PACE Trial summaries/critiques/links thread - no discussion please

Dolphin · Jan 10, 2012

I thought I'd set up this thread, as a lot of interesting points have been made on the PACE Trial but they have been buried in the PACE Trial mega-thread http://forums.phoenixrising.me/showthread.php?4926-PACE-Trial-and-PACE-Trial-Protocol .

So this is a thread where people can go to find information more easily.

I think discussion should be kept off it as much as possible to keep it "clean" - if people want to discuss anything in it, (including whether such a piece should be added if they have doubts) they can do so in the mega-thread: http://forums.phoenixrising.me/showthread.php?4926-PACE-Trial-and-PACE-Trial-Protocol

So what I think should go here are pieces that have already taken a bit of work rather than new pieces written for this thread e.g. letters submitted on the topic, links to websites, summary pieces, etc.

Dolphin · Jan 10, 2012

Letters submitted to the Lancet - published and unpublished

There are two threads that have already summarised some pieces which I thought would be good to highlight:

PACE Trial - letters that were published and authors' response (and editorial)
http://forums.phoenixrising.me/show...ublished-and-authors-response-(and-editorial)

PACE Trial - letters that were not accepted by the Lancet:
http://forums.phoenixrising.me/show...-letters-that-were-not-accepted-by-the-Lancet

Esther12 · Jan 11, 2012

This is the best concise summary I've seen so far. It misses a lot out... but otherwise it would be over 150 pages.

"Methodological Inconsistencies in the PACE trial for ME/CFS" by Tate Mitchell

edited to remove a link which doesn't work, there's a plain text version (graphs linked to at the end) at:

https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1112A&L=CO-CURE&P=R540&I=-3

I've been trying to attach a fuller version beneath, but having trouble! The version above can easily be copied and pasted in to a word file (I find listserv a bit of a pain to read).

Dolphin · Jan 11, 2012

Letter published in the June 2011 issue of the Psychologist magazine

Letter published in the June 2011 issue of the Psychologist magazine

Your summary of the findings of the PACE trial (White et al., 2011), which evaluated the effectiveness of CBT and graded exercise therapy as treatments for ME/CFS (Fatigue evidence gathers PACE, April 2011), gave a somewhat misleading impression of the outcomes of this study. You said that self-reports on measures of fatigue and physical function showed that 30% of CBT patients and 28% of exercise patients had returned to normal function. This suggests that nearly one-third had recovered with these treatments. Unfortunately this is far from the case.

First, the thresholds for normal were set so low they could include those with considerable disability. The authors defined within the normal range as a Short Form-36 Physical Function (SF-36) score of 60 or more (0-100 scale), yet the problems with physical functioning that characterise CFS were defined by a SF-36 score of up to 65 - which overlaps with normality. The situation with fatigue scores is similar, so that a participant may have met the trial fatigue criteria for CFS yet simultaneously have met the criteria for normal. Consequently the figures you quoted tell us little meaningful about the PACE trials effectiveness.

Secondly, it is of some concern that the authors inexplicably changed the criteria for positive primary outcomes originally proposed by them in the protocol for the study
(White et al., 2007). On the Chalder Fatigue Scale, for example, they stated that a positive outcome would be a 50% reduction in self-reported fatigue, or a score of 3 or less. And on the SF-36 scale of physical function a score of 75 or more, or a 50% increase from baseline would be required. So the figures you reported are misleading.

Thirdly, you omitted to mention the disappointing outcomes on more objective measures of functioning. For example, after a year of treatment, patients receiving graded exercise therapy had on average increased the distance they were able to walk in 6 minutes from 312 to 379 metres. Even patients suffering from serious chronic cardiopulmonary diseases can manage more than this (in a sample of over 1,000 such patients the mean distance walked was 393 metres [Ross, Murthy, Wollak, & Jackson, 2010]), and at normal walking speed people typically cover around 500 metres. CBT treatment had no significant effect on walking distance.

Perhaps these results are unsurprising, given that the treatments focused on reducing patients assumed fear of engaging in activity, and completely failed to acknowledge the complexity of this illness. We are much concerned that exaggerated claims for these treatments will create a false impression of the effectiveness of PACE amongst psychologists, and will continue to divert scarce resources away from effective medical treatments for this devastating condition.

References
Ross, R.M., Murthy, J.N., Wollak, I.D., & Jackson, A.J. (2010). The six-minute walk test accurately estimates mean peak oxygen uptake. BMC Pulmonary Medicine, 10.31. http://www.biomedcentral.com/1471-2466/10/31

White P.D., Sharpe M.C., Chalder T., DeCesare J.C., Walwyn R., and the PACE Trial Group (2007). Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BioMed Central Neurology, 2007;7:6. http://www.biomedcentralcom/1471-2377/71/6

White, P.D., Goldsmith, K.A., Johnson, A.L, Potts, L., Walwyn, R., DeCesare, J.C, Baber, H.L., Burgess, M., Clark, L.V., Cox, D.L., Bavinton, J., Angus, B.J., Murphy, G., Murphy, M., ODowd, H., Wilks, D., McCrone, P., Chalder, T., Sharpe, M.C., on behalf of the PACE trial management group (2011). Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE). The Lancet, published online February 2011. DOI:10.1016/So140-6736(11)60006-2.

Esther12 · Jan 13, 2012

There is a section (section 6) on the reporting of harms in the PACE Trial in:
Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Bulletin of the IACFS/ME. 2011;19(2):59-111.

http://www.iacfsme.org/LinkClick.aspx?fileticket=Rd2tIJ0oHqk=&tabid=501

Esther12 · Jun 3, 2012

And of course, there's the PR evaluation of PACE:

http://evaluatingpace.phoenixrising.me/home.html

Dolphin · Jul 24, 2012

Esther12 said: ↑

This is the best concise summary I've seen so far. It misses a lot out... but otherwise it would be over 150 pages.

"Methodological Inconsistencies in the PACE trial for ME/CFS" by Tate Mitchell

http://www.mediafire.com/file/58xlwu12afj903x/PACE trial critique Dec. 02, 2011.docx

(or if that link doesn't work, see a plain text version (no graphs) at: https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1112a&L=co-cure&T=0&P=1152

Neither link works for me at the moment. Here's the plain text link:
https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1112A&L=CO-CURE&P=R540&I=-3 .

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