PACE Trial and PACE Trial Protocol

[alex3619]

Hi Oceanblue, the defining feature of pacing is to stay below an exacerbating level. Ellen Goudsmit: "As I've noted before, pacing does not rely on plans. Indeed, if you see references to plans, goals or targets, you are probably reading about some form of graded activity." Any estimate of potential activity is going to be imprecise, so a buffer would be needed. If you picked 75% then you want to stay below this. So pick a target, stay below that target. PACE APT was about picking a target and staying above that target.

http://www.wames.org.uk/pacingweb.pdf
http://freespace.virgin.net/david.axford/me-pace.htm

This above/below a target are the opposite of each other, though there could be overlapping ranges if the targets are different.

Bye, Alex

 

[Bob]

...the defining feature of pacing is to stay below an exacerbating level... Ellen Goudsmit: "As I've noted before, pacing does not rely on plans. Indeed, if you see references to plans, goals or targets, you are probably reading about some form of graded activity."

I like that description of pacing... That's what I do, very informally... I just try to avoid getting to a certain level of physical tiredness or fatigue.

I agree with your thoughts Alex, that we should always point out, very forcefully, that APT has no relation to pacing.
APT was an unsuccessful novel 'therapy' that was devised solely for the purpose of the PACE Trial. No more than that.

Given that AfME with cited as the key advisers on pacing, I contacted them last year to ask for the rationale behind the 75% rule. After a fair bit of tooing and froing, they came back to say 'we don't know'. Apparently the people who were invovled in drawing up the 75% rule, endorsed by AfME, had left the organisation and no one there now could explain the logic behind it.

That's interesting about AfME.

 

[oceanblue]

Hi Oceanblue, the defining feature of pacing is to stay below an exacerbating level. Ellen Goudsmit: "As I've noted before, pacing does not rely on plans. Indeed, if you see references to plans, goals or targets, you are probably reading about some form of graded activity." Any estimate of potential activity is going to be imprecise, so a buffer would be needed. If you picked 75% then you want to stay below this. So pick a target, stay below that target. PACE APT was about picking a target and staying above that target.

This above/below a target are the opposite of each other, though there could be overlapping ranges if the targets are different.

I completely agree that "the defining feature of pacing is to stay below an exacerbating level", but as you say, if the targets are different then they don't have to be opposite one another.

As for plans being being about graded activity, that's perhaps too simplistic (note Ellen's 'probably'). You can have a plan to do more within pacing but very gently; I think the APT manual says something like 'as energy permits'. The big difference between this and graded activity is that there's no rigid target or goal, instead at all times pacing aims to "stay below an exacerbating level". If this means you can't achieve your plans, then that's how it is. So with my experience with the OT, she was encouraging me to stay within my limits, not to acheive the plans - that's the big difference. Pacing does not rely on plans, but they can be part of it. And better pacing usually means that people can do more overall (which ties in with having plans), that's part of the rationale for it.

Just to restate, though, APT was a distorted and rather meanigless form of pacing because of it's excessive restrictions through the 75% rule.

 

[Dolphin]

Off-topic: MS Society funding two Moss-Morris trials of CBT (CFS-like) for MS

Doesn't this tell you everything you need to know about how CBT 'cures' fatigue?

"Interestingly, at the end of treatment,
the CBT group reported significantly lower levels of fatigue
compared with the healthy comparison group normative score
(t (107) 6.67; p .001). This trend for lower fatigue than
healthy participants was maintained at 3 (t (107) 4.48; p
.001) and 6 months follow-up (t (107) 2.51; p .01).
Fatigue levels for the RT group at the end of treatment were
equivalent to those of the matched healthy comparison group
(t (109) 1.32; p 0.19). At 3 months follow-up, their
fatigue was significantly less than the healthy participants
fatigue levels (t (109) 2.08; p .05), while the two
groups had similar fatigue severity scores at the last follow-up
point (t (109) 0.14; p .89)."

Unless CBT miraculously produced physiological changes making participants healthier than healthy controls?

In case people are confused, Marco is not referring to the PACE Trial but to this trial:

van Kessel K, Moss-Morris R, Willoughby E, Chalder T, Johnson MH, Robinson E.
A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. Psychosom Med. 2008 Feb;70(2):205-13. Epub 2008 Feb 6.

Thus the point is that people who have done CBT may artifically rate their fatigue levels as lower than they really are (because it's unlike people with MS actually have lower fatigue levels than a comparison group with a similar age and gender profile).

Full text at: http://www.psychosomaticmedicine.org/content/70/2/205.long

The CBT manual was written specifically for this trial1 and was based on a cognitive behavior model of fatigue (19).

Both the CBT and RT manuals were based in part on the work by Deale and colleagues, who developed a CBT and relaxation manual for their RCT of CBT for chronic fatigue syndrome (20). However, a number of the CBT chapters were developed specifically for MS.

Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry 1997;154:40814.[Abstract]

http://www.iop.kcl.ac.uk/staff/profile/default.aspx?go=13066

Professor Rona Moss-Morris BSc MHSc PhD
Head of Health Psychology
Chair in Psychology as Applied to Medicine

[..]

ACTIVITIES AND INTERESTS

Web based version of CBT Package: MSInvigor8. Funded by MS Society

(http://octopussy.ecs.soton.ac.uk/MSInvigor8/sections/introduction/welcome.php)

Primary investigator on the MIBS trial (Management of Irritable Bowel Syndrome in primary care) funded by NIHR.

Leading on a patient self-management cognitive behavioural therapy website.

I have a small role in SCOPE - a large international, multi-site study of predictors of major diseases of pregnancy outcome.

Psychological predictors of pregnancy outcomes such as preeclampsia and preterm birth. http://www.scopestudy.net/research.aspx

CBT intervention for early stage Multiple Sclerosis funded by MS Society

saMS Trail (http://www.youtube.com/watch?v=IVJHW8rntCI)

 

[Marco]

The only value of this may be contextual but I was reading one of the library papers discussing the incidence of CFS arising after a giardia lamblia outbreak in Norway which mentioned reference Norwegian norms for SF36 (not discussed in detail in the paper and only the abstract of the Norwegian norms in available free online).

Anyway, while searching I came across a paper to validate and produce SF36 norms for the Turkish population :

http://www.biomedcentral.com/1471-2458/6/247


Table 4 gives a breakdown for each SF36 subscale by age range.

The data for SF 36 PF (both genders) are


Age 18-44 : mean 94.7, SD 16.5
45-64 : mean 81.3, SD 25.5
65 + : mean 56.3, SD 37.2

Note : sample size decreases with age range.

Without wishing to make too many assumptions, it is likely that the overall health of the UK population is at least comparable to the Turkish.

This being the case, if this data set were used as norms for comparison with the PACE results, then the cut-off of the mean minus 1 SD for the appropriate age range would give a figure of approximately 78 for SF36 PF.

 

[Esther12]

Those Turkish figures look much lower than the ones I've seen for the UK eg the Bowling ones cited by PACE.

 

[Snow Leopard]

You need to use population norms for the same country, otherwise you get translation and or cultural biases in the reporting.

 

[biophile]

In all the relevant datasets I've seen, the mean+/-SD rule gives 80/100 as the rounded lower threshold for "normal" physical function. Also, there are several CFS studies mentioned already on this thread, where the rule when applied to the physical function scores of the healthy age-matched control group, gives a higher threshold of 90/100 points! The PACE Trial's usage of the mean+/-SD rule on the physical function scores of a general population (including the elderly and diseased) to arrive at a 60/100 goalpost for middle aged CFS patients aiming for recovery, and the way the related results were presented at the press conference, was disgraceful.

 

[Dolphin]

(Not exciting at all!) PACE trial clarification - Lancet February 18, 2012

In the 1st anniversary edition of when the Lancet first published the results of the PACE Trial, we get the following:

The Lancet Correspondence Vol 379, Issue 9816, Page 616, February 18, 2012 ?

PACE trial clarification

In the PACE trial,[1] we stated that we used the Chalder fatigue question-naire.[2] We would like to clarify that we used an updated version of the scale.[3] The item Do you have problems thinking clearly? was replaced with Do you find it more difficult to find the correct word? This updated version has slightly better reliability than the original scale.[2,3] In practice, either item can be used without altering the interpretation of the scale.[2]

TC has done consultancy work for insurance companies and has received royalties from Sheldon Press and Constable and Robinson. MS has done voluntary and paid consultancy work for government and for legal and insurance companies, and has received royalties from Oxford University Press. PDW has done voluntary and paid consultancy work for the UK Departments of Health and Work and Pensions and Swiss Re (a reinsurance company).

*T Chalder, M Sharpe, P D White
trudie.chalder@kcl.ac.uk

Department of Psychological Medicine, Kings College London, London SE5 9RJ, UK

[1] White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011; 377: 82336.

[2] Chalder T, Berelowitz G, Hirsch S, et al. Development of a fatigue scale. J Psychosom Res 1993; 37: 14753.

[3] Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom Res 2010; 69: 1722.

 

[Dolphin]

Portuguese uses pedometers

Thought this was interesting:

The intervention consists of:
[..]
4. A pedometer to register physical activity (steps taken) on a daily basis.

It is also being used as a (secondary) outcome measure

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

http://apps.who.int/trialsearch/trial.aspx?TrialID=ISRCTN70763996
Scientific title: Four steps (4-STEPS): A self-regulation based intervention for physical activity adherence in chronic fatigue patients - A Randomized controlled trial

---------

 

[Snow Leopard]

I wonder what they will conclude when they find the 'adherence' is poor?

 

[alex3619]

http://apps.who.int/trialsearch/trial.aspx?TrialID=ISRCTN70763996
Scientific title: Four steps (4-STEPS): A self-regulation based intervention for physical activity adherence in chronic fatigue patients - A Randomized controlled trial

The link cites this as inclusion criteria:
clusion criteria: 1. Meeting the operationalised criteria for [idiopathic chronic fatigue/ chronic fatigue syndrome (ICF/CFS) (CDC criteria)]

I suspect this means the CDC empiric/Reeves criteria. It certainly involves chronic fatigue rather than ME - though this is a better way to acknowledge this than simply saying Oxford criteria without acknowledging its really idiopathic chronic fatigue.

Bye, Alex

 

[Dolphin]

The link cites this as inclusion criteria:
clusion criteria: 1. Meeting the operationalised criteria for [idiopathic chronic fatigue/ chronic fatigue syndrome (ICF/CFS) (CDC criteria)]

I suspect this means the CDC empiric/Reeves criteria. It certainly involves chronic fatigue rather than ME - though this is a better way to acknowledge this than simply saying Oxford criteria without acknowledging its really idiopathic chronic fatigue.

Bye, Alex

The Fukuda criteria have separate categories.
It looks like they will look at both:

Secondary outcome measures:

11. ICF and CFS diagnosis (CDS-CFS symptom inventory)

There is no mention of the MFI-20 (they're using the CIS-R to measure symptom severity) and are using the SF-12 not SF-36 so if they don't use the MFI-20 and SF-36, they won't be able to use the so-called "empiric" criteria (Reeves et al., 2005).

 

[Bob]

Well, this is interesting... I think it's chaired by Richard Horton of the Lancet...
From everything I've read about Richard Horton, he seems to be quite a decent person, politically speaking...
He seems to be skeptical of establishment power and has written some radical stuff in the past about vested interests, and the reform of the peer review process...
(This is going by my vague memory, so I might have it wrong.)

Anyway, here's a debate that he is chairing... I thought it was quite apt, considering the PACE Trial...

Are conspiracy theories the greatest threat to global health?
in the series Global Health Lab Discussions
Date: Tuesday 28 February 2012
Chair(s): Martin McKee, LSHTM, ECOHOST and Richard Horton, T
http://www.lshtm.ac.uk/newsevents/e...theories-the-greatest-threat-to-global-health

Some people attribute all sorts of adverse events, from disease outbreaks to political violence, to the covert activities of powerful organizations. These conspiracy theories go hand in hand with the phenomenon of denialism, whereby powerful vested interests do seek to refute, or more often create confusion about the genuine scientific evidence which should be used to inform health policy. Such narratives have been used successfully by industries to protect their profits in the face of evidence that their products cause harm. Therefore, while conspiracy theories may be a natural backlash against the certainties of modernity and falling trust in institutions, they also severely complicate the policy environment for those working in public health. This session draws on both practical and theoretical perspectives to explore the nature of conspiracy theories, the strength of such beliefs and possible policy responses to them.

 

[Esther12]

From everything I've read about Richard Horton, he seems to be quite a decent person, politically speaking...

He can talk the talk, but he didn't take the time to look carefully at the evidence with regards to the way the results from PACE were spun, or patient's concerns about it. Instead it was just deference to assumed authority, and something verging on open disdain to patients. The way he introduced the published letters raising concerns about PACE was pretty shameful.

 

[Bob]

He can talk the talk, but he didn't take the time to look carefully at the evidence with regards to the way the results from PACE were spun, or patient's concerns about it. Instead it was just deference to assumed authority, and something verging on open disdain to patients. The way he introduced the published letters raising concerns about PACE was pretty shameful.

Oh yes, I completely agree with you Esther...
His attitude re the PACE Trial is why his opinions about non-PACE-Trial-stuff surprised me so much.
Small-p politically speaking, he seems quite subversive, and disruptive, in a constructive and positive way.
His behaviour re the PACE Trial is very strange considering that, on paper, I'd have thought he'd be on our side.
Maybe he might have backed himself into a corner by publishing the PACE Trial on trust.
But that doesn't explain his attacks on the ME patient community.

 

[Esther12]

Oh yes, I completely agree with you Esther...

Oops. Hope I didn't come across as being critical of what you said (I've noticed myself writing even more bluntly than normally recently).

To be fair to him, it is a lot of work to be consistently sceptical of authority, and ensure that the evidence supports the claims being made. We're all lazy in this regard to some extent. That his area of laziness seemed to be so related to his unreasonable views about CFS patients makes it particularly shameful though.

Ah well... thanks for the titbit.

 

[Bob]

Oops. Hope I didn't come across as being critical of what you said (I've noticed myself writing even more bluntly than normally recently).

No, you didn't Esther.

To be fair to him, it is a lot of work to be consistently sceptical of authority...

But in the case of the PACE Trial, he should be the authority!!!

 

[markmc20001]

Well, this is interesting... I think it's chaired by Richard Horton of the Lancet...
From everything I've read about Richard Horton, he seems to be quite a decent person, politically speaking...
He seems to be skeptical of establishment power and has written some radical stuff in the past about vested interests, and the reform of the peer review process...
(This is going by my vague memory, so I might have it wrong.)

Anyway, here's a debate that he is chairing... I thought it was quite apt, considering the PACE Trial...

Are conspiracy theories the greatest threat to global health?
in the series Global Health Lab Discussions
Date: Tuesday 28 February 2012
Chair(s): Martin McKee, LSHTM, ECOHOST and Richard Horton, T
http://www.lshtm.ac.uk/newsevents/e...theories-the-greatest-threat-to-global-health

Some people attribute all sorts of adverse events, from disease outbreaks to political violence, to the covert activities of powerful organizations. These conspiracy theories go hand in hand with the phenomenon of denialism, whereby powerful vested interests do seek to refute, or more often create confusion about the genuine scientific evidence which should be used to inform health policy. Such narratives have been used successfully by industries to protect their profits in the face of evidence that their products cause harm. Therefore, while conspiracy theories may be a natural backlash against the certainties of modernity and falling trust in institutions, they also severely complicate the policy environment for those working in public health. This session draws on both practical and theoretical perspectives to explore the nature of conspiracy theories, the strength of such beliefs and possible policy responses to them.

This must be the most catchy title I've seen for a conference.

They going to "educate" everybody on the proper way to interpret the conspiracies I suppose?

I got a AE911Truth.org (examine the evidence) bumper sticker and would like to park right in front of the conference room!

People are waking up fast...!!

 

[Bob]

This must be the most catchy title I've seen for a conference.

They going to "educate" everybody on the proper way to interpret the conspiracies I suppose?

I got a AE911Truth.org (examine the evidence) bumper sticker and would like to park right in front of the conference room!

People are waking up fast...!!

Yes, it is an unusual conference for the editor of an extremely 'prestigious' scientific journal to be chairing, isn't it!