The U.K. Cass report (herein Cass) has spurred many headlines, most of which tout the findings of “weak evidence” for gender-affirming care (GAC). What “weak” and “strong” mean in the context of systematic reviews is a bit more nuanced than how it is portrayed in the media.
We have previously written about the U.S. implications of Cass. Here, we expand on the ethical considerations of pediatric GAC, and emphasize that a careful reading of Cass makes it clear that the report does not support bans but rather an improved model of care.
A Brief Overview of Cass
Despite some of Cass’s recommendations promoting better care and access for youth — even acknowledging problems related to rigid gender binaries — the report at times seems to be exacerbating controversy by speculating about causes of gender discordance in youth. Many of the recommendations around treatment, such as developmental and psychological support, already exist in guidelines from the World Professional Association for Transgender Health (WPATH) and the Endocrine Society. Cass does put forward an ideal model of care based on its recommendations and focuses on expansion of access, education, and data collection. For more comprehensive analyses of Cass and GAC, see the report from Yale Law School and a recent article by Armand H. Matheny Antommaria, MD, PhD.
An Unfair Weighing of Evidence
One of the main issues that comes across in Cass is the notion that randomized controlled trials (RCTs) are the gold standard for all medical treatment. This is true as an ideal, but they are not the only valid form of evidence. When an RCT cannot be ethically or feasibly undertaken, its absence does not equate to a lack of efficacy. For example, performing an RCT for puberty blockers is not feasible because randomization between treatment and control cannot be blinded. Additionally, since studies show benefit of this intervention compared to the alternative of non-treatment for gender-discordant youth, there is a lack of clinical equipoise necessary to ethically justify having a control group.
So what are the alternatives? Systematic reviews are another important way to evaluate evidence and improve what we know to better apply treatment. Likewise, the absence of systematic reviews does not equal an absence of benefit. This nuance is often misunderstood by the public, particularly when terms such as “off-label” or “not FDA-approved” are used.
The lack of RCTs, especially when they are both unethical and infeasible, should not devalue other forms of evidence. The methods for review such as GRADE, used by Cass and WPATH, rate only RCTs as “high evidence” and require a considerable amount of subjectivity. “Weak evidence” as a finding in a systematic review designed to weigh RCTs as higher-value leads us to problematic conclusions that devalue evidence of benefit. A rating of weak does not equal non-beneficial. As the BMJ best practices remind us, “The strength of recommendations are actionable: a weak recommendation indicates that engaging in a shared decision-making process is essential.”
Overall, we believe that a further review of a wide scope of interventions in pediatrics is helpful, given that very few interventions, such as medications, are tested on children. While GAC is not reducible to puberty blockers alone, this is often the treatment most singled out with claims of safety concerns.
But there are safety data for puberty blockers — these medications have been used for decades to treat other conditions such as precocious puberty — however, the ethical question is whether suppressing puberty in cases of gender dysphoria is beneficial in proportion to the burdens the medications bring and the burdens to the child of doing nothing. This type of analysis requires shared decision-making in pediatrics involving the clinician or medical team, parents, and patient.
The Role of Shared Decision-Making and Assessing Risk Versus Benefit
Cass notes that “…treatments should be offered on the best available evidence,” and goes on to say that in “evidenced-based practice, three factors determine treatment decisions: research evidence, clinical expertise, and patient values.” These factors are necessary in the shared decision-making process where medical facts need to align with patient values. This framework is not new to pediatrics; these questions are already an essential feature of ethics and shared decision-making.
Questions around the proportionality of benefit to burden, where there is uncertainty, along with considerations for current and future self and outcomes, are foundational in most ethical decision-making in pediatrics. Informed decision-making is always required with autonomy balanced by considerations of best interests and harms (current and future). Considerations around capacity, assent, and consent are everyday developmental considerations in most pediatric decision-making and go on every day in pediatrics. This is not unique to GAC.
There are further considerations in pediatric GAC. Gender binaries are relaxing and youth have more ability to explore their own gender identity. While Cass accounts for these considerations, the report goes on to offer problematic speculation. Not every child who is exploring this will desire or gain benefit from medical intervention. However, there are children who will, and we have evidence that they have.
There is reason to be concerned about the child’s future self — the future autonomous adult — but this must be balanced with the benefits and harms to their current self. There is a risk in doing nothing as this can lead to harm that can affect a child’s future through worse mental health, which can affect their health as an adult.
We believe this lays a foundation for the need for good process, individualized to each patient, balancing current benefits and harms against future benefits and harms that acknowledge developmental considerations, both current and over time. We should hold space during the process of GAC for those whose identity shifts. This means good family and team conversations, comprehensive and ongoing assessment, and developmental and psychological support.
Ethical Considerations for the U.S.
The ethics of GAC for youth are not novel, and fall within the current well-accepted consensus recommendations from pediatric ethics experts. U.S. gender clinics should operate on a robust and well-coordinated comprehensive care model. Developmental and psychological ongoing assessment should be the standard (as WPATH recommends).
Cass doesn’t offer anything new here. Any close reading of Cass is clear that the report does not support bans, but rather an improved service model. The service model proposed by Cass is certainly idealistic in nature, particularly if applied to the fractured U.S. system. However, banning and criminalization restrict the ability for a family to access a good process, does not lead to increased knowledge and data collection, and increases pressure on operating clinics that are inundated due to bans. A nuanced understanding of the evidence is needed, but ethical frameworks for GAC already exist. Providing good care for this population requires access, not restriction.
Ian D. Wolfe, PhD, MA, RN, is director of ethics at Children’s Minnesota and affiliate faculty in the University of Minnesota’s Center for Bioethics. Justin M Penny, DO, MA, is an assistant professor in the Department of Family Medicine and Community Health at the University of Minnesota and a clinical ethics assistant professor in the Center for Bioethics.
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