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

Dolphin

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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

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Esther12

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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

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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.
 

Dolphin

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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 .
 

Dolphin

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Dolphin

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6 letters were published in Psychological Medicine following this paper:

Psychol Med. 2013 Oct;43(10):2227-35. doi: 10.1017/S0033291713000020.

Recovery from chronic fatigue syndrome after treatments given in the PACE trial.

White PD1, Goldsmith K, Johnson AL, Chalder T, Sharpe M.
have been collated here: http://www.meassociation.org.uk/201...ournal-of-psychological-medicine-august-2013/

---

Unpublished letter by Tom Kindlon is on PubMed Commons: http://www.ncbi.nlm.nih.gov/pubmed/23363640#cm23363640_751
 

Dolphin

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Not open access

http://www.ncbi.nlm.nih.gov/pubmed/25304959

Qual Life Res. 2015 Apr;24(4):905-7. doi: 10.1007/s11136-014-0819-0. Epub 2014 Oct 11.

Assessment of recovery status in chronic fatigue syndrome using normative data.

Matthees A1.

Author information

Abstract

INTRODUCTION:

Adamowicz et al. have reviewed criteria previously employed to define recovery in chronic fatigue syndrome (CFS). They suggested such criteria have generally lacked stringency and consistency between studies and recommended future research should require "normalization of symptoms and functioning".

METHODS:

Options regarding how "normalization of symptoms and functioning" might be operationalized for CFS cohorts are explored.

RESULTS:

A diagnosis of CFS excludes many chronic disabling illnesses present in the general population, and CFS cohorts can almost exclusively consist of people of working age; therefore, it is suggested that thresholds for recovery should not be based on population samples which include a significant proportion of sick, disabled or elderly individuals. It is highlighted how a widely used measure in CFS research, the SF-36 physical function subscale, is not normally distributed. This is discussed in relation to how recovery was defined for a large intervention trial, the PACE trial, using a method that assumes a normal distribution. Summary data on population samples are also given, and alternative methods to assess recovery are proposed.

CONCLUSIONS:

The "normalization of symptoms and function" holds promise as a means of defining recovery from CFS at the current time. However, care is required regarding how such requirements are operationalized, otherwise recovery rates may be overstated, and perpetuate the confusion and controversy noted by Adamowicz et al.
 

Dolphin

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Published responses to:

Lancet Psychiatry. 2015 Feb;2(2):141-52. doi: 10.1016/S2215-0366(14)00069-8. Epub 2015 Jan 28.
Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial.
Chalder T1, Goldsmith KA2, White PD3, Sharpe M4, Pickles AR2.
---

Lancet Psychiatry. 2015 Apr;2(4):e9-e10. doi: 10.1016/S2215-0366(15)00054-1. Epub 2015 Mar 31.
Doubts over the validity of the PACE hypothesis.
Courtney R.
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00054-1/abstract
Lancet Psychiatry. 2015 Apr;2(4):e8-9. doi: 10.1016/S2215-0366(15)00044-9. Epub 2015 Mar 31.
Post-exertional malaise in chronic fatigue syndrome.
Twisk F1.
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00044-9/abstract
Lancet Psychiatry. 2015 Apr;2(4):e7. doi: 10.1016/S2215-0366(15)00089-9. Epub 2015 Mar 31.
In non-blinded trials, self-report measures could mislead.
Faulkner G.
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00089-9/abstract
Lancet Psychiatry. 2015 Apr;2(4):e7-8. doi: 10.1016/S2215-0366(15)00085-1. Epub 2015 Mar 31.
Omission of data weakens the case for causal mediation in the PACE Trial.
McGrath S1.
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00085-1/abstract
Lancet Psychiatry. 2015 Apr;2(4):e10. doi: 10.1016/S2215-0366(15)00110-8. Epub 2015 Mar 31.
Methods and outcome reporting in the PACE trial.
Kirby SB1.
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00110-8/abstract
 
Last edited:

Dolphin

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http://www.bmj.com/content/350/bmj.h227/rr-10

Objective measures found a lack of improvement for CBT & GET in the PACE Trial: subjective improvements may simply represent response biases or placebo effects in this non-blinded trial

18 January 2015
Tom P Kindlon
Information Officer

Irish ME/CFS Association
PO Box 3075, Dublin 2, Rep. of Ireland


This BMJ article and a flurry of articles in the lay media this week followed the publication in Lancet Psychiatry of an analysis of the mediators of change in the important PACE Trial, a chronic fatigue syndrome (CFS) trial which cost UK taxpayers £5 million[1,2]. What seems to have been lost in the coverage is that, although there were some modest improvements in the self-report measures, there was an almost complete absence of improvements in objectively measured outcomes for cognitive behavioural therapy (CBT) and graded exercise therapy (GET) compared to the control group (specialist medical care only (SMC)).

This is a non-blinded trial, where participants were told CBT and GET had previously been found to be effective in CFS and other conditions[3,4]: one way to look at the mediation results for subjective measures when there was a lack of objective improvements is that they may merely tell us how response biases and/or placebo effects are mediated[5].

The focus on subjective measures in some CFS studies was previously criticised in a systematic review published back in 2001 (long before the PACE Trial started)[6]. They suggested instead "a more objective measure of the effect of any intervention would be whether participants have increased their working hours, returned to work or school, or increased their physical activities."

The model presented for cognitive behaviour therapy (CBT) in the PACE Trial manuals posits that the impairments and symptoms are reversible with the therapy[3,7]. However, the latest paper shows that fitness, as measured by a step test, didn't improve following CBT[2]. An earlier PACE Trial publication reported that the addition of CBT to SMC did not result in an improvement in 6-minute walking test scores compared to SMC alone[8].

The PACE Trial was part funded by the UK Department of Work and Pensions, a rare move for them, presumably done due to an expectation that the therapies would improve measures of employment and levels of benefit receipt. However, again CBT brought about no improvement using objective measures, such as days of employment lost, levels of disability benefits received and levels of receipt of insurance payments[9].

These results are in line with earlier studies of CBT. For example, an analysis of three randomized controlled trials of CBT interventions for CFS found no improvement in objectively measured activity, despite participants reporting a reduction in (self-reported) fatigue and (sometimes) functional impairments[10]. Similar results were found in another uncontrolled trial where changes in objectively measured activity did not predict fatigue levels, and objectively measured activity on completion remained low compared to population norms[11]. An uncontrolled study found improvements in self-reported physical functioning and fatigue were reported despite a numerical decrease in (objectively measured) activity[12]. In another study, the level of self-reported cognitive impairment in CFS patients decreased significantly after CBT, however, cognition had not improved when it was measured objectively using neuropsychological test performance[13].

It is unsurprising that 15 sessions of CBT (and the associated homework exercises and management program) might alter how participants respond to self-report questionnaires. A PACE Trial manual itself says "the essence of CBT is helping the participant to change their interpretation of symptoms": this could lead to altered or biased fatigue scores, one of the two primary outcome measures[14]. Also, one of the aims of CBT (for CFS) has been said to be "increased confidence in exercise and physical activity"[15]. The possible responses for the other primary outcome measure, the SF-36 physical functioning subscale, are "yes, limited a lot", "yes, limited a little" and "no, not limited at all" to questions on a range of physical activities. Such responses could be easily be artificially altered following a therapy like CBT for CFS.

The results were not that different with the GET cohort in the PACE Trial. Again the manuals predicted that the impairments and symptoms are reversible using the intervention[4,15]. The model said there was no reason participants should not be able to get back to full functioning. Deconditioning was posited to be an important maintaining factor. However, GET did not result in an improvement in fitness, as measured by the step test. GET did result in a small improvement on the six minute walking test to a final distance of 379 metres, or 35 metres more than the SMC-only group[7]. However, as Knoop and Wiborg commented in an accompanying editorial in Lancet Psychiatry: "an increase in distance walked during a test situation without an increased fitness suggests that patients walk more because of a change in cognitive processes (eg, daring to do more or an increased self-efficacy with respect to activity), not because of a change in physiological capacity”[16]. The result remained very poor given that normative data would suggest a group of similar age and gender should walk an average of 644 or so metres[17]. The distance walked remained comparable to people with many serious conditions[18-21], and considerably worse than the distance walked by healthy elderly adults[22,23], despite the PACE trial cohort having a mean age of only 40[8]. Also, to be allowed entry into CFS research studies such as the PACE Trial one can not have a range of chronic illnesses so with genuine recovery one would expect results comparable to healthy people[8].

As with CBT, measures relating to employment showed no improvement following GET in days of work missed, which remained very high, nor a reduction in levels of benefits (financial support from the state) or payments from insurance companies[9].

These results are in line with an audit of Belgian rehabilitation centres for CFS offering CBT and GET[24-26]. Some improvements in subjective measures were found, but there was no improvement in the results of the exercise test and hours in employment actually decreased.

Probably the main contribution of the PACE Trial has been to add to a growing body of evidence that while CBT and GET for CFS have resulted in some changes on subjective measures, they haven't lead to improvements on objective measures.

References:

1. Torjesen I. Tackling fears about exercise is important for ME treatment, analysis indicates. BMJ 2015;350:h227 http://www.bmj.com/content/350/bmj.h227

2. Chalder T, Goldsmith KA, White PD, Sharpe M, Pickles AR. Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial. Lancet Psychiatry 14 Jan 2015, doi:10.1016/S2215-0366(14)00069-8.

3. Burgess M, Chalder T. Manual for Participants. Cognitive behaviour therapy for CFS/ME.http://www.pacetrial.org/docs/cbt-participant-manual.pdf (accessed: January 17, 2015)

4. Bavinton J, Darbishire L, White PD -on behalf of the PACE trial management group. Graded Exercise Therapy for CFS/ME. Information for Participants http://www.pacetrial.org/docs/get-participant-manual.pdf (accessed: January 17, 2015)

5. Wechsler ME, Kelley JM, Boyd IO, Dutile S, Marigowda G, Kirsch I, Israel E, Kaptchuk TJ. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. N Engl J Med. 2011;365(2):119-26.

6. Whiting P, Bagnall AM, Sowden AJ, Cornell JE, Mulrow CD, Ramírez G. Interventions for the treatment and management of chronic fatigue syndrome: a systematic review. JAMA. 2001 Sep 19;286(11):1360-8.

7. Burgess M, Chalder T. PACE manual for therapists. Cognitive behaviour therapy for CFS/ME.http://www.pacetrial.org/docs/cbt-therapist-manual.pdf (accessed: January 17, 2015)

8. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, et al, for the 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.

9. 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(8):e40808. doi: 10.1371/journal.pone.0040808

10. Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Aug;40(8):1281-7. doi: 10.1017/S0033291709992212. Epub 2010 Jan 5.

11. Heins MJ, Knoop H, Burk WJ, Bleijenberg G. The process of cognitive behaviour therapy for chronic fatigue syndrome: which changes in perpetuating cognitions and behaviour are related to a reduction in fatigue? J Psychosom Res. 2013 Sep;75(3):235-41. doi: 10.1016/j.jpsychores.2013.06.034. Epub 2013 Jul 19.

12. Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue syndrome: is improvement related to increased physical activity? J Clin Psychol. 2009 Apr;65(4):423-42. doi: 10.1002/jclp.20551.

13. Knoop H, Prins JB, Stulemeijer M, van der Meer JW, Bleijenberg G. The effect of cognitive behaviour therapy for chronic fatigue syndrome on self-reported cognitive impairments and neuropsychological test performance. Journal of Neurology and Neurosurgery Psychiatry. 2007 Apr;78(4):434-6.

14. Bavinton J, Darbishire L, White PD -on behalf of the PACE trial management group. Graded Exercise Therapy for CFS/ME (Therapist manual): http://www.pacetrial.org/docs/get-therapist-manual.pdf(accessed: January 17, 2015)

15. O'Dowd H, Gladwell P, Rogers CA, Hollinghurst S, Gregory A. Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme. Health Technology Assessment, 2006, 10, 37, 1-140.

16. Knoop H, Wiborg JF. What makes a difference in chronic fatigue syndrome? Lancet Psychiatry 13 Jan 2015 DOI: http://dx.doi.org/10.1016/S2215-0366(14)00145-X

17. 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):59-111http://iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/ta...

18. Lipkin DP, Scriven AJ, Crake T, Poole-Wilson PA. Six minute walking test for assessing exercise capacity in chronic heart failure. Br Med J (Clin Res Ed) 1986. 292:653–655.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1339640/pdf/bmjcred00224-001...

19. Marin JM, Carrizo SJ, Gascon M, Sanchez A, Gallego B, Celli BR. Inspiratory Capacity, Dynamic Hyperinflation, Breathlessness, and Exercise Performance during the 6-Minute-Walk Test in Chronic Obstructive Pulmonary Disease. Am. J. Respir. Crit. Care Med. 2001 63(6):1395-1399.http://171.66.122.149/content/163/6/1395.full

20. Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Multiple Sclerosis 2008. 14(3):383-390.
http://pocketknowledge.tc.columbia.edu/home.php/viewfile/download/65399/The six-minute walk test.pdf

21. Ross RM, Murthy JN, Wollak ID, Jackson AS. The six minute walk test accurately estimates mean peak oxygen uptake. BMC Pulm Med. 2010 May 26;10:31. PMID 20504351.http://www.biomedcentral.com/1471-2466/10/31

22. Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S. Six minute walk distance in healthy subjects aged 55–75 years. Respir Med. 2006. 100:658-65
http://www.resmedjournal.com/article/S0954-6111(05)00326-4/abstract

23. Troosters T, Gosselink R, Decramer M. Six minute walking distance in healthy elderly subjects. Eur Respir J. 1999. 14:270-4. http://www.ersj.org.uk/content/14/2/270.full.pdf

24. Rapport d'évaluation (2002-2004) portant sur l'exécution des conventions de rééducation entre le Comité de l'assurance soins de santé (institué auprès de l'Institut national d'assurance maladie invalidité) et les Centres de référence pour le Syndrome de fatigue chronique (SFC), Bruxelles, juillet 2006. (French language edition)

25. Evaluatierapport (2002-2004) met betrekking tot de uitvoering van de revalidatieovereenkomsten tussen het Comité van de verzekering voor geneeskundige verzorging (ingesteld bij het Rijksinstituut voor Ziekte- en invaliditeitsverzekering) en de Referentiecentra voor het Chronisch vermoeidheidssyndroom (CVS). 2006. Available online:https://drive.google.com/file/d/0BxnVj9ZqRgk0QTVsU2NNLWJSblU/edit(accessed: January 17, 2015) (Dutch language version)

26. Stordeur S, Thiry N, Eyssen M. Chronisch Vermoeidheidssyndroom: diagnose, behandeling en zorgorganisatie. Health Services Research (HSR). Brussel: Federaal Kenniscentrum voor de Gezondheidszorg (KCE); 2008. KCE reports 88A (D/2008/10.273/58)https://kce.fgov.be/sites/default/files/page_documents/d20081027358.pdf(accessed: January 17, 2015)

Competing interests: I am a committee member of the Irish ME/CFS Association and perform various types of voluntary work for the Association.
 

Dolphin

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Here's a list of PACE Trial papers
(copied from Bob's post):

Updated December 2015.

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

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


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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
 

Esther12

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This thread should be updated... we don't have even have Tuller in here!

Tuller's first PACE pieces (there are more if you look):

http://www.virology.ws/2015/10/21/trial-by-error-i/
http://www.virology.ws/2015/10/22/trial-by-error-ii/
http://www.virology.ws/2015/10/23/trial-by-error-iii/

Tuller Virology podcast: http://www.microbe.tv/twiv/twiv-397/

The Goldin Sense About Statistics piece that focuses on problems with the trial's statistics and recovery claims:

http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/