A general thread on the PACE trial!

strategist said:
Do you know how they assessed severity of PEM? What questions were asked, how was PEM defined?
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No. All they have is a table with numbers of patients reporting "symptoms of PEM" at baseline and 52 weeks. I cannot find a suitable questionnaire in the protocol that might have been used for this. Given that ~40% of the SMC group were no longer reporting "symptoms of PEM" at the end of the trial [and 15% overall weren't at baseline], there might be a problem with exactly what they were measuring.
 
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Lucibee said:
Given that 40% of the SMC group were no longer reporting "symptoms of PEM" at the end of the trial, there might be a problem with exactly what they were measuring.
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It's another anomaly that doesn't pass the common sense test. Standard medical care of for ME/CFS is useless, and such marked regression to the mean seems unlikely and is inconsistent with other measurements, yet 40% of were supposedly PEM free (it was no PEM at all, right?).
 
Lucibee said:
In fact, I've just searched the trial protocol and there is no mention of post-exertional malaise or PEM *at all*. So anything related to symptoms of PEM would have had to have been done post hoc.
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Maybe they used this one item from the CDC checklist?:

"Feeling ill after exertion" (rated 'not at all present', 'present a little', 'present more often than not', 'present most of the time' or 'present all the time').

The London criteria for ME that they used rates this item as present or not:

'Exercise-induced fatigue precipitated by trivially small
exertion (physical or mental) relative to the patient's/
participants previous exercise intolerance'
 
Lucibee said:
I wondered about that, but then the "individual symptoms of PEM" bit makes that a bit more doubtful. It's terrible that they didn't specify what they did here, given it's such an important factor.
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Yeah, none of the other items would seem to count as 'symptoms of PEM'. Maybe they messed up their language? I'd not really thought about this before as no-one seems to mention it and I'd just assumed it was some BS self-report thing, but it is annoying it's not clear what they did to measure this. Thanks @Lucibee you've given me another thing to be annoyed about with PACE!
 
I think the grammar of that sentence is causing confusion.
It says:
... and individual symptoms of post exertional malaise and poor concentration or memory, ....
I think that refers to the 2 rows in the table for the 2 'individual symptoms' they picked from the list, namely 1. PEM and 2. poor concentration or memory.
They are not referring to 'individual symptoms of PEM', rather that PEM is one of the individual symptoms.

The thing that strikes me from that table is how many in all the groups had their PEM vanish within a year.

Possible interpretations of this:

a) they didn't understand what PEM is,
b) they had been persuaded to see PEM as 'healthy' - as a sign the treatment is working - 'no pain, no gain' etc.
c) to re-interpret crashes as having an infection.
d) that they had stuck with the initial stage of their treatment of cutting back to a base level of activity that doesn't set off PEM, and then hadn't actually increased their activity, in other words were actually pacing better than they had before they entered the trial, and were therefore having having fewer crashes.
e) they recovered - not supported by the recovery re-analysis.
 
I got a question on what exercise exactly was used in the PACE-trial's GET. Didn't know the answer to this and am unsure where to look (can't read lots of text now). Was it just about walking, as a walking-test was one of the measures, or did the trial involve other exercise practices as well?
 
Sly Saint said:
It's also very misleading; as Pacing is APT (developed specifically for the trial), Graded activity is GET, and Cognitive behaviour therapy is also a 'special version' developed for CFS.

So right from the title the deceit/manipulation began....
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This reminds me of a situation where I mentioned the flaws of the PACE Trial, and someone asked "What's wrong with pacing?"

The name is definitely misleading and I can't believe it's pure chance they selected those letters. It's an uncommon selection pattern.
 
Kalliope said:
I got a question on what exercise exactly was used in the PACE-trial's GET. Didn't know the answer to this and am unsure where to look (can't read lots of text now). Was it just about walking, as a walking-test was one of the measures, or did the trial involve other exercise practices as well?
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I've had a look through the GET manual to see what was specified:
From page 44 of GET therapists manual:
Long term goals (Six months or longer)
These may be functional activities, hobbies, or an exercise that the participant would like to do. It may be an activity they used to enjoy, or a new activity.
For example:
• Walking to the shops three times a week.
• Riding an exercise bike for twenty minutes every day.
• Weeding the garden for an hour at a time.
• Managing to vacuum the home all in one go.
• Swimming 20 lengths three times a week.

Short-term goals
It is helpful to break these long-term goals into smaller components, e.g. walking to the shops could be broken down into walking half- way to the shops in three months time. This goal can then broken down further into weekly or fortnightly exercise goals. Goals with more complex components, such as returning to play badminton, may require a number of individual goals corresponding to flexibility, strength, and endurance. The ‘Setting Goals: Breaking goals down into manageable sections’ worksheet will help to set short term goals.

NB: Participants may be tempted to set unrealistic goals for themselves. Ensure that goals set with participants are realistic and balanced: e.g. it would not be recommended to set goals that involve working 80 hours a week, playing football 5 times a week and staying out until 4 in the morning at weekends.
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The only definition or example of "low intensity exercise" given in the manuals is gentle walking. It seems they relied on Borg for intensity.
 
From page 44 of GET therapists manual:
Long term goals (Six months or longer)
These may be functional activities, hobbies, or an exercise that the participant would like to do. It may be an activity they used to enjoy, or a new activity.
For example:
• Walking to the shops three times a week.
• Riding an exercise bike for twenty minutes every day.
• Weeding the garden for an hour at a time.
• Managing to vacuum the home all in one go.
• Swimming 20 lengths three times a week.

Short-term goals
It is helpful to break these long-term goals into smaller components, e.g. walking to the shops could be broken down into walking half- way to the shops in three months time. This goal can then broken down further into weekly or fortnightly exercise goals. Goals with more complex components, such as returning to play badminton, may require a number of individual goals corresponding to flexibility, strength, and endurance. The ‘Setting Goals: Breaking goals down into manageable sections’ worksheet will help to set short term goals.

NB: Participants may be tempted to set unrealistic goals for themselves. Ensure that goals set with participants are realistic and balanced: e.g. it would not be recommended to set goals that involve working 80 hours a week, playing football 5 times a week and staying out until 4 in the morning at weekends.

We've talked on other threads about GET approach getting renamed/regurgitated. Every time I read more about GET it strikes me more and more that because of the change of name and despite the fact that I was aware of the need not to do exercise and deliberately didnt do walking I did get hooked into a GET approach. I was encouraged in 2016 by the CFS ME clinic on their 'management programme' to set goals around activity and I decided that was decluttering my bedroom - sorting through and lifting, moving boxes of various sorts. As this didnt involve much walking I thought I was getting around the exercise aspect and I did make a start on this for a couple of weeks. I was naively doing exactly what they wanted. However I very quickly cottoned on to the fact that all I had to do was report progress without actually doing anything. I didnt do the activity I was telling them I was doing because I couldnt manage it. And after the first couple of weeks when I had taken holiday from my part time job so was able to cope fine with going to the clinic also had to reduce one of my working days to compensate for the day attending the clinic. I had been unable to manage 4 rather than 3 busy days. So I literally adjusted my activity back down to a manageable level, no overall increase in activity.


ETA above - for clarity
ETA incidentally since I stopped working last year I have actually been gradually doing this refurbishment work - partly through necessity - but I have coped because I had my energy on 3 days a week freed up.
 
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Inara said:
This reminds me of a situation where I mentioned the flaws of the PACE Trial, and someone asked "What's wrong with pacing?"

The name is definitely misleading and I can't believe it's pure chance they selected those letters. It's an uncommon selection pattern.
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no it was deliberate, and apparently with AfMEs blessing;see my post here:
https://www.s4me.info/posts/60515/
 
In relation to attempts by the PACE researchers to present APT in PACE as being the treatment that patients want/support/promote, someone drew my attention to this info on pacing from the NICE guidelines, which clearly distinguishes APT from the self-management strategy that people with CFS/ME generally support:

Pacing

The report of the Chief Medical Officer's working group[12] defined the principles of pacing, and these are supported by people with CFS/ME and patient groups. Many of the principles are included in this guideline's recommendations on CBT, GET and activity management. Examples include spreading activities over the week, breaking tasks down into small manageable parts, interspersing activity with rest and setting appropriate, realistic goals for increasing activity.

In this guideline, pacing is defined as energy management, with the aim of maximising cognitive and physical activity, while avoiding setbacks/relapses due to overexertion. The keys to pacing are knowing when to stop and rest by listening to and understanding one's own body, taking a flexible approach and staying within one's limits; different people use different techniques to do this.

However, in practice, the term pacing is used differently by different groups of people. One understanding of its meaning is as adaptive pacing therapy, which is facilitated by healthcare professionals, in which people with CFS/ME use an energy management strategy to monitor and plan their activity, with the aim of balancing rest and activity to avoid exacerbations of fatigue and other symptoms.

Another understanding is that pacing is a self-management strategy, without specific intervention from a healthcare professional. People with CFS/ME generally support this approach.
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https://www.nice.org.uk/guidance/cg53/chapter/Appendix-D-Definitions-used-in-this-guideline
 
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