A general thread on the PACE trial!

GET carries within it the idea that the illness is being perpetuated by not doing enough and deconditioning. Pacing accepts that we are sicker when we do too much. They are completely opposite. The confusion is caused by BPS ideas. Balancing life in a better way can be a good basis for pacing but not when it is part of an overall goal to increase exercise.

The woman who though she got better with GET was not doing a misplaced form of pacing as the therapist was aiming to get her to change her life so that she could do more. Luckily, in practice, it allowed her to do enough less so she improved. The next patient at the clinic may have had no way to reach a level that let them improve.

Pacing is finding the baseline at which you can have an acceptable life without causing payback. Because this varies individually it has to be patient led and some reach a very low level of life indeed.

It is important for us to be clear that it is the idea of ME/CFS being caused by under doing or overdoing that is the important point.

 

Although I agree with the rest of your post, I disagree with the sentence above.

I have been pacing for most of the past 25 years, but my life is in no way acceptable - not just because of what I am not able to do, but because of the levels of discomfort and pain that I endure. For me, pacing is about maximising quality of life and minimising the risk of becoming more unwell and disabled. In some cases that may enable patients to have an acceptable life, but in many cases it does not - and it is important for us to be clear about that too.

 

Of course. We don't even have the capacity for this so I thought it was implied

The records are sealed anyway, this would have to be done proper with authorization from whoever has that authority.

 

I see what you are saying. It is like the way I say I am a little bit tired when I mean I am about to fall over Acceptable can be heard as much more positive than it was meant which was what we are willing to put up with.

I was really talking about the reason for pacing. The clinics and some doctors try to use it is a way of recovering but it is only a way of coping. For me it is what I am willing to accept.

I rest so I can go to see my grandchildren knowing I will be in more pain than usual and much sicker for the next few weeks. I am even willing to risk a permanent deterioration for that, other things carry there own calculation of risk against want.

Our lives are rarely what the able bodied would class as acceptable.

 

Apologies for just popping up and additional anticipated apologies in case of being redundant: I am tidying up my S4ME drafts folder – this is a message from the past.

In addition to all the work already published correcting the PACE trials' claimed figures regarding improvements by GET and CBT, I thought it might be worthwhile to analyze how "pacing" was conceived in the trial and how the APT (Adaptive Pacing Therapy) part was designed.

First, if the participants in the APT group were the only ones who kept an activity/ pacing diary, they also would have been the only ones who had a realistic protocol of the course of their activity levels – and the only ones who filled in the questionnaires accordingly.

Then, had participants of the APT arm already been practicing their own concept of pacing before the trial?

In either case, pacing as I understand it, and as other forum members have pointed out, does not promise to increase physical functioning and/or to reduce fatigue significantly in the long run. It's only thought to reduce the frequency and severity of additional PEM or crashes, thus stabilizing as much as possible, i.e. depending on the type of course of the illness, preventing or reducing the risk of or slowing down a long term decline. (*)

However, the trial's APT concept seems to have been contradictory. Although it is said in the Lancet paper (2011) that APT was conceived as simply adapting to reduced capabilities, the underlying hypothesis being the "energy envelope theory" (**), it is also said that participants were encouraged to increase their activities "If the participant felt able". Perhaps it actually was directed to mainly organize things better, with the premise that this will easily increase the efficacy of activities, leading to perceiving activities as doable and satisfactory, thus leading to less fatigue, followed by finally increased activiy levels?

The Lancet paper:

Haven't found the APT manuals for therapists and patients, but stumbled over those "PACING" rhymes by G.T. Buchan in the participants' newsletter (Issue 2, March 2007):

https://www.qmul.ac.uk/wolfson/media/wolfson/current-projects/participantsnewsletter2.pdf (p.2)

What if you still aren't able to work properly or work at all even when you already have shifted tasks and shortened lists? Or, if you already adjusted your scope of work and homework, yet you get both done only at the expense of your entire leisure and social activities?

It might have been discouraging not being able to accomplish the proposed goals?

Taken together, participants in the APT group (a) initially might have had not expected to get better, (b) might have been become discouraged during the course of the trial by being told they could get better if they only were better organized, and (c) in addition might have been the only ones who recorded their daily activities properly, thus had a realistic account they might have recalled when filling in the subjective outcomes questionnaires.

As others have pointed out elsewhere, the trial was flawed in a manner that makes it impossible to use the presented figures in any way. Thus, if my points make any sense at all, they still won't add any substantial critique to the alleged results regarding GET.

My point is that PACE's results regarding pacing are invalid in many regards, too. However, if you singled them out and they were valid, APT would, measured against the underlying hypothesis, actually be very effective: Not only did most APT group participants not deteriorate, but an impressive figue of 42%, according to the trial's definition, even "improved". Surprised that there is no difference to the "SMC alone" group? Then, how to make sure that the trial participants in the "SMC alone" arm didn't practice some form of pacing, too?

I think it could be worthwhile to have some capable researchers looking at the data of the activity diaries. Perhaps these could be used to conceive a reasonable future study that actually investigated pacing.

Footnotes:

(*) At the same time, the concept of pacing as I understand it allows to acknowledge that remission might occur, but it is not known yet why a certain percentage of ME sufferers improves significantly or gets completely well again (not sure whether the latter is true/ whether there are reliable figures, though?)
(**) "This theory regards chronic fatigue syndrome as an organic disease process that is not reversible by changes in behaviour and which results in a reduced and finite amount (envelope) of available energy." https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext

(minor edits for spelling and grammar)

 

I have saved copies of all the manuals.

All the intervention groups (APT, CBT, GET) kept daily activity diaries, at least for the first 4 weeks.

APT group pts kept daily activity and rest diaries -
"Daily Diary" recorded time, activity and fatigue level (rated 0-10) [hmmm... interesting....]*
"Rest and Relaxation" recorded on weekly sheets, list of activities and duration by day.
They also had to fill in daily program schedules, weekly plans of activity, actual weekly schedule, activity analysis sheets, activity modification worksheets, energy requirement worksheets, and the all-important baseline activity worksheet.

CBT group also kept daily activity diaries, but also filled in diaries on sleep (for 2 weeks), completed worksheets on "targets", planning patterns of rest and activity, but only for the first few weeks. Sessions then seemed to switch to a more behavioural slant, dealing with unhelpful thoughts and tackling anxiety.

GET group completed daily exercise/physical activity diaries, and also worksheets on goals, GET plans and progress sheets, and more extensive exercise records, which recorded Borg scores and heart rate. However, there seems to be a difference in how "activity" was defined in this group, in that it seems to mean exclusively physical activity.

There seemed to be no standardisation between in the groups in what participants were asked to record or for how long. Even the format of the activity diaries varied hugely between the intervention groups.

The group who seemed to have the most daily paperwork to do was the APT group.

-------------------------------
*The APT group were the only group required to record their fatigue in this way - in that they systematically gave it a score on their daily diary in a designated box.

The GET group were asked to do this too, but only more informally -
"Symptoms: At relevant times, make a note of any important symptoms on a scale of 1-10 (10 being worst), e.g. fatigue 7/10 after going to shop, 2/10 when enjoying lunch with friend." - in the physical activity diary completed in the first week, although the diary sheets don't have a designated area to record this information.

The CBT group weren't asked to record fatigue in this way at all.

 

More evidence the PACE trial was not a controlled trial.

 

As I was taught by diverse forum members, the PACE trial investigators, at least in the 2011 paper, didn't even claim PACE was a controlled trial (however, Cochrane etc...):

https://www.s4me.info/threads/a-general-thread-on-the-pace-trial.807/page-11#post-90478

https://www.s4me.info/threads/a-general-thread-on-the-pace-trial.807/page-11#post-90488

https://www.s4me.info/threads/a-general-thread-on-the-pace-trial.807/page-11#post-90512

 

Excellent.

Thank you for correcting me and adding important details.

Unfortunately, I have to refrain myself from writing more for a while now.

 

I think the activity diaries should be seen as part of the intervention, so it's not that abnormal that there are differences between them IMHO.

 

Indeed. But if 'completing an activity diary' forms a large part of your activity for the day, then it becomes part of the problem!

[ETA1 - I have done this. For 3 weeks. It becomes a task in and of itself.]

[ETA2 - If activity diaries were the intervention, then they should have done a trial explicitly of activity diaries. There were potentially useful bits to all the interventions, as far as I can see. GET had HR monitoring and Borg scoring. CBT had sleep diaries. APT had fatigue scoring in activity diaries. But far too messy as a trial to work out wtf it all meant. Could. Do. Better.]

 

Completely agree. At one point, many years ago, I was advised to keep an activity diary that also recorded symptoms and their severity. It not only became a burden to complete, but it was also very dispiriting. It felt like I was continuously having my symptoms and limitations rubbed in my face. I felt like I was being made to constantly focus on symptoms and I found it was a very negative experience.

In a trial where subjective outcomes are king, keeping a diary as required in the APT group, may have introduced yet another bias.

 

Only now I see that the treatment manuals are available on the MEpedia page (or maybe I saw it before and that's the reason why my post was sleeping in my drafts folder for such a long time?)

• MediaACE-get-therapist-manual.pdf
• MediaACE-get-participant-manual.pdf
• MediaACE-cbt-therapist-manual.pdf
• MediaACE-cbt-participant-manual.pdf
• Media:Apt-participant-manual.pdf
• Media:Apt-therapist-manual.pdf
• Media:Ssmc-doctor-manual.pdf

source: https://www.me-pedia.org/wiki/PACE_trial

Also, the MEpedia page on APT seems to be very informative (only skimmed it):
https://www.me-pedia.org/wiki/Pacing#Adaptive_pacing_therapy_.28APT.29

 

I think this is the normal procedure in most ME/CFS studies. GP's refer patients they suspect to have ME/CFS to a specialist clinic. There they check if there are other causes that might explain the symptoms which is the case in many (around 40%) of such referrals. There has to be some consistency in how the specialist centres diagnose ME/CFS patients, so I think it’s not abnormal to see passages like these in PACE-trial meetings.

I do think that many ME/CFS studies have a bias as most recruit patients from specialist services. I suspect that ME/CFS patients only go to these centres at a particular time point in their illness, usually in the beginning when they are still uncertain about the diagnosis and looking for treatment options. As years go by they will probably go less to these specialist services and try to cope with the illness themselves (or look for alternative treatments). So I think ME/CFS studies have a bias in including patients who are recently diagnosed, but that PACE wasn't alone in this respect.

This interesting. The fact that they prefer SMCC indicates that they were not afraid of missing out on their preferred treatment. Instead it seemed like they thought all treatments were bogus.

Thanks for pointing this out. I tried to have a go at these TSC documents but it was hard to keep focus. It's very boring reading material. So thanks for your perseverance in reading them thoroughly.

 

The trial authors explained more about their recruitment strategy in the protocol:

They mentioned that when previous studies had tried to recruit directly from primary care networks, uptake was poor and it was hard to reach recruitment targets. I guess with specialist centres, they know how many patients are coming through their doors each year, so have a much better idea of how long it will take to recruit the necessary numbers.

I've had a look through the TMG minutes, and this is what I've found about recruitment.

From TMG #15 (2005-06-15):

From TMG #16 (2005-09-14):

The reason I'm looking through is because I seem to remember they had problems with the recruitment at one centre and did decide to go through GPs - but I'm not sure whether that's correct. I'll add it here when I find it...