site wound infection compared with smokers.

Sorensen et al (2012) reported on the results of a meta-analysis that sought to clarify the evidence on smoking and postoperative healing complications across surgical specialties and determine the impact of perioperative smoking cessation intervention. Smokers and non-smokers were compared in 140 cohort studies that included 479K patients. Pooled adjusted odds ratios (95% CI) were 3.60 (2.62 - 4.93) for necrosis, 2.07 (1.53-2.81) for healing delay and dehiscence, 1.79 (1.57-2.04) for surgical site infection, 2.27 (1.82-2.84) for wound complications, 2.07 (1.23-3.47) for hernia, and 2.44 (1.66-3.58) for lack of fistula or bone healing. Investigators concluded that postoperative healing complications occur significantly more often in smokers compared with non-smokers and in former smokers compared with those who never smoked. 

Nolan and Warner (2015) authored a narrative review to discuss the current evidence for nicotine replacement therapy’s (NRT)efficacy and safety in patients scheduled for surgical treatment and other invasive procedures. Noting the lack of human trials, the authors stated that although available data are limited, there is no evidence from human studies that NRT increases the risk of healing-related or cardiovascular complications. Clinical trials of tobacco use interventions that include NRT have found either no effect or a reduction in complications. Authors concluded that given the benefits of smoking abstinence to both perioperative outcomes and long-term health and the efficacy of NRT in achieving and maintaining abstinence, any policies that prohibit the use of NRT in surgical patients should be reexamined.

In 2020, Stefan et al reported on a retrospective study (n=147,506). Researchers analyzed the association between nicotine replacement therapy (within 2 days of admission) and inpatient complications and outcomes. In the propensity-matched analysis, there was no association between receipt of NRT and in-hospital complications (OR, 0.99; 95% CI, 0.93-1.05), mortality (OR, 0.84; 95% CI, 0.68-1.04), all-cause 30-day readmissions (OR, 1.02; 95% CI, 0.97-1.07), or 30-day readmission for wound complications (OR, 0.96; 95% CI, 0.86-1.07). Authors concluded that this demonstrates that perioperative NRT is not associated with adverse outcomes after surgery. These results strengthen the evidence that NRT should be prescribed routinely in the perioperative period.

Practice Guidelines and Position Statements 

American Academy of Pediatrics 

Any discrimination based on gender identity or expression, real or perceived, is damaging to the socioemotional health of children, families, and society.  In particular, the AAP recommends the following, among other recommendations:

1. that youth who identify as TGD have access to comprehensive, gender-affirming, and developmentally appropriate health care that is provided in a safe and inclusive clinical space;
2. that insurance plans offer coverage for health care that is specific to the needs of youth who identify as TGD, including coverage for medical, psychological, and, when indicated, surgical gender-affirming interventions;
3. that the medical field and federal government prioritize research that is dedicated to improving the quality of evidence-based care for youth who identify as TGD

The American Academy of Pediatrics takes a “gender-affirming,” nonjudgmental approach that helps children feel safe in a society that too often marginalizes or stigmatizes those seen as different. The gender affirming model strengthens family resiliency and takes the emphasis off  heightened concerns over gender while allowing children the freedom to focus on academics, relationship-building and other typical developmental tasks. Additional AAP recommendations include: •Providing youth with access to comprehensive gender-affirming and developmentally appropriate health care. • Providing family-based therapy and support be available to meet the needs of parents, caregivers and siblings of youth who identify as transgender. • Making sure that electronic health records, billing systems, patientcentered notification systems and clinical research are designed to respect the asserted gender identity of each patient while maintaining confidentiality. • Supporting insurance plans that offer coverage specific to the needs  of youth who identify as transgender, including coverage for medical, psychological and, when appropriate, surgical interventions. • Advocacy by pediatricians within their communities, for policies and laws that seek to promote acceptance of all children without fear of  harassment, exclusion or bullying because of gender expression. 

American Psychological Association (APA)’s Society for Pediatric Psychology Special Interest Group for Gender Health  

• Transgender and gender-diverse (TGD) youth experience significant mental health disparities, including increased suicidality. Gender affirming healthcare can be a life-saving intervention. 
• Access to timely gender-affirming medical interventions during puberty and adolescence is critical to promoting positive mental health outcomes. 
• Restricting access to gender-affirming care is healthcare discrimination and will perpetuate health disparities.  

Diagnostic and Statistical Manual of Mental Disorders Version V, Text Revision (DSM-V-TR) The recently published text revision of DSM-V, AND provides the criteria for diagnosis of gender dysphoria as well as information on the overarching diagnosis of gender dysphoria:

• Gender dysphoria refers to the distress that may accompany the incongruence between one's experienced or expressed gender and one's assigned gender. Although not all indi¬ viduals will experience distress as a result of such incongruence, many are distressed if the desired physical interventions by means of hormones and/or surgery are not available. The current term is more descriptive than the previous DSM-IV term gender identity disor¬ der and focuses on dysphoria as the clinical problem, not identity per se.

Association of American Medical Colleges-AAMC Statement on Gender-affirming Health Care for Transgender Youth 

The AAMC is committed to ensuring access to high-quality care that treats all people, including transgender individuals, equally and with respect, and providing training to physicians and other health care professionals that is consistent with those values.  In medical decision making, the doctor-patient relationship must be paramount, and the needs of the patient must be given precedence. Efforts to restrict the provision of gender-affirming health care for transgender individuals will reduce health care access for transgender Americans, promote discrimination, and widen already significant health inequities. In addition to harming some of the most vulnerable patients, efforts to restrict care undermine the doctor-patient relationship and the principle that doctors are best equipped to work with patients and their families to arrive at shared decision-making. The AAMC is committed to improving the health of all people everywhere, and we will continue to oppose any effort to restrict the health care community’s ability to provide necessary care to any patient in need. Scientific research supports the effectiveness of gender-affirming medical care (GAMC) for the mental health and quality of life of transgender youth, dispelling misinformation upon which anti-GAMC policy initiatives are based. 

The Standards of Care for the Health of Transgender and Gender Diverse People, Version 8 from the World Professional Association for Transgender Health (WPATH).  Extensive updates and changes in recommendations were made in the newest World Professional Association for Transgender Health (WPATH version. Guidelines encourage the use of a patient centered care model for initiation of gender affirming interventions and update many previous requirements to reduce barriers to access. These include but are not limited to nomenclature changes, healthcare provider requirements, referral specifics, hormone therapy use, and patient autonomy considerations.

In 2020, The Society for Perioperative Assessment and Quality Improvement (SPAQI) convened a multidisciplinary panel of 17 experts in perioperative smoking cessation. Members of the Task Force were from the fields of anesthesiology, internal medicine, surgery, public health, and pharmacy from both academic and nonacademic settings in Canada, United States, Australia, New Zealand, Asia, and Europe. The panel issued the following consensus statement: Interventions should occur as soon as practicable in relation to surgical scheduling. Evidence from observational studies of spontaneous quitting suggests that longer durations of preoperative abstinence are associated with lower rates of respiratory and wound healing complications. Evidence from RCTs supports an effect of preoperative smoking cessation interventions that are 4–8 weeks long.

In 2024, The National Comprehensive Cancer Network (NCCN) published guidelines on smoking cessation. The guideline states the following: Nicotine replacement therapy (NRT) is not a contraindication to surgery. There is no evidence that NRT degrades the wound-healing benefits of abstinence from smoking in humans. NRT offers benefits over continued smoking. NRT typically provides less nicotine than cigarettes, and nearly doubles the chance of smoking abstinence.

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