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The PACE Trial Recovery Rates

The PACE Trial Recovery Rates

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Published by Peter Kemp

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Published by: Peter Kemp on Dec 03, 2012
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09/17/2013

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The PACE Trial Recovery Rates
The PACE Trial Protocol states that:
"Recovery" will be defined by meeting all four of the following criteria:
1.
a Chalder Fatigue Questionnaire score of 3 or less
[27]
,
2.
SF-36 physical Function score of 85 or above
[47,48]
,
3.
a CGI score of 1
[45]
, and
4.
the participant no longer meets Oxford criteria for CFS
[2]
, CDC criteria for CFS
[1]
or the London criteria for ME
[40]
.This could not be more straightforward. All the data for the above must be readilyavailable. Yet the Lancet article reporting the PACE Trial results makes only onereference to ‘recovery’ and that is in a description of the rationale for Adaptive PacingTherapy (APT).For those frustrated by the omission this article will attempt to provide some figuresand analysis working from the restricted data that was published; though it cannotexplain why the researchers went to the trouble to define and publish ‘Recovery’ criteria in the Protocol then completely omitted this data in the results.The PACE Protocol states: “The trial will be conducted in compliance with theDeclaration of Helsinki”. The Declaration of Helsinki is a set of ethical guidelines formedical research which states:
 “
27. Both authors and publishers have ethical obligations. In publication of theresults of research, the investigators are obliged to preserve the accuracy ofthe results. Negative as well as positive results should be published orotherwise publicly available.
” 
Until we see the official recovery data and an explanation for the omission from theLancet article it will not be possible to evaluate why this information was withheld.In the interim some of the figures that were published in the Lancet can be used toestimate the number of recovered participants.
Recovery Condition 1.A Chalder Fatigue Questionnaire score of 3 or less
The first ‘recovery’ criteria in the Protocol is a Chalder Fatigue Questionnaire score of 3 or less. The researchers published data from the questionnaire with a differentscoring method to the Protocol (though using the raw data reconverting to the originalmethod would be a simple matter). With the method used in the Lancet a maximumof ‘9’ on a scale of 0 to 33 (0 very good, 33 very bad) is required to meet the criteriafor ‘recovery’. Here is a chart from the Lancet showing the results:1
 
This looks rather good. However, a score of ‘9’ is not even visible on this chart.Here is exactly the same data adjusted to show the full scale of the FatigueQuestionnaire ranging from 0 to 33:This does not look so impressive. The difference between treatment and control issmall. It is certainly not a difference that one would associate with an effectivetreatment.Compared to the PACE Trial’s own criteria for recovery, or to van Kessel et al, thePACE Trial results are very poor.
(Van Kessel et al. 2008. ‘A Randomized Controlled Trial of Cognitive Behavior Therapy for Multiple Sclerosis Fatigue’. Psychosomatic Medicine February/March2008 vol. 70 no. 2 205-213).
 2
 
Recovery Condition 2.An SF-36 Physical Function score of 85 or above
Here is another graph from the Lancet showing Physical Function. This also does notshow the ‘recovery’ score, which is 85: And here is the same data again expanded to show the full range of 0 to 100(100=best, 0=worst). Seen in this context the difference between groups is minor:The difference between treatment and no-treatment is smaller than the improvementseen in untreated participants. This does not accord with participants receiving aneffective treatment. The cohorts are not remotely close to ‘recovery’.3

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