PACE Trial and PACE Trial Protocol

[Dolphin]

Newly-submitted FOI request:

From: Anna Sheridan

28 March 2013

Dear Queen Mary, University of London and the PACE Trial Management
Group

I have been following the PACE trial with interest for a number of
years, both as an ME sufferer, and as the relative of two clinical
psychologists involved in administering CBT.

I am particularly interested in the results of the 6 min walking
test,(as reported in the original PACE paper) and would be grateful
if you could provide me with mean and standard deviation results
for those who, in your latest paper: 'Recovery from chronic fatigue
syndrome after treatments given in the PACE trial.' are considered
recovered. Please break these down, if possible into therapy type.

Thank you in advance

Yours faithfully,

Anna Sheridan (Dr)

https://www.whatdotheyknow.com/request/6min_walking_test_results_for_re/new

 

[Graham]

Now that would be interesting. Call me suspicious if you like, but I think that if the results of the 6 minute walk reflected an improvement in the "recovered" group, they would have been included in the report.

 

[Esther12]

From that FOI, is it clear that they want results for patients before and after treatment? I'd expect that those classed as recovered' would have higher means than those not classed as recovered.

It could still be interesting if those who did SMC alone and APT and were classed as recovered had better 6mwt results than those who were classed as recovered following CBT and GET, as this could indicate that the 'positive' psychosocial interventions led to 'positive' questionnaire scores which exaggerated improvement.

 

[Esther12]

I was just reading a thread on this paper:

Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale.

Journal of Psychosomatic Research xx (2011) xxxxxx

Matteo Cella, Michael Sharpe, and Trudie Chalder

It makes an interesting read, now that we have the figures on employment from PACE. Sections like this stand out more:

However, occupational outcomes tend
to improve substantially for CFS patients who receive
treatment such as cognitive behavioral therapy and graded
exercise therapy [6].

Also - noticed that biophile had already criticised this claim, regardless of the fact that they were sitting on data from their own trial which contradicted it:

http://forums.phoenixrising.me/inde...-a-rct-burgess-et-al.14222/page-2#post-235243

Also another comment from Dolphin on it:

I can't remember that paper 2005 off the top of my head but most studies haven't published this data. Indeed, the famous Sharpe et al. (1996) CBT study in the BMJ was supposed to publish the data but they didn't - funny that.

Their point that...

Associations between objective
tests of physical fitness, such as the walking and the step test,
although significant, were small. This may be indicative of a
degree of dissociation between physical capacity and
patient's perception of their disability levels.

...seems important, although perhaps not in the way that they mean, given the poor results from CBT for objective measures of disability.

As they said in their protocol:

11. The Client Service Receipt Inventory (CSRI), adapted for use in CFS/ME [31], will measure hours of employment/study, wages and benefits received, allowing another more objective measure of function.

Side note: I'm not sure that I noticed that this paper was based on data from the 90s. I should go back and re-read that paper:

By the way, I think there is a good chance that this paper was written with the PACE Trial results in mind, just as I think

Measuring fatigue in clinical and community settings.
Cella M, Chalder T.
J Psychosom Res. 2010 Jul;69(1):17-22. Epub 2009 Dec 11.​

was published with the PACE Trial results in mind (it actually used data from the mid-1990s); people will recall that it was used to give the mean and standard deviation for the Chalder Fatigue scale for the general population (based on people who had attended GPs in the previous year i.e. it excluded a lot of the healthier people) when the protocol paper already quoted previous research by Trudie Chalder et al which gave a threshold for "fatigue casesness" - a definition which most likely didn't give the results they wanted (it is quite strict while the new one is much looser).

 

[Andrew]

I think it was in this thread that someone uploaded a copy of the peer review comments for the pace trial publication. I downloaded it to my computer, but now I cannot find it. Can someone point me to this please?

 

[Esther12]

I think it was in this thread that someone uploaded a copy of the peer review comments for the pace trial publication. I downloaded it to my computer, but now I cannot find it. Can someone point me to this please?

I'm pretty sure that they've not been released. It would be very interesting to see them though. Anyone want to contradict me? I may have missed them. It would be great if they were available. I don't think any of the PACE stuff has been published in a journal which makes peer review comments public.

 

[Andrew]

My mistake, the peer review comments seem to be in response to "A preliminary prospective study of nutritional, psychological and combined therapies for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in a private care setting."

 

[Bob]

I've moved this post to a more appropriate thread:
http://forums.phoenixrising.me/inde...te-usa-latest-developments.14932/#post-347080

(It's about UK government policy towards open access publishing of research papers.)

 

[Dolphin]

The PACE Trial team said this in an e-letter: http://www.biomedcentral.com/1471-2377/7/6/comments#306608

Beliefs and expectations of treatment and who is running the trial
The trial has been designed and is being managed by many different healthcare and research professionals, including doctors, therapists, health economists, statisticians and a representative of a patient charity. The Trial Management Group includes five physicians and four psychiatrists. To measure any bias consequent upon individual expectations, all staff involved in the PACE trial recorded their expectations as to which intervention would be most efficacious before their participation, and we will publish these data after the end of the trial.​

I'm pretty sure this hasn't been published. Can anyone remember any talk of the results in recent years.

This might be worth a freedom of information act request. If they are going to publish the data, they can say that.

I'm concerned this promise could easily be broken, given it isn't in the full protocol.

I think freedom of information act requests are ideally done by people in the UK.

 

[Dolphin]

Reposted from the thread on this paper:

Measuring fatigue in clinical and community settings.

J Psychosom Res. 2010 Jul;69(1):17-22. Epub 2009 Dec 11.

Cella M, Chalder T.

http://forums.phoenixrising.me/inde...ical-and-community-settings.7946/#post-348840
--------
This study was used to define normal fatigue for the PACE Trial paper in the Lancet (main one) and the recovery paper.
They used a sample of people who had attended their GP in the last year:

I happened to see the following on Twitter today:

Irish Dental Associ ‏@IrishDentists
#IDA2013 UK study of male adults shows only 15% visited their medical GP within past two years; how should dentists respond? #IDA2013

This would suggest the sample is likely not representative at all.

 

[Esther12]

Just a little point raised by someone else who was a participant in some research that invovled some psych questionnaires, and saying that they think that they filled them out really differently depending upon whether they were doing them at home, or at a medical appointment. Attending an appointment is often inconvenient/difficult, when it's just forms to be filled in at home, they can be left until you're feeling well enough to do them.

I expect that these points have been mentioned before, but thought I would repeat it anyway as it was brought up by someone being researched upon.

 

[user9876]

Just a little point raised by someone else who was a participant in some research that invovled some psych questionnaires, and saying that they think that they filled them out really differently depending upon whether they were doing them at home, or at a medical appointment. Attending an appointment is often inconvenient/difficult, when it's just forms to be filled in at home, they can be left until you're feeling well enough to do them.

I expect that these points have been mentioned before, but thought I would repeat it anyway as it was brought up by someone being researched upon.

I remember reading some research done on the SF36 scale comparing interviewer or self filled in surveys and I think they were finding differences but can't remember which way.

I think the time window of when the survey is filled in could lead to a very important source of bias if people wait until they are well enough to fill the survey in.

 

[Dolphin]

New thread:

"Use of Trial Register Information during the Peer Review Process" - only 1/3 checked
http://forums.phoenixrising.me/inde...e-peer-review-process-only-1-3-checked.22897/

I wonder what has happened with PACE Trial papers?

 

[WillowJ]

I found some data that might be helpful at some point: population norms (broken down by age) for people who have difficulty with various activities, like going up 10 stairs without resting and walking 1/4 mile (about 400 meters?)

http://205.207.175.93/HDI/TableViewer/tableView.aspx?ReportId=641

 

[Mark]

There were a couple of superb quotes on the PACE trial in the FDA Workshop; Chris Snell's analysis was particularly noteworthy. Followers of this thread might like to look them up (the video's online now) and pull out the quotes to post here.

 

[Sean]

Mark

Is that these videos?

http://www.tvworldwide.com/events/fda/130425/

If so, which one has Snell's comments?

 

[ukxmrv]

Sean, I'm looking at panel 3 at the moment. Dr Snell is about to speak at 48:35.

 

[Sean]

Ta.

ETA: Just realised that the Snell video had not yet been posted when I made my first post above. They must have been in the process of adding them as I posted.

 

[Bob]

I've just watched two speakers talk, fairly briefly, about the PACE Trial on an FDA conference video.
The 1st was Prof Peter Rowe and the 2nd was Dr Christopher Snell.
Both helpful.

Video link:
http://www.tvworldwide.com/events/f..._archive.cfm?gsid=2251&type=flv&test=0&live=0

Watch Prof Peter Rowe at: 24.00
Watch Dr Christopher Snell at: 71.30


See next post for a very brief summary of their presentations...

 

[Bob]

Very brief summary of presentations:

Prof Rowe points out that only 13% of patients responded to treatment, and that an average 3 point improvement on a 33 point scale (for fatigue) after a year of treatment, was unimpressive, and that he would expect to see more of an improvement in patients over a year (He was referring to his own work, and his expectations for the patients that he deals with.) He says that the 'modest improvements in the PACE Trial were 'significant' because of the large size of the study.
He has a short discussion of the Chalder and SF-36 PF scales, but doesn't have too much to say about them.

Dr Christopher Snell says that the 6MWDT was the only objective test used in the PACE Trial ("the only true objective measure that they had in the whole study"), and the final results for the 6MWDT indicate 'severe disability' (The reference given for this claim was: "Weber/NYHA")*.
He also notes that a large proportion of participants did not complete the 6MWDT and asks why?
He also discussed various reasons why the 6MWDT is not an appropriate or helpful test, especially for CFS patients. (This discussion might be a bit earlier, or later, in the video.)

*(Weber/NYHA: Dr Snell didn't specify the exact paper. I think he was referring to a paper that discusses walking speeds rather than the 6MWDT specifically.)