PACE results for CFS - do they apply to people with the neurological disorder, ME?
Dear Queen Mary, University of London,
"Comparison of adaptive pacing therapy, cognitive behaviour
therapy, graded exercise therapy, and specialist medical care for
chronic fatigue syndrome (PACE): a randomised trial"
I request, the number of persons who found that PACE-GET, caused post-exertional amplification of symptoms.
I request the number, of people that "dropped" out of each of the arms of the initial trial, and the reasons given for the drop out.
I request the number of participants who subsequent to the initial trial, volunteered for PACE-GET, and for PACE-CBT.
I request to be provided with copies of documentation, that formed the basis for the decision, to use subjective measures for recovery, over objective measures (e.g. true resting heart rate, heart rate variability, walking test).
I request copies of the steps taken, to ensure that each arm of the study, contained a range of the various types patients; Including but not limited to the numbers of patients with primary depression and those with and those without post exertional neuroimmune exhaustion (PENE).
This is not a vexatious request.
ME and CFS are defined by WHO as different disorders. The conclusions of the PACE trial, in which patients with CFS as defined by the Oxford criteria appear to be, being extrapolated, to people with ME (ICC 2011) and/or ME/CFS (CCC 2003).
Further information is required, to understand how the PACE trial results, are at odds, with the findings of the ME patient community. The information will assist in determining, the applicability, of this study, too ME patients selected under less inclusive criteria, such as the ICC (2011), the CCC (2003).
Yours faithfully,
Ms R. Ellis
FOI 2015/F316
Dear Ms Ellis
Thank you for your email of 18^th December.
I have numbered your requests for convenience
1. I request, the number of persons who found that PACE-GET, caused
post-exertional amplification of symptoms.
This information is not held.
2. I request the number, of people that "dropped" out of each of the arms
of the initial trial, and the reasons given for the drop out.
This information is shown in tables 2 and 4 of White PD et al. Comparison
of adaptive pacing therapy, cognitive behaviour therapy, graded exercise
therapy, and specialist medical care for chronic fatigue syndrome (PACE):
a randomised trial. The Lancet 2011;377:823-36 and as such is exempt under
s.21 of the Freedom of Information Act 2000.
3. I request the number of participants who subsequent to the initial
trial, volunteered for PACE-GET, and for PACE-CBT.
Although not strictly PACE therapies, this information is available in
Sharpe M et al. Rehabilitative treatments for chronic fatigue syndrome:
long-term follow-up from the PACE trial. Lancet Psychiatry 2015:2:
1067-1074.
4. I request to be provided with copies of documentation, that formed the
basis for the decision, to use subjective measures for recovery, over
objective measures (e.g. true resting heart rate, heart rate variability,
walking test).
This information is not held beyond the explanations already in the public
domain in White et al. 2011 (see above) and White et al. Recovery from
chronic fatigue syndrome after treatments given in the PACE trial.
Psychological Medicine 2013;43:2227-235 and the response to correspondence
following that paper, please see attached.
5. I request copies of the steps taken, to ensure that each arm of the
study, contained a range of the various types patients; Including but not
limited to the numbers of patients with primary depression and those with
and those without post exertional neuroimmune exhaustion (PENE).
Please see the main paper cited above in 2 (White et al. (2011)) for an
explanation of this – i.e. by randomisation and by stratification by the
presence of depressive illness (all patients had comorbid rather than
“primary” depression). PENE was not measured but post-exertional fatigue
was, and the between treatment odds ratios for this symptom is given in
appendix C (available at
[1]https://www.ncbi.nlm.nih.gov/pmc/article...)
If you are dissatisfied with this response, you may ask QMUL to conduct a
review of this decision. To do this, please contact the College in
writing (including by fax, letter or email), describe the original
request, explain your grounds for dissatisfaction, and include an address
for correspondence. You have 40 working days from receipt of this
communication to submit a review request. When the review process has
been completed, if you are still dissatisfied, you may ask the Information
Commissioner to intervene. Please see [2]www.ico.org.uk for details.
Yours sincerely
Paul Smallcombe
Records & Information Compliance Manager
References
Visible links
1. https://www.ncbi.nlm.nih.gov/pmc/article...
2. http://www.ico.org.uk/
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