'Recovery' from chronic fatigue syndrome after treatments given in the PACE trial

[Bob]

I haven't read the everything in this thread yet, so I might be repeating stuff here...
I was just thinking about the response from White et al...

White et al (weakly) claimed that it's not possible to rely on employment stats to indicate 'recovery', yet they were happy to rely on the patients saying that they felt 'much better', and SF-36 PF scores that indicate severe disability, to define a 'recovery'.

If a participant had severe disability, but felt 'much better', then it's a no-brainer... Clearly they were 'recovered'.

 

[Graham]

6 centres?????? I forgot that. That makes it even worse.

Let me bore you with the sums.

The forms state that the assessments were to be carried out over 7 days. So allowing for issuing, using, returning, and collating the data, it would be safe to assume a 2 week cycle. Each centre would have 2 actometers. During the first year, assuming a steady dribble of participants (there can't be a sudden burst because assessment has to take place in the early few weeks, so it cannot be spread out), and realising that they can only use one actometer, as the other has to be reserved for assessment at the end of each patient's year, they would deal with two patients a month. Say 24 a year allowing for holidays, or 5 years to reach their full quota of a little under 120 patients. Then add another year for the final ones to be assessed, and we have a total of a 6 year trial period, assuming that there are no hiccups and the convector belt runs smoothly.

(They couldn't use both actometers at the start to get things moving, because they wouldn't be able to assess them at the end of the year with only one actometer then available).

But only 20% of those screened were accepted on the trial, so it seems that recruitment would be patchy. This lengthens the guess of a 6 year period. Any loss or damage to one actometer would really mess up the process.

When you think how cheap they were in comparison with the total budget, you have to quote John McEnroe, "You cannot be serious!"

 

[Graham]

I haven't read the everything in this thread yet, so I might be repeating stuff here...
I was just thinking about the response from White et al...

White et al (weakly) claimed that it's not possible to rely on employment stats to indicate 'recovery', yet they were happy to rely on the patients saying that they felt 'much better', and SF-36 PF scores that indicate severe disability, to define a 'recovery'.

If a participant had severe disability, but felt 'much better', then it's a no-brainer... Clearly they were 'recovered'.

If I were in constant pain and suffered from very poor sleep patterns, and the specialist gave me something to ease the pain and give me some sort of sleep, I would tick the box "feeling much better", even though it didn't affect my ability to do things. If I was in agony from massive burns, pain control would improve things no end, but not even begin to be part of a cure.

 

[Dolphin]

If I were in constant pain and suffered from very poor sleep patterns, and the specialist gave me something to ease the pain and give me some sort of sleep, I would tick the box "feeling much better", even though it didn't affect my ability to do things. If I was in agony from massive burns, pain control would improve things no end, but not even begin to be part of a cure.

Good point.

Also, if a participant has ticked "much better" it means they haven't ticked "very much better" as they don't consider it suitable. which makes me think all or almost all who tick "much better" aren't recovered.

In case anyone doesn't remember, "very much better" (a CGI score of 1) was the criterion in the recovery outcome measure in their published protocol.

 

[Bob]

Perhaps it would also be helpful to include 'recovered' in the CGI answers, so that the options are 'much better', 'very much better' and 'recovered'. 'Very much better' doesn't indicate a recovery, esp because it's a relative measure and can only be interpreted subjectively by each participant.

 

[Graham]

Perhaps it would also be helpful to include 'recovered' in the CGI answers, so that the options are 'much better', 'very much better' and 'recovered'. 'Very much better' doesn't indicate a recovery, esp because it's a relative measure and can only be interpreted subjectively by each participant.

True. In fact I would compare myself as feeling very much better than I did when, before I was diagnosed, I was struggling to stay at work (who would sign me off with no abnormal test results?). But I know that, put back in the same circumstances, I would revert to the same dire straits.

 

[Dolphin]

Perhaps it would also be helpful to include 'recovered' in the CGI answers, so that the options are 'much better', 'very much better' and 'recovered'. 'Very much better' doesn't indicate a recovery, esp because it's a relative measure and can only be interpreted subjectively by each participant.

Yes, perhaps.
My point wasn't that a CGI score of 1 from 7 on this scale [i.e. "very much better"] was perfect but that a CGI score of 2 [i.e. "much better"] wasn't. [Adding a CGI score of 2 was one of the changes made from the protocol].

 

[Dolphin]

True. In fact I would compare myself as feeling very much better than I did when, before I was diagnosed, I was struggling to stay at work (who would sign me off with no abnormal test results?). But I know that, put back in the same circumstances, I would revert to the same dire straits.

That's the other thing about recovery: symptoms often have to be provoked. How one feels living a quiet life and not working isn't necessarily the same as how one would feel while working. If you're recovered, one should be able to work.

 

[biophile]

I was just thinking about the response from White et al... White et al (weakly) claimed that it's not possible to rely on employment stats to indicate 'recovery', yet they were happy to rely on the patients saying that they felt 'much better', and SF-36 PF scores that indicate severe disability, to define a 'recovery'. If a participant had severe disability, but felt 'much better', then it's a no-brainer... Clearly they were 'recovered'.

There is a paper which CBT/GET proponents often cite as evidence that the effects are "sustained" in the long-term, although the paper itself demonstrates a mixed bag with effects wearing off and methodological limitations. Anyway, I mentioned it in one of my PEM-inducing posts which you may have not read yet. The authors used full time employment as a criterion for complete recovery, and included PACE's original thresholds for normal fatigue and physical function.

Deale A, Husain K, Chalder T, Wessely S. Long-term outcome of cognitive behavior therapy versus relaxation therapy for Chronic Fatigue Syndrome: a 5-year follow-up study. American Journal of Psychiatry 2001, 158(12)2038–2042. http://psychiatryonline.org/data/Journals/AJP/3731/2038.pdf

Predetermined criteria for 'complete recovery' required that patients no longer met chronic fatigue syndrome criteria, were employed full-time, and scored less than 4 on the Fatigue Questionnaire and more than 83 on the Medical Outcomes Study Short-Form General Health Survey physical functioning scale.

Re asking patients if they have improved or recovered, I wonder what would happen if, when patients were answering follow-up questions, they were allowed access to their baseline answers/scores for comparison?

 

[Bob]

That's the other thing about recovery: symptoms often have to be provoked. How one feels living a quiet life and not working isn't necessarily the same as how one would feel while working. If you're recovered, one should be able to work.

Yes, that's a very important issue with ME/CFS.
I suppose it's one of the differences between 'remission' and 'recovery'.
The psychosocial lobby don't understand the interplay between activity, symptoms and disability for ME/CFS patients.
It's an issue that makes welfare benefits systems very difficult to negotiate for ME/CFS patients.

 

[Bob]

Some interesting online responses to a stupid article in Psychology Today, including an excellent letter by the author and CFS advocate Katrina Berne.

Psychology Today article:
http://www.psychologytoday.com/blog/sleep-newzzz/201303/exercise-and-cbt-can-help-chronic-fatigue

Responses:
http://www.psychologytoday.com/blog...ise-and-cbt-can-help-chronic-fatigue/comments


See Katrina Berne's books here:
http://www.goodreads.com/author/show/125759.Katrina_Berne


Thanks to Tom Kindlon for flagging it on Twitter:
https://twitter.com/TomKindlon/status/361832120857018369

 

[Sean]

I suppose it's one of the differences between 'remission' and 'recovery'.

Not to mention between 'recovery' and recovery.

 

[alex3619]

True. In fact I would compare myself as feeling very much better than I did when, before I was diagnosed, I was struggling to stay at work (who would sign me off with no abnormal test results?). But I know that, put back in the same circumstances, I would revert to the same dire straits.

I too am very much better compared to where I was in about 1997. A shift from severe to moderate ME is a huge improvement, and constitutes very much better. Its not even close to recovered though.

 

[alex3619]

That's the other thing about recovery: symptoms often have to be provoked. How one feels living a quiet life and not working isn't necessarily the same as how one would feel while working. If you're recovered, one should be able to work.

Yes Dolphin, by using Oxford CFS and ignoring ME diagnoses, plus ignoring the exercise physiology, the focus is on fatigue as a constant phenomenon and ignoring other symptoms. The problem in ME is not about fatigue, but how easily it is exacerbated, and how other symptoms are provoked at the same time. I think a lot can be made about this point in future advocacy.

 

[alex3619]

I know at least one person with ME who has worked full time. Its possible for well-managed mild ME. Working, coming home and crashing into bed, spending all weekend resting, taking holidays in spaced blocks so there is recovery time, not having hobbies, sports, exercise ... lots of sacrifices to be able to get to work and get home without collapsing. Working full time is NOT recovery either. Its conflating functional capacity with work capacity, which is what you would expect to be hearing from insurance companies. Work capacity is part of functional capacity, but its not the whole thing.

Oh, PS, this described me for years, plus I used up all my sick days and had to take leave without pay instead.

 

[Esther12]

I thought I'd post a link to a thread I just started in here: http://forums.phoenixrising.me/inde...overy-with-ammusing-quote-from-chalder.24775/

KCL on PACE recovery, with amusing quote from Chalder

 

[Dolphin]

From:

When Government Propaganda Masquerades as Science
The latest on the STAR*D scandal
Published on March 25, 2011 by Robert Whitaker in Mad in America
http://www.psychologytoday.com/blog...hen-government-propaganda-masquerades-science

The PACE Trial recovery paper didn't look at different timepoints, so not as flawed as this method. But they both use the same criterion: a "good" result at one timepoint is sufficient to be classed as recovered.

But the protocol also included an unusual method for determining whether patients had "remitted." During the 14 weeks of acute treatment, the patients' symptoms were assessed every two weeks. Now depressive symptoms are known to wax and wane, particularly in patients who are only mildly depressed, and if a patient -- at any one of these two-week assessments -- was assessed as having remitted, then the patient was removed from the acute part of the trial and whisked into the long-term followup, marked down as having remitted on the drug. That patient might have become depressed again in the following days, and have ended up quite depressed at the end of 14 weeks (and thus enjoyed only a few days of relief), but still would be counted as a "remitted" patient in the published reports.

Wrote Pigott: "I termed it the ‘tag, you're healed' research design, since once ‘tagged,' patients were counted as remitted without the possibility of unremitting during the remaining weeks of acute-care treatment. Everyone knows that depression ebbs and flows . . . I'd never before seen such an obviously biased research design whose very purpose seemed to be to inflate the reported remission rate."

There's a PR thread on this summary at: http://forums.phoenixrising.me/index.php?threads/when-government-propaganda-masquerades-as-science-on-an-antidepressants-study.9472

 

[Dolphin]

I just saw this posted elsewhere on the internet. I saw it previously in a magazine for a local group in England in the early- to mid-2000s. PDW having a weird view of recovery doesn't explain the big changes made in the recovery criteria - he had these views about recovery when the recovery criteria were set:

"What do you class as recovery?

Peter White would say I'm a success story.

I would like to know what level other people are at whom he classes as having recovered.

To me if I'm recovered, I'm able to come off benefits, work full time, do my house work and have a life.

But when I said this he asked me: "Do you want to go back to the life that gave you ME?"

That's a cop out.

I disagree with his definition of recovery.

If you've improved significantly, to him that is recovery.

I don't believe in what they say 100%.

I believe you get ME and you just have to overdo it and the symptoms come back.

I can manage to a certain extent but part of it you can't control.

I know if I do too much I feel worse but according to them I bring this on by expecting to feel worse.

According to them this is not founded and irrational.

My belief system is holding me back.

They do not believe in any physical basis for the illness like a virus.

At the end of the day it's all very well to talk about attitude but I have a real illness which is more deep rooted.

I take what I need and don't give myself a hard time.

I don't blame myself.

Last time I saw Dr White I could tell he still thought it was partly to do with me.

He said,'Do you think it's down to you?' On my report he has written: "[name] is making good progress. [Name]'s only remaining barriers are [name]'s illness beliefs"

 

[Esther12]

"Do you want to go back to the life that gave you ME?"

I'd do anything to avoid the life that gave me him.

I'm not convinced it's entirely patient's lifestyle choices which lead to them falling ill and being placed under the authority of quacks though.

If they'd been honest about the value of their treatments when I'd fallen, I'd have never bothered with them. I can 'manage' being ill just fine on my own.

 

[Mark]

"Do you want to go back to the life that gave you ME?"

I'd do anything to avoid the life that gave me him.