Dutch Protocol

Not to be confused with Groningen Protocol.

The Dutch Protocol is an approach (protocol) to the treatment of gender dysphoria in children that involves the use of puberty blockers to prevent puberty. It was developed by Dr Peggy Cohen-Kettenis in the 1990s.^[1] The treatment takes its name from the Dutch researchers who developed and applied it in the late 1990s. The first official version of the Dutch protocol was published in 2006.^[2][2]

The claim was made that the treatment was fully reversible, and that a study of 70 children showed evidence that it had an overall positive outcome for those treated.^[3] A number of subsequent studies appeared to support this treatment as safe and effective, and it became the standard treatment in the field.^[4]

Although many studies have shown the use of puberty blockers in transgender adolescents to be generally safe, effective, and reversible,^[5] doubts about the long-term safety and efficacy of the treatment have been raised.^[1] In the United Kingdom, the Cass Review stated that there was inadequate evidence to justify the widespread use of puberty blockers for gender dysphoria, and that more research was needed to provide evidence as to the effectiveness of this treatment.^[1] This has led to a de facto moratorium of the routine provision of puberty blockers for gender dysphoria within NHS England outside of clinical trials,^[6][7] and political calls for doctors to be prevented from private prescription of puberty blockers in England.^[8]

History

The idea of using puberty blockers originated in the Netherlands and was developed by Prof. Peggy Cohen-Kettenis, Professor of Pediatrics Henriette Delemarre, child psychiatrist Annelou de Vries, and psychologist Thomas D. Steensma.^[9] The first patient received these drugs in 1987.^[10] Cohen-Kettenis collaborated with endocrinologists in Amsterdam, one of whom had experience prescribing gonadotropin-releasing hormone analogs, which were relatively new at the time. At the time, gender dysphoric teenagers had to wait until they were of age for cross-sex hormones, but the team proposed that earlier interventions might benefit carefully selected minors.

In 1998, Cohen-Kettenis and Stefanie van Goozen published the first case study in which a trans boy (B) ("female-to-male transsexual") received puberty blockers.^[11] Because a psychiatrist had previously diagnosed B with gender dysphoria, he decided to administer puberty blockers after consulting with a pediatric endocrinologist.^[11] This gave B more time to explore the patient's gender identity. At age thirteen, B was referred to the gender clinic for young people, then located in Utrecht.^[11] After several conversations with both the trans boy and his parents, a multidisciplinary team decided to continue prescribing puberty blockers.^[11] Finally, at age eighteen, B decided to start testosterone treatment. Some time later, it was decided to have B's breasts and ovaries removed. In a conversation after these interventions, it was indicated that B no longer had gender dysphoria.^[11] The questionnaires also showed that there were no psychological, somatic, or personality problems.^[11] Based on this case, Cohen-Kettenis and Van Goozen argued that puberty suppression could have physical and psychological benefits in the diagnosis and treatment of transgender adolescents.^[11]

First studies

De Vries et al. (2011) published a cohort study of the first 140 adolescents who received puberty blockers and/or gender affirming hormones between 2000 and 2008.^[12] The study group consisted of the first 70 adolescents who received puberty blockers: 33 born boys and 37 born girls.^[12] All participants had experienced gender dysphoria since childhood, were supported by their environment, had no comorbidities that could influence the diagnosis, and had reached at least Tanner stage 2 or 3.^[12]

The group was examined twice: shortly before starting puberty blockers and shortly before starting cross-sex hormones.^[12] Various questionnaires were used to measure IQ, emotional and behavioral problems, depressive symptoms, the intensity of anxiety and anger, general psychological functioning, gender dysphoria, and body satisfaction.^[12] Comparing the two measurement points showed that adolescents had significantly fewer emotional and behavioral problems shortly before starting gender-affirming hormones than before starting puberty blockers.^[12] The participants also had significantly fewer depressive symptoms and improved their general psychological functioning.^[12] No significant improvement in anger, anxiety, or gender dysphoria was measured.^[12] Because puberty suppression reduces the associated stress of gender dysphoria, De Vries et al. (2011) concluded that it offers a valuable opportunity to give adolescents time to consider their gender identity and any subsequent medical steps.^[12]

In 2014, a follow-up study was conducted on some of the participants as well as new adolescents.^{[13] [Note 1]} After treatment with sex hormones and surgery, the same variables were measured as in 2011, as well as the subjective and objective well-being of the participants.^[13] The results showed that both the intensity of gender dysphoria and of anxiety and anger had decreased significantly at the end of the study.^[13] The subjective and objective well-being of the participants was comparable to that of their peers without gender dysphoria.^[13] Their measured well-being based on environment (i.e., support from parents, friends, access to health care, etc.) was even significantly better than that of the average Dutch adolescent.^[13] Based on the results of these two studies, De Vries et al. (2014) concluded that the protocol-based use of puberty blockers, followed by hormone treatment and gender reassignment surgery, improves the psychological functioning of transgender adolescents.^[13]

De Vries became known in the media for her working method through her appearance on the television program De Wereld Draait Door (DWDD) with Valentijn de Hingh, who was a teenager in transition at the time.^[14] A year later she appeared again on DWDD, this time with three girls who wanted to transition to male.^[15]

For the participants of the first cohort studies, the minimum age of twelve years was maintained. However, there was now discussion whether this was desirable.^[13],^[16] For example, de Vries et al. (2014) indicated that the age of twelve years could not be desirable for born girls, in whom puberty often begins before that age.^[13] In 2017, the Endocrine Society published its recommendations for the clinical management of gender dysphoric individuals.^[17] They abandoned the minimum age and recommend the use of puberty blockers from Tanner stage M2 or G2 in the development of sexual characteristics.^[17] This recommendation was adopted in the Netherlands by 2018 at the latest.^[18]

Protocol

The current form of the Dutch protocol was established in the 2018 report "Kwaliteitsstandaard Transgenderzorg – Somatisch" (Transgender Care Quality Standard). This was compiled based on the seventh version of the WPATH Standards of Care and the 2017 Endocrine Society guidelines.^[18] The diagnosis of gender incongruence is made by a multidisciplinary team. In the case of adolescents in puberty, this should consist of at least a specialized psychologist, psychiatrist or educational psychologist and a pediatric endocrinologist.^[18] If there is a direct reason for it, this team can be expanded.^[18] It is common for a fertility doctor and ethicist to be present in addition to these specialists.^[19] The team meets at least once a month to discuss the diagnosis and progress of the treatment, as well as to discuss the adolescent's questions and concerns.^[18]

Before puberty blockers can be started, a number of requirements must be met. For example, the psychologist or psychiatrist must determine that the young person has experienced long-term gender incongruence and is suffering from it.^[18] This must also have arisen or worsened at the onset of puberty.^[18] In addition, there must be no psychological comorbidities that could hinder the treatment or the young person's consent. Finally, the adolescent must have the capacity to give informed consent.^[18]

The adolescent must also have received sufficient information about the effects and side effects of puberty blockers. In the event that hormone treatment is desired after puberty blocking, it should already be indicated that it can lead to loss of fertility.^[18] In addition, the adolescent must have been informed about the possibilities of freezing sperm or eggs. Both the adolescent and their parents must have given informed consent for the treatment. It is also necessary that both parents support the adolescent throughout the treatment.^[18]

If these psychological requirements are met, the pediatrician must give permission for the initiation of puberty blockers.^[18] In addition, the pediatrician must have established that the adolescent has undergone puberty (at least Tanner stage M2 or G2) and that there are no medical contraindications. Only then can treatment with puberty blockers be initiated.^[18] In consultation with the adolescent and the parents, the pediatrician will determine which type of GnRH injection will be used.^[20]The adolescent must come for a check-up every six months to monitor the effects of puberty blockers. This consists of a bone density test to determine whether the adolescent's bones are strong enough.^[20] At the doctor's request, a hand x-ray can also be taken to measure growth using the growth plates.^[20]

If a young person decides not to take cross-sex hormones, they can stop taking puberty blockers.^[20] After this, their own puberty will resume. If an adolescent does want to start taking cross-sex hormones, they may do so from the age of sixteen. Before this can happen, the same diagnostic and medical requirements as for puberty blockers must be met, and both the adolescent and their parents must give informed consent.^[18]The adolescent is again informed about the irreversible fertility effects of hormone treatment and/or gender reassignment surgery. Possible heart problems that the treatment, in combination with smoking and obesity, could cause are also discussed.^[18] Once hormone treatment is started, the adolescent is expected to be regularly monitored as an adult. Although it is not clear which specific follow-up schedule is best, bone density should be monitored after puberty blockers.^[18]

Duration of gender dysphoria

The protocol has been adapted over time. Initially children needed to have to experienced gender incongruence before puberty. Subsequently an adolescent can also be treated if these feelings arose during puberty.^[21]

Minimum age

The original protocol recommended a minimum age of twelve for puberty blockers.^[2] A 2012 study by De Vries and Cohen-Kettenis states that this age was chosen because at the time, virtually nothing was known about the use of puberty blockers in transgender adolescents.^[4] Also, children around this age have already completed part of their cognitive and emotional development and, under Dutch law, are allowed to make medical decisions, provided they have parental consent. De Vries and Cohen-Kettenis indicated that this minimum age could be dropped once more is known about puberty blockers.^[4]

Scientific debate

In January 2023, Stephen B. Levine, E. Abbruzzese, and J. W. Mason published an analysis of the Dutch protocol, The Myth of "Reliable Research" in Pediatric Gender Medicine: A critical evaluation of the Dutch Studies—and research that has followed. They argue that the protocol lacks a sound scientific basis and warn of its potential negative consequences for vulnerable young people.^[22] A related study by Sarah Jorgensen, N. Athéa, and C. Masson (May 2024), Puberty Suppression for Pediatric Gender Dysphoria and the Child 's Right to an Open Future, concludes that the use of puberty blockers "relabels a normal physiological process as a disease and may trigger a cascade of increasingly invasive medical interventions," and that "no one can know with certainty how a child's gender self-concept and body ideals will develop over time." ^[23]

International application

Several international organizations, such as the World Professional Association for Transgender Health (WPATH),^[24] the American Academy of Pediatrics (AAP),^[25] the Endocrine Society,^[17] and the European Society for Sexual Medicine (ESSM),^[26] support the use of puberty blockers in transgender youth. The varying implementation of the Dutch protocol in different European countries is described below.

The Netherlands

As described above, puberty blockers have been prescribed since the late 1990s. In 2006, the Dutch protocol was standardized for the first time.^[2] Because the demand for care among adolescents rose sharply in the 2010s, capacity was further expanded in the 2020s. For example, the Radboud University Medical Center opened a gender clinic for adolescents on March 2, 2020 and for adults on March 1, 2021.^[27][28] The Beatrix Children's Hospital, part of UMC Groningen|, opened a gender clinic for minors in April 2024.^[29] Young people can now go there for puberty blockers and (from the age of sixteen) gender-affirming hormones.^{[29] [Note 5]}

Doubts about the Dutch Protocol also reached the Netherlands, where several researchers spoke out about the approach.^[30] For example, in August 2023, Lodewijk Smeehuijzen, Jilles Smids and Coen Hoekstra published a study in which they expressed legal and ethical concerns.^[31] In October 2023, the television programme Zembla drew attention to the controversy that had arisen over the Dutch Protocol.^[32] A few months before the Zembla broadcast, the Volkskrant had also published a critical review.^[33]

On February 27, 2024, the House of Representatives adopted a motion, drafted by Rosanne Hertzberger, to initiate an investigation into the scientific quality of the care model based on the Dutch protocol.^[34]

England and Wales

See also: NHS Gender Identity Development Service

According to an interim report from the Cass Review (2023), the independent working group set up to investigate the Tavistock clinic's practices, there are "significant differences" between the Dutch Protocol and Tavistock's practices.^[35] For example, young people in the did not receive psychological support for neurodiversity and/or comorbidities before being prescribed puberty blockers, while the Dutch Protocol requires this.^[35] Furthermore, NHS endocrinologists did not attend multidisciplinary meetings where complex cases were discussed and had no contact with clinic staff treating the young person until shortly before the report was published.^[35] Finally, the number of clinical appointments following the administration of puberty blockers decreased, while the Dutch Protocol suggests this should increase.^[35]

Based on the recommendations of the interim review, an NHS England preliminary report decided that puberty blockers should only be given to transgender children and adolescents in a research setting.^[36] The report also recommends that the relationship between gender dysphoria and social/psychological relationships should be explored during therapy.^[36] It also proposes that the care transgender young people receive should be primarily psychological in nature.^[36]

A joint response from Professional Associations for Transgender Health (WPATH, ASIAPATH, EPATH, PATHA, and USPATH) criticized a number of assumptions and recommendations in the NHS report.^[37] For example, they labeled the choice to prescribe puberty blockers only in the research setting as unethical.^[37] They argued that "it is ethically problematic to persuade adolescents to participate in research in order to access medically necessary treatment.";^{[37] [Note 6]} They also expressed concern that the NHS document's emphasis on psychotherapy as the primary intervention.^[37] They fear that in such a situation, gender dysphoria could be considered a mental disorder that can be treated with psychotherapy. They emphasize that decades of research has shown such therapy to be ineffective. Finally, they criticised the proposal that parents' names be reported to child protection services if their child receives puberty blockers through a source other than the NHS.^[37]

A later, interim policy report ruled that a multidisciplinary team may prescribe puberty blockers in exceptional circumstances outside of research, provided they support their use in the specific case.^[38]] A joint response from EPATH and WPATH condemned this interim policy report. The organizations criticized the decision to stop routinely prescribing puberty blockers while no new gender clinics have yet opened.^[39] They argue that this is in breach of NHS statutes.^[39] They also argue that the decision to stop using puberty blockers compromises WPATH's scientific standards.^[39] They express concern about the lasting negative impact this could have on transgender young people in the UK.^[39]

Scotland

In Scotland, there are four clinics for people with questions about their gender identity.^[40] One of these, Glasgow Sandyford Gender Identity Centre, also treats children with puberty blockers. ^{[Note 7]} Following the recommendations of the Cass Review, Sandyford Clinic decided on 18 April 2024 to temporarily stop prescribing puberty blockers to new clients.^[41]

Belgium

In Belgium, too, a debate arose in 2023 about the protocol's validity. The gender team at Ghent University Hospital claimed that the treatment helped many young people, but Professor of Family Medicine Patrik Vankrunkelsven, director of CEBAM, had serious doubts about this claim. CEBAM researches the scientific basis of medical procedures, now including puberty blockers and hormone treatments . The Dutch protocol states that puberty blockers function as a "pause button" to gain time to think. In practice, however, transitions are almost never stopped during this period. The gender teams say this is due to the accurate preliminary research. Critics, on the other hand, argue that puberty blockers appear to function as a trap in practice. Once initiated, children are said to no longer have the opportunity to change their minds. [ 5 ]

Finland

The head of the Finnish national pediatric gender program, psychiatrist Riittakerttu Kaltiala-Heino, has repeatedly highlighted significant complications of the Dutch, gender-affirming treatment model.^[42] Partly at her urging, COHERE, the Finnish Board of Health, decided in mid-2020 to retain the Dutch protocol only in its original 2006 form.^[43] For example, adolescents are only eligible for puberty blockers if they experience lifelong gender incongruence that worsened after puberty. If an adolescent also experiences psychological "comorbidities," these must first be addressed by regional care providers. If the adolescent still experiences gender dysphoria, they are treated at one of the university hospitals. A decision on whether puberty blockers should be administered to the adolescent after a diagnosis is made on an individual basis. If so, the adolescent is treated at Tampere University Hospital or Helsinki University Hospital.

Footnotes

• 1 A number of participants ( n = 15) were excluded from the data processing for various reasons (including refusal, failure to complete questionnaires, etc.). One trans woman was excluded because she died after her gender reassignment surgery from necrotizing fasciitis, a rare bacterial infection that can occur after wound formation and destroys muscle, skin, and fat tissue in a short period of time (de Vries et al., 2014, p. 697). There was no further significant statistical difference between the variables before puberty suppression in participants and non-participants (ibid.).
• 2 "Since it's [sic] opening in 2007, the Pediatric Gender Clinic offered psychological and medical assessment and treatment by a multidisciplinary team (psychologists, psychiatrists, endocrinologists, social workers). The clinical frame work has been elaborated throughout the last decade [2011-2020, ed.], using the guidelines of the Standards of Care, formulated by the World Professional Association for Transgender health (WPATH) and the guidelines of the Endocrine Society" (From Cauwenberg et al., 2021, p. 672).
• 3 "Jusqu'ici [2017, the year in which the Transgender Care Convention came into force, ed.], a French consultation with a structured approach to the preparation of transgenre minors. Wallonie-Bruxelles, depending on the capacity of the region, the language of the region."
• 4 "Inaugurée on October 1, 2019 on the site of the ND des Bruyères, the new consultation is due to an excellent assessment of the young patient." (…) "With the care of Pr. Alain Malchair and Pr. Anne-Simone Parent, a consultation mixed with Pédopsychiatrie et Endocrinologie pédiatrique pour enfants transgenres au le jour fin 2019 sur le site ND de Bruyères."
• 5 The diagnosis, indication and psychological support have been outsourced to Top GGZ Jonx (or another partner of UMC Groningen) (Kruse, 2024).
• 6 "It is ethically problematic to compel adolescents to participate in a research study to access medically necessary treatment; (…)" (WPATH et al., 2022).
• 7 Since the Scotland Act 1998, Scotland has had the power to form its own parliament and make its own laws. Following this Act, the Welsh, Scottish, and Northern Irish parliaments have also had authority over their own health care systems since 1999 (respectively NHS Wales, NHS Scotland, and NHS Northern Ireland; https://www.instituteforgovernment.org.uk/explainer/devolution-and-nhs). Therefore, there may be differences in working methods between NHS Scotland and NHS England.

See also

• Transgender hormone therapy