PACE Trial and PACE Trial Protocol

[Dolphin]

Do they amend these in say a Trial to take into account circumstance? For example, what is 'usual' in the Chalder fatigue questionnaire may be very relevant to circumstance and to whether a person is newly diagnosed or not. Unless this is specifically related to time and the individual then it's pretty weak when used across a cohort I would think unless there are specifics established.

This is what they had (with same underlining):

We would like to know more about any problems you have had with feeling tired, weak or lacking in energy in the last month. Please answer ALL the questions by ticking the answer which applies to you most closely. If you have been feeling tired for a long while, then compare yourself to how you felt when you were last well. (Please tick only one box per line).

 

[Bob]

Do they amend these in say a Trial to take into account circumstance? For example, what is 'usual' in the Chalder fatigue questionnaire may be very relevant to circumstance and to whether a person is newly diagnosed or not. Unless this is specifically related to time and the individual then it's pretty weak when used across a cohort I would think unless there are specifics established.

It's a good question, and it's one of the weaknesses of the methodology. As Dolphin says, it's supposed to apply to your circumstances before the illness, but unless the participants are continuously reminded of this, then I'm sure that it's easy to forget or to get confused. And, in any case, if you've been ill for 10 years, and have adapted to it in many ways, and you have memory issues, then it's very difficult to remember exactly how vibrant and energetic you were before getting ill. After a long time of illness, living with illness becomes 'normal', so it's difficult to respond to a question that asks questions about your 'usual' health.

 

[Graham]

Using their instructions to the patients to compare themselves with how they were prior to having ME (which does not necessarily mean 100% fighting fit), by definition a Likert score of 11 is each patient's normal. On that basis, there was no need to perform their weird and false statistical exercise to define recovery. As the patients would vary in standards of "fitness" before falling ill with ME, this instruction almost standardises each scale.

 

[Bob]

Using their instructions to the patients to compare themselves with how they were prior to having ME (which does not necessarily mean 100% fighting fit), by definition a Likert score of 11 is each patient's normal. On that basis, there was no need to perform their weird and false statistical exercise to define recovery. As the patients would vary in standards of "fitness" before falling ill with ME, this instruction almost standardises each scale.

Interesting point, but aren't you making the assumption that subjective answers give objective results?

 

[Firestormm]

It's a good question, and it's one of the weaknesses of the methodology. As Dolphin says, it's supposed to apply to your circumstances before the illness, but unless the participants are continuously reminded of this, then I'm sure that it's easy to forget or to get confused. And, in any case, if you've been ill for 10 years, and have adapted to it in many ways, and you have memory issues, then it's very difficult to remember exactly how vibrant and energetic you felt before getting ill. After a long time of illness, living with illness becomes 'normal', so it's difficult to respond to a question that asks questions about your 'usual' health.

Not always before the illness then Bob, based on Dolphin's post. Unless the participants were all recently diagnosed in the previous month I suppose. More like 'before trial' in this instance. But it still establishes the point we are making. The answers are not comparable. No 'like-for-like' happening here.

And there is a problem that should be acknowledged in patients comparing themselves now to 'pre-illness' health. It is largely a fantasy notion. I mean I used to run on the beach. I'd like to think I did it every day. I know I didn't. But if when completing such a questionnaire I compare my 'general health' now to that run on the beach - it is hardly comparable is it?

Poor example perhaps but I think it has to be acknowledged that being human I might view myself as 'He-Man' when I clearly never was. Although I'd probably see myself more of a highly accomplished over-achiever if we want to go down that route - NOT!

 

[biophile]

Do they amend these in say a Trial to take into account circumstance? For example, what is 'usual' in the Chalder fatigue questionnaire may be very relevant to circumstance and to whether a person is newly diagnosed or not. Unless this is specifically related to time and the individual then it's pretty weak when used across a cohort I would think unless there are specifics established.

Oops, I forgot to include that it was over the last month or compared to before illness. Dolphin beat me to answering.

 

[Bob]

This is what they had (with same underlining):

We would like to know more about any problems you have had with feeling tired, weak or lacking in energy in the last month. Please answer ALL the questions by ticking the answer which applies to you most closely. If you have been feeling tired for a long while, then compare yourself to how you felt when you were last well. (Please tick only one box per line).

Not always before the illness then Bob, based on Dolphin's post.

I'm not sure exactly what you mean here, Firestormm, but I think we maybe slightly at cross-purposes.

They asked participants to compare their symptoms in the past month with their symptoms when they were well.

I've always interpreted "well" to mean 'before the illness', but I've just noticed that it could be interpreted to mean when the participant was last in remission, and feeling well. (Perhaps this is what you meant?) This adds another complication, because when in remission we might sometimes consider ourselves to be 'well', but in truth we might be feeling good about ourselves but are only actually 'relatively well' when compared to being in incredibly ill. So, participants scoring within the 'recovery' range' might only be referring to their last period of remission, rather than pre-illness, which muddles the results.

And there is a problem that should be acknowledged in patients comparing themselves now to 'pre-illness' health. It is largely a fantasy notion. I mean I used to run on the beach. I'd like to think I did it every day. I know I didn't. But if when completing such a questionnaire I compare my 'general health' now to that run on the beach - it is hardly comparable is it?

Poor example perhaps but I think it has to be acknowledged that being human I might view myself as 'He-Man' when I clearly never was. Although I'd probably see myself more of a highly accomplished over-achiever if we want to go down that route - NOT!

Exactly. And I'm the opposite, in that I tend to forget, and underestimate, what I could achieve before I was ill, because it's such a distant memory. So I'd have to think really hard about such questions.

 

[Dolphin]

As I recall, quite a bit of CBT-influenced stuff for ME/CFS can be about trying to persuade people that they shouldn't expect to get back to their previous life, as it likely led to them being ill, and generally about lowering people's expectations. So people may think they're recovered when most healthy people wouldn't consider they were in terms of the symptoms they have, what they can do, etc.

 

[Esther12]

As I recall, quite a bit of CBT-influenced stuff for ME/CFS can be about trying to persuade people that they shouldn't expect to get back to their previous life, as it likely led to them being ill, and generally about lowering people's expectations. So people may think they're recovered when most healthy people wouldn't consider they were in terms of the symptoms they have, what they can do, etc.

And emphasising how 'normal' and un-concerning symptoms are, which can lead to people viewing their current symptoms as being relatively less serious, without there being any change in symptom levels. Originally, bimodal scoring was used for PACE's primary outcome, which would have reduced the danger of this sort of change being misinterpreted as a 'positive' result. But then they changed to Likert, and have refused to release the primary outcome laid out in their protocol.

I've spoken to people who have found CBT/LP/psychosocial type-stuff helpful, and they did talk about seeing the illness as a positive thing, that helped them realise it was good to do less. I nodded slowly while thinking: 'You crazy?! I love doing super-fun stuff, why would I want to do less?'. Also, none of these people needed to work or claim benefits, which probably makes being able to do a lot less not so much of a problem.

 

[Firestormm]

Dolphin whether it be CBT inspired dogma or not; it is hard to be realistic about something relating to how we thought of ourselves before I think. I would look at it in terms of my ability to do the job I could then; but I am 13 years older now so would I be able to do the same thing now anyway; how do we judge our health before we became sick or even in the period before receiving a diagnosis? What measures might we use? It's interesting.

It's also about expectation too isn't it? And I think this might be where 'CBT' comes in. What can we/should we expect realistically in terms of living with a managed condition; recovery from a long term condition; or even remission from the condition?

And then it's also about our own individual goals I suppose. If I can manage with some sort of part-time work from home but part-paid consultancy - will I think of myself as 'recovered' or 'managing'? How does what I can do in life relate to what I think of as my state of health?

For the purposes of the trial I still think it is hard to be specific (not that they are asking you to be I don't think) in relation to how I was a month ago: unless a month ago I had been answering specific measures and could compare I guess.

My greater concern here is not with the answers but with the interpretation of them - as I think is probably a concern we all would share. Yesterday I completed this ME management course and I was skeptical of course that we would be asked about how we were feeling compared to how we were before the course.

I mean they need some measure to assess if what they are trying to help us with is effective or not, right? Anyone would. So how might they do it?

It's not like a Trial and I think we agreed some time ago that PACE could have done far better in this regard than it did. That the claims being made based on these assessments were unrealistic and wrong.

It's hard to know outside of a Trial how to measure effectiveness, or usefulness, or measure expectation let alone inside of one when you aren't always dealing with things that can be objectively defined.

Not saying that PACE couldn't/shouldn't have bloody well used objective measures before spouting the nonsense that flowed from certain mouthpieces of course.

And I am not suggesting that 'we' shouldn't seek to change the way this part of the industry seeks to measure results either. There has to be a better way to record and explain whether or not something has been 'helpful'.

So much, drugs and therapies, thrive on a person thinking or feeling or knowing that it has been 'helpful' and the only way to change it - if change is what we are all about - is to come up with better ways.

Sorry. Rambling

 

[Graham]

But these possible interpretations of what patients could have been led to believe is "normal" underlines even more strongly that the only acceptable score for "normal range" is 11, as that includes normal variability.

 

[Tom Kindlon]

Dr. Nicole Phillips had a letter published in Clinical Psychiatry News (Australia) back in 2011/12. Here's what she said about it in Emerge, the magazine of ME/CFS Australia (VicTasNT) which includes the letter she submitted.

http://www.mediafire.com/?v5u6heivwkkjhtc

Unfortunately, it's not a text file. All I have is a photocopied version of what was in Emerge and despite playing around with the settings a bit when scanning it in, my OCR software isn't recognising the text. Perhaps scanning from the original blue might do the job, but I don't have it any more. Also, it was too big to add as an attachment (when I tried to create smaller files, the quality of the image deteriorated so it couldn't be read/read easily).

 

[alex3619]

As I recall, quite a bit of CBT-influenced stuff for ME/CFS can be about trying to persuade people that they shouldn't expect to get back to their previous life, as it likely led to them being ill, and generally about lowering people's expectations. So people may think they're recovered when most healthy people wouldn't consider they were in terms of the symptoms they have, what they can do, etc.

[Sarcasm] So they get people to recover by lowering their expectations until their expectations match their current health? Is that why they rewrote the definition for recovery so that it overlapped with severely disabled?

Is the next step for the long term patient to claim that their current incapacity is because they are now much older, and not because of ME?

 

[biophile]

The average onset of CFS is middle-age, so for the average patient, they do not need to compare their recovery to some romanticized version of their wild youth. Most people settle down a lot between the ages of 20 and 30 anyway.

Table 1 of the 2011 Lancet paper shows that the mean(SD) age of participants was 38(12) years at baseline, and the median(IQR) of illness duration was 32(16-68) months. So for most participants, pre-illness was not some mysterious archaeological age which they can barely remember, it was only a few years ago.

Yes, some of us have been ill much longer and became ill in our youth but are much older now. What we should personally expect from a "recovery" is to be able to feel how and do what people our age are feeling and doing, relative to our natural abilities and limitations of course. I do not think the average 40 or 50+ year old patient is seriously going to expect being able to work and play as hard as they did when they were 20 or 30 years younger.

Judging from the several small studies I have seen which used healthy age-matched controls for their study participants, what is "normal" is no significant fatigue and scoring at or close to 100% in physical function. Scoring 5 (bimodal) or 18 (Likert) in fatigue and 60 in physical function is not normal for healthy 40 year olds as PACE would have us believe.

Getting 640 healthy age-matched controls for the PACE Trial would have been ideal, but even if White et al just properly analyzed wider population data from genuinely healthy adults of the same age as the PACE Trial participants, they would have come up with much better thresholds for normal. Instead for example, the threshold for normal physical function has been plagued with several amateurish blunders which undermine their credibility as "experts".

OK, so what about the minority of healthy people in the population who experience some transient fatigue? Common reasons include over-work and lack of sleep. CBT/GET should have addressed some of the problems causing fatigue in healthy people. Like some patients I do have a few grand fantasies about what I should be doing if I was healthy, but in practical reality I do not expect to be absolutely and perfectly free of anything resembling minor symptoms. I am in the early 30's so I do however expect what is usual for my age group, relative to my own natural abilities and limitations.

I suspect that the trap for the average long-term patient is not unrealistic expectations about recovery, but mistaking (or pushed into believing) a significant improvement for a full recovery. As Bob indicated, some patients may have forgotten what they are really capable of, after years of adapting to pervasive impairments. Compared to a PACE "recovery", a genuine recovery may be like waking up for real after a false-awakening in the dream state.

 

[Esther12]

they do not need to compare their recovery to some romanticized version of their wild youth

I totally am.

 

[biophile]

they do not need to compare their recovery to some romanticized version of their wild youth

I totally am.

 

[Esther12]

 

[Bob]

Dr. Nicole Phillips had a letter published in Clinical Psychiatry News (Australia) back in 2011/12. Here's what she said about it in Emerge, the magazine of ME/CFS Australia (VicTasNT) which includes the letter she submitted.

http://www.mediafire.com/?v5u6heivwkkjhtc

Unfortunately, it's not a text file. All I have is a photocopied version of what was in Emerge and despite playing around with the settings a bit when scanning it in, my OCR software isn't recognising the text. Perhaps scanning from the original blue might do the job, but I don't have it any more. Also, it was too big to add as an attachment (when I tried to create smaller files, the quality of the image deteriorated so it couldn't be read/read easily).

Thanks Tom. Dr Phillips makes helpful points. This point caught my eye as being particularly interesting (I typed it out):

Despite stating that they screened for mood disorders, they had a "46% prevelence of mood and anxiety disorders at baseline". They state "....CBT provided the largest reduction in depression". It is quite clear that without screening out depression, their improvements with CBT can be related to CBT's affect on depression and not on the core symptoms of the illness.

 

[biophile]

Despite stating that they screened for mood disorders, they had a "46% prevalence of mood and anxiety disorders at baseline". They state "....CBT provided the largest reduction in depression". It is quite clear that without screening out depression, their improvements with CBT can be related to CBT's affect on depression and not on the core symptoms of the illness.

What about D and H in Figure 2 which suggest that the presence of depression did not really matter?:

[Edit: Again, perhaps the placebo response is not much different in the depressed group vs non-depressed group].

"Figure 2 : Physical function subscale and fatigue questionnaire scores by treatment group.
Data are unadjusted means (95% CI). p(interaction) is the p-value of the interaction between treatment and criteria or disorder from the adjusted model. CFS=chronic fatigue syndrome. ME=myalgic encephalomyelitis. (A–D) Lowest fatigue score is best. (E–H) Highest physical function score is best."

http://www.thelancet.com/journals/l...3611600962/images?imageId=gr2&sectionType=red

 

[Firestormm]

Dr. Nicole Phillips had a letter published in Clinical Psychiatry News (Australia) back in 2011/12. Here's what she said about it in Emerge, the magazine of ME/CFS Australia (VicTasNT) which includes the letter she submitted.

http://www.mediafire.com/?v5u6heivwkkjhtc

Unfortunately, it's not a text file. All I have is a photocopied version of what was in Emerge and despite playing around with the settings a bit when scanning it in, my OCR software isn't recognising the text. Perhaps scanning from the original blue might do the job, but I don't have it any more. Also, it was too big to add as an attachment (when I tried to create smaller files, the quality of the image deteriorated so it couldn't be read/read easily).

I liked this very much, thank you Tom. Loved this conclusion:

"When the multiple sclerosis population agrees that CBT and GET fixed them up and got them back to work, so will the ME/CFS population. I doubt that is going to happen."

Just goes to show that not all psychiatrists swallow the same doctrines.

edit: ok just reading biophile's point...