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.
 
Mithriel said:
Pacing is finding the baseline at which you can have an acceptable life without causing payback.
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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.
 
Michiel Tack said:
This is interesting. I think I remember Charles Shepherd saying something similar: that some cfs centres claim to use GET for the record, but actually apply something more akin to pacing.
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But their type of pacing is GET lite actually still subtly encourage increase in activity

even on the CFS management course I did 2 years ago, elements of CBT and GET were in it
 
Robert 1973 said:
Although I agree with the rest of your post, I disagree with the sentence above. (Pacing is finding the baseline at which you can have an acceptable life without causing payback.)

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.
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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:

"This adaptation was achieved by helping the participant to plan and pace activity to reduce or avoid fatigue, achieve prioritised activities and provide the best conditions for natural recovery."
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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):

Work, rest, play balance
To the office reluctantly I trudge
Shifting tasks, shorter lists
Reduces all the drudge
Once you get the system straight
PACING can be fun
And, it is no surprise,
You get the job done!
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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)
 
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MSEsperanza said:
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.
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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.

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*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.
 
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Snow Leopard said:
More evidence the PACE trial was not a controlled trial.
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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
 
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Lucibee said:
I have saved copies of all the manuals.
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Excellent.

Lucibee said:
All the intervention groups (APT, CBT, GET) kept daily activity diaries, at least for the first 4 weeks.
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Thank you for correcting me and adding important details.

Unfortunately, I have to refrain myself from writing more for a while now.
 
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Michiel Tack said:
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.
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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.]
 
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Michiel Tack said:
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.
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I think I understand what you are saying - that the activity diaries don't need to be the same, as they are part of each treatment, not used as outcome measures.

However, when designing a study to show whether are differences in outcomes between a treatment based on pacing and a treatment based on incremental increases in activity, surely they should try to keep all parameters of the trial as similar as possible except the factor they are testing, so any effect can be attributed directly to that factor.

So, for example, the number and duration of treatment sessions should be the same. I would think that the time spent diary keeping should be the same for all interventions too. Otherwise, if one group had to spend a lot of time every day recording symptoms and activities, which is in itself burdensome, and another group didn't, that could contribute to the outcomes in a way that is not recognised, and potentially make the outcomes invalid.
 
Lucibee said:
Indeed. But if 'completing an activity diary' forms a large part of your activity for the day, then it becomes part of the problem!
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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.
 
Invisible Woman said:
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.
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Yes, I've never understood this blatant contradiction: patients are told that focusing on symptoms is a factor in perpetuating them. Yet the first thing you're ordered to do in a CBT course is to keep a diary of your symptoms which makes you focus on them.
(I guess it's the same logic as in the "fear of exercise" paradigm, when they have to tell people supposedly afflicted with a phobia of exercise to stop doing too much.)

These people are too complex and intelligent for us, mere neurotic patients.
 
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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?)

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
 
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I have finally got some time to start reading through the minutes of the TSC.

Something I noticed has relevance to the discussion I @Michiel Tack and others were having about the patients. It's in the minutes for the third meeting of the TSC, on 29/06/2005 (or possibly 29/07/2005).

On page 4:
It was also noted that conversely some participants have refused PACE on the grounds that they would prefer to receive SSMC alone and did not wish to take the chance of being randomised to one of the therapies.

Then on page 5:
d) Acceptance rate as a proportion of those offered the trial
It was explained that at present it appears as though there is a large difference between the number of participants screened and those offered
and accepting the trial. The TMG members offered the following explanations for this:
i. Screening takes place at two stages: Patients are screened at the secondary care clinic by the clinic doctors for their suitability for the PACE trial. If thought suitable they are referred to the research nurse. Secondly, referred patients are screened at the baseline 1 visit for the trial. Suitable patients are randomised at the baseline 2 visit.
ii. NHS activity complicates this diagram because it can take some time for a patient’s diagnosis to be confirmed. The CONSORT diagram presented includes all patients referred to one of the participating secondary care clinics with a suspected diagnosis of CFS/ME. Once these patients have been assessed by a clinic doctor, other reasons for their CFS may emerge (e.g. hepatitis, thyroid problems etc). In order to confirm a diagnosis it may be
necessary to refer the patient for other investigations in other clinics first. The screening figures presented do not differentiate between those participants referred with a suspected diagnosis of CFS/ME and those who go on to have this diagnosis confirmed.
iii. There are a proportion of participants (17) who have been offered the trial subject to blood results being obtained to confirm diagnosis and eligibility.
iv. Therefore, the largest proportion of patients that appear as screen failures are those either definitely screened out by the clinic doctors, or those awaiting confirmation of diagnosis or those awaiting blood results. Only a very small portion of patients fail at the baseline 1 screening stage (i.e. after diagnosis and blood results are known).

What I take from this is:
1. From page 5, a high proportion of patients were recently diagnosed.
2. Also from page 5, the original selection was not patients with 'CFS/ME' but those with a 'suspected diagnosis of CFS/ME'.
3. From page 4, patients were indeed self-selecting: there were those who refused to join the trial if it meant they were going to get CBT or GET (or indeed, it would appear, APT).



ETA: Corrected 'page 6' to 'page 5'.
 
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JohnTheJack said:
Also from page 6, the original selection was not patients with 'CFS/ME' but those with a 'suspected diagnosis of CFS/ME'.
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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.

JohnTheJack said:
It was also noted that conversely some participants have refused PACE on the grounds that they would prefer to receive SSMC alone and did not wish to take the chance of being randomised to one of the therapies.
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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.
 
Michiel Tack said:
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.
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Yes, I agree it is apparently common and not specific to PACE.
 
The trial authors explained more about their recruitment strategy in the protocol:

The trial will recruit new patients from secondary care clinics run by three different
disciplines (immunology, infectious disease and psychiatry) in six different centres in both
England and Scotland. This recruitment plan will ensure sufficient heterogeneity to allow
generalisation of the findings. We will not recruit directly from primary care because we
wish to compare the efficacy of these treatments in patients whom GPs regard as
requiring additional help and who are likely to have a worse prognosis (one of the
recommendations CMO's report [43). Furthermore, direct recruitment from primary care has
been found to be problematic in previous studies.
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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):
5. Recruitment
a) Screening
- We are picking up other illnesses through the screening process showing the usefulness of this process.
- Oxford criteria includes the main symptom being fatigue (or a synonym); pain secondary. Centres are finding that some participants emphasise pain more post-randomisation. This is not a problem in eligibility since this is judged at the baseline visit 1 assessment. The Oxford criteria relies on the observer deciding which is the primary problem at the first visit, although it may be worth clarifying this at visit 2 if there is a doubt.
- The main reasons for exclusion at present are: SF-36 score too high, and not meeting Oxford.
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From TMG #16 (2005-09-14):
Edinburgh reported a summer dip in recruitment due to both PACE doctors being on holiday. There are only two/three screening doctors and so throughput of new patients will be slower than for other centres.
Proportion of patients screened and then entered is high at Edinburgh however.

At King’s a larger portion of patients opt for CBT over the trial. King’s also has a higher portion of referral with mis-diagnoses or previous treatment.

The TMG clarified that if patients have had one of the trial treatments for CFS in a secondary care fatigue clinic they are ineligible. Broadly the patients could still be eligible if they have had CBT/GET for any other problem, or have had CBT/GET in the community for CFS. This should be judged on a case-by-case basis.

ACTION 11: to include the clarification of ‘previous treatment for CFS’ in a SOP.

King’s has a high number of patients excluded on SF36 scores. This may be an issue of explaining the questionnaire carefully to the patient to ensure that they are describing a typical day.
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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...
 
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