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New PACE paper, more SMC spin.

Tom Kindlon

Senior Member
Messages
1,734
Another substantial BMJ e-letter on the UK£5 million PACE Trial, this time from Alem Matthees.

He highlights various changes to the protocol.

He also highlights how the recovery criteria are much easier than planned (and there was an error in the justification given for changing them).

http://www.bmj.com/content/350/bmj.h227/rr-16
Erica Verrillo has done a new (Jan 30) piece on this:
Australian Researcher Challenges Measures of "Recovery" in PACE Trial:
http://cfstreatment.blogspot.ie/201...challenges.html#sthash.bmmt0iZc.e2e3nZ3D.dpuf
 

Dolphin

Senior Member
Messages
17,567
.
Trudie Chalder has just made a response in the BMJ Rapid Responses on 'Tackling fears about exercise':
http://www.bmj.com/content/350/bmj.h227/rapid-responses
.
29 January 2015
Trudie Chalder
Professor
Kimberley Goldsmith, Peter White, Michael Sharpe, Andrew Pickles
King's College London
.

(This may have been discussed before)
Chalder et al. BMJ e-letter said:
Whilst some correspondents have complained that the primary outcomes of the trial were self-rated, we argue that these are the most appropriate measures to judge improvement in an illness that is currently defined by symptoms.
Note that the Mediators paper revolved about two outcome measures: a fatigue scale (the chalder fatigue questionnaire) and a questionnaire that asks about physical functioning (the SF-36 physical functioning subscale).

The point they raise about symptoms only applies to one (fatigue). It doesn't explain why a subjective measure of physical functioning would be better than a more objective one.
 

Countrygirl

Senior Member
Messages
5,429
Location
UK
Margaret Williams has just had her second comment accepted by the BMJ, leaving Prof White squirming on the hook...........hopefully.

http://www.bmj.com/content/350/bmj.h227/rr-23

In their rapid response, Professors Trudie Chalder and Peter White et al state: “in an illness where exercise increases symptoms, we believe that being cautious about engaging in activity is understandable” (1).

Do the PIs mean by this that they themselves believe caution is necessary, or do they mean that they understand why patients are cautious about engaging in activity?

In order to avoid “intellectual embarrassment” (2), as Chief Principal Investigator of the PACE trial, could Professor White explain this apparent change of direction because, referring to “exercise treatment” in chronic fatigue syndrome, he is on record as advising patients with CFS to continue exercising regardless of symptoms: “If patients complained of increased fatigue they were advised to continue at the same level of exercise for an extra week….All patients were instructed to continue with regular exercise” (3).

For the avoidance of doubt, Professor White has declared categorically that he believes “CFS/ME” to be a behavioural disorder (4) and the PACE trial Therapists’ Manual on CBT is clear that they were actively to discourage participants from seeking medical advice about symptoms they developed during the trial: participants were encouraged “to hold off having further investigations until after they have completed a course of CBT” (5).

The Therapists’ Manual on GET is equally forthright: “Participants are encouraged to see symptoms as temporary and reversible, as a result of their current physical weakness, and not as signs of progressive pathology” (6).

Such directives are very far from “being cautious about engaging in activity”.

Furthermore, perhaps Professor White could explain another post-hoc change of direction in the PACE trial.

The PIs received ethical approval to study what they themselves referred to as CFS/ME: the Patient Clinic Leaflet that encouraged patients to become PACE Trial participants stated: “Chronic fatigue syndrome” is “also known as post-viral fatigue syndrome, myalgic encephalomyelitis (ME) or myalgic encephalomyelopathy (ME)…..Medical authorities are not certain that CFS is exactly the same illness as ME, but until scientific evidence shows that they are different they have decided to treat CFS and ME as if they are one illness” (7).

However, just after publication of selective results of the PACE trial in The Lancet online in February 2011 Peter White wrote to the senior editor of The Lancet in the following terms: “The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME” (8). Professor White was, however, funded to the tune of £5 million to study “CFS/ME” (9).

Such inconsistencies leave not only patients but also their clinicians at a loss.

References
 

ljimbo423

Senior Member
Messages
4,705
Location
United States, New Hampshire
I bought a treadmill and started doing a very slow jog every other day in 1993. I continued to jog for about 10 years. I could never get past 15 minutes of jogging at a very slow pace, my body just could not adapt to the exercise.

No matter how small an increment I tried to increase the time by. I still could not get past 15 minutes even after 10 years without crashing. It is clear to me now, that my body just could not heal and strengthen like it should.
 

Dolphin

Senior Member
Messages
17,567
(In case anyone missed it)
The journalist, David Tuller DrPH, has today posted a substantial piece on the PACE Trial:

TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
http://www.virology.ws/2015/10/21/trial-by-error-i/

There's an introduction and summary at the start if you don't want to take on the whole thing.

It's being discussed in this PR thread:
http://forums.phoenixrising.me/inde...he-pace-chronic-fatigue-syndrome-study.40664/

ME Network have also posted their own summary piece:
http://www.meaction.net/2015/10/21/david-tuller-tears-apart-pace-trial/