Cass report, quality of evidence in evidence-based medicine and double-blinding

I hope to keep discussion strictly on the methodology aspect, but I noticed how many of the issues overlap with the general problem of evidence-based medicine, the arbitrary application of standards, seemingly based entirely on preferences, and how very low quality evidence can influence real life clinical decisions.

I'll let Copilot/GPT4 summarize the issue broadly:

And I saw that the report apparently filtered out some studies that showed good outcomes on the basis of not being double-blinded, but kept some that showed negative outcomes that weren't double-blinded, confirmed by Copilot/GPT4:

I noticed this because of this cartoon, which by simply replacing a few words applies perfectly to, well, all of evidence-based medicine as applied to us for the last few decades:

Almost all of those issues apply to us, and conclusions clearly go whichever way the lead authors of a review want to.

To me all this shows is how completely arbitrary not only all of evidence-based medicine, but how utterly dysfunctional and broken the use of PROMs, how they become valid when people like their results and invalid when they don't. EBM is clearly mostly just opinions propped up by pseudoscience.

(Let's really keep this to methodology and evidence, this is a controversial topic and its relevance is strictly about how completely arbitrary the process of EBM is)

 

I'm reading Time to Think by Hannah Barnes which is an examination of the inside story of GIDS and goes into detail about the lack of evidence, poor methods, difficult work culture, mission creep etc. It's well written and balanced with detailed examination of the issues.

 

Guess who's going to lead the new Children and Young People’s Gender Dysphoria Research Oversight Board? Why, it's our old friend Sir Simon Wessely.

I am highly sceptical of the way the Cass Review tries to use NICE-like arguments around evidence quality, for the reasons rvallee points out, but also because of this. If you read closely, you'll find the same slippery use of referencing -- sources which don't actually back up the argument made, or which are reported on selectively. I think there was a conscious decision to appropriate what worked against GET in ME and apply it to another area in which people wanted to make unevidenced recommendations. They also didn't include trans people in the decision-making, unlike NICE, and didn't engage with charities (again, unlike NICE).

In this case, exploratory therapy also comes with some major ideological baggage and a lack of evidence. A refusal to ban "exploratory therapy", in particular, raises alarm bells much like GET does for us, or ABA does for people with autism. It is conversion therapy, and those using it have professed that they wish to cure or eradicate "transsexualism" (or similar terms), so we have to be cautious of the "GET is only pacing" approach being used here, too.

I welcome better quality research in the area, but not the way Cass uncritically accepts other therapies and approaches which are also unevidenced, and the strange ideological language used throughout.

I haven't read Barnes' book, although my own assessment of reading multiple reports was that GIDS' biggest failing was that it was under-resourced to deal with its huge waiting lists and this led to inconsistent treatment and record-keeping. In theory, replacing it with multiple new clinics is a lot better, as is better access to testing for neurodiversity (though ADHD and ASD services are also experiencing a crisis in funding and waiting list sizes). That part, I think, most people are agreed on. As always, though, the devil's in the details.

 

Listened to a brief stats podcast (BBC radio “More or Less”) about how they assessed the evidence (due to lack of RCTs).
It’s called the Newcastle-Ottawa Scale.
(Wikipedia has https://en.wikipedia.org/wiki/Newcastle–Ottawa_scale)
Here’s a random (did an image search) copy of the sorts of factors assessed in such a scale:


Does anyone have a stats background and understanding of this system?

Personally have not read the Cass report.

My impression is that it said that the evidence is poor (I.e. we need to do better in studying this stuff, something we on this forum find is all to common in far too much ‘medical research’). And that one of the reasons for that in this case is that we’ve not been studying the outcomes for these young people for long enough. As in the studies usually had a lack of long term followup.
If that is indeed the case, I’d agree with that as a criticism. It comes up a lot for pwME too (it’s easy for me to report a benefit in the short term but with longer followup we get a better picture of outcomes for me).

As for what they recommended, that’s another thing again.

 

This is an appropriate thing to do, for two reasons.

One is that safeguards like double blinding are there to avoid bias, which is nearly always bias towards a positive result. A negative result usually stands pretty well without double blinding.

The other is that the bar for noting risk of harms is always much lower than the bar for establishing benefit. That does not always apply if harms and benefits are pretty equivalent - as in influences on mortality in a cancer trial, plus or minus, but even there the principle of first do no harm is generally understood to be based on a human value judgment that causing additional harm outweighs causing benefit. In the situation here it is reasonably clear that an irreversible decision to alter physiology could produce a devastatingly bad effect life long, which probably does outweigh any speculative benefit of intervening early.

Harms cause guilt and guilt is one of the most distressing and long-lasting emotions.

 

One aspect I found troubling is that Cass wanted the NHS clinics providing gender-related care to provide the medical records of their patients to her preferred group of researchers at the University of York on a opt-out basis on the grounds that, because they planned to look at ~9000 records, "it is not feasible to get individual consent".

It doesn't seem at all infeasible to me - informed consent is far too important a principle to be discarded so readily. That the Government is apparently minded to insist that the various NHS clinics hand over the records seems to me to be setting an appalling precedent.

 

Usually anyway. Not for us, that's for sure. In fact even noting any harm is met with hostility, we're just being negative, taking away people's hope. This unequal application of standards is, well, non-standard, all over the place, arbitrary, motivated, biased, and so on.

 

Although that's not quite fair. With us they simply work around it by asserting that harm is impossible, and accordingly not recording incidences of harm related to the illness, only those like hospitalizations, heart arrests, injuries and other types of possible harm from exercise.

And ignoring a huge number of reports of harm outside of those trials.

 

The downgrading I don't have a particular issue with. My issue is more with what's used to "fill the gaps".

E.g., there are trials that weren't downgraded, where all the people who didn't respond to follow-up were automatically deemed, en masse, to be "treatment desisters" and thus all of them were also assumed to be "detrans". But we can't infer that; it's like jumping from "we can't find anything wrong on standard tests" to "there's nothing wrong".

I'm also doubtful that the research oversight board headed by Wessely will have the rigorous standards we need to answer any questions that remain anyway. The NHS's plan for a new study into puberty blockers is also the only legitimate gateway for most young people to access those treatments now, so it creates an incentive for people to sign up to the trial and report benefits.

By contrast, there aren't any new studies looking at the long-term impact of blockers on adult trans people or people who had precocious puberty -- which could help answer a lot of questions about long-term effects and harms.

In the meantime, the use of blockers and cross-sex hormones bought online will increase without medical oversight. A lot of data will therefore fall through the cracks and young people will be reliant on costly and potentially unsafe medicines. Those who can't afford this will, as prior studies have shown, be at heightened risk of mental health problems, self-harm, risk-taking behaviours and suicide.

We already have the problem that many adults who can't otherwise afford to go private and who can't wait for NHS treatment (with waiting lists several years long) fund their own treatments overseas. Speaking frankly, many people turn to sex work to afford this, since the alternative is often unbearable for them (and holding down standard, never mind well-paying, jobs while trying to transition without any help is really hard). For children, who are also at the whims of their parents, the situation could feel a lot more bleak. (Sidenote: The biggest risk to LGBT kids is often their parents.)

In the case of ME, we have a consistent body of patient literature reporting harms for over 20 years. There hasn't been the same body of evidence for trans and gender diverse people. In fact, most trans and gender diverse people are very pleased with the treatments they receive, with a reported regret rate of 1% in most studies (lower than for knee operations, IIRC).

Of those who stop treatment via a clinic, most do so because they reach a point they're comfortable with and so they don't seek further medical intervention. They may have a prescription for cross-sex hormones but they don't need to keep engaging with a clinic for that.

It's also common for people to be more adamantly "performative" at the beginning of their journey, because that's often what's needed to convince medical gatekeepers (not to mention friends and family) of how genuine their feelings are. But once they begin receiving treatment, they're actually usually happy to stop at the point that feels right for them, and then they sort of ease into a more nuanced expression of their identity.

That's why many newly "out" trans girls wear pink and grow their hair really long, but later on are perfectly happy wearing whatever. They feel they no longer have to "prove" their gender identity to anyone. But to an outsider, this might look like regret or them "getting over it" -- in fact, its the opposite.

Most who actually "detransition", in the way the anti-trans lobby means it, report doing so because of social pressure from friends, family, etc. I.e., because they experience transphobia and return to the closet. Some who have "detransitioned" and have gone on to "retransition" again, especially when free of family and "friends" who caused them problems.

Yet the Cass Review makes quite baffling claims like saying it's easier for kids to come out as trans instead of gay, when that's definitely not the experience of most LGBT people (and many trans people are also gay, bi, etc, or ironically "become" gay or bi when they transition to their new gender).

It just reads like a review that hasn't had much actual input from people with lived experience. It also lacks the transparency of something like the NICE guidelines, and it can't be separated from the politics of those who commissioned the review.

The reality is that most trans and gender questioning young people won't seek a medical route for transition anyway, and of those who do, it's mostly puberty blockers and "watchful waiting". Cross-sex hormones and surgical interventions are usually given only in adulthood, and the latter are usually quite rare (because they're irreversible, invasive and often not wanted by most trans people).

There's certainly debate about how reversible blockers are, but the same can be said about puberty. Once people go through it, the cost for "correcting" the "side effects" becomes much higher -- if we deny people the time to wait and figure things out, they may actually be more likely to seek those surgical, even less reversible treatments later on. They may also be permanently disqualified from, say, certain sports because of the changes they've undergone, so we're effectively punishing those people twice (forcing them to go through puberty for a sex they don't identify with, and then saying they can't participate in certain areas of life because we made them do that). So we have to balance the risks there, too.

Puberty blockers are also used in precocious puberty (often at much younger ages) without huge outrage, and without any noticeable impact on reproductive health. (Which is why I think longitudinal studies of these patients could be indicative for trans/gender diverse kids.) Given that we are in the middle of a moral panic about trans people and "trans contagion", that's relevant context. When Paul Garner argues that George Monbiot is causing a spread of Long COVID just by writing about it, it's a similar argument. Ditto the argument about pwME and "online support groups".

What concerns me most about Cass is how it's already being used to advocate for a conversion therapy approach based on similar rationales to CBT for ME, and has already contributed to deepening prejudice against trans people (along with the DfE's schools guidance). This has very real impacts on people's lives.

From the perspective of pwME, however, the main concern is about Gillick competence. Gillick competence is the principle that people under 18 can make informed choices about their own healthcare if certain criteria are met. This is what allows teenagers to access sexual health services without parental consent, for example, which has been useful in reducing teen pregnancies and STDs.

For young people with ME, it also means they can advocate for themselves and decide which treatments they do or don't want.

Obviously, the principles of Gillick competence aren't applied consistently for kids with ME anyway. If adults can't choose what treatments they can/can't have without paternalistic doctors deciding for them, then it's clearly going to be even harder for kids.

But we don't want to lose those rights altogether. The Cass Review makes a meal of the "human brains aren't developed until 25" thing, and gives very little weight to the wants and needs of the children/young people by comparison. Given how quickly NHS England is acting to put the Cass recommendations into practice (again, compared to ME), we need to remain vigilant in case that sort of attitude becomes more commonplace elsewhere.

 

I came across this article by Jennie Kermode, "The Cass review: trans care or trans scare?"
https://yorkshirebylines.co.uk/politics/the-cass-review/

I was struck by how much similarity there is between the issues we've had to face as ME/CFS patients.

A couple of things stood out:
"100 of the 103 studies on the use of puberty blockers and hormones, were ruled out"
= essentially cancelling the patient voice.

Also:
"The methodology for the Cass review was established by a team from the University of York including Tilly Langdon, who has previously been involved in promoting Gender Exploratory Therapy – an approach which, despite its neutral-sounding name, discourages children from identifying as trans and has been likened to conversion therapy."

Doesn't this smack of the PACE-type CBT used in ME/CFS, designed to address "unhelpful illness beliefs"?

Soon after the Cass report was published, the Guardian wrote this article:
https://www.theguardian.com/society...er-vile-abuse-over-nhs-gender-services-review
"Hilary Cass warned of threats to safety after ‘vile’ abuse over NHS gender services review
The paediatrician, who has been advised to stop using public transport, describes ‘straight disinformation’ about report"

I mean, isn't this just a rehash of the Guardian's story regarding Simon Wessely claiming death threats from CFS patients?
... where Wessely's parting comment was: "That has taken me to Iraq and Afghanistan where quite frankly I feel a lot safer – and I don't mean that as a joke." ?
https://www.theguardian.com/society/2011/aug/21/chronic-fatigue-syndrome-myalgic-encephalomyelitis

Sorry if I'm straying into territory that this forum is not set up for, but as @rvallee said in his opening post, almost all these issues apply to us.

It seems the same tactics are being used

• to silence the patient voice
• to frame patients as dangerous and unhinged
• to frame the providers of "Gender Exploratory Therapy" as benevolent, science-based = 'only trying to help'?

Sinister stuff. There's definitely an agenda here and the tried and trusted methods are being rolled out full force.

 

I listened to the episode of the Newsagents podcast https://www.globalplayer.com/podcasts/episodes/7Dri7Jv/ with Hannah Barnes, who wrote the book about it, and thought much the same.

You could have swapped GIDS for the word ME as they were saying exactly the same things. Frighteningly so.

 

Exactly. And on a slightly fatuous note: Gender Exploratory Therapy = GET. So...

Maybe Sir Simon has a thing for people GETting it?