Radio on ME/CFS Sat 5th Nov 9-10amGMT

user9876

Senior Member
Messages
4,556
Likes
18,067
The people doing the reanalysis used the PACE investigators' criteria from their own pre-published protocol. And this is the first time I've heard it claimed that PACE was too small to find an effect for these therapies
There is an argument that given the small effects the trial was under powered to show anything in terms of recovery. But that is bad trial design it doesn't mean that you can substitute in an alternative 'recovery' definition. It simply means you cannot conclude anything from the trial. We should remember that the power calculations for the trial were done expecting a much bigger effect than actually happened. Of course having large numbers does tend to allow significant tests to succeed.

Looking at the data it is clear the quality of recovery is better for those in the SMC or APT group especially with the 6mwt.
 

user9876

Senior Member
Messages
4,556
Likes
18,067
This is also frustrating because we want to say study has already been done and was null. However, I'm not convinced that new FITNET improves on control issues. the control group is still doing activity management focused on increased activity.

the aim is to test the at home internet scenario.
Having a start of trial press campaign claiming one intervention leads to recovery doesn't help in getting results that could be in anyway meaningfully interpreted.

A control using alternative internet mechanisms would be good but the problem is where expectations of recovery are set up differently for different trial arms. When the only reporting mechanisms are subjective measures this will naturally lead to bias in the results. That is probably the situation in this trial but to confirm we would need to look through the manuals.

Of course it may be that internet based means ignorable and hence it becomes the control condition for the control. Having people go to sessions is not a good measure of compliance. I know that I attend work meetings from home and some I will do other stuff during the meeting and just listen in the bits I am interested in. So there needs to be a much better way of monitoring compliance to the intervention. Compliance to treatment was also not tested in PACE just turning up to sessions. But I think it is easier to lie about what you have done online.
 

eafw

Senior Member
Messages
936
Likes
3,411
Location
UK
Having a start of trial press campaign claiming one intervention leads to recovery doesn't help in getting results that could be in anyway meaningfully interpreted.

A control using alternative internet mechanisms would be good but the problem is where expectations of recovery are set up differently for different trial arms. When the only reporting mechanisms are subjective measures this will naturally lead to bias in the results. That is probably the situation in this trial but to confirm we would need to look through the manuals.
Yes, telling people that they're getting the treatment that has been "proven" to work. It's just .... ???
 
Messages
1,176
Likes
3,922
Location
Bristol
Compliance to treatment was also not tested in PACE just turning up to sessions.
A good guess at lack of difference between groups in PACE, and fewer reports of harm, is that people didn't comply with GET. Or they did it by reducing other activities. there's another study which evidences that as a pwme GET response: it is begging Peter to pay Paul.

Every one of these studies requires objective activity measures.
 

trishrhymes

Senior Member
Messages
2,157
Likes
17,719
I would love someone people respect to go around all the media and get them to publish the fact that Crawley has scuppered any validity her FITNET trial might have had before it even starts by the combination of advance publicity that claims the treatment works and subjective outcome measures. What a shambles. This is not science.
 

user9876

Senior Member
Messages
4,556
Likes
18,067
[29.52 EC] So the evidence, the best evidence that you can ever get is what’s called the Systematic Review, it’s when you look at all of the papers, and all of the research that’s ever been done, and you combine the data. And the largest systematic review, of over 1,500 people was absolutely clear, there was no evidence of harm.
Most of the small trials had no recording of harms. So it is not clear that this is a valid statement it is no evidence because we didn't look. PACE changed their definition of harm. Also you need to look at drop outs.



[30.45 EC] … and I want to say something – which is that we interviewed all the children in our trial – they really like Graded Exercise Therapy – and the only complaint that we’ve had is that we’re restricting their activity too much. So this isn’t about making children go and do more exercise, that’s probably why we don’t see harm in our trials, compared to patient report of harms, which is probably more about someone saying ‘go and do more exercise’ or themselves doing more exercise.
This sounds to me like there is activity substitution happening if they do no monitoring of what people are doing how can they draw any conclusion from the trial.
 

TiredSam

The wise nematode hibernates
Messages
2,677
Likes
21,245
Location
Germany
[30.45 EC] … and I want to say something – which is that we interviewed all the children in our trial – they really like Graded Exercise Therapy – and the only complaint that we’ve had is that we’re restricting their activity too much.

If I was a child who didn't have ME but I had to go and see a woman who, after a conversation on the phone with my parents, decided that my activity level needed supervising, I'd probably complain too. This isn't children with ME we're talking about here - they get diagnosed with Pervasive Refusal Syndrome for not following the program.
 
Messages
44
Likes
110
Is there any evidence that diagnosing children with Pervasive Refusal Syndrome is a regular occurrence, and not only isolated cases? (Obviously no details of individual cases should be discussed here) If there is, could somebody give me details of where to find it, please?
 

user9876

Senior Member
Messages
4,556
Likes
18,067
Is there any evidence that diagnosing children with Pervasive Refusal Syndrome is a regular occurrence, and not only isolated cases? (Obviously no details of individual cases should be discussed here) If there is, could somebody give me details of where to find it, please?

I think it is more complicated in my case Crawley said it had been going on for too long to be CFS. She claimed to have cured the CFS and said that my child had a disassociative disorder due to the pressures of being ill. She wrote something along those lines in a letter but then in a phone call to a CAMHS consultant she recommended a PRS diagnosis and admission to a unit in london (as reported to me from the CAMHS consultant). The CAMHS consultant said they don't do modern diagnoses like that. I was warned before hand that that could happen and told the CAMHS consultant that and I did record all the consultations (without saying I was doing it).
 

Grigor

Senior Member
Messages
462
Likes
1,049
Location
Amsterdam
To be honest I think Crawley js very good dealing with the media. She sounds totally convincing for someone who doesn't know enough about the situation . Laymen but also many clinicians . Honestly I am a bit scared of her to some degree .
On the other hand she's making a lot of mistakes which is hopeful .
But we need someone with authority to take her down and point out the mistakes and lies she's spreading around .

Simple thing is that she's very unclear with its biological , recovery is different for everyone . Everyone has its own way of feeling recovered .
On the other hand she claims that people recover and actually get better ??
So she does think with the right behavioral changes you can just get better . Which js bullocks when you have ME.
But again most people won't know. They don't know the difference between fatigue and ME . And she's great at milking it like the PACE authors .
 

user9876

Senior Member
Messages
4,556
Likes
18,067
To be honest I think Crawley js very good dealing with the media. She sounds totally convincing for someone who doesn't know enough about the situation . Laymen but also many clinicians . Honestly I am a bit scared of her to some degree .
On the other hand she's making a lot of mistakes which is hopeful .
But we need someone with authority to take her down and point out the mistakes and lies she's spreading around .
.
Remember she is doing press when her word is not being challenged and she is being allowed to say what ever she likes without question. I think an interview where she was challenged to justify her statements would be interesting.
 

Sidereal

Senior Member
Messages
4,856
Likes
17,277
Some random observations about EC appearance on BBC radio:

First time I've heard her speak. Very energetic individual. Sounds full of herself and deeply unpleasant. I would be terrified if I had to work with her or if she were my doctor. High verbal fluency gives the illusion of mastery of a subject and overall competency. Many subpar individuals mask their lack of skill in this way whereas many highly intelligent people are often quite hesitant or measured when they speak which makes them sound less impressive than you'd expect. Uninformed listeners (i.e. everyone but us here on PR) listening to this broadcast will have no doubt been impressed by someone rattling off 'facts' at 100 miles an hour. Utterly exhausting to listen to.

She is really quite typical of medical school graduates these days: not very bright, high energy, great at memorising what the masters said/wrote but zero insight/creativity/originality. This combination of factors is a huge problem when these clinicians try to become medical researchers. They think they are better than career scientists because of their MD degree but they know squat about science and they're super arrogant and condescending and great at hoovering up research funds for their shitty work. I've worked with many MDs of her calibre trying to play researcher and it was an absolute nightmare dealing with these people. :confused:

All in all, she is a persuasive speaker/advocate for her cause but fortunately for us she's nowhere near as sophisticated as the likes of SW and PDW so the psychosomatic stuff coming out of the UK should be easier to challenge now that the brighter people who are better at manipulation are nearing or entering retirement and they're passing the baton to towering intellects like Crawley and Chalder.

Her comments re: recovery reanalysis were incoherent. Word salad. I couldn't make heads or tails of what she was trying to say. Perhaps that was the intention, to obfuscate? I'm sure it sounded very convincing and authoritative to uninformed listeners.

The reanalysis didn't look at 'lots of ways you could define recovery', it simply followed the already fairly lenient recovery thresholds the PACE authors set out for themselves in the trial protocol. Those thresholds were already below healthy population norms, e.g. a score of 85 on the SF-36 was enough for recovery in PACE protocol, whereas healthy working age adults tend to score 100. So, the authors of the reanalysis didn't define recovery in some insanely strict way to get the results they wanted.

She has asked teenagers what recovery means to them and she found that everyone had their own definition. Here's a proposal, why don't we just ask teenagers to also define clinical endpoints in cancer drug trials? No? Dumb idea? Oh ok then, how about we just define recovery as you would define it in a standard dictionary meaning of the word, like being disease free and returned to premorbid level of functioning.

Patients in her clinic all sleep too much. She used the word 'always'. What advice does the venerable Professor Crawley have for the likes of many here who can't sleep to save their lives? Or people like me who 95% of the time have zero hypersomnia or insomnia and sleep 7-9 hours each night, during normal person hours? Why do we still wake up feeling worse than when we went to bed?

This illness is not caused by poor sleep. We've seen over and over again uninformed people entering this field and doing trials of sleep drugs (including a recent CMRC effort) only to discover that the patient's functioning does not improve at all if you make him/her sleep more/better with drugs. Poor sleep is a symptom of the illness not the cause!

GET in her clinic usually involves telling patients to do LESS activity. Who the heck are these alleged CFS teenagers who are too disabled to go to school but still playing football and going to ballet? Unreal. Hypersomnia and enjoyment of pleasurable activities while struggling to cope with regular stuff, man, those are the defining features of atypical depression. I don't suppose she owns a copy of the DSM? No wonder sleep deprivation works for these patients, it's one of the most acutely effective treatments for depression.

GET has now truly morphed into something totally unrecognisable from those early 1990s damaging programmes where patients were made to increase their activity levels each week no matter what. I guess they quietly learned their lesson from all the permanent & severe disabilities they've created and now GET seems to consist of a mishmash of CBT, advice to do less (i.e. pacing) and random life advice thrown in like sleep hygiene? Good lord.

She reiterated several times that she has been trying to get a large study off the ground for years, clearly referring to MEGA. It is crystal clear that MEGA is her brainchild and all this nonsense about biomed investigators and -omics is just there to bamboozle the patients and our obsequious charities into supporting a project where 12,000 fatigued people will be filling out somatization questionnaires. In the end there will be no money to recruit the severe housebound people and the -omics will probably done on some trivially small samples. I urge everyone very strongly to oppose this study and destroy it before it gets off the ground or else we'll find ourselves in the 2020s dealing with the same sort of damage and mess we're dealing with right now re: PACE.
 
Last edited:

Grigor

Senior Member
Messages
462
Likes
1,049
Location
Amsterdam
Remember she is doing press when her word is not being challenged and she is being allowed to say what ever she likes without question. I think an interview where she was challenged to justify her statements would be interesting.
True . But to be honest the interviewer did ask a lot of good questions . And she handled them pretty well . I didn't hear her speak but from what I read .
That's why it scares me. She sounds convincing even when she is lying or making stuff up.
Obviously it's easier to do when your research is based in subjective measures . But still .
Who's going to stop her ?
 
Last edited:
Messages
1,446
Likes
3,623
.
"GET in her clinic usually involves telling patients to do LESS activity."


GET as practiced in the clinics and by Crawley tells them to do less activity initially, then the graded, gradual increase in activity/exercise starts.
.
 

Sidereal

Senior Member
Messages
4,856
Likes
17,277
.
"GET in her clinic usually involves telling patients to do LESS activity."


GET as practiced in the clinics and by Crawley tells them to do less activity initially, then the graded, gradual increase in activity/exercise starts.
.
Yes, but does anyone actually increase their activity levels?
 
Messages
1,446
Likes
3,623
.
The interviewer was her colleague, who works for her. She would have been well prepared for the questions, which were designed to respond to all the protest about her being involved in MEGA, and complaints about FITNET, MAGENTA etc.

A radio phone in with questions would have been less predictable for Crawley to answer
.
 
Messages
1,446
Likes
3,623
.
"Yes, but does anyone actually increase their activity levels?"

The people who have become more ill as a result of GET did increase their activity, to their detriment.
.

Trouble is, Esther Crawley is such a thespian, we can't trust anything she says to be true.
.
 

Sidereal

Senior Member
Messages
4,856
Likes
17,277
.
Very good post @Sidereal ... just one or two points I wanted to expand on
No, you raise a good point, in theory they claim you're supposed to establish a stable baseline of activity, which can involve initially doing less, and then gradually raising your activity levels. I'm sceptical that this actually happens in real life. If it did, it's safe to assume they wouldn't so studiously avoid using objective outcome measures like actimeters in their studies.