Commentary on Levine et al.: A Tale of Two Informed Consent Processes

https://doi.org/10.1080/0092623X.2022.2070565

Excerpt (full article below)

Abstract

This commentary compares two recently published informed consent recommendations for gender dysphoria. One key difference identified is in their assessment of the strength of the evidence base for the gender affirming treatment model. An evaluation of both authors’ citations supports the claims of a weak evidence base for the use of puberty blockers and gender affirming hormonal treatments in youth with gender dysphoria. This commentary then reflects on the implications of this. In particular, it asks whether it would be best practice to provide gender affirming treatments for youth only under clinical research conditions, rather than as routine clinical practice.

Introduction

“Reconsidering Informed Consent for Trans-Identified Children, Adolescents and Young Adults” (Levine, Abbruzzese, & Mason, 2022) is a timely and important paper. This Commentary asks the question: How does Levine et al.’s recommended informed consent process compare to current informed consent practices for youth with gender dysphoria? This question is addressed through an evaluation and comparison of Levine et al.’s informed consent process with those of a recently published “Informed Consent Standards of Care” (AusPATH, 2022). A key difference is the respective authors’ evaluation of the strength of the evidence base for the gender affirming treatment model. This Commentary interrogates the citations these authors use for their respective claims regarding the strength of the evidence base. It finds that Levine et al.’s claims of a weak evidence base are well supported. A second question then reflected upon is: Given the weak evidence base for gender affirming treatments for youth, should these interventions be only available as part of clinical research trials, rather than implemented as routine treatments?

What Are We Doing to These Children? Response to Drescher, Clayton, and Balon Commentaries on Levine et al., 2022

Stephen B. Levine, E. Abbruzzese & Julia W. Mason

https://doi.org/10.1080/0092623X.2022.2136117

Response to Clayton

In the process of comparing our informed consent recommendations to those authored by WPATH’s affiliate AusPATH, Clayton revealed that the guidance widely used in Australia and New Zealand is not entirely data dependent. Given AusPATH’s close links to WPATH, we agree with Clayton that her commentary “holds much relevance to the international context” (Clayton, 2022Clayton, A. (2022b). Commentary on Levine et al.: A tale of two informed consent processes. Journal of Sex & Marital Therapy. Advance online publication. doi:10.1080/0092623X.2022.2070565 [Taylor & Francis Online], [Web of Science ®], [Google Scholar]b p. 1).

Clayton juxtaposed two sets of opposing claims regarding the evidence for “gender affirmation” of youth: the claim by advocates of this practice who insist that data show significant benefits and low risks, and the assertions of critics that the benefits are highly uncertain, and the risks are significant. She suggested that this contradiction may be resolved by engaging in “close reading of the cited primary sources” (Clayton, 2022b p. 3). As Clayton’s prior research demonstrated, there is a troubling “asymmetry” in how the results from gender clinics-based research are frequently reported: “[f]indings of positive outcomes of medical interventions are trumpeted in abstracts, while their profound limitations remain behind the paywall, thus, below the radar of busy clinicians” (Clayton et al., 2022, p. 3). Once the individual studies are scrubbed of uncertainty in the abstracts, the evidence enters a new cycle of laundering where “[n]ew publications reference prior ones with increasing and unwarranted confidence” (Clayton et al., 2022, p. 3).

Unfortunately, not only individual studies, but even systematic reviews of evidence, which generally reside on the highest rung of the evidence pyramid, can suffer from bias. Clayton’s prior research focused on a problematic “systematic review” by Rew, Young, Monge, and Bogucka (2021), which exemplified a “concerning trend to overstate the evidence underpinning clinical practice recommendations for youth with GD [gender dysphoria]” (Clayton et al., 2022, p. 3).

We see similar problems in the review commissioned by WPATH as the basis for its “Standards of Care 8” (Baker et al., 2021). This review failed to examine any physical health risks of hormonal interventions and found only low-quality or insufficient evidence of psychological benefits due to high risk of bias in study designs, small sample sizes, and confounding with other interventions. This did not preclude the authors from endorsing “hormone therapy,” including puberty blockers and cross-sex hormones for youth as an “essential component of care” (Baker et al., 2021, p. 13.). These conclusions, which cannot be substantiated by the review’s actual findings, have since been used by WPATH to issue the recommendations to treat gender dysphoria medically, stating that “delay in transition” is rarely advisable and should only be used as a “last resort” (Coleman et al., 2022, p. S37).

It is worth noting that Baker, the lead author of the WPATH-comissioned systematic review, appears to have coauthored another highly flawed evidence review widely known by its pithy subtitle, “What We Know” (Frank & Baker, 2018). Baker’s commitment to generating research that furthers a policy agenda to promote access to hormones is well-publicized (Health Policy Research Scholars, 2019). Had the goal been scientific accuracy, rather than political advocacy, the title of that review would have been “What We Don’t Know.”

It is notable that when led by researchers with no intellectual or financial conflicts of interest, evidence reviews universally find the benefits of pediatric gender reassignment unconvincing, and the unquantified risks of harm alarming. This includes recent evidence reviews commissioned by health authorities in the UK (NICE, 2020a, 2020b); Sweden (SBU, 2022); Finland (Pasternack, Söderström, Saijonkari, & Mäkelä, 2019), and most recently, the state of Florida in the United States (Brignardello-Peterson & Wiercioch, 2022).

Clayton reminded readers that advancing from the current lack of evidence requires rigorous study designs capable of generating high quality evidence. She illustrated the importance of rigorous research designs by invoking the placebo effect—the well-established powerful influence of “the whole therapeutic ritual, including medical marketing” that “affects the patient’s neuro-psycho-biological state…” (Clayton, 2022b, p. 5). Clayton questioned the extent to which the observed short-term improvement reported by uncontrolled studies may be subject to the placebo effect, with clinicians themselves operating under a “therapeutic illusion” enabled in part by the widespread promotion of the expected benefits of gender transition in “social media, and celebrity culture” (p. 5). She noted that when “interventions have high risk of serious and irreversible adverse effects” (p. 5), rigorous study designs that control for these factors are essential.

Clayton also reflected on the blurred line that separates “innovative clinical practice,” which can be offered widely by any willing provider, from “research,” which is subject to a tightly regulated process. She questioned whether “affirming” interventions for youth can only ethically be performed in research settings, in view of these interventions’ irreversible effects and the risks involved to very young individuals. This is the direction that Sweden recently assumed (Socialstyrelsen, 2022a, 2022b). In the U.S., such a change is not likely to come from the Federal government, but it can take place at the state level, as U.S. laws delegate the responsibility to regulate the practice of medicine to individual states. If this were to happen, gender clinics in participating states might be more motivated to design research that generates useful data to answer the unanswered questions about outcomes.

Having interrogated the evidence, Clayton concluded, “[a]ny claims of certainty are premature and risk more harm than benefit” and observed that the gender medicine establishment’s misguided insistence that the science is settled “hinder[s] the rigorous debate and research required to improve the state of knowledge in this area of medicine” (Clayton, 2022b, p. 6). Clayton’s overview of medicine’s misadventures detailed in her previous publication (Clayton, 2022a), and in the relevant examples in her present commentary (Clayton, 2022b), provide a powerful argument to all clinicians to reconsider their informed consent processes for youth gender transitions. We highly recommend her erudite commentary to all individuals in the field.

---

Stephen B. Levine, E. Abbruzzese & Julia W. Mason (2022) Reconsidering Informed Consent for Trans-Identified Children, Adolescents, and Young Adults, Journal of Sex & Marital Therapy, 48:7, 706-727, DOI: 10.1080/0092623X.2022.2046221

The recommendations for informed consent process for children, adolescents, and young adults

Noninvasive medical care or care that carries little risk of harm does not require a signed informed consent document; rather, consent is implied through the act of a patient presenting for care. For example, when a parent brings in a child for a skin laceration or abscess, consent for sutures or simple incision and drainage is implied. Similarly, when a child presents with pneumonia and is hospitalized, consent for chest x-ray, IV fluids, and antibiotics is also implied. It is assumed that patients or their guardians agree to the interventions and understand the benefits and risks. When risks are greater, such as prior to surgery, chemotherapy, or another invasive procedure, an informed consent document is signed. Such situations require an explicit, or express informed consent.

In the context of interventions for gender dysphoria or gender incongruence, the uncertainties associated with puberty blocking, cross-sex hormones, and gender-affirmative surgeries are well-recognized (Manrique et al., 2018; National Institute for Health & Care Excellence, 2020a; 2020b; Wilson et al., 2018). In these cases, consent should be explicit rather than implied because of the complexity, uncertainty, and risks involved.

Informed consent for social transition represents a gray area. Evidence suggests that social transition is associated with the persistence of gender dysphoria (Hembree et al., 2017; Steensma, McGuire, Kreukels, Beekman, & Cohen-Kettenis, 2013). This suggests that social gender transition is a form of a psychological intervention with potential lasting effects (Zucker, 2020). While the causality has not been proven, the possibility of iatrogenesis and the resulting exposure to the risks of future medical and surgical gender dysphoria treatments, qualifies social gender transition for explicit, rather than implied, consent.

Full unbiased disclosure of benefits, risks and alternatives is requisite

When mental health professionals are involved in evaluations and recommendations, the informed consent process begins either as part of an extended evaluation or is integrated in a psychotherapeutic process, separately or together, with the parents and patient. When pediatricians, nurse practitioners, or primary care physicians perform the initial evaluation, the informed consent process is more likely to be labeled as such in a briefer series of meetings.

In all settings, the informed consent discussions for gender-affirmative care should include three central ideas:

1. The decision to initiate gender transition may predispose the child to persist in their transgender identity long-term.
2. Many of the physical changes contemplated and undertaken are irreversible.
3. Careful long-term studies have not been done to verify that these interventions enable better physical and mental health or improved social functioning, or that they do not cause harm.

The informed consent process, culminating with a signed document, signifies that parents and patient have been educated about the short- and long-term risks, benefits and uncertainties associated with all relevant stages of the gender-affirmative interventions. The process must also inform the patients and families about the full range of alternative treatments, including the choice of not socially or medically treating the child’s or adolescent’s current state of gender/body incongruence.

Decisional capacity to consent needs to be assessed and family should be involved

Trans-identified youth typically present themselves as strongly desiring hormones and ultimately, surgery. It should not be assumed that their eagerness is matched with the capacity to carefully consider the consequences of their realized desires. Trans-identified youth younger than the age of consent should be part of the informed consent process, but they may not be mature enough to recognize or admit their concerns about the proposed intervention. For this reason, it is the parents who, after careful consideration, are responsible for signing an informed consent document.

The issue of the exact age at which adolescents are mature enough to consent to gender transition has proven contentious: courts have been asked to decide about competence to consent to gender-affirmative hormones for youth in the United Kingdom and Australia (Ouliaris, 2021). In the United States, the legal age for medical consent for gender-affirmative interventions varies by state.

When patients are age 18 and older, and in some jurisdictions as young as age 15 (Right to medical or dental treatment without parental consent, 2010), they do not legally require parental approval for medical procedures. But because an individual’s change of gender has profound implications for parents, siblings, and other family members, it is usually prudent for clinicians to seek their input directly or indirectly during the informed consent process. This is done by requesting a meeting with the parents.

A recent study by a Dutch research team attempted to evaluate the decisional capacity of adolescents embarking on gender transition (Vrouenraets, de Vries, de Vries, van der Miesen, & Hein, 2021). The researchers administered the MacCAT-T tool, comprised of the understanding, appreciating, reasoning, and expressing a choice domains, to 74 adolescents who were 14.7 years old on average (with the minimum age of 10). They concluded that the adolescents were competent to consent to starting pubertal suppression, calling for similar research for the <12 group, particularly because “birth-assigned girls … may benefit from puberty suppression as early as 9 years of age” (Vrouenraets et al., 2021 p.7).

This study suffers from two significant limitations involving the MacCAT-T tool. It was never designed for children. Rather, it was designed to assess medical consent capacities of adults suffering from conditions such as dementia, schizophrenia, and other psychiatric disorders. There is a fundamental lack of equivalency between consenting to treatment by adults with cognitive impairments and obtaining consent from healthy children whose age-appropriate cognitive capacities are intact, but who lack the requisite life experiences to consent to profound life-changing medical interventions. We doubt, for example, whether even highly intelligent children who have not had sexual experiences can meaningfully comprehend the loss of future sexual function and reproductive abilities.

In addition, even for adults, the MacCAT-T tool has been criticized for its exclusive focus on cognitive aspects of capacity, failing to account for the non-cognitive aspects such as values, emotions and other biographic and context specific aspects inherent in the complexity of the decision process in real life (Breden & Vollmann, 2004). Children’s values and emotions undergo tremendous change during the process of maturation.

The authors’ conclusion about their young patients’ competence to consent should be compared with what a panel of judges wrote in the challenge to the Tavistock treatment protocol (Bell v Tavistock, 2020):

…the clinical intervention we are concerned with here is different in kind to other treatments or clinical interventions. In other cases, medical treatment is used to remedy, or alleviate the symptoms of, a diagnosed physical or mental condition, and the effects of that treatment are direct and usually apparent. The position in relation to puberty blockers would not seem to reflect that description. [para 135]

…we consider the treatment in this case to be in entirely different territory from the type of medical treatment which is normally being considered. [para 140]

… the combination here of lifelong and life changing treatment being given to children, with very limited knowledge of the degree to which it will or will not benefit them, is one that gives significant grounds for concern. [para 143]

It seems clear that perceptions of children as young as 10 years of age as medically competent vary by country, state, and the institution where the doctor works, and, by clinicians’ beliefs about the long-term benefits of these interventions. We maintain that the claim that children can consent to extremely life-altering intervention is fundamentally a philosophical claim (Clark & Virani, 2021). Our view in this matter is that consent is primarily a parental function.

Informed consent should be viewed as a process rather than an event

Most institutions that care for transgender-identified individuals have devised obligatory consent forms that outline the risks and uncertainties of hormonal and surgical gender-affirmative interventions. However, the requisite signatures are frequently collected in a perfunctory manner (Schulz, 2018), akin to signatures collected ahead of a common surgical procedure. The purpose of such informed consent documents appears to be to protect practitioners from lawsuits, rather than attend to the primary ethical foundation of the process.

Although obtaining the signatures is important, the signed document should signify that the process of informed consent has been undertaken over an extended time period and is not simply quickly completed (Vrouenraets et al., 2021). We believe the latter approach poses an ethical concern (Levine, 2019).

The internal dynamics of the trans-identified young person and their families vary considerably. Parental capacities, their private marital and intrafamilial relationships, their cultural awareness, religious and political sensibilities all influence the amount of time necessary to undertake a thorough informed consent process. It is not prudent to suggest a specific duration for the process of informed consent, other than to emphasize that it requires a slow, patient, thoughtful question and answer period as the parents and patient contemplate the meaning of what is known and unknown and whether to embark on alternative approaches to the management of gender dysphoria before the age of full neurological maturity has been reached, mental health comorbidities have been addressed, and a true informed consent by the patient is more likely.

Final thoughts

Sixty years of experience providing medical and surgical assistance to transgender-identified persons have seen many changes in who is treated, when they are treated, and how they are treated. Today, the emphasis has shifted to the treatment of the unprecedented numbers of youth declaring a trans identity. As adolescents pursue social, medical, and surgical interventions, health care providers may experience unease about patients’ cognitive and emotional capacities to make decisions with life-changing and enduring consequences. An unrushed informed consent process helps the provider, the parents, and the patient.

Three issues tend to obscure the salience of informed consent: conspicuous mental health problems, uncertainty about the minor’s personal capacity to understand the irreversible nature of the interventions, and parental disagreement. Physical and psychiatric comorbidities can contribute to the formation of a new identity, develop as its consequence, or bear no connection to it. Assessing mental health and the minor’s functionality is one of the reasons why rapid affirmative care may be dangerous for patients and their families. For example, when situations involve autism, learning disorders, sexual abuse, attachment problems, trauma, separation anxiety, previous depressed or anxious states, neglect, low IQ, past psychotic illness, eating disorders or parental mental illness, clinicians must choose between ignoring these potentially causative conditions and comorbidities and providing appropriate treatment before affirmative care (D’Angelo et al., 2020).

For youth less than the age of majority, informed consent via parents provides a legal route for treatment but it does not make the decision to socially transition, provide hormones, or surgically remove breasts or testes less fraught with uncertainty. The best that health professionals can do is to ensure that the consent process informs the patient and parents of the current state of science, which is sorely lacking in quality research. It is the professionals’ responsibility to ensure that the benefits patients and parents seek, and the risks they are assuming, are clearly appreciated as they prepare to make this often-excruciating decision.

Young people who have reached the age of majority, but who have not reached full maturation of the brain represent a unique challenge. It is well-recognized that brain remodeling proceeds through the third decade of life, with the prefrontal cortex responsible for executive function and impulse control the last to mature (Katz et al., 2016). The growing number of detransitioners who had been old enough to legally consent to transition, but who no longer felt they were transgender upon reaching their mid-20’s, raises additional concerns about this vulnerable age group (Littman, 2021; Vandenbussche, 2021).

When the clinician is uncertain whether a young person is competent to comprehend the implications of the desired treatment—that is, when informed consent cannot inform the patient—the clinician may need more time with the patient. When parents or guardians do not agree about whether to use puberty blockers or cross-sex hormones, clinicians are in an uneasy spot (Levine, 2021). This occurs in both intact and divorced families. Australia has given legal instructions to clinicians facing these uncertainties: the court is to be asked to decide (Ouliaris, 2021). The court system in the UK has been grappling with similar issues in recent years. While it is a rare case that ends up in a courtroom, clinicians devoted to a deliberate informed consent process are still likely to encounter ethical dilemmas that they cannot resolve.

---