Tuesday, February 12, 2013

Made worse by CBT or GET? The PACE Trial calls that recovery


IIME-Newslet-1302-01:

The PACE Trial recovery rates were finally published - a publication initially refused but then  forced on the Principal Investigator by patient pressure, and despite the media being used to gloss over the inadequacies and failings of the whole project.

Flawed from the start, with the goalposts changed mid-course, and ending in ignominy with requests to have the data published being met by silence or rejection, and with a media being orchestrated to stop the whole boat from sinking by making ridiculous and feeble supportive statements.

The PACE Trial was a failure!

It failed to produce any valuable data, it failed to support the biased views of those who only wish to promote ME as a somatoform illness, it failed the patients for whom £5 million of scarce funding was wasted.

Recovery was redefined to mean almost anything the authors wanted it to be as so much deviation had occurred from the original PACE protocol.[1]

Out of the four original definitions for the trial three have been changed.[2]
Recovery was supposed to be defined by meeting all four of the following criteria:

(i) a Chalder Fatigue Questionnaire score of 3 or less (out of maximum 11)

This was changed to 18 out of maximum 33
"We therefore considered a score of 18 (highest integral score below the mean plus 1s.D.) or less as within the normal range for fatigue."
(ii) SF 36 physical Function score of 85 or above

This was changed to 60 or more. The entry criteria accepted people with SF-36 scores of equal or less than 65. So patients could have entered the trial with higher scores and deemed recovered at lower scores. This does not make any sense and the investigators should have explained this as well as discussed what happened to the 78% of participants who did not recover. How many deteriorated?
See also: Revalidation Update: why doctors who use or promote CBT or GET for ME/CFS will fail their revalidation

1 comment:

Anonymous said...

The deterioration rates are yet to be published.

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