PACE Trial media coverage UK

[Peter Kemp]

Do you like spin? Now available as PDF or Doc: examples of media coverage of the PACE Trial:
http://www.scribd.com/doc/112487732/Media-Coverage-of-the-PACE-Trial

Some PACE Trial details in easy to read bullet points as doc or pdf:
http://www.scribd.com/doc/110421439/The-PACE-Trial-Psychiatrists-Spinning-Out-of-Control-4

An alternative cost analysis of the PACE Trial:
http://www.scribd.com/doc/112491377/An-Alternative-Cost-Analysis-of-the-PACE-Trial

 

[Sparrow]

I've only read the last one so far, but it was excellent. Thank you for posting these.

 

[Esther12]

Thanks Peter. I only had time to look at the first one, but that looks like a really handy resource. Ta for your work collating it all.

 

[Bob]

A handy resource, and interesting analysis. Thanks Peter.

 

[Esther12]

Hi Peter.

I've just looked through the second one, and had some comments. I thought it was sometimes written in an overly inflammatory manner, but didn't know who your audience is.

The Science Media Centre ‘expert’ for M.E. and CFS news stories is Professor Simon Wessely who was in the PACE Trial management group. For many years he has claimed that M.E. and CFS are psychological illnesses. He stated: "I will argue that ME is simply a belief, the belief that one has an illness called ME."
(Microbes, Mental Illness, TheMedia and ME: Institute of Psychiatry, London, 12 May 1994)
News Coverage of t

I think that people could argue this is unfair. It's really f-ing hard to summarise Wessely's approach to ME/CFS. Personally, I think it's best not to try, but if you were to I think it's fairer to say that he claims that ME and CFS should be treated as psychological illnesses rather than that they are psychological illnesses.

re

"'...must have had complete control over the information given to the Press"

That sounds too strong, as they were not stopping others from commenting, just providing them with no place to do so, and no advance access to the paper. Something like "...chose to present information in a way which led to an exaggerated view of the efficacy of their treatments, while the SMC provided no commentary from those critical of their work" would prevent any confusion.

The PACE Trial relied almost entirely on subjective measures (questionnaires). This is a contradiction. The Trial treatments GET and CBT were based on theories that participants are not physically ill but are incapable of accurately interpreting their own symptoms because of phobia and hysteria. Yet the opinions of these supposedly delusional participants are considered reliable to provide data for a clinical trial.

I think that there are aspects of that which are too strong (eg inappropriate interpretation of normal sensations is a common theme of psychosocial work, but hard to summarise), and that the point about the problem with merely measuring questionnaire taking behaviour could be strengthened by mentioning here that they dropped the use of actometers as an outcome measure after actometers had been purchased, and that 3 other trails have shown CBT leads to improvements in questionnaire results without leading to an increase in the amount of activity patients can carry out.

A 6 Minute Walk Test was the objective measure used at the start and end of thetreatment. However,
the researchers did not follow the protocol for the 6 Mi
To obtain reproducible data with this test a practice walk is required butthis was omitted without explanation and without being declared.

I didn't know about the practice walk part. Do you have any extra details for that? Ta.
CE Trial participants

White et al and safety monitor Miller, seem to view M.E. and CFS patients as somewhat loony. The ‘good’ thing about tampering with the minds of loonies is that if you screw-up and make things worse nobody is going to blame you.

Personally, I think that's pretty close to the truth. It's rather speculative though, and the language is not going to convince anyone who currently think CFS is well treated by people like White. It's another really complicated thing that it could be best to be cautious around.
Those were my thoughts. Ta.

 

[Dolphin]

Do you like spin? Now available as PDF or Doc: examples of media coverage of the PACE Trial:
http://www.scribd.com/doc/112487732/Media-Coverage-of-the-PACE-Trial

Some PACE Trial details in easy to read bullet points as doc or pdf:
http://www.scribd.com/doc/110421439/The-PACE-Trial-Psychiatrists-Spinning-Out-of-Control-4

An alternative cost analysis of the PACE Trial:
http://www.scribd.com/doc/112491377/An-Alternative-Cost-Analysis-of-the-PACE-Trial

Well done, Peter Kemp, for these documents.


I'm just going to nit-pick, but I generally would only tend to do this if a (non-published) piece is mostly good, rather than things which I think are irredeemable.

On Document 3:
Point #1:

The FINE Trial, published a year earlier, established that rehabilitation therapies do not benefit severely ill patients (BMJ 2010:340:c1777). If the PACE Trial had included 25% of severely ill patients to reflect the general patient population it is reasonable to project that ‘Positive Change’ resulting from GET or CBT would have occurred in 8%

Although the initial intention was for the FINE Trial to be for the severely affected, I'm pretty sure I read that that was dropped at some stage.
And indeed when one looks at the entry criteria:
http://www.biomedcentral.com/1741-7015/4/9 :

As GPs may experience difficulty in determining patients' levels of activity, we require that patients are sufficiently functionally impaired to score 70% or less on the SF-36 physical functioning scale [35]. Additionally, patients are required to score 4 or more on the 11-item Chalder fatigue scale [36]. In accordance with the Oxford and CDC criteria [1,2], patients whose fatigue is explained by any active medical condition are excluded, as are patients with schizophrenia, bipolar disorder, dementia, eating disorders or substance abuse.

neither requirement ensures the people are severely affected. (The full criteria are longer but they are the basics).

[Indeed, people satisfying the PACE Trial criteria for normal fatigue and functioning could enter the trial].

However, looking at the baseline data, the group does seem to be more severely affected than the PACE Trial cohort at baseline: Mean (SD) SF-36 PF (pragmatic rehabilitation group) (0-100): 30 (18.6). CFQ (0-33): 29.39 (3.46)
(average for baseline in PACE Trial: around 38 and 28 respectively).

PACE Trial participants had to be able to attend outpatient appointments which would have excluded some of the FINE Trial participants.

-------
Point #2:

The researchers decided that an SF36 score of 60 was ‘normal range’. This is 24 points below the UK mean (average) of 84 in the ‘working age population’

That is what the authors put in the paper. However, it is incorrect and they corrected it in their letter in reply to the letters:

We determined the normal range by use of the conventional mean plus or minus 1 SD from what we regarded as the most relevant general population data. For physical function, this was a demographically representative sample (in our paper we stated that this was a UK working-age population, whereas more accurately this should have been an English adult population).3

 

[Dolphin]

An alternative cost analysis of the PACE Trial:
http://www.scribd.com/doc/112491377/An-Alternative-Cost-Analysis-of-the-PACE-Trial

Some points I liked in this, for what it's worth:

- Use of SF-36 PF and CFQ questionnaires, to see the small changes achieved for the GET+SMC and CBT+SMC over the SMC alone groups (same figures would work for "improvement"). Also, used to highlight what could qualify as "normal" functioning and fatigue.

- The graphs showing the dramatic improvements seen in CFQ scores following CBT for MS trial and how final levels in PACE for GET and CBT were similar to baseline scores for MS in that:

The baseline fatigue in Multiple Sclerosis participants, which was considered severe enough to be worth treating, was virtually the same as the outcome from GET and CBT in the PACE Trial.

This part from the section, "Human Costs and Monetary Costs":

-As well as damaging a patient’s medical support; misperceptions about what the PACE Trial actually showed may lead to widespread scepticism and criticism of patients for not improving with GET or CBT. Family, partners and friends; employers, teachers etc., may withdraw support and blame the patient for not improving.

- Patients in receipt of Sickness Benefits will encounter doctors and staff from the DWP, ATOS, their employers and insurance companies who may mistakenly believe that the PACE Trial proved that M.E. and CFS can be treated with GET and CBT. They may believe that this means the illnesses are simply lack of fitness and oversensitivity to pain. As a result many could be refused state and other financial support for sickness and may be forced to claim Unemployment Benefits and actively seek and accept employment even though they are too ill to work; or depend on support from others or simply be left to starve and die