PACE Trial and PACE Trial Protocol

[Esther12]

Saw this posted on an ME mailing list. Haven't looked in to it:

From the PACE one:

4.1 Withdrawal of Data Following Participation in a Study.
Janet Wisely explained that following the Panel‟s discussion of this item at the last meeting the
Information Commissioner has insisted that the study participant‟s data be removed from any analysis in
the study that prompted the initial discussion of this issue.
It was noted by the Panel that this is likely to mean that the study will now not be published. The Panel
noted that the decision taken by the Information Commissioner might have been constrained by the
existing date protection law, but strongly indicated that the consequence was that a study might be
wrecked and that the autonomy of other participants in the study harmed

Apparently this refers to PACE, as later on they say:

4.2 Withdrawal of Data Following Participation in a Study.
AG informed the panel that he had received further confirmation from Professor Janet Darbyshire
(Head of the MRC Clinical Trials Unit and Joint Director of NIHR CRN CC) that they had received
a response from the Information Commissioner‟s Office which they have interpreted as meaning
that they do not need to withdraw the individual‟s study data from the PACE trial.

So PACE was nearly not published because one patient asked to have their data withdrawn? Sounds a bit odd. Would be interesting to get some more info on that.

 

[biophile]

The PACE document was pretty boring except towards the end where it discusses disruption of research.

https://dl.dropboxusercontent.com/u/89858260/NREAP on PACE.pdf

(NREAP Minutes 13 June 2012)

8. Disruption of Research – Caroline Harrison

CH started her presentation by indicating that there was no easy answer to the question of whether there were legal remedies available to counter any organised disruption to research. The fundamental difference was between criminal offences (which may be prosecuted once committed; but where preemptive remedies are more difficult and of less „value‟ in terms of protecting researchers) and conduct regulated by the civil law, where pre-emptive remedies to govern future conduct may be obtained. In criminal law, the offence is committed when all the necessary „elements‟ have occurred. Those elements are the „actus reus‟ and the „mens rea‟ – i.e. the actions + accompanying mental intent. Crimes may also be „attempted‟, but only if acts have been done which are „more than merely preparatory‟ to the substantive offence. Conspiracy to commit crime is also an offence, but proving the requisite degree of agreement to amount to a conspiracy is difficult. Hence criminal law has its limitations, in this context.

However, she noted that if the desired objective was to protect researchers and ancillary staff from actual violence, or the imminent threat of violence, then this would primarily fall within the domain of criminal law and could be prosecuted once sufficient evidence was available. Prosecutions may be undertaken privately, or by the police. However, assaults also amount to a trespass against the person, and so the civil law could be used to restrain people from committing such acts, if there are good grounds for suspecting that this will occur or recur.

Concerted campaigns by groups to disrupt research (where the conduct of the group‟s members falls short of threatening violence) was a much vaguer and more controversial area. Legal remedies to combat e.g. non-violent or abusive campaigns to dissuade researchers from undertaking certain types research was in practical terms a "nonstarter", because the courts would have to balance the rights of researchers to go about their daily business, with the rights of protesters to free speech and freedom of expression. Where that balance will be struck in any one case, will be a matter of fact in any situation, and will be difficult to predict in advance. There were also practical problems, such as identifying defendant(s) – see below. There is no specific statutory provision that CH could find, that was designed specifically to protect staff involved in clinical research. CH stated that she could not conceive of legislators or ministers being persuaded that there should be some specific regulation that should be passed, that would apply to researchers, but that did not also apply to the general public. She noted that within the existing law, there were three statutes that may have the greatest relevance to this area:

1) Protection from Harassment Act 1997;
2) Public Order Act 1986; and the
3) Malicious Communications Act 1988

CH noted that under civil law injunctive relief can be used to limit certain behaviours (e.g. preventing people from going to specified locations, or from contacting the claimant(s) etc., but it cannot require them to do positive acts). However in order to be able to bring a claim under the civil law, a claimant has to be able to identify an actual defendant that is recognised in law (i.e. something that has legal personality, such as a limited company, or an unincorporated association, or an individual person). Without this, there is no-one to sue, and no-one upon whom to serve papers, or to punish for breach of any Order made by the Court. This is likely to cause a real difficulty in the case of research disruption, because the people engaged in such conduct are likely to be part of a loose grouping of like-minded individuals; they may be difficult to identify as individuals, and many will have have no assets or insurance. Like the Hydra, once you cut off one head, more will spring up in its place The real problem in both criminal and civil cases is the balance between an individual's right to freedom of expression and the rights of others to carry out their business without harassment.

CH explained that there were two main cases in this area that provided useful parallels:

[case involving an anti-abortionist who sent graphic images of aborted foetuses to pharmacies]

[case involving an animal rights group organizing a protest]

Basically, there are laws in place helping to prevent researchers from being subjected to abuse and harassment. But since ME militancy isn't actually bad enough to lead to arrests and successful prosecutions, it is more difficult to control because it has to be balanced with freedom of expression. The above quote doesn't mention ME militancy per se, but AFAIK the media coverage of such has not mentioned any related arrests or prosecutions, so there probably haven't been any.

IIRC a few of the news articles, despite the lazy comparison to animal rights extremists and Wessely's absurd comparisons to Islamic extremists and war zones and going over Niagra falls in a barrel, point out that only a very slim minority of the "50-80 ME extremists" have resorted to threats and have generally fallen short of actual violence, and attempting to prosecute is pointless because chances of success are poor (perhaps because it isn't quite as bad as we've been lead to believe?).

This suggests that the vast bulk of the ME "extremism" has not been threats, but protests, objections, and criticisms, possibly some of which got heated. Researchers have labeled this "research disruption", but much of that has also been justified critique such as this thread and letters to the editor. van der Meer & Lloyd have falsely framed letters to the editor as unscientific personal attacks, and a Collaborative meeting framed FOIs as the "most damaging" form of harassment.

 

[MeSci]

IIRC a few of the news articles, despite the lazy comparison to animal rights extremists and Wessely's absurd comparisons to Islamic extremists and war zones and going over Niagra falls in a barrel, point out that only a very slim minority of the "50-80 ME extremists" have resorted to threats and have generally fallen short of actual violence, and attempting to prosecute is pointless because chances of success are poor (perhaps because it isn't quite as bad as we've been lead to believe?).

They have ALL fallen short of actual violence, haven't they?

 

[user9876]

They have ALL fallen short of actual violence, haven't they?

What I find surprising is how unquestioning the ethics committee seems to be. They seem to be falling in line behind the 'those nasty patients are trying to stop research' line rather than asking why there is such a degree of activism. They should be asking are there ethical questions being raised that makes such activism necessary and that they haven't seen. They talk about a hydra analogy where if you remove an activist you get more and don't ask why people with ME feel the need to speak out against the approach that this research engenders. From an ME perspective I find this worrying but from a wider societal perceptive it is also worrying. What other research will they allow and dismiss those who complain or raise genuine technical or ethical issues as extremists.

 

[biophile]

They have ALL fallen short of actual violence, haven't they?

I think there may have been a single incident where a researcher was allegedly hit in the street? But I don't remember the circumstances, maybe it was spontaneous and unrelated to the usual crowd.

 

[ukxmrv]

The claim that someone was hit on the street was from The Observer newspaper

"One researcher told the Observer that a woman protester who had turned up at one of his lectures was found to be carrying a knife. Another scientist had to abandon a collaboration with American doctors after being told she risked being shot, while another was punched in the street. All said they had received death threats and vitriolic abuse"

http://www.theguardian.com/society/2011/aug/21/chronic-fatigue-syndrome-myalgic-encephalomyelitis

 

[MeSci]

The claim that someone was hit on the street was from The Observer newspaper

"One researcher told the Observer that a woman protester who had turned up at one of his lectures was found to be carrying a knife. Another scientist had to abandon a collaboration with American doctors after being told she risked being shot, while another was punched in the street. All said they had received death threats and vitriolic abuse"

http://www.theguardian.com/society/2011/aug/21/chronic-fatigue-syndrome-myalgic-encephalomyelitis

So where are the prosecutions? I don't think anyone here has been able to locate any. Isn't that strange? I mean seriously.

 

[Daisymay]

From the PACE one:



Apparently this refers to PACE, as later on they say:



So PACE was nearly not published because one patient asked to have their data withdrawn? Sounds a bit odd. Would be interesting to get some more info on that.

How could the withdrawal of one persons data have such a profound effect, the results are not so weak that removal of one persons data would statistically invalidate the conclusions are they?

Is this not mere scaremongering to stop this person, whomever they are, from being allowed to remove their data?

I thought an individuals rights in research were paramount?

 

[Esther12]

Is this not mere scaremongering to stop this person, whomever they are, from being allowed to remove their data?

I thought that was a possibility. Hard to say though.

 

[Art Vandelay]

So where are the prosecutions? I don't think anyone here has been able to locate any. Isn't that strange? I mean seriously.

Exactly! I'm willing to bet that not one person has been charged for threatening, harassing or committing violence against one of these nitwit researchers.

As I've pointed out elsewhere, cooking up fake threats is a tactic that has been employed by researchers in other fields in Australia recently in order to de-legitimise and silence any opposition.

 

[Dolphin]

Latest response now up.

Peter Denton White/Queen Mary, University of London again refuse to release data from £5m PACE Trial
http://forums.phoenixrising.me/inde...se-to-release-data-from-£5m-pace-trial.31436/

Not sure whether Queen Mary, University of London should be chosen to do important research if such a task would take them over 18 hours!

 

[Dolphin]

See this thread:

IMEG (UK) Report on Infectious diseases & sequelae in recent deployed service with focus on CFS(PDW)
http://forums.phoenixrising.me/inde...deployed-service-with-focus-on-cfs-pdw.32822/

for a Sept 2013 Ministry of Defence report on CFS and related matters, drawn up by Peter White and others it appears.

There is no mention of the employment outcome measures (in the relevant section) from the PACE Trial which cost £5m of UK taxpayers' money, yet the subjective outcomes are mentioned.

 

[Dolphin]

From: Leonard Jason

See pages 67 to 70 for an article "Beyond Tired: Chronic Fatigue Syndrome remains misunderstood and understudied. Psychologists are among those trying to change that" This article just appeared in the Oct 2014 issue of the American Psychological Association’s publication the Monitor
http://www.apamonitor-digital.org/apamonitor/201410#pg70
---
Note that cognitive behavioural stress management is not the same as graded activity-oriented CBT.

Includes the following on the PACE Trial:

Other researchers have been critcial of that trial. A number of experts have taken issue with the authors' definition of recovery, Jason says

ETA:
Here's more - what came next:

Further, he adds, the researchers used a broad case definition of CFS and likely included people who actually suffered from depression.

“We know that cognitive-behavioral therapy is one of the best treatments for major depressive disorder,” Jason says, so you’d expect them to improve following the treatment.

Incorrectly including those people in the study could have skewed the results.

In Jason’s view, it’s dangerous to promote cognitive- behavioral therapy as a cure for CFS.

“We have to be very careful. The patient community generally has a strong disdain for most psychologists because they feel they’ve been blamed for their own problem,” he says.

“One of the most common treatment approaches is to convince patients that they’re not sick.”

Zinn is also wary of cognitive-behavioral therapy — or any therapy that attempts to treat CFS as a psychological phenomenon.

If a therapist tries to tell people with CFS that their dysfunctional thinking is causing the disease, she says,

“They will walk out the door and not come back.”

Such a scenario can be particularly harmful, she adds, if it prevents patients from seeking the help they need

 

[Sean]

This is a letter Adrian Baldwin and I just had published in Evidence Based Mental Health.

http://ebmh.bmj.com/content/early/2014/09/19/eb-2014-101961.extract

Unfortunately it is not open access.

Just found this full version:

http://www.readcube.com/articles/10.1136/eb-2014-101961

 

[Min]

They have ALL fallen short of actual violence, haven't they?

This is the only incidence of violence I have heard reported:
http://www.theoneclickgroup.co.uk/news.php?id=811

 

[Dolphin]

Well-researched comment from Dan Clarke. Mainly about the PACE Trial and how it has been reported:
http://www.insight.mrc.ac.uk/2014/11/12/encouraging-new-ideas-for-cfsme-research/#comment-168209

Dan Clarke #
“The CFS/ME field has been marred by a breakdown in trust between patients, clinicians, researchers and funders;”

While I agree with much of this blog, I disagree with this and think that, given the poor quality of much of the research in the area and the way in which results have often been misrepresented, it is vital that patients do not just trust clinicians, researchers or funders: many of them have shown that they are untrustworthy, so the breakdown in trust should be recognised as a good thing. Any attempt to increase patients’ trust in those who have authority over them without first taking steps such as requiring the release of the PACE trial’s results in the manner laid out within it’s protocol, will do more harm than good.

It is important that we do not allow irrelevant truisms about about the inevitable role of ‘psychological factors’ in all human experience or the biological underpinnings of the human mind to distract from the legitimate concerns of patients about those who have exaggerated the benefits of their biopsychoosocial interventions for CFS or promoted the routine medicalisation of the psychosocial aspects of CFS patient’s lives without informed consent from the patient.

For those not aware of the any of the specifics of problems in this area, I’ll use the PACE trials use of the SF36-PF scale as an example of one of the many concerns patients and patient organisations have with the way CFS research is too often conducted.

The £5 million+ PACE trial is the most expensive piece of CFS research funded by the MRC[1] and was a non-blinded trial using subjective self-report measures as it’s primary outcomes[2]. It’s published protocol defined ‘recovery’ as requiring an SF-36 Physical Functioning (SF36-PF) questionnaire score of at least 85 out of 100, while the trial’s entry criteria required a score of 65 or under, which was taken to indicate that patients’ fatigue was disabling[2]. The post-hoc criteria for recovery allowed patients with an SF36-PF score of 60 to be classed as recovered. This change was justified by the claim that a threshold of 85 would mean “approximately half the general working age population would fall outside the normal range.”[3] In fact, the data cited showed that the median score for the working age population was 100, less than 18% of the general working age population had a score under 85 when 15% had declared a long-term health problem[4,5].

An SF36-PF score of 60 was claimed in the Lancet PACE paper to be the mean -1sd of the working age population, and thus a suitable threshold for ‘normal’ disability[6]. They had in fact used data which included all those aged over 65, reducing the mean physical function score and increasing the SD[4]. For the working age population the mean -1sd was over 70, requiring patients to score at least 75 to fall within this ‘normal range’[5]. Also, the trial’s protocol makes it clear that the thresholds for recovery (including ≥85 for SF-36 PF) were intended to be more demanding than those for the mean -1sd, reporting that: “A score of 70 is about one standard deviation below the mean… for the UK adult population”[2].

The post-hoc criteria for recovery so clearly overlapped with the trial’s own criteria for severe and disabling fatigue that a specific requirement mandating that ‘recovered’ patients not also fulfil every aspect of the trial’s criteria for CFS[3] needed to be used. Even so, patients could still have been classed as recovered when reporting no change, or even a decline, in either one of the trial’s primary outcomes.

Even using the loose post-hoc criteria for recovery, only 22% of patients were classed as recovered following treatment with specialist medical care and additional CBT or GET[3]. Regardless, the BMJ had reported that PACE showed CBT and GET “cured” 30% and 28% of patients respectively[7], a Lancet commentary claimed that about 30% recovered using a “strict criterion” for recovery[8], and a paper aimed at NHS commissioners stated PACE indicated a recovery rate of 30-40% for CBT and GET[9,10]. It is wrong for such misstatements of fact to be allowed to go on affecting how doctors treat their patients, how funding decisions are made, and the information that patients are provided with before deciding whether to consent to particular interventions.

The changes to the outcome measures used in the PACE trial may not be deliberately deceptive, but they were misguided, justified by inaccurate claims, and have been misleading to others. The refusal to allow patients access to data on the outcome measures laid out in the trial’s protocol, and seemingly contradictory nature of the responses to Freedom of Information requests for this data reflects a sad dismissal of their right to be informed about the medical treatments they are being encouraged to pursue[11,12,13].

There was a time when it was claimed by some that even homeopathy was a promising medical treatment, based upon minor improvements in subjective self-report measures following non-blinded trials. It is now more widely and that it is not ethical to promote homeopathy as a legitimate form of medicine.

In the case of cognitive and behavioural interventions for CFS/ME, we have evidence from the PACE trial that they are able to lead to modest improvements in patient questionnaire scores in a non-blinded trial, without leading to improvements in real world outcomes such as employment rates, or claims for disability benefits[14]. A meta-analysis of actometer data from CBT trials for CFS also found that CBT was able to lead to improvements in questionnaire scores in non-blinded trials, but not to improvements in the amount of activity that patients were actually able to perform[15]. Sadly, the PACE trial dropped actometers as an outcome measure, although they were purchased and used at baseline[16].

Recent evidence from a large study of NHS CFS/ME specialist services indicated that reported results for CBT and GET are poorer than those reported in PACE, and that centres offering CBT and GET achieved marginally worse results than centres offering ‘activity management’[17]. We do not currently have compelling evidence that CBT or GET are more effective medical interventions for ME/CFS than homeopathy, despite some of the claims made by proponents.

It should be seen as no more acceptable for those with financial, professional or ideological interests in promoting CBT or GET as treatments for ME/CFS to exaggerate the value of these interventions than it is for others to exaggerate the value of homeopathy. Anyone with a real interest in helping patients with ME/CFS, and in allowing them to make informed decisions about their own health care, should now call for the release of results for all of the outcomes laid out in the PACE trial’s published protocol[2].

[1] http://gtr.rcuk.ac.uk/project/7EC0DBA0-0FC2-44F1-8708-8676EBEDA4C9

[2] White PD, Sharpe MC, Chalder T, DeCesare JC, Walyin R: Protocol for the PACE trial: a randomised controlled trial of adaptative 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

[3] White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med 2013;1-9, published online 31 Jan. doi:10.1017/S0033291713000020.

[4] Bowling A, Bond M, Jenkinson C, Lamping DL. Short form 36 (SF-36) health survey questionnaire: which normative data should be used? Comparisons between the norms provided by the Omnibus Survey in Britain, The Health Survey for England and the Oxford Healthy Life Survey. J Publ Health Med 1999, 21: 255–70.

[5] Office of Population Censuses and Surveys. Social Survey Division, OPCS Omnibus Survey, November 1992. Colchester, Essex: UK Data Archive, September 1997. SN: 3660, http://dx.doi.org/10.5255/UKDA-SN-3660-1

[6] 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. 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.

[7] BMJ Short Cuts: ‘All you need to read in the other general journals’ BMJ 2011;342:d1168

[8] Knoop H, Bleijenberg G. Chronic fatigue syndrome: where to PACE from here?. Lancet 2011; 377: 786-788.

[9] Collin SM, Crawley E, May MT, Sterne JAC, Hollingworth W: The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database. BMC Health Serv Res 2011, 11:217.

[10] Interview with Amy Chesterton and Esther Crawley. Available athttp://www.thenakedscientists.com/HTML/content/news-archive/news/2384/

[11] Freedom of Information request http://www.meassociation.org.uk/?p=6171

[12] Freedom of Information responsehttp://www.meassociation.org.uk/wp-content/uploads/2011/06/FOI from Queen Mary.pdf [3]

[13] Follow up Freedom of Information request:https://www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po

[14] McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. (2012) Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS ONE 7: e40808.

[15] Bleijenberg G, Prins JB, Wiborg JF, Knoop H, Stulemeijer M,. ‘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.

[16] PD White, MC Sharpe, T Chalder, JC DeCesare, R Walwyn, for the PACE trial management group: Response to comments on “Protocol for the PACE trial” http://www.biomedcentral.com/1471-2377/7/6/comments#306608

[17] Crawley E, Collin SM, White PD, Rimes K, Sterne JA, May MT; CFS/ME National Outcomes Database. (2013) Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database. QJM. 106:555-65.

November 13, 2014

 

[Dolphin]

http://paradigmchange.me/exercise-quotes/

Those physicians and researchers who are familiar with the disease of Myalgic Encephalomyelitis (M.E.) are in agreement that activity or exercise can lead to a severe relapse.

How to engage in desired or necessary activities in a way that does not lead to a crash thus is an important topic for those with the disease.

Following are more than two dozen comments from experts in M.E. on this topic.

Except where indicated otherwise, the quotes were supplied directly by the named individuals for this collection (in some cases a few years ago).

Some of these quotes refer to the “PACE Study,” which is discussed on this page http://paradigmchange.me/pace of the Paradigm Change site.

I've started a thread on this page here: http://forums.phoenixrising.me/index.php?threads/exercise-intolerance-quotes.33975/

 

[Dolphin]

A sign that the mediators paper should be out soon (although not necessarily before this conference)

http://www.bacme.info/document_uploads/BACME_Events/BACME15ConferencedraftProgrammeEarlybird.pdf

BACME conference, March 2014

[..]

Professor Trudie Chalder, Dept. of Psychological Medicine. King's College London : Mediators of treatment outcome in the PACE trial of rehabilitative therapies for chronic fatigue syndrome/ME

 

[Bob]

Edit: I've placed this list in a new thread, as a handy wiki-style reference:
http://forums.phoenixrising.me/index.php?threads/pace-trial-list-of-all-papers-published.34099/



I thought this might be a handy reference to share...
It's all the PACE-related papers published to date, unless I've missed any...

Published protocol (2007):
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 Mar 8;7:6.
http://www.biomedcentral.com/1471-2377/7/6

Main PACE trial paper (2011):
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 Mar 5;377(9768):823-36.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

Cost-effectiveness analysis (2012):
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(7): e40808. doi:10.1371/journal.pone.0040808.
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0040808

[Alleged] "recovery" paper (2013):
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;43:2227-235.
http://journals.cambridge.org/abstract_S0033291713000020

Statistical Analysis Plan (2013):
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 Nov 13;14:386.
http://www.trialsjournal.com/content/14/1/386

Adverse events and deterioration (2014):
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 Jul;77:20-6.
http://www.sciencedirect.com/science/article/pii/S0022399914001883


Minor PACE-related papers:

Lawn T, Kumar P, Knight B, Sharpe M, White PD.
Psychiatric misdiagnoses in patients with chronic fatigue syndrome.
JRSM Short Rep. 2010 Sep 6;1(4):28.

Cella M, Sharpe M, Chalder T.
Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale.
J Psychosom Res. 2011 Sep;71(3):124-8.

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

Bourke JH, Johnson AL, Sharpe M, Chalder T, White PD.
Pain in chronic fatigue syndrome; response to rehabilitative treatments in the PACE trial.
Psychological Medicine 2013; Page 1- 8. (online) doi:10.1017/S0033291713002201

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

 

[Sasha]

Top stuff, @Bob!

Should that have its own thread, with people able to add new links when new studies are published?

It's going to get buried here, and it's such a useful thing.