Restructuring the Informed Consent to Treatment to Reduce Narratives of Regret

Abstract

Informed consent [IC] is a verbal agreement or standardized legalese with medical jargon few understand. Spending little time with the patient to meet numbers and generate profit in fulfilling the basic minimum criteria may result in patients experiencing regret. IC is more about reducing legal liability for the provider and less costly options for the insurance company as opposed to what the patient needs to know about their provider’s training with gender-affirming care and surgery [GACS]. The patient must understand the risks when consenting to GACS that may result in regret months or years later. World Professional Association for Transgender Health [WPATH], standards of care, version 8 [SOC8], recommends GACS providers continue with their training and education but does not conduct medical or surgical oversight. Collaboration and coordinated care among providers and staff are sometimes lacking. Patients reported that their providers abandoned them post surgery. This author recommends restructuring the informed consent to include the physician/surgeon’s training and the volume of cases treated, including critical providers involved with the patient’s mental and medical care, and disclosing surgical complications and mortality risk. The author will address the need for accreditation.

1. Introduction

The average patient’s expectation that surgeons must have training before embarking on gender-affirming surgery [GAS] is misleading. There are no formal guidelines or stipulations as there are with other types of surgeries. In general, surgeons typically do not disclose the volumes of GAS cases [1, 2].

WPATH serves as an International, multidisciplinary professional association whose global members range from various clinical and anthropological backgrounds who establish ethical guidelines, and high standards of care, develop best practices and policies for physicians treating and seeing individuals for gender-affirming care and surgery [GACS] using the Delphi Technique, a scientific evidence-based process. WPATH members range from nurses, physician assistants, medical doctors, surgeons, and therapists to psychiatrists, among many others in the medical and mental health field. WPATH SOC8 reminds professionals serving the transgender and gender-diverse [TGD] population that the gold standard of care is more about delivering expert, safe, compassionate care and offering more resources to access care. WPATH offers mentoring and certification [3].

In 2018, a WPATH open letter from transgender individuals with lived experience called for oversight, intervention, transparency, and the need for accreditation to reduce harm to the community by WPATH surgeons capitalizing on the trans population to gain experience. Some pursuing legal action for poor surgical outcomes and abandonment. They further called for accountability when surgeons need to be held to a higher standard since they are WPATH members [4, 5].

2. Informed consent and the need for transparency

Parents seeking guidance on behalf of their child or young adolescent need more advice and support, when providers assume to treat the child without thoroughly evaluating the history for mental health comorbidities or whether the child has been under a tremendous amount of peer pressure or social isolation. Parents report they often cannot connect with a clinician who does not recommend puberty blockers or hormone replacement therapy [HRT] [6]. American Medical Association [AMA], the organization for the Code of Medical Ethics and the first to nationally develop IC, defines it as necessary for medical and surgical treatments and to ensure that patients receive information and can ask questions about the risks and benefits before making an informed decision. The physician assesses if the patient can comprehend the diagnosis, the recommendations for treatment, benefits, risks, and alternatives. It is an ethical and legal obligation for all providers to cover the IC with the patient, and many states use the required standard based on what a typical patient needs to know and have been given options and alternatives [7, 8].

Authors studying risk in coronary artery bypass procedure [CABP] disclaim that the burden is placed upon patients to seek information about a surgeon’s or physician’s expertise and experience. Still, short of asking directly for this information, some providers aren’t openly transparent. When the patient does not know to ask, they will not know that the provider does not have the training or performed enough surgical volumes. Having this information ahead of time may help the patient decide whether or not they want the surgeon to perform surgery. Without this knowledge, the patient is taking a risk when the surgeon’s experience is not readily transparent. The authors recommend report card grading would raise transparency and be helpful to patients. Outcomes are predictable, hinging on the surgeon’s experience, and since some surgeries are riskier than others adding the risk information would be material to the IC. The IC cannot be considered informed when material risk information is withheld. Previously this type of information would have been kept internally, but with time the public is pressuring providers, institutions, government, and insurance companies to disclose material risks [9].

Angie’s List, healthgrades and consumer reports include physician/surgeon and hospital ratings. Some medical doctors critique this service as insufficient because it cannot be compared to those skilled in a trade, and the reviews are minimal and none of the reviews include experience, training or medical and surgical volumes, according to USA Today [10].

Patients could obtain information about malpractice suits against physicians through the Federation of State Medical Boards [FSMB], but this is a voluntary credentialing service that charges members for a fixed fee. It is not approved as a credentialing service by Joint Commission, National Committee for Quality Assurance [NCQA], or Det Norske Veritas [DNV] [11].

In a study examining medical errors and full disclosure, not all physicians were comfortable, worried about alienating patients, feared being sued and ending up in malpractice. Historically hospitals would deny any wrongdoing. Physicians were comfortable covering adverse events, but not talking about errors. Patients were less apt to file a lawsuit when the physician fully disclosed the error with an apology. Not all states disclose malpractice information. Currently, there are eight states that prohibit admission of error in court [12].

In a Georgetown law review, some states determined that information about a provider’s credentials or experience with a given procedure may need to be disclosed on the IC through Artificial Intelligence [AI], mainly to reduce increased risks of injuries. While the law review did not address gender-affirming surgery, it did address other types of surgeries where a patient’s IC in the section on Substitute Physicians, did not mention that a non-doctor would perform a portion of their surgery. In some of these events, patients experienced complications and sued. In the same section on Substitute Physicians, patients were not necessarily informed when surgeons were part of a team since deciding who would operate would not occur up until right before surgery. This practice is referred to as Ghost surgery or overlapping surgery when another surgeon steps in to perform part of the surgery [13].

In a Florida State Law Review, critics argue that as a nation, we over-treat versus under-treat to capitalize on gains when some unnecessary treatments harm the patient. The critics establish that fraud occurs based on failure to show that there was a medical necessity, rendering the IC inadequate. The information would afford a patient a better outcome, but some clinicians do not agree that they would make better clinical decisions. Some state that this is a false belief rather than checking the patient’s level of understanding. The IC is regarded as a worthless document that disregards a number of discussions at the discretion of the physicians/surgeons. When things go wrong, or there are complications that were never covered in the IC, third-party payers are usually left out. If the False Claims Act [FCA] were involved, then claims filed for reimbursement could be denied when the physician/surgeon failed to provide the promised services, did not discuss complications with the patient, provided unnecessary service/treatment, or abandoned the patient. The Law Review points out that when the surgeon claims that care was medically necessary when it was not, then they have essentially committed fraud. The review points out that if the regulatory body linked the third-party payer, the third-party payer could deny payment for services [14].

Most patients would opt differently if the level of the surgeon’s or physician’s expertise with the volume of cases treated is public. Johns Hopkins in 2016 added a web page titled Volume Pledge to list patient safety for public transparency. Mortality with some surgeries is highest when surgeons have performed one or two surgeries and lowest when surgeons have performed high number of same surgeries [15, 16].

3. AI, collaboration, and the informed consent

The algorithm to treat or not to treat hinges on how experienced the provider is in treating individuals seeking medical/surgical treatments. In the first paragraph of the introduction, the authors refer to Walsh study on AIs ability to predict suicidal ideation and attempts based on patients health records but further in the section of the Pitfalls of AI, algorithms involve a profile of a patient with a specific ethnicity that may not apply to a patient whose ethnicity is different [17]. In the Georgetown Law Review, in the AI section, algorithms are referred to as blackbox and not easily understood by human-beings [13].

IC is shared decision-making; the informed consent model [ICM] is built on the initial assessment using a bio-psycho-social screening conducted by the primary physician. In most cases, patients must know more about what they agree to when signing off. To ensure the patient’s autonomy, the provider must assess that the patient does not have a misguided perception, and even then, it may not be considered a shared effort or even ethical [18].

In a study, this wasn’t a split second, with youth 14–18-years-of-age, the youth stated that they conducted thorough research on the internet. Some cross referenced their findings with their physician to ensure that what they read was correct information. Other youth stated that if they did not have support and access to GAC that they probably would not be alive today. The IC model of care places the self-determining choice onto the pediatric patient as a shared exchange between the youth, parent, and clinician, permitting self-agency across decision-making. One provider expressed that the signature on the document indicates the individual has the total capacity to understand. Just because a youth is able to conceptualize regret, does not mean they can recognize the risks involved therefore it is critical to evaluate if they are able to realize the consequences of those risks and felt that some youth were easily influenced by peers [19].

Collaborating on IC may require more than exchanging information between provider and patient. Mental health professionals or providers from specialty areas treating the patient often are not involved, included or added to the IC, but are considered best at engaging patients about GAC. Gender identity for some individuals is on a spectrum, and therefore it may not be solidified but malleable over time. A mental health provider would add this as a concern if they determined that the youth may not fully grasp the consequences [20].

Collaboration between medical and social services and other systems has not been shown to benefit patients or their overall health in a study reviewing 36 studies with the authors using Nvivo 12, a qualitative data analysis. In other studies, collaboration may contribute to lowering health inequities, opening avenues for economically disadvantaged patients to access services to mental health care. Partnering improves efficiency, but comes with the challenges of coordinating care and services and gatekeeping within systems not willing to share resources and knowledge [21].

4. Risk management and its’ role in identifying risks

Risk management’s role in the healthcare industry covers many areas. Risk management’s role is to identify risks that lead to poor outcomes and death. Contracts are also reviewed to evaluate potential for risk to the corporation. Forecasting is also part of the assessment. Hospitals that rely on accreditation through Joint Commission are called to a higher standard and benefit when they do not operate as silos [22].

While staff have different roles and responsibilities, in surgical procedures, the nurse, nurse anesthetists, anesthesiologist, scrub nurse, surgeon, are some of the key people who must ensure that the patient is informed every step of the way, is safe, in proper hands, monitored throughout surgery and post surgery, and none of this is possible without teamwork. All steps must have checks and balances. Checklists must be utilized. Overlooking a simple step, such as verifying the patient’s name could result in a serious outcome [23].

4.1 Disclosing surgical complications and risks of mortality in the informed consent

A 25-year-old trans man from Georgia passed away from sepsis post-hysterectomy. The reported estimate of percentages of those who develop serious life-threatening complications post hysterectomy in a 2013 study showed a data range between 10.5–9% hinging on the type of surgical approach. The abdominal route carries the highest complication, the vaginal route falls in midrange and laparoscopic hysterectomy has the lowest complications. While over 600,000 hysterectomies are performed annually, death rates are 1% [24]. In the U.S., over half of the hysterectomies are performed via the abdominal route due to a large number of gynecologists not having enough advanced training in laparoscopic procedures while in residency. The abdominal route is the easiest to perform, and improving skill and technique would require performing up to 50 surgical volumes. Still, to date, the average gynecologist may perform no more than 15 cases [25].

A 45-year-old trans male with a history of Factor V Leiden deficiency, Guillain Barre, infective endocarditis, caused by bacteria with a history of drug use, developed postoperative penile artery thrombosis [blood clot], among other complications post phalloplasty. The authors concluded that more research is needed on complications in these surgeries [26].

Dr. Burt Webb, a highly trained gender surgeon recommends that surgeons need at minimum ten years of experience performing phalloplasty surgery [24].

Black TGD population and White TGD population in private insurance between 2011 and 2019 were compared to Black cisgender population and White cisgender population. The findings were not without some setbacks that mainly included individuals who were not out publicly and so did not get counted in as transgender. However, the findings showed inequities in mortality risks among Black TGD people. Black TGD female assigned male at birth were more likely to die at higher rates than Black TGD males and even higher rates as Black cisgender males and females [27].

The most common phalloplasty complication has an incidence of 10–64%. The urethral complication [UC] with a fistula usually presents postoperatively at six months, with the patient complaining of incomplete voiding and difficulty voiding due to a visible fistula [28].

In 2016, Dutch researchers weighed in on a healthy 16-year-old trans female who was part of a study and developed complications 24 hours post surgery. She died from a bacterial infection, called necrotizing fasciitis during the creation of a neovagina using the patient’s intestines. This patient had underdeveloped genitals from taking puberty blockers and died days later after large doses of IV antibiotic treatments, repeated wound debridement and went into organ failure. The researchers concluded that the puberty suppression is what caused her demise [29].

A 24-year-old transgender female without any medical comorbidities presented with complaints of fecal matter leaking from her vagina three months post penal flap vaginoplasty. She was followed for two months without any intervention. She was diagnosed with a recto neo-vaginal fistula. The fecal matter was redirected through a Transverse end colostomy until healing occurred and the fistula was later repaired with success [30].

Increasing numbers of complications pertaining to genital surgeries are on the rise. In a study done on Truven MarketScan Database reviewing inpatient and outpatient claims, ICD-9 codes were analyzed for keywords that included breast augmentation, mastectomy, vaginoplasty and phalloplasty. Overall, 1047 insured patients with mastectomy as the most common and phalloplasty as the least common procedure performed. Sixty two complications were reported or 5.8% with wound infection listed as the most common complication and the highest complications came in for phalloplasty surgery [31].

Medical errors in the U.S. are not added to the death certificate. The CDC has listed that some causes of death are due to communication breakdowns between patients, doctors, specialists, and mental health providers, including a lack of adequate volumes in medical care and no follow-up [32].

4.1.1 Disclosing volumes in the informed consent

Patients who suffered injuries have filed lawsuits and wished they had knowledge about the provider’s experience and competency. The success of a procedure, some legalists weigh in, hinges on the provider’s expertise [33].

Surgeons must be transparent in areas of their expertise during the IC process. Most people obtain this information from others within their community, not via medical vehicles or the surgeon. It is an ethical problem that surgeons omit disclosing how much training they had to perform some of the surgeries [1].

Some researchers argue that the surgical profession needs to provide information about the surgeon’s level of expertise and the volume of cases the surgeon has treated [9].

In trauma cases unrelated to GACS, the association between physician volume and patient mortality was made and the authors concluded that higher case volumes were associated with lower mortality [34].

In an oral presentation at the American Urogynecologic Society, Pelvic Floor Disorders Week in October of 2020 and at the Virtual Experience in November of the same year at an oral presentation at WPATHs Virtual Scientific Symposium, the authors of a study determined that neourethral complications in patients receiving asynchronous hysterectomy were possibly due to the inexperience of the surgeon. The authors concluded that two stage steps slightly raised the risk for complications opposed to performing a hysterectomy along with phalloplasty [35].

High rates of urethral stricture disease occur post-metoidioplasty but are much higher with phalloplasty due to the lack of corpora that ordinarily would provide blood flow in cisgender males. Experienced and highly competent surgeons use methods to reduce the odds of urethral constrictions. In contrast, an inexperienced surgeon would cause undue harm and leave the patient with a significant risk of developing strictures and fistulas in these two procedures. Experienced surgeons in GAS have clarified that common repairs occur with strictures at higher recurrence rates and complications as high as 51% than those in cisgender men and stressed that long-term quality data is needed [28].

In a multivariate analysis, penile flap inversion surgical procedures for young trans females with bleeding complications were correlated to the surgeons’ clinical and surgical experience. The authors looked at learning curves on the amount of time taken to complete surgery in light of perioperative complications. The authors determined that while this procedure was relatively safe, the younger patient was more challenging due to increase in pelvic muscles and tissue turgor. Operating time was reduced after 22 surgeries for penile flap inversion and even more so after 76 surgeries. The multivariate analysis showed that for vaginal depth, accumulative complications peaked after 32 surgeries and then declined. The authors concluded that surgical experience improved after 30 surgeries. This study was done on one surgeon and the authors expressed that more of these studies are needed on less experienced surgeons for a comparative analysis [36].

According to UCSF Transgender Care, 12% of masculinizing chest surgeries end in complications and are rare for hematoma and infection. The surgical procedure ranges from 2 to 4 hours in duration and hinges on the plastic surgeon’s expertise and the patient’s physique and composition. Hematomas occur early on and may require reoperation [37].

When hospital surgeons have higher volumes of cases, it speaks to the number of experiences they had performing procedures. A hospital rating is insufficient and will not show the volume of cases the surgeon performed. The connection between volumes and experiences was examined, and the correlation was evident for the risk of death [38].

In an online article by thehealthy.com, Crouch, M., writes about the secrets surgeons withhold from their patients. At Columbia University, Advincula, A., M.D. encourages patients to ask about the surgeon’s complication rate but cautions be wary if the surgeon downplays or denies any, because it probably means they have not had enough cases or they are not disclosing the truth. Advincula also emphasizes that some surgeons will not disclose if they know how to perform a type of surgery [39].

In one study on trauma cases, the association between physician volume and patient mortality concluded that higher case volumes were associated with lower mortality [32].

In chapter 22 of Saylor Academy’s book on insurance, Medicare, Medicaid, PPOs, HMOs, and individual practice association for Physicians [IPAs] are just some of the insurance plans that have gatekeepers. Gatekeepers who must approve drugs, supplies, durable medical equipment, specialists, and surgeries [40].

4.1.2 Disclosing training in the informed consent

Education for GAS is needed and the estimated time allotted annually is one hour. Slightly over half and under 70% of subjects who participated in a poll stated they were not comfortable with GAS and facial surgery since they had not received much surgical training while 83% recommended increasing the surgical volumes so they could become proficient at GAS [41].

Surgeons providing GAS do not necessarily have the expertise or volumes in areas when performing surgical procedures. Unlike any other type of medical or surgical intervention, physicians and surgeons must have the training and continuous education, but medical or surgical competence is not inherently transparent. Gender affirming surgeries need to be included in medical residency. Masculinizing surgical procedure is an area that needs attention since urethral complications in masculinizing genital surgery range from 25 to 75%. In one case a patient ended up in surgical ICU because he did not disclose his medical history and the treating surgeon and staff who saved his life had to request his records [42, 43].

Genital surgeries require that surgeons have expertise, adequate training in this area, volumes of cases, and collaborative care. Hence, everyone on the team addresses the holistic person’s needs, ranging from providing support across many layers inside and outside the family [44].

4.1.3 Research to inform the informed consent

Research paves the way to identify potential problems, life-threatening events, and unforeseen consequences. These guidelines have been included in WPATHs standards of care. We need more input from the TGD individuals with lived experience [45].

Research is needed to inform clear guidelines on supporting detransitioners reversing all or parts of this process. Dr. Kinnon MacKinnon points out that there are insufficient numbers to know how many individuals have detransitioned and recommends setting goals to reduce stress for detransitioners and that longitudinal studies are needed. Some WPATH leaders are concerned and have expressed the need to learn from the detransitioners to better serve the transgender population [46].

In Germany, an analysis was conducted on the quality of ICs unrelated to GACS. Ten forms of medical treatments’ content were analyzed in 14 areas and determined to be insufficient in evaluating important areas, risks, and benefits and for the opting out of procedures and treatment, among others but overall found sufficient evidence that ICs did not support an informed decision. Thirty-seven informed consents were reviewed from publishers and practices throughout Germany. Regulations in Germany call for a model professional code for physicians to engage in pre-discussions before treatment [47].

In the Open Letter to WPATH community members strongly recommended that WPATH consider an advisory board of patients with lived experience to inform surgical guidelines [3].

Guidelines are developed through a consensus process led by TGD experts that prevent harm, improve the patient’s well-being, and address any medical and mental health concerns to provide quality care to the individual [6].

Guidelines are developed without input from those with lived experience. Funding is needed for research and quality measures and outcomes to advance best practices [3].

Research is lacking, and there are currently no clear guidelines on supporting detransitioners reversing all or parts of this process. There are insufficient numbers to know how many have detransitioned or recommend setting goals to reduce stress for detransitioners. In an online survey on 237 detransitioners most of their gender dysphoria related to other comorbidities that ranged from PTSD to ADHD [48].

4.2 Research to inform training

In the Open Letter by community members having undergone GAS sent to WPATH call for research on learning curves and only granting surgeons accreditation after completely satisfying supervised number of hours and procedures. The members reported concerns with WPATH surgeons with insufficient training capitalizing on building volume by offering free or low-cost surgeries to under-resourced patients. Patients reported feeling abandoned in aftercare among misstatements by board-certified plastic surgeons who dismissed knowledge about nerve coaptation [3].

Medical residents need a full-fledged educational curriculum in their surgical program for gender-affirming surgical procedures that range from facial feminization to feminizing and masculinizing genitalia surgical procedures. Residency training is needed because many residents do not feel adequately prepared [49].

5. Accreditation in gender-affirming care

Joint Commission has raised concerns with ICs and reports that IC is compromised and protects the providers, and is not sufficiently informing the patient without discussion. Joint Commission cites a study from 2016 that reported four essential elements were left out in 26.4 percent of the ICs. The fourth element included the alternatives to medical or surgical treatment. Between 2010 and 2021, 1.3% of reported cases received wrong-site surgical procedures and six cases were related to operative and post operative complications according to Joint Commission’s Sentinel Event Database. A sentinel event results in semi or permanent harm to a patient, such as near death or death. A Sentinel Event in Joint Commission’s report calls for immediate investigation because the event is a serious adverse outcome. Medical errors are the second leading cause of death, creating a serious public health problem [50, 51].

Joint Commission in 2020 published an article on patient’s reporting adverse events and harm caused by their health care provider. Joint Commission deemed these as significant and identified surgical/medication events, hospital-acquired infection, diagnostic error as some of the types of harm. One of the contributing factors listed the patient had not received sufficient information to make an informed decision [52].

Safety and regret are synonymous when the outcomes result in depression, suicidal ideation, and attempted suicide. Healthcare professionals also suffer, and no data exist on physicians taking their lives because of botched procedures, possibly because professionals fear retaliation and reluctance to report errors or patient regret [53].

In a seminal study from 1990, Joint Commission was created in 1951 for the purpose to accredit hospitals to meet safety standards, recognize the pitfalls of IC serving as a piece of paper for a patient to sign without any discussion and that, too many times, patients do not fully understand what risks and benefits entail. In the PROs and CONs section of the study, the downside of accrediting a process is the limited availability of surveyors from professional agencies. The other downside is when there is noncompliance, the accreditation is not a guarantee until it has been proven that conditions were met. Additional impediments were listed in the conclusions of quality assurance through certification and accreditation that set federal standards of care. Accreditation agencies are important in healthcare. They ensure that agencies and hospitals meet the highest quality of care and safety standards so patients can make informed decisions [54].

5.1 Detransitioners and AI

In a mixed method analysis codes were classified as external factors from internal factors on detransitioners. Vast majority reported it was due to external factors, pressures to fit in society, having to take care of a loved one, not feeling safe at work with some due to internal factors among others. The authors expressed that these could have run interference with the aide of a mental health provider. Trans females were more likely to detransition [55].

Detransitioners are speaking out about their experiences. In an article in Reuters titled Why detransitioners are crucial to the science of gender care, some transgender rights activists are at odds with detransitioners and express that detransitioners are underhanded and creating problems for the trans community. A lead at the Amsterdam University Centre for Expertise on Gender Dysphoria encourages everyone to listen to these narratives as these afford a time of reflection on what we have learned so far and what we need to know to improve care. Detransitioners reported mental health co-morbidities as teenagers [47].

One study concluded that barriers exist in pediatricians who may lack the expertise to care for TGD youth. Fifty caregivers and 15 youths were dissatisfied with services due to inconsistent care and lack of cultural competency. They expressed concerns about gatekeeping and delays in accessing medical treatment for blockers and hormones [56].

Some transgender and gender diverse [TGD] individuals reported regret in several areas ranging from misdiagnosis and hormonal transition to post-surgical regret. Guardian released an article by Rachel Cooke on British Broadcasting Corporation [BBC] journalist Hannah Barnes’s book titled Time to Think. England’s Tavistock’s gender identity clinic changed the informed consent [IC] process from its original intent to provide support for gender development. In the fifth column of the article, the clinic’s revenue grew as more and more children and adolescents were seen and treated by providers with little to no expertise in prescribing puberty blockers and gender-affirming hormonal treatment [GAHT]. In addition, complaints were filed for a lack of follow-up care, and lack of data entering and tracking on cases seen and treated through the clinic [57].

Pressure on providers to meet the demands in responding to the growth in GAC has led to some providers treating GAC as the standard of care with some lacking the expertise to evaluate youth [6].

The concerns over time with delays in treatment for GAS led to a revision in WPATHs SOC8. WPATH offers a gold standard for guidelines. In the frequently asked question section of SOC8, WPATHs revised guidelines now recommend only one letter of recommendation [LOR] versus two [4].

A retrospective audit was conducted on all new patients seeking GAHT who reported great satisfaction with their general practitioner and 80 percent of 43 participants in a survey chose a mental health provider for support while nine others did not. The conclusion in this audit deemed quicker access to care and lower wait times as part of the reason in addition to participants choosing a mental health provider [58].

A physician who takes the time to evaluate, investigate, and rule out the patient’s diagnosis can reduce the likelihood of liability. Unfortunately, a study showed that doctors interrupt the patient within 11 seconds [59].

The Accreditation Council for Graduate Medical Education [ACGME] committee opinion reviewed communication among OBGYNE doctors. ACGME identified physicians as needing training in communication as it has been shown to improve patient outcomes. Several models to improve communication served as examples [60].

In a systemic review on post-surgical regret, in a section titled Reasons for Regret, 10 out of 14 patients opted to detransition surgically. These individuals expressed social regret or inwardly feeling a deep sense of regret or no longer identified as male or female but somewhere in between [61].

Given the uncertainty and lack of reported outcomes, medicalizing a condition as part of development is risky. A study on a population of 100 detransitioners revealed that those who detransitioned did so because of stigmatization, unsatisfactory surgical results, realizing that they were struggling with homophobia, adverse reaction to GAHT, and reidentifying with their natal sex [62].

Claims of puberty-blocking agents have been made reversible without unsupported evidence, and the natural experience for an adolescent to experience puberty is disrupted [63]. A qualitative study using constructivist grounded theory reported that 28 Canadian adults who transitioned did so without regret but avoided any follow-up with their clinician to prevent stigma because the clinician lacked clinical knowledge in this area [64, 65].

Some scholars determine that a diagnosis for gender incongruence is of poor quality with mistaken assumptions about the patient in providing gender-affirming treatment and surgery [GATS]. Patients, caregivers, and parents receive incomplete or inaccurate information and even disinformation that if a child or teen does not receive gender-affirming care [GAC], this will lead to suicide. Mistaken assumptions, incomplete or erroneous information, and disinformation are all fueled by the rise in individuals seeking GACS and GAT. Protocols are lacking for individuals who identify as non-binary or who seek micro-dosing to qualify for hormonal treatment. The IC lacks certainty because the focus is more on gender dysphoria as opposed to what may lie behind this diagnosis, as in some cases of regret, patients realized that it had more to do with their mental illness than it did with gender dysphoria [6].

One study concluded that barriers exist in pediatricians who may lack the expertise to care for TGD youth. Fifty caregivers and 15 youths were dissatisfied with services due to inconsistent care and lack of cultural competency. They expressed concerns about gatekeeping and delays in accessing medical treatment for blockers and hormones [57].

5.2 The cost of transgender care

Volumes in GAS are growing, but adding a multidisciplinary team would build an integrated process strictly devoted to a multitude of interventions ranging from mental health care, to providers involved in the patient’s care prior to transitioning to surgical services and follow-up care for any concerns, complications, or revisions [66].

High costs may hamper GAS and is on demand. Its projected value for 2032 is USD 1.9 billion. The GAS market size in Europe is estimated to rise above 482 million. The market index shows an 11% growth from 2020 to 2021 for GAS, with revenue reported as $1.9 billion. Mount Sinai Center for Transgender Medicine and Surgery performed 639 female gender affirming surgeries [fGAS], 222 volumes above transgender male affirming surgeries [mGAS] [66, 67].

Prediction models by design help patients and physicians make patient-tailored decisions, as evidenced in a Thoracic Surgery Evaluation and Treatment model. Prediction models focus on variables that could predict negative and positive outcomes. These outcomes help facilitate a shared decision-making between patient and the provider. Some of the prediction models can calculate a patient’s surgical risks [68].

When malpractice suits are filed because the surgeon failed to disclose their inexperience and the risks, the informed consent in a number of these cases was not considered adequate and was deemed to have failed the patient [69].

6. Conclusion

As with any other specialty, GAS warrants cycling through a vigorous accreditation process. Acknowledgment that higher volumes are linked to better outcomes indicates that surgeons must perform many surgeries before they are considered eligible to perform a procedure. Surgical residencies need to offer GAS and surgeons seeking experience should be required to meet a standard established by experts. Surgeons must comply and meet the educational requirements and experience in number of volumes. Patients need follow-up care and revisions to address complications post-surgery. The Open Letter to WPATH clearly signals a disturbing pattern with patient abandonment post surgery. As the Open Letter addresses concerns with lack of oversight and lack of competency, WPATH could collaborate with TGD individuals whose lived experience would best inform needed surgical policies and procedures for pre and post care, training, and oversight. The IC is limiting and needs to include the surgeons expertise and training.

WPATH offers certification to members in good standing. Insisting on certification and vigorous training before surgeons can operate necessitates oversight. Seeking accreditation may benefit WPATH. Programs that seek Joint Commission accreditation benefit as this elevates the organization’s credentials, however the downside is the limited availability of surveyors from professional agencies that oversee accreditation.

Adverse events are not tracked in gender-affirming care as there are no guidelines for what constitutes an adverse event and when to report one. To say that complications are rare is a bit premature given we do not have enough data. Some of the data is skewed given the different descriptive words used for conditions.

The insurance industry has information that is valuable and could inform patterns in areas of competency with surgeons, number of surgical revisions typical and atypical among surgeons and ratings of outcomes among surgeons. Insurance companies are gatekeepers and the idea that the IC needs to avoid gatekeeping is erroneous. The IC over time has deteriorated to nothing but a piece of paper warranting the patient’s signature but very little effort is placed on protecting the patient’s best interest.

Some surgeons are not WPATH members and do not require the person to have a letter of recommendation [LOR] for GAS that is opposite of what WPATH SOC8 recommends. WPATH could consider collaborating with a legislative body to require that all surgeons must adhere to WPATH standards. Regulatory bodies could work with the insurance industry and require LORs before surgeons can perform GAS.

Preexisting conditions could prove to be fatal if not addressed prior to implementing GAC. IC could list patients’ potential risk factors using electronic data records. While a number of gender surgery centres with high volume cases review patient’s history, this may not be in the case of the surgeon owning their own surgical centres, with little to no experience, scheduled to perform phalloplasty or vaginoplasty. TGD care is a specialty.

Knowing a doctor’s experience helps patients determine if they can risk opting for treatment or surgery, forego both and opt for alternatives instead. Doctors need to supply their patients with alternative information responsibly.

The consensus is lacking for AI development in identifying individuals with a propensity for detransitioning that may have been intercepted early on if several factors were in place. Utilizing codes for detransitioners from surveys and translating these into AI could filter through predictive indicators reported by detransitioners to determine whether the individual needs guidance and support for typologies associated with a propensity for depression or complications due to medical preconditions. The downside of AI is the assumption that everyone is alike when two people present with a clean bill of health but the AI focused only on one type of profile. One person undergoing masculinizing genital surgery may end up with regret for a number of reasons that include poor recovery and complications, and the other will have a successful uneventful transition, but the predictability narrows the more experienced the surgeon and with collaborative efforts of others.

Augmenting the IC with a risk prediction model may be beneficial in informing the patient about the risks and benefits based on their preexisting conditions and comorbidities from their electronic [ED] record.

Given we do not have enough data to determine how many other individuals will report they detransitioned because of surgical regret or medical regret, it would be beneficial to require monitoring and keeping track of this data.

Utilizing codes for detransitioners from surveys and translating these into AI could filter through predictive indicators as reported by detransitioners. AI could determine whether the individual needs guidance and support for typologies associated with a propensity for depression or complications due to medical preconditions. AI may be beneficial in linking typologies specific to the patient or their familial history and AI could potentially review risk factors based on the patient’s history before deciding on GAC or GAS. The IC is then built upon this model of care that includes comorbid conditions affected by GAHT and GACS. For example, if a patient has a history of a blood clotting disorder and is planning on undergoing phalloplasty or vaginoplasty, coordinating care with hematology or the treating provider, may best serve this patient. Having discussions about GAHT so that the individual has relative information and can opt to seek alternatives if so desired as opposed to the IC only fulfilling the four elements.

Reports of low mortality risks in GAS are questionable given that we need to collect data from systems serving uninsured patients and combine these reports with the insurance industry. Despite reports of low mortality risks in GAS, risk managements’ role is vital, such as in the case of patients left abandoned, in need of post surgical care or revision surgery.

When prediction models to gauge patient’s surgical risks are not used, patient’s such as the gentleman with a history of Guillan Barre and Factor V Leiden may have had a different outcome had one been used to predict his surgical risk. Not having this information readily available, it is difficult to determine if a prediction model was used or if the patient even disclosed his history. If the patient did not disclose his history, but his records were accessed or other clinicians were part of his IC, perhaps they may have added his history and consulted with a hematologist. The reality exists that some patients are poor historians or do not share their medical history.

In the case of patients left with poor outcomes, complications that have posed difficulty for the person to navigate through life, such as the case with a patient who ends up abandoned by the system and cannot afford or is denied a revision, a coordinated team would guide and connect the patient to services. In the case of a detransitioner expressing surgical regret, the doctor’s role is to offer alternatives. The role of the mental health provider is to support the person’s transition from the beginning through the middle all the way up to the end of the person’s transition. But even beyond transition as life events do occur.

Training, education, coordinated care, mental health care, regulation, accreditation, and expanding the IC are just some of the recommendations that could improve GACS in hopes to reduce narratives of regret.

Acronyms

ACGME

Accreditation Council for Graduate Medical Education

AI

artificial intelligence

AMA

American Medical Association

CABP

coronary artery bypass procedure

DNV

Det Norske Veritas

ED

electronic record

FCA

False Claims Act

fGAS

female genital affirming surgery

GACS

gender-affirming care/surgery

GAHT

gender-affirming hormone treatment

GAS

gender-affirming surgery

HRT

hormone replacement therapy

IC

informed consent

IPA

Individual Practice Association

mGAS

male genital-affirming surgery

NCQA

National Committee for Quality Assurance

TGD

transgender-gender diverse

SOC8

standards of care—version 8

UC

urethral complication

WPATH

World Professional Association for Transgender Health