PACE Trial and PACE Trial Protocol

[Dolphin]

Open Access Piece on PACE Trial in journal EXPLORE

Open Access Piece on PACE Trial in journal EXPLORE (section: Evidence-Based Integrative Medicine Updates): http://www.sciencedirect.com/science/article/pii/S1550830711003065

Exercise Therapy or Cognitive Behavioral Therapy Improves Fatigue and Physical Functioning in Patients with Chronic Fatigue Syndrome
Level 1 (likely reliable) evidence

Somebody (whose first language isn't English) wrote to me saying somebody should write a letter. I don't see myself doing it - too busy.

 

[Megan]

Thanks dolphin for starting the other thread http://forums.phoenixrising.me/show...s-critiques-links-thread-no-discussion-please. I have not followed the PACE trial as closely as I know many here have. But now I need to be on top of it, and it is beyond me to read 145 pages, so a summary thread would be very helpful.

 

[alex3619]

I do not know if this has been mentioned before in quite this way, its a long thread and its been forever since I read the first posts. I do know its been said that PACE and simlar studies are not for the very sick patients - indeed most ME studies recruit mostly mild patients.

The whole point of evidence based medicine is clinical trials showing efficacy. So in the meta-analysis it was claimed that CBT/GET had some effect. The PACE trial, and every other one, probably had nearly all patients who would only be considered mild in the new ICC ME definition. So the arguments raised are about mild patients for the most part, as moderate, severe and very severe are non-participants and have never been tested - in other words there is no evidence base for any good effect by CBT/GET. Therefore under the usual evidence based guidelines, CBT/GET cannot be recommended for ME unless the patient is only a mild patient - and that is of course where the rest of the debate is.

Now this is tacitly acknowledged in various caveats and disclaimers all over the place, but I wonder if we should not be insisting that if they want to claim evidence based medicine as a justification for using CBT/GET, it is a violation of their own medical practice to use CBT/GET on moderate, severe and very severe patients. Its seems like they are hanged with their own rope, though I doubt it will be easy to convince anyone.

Bye, Alex

 

[oceanblue]

Don't know if this is relevant, but it's 6MWT data for Fibromyalgia patients:

Rev Bras Fisioter. 2011 Dec;15(6):474-80.

Impaired functional capacity and exacerbation of pain and exertion during the 6-minute walk test in women with fibromyalgia.
[Article in Portuguese]
Homann D, Stefanello JM, Ges SM, Leite N.
Ncleo de Pesquisa em Qualidade de Vida, Departamento de Educao Fsica, Universidade Federal do Paran, Curitiba, PR, Brasil.

Abstract

BACKGROUND:
Fibromyalgia has been association with physical performance limitations. Additionally, activities of daily living have been reported to be directly associated with the exacerbation of pain and perceived exertion in this patient population.

OBJECTIVES:
To compare the performance of a 6-minute walk (6MWT) test in patients with fibromyalgia and controls and to evaluate the relationship between test performance and quality of life, limitations of activities of daily living and physical activity level.

METHODS:
The study included 19 women with fibromyalgia (FM) and 20 healthy controls (CG). A 6MWT was conducted and pain intensity and perceived effort (PE) were assessed during the test. In addition, Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire (HAQ) and International Physical Activity Questionnaire (IPAQ) were applied.

RESULTS:
The fibromyalgia group walked significantly shorter distances when compared to the control group (FM: 473.5277.84 m vs. CG: 541.7585.62 m; p=0.02). In the fibromyalgia group, there was a negative correlation between distance in 6MWT and FIQ (r=-0.46; p=0.05), HAQ (r=-0.49; p=0.03) and oxygen consumption (r=0.78; p<0.01). There was also a correlation between HAQ and oxygen consumption (r=0.52; p=0.02). Participants with fibromyalgia had higher pain intensity and perceived effort during the test when compared to the control group.

CONCLUSIONS:
Women with fibromyalgia had greater impaired of functional capacity, exacerbation of pain and exertion during the 6MWT when compared to healthy women.

 

[alex3619]

It seems there is too much misinformation about our favourite Dr. Wessely. He is now advertising on Co-cure that for the real information you should go to his website:

http://simonwessely.com/about.html

I have not checked the link, I have little interest in going there at the moment.

The message is very authority driven. He is this, and he is that. Argument from authority, where in fact its his very capacity to act in that role that we question. So his advocates are appealing to the conservative elements in the ME and CFS communities: trust me, I am the authority.

Bye, Alex

 

[Esther12]

Ta Alex. I'm sure we can trust everything he says. Do you have a link to the co-cure post?

 

[Dolphin]

Ta Alex. I'm sure we can trust everything he says. Do you have a link to the co-cure post?

Here's the post: https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1201C&L=CO-CURE&P=R436&I=-3

He isn't Kelly - Kelly presumably just posted it because she thought others would find it of interest.

 

[Esther12]

Thanks.

I don't really know how that site works (I've only used forums, so listserv scare me) - is there a related discussion, or just one off posts?

I'm interested to know where the wessely site is being promoted.

 

[Dolphin]

Thanks.

I don't really know how that site works (I've only used forums, so listserv scare me) - is there a related discussion, or just one off posts?

I'm interested to know where the wessely site is being promoted.

Co-Cure https://listserv.nodak.edu/archives/co-cure.html is an announcement list so doesn't have discussions. Although one can read posts on the site, I imagine most people are subscribed by E-mail, either to individual e-mails or digest (i.e. the digest format means one gets one message a day). Over the years, I have found it a useful list to keep track of generally what is happening - it's much less time-consuming than a busy forum like this one. Messages are often then posted on other lists where discussions take place e.g. yahoogroups like http://health.groups.yahoo.com/group/MEActionUK/messages .
I'm not sure if there is that much discussion of this yet - see a little discussion on LocalME.

 

[Esther12]

Thanks for the little guide.

 

[alex3619]

Ta Alex. I'm sure we can trust everything he says. Do you have a link to the co-cure post?

Hi Esther12, I think Co-cure has a digest, but I get it as email. I can PM you (or anyone else) the text if you want. Bye, Alex

PS. Doh, Dolphin has posted a link, post 1447. Co-cure is a subscription list for dissemination of information for those interested - and it has about 2000 subscribers.

 

[Esther12]

Ta Alex. Dolphin sorted me out.

 

[oceanblue]

This rang I bell when I reread it recently, but maybe because it's been posted on this thread before. I'm finding it hard to let PACE go; maybe CBT would help.

Hugely influential paper by John Ioannidis:
Why most published research findings are false

First, let us define bias as the
combination of various design, data,
analysis, and presentation factors that
tend to produce research findings
when they should not be produced.
... Bias should not
be confused with chance variability
that causes some findings to be false by
chance even though the study design,
data, analysis, and presentation are
perfect. Bias can entail manipulation
in the analysis or reporting of findings.
Selective or distorted reporting is a
typical form of such bias.

 

[alex3619]

Hi oceanblue, the report or book I am writing is focussing very heavily on confirmational bias and other issues. There is a LOT of information on this, and I suspect a lot is directly targeted at things like CBT/GET, we just don't usually get to read about it as it is not directly ME or CFS related. I am looking into this, I might have more to say in a few weeks. However, I think it goes beyond this to an issue called dogmatic verificationism. See my introductory blog:

http://forums.phoenixrising.me/entry.php?1324-My-Opinion-on-Conspiracies

More blogs to follow, one half written at the moment.

Bye, Alex

 

[Snow Leopard]

Don't know if this is relevant, but it's 6MWT data for Fibromyalgia patients:

Rev Bras Fisioter. 2011 Dec;15(6):474-80.

The problem with these sorts of small studies is how patients are gathered. If it is a convenience sample, then it is going to be biased towards those who are less disabled and are willing to walk for 6 minutes. I haven't read the paper as it is in Portuguese. http://www.scielo.br/scielo.php?pid=S1413-35552011000600008&script=sci_arttext

But for that matter, patients forwarded from primary care tend to have much greater 'medical seeking behaviours' and depression (this effect is found across most diseases). Patients from population/community studies are still biased as not everyone wants to answer the phone or a mail questionnaire unless there is an incentive or coercion (eg you have to answer govt surveys in some countries).

It's not just about clinical criteria, getting a truly representative sample is tough...

 

[oceanblue]

The problem with these sorts of small studies is how patients are gathered. If it is a convenience sample, then it is going to be biased towards those who are less disabled and are willing to walk for 6 minutes. I haven't read the paper as it is in Portuguese. http://www.scielo.br/scielo.php?pid=S1413-35552011000600008&script=sci_arttext

But for that matter, patients forwarded from primary care tend to have much greater 'medical seeking behaviours' and depression (this effect is found across most diseases). Patients from population/community studies are still biased as not everyone wants to answer the phone or a mail questionnaire unless there is an incentive or coercion (eg you have to answer govt surveys in some countries).

It's not just about clinical criteria, getting a truly representative sample is tough...

I agree. But the same problem of patients forwarded from primary care would apply to the PACE trial too, and possibly to several of the other 6MWT comparisons as well - ie they all have the same type of bias (though not necessarily to the same degree).

 

[Dolphin]

Peter White workshop in Sept 2012

Saw this highlighted on Twitter:

http://www.rsm.ac.uk/academ/ifdm2012.php

6th International Forum on Disability Management (IFDM 2012)
Monday - Wednesday 10 - 12 September 2012
Venue: Imperial College London, South Kensington Campus, LONDON, SW7 2AZ

[..]

Aims and objectives:
The conference aims to gather representatives and stakeholders in disability management from all over the world, to assemble global perspectives on consensus-based best practices, cutting-edge research and successful disability management policies and programs. Disability management refers to the actions of the health and rehabilitation community to restore those disabled by injury or illness, to health and productivity.

[..]

D) Rehabilitation non-pharmacological therapies for functional somatic syndromes
Facilitator: Prof Peter White, Professor of Psychological Medicine, Barts and The London Medical School

 

[alex3619]

Something that just occurred to me that isn't really new but is perhaps a more powerful way to highlight one of the PACE problems. APT, adaptive pacing therapy, is ant-pacing, a mutually exclusive activity to pacing. It resembles, of anything, the old style of GET (Mk 1) which had no give in it. The newer GET, as practiced in PACE, is a little more forgiving. So its not suprising that GET was shown to be better than APT. By moving away from GET Mk. 1 partway toward pacing improved the outcome. What a surprise. To put this another way, this was not a comparison of GET and pacing, it was a comparison of two forms of GET (which others have said) one of which was relabelled as APT. This is of course a highly confusing label, a point we can make much more of than we have been so far. Bye, Alex

 

[oceanblue]

Something that just occurred to me that isn't really new but is perhaps a more powerful way to highlight one of the PACE problems. APT, adaptive pacing therapy, is ant-pacing, a mutually exclusive activity to pacing. It resembles, of anything, the old style of GET (Mk 1) which had no give in it. The newer GET, as practiced in PACE, is a little more forgiving. So its not suprising that GET was shown to be better than APT. By moving away from GET Mk. 1 partway toward pacing improved the outcome. What a surprise. To put this another way, this was not a comparison of GET and pacing, it was a comparison of two forms of GET (which others have said) one of which was relabelled as APT. This is of course a highly confusing label, a point we can make much more of than we have been so far. Bye, Alex

Having read the manual, I'm not sure I'd agree APT is mutually exclusive to pacing, but it's certainly weird with it's '75%' rule; if you leave a quarter of your available energy unused every day that's a recipe for decline, or at best minimal progress.

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.

What's particularly odd about this is that I had some pacing help from a former Westcare OT; it as Westcare that pioneered pacing in a formal sense (as opposed to what patients had figured out for themselves). The point is that my ex-Westcare OT was very helpful but never mentioned a 75% rule or anything like it: if anything there was just a 'no more than 100%' rule.

 

[anciendaze]

...I think that Anciendaze could be a better bet for understanding what is being said in the paper though.

It took me a while to figure out why my ears were burning before I discovered this reference.

It took me a little longer to find the referenced paper. I have only glanced at it, but don't feel particularly scared by the math(s), only tired. The kinds of flaws mentioned in it seem small potatoes compared to the major flaws in PACE. It is also entirely possible they were simply shopping for flattering measures, and used this excuse.

I've written a short analysis based on the idea that, regardless of diagnostic criteria, PACE contains internal contradictions. This is in the hands of a fairly sympathetic journalist, who I've encouraged to seek statistical expertise. Not only is special expertise in medical/psychological statistics not required, from what I've seen in the literature, it may be a hindrance. We are in a situation where a majority vote would favor incompetence and absurdities.