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Gender-affirming guideline 'fails' to make the grade
A transgender treatment guideline, celebrated by The Lancet journal for its promotion of gender-affirming care of minors, is not “trustworthy”, according to a pioneer of the evidence-based movement in medicine, Professor Gordon Guyatt.
Asked to assess the gender dysphoria guideline from the Royal Children’s Hospital Melbourne (RCH), Professor Guyatt seized on the statement by the Australian guideline authors that, “The scarcity of high-quality published evidence on the topic prohibited the assessment of level (and quality) of evidence for these recommendations.”
“[That claim] is enough for me to say this is not a trustworthy guideline”, Professor Guyatt told GCN.
The claim appears in the peer-reviewed version of the RCH guideline published by the Medical Journal of Australia.
Dr Guyatt, distinguished professor in the Department of Health Research Methods, Evidence, and Impact at Canada’s McMaster University, was a leader in creating the widely used GRADE system for rating evidence quality; he also took part in developing the criteria necessary for a treatment guideline to be “trustworthy”.
GRADE rates the quality of evidence as very low, low, moderate or high; treatment recommendations are graded as weak or strong. This means the lack of high-quality studies on gender-dysphoric youth should not prevent an assessment of the evidence for the RCH recommendations, which include life-altering hormonal and surgical interventions that may sterilise minors.
The rationale of evidence-based medicine is to maximise the benefits of treatment, minimise harm, and take into account bias and the robustness of research methodology.
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Pride in research
Australia’s centre-left Labor government has announced during the Sydney WorldPride 2023 event this week that it will allocate $26 million to health and medical research focused on “LGBTIQA+ communities”, in tandem with an LGBTIQA+ Health Advisory Group and 10-Year National Action Plan.
One of the four streams of research grants offered through the National Health and Medical Research Council (NHMRC) covers “multidisciplinary, patient-centred models of physical and mental health care for transgender and gender-diverse children, adolescents and young adults including those with intersectional disadvantages, through co-design with consumers”.
The grant guidelines say: “There are many types of sexuality diversity including lesbian, gay, bisexual, pansexual, asexual and/or queer individuals.
“Some people have an innermost sense of their gender that does not align with the sex they were assigned at birth.
“Gender diversity can include transgender, non-binary, genderqueer, two-spirit, pangender and agender identities.”
The document acknowledges the need for “a strong evidence base” to ensure “safe and effective clinical care” for the increasing number of trans-identifying adolescents.
However, it cites the RCH treatment guideline to support the claim that some of these adolescents might “benefit from well-coordinated, individualised multi-disciplinary care” potentially involving “paediatricians, GPs, endocrinologists, psychologists, speech therapists and other specialists.” This appears to include hormonal and surgical interventions.
The NHMRC grant guidelines cite the “minority stress” model, which attributes the poor mental health of trans-identifying adolescents to a bigoted, transphobic society.
The 2018 RCH treatment guideline was praised by The Lancet in an unsigned editorial for its “respectful, gender-affirming treatment” of the distressing condition of gender dysphoria, and for its child-led approach to social transition involving adoption of an opposite-sex identity.
The guideline — titled “Australian Standards of Care and Treatment Guidelines for Transgender and Gender Diverse” — was hailed as the world’s “most progressive” because it did away with “arbitrary” minimum ages for medical interventions.
The Lancet said it was the first set of treatment recommendations specific to children and adolescents with gender dysphoria.
All four published authors had appointments at both the RCH gender clinic and its research partner, the Murdoch Children’s Research Institute.
In 2017, a draft of the RCH guideline helped persuade Australia’s Family Court that the science of gender dysphoria had advanced to such a point that the judges could safely scale back their supervision of trans medical treatment of minors, placing more trust in clinicians.
There is uncertainty about whether or not the RCH administration is distancing itself from the 2018 gender dysphoria guideline, which is publicly available online and bears the hospital logo.
This week, chief responsibility for a major revision of the guideline reportedly passed from RCH to the Australian Professional Association for Trans Health (AusPATH), a hybrid activist-professional body.
In December, however, it was reported that she would step down as director of the gender clinic and take up a six-month appointment as acting chief of medicine at the hospital.
These changes have not been publicly announced by RCH, which has ignored requests for comment.
Video: Gordon Guyatt explains the GRADE system
Who guides the guides?
Quoted in an investigation article published last week by the BMJ, Professor Guyatt found fault with guidelines from the World Professional Association for Transgender Health (WPATH) and the Endocrine Society. Both documents are cited by RCH as influencing its treatment recommendations.
All three guidelines are being scrutinised by England’s independent review of youth dysphoria care under the leadership of paediatrician Dr Hilary Cass.
In the BMJ investigation, Dr Guyatt challenged the claim by WPATH that the limited evidence base precluded a systematic review of outcome studies for adolescents undergoing medicalised gender change.
Dr Guyatt insisted that “systematic reviews are always possible”, even if few or no studies met the criteria for inclusion in the review.
He said a systematic review of the evidence was necessary for the development of a trustworthy treatment guideline.
Since 2020, Finland, Sweden, England and the state of Florida have carried out systematic reviews of the evidence for medicalised gender change with minors. All found the evidence to be weak and uncertain, and their approach to gender dysphoria care has shifted away from invasive physical treatments towards greater caution.
The RCH guideline does not mention a systematic review.
The current 2020 version of the guideline does not cite the first systematic review of trans hormonal treatment of adolescents, a 2018 paper published in Pediatrics. This review’s authors included the research director of the RCH gender clinic, Dr Pang.
The Pediatrics review found only “low-quality evidence” that puberty blockers and opposite-sex hormones did what they were supposed to do physically.
Evidence on the psychosocial and cognitive effects of the treatments was “generally lacking.”
A 2019 protocol for the RCH clinic’s Trans20 study noted the mental health issues in today’s rapidly expanding gender dysphoria caseloads and warned “there is an urgent need for more evidence” to underpin treatment.
The RCH guideline was considered for inclusion in the National Health and Medical Research Council’s online portal of Australian Clinical Practice Guidelines but did not qualify.
An NHMRC spokeswoman said: “At the screening stage, it was determined that the guideline did not include a funding statement, an evidence base for the recommendations or information about conflict of interest, and that it would not meet the portal selection criteria, so a full assessment was not carried out.”
In 2019, following critical media coverage of the guideline, the Royal Australian & New Zealand College of Psychiatrists (RANZCP) quietly removed from its LGBTQ mental health policy an explicit endorsement of the RCH guideline.
Asked why, the college said the change was made pending a review. In 2021, the college released a new policy on gender dysphoria that did not restore its endorsement of the RCH guideline.
In a December 2020 submission to a federal parliamentary committee, Dr Telfer claimed that the RCH guideline is “accepted as the current gold standard care for Australia and is used as such across the country.”
However, a recent internationally significant paper by researchers associated with the gender clinic of The Children’s Hospital at Westmead, Sydney, has argued that the RCH guideline’s “Australian Standards of Care” title is “misleading”.
“In Australia there are no official or authorized government-commissioned standards for assessing or treating gender dysphoria,” the Westmead researchers said.
They noted the “gender-affirmative” worldview of the RCH guideline, and contrasted this with the more cautious approach of a policy statement from Australia’s National Association of Practising Psychiatrists, which advises psychological and social interventions as first-line treatments, rather than “experimental puberty-blocking drugs and other medical interventions”.
In 2019, the RCH administration defended the gender clinic’s treatment guideline, saying it had been “peer reviewed at the highest level, published in the Medical Journal of Australia and adopted by healthcare providers across Australia and the globe.”
The guideline is reportedly used by the controversial online gender clinic, GenderGP.
A May 2021 GenderGP blog said: “These [RCH] guidelines not only set a model for gender-affirming care both in Australia and around the world, but also help counter the narrative that transgender care for young people is harmful or experimental.”
Note: GCN put questions to RCH, the Murdoch Children’s Research Institute, Dr Telfer, Dr Pang, and AusPATH. GNC does not dispute that gender-affirming clinicians believe their interventions are of benefit to vulnerable patients in distress.