A general thread on the PACE trial!

You may have heard of it? At the other place, some of us wrote a word or two about it. I thought it might be good to have a thread for PACE chats, or for new people to ask questions, that didn't necessarily relate to important new papers, or anything that warranted a new thread. I could post some summaries of PACE issues into this first post.

Criticism:

Links to David Tuller's work on the PACE trial are being linked to from this page: http://me-pedia.org/wiki/David_Tuller

Tuller's compendium on Virology is currently up to date, but has been less consistently updated than his me-pedia pages: http://www.virology.ws/mecfs/

Rebecca Goldin from Sense About Statistics criticised PACE here: http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/

The Special Edition of the Journal of Health Psychology, devoted to PACE, is available here: http://journals.sagepub.com/toc/hpqa/22/9

Julie Rehmeyer's piece on the PACE recovery re-anaylsis is here: https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/

Pre-print of "Rethinking the treatment of chronic fatigue syndrome—A reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT" by Wilshire et al.: https://www.researchgate.net/public...recent_major_trial_of_graded_exercise_and_CBT

And the thread discussing it: https://www.s4me.info/threads/rethi...-major-trial-of-graded-exercise-and-cbt.2282/


Some historical pieces:

2011 summary of PACE concerns: "Methodological Inconsistencies in the PACE trial for ME/CFS" by Tate Mitchell

Here's a plain text version ( with graphs linked to at the end): https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1112A&L=CO-CURE&P=R540&I=-3

Section 6 of this focusses on the PACE trial:
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://iacfsme.org/PDFS/Reporting-of-Harms-Associated-with-GET-and-CBT-in.aspx

Critical letters sent about the PACE recovery paper: http://www.meassociation.org.uk/201...ournal-of-psychological-medicine-august-2013/

(Most of the main) PACE papers:

Whoops, just noticed Woolie already has a thread on this in the Research Library: https://www.s4me.info/index.php?threads/publications-from-the-pace-trial.60/

2007 Published protocol:
White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group.
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.
BMC Neurol. 2007; 7:6.
http://www.biomedcentral.com/1471-2377/7/6

2011 Main PACE trial paper:
White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group.
Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial.
Lancet. 2011; 377:823-36.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

2012 Cost-effectiveness analysis (Includes employment and welfare benefits data):
McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD.
Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: A cost-effectiveness analysis.
PLoS ONE 2012; 7:e40808.
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0040808

2013 [Alleged] "Recovery" paper:
White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC.
Recovery from chronic fatigue syndrome after treatments given in the PACE trial.
Psychological Medicine 2013; 43:2227-35.
http://journals.cambridge.org/abstract_S0033291713000020

2013 Statistical Analysis Plan:
Walwyn R, Potts L, McCrone P, Johnson AL, DeCesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD.
A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan.
Trials 2013; 14:386.
http://www.trialsjournal.com/content/14/1/386

2014 Adverse events and deterioration:
Dougall D, Johnson A, Goldsmith K, Sharpe M, Angus B, Chalder T, White P.
Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome.
J Psychosom Res. 2014; 77:20-6.
http://www.sciencedirect.com/science/article/pii/S0022399914001883

2015 Secondary Mediation Analysis (contains the step test results - graph only):
Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial.
Chalder T, Goldsmith KA, White PD, Sharpe M, Pickles AR.
Lancet Psychiatry 2015; 2:141–52
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(14)00069-8/abstract

2015 Two Year Follow Up:
Sharpe M, Goldsmith KA, Johnson AL, Chalder T, Walker J, White PD.
Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial.
Lancet Psychiatry 2015; 2:1067–74
DOI: http://dx.doi.org/10.1016/S2215-0366(15)00317-X
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00317-X/fulltext


2015 Longitudinal Mediation Analysis - conference abstract only:
Goldsmith K, Chalder T, White P, Sharpe M, Pickles A.
Longitudinal mediation in the PACE randomised clinical trial of rehabilitative treatments for chronic fatigue syndrome: modelling and design considerations
Trials 2015; 16(Suppl 2):O43 doi:10.1186/1745-6215-16-S2-O43
http://www.trialsjournal.com/content/16/S2/O43


------------------------------------------------------------------------------------------------------


Minor papers and PACE-related papers:

Lawn T, Kumar P, Knight B, Sharpe M, White PD. (2010)
Psychiatric misdiagnoses in patients with chronic fatigue syndrome.
JRSM Short Rep. 1:28.

Cella M, Sharpe M, Chalder T. (2011)
Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale.
J Psychosom Res. 71:124-8.

Cella M, White PD, Sharpe M, Chalder T. (2013)
Cognitions, behaviours and co-morbid psychiatric diagnoses in patients with chronic fatigue syndrome.
Psychological Medicine 43:375-380. doi:10.1017/S0033291712000979

Bourke JH, Johnson AL, Sharpe M, Chalder T, White PD. (2014)
Pain in chronic fatigue syndrome; response to rehabilitative treatments in the PACE trial.
Psychological Medicine 44:1545-52. doi:10.1017/S0033291713002201

Cox D, Burgess M, Chalder T, Sharpe M, White P, Clark L. (2013)
Training, supervision and therapists' adherence to manual-based therapy.
International Journal of Therapy and Rehabilitation 20:180-186.

White PD, Chalder T, Sharpe M. (2015)
The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial.
BJPsych Bull. 39:24-7. doi: 10.1192/pb.bp.113.045005
http://www.ncbi.nlm.nih.gov/pubmed/26191420

Lewith G, Stuart, Chalder T, McDermott C, White PD. (2016)
Complementary and alternative healthcare use by participants in the PACE trial of treatments for chronic fatigue syndrome.
J Psychosom Res. 2016 Aug;87:37-42. doi: 10.1016/j.jpsychores.2016.06.005. https://www.ncbi.nlm.nih.gov/pubmed/27411750

Williams TE, Chalder T, Sharpe M, White PD. (2017)
Heterogeneity in chronic fatigue syndrome - empirically defined subgroups from the PACE trial.
Psychol Med. 2017 Jun;47(8):1454-1465. doi: 10.1017/S0033291716003615. https://www.ncbi.nlm.nih.gov/pubmed/28112075


PS: I was planning to be more extensive... but there's so much criticism of PACE now I wanted to give up. Will add more in on request/later.

 

I was just re-reading the PACE PI's March 2017 piece 'Myth-busting a myth busting'. Wow is it annoying. It already has responses from Tuller, Wilshire, Vink, etc.

https://www.observantonline.nl/Home...w/articleId/12101/Myth-busting-a-myth-busting

This is how they describe the revelation that, when using the recovery criteria that the PACE researcher themselves had devised for their own protocol, there was no difference in recovery rates between groups:

The PACE researchers refused to release results for their own recovery criteria, creating an absurdly loose new 'recovery' criteria instead, so patients had to win a legal battle to gain access to the data.

I do not understand how they can have any supporters in academia. They're so obviously dodgy. Who would be willing to publicly defend their portrayal of events?

Also - "being within the normal range for fatigue and physical function" a newly devised 'normal range' which meant that patients who had been classed as suffering from severe and disabling fatigue at the start of the trial could report a worsening of fatigue and disability, and yet still be classed as 'recovered'!

I've already read this article, but I'm once again tongue tied over how bad it is.

 

This Chalder presentation on PACE is currently on-line here:

http://www.fom.ac.uk/wp-content/uploads/Hidden-Disabilities-Trudie-Chalder.pdf

Slide 23 has results for: % “normal” levels

Of course, patients could actually decline from baseline yet still be classed as having 'normal' levels of fatigue and disability by Chalder.

Slide 31 is on recovery, and it always bugs me how they act like they've explored an exciting range of ways of defining r'recovery' when they're all absurd BS:

Slide 35 conclusion:

"• Pushing limits > staying within limits"

 

Don't forget @Woolie has created this in the Science Library as well - https://www.s4me.info/index.php?threads/publications-from-the-pace-trial.60/

 

Thanks, @Andy, and @Esther12. Its good to have this thread as well, I can select articles people suggest and add them to the Science library.

 

All his stuff on Virology:

http://www.virology.ws/mecfs/

 

I don't think the question mark at the end of the thread title is necessary. Just make this thread "A general thread on the PACE trial".

 

Would be good to also include as many of the pro-PACE documents as well, because they can be very useful to refer back to. Kicking myself for not keeping a record. For instance, I'm pretty sure there was a letter/paper/blog back in July/August, possibly by a lesser known member of the BPS species, that was proposing objective measures as being overrated anyway (though not quite in those words). Be good to be able to find something like that reasonably easily.

 

I went for the exclamation mark. We deserve it.

 

I'm so stupid that I saw that, liked it, and then forgot about it did my own list.

 

I posted that, it was added to the OP so i deleted
Perhaps i should have left it for posterity

I do this sometimes too, i call it ME/CFS brain (as an allegory to pregnancy brain which is a thing)

 

I thought about giving you credit... but decided to let Sean take all the glory instead.

 

how mean

 

I'll take what I can get.

 

i challenge you to a duel, which for ME/CFS people probably means we both sit on opposing couches and think about purchasing foils someday in the distant future

 

I parry your thought about purchasing foils with a slightly furrowed brow in your general direction.

Your turn...

 

I need a PEM break

 

I'm not sure I will read this but I thought this was interesting:

People will recall a score of 60+ was a recovery criterion in the PACE Trial in which Trudie Chalder was a principal investigator.

 

The copy of the initial KCL letter denying Coyne access to PACE data no-longer seems to be on-line. Anyone have a copy they could attach here? http://www.meaction.net/2015/12/12/...-james-coynes-request-for-plos-one-pace-data/

 

Is this it:

https://web.archive.org/web/20160314024024/https://dl.dropboxusercontent.com/u/23608059/PACE F325-15 - Prof. James Coyne - Response-2.pdf