New children's gender identity clinic, clinical trials and Cass

Designs like that want to establish if there is a difference between just the one (psych support) or psych support + blockers. If they had a blockers without any pysch support (dubious) or children getting nothing (waiting list) then it should be possibly to detect nuanced differences. It might be feasible that some combinations considerably worsen outcomes or improve outcomes in a way that goes beyond additive and becomes more gestalt (if that makes sense - like taking a painkiller with a cup of tea and a biscuit).

Yes. There are studies designed liked this. You can have a protocol with multiple arms in which there is a

• waiting list option (those waiting for the psychological support?)
• number of people who have opted for the psychological support (and there might be subgroups within that for different support, and maybe those who have socially transitioned and those thinking about it)
• number of people who have opted for the puberty blockers

I'm not sure it would be ethical to have an arm with puberty blockers and no psychological support. It's sad yet accurate that there are children waiting a long time for psychological support.

I hope the protocol makes all of this very clear.

Ok I'll try on Site Stuff.

Maybe ask on Site Stuff?

Depends what they're comparing. Psychological support plus blockers, vs psychological support alone would be fair enough.

I wish that Mumsnet HQ would ask Hilary Cass to come on here.
Not within the bounds of possibility surely as we are a huge resource of concerned parents.
So many questions to ask her.

I don’t understand why the proposed study confounds things by combining psychological support and blockers - if both interventions are tried at the same time will we really know which intervention had most or least effect. Can the effects of each be separated out?

Found this on the T UK subreddit - dunno where the op over there found it, but it looks like it’s the data finding research that Cass tasked to York University and that the adult GICs subsequently refused to engage with (leading to the new Cass style review of adult services now being undertaken by Dr David Levy).

There is lots of muttering about all the ‘transphobes’ on the Paediatric Gender Dysphoria Research Oversight Board but I must admit, the sheer volume of experienced clinicians involved makes me feel fairly positive that nothing like the GIDS @ Tavistock debacle will be allowed to happen again - it won’t be a shadowy team of Gender Ideologues in an isolated office building doing whatever the WPATH they fancy and answering to no-one (with an ever expanding NHSE funding pot keeping the whole trust afloat).

www.england.nhs.uk/commissioning/spec-services/npc-crg/gender-dysphoria-clinical-programme/implementing-advice-from-the-cass-review/cyp-gender-dysphoria-research-oversight-board/

Nottingham is often discussed as being the most favourable of the adult GICs as it’s less gatekeepy/ more compatible with gender identity ideology than say, London, which is still as far as I’m aware, run by James Barrett, who is one of the more old fashioned, paternalistic, doctor-decided-if-you-are-woman psychiatrists still working in Gender services. (The wildly differing reviews on his book seem to split perfectly between HCP and patient, with the low ratings all from the latter)

As a charitable interpretation of the advert perhaps the new service is going to be split so that it’s more experienced clinicians doing exploratory work/differential diagnosis in the early stages and then the ones who are approved for medical intervention are referred to a different psychology team, who are tasked with supporting them via that process/making sure they are still seen in clinic/supervised? One of Cass’
criticisms was the lack of consistency between clinicians so it would sort of make sense to divvy the skeptical staff and the gushy staff into two different sections of a pathway protocol (and some kids will never be referred to the gender cheerleaders?)

Jon Arcelus is at Nottingham, too.

Dr Walter Bouman has worked at the Nottingham gender identity clinic since 2007, he is a past president of WPATH and played a role in the creation of SOC8 (WPATH's latest Standards of Care published September 2022)

https://x.com/BayswaterSG/status/1765128386433978406

https://uk.linkedin.com/in/walter-pierre-bouman-87725a21

www.economist.com/united-states/2024/06/27/research-into-trans-medicine-has-been-manipulated

The reference to WPATH SOC 8 is concerning. How can they be following WPATH SOC 8 but also implement Cass?

Re the job advert - it talks about children on existing puberty blockers as well.

Also, Cass talked about all modalities of treatment of gender care requiring study - including psychotherapy. So the 'no upper limit' may not refer purely to the puberty blocker arm, if there is one, but to the whole model of gender care.

There are do many areas that require longitudinal research - social transition, the effect of therapeutic affirmation, the effect of treating comorbidites, different forms of therapeutic intervention.... these will not all fit into the RCT model. I think we can only wait for the protocol. I don't think it will be a free for all on puberty blockers.

I don’t see why you couldn’t or wouldn’t have a group that get “only” psychological support - otherwise you’ve no way of knowing if your trial group has had a better outcome than no intervention at all surely ?

I agree you can’t have a control group who are given a placebo. Surely not all children will be given PB, so why would collecting data on those not given PB not provide a reasonable level of comparison? It would not be as good quality but still valuable data.

I still think there is a big issue around informed consent.

For considerations around study | trial design, I always suggest reading Testing Treatments, a book that is free to download.

www.testingtreatments.org/

Ethics in UK studies etc: https://www.ukri.org/publications/mrc-guidance-for-applicants/ethics-and-approvals/

https://www.ukri.org/councils/mrc/facilities-and-resources/find-an-mrc-facility-or-resource/mrc-regulatory-support-centre/understanding-health-research/ethical-approval/

It's not common for ethics' discussions to be published beyond the outcomes of the decision-making. I would expect the protocol to be published near the end of the year. I may be wrong on both counts given the amount of interest in this work.

I found this explanation of the difference between a study and a trial. In brief a clinical trial is a specific type of clinical study but not all studies are trials

I reckon some parents (surely they consent on behalf of their children?) might consent to being in a group that received exactly the same amount of professional attention, but no medication.

People are often reassured and encouraged to receive regular attention from trained professionals.

How can they evaluate the outcomes without a control group?

They can't. But a control just wouldn't be workable. A control group would require that a group of children who desperately want to go on PBs are given a placebo. What child would agree to be in the control group. In a normal trial neither group would know whether or not they are given the drug or the placebo but obviously it wouldn't take long for them to realise that they had not been given the PB (because puberty would continue) and this would likely result in them either refusing to take part any longer or attempting to access the drugs elsewhere.

Are they having a control group?

They won't be having a control group no. This would be considered to be unethical and unworkable. Sterilising future gay adults however will be considered to be perfectly ethically acceptable.

Are they having a control group?

Are they also having a group of children who receive the same amount of contact with interested professionals in meetings with their parents, but no hormones?

Lots of scheduled meetings with kind professionals who are interested in your life, regular scheduled time where your parents have to attend and no siblings allowed; it's obvious that this is going to go some way towards answering the needs of some of these children.

But presumably any gains would be attributed to hormones unless they are also studying other groups.