GETSET (white) in Lancet 22/06/17

[Sean]

Julie's story is not just fiction, it is a despicable fraud. Nothing in that resembles the reality of ME/CFS in any way at all.

Apparently Julie's CFS is defined as not being quite fit enough to make it up Mt Everest without oxygen. If Julie has CFS, then so does everybody.

Furthermore, if Julie is in any way representative of the patients selected for the study, then the tiny shift in subjective scores for a small number of patients that the study's authors are crowing about is even more meaningless and pathetic than it first seemed.

 

[Sean]

https://t.co/Ctm3Q0cCBL

However, most patient organisations in the UK do not recommend treatments based on GET, and even suggest they can be damaging, which makes a positive expectation less likely.

Yeah, yeah, it is all our fault.

Gutless mongrels.

 

[Dolphin]

Those who started off with an SF-36 physical functioning score of 45 or more only ended up at an average of 54.9. This is nothing close to a ceiling score. Healthy people of working age tend to score 95 or 100.

I read it as a ceiling of benefit of GET rather than reaching the ceiling of normality. So for example if the maximum gain that could be had was to say 60, a person at 45 who improved to 60 did better than a person at 55 who improved to 60. I'd have to reread it to see whether I understood them properly

Perhaps the language is ambiguous. But I don't think Peter White would go on record and say that you can only get up to a SF-36 physical functioning score of 60 with GET. He doesn't believe there is a ceiling of activity below normal functioning. Everyone with CFS can do more until they are healthy. The entry level for the PACE trial was 65 or less. They wouldn't use that threshold if they thought people could only get up to 60. 60 is a very low score.

Figure 1. Distribution of SF-36 physical function scores from the subsample of Bowling et al's. [18] British community participants who were aged 18–59 and without long-term illness or disability (as calculated from the published data [17Office of Population Censuses and Surveys. Social Survey Division. OPCS Omnibus Survey, November 1992. UK Data Service. 1997. DOI:10.5255/UKDA-SN-3660-1[Google Scholar]]). Also presented for comparison are: (a) the recovery criteria specified in the original protocol [12White PD, Sharpe MC, Chalder T, et al. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol. 2007;7(1):118. doi: 10.1186/1471-2377-7-6]; (b) the revised criteria used in the recovery paper [3White PD, Goldsmith K, Johnson AL, et al. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013;43(10):2227–2235. doi: 10.1017/S0033291713000020 ] and (c) mean scores for several chronic illness populations.

http://www.tandfonline.com/doi/figure/10.1080/21641846.2017.1259724?scroll=top&needAccess=true

 

[Tom Kindlon]

5. How do you know that GET does not cause harm?

Surveys undertaken by patient organisations report that some people with CFS/ME found that GET was harmful to them; however, deeper analysis of one of these surveys suggests that this may be because the exercise was not necessarily delivered by trained GET therapists, was probably provided at too high a level of intensity, or without taking into consideration the patient’s response to exercise.

http://www.wolfson.qmul.ac.uk/images/pdfs/getset/FAQ How should CFS ME be treated.pdf

They may be referring to the Gladwell et al. paper. The lead author was a physiotherapist and I think spun the results a bit. I had a letter published in reply:

Elements of rehabilitative strategies associated with negative outcomes in CFS/ME: The need for further investigations
https://www.researchgate.net/public..._in_CFSME_The_need_for_further_investigations

 

[Dolphin]

6. How do we know that the results were not biased in any way?
Bias means that the results were incorrect because of a limitation in the methods. There are many forms of bias:
Bias in design and conduct of the trial: The trial was subject to independent scrutiny by both a Trial Steering Committee and a Data Monitoring and Ethics committee throughout. A patient charity helped to design, implement and oversee the study throughout its existence. A patient representative also sat on the trial management group.

Outcome measurement bias: This can sometimes occur when the research assessor knows which treatment each participant has received, as in this trial. However, as the participants rated the main outcomes themselves, any measurement bias would have been determined by participants themselves. It is possible that participants expected GES would work better than SMC. However, most patient organisations in the UK do not recommend treatments based on GET, and even suggest they can be damaging, which makes a positive expectation less likely.

Bias in assessing safety outcomes: These were reported by participants themselves, and finally assessed by independent scrutineers, so this is unlikely.

Bias in the analysis: The statistician who analysed the main results did not know which outcome data referred to which treatment, so this is unlikely.

Whilst it is never possible to completely eliminate all bias in trials we are confident that the findings of the trial were not significantly affected by bias.

http://www.wolfson.qmul.ac.uk/current-projects/getset-trial#faqs

A pretty ridiculous statement to make in a nonblinded, open-label trial that has so far just reported subjective measures.

 

[Tom Kindlon]

Just a reminder that people can submit letters for publication. You don't need to have any specific qualifications to do this (I have had I think 18 letters published in journals but have no degree).

I'm not sure I will submit one myself on this occasion but should be happy to help if somebody does a draft and/or I may be able to pass it on to others who might be able to help.

The Lancet published 8 letters (including one by me) in reply to the PACE trial 2011 and 2 letters (including one by me) in reply to the FITNET trial in 2012. The Lancet Psychiatry journal also published some letters in reply to a PACE Trial paper.

Correspondence
• We welcome correspondence on content published in The Lancet or on other topics of interest to our readers

• Letters for publication in the print journal must reach us within 2 weeks of publication of the original item and should be no longer than 250 words

• Letters of general interest, unlinked to items published in the journal, can be up to 400 words long

• Correspondence letters are not usually peer reviewed (we rarely publish original research or Case Reports in this section), but the journal might invite replies from the authors of the original publication, or pass on letters to these authors

• Only one table or figure is permitted, and there should be no more than five references and five authors

• All accepted letters are edited, and proofs will be sent out to authors before publication

• Some letters might be chosen for online-only publication

http://www.thelancet.com/pb/assets/raw/Lancet/authors/tl-information-for-authors-may-2017.pdf

 

[Dolphin]

Yet another publication with misleading conclusions from PACE-land
Lou Corsius
https://corsius.wordpress.com/2017/...th-misleading-conclusions-from-pace-land/amp/

 

[RogerBlack]

http://www.virology.ws/2017/06/24/trial-by-error-continued-is-pace-a-case-of-research-misconduct/

Next post: The Lancet’s awful new GET trial

If you appreciate my work, please consider supporting my crowdfunding effort , which ends June 30th.

 

[Snow Leopard]

I missed this discussion as I've been away...

They claim that graded exercise is safe due to a lack of an increase in adverse effects reported - but this is not evidence at all as they haven't provided any objective evidence that patients actually did any exercise or increased their activity levels.

Graded exercise therapy in CFS doesn't increase fitness, or activity - it is a psychological therapy designed to alter people's beliefs. This particularly affects short term questionnaire answering behaviour. The trial protocol is inadequately designed since short term questionnaire results are simply untrustworthy in unblinded trials, as pointed out by a number of others.

 

[TiredSam]

If you are trying to stop the NICE guidelines being reviewed, or if you want any review to continue to recommend GET and CBT, then bringing out a paper just before the review of the decision to review with "NICE" splashed all over it allows you to say "see, our paper is most relevant to NICE, we used the actual diagnostic criterea, so it's bang-on relevant." Never mind that the NICE criteria aren't intended for use in studies - "it's NICE, and you're talking about NICE, so it's a perfect fit, geddit?"

Nice to see that Julie goes out after work on a Thursday night for 3 hours. Hang on - after what?? I wonder what her Friday looks like after that.

On Friday evening, after her full working week and having been out the night before, Julie is allowed to cook/eat for an hour and then she studies for an hour on Friday evening.

You have to be absolutely shitting me.

 

[Jenny TipsforME]

Probably best to spin this off into its own thread.

I'm just being a bit cheeky asking here because I know people already on this thread have informed opinions on existing disability scales/questionnaires

Ah, then just the Bell's.

Yes could be a good one thanks (actually we could maybe use for part of participant criteria)

The Clinician's Guide to the Institute of Medicines report has a nice list that could be worth working through to see what might suit your purposes? From p.13 of this document: http://www.nationalacademies.org/hmd/~/media/Files/Report Files/2015/MECFS/MECFScliniciansguide.pdf

We'll have a look, thanks

 

[Molly98]

If you are trying to stop the NICE guidelines being reviewed, or if you want any review to continue to recommend GET and CBT, then bringing out a paper just before the review of the decision to review with "NICE" splashed all over it allows you to say "see, our paper is most relevant to NICE, we used the actual diagnostic criterea, so it's bang-on relevant." Never mind that the NICE criteria aren't intended for use in studies - "it's NICE, and you're talking about NICE, so it's a perfect fit, geddit?"

Nice to see that Julie goes out after work on a Thursday night for 3 hours. Hang on - after what?? I wonder what her Friday looks like after that.

You have to be absolutely shitting me.

Julie's stabilized diary

If you are trying to stop the NICE guidelines being reviewed, or if you want any review to continue to recommend GET and CBT, then bringing out a paper just before the review of the decision to review with "NICE" splashed all over it allows you to say "see, our paper is most relevant to NICE, we used the actual diagnostic criterea, so it's bang-on relevant." Never mind that the NICE criteria aren't intended for use in studies - "it's NICE, and you're talking about NICE, so it's a perfect fit, geddit?"

Nice to see that Julie goes out after work on a Thursday night for 3 hours. Hang on - after what?? I wonder what her Friday looks like after that.

You have to be absolutely shitting me.

Julie's diary

I wish I had what ever disease Julie supposedly has!

 

[TiredSam]

Ah, she has 3 ten-minute rests per day while at work. I must try that.

Wait a minute - I have tried that!

On Mondays I go to work for 6 hours, 20 minutes of which involves me locking my office door and lying on the floor. When I get home I go to bed for two hours, no going out on Monday evening for me. I also have to take Tuesday morning off.

Three hours work max on Tuesday afternoon. Wednesday I teach for 2 hours in the morning, come home and go to bed, then teach for 3 hours in the afternoon. Thursday I do 4 hours in the morning every 2nd week. That means staying home Thursday afternoon and evening.

Before I banned myself from making appointments in the evenings or Tuesday morning or Thursday afternoon, Tuesday and Friday were headache days. I used to go out for 3 hours on Thursday evening too, just like Julie, to do voluntary work. That had to stop, along with all my social life and hobbies, if I was to carry on being able to teach 15-20 hours a week fairly symptom free.

I usually have Friday, Saturday and Sunday completely off, as in doing absolutely nothing except sitting on my sofa with a laptop, in order to be able to do it all again the next week.

So thanks Julie and Peter White, I'll call you if I need any advice. FFS.

 

[Barry53]

Lots of things are subjective, pain let's say. So if I'm in front of a doctor being asked to rate my pain level 1 - 10, the resulting number will of course be subjective. The clinician may also have to provide some subjective input. These numbers may then get fed into further calculations and clinical process as the patient's condition is investigated and treated. The subjective bits will effectively leave breadcrumb trails through the whole process, and though it may get a bit opaque according to what is being done, the subjectivity will be trackable and identifiable.

Providing the science properly accounts for all this, and the clinical tools and procedures are properly based on this good science, then the patient is in with a good chance.

The crucial thing though is that the science underpinning it all has NOT been developed subjectively, but is as rigorously objective as it possibly can be. This way the clinician and patient know that any subjectivity does not also include generic subjectivity, picked up from the dodgy tools and procedures etc. along the way.

So even though the clinical situation involves accepted and understood subjectivity, the science underlying it all does not and must not. This seems to be an alien concept to the PACE team. They live in a subjective world, and seem to at best pay lip service to objectivity in the development of their supposed science.

How did this bunch of shamans ever get to run a clinical trial?

Do clinical researchers not have to be properly licenced or something?

 

[Valentijn]

That bastard can shower every day?!? It's also astonishing that the quacks rate showering as being approximately as strenuous as resting. Those are some serious Grade A morons.

 

[TiredSam]

It's also astonishing that the quacks rate showering as being approximately as strenuous as resting.

An hour of phone calls to friends also as strenuous as resting.

 

[Barry53]

An hour of phone calls to friends also as strenuous as resting.

You'd think they don't really understand what ME is

 

[Londinium]

Julie's stabilized diary

Julie's diary
View attachment 22091
I wish I had what ever disease Julie supposedly has!

Arguably this calls into question whether partipants really did meet the NICE criteria for diagnosis, given the NICE guideline requires that the patient

• has resulted in a substantial reduction in activity level

Julie's week doesn't look like a substantial reduction to me.

 

[Solstice]

That bastard can shower every day?!? It's also astonishing that the quacks rate showering as being approximately as strenuous as resting. Those are some serious Grade A morons.

Well to be honest it's one of the few things I can still do every day. That and 3 hours of browsing stuff I can't comprehend before being couchbound the rest of the day. It does take something out of me though, showering. Doesn't same they have a very good handle on exactly what m.e. is.

 

[Luther Blissett]

@Karen Kirke , Thanks for finding these particular 'diaries' and drawing our attention to them. I hope you made it back safely from the surreal environment you found yourself in!

Suddenly everything has taken a bit of a

“We were somewhere around Barstow, on the edge of the desert, when the drugs began to take hold.”
― Hunter S. Thompson, Fear and Loathing in Las Vegas

turn.

They are the Las Vegas of ME Researchers.