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

[Purple]

PACE recovery paper in Psychological Medicine.

Thank you. So a medical/scientific journal had a draft editorial which referred to a newspaper article...

 

[biophile]

Just to be clear, here are at least two factual errors published in the recovery paper:

We changed our original protocol’s threshold score for being within a normal range on this measure from a score of >=85 to a lower score as that threshold would mean that approximately half the general working age population would fall outside the normal range. The mean (S.D.) scores for a demographically representative English adult population were 86.3 (22.5) for males and 81.8 (25.7) for females (Bowling et al. 1999). We derived a mean (S.D.) score of 84 (24) for the whole sample, giving a normal range of 60 or above for physical function.

FAIL. In the general working age population, the median (middle score) is 100 and the 1st quartile (25th percentile) is 90. A threshold of >=85 only excludes about 18% of the general working age population, and 8% of the working age population without long-term health problems, the population which 'recovered' participants should be compared to. White et al appeared to wrongly assume that the mean (average score) was about the same as the median.

So the stated justification for changing the threshold is based on a falsehood and/or misinterpretation. Unfortunately, those figures are derived from raw data from the UK Data Archive and not published in a paper (however, one can estimate from the histogram in the Bowling paper that about 28% of the general population score 85 or higher). Psychological Medicine were made aware of this error but did not publish the submitted letter with this information, claiming that the same point was already made in one of the other letters to be published, which is clearly false. There was no correction issued either. Another letter made a different point about the threshold, but here is a factual error which they are obliged to investigate and correct.

How do these results compare with previous studies? We are not aware of any previous studies that have compared comprehensively defined recovery between different treatments. Two studies of recovery in adults after CBT found similar proportions in recovery: 23% and 24% (Deale et al. 2001; Knoop et al. 2007), compared with 22% in the PACE trial. [...] The other study used similar criteria and domains for recovery (Knoop et al. 2007), but the definition for normal range used was the more liberal population mean -2S.D. rather than the more conservative 1 S.D. that we used; the treatment was delivered by therapists in one specialist CFS centre and outside of a trial setting.

FAIL. The PACE Trial recovery thresholds were not 'more conservative' than the Knoop et al paper. Both used mean -1S.D. The threshold for normal physical function was 80 in Knoop et al but only 60 in the PACE Trial. White was a co-author of both papers, which makes the blunder more baffling. Fortunately, the above error is very easy to confirm. I don't know if Psychological Medicine know of this error, but they don't seem interested in corrections anyway.

PS: PACE referred to Bowling et al for their normative data (general population), which was based on the 1992 ONS Omnibus Survey sample. The mean±S.D. and median(IQR) physical function score for the working age population without chronic illness in this sample is 95.0±10.2 and 100(95-100) points respectively. Presenting 60 as a 'conservative' threshold for complete recovery is scandalous, particularly as it overlapped with trial criteria for 'significant disability' i.e. 65 or less.

 

[Dolphin]

Just another quote showing why it is important we should have good data on recovery i.e. to see if it's reasonable for one's position to be "curable" or "incurable":

PD White:

"The ME Association helps patients suffering from ME but often acts to perpetuate the disease process which, by some, is considered incurable"

http://www.derbymedicalsociety.co.uk/archive/2009-10/DMS minutes 17-11-2009.PDF

 

[biophile]

These new videos from ME Analysis were recently posted on Co-Cure:

6: ME Recovery Song (cheeky, amusing, catchy, banjo song about 'recovery' in the PACE trial)

7: How's That Recovery? (a more formal explanation of problems with the 'recovery' criteria)

 

[Dolphin]

(on the revised recovery criteria)

MEA chairman Neil Riley unpicks a central thread in the PACE Trial
http://www.meassociation.org.uk/2014/02/mea-chairman-neil-riley-unpicks-a-central-thread-in-the-pace-trial-16-february-2014/

Here's an extract, for what it's worth, from a blogpost linking to that MEA article on the recovery criteria, "Someone at the M.E. Association said something accurate and wonderful about the PACE trial"

(This is a woman who is able to walk 5 miles sometimes. She also works part-time from home)

But here’s the thing. I am not recovered. I am nowhere near my pre-illness state. I cannot do the vast majority of things I could do before I had M.E. My life is still severely and dramatically restricted and limited by this condition. I cannot get out of bed at 5am, go for a run or a cycle, get ready for work, commute, work at full day, maybe stop for grocery shopping on the way home, repeat four more times, then spend the weekend mountain biking, camping or dancing. I cannot work full time. A full week’s exercisey moving around stuff now is about the equivalent of one day’s gym-going pre-illness, if I can do it at all. It takes a looooong time to recover from a cold or flu.

I am better than I was. I have better days, weeks and months. I have fewer periods of being completely bed-bound or house-bound. But I am not recovered. Even when I say I’m feeling great today.

To quote the article linked at the top, “Here’s a suggestion, dear researchers. Why not go back and ask those patients if they can now do what they did before they were ill”.

 

[Dolphin]

Another study showing fatigue can be common in society suggesting population norms could be problematic

Free full text: http://bmjopen.bmj.com/content/4/6/e005374.full

BMJ Open 2014;4:e005374 doi:10.1136/bmjopen-2014-005374

Epidemiology

How common are symptoms? Evidence from a New Zealand national telephone survey

Keith J Petrie1,
Kate Faasse1,
Fiona Crichton1,
Andrew Grey2

+Author Affiliations

1Department of Psychological Medicine, University of Auckland, Auckland, New Zealand
2Department of Medicine, University of Auckland, Auckland, New Zealand

Abstract

Objective

To assess the frequency of symptoms in a general population sample over the previous week and the associations between symptom reporting and demographic factors, medical visits and medication use.

Design

A representative general population sample (n=1000) was recruited using random digit dialling. Participants were asked whether they had experienced any of a list of 46 symptoms in the previous 7 days and if so, whether the symptom was mild, moderate or severe. Demographic data and information on medical visits and medication use were also collected.

Results

Symptom reporting was very common. The median number of symptoms reported by participants in the previous week was 5 with only 10.6% of participants reporting no symptoms. The five most common symptoms in the previous 7 days were: back pain (38%), fatigue (36%), headache (35%), runny or stuffy nose (34%) and joint pain (34%). The five symptoms rated highest in terms of severity were sexual difficulties, vomiting, tremor, suicidal thoughts and sleep problems. Symptom reporting was significantly positively associated with medical visits in the previous year and current medication taking. Women reported a significantly greater number of symptoms. We found no significant association between age or household size and symptom reporting.

Conclusions

This population-based study found that symptoms are more commonly experienced in the general population than previously estimated and are strongly associated with healthcare visits. Appreciation of the high prevalence of symptoms may help normalise the experience of symptom reports among the general population.

Note: I've come across Keith Petrie before and find him quite a psychobabbler so I might not agree with a lot of what is said in this study (haven't read it so far).

 

[heapsreal]

Scanning the forum today i saw the heading and thought if this cbt/get crap worked we would have alot of people discussing how great they feel after being treated etc. if there is any positive personal experiences with it posted then there isnt many.

Its good they did that study so now we definately know its a crock of s-it.

 

[Dolphin]

Scanning the forum today i saw the heading and thought if this cbt/get crap worked we would have alot of people discussing how great they feel after being treated etc. if there is any positive personal experiences with it posted then there isnt many.

Its good they did that study so now we definately know its a crock of s-it.

The problem is that they had a "crock-of-s*it" definition of recovery so they're claiming 21%/22% recovery rates. If they'd published what they said they would publish (the recovery criteria in the protocol), everyone could see what you say.

 

[Dolphin]

New thread:

Peter Denton White/Queen Mary, University of London again refuse to release data from £5m PACE Trial
http://forums.phoenixrising.me/inde...se-to-release-data-from-£5m-pace-trial.31436/

 

[alex3619]

Do we need a thread for stories from people who were in the PACE trial? Then advertise it?

 

[Graham]

That might be a good idea, but we would have to ensure that it was truly open, and not phrased in such a way that only the dissatisfied would get involved. It would also need to be monitored carefully so that anyone posting positive comments was not harassed.

 

[Dolphin]

http://medicine.stonybrookmedicine.edu/psychiatry/news/friedberg_commentary

Fred Friedberg Warns Against Overstating Recovery Results in Studies of Chronic Fatigue Syndrome

commentary, Dr. Friedberg and Ms. Adamowicz pointed out that because the term “recovery” was used to refer only to recovery from the current episode, the outcomes would more accurately be described in terms of remission rather than recovery. They noted too that the definition of recovery used in the report does not include the subjects’ perceptions of their health status, particularly if they view themselves as recovered.

They concluded that because a recovery rate below 25% still leaves the majority of patients with significant symptoms and impairments, “the publicity generated by trumpeting recovery outcomes in CFS far exceeds the relatively modest results found for most patients in behavioral treatment research.”

Dr. Friedberg is an Associate Professor and Ms. Adamowicz is a Senior Research Analyst in the Department of Psychiatry at Stony Brook University. Their commentary, titled “Reports of recovery in chronic fatigue syndrome may present less than meets the eye,” was published in the August 2014 issue of Evidence Based Mental Health. It was first published on line on May 21, 2014. The recovery data from the PACE trial were reported in an article by Peter D. White, et al. published in the October 13 edition ofPsychological Medicine under the title “Recovery from chronic fatigue syndrome after treatments given in the PACE trial.”

Thread on this short commentary here: http://forums.phoenixrising.me/inde...me-may-present-less-than-meets-the-eye.31868/

 

[alex3619]

That might be a good idea, but we would have to ensure that it was truly open, and not phrased in such a way that only the dissatisfied would get involved. It would also need to be monitored carefully so that anyone posting positive comments was not harassed.

It would have to be a highly moderated thread, constantly monitored. Anything less would be a bad idea.

 

[Dolphin]

I just made this point to somebody who was confused by the recovery criteria. I'm not sure if the observation in the second paragraph was made before but no harm making it again:

You can score 60 or 65 and be counted as recovered in the overall sense if you score 5 or less on the CFQ (Chalder Fatigue Questionnaire). If you score 5 or less on the CFQ, you no longer satisfy the Oxford criteria. So, for example, a score of 20 on the SF-36 PF and CFQ=5 and the person would no longer satisfy the Oxford criteria - it isn't just people with scores of over 65 who no longer satisfy the Oxford criteria. So you can be recovered using all the criteria with a score of 60 or 65.

If one looks at Table 1 in the recovery paper (i'll send it on to you), one can see that more people in the APT group don't satisfy the Oxford criteria than are in the normal range on the SF-36 PF i.e. some people who don't satisfy the Oxford criteria have SF-36 PF scores of less than 60.

 

[Tom Kindlon]

This is a letter Adrian Baldwin and I just had published in Evidence Based Mental Health.

http://ebmh.bmj.com/content/early/2014/09/19/eb-2014-101961.extract

Unfortunately it is not open access

It is about the recovery definition used in the PACE Trial.

Friedberg & Adamowicz say that the recovery criteria in the PACE Trial were similar to those used by Deale et al (2001) in an earlier CBT trial, echoing PACE Trial authors claimed. We disagree pointing out how they are different.

We then also say the use of a threshold of SF-36 PF of 60 or more to define recovery is inappropriate, including by quoting population data.

 

[Dolphin]

From: Leonard Jason

See pages 67 to 70 for an article "Beyond Tired: Chronic Fatigue Syndrome remains misunderstood and understudied. Psychologists are among those trying to change that" This article just appeared in the Oct 2014 issue of the American Psychological Association’s publication the Monitor
http://www.apamonitor-digital.org/apamonitor/201410#pg70
---
Note that cognitive behavioural stress management is not the same as graded activity-oriented CBT.

Includes the following on the PACE Trial:

Other researchers have been critcial of that trial. A number of experts have taken issue with the authors' definition of recovery, Jason says

ETA:
Here's more - what came next:

Further, he adds, the researchers used a broad case definition of CFS and likely included people who actually suffered from depression.

“We know that cognitive-behavioral therapy is one of the best treatments for major depressive disorder,” Jason says, so you’d expect them to improve following the treatment.

Incorrectly including those people in the study could have skewed the results.

In Jason’s view, it’s dangerous to promote cognitive- behavioral therapy as a cure for CFS.

“We have to be very careful. The patient community generally has a strong disdain for most psychologists because they feel they’ve been blamed for their own problem,” he says.

“One of the most common treatment approaches is to convince patients that they’re not sick.”

Zinn is also wary of cognitive-behavioral therapy — or any therapy that attempts to treat CFS as a psychological phenomenon.

If a therapist tries to tell people with CFS that their dysfunctional thinking is causing the disease, she says,

“They will walk out the door and not come back.”

Such a scenario can be particularly harmful, she adds, if it prevents patients from seeking the help they need.

 

[Sean]

Your link is borked.

http://www.apamonitor-digital.org/apamonitor/201410#pg70

 

[Snow Leopard]

From: Leonard Jason

See pages 67 to 70 for an article "Beyond Tired: Chronic Fatigue Syndrome remains misunderstood and understudied. Psychologists are among those trying to change that" This article just appeared in the Oct 2014 issue of the American Psychological Association’s publication the Monitor
http://www.apamonitor-digital.org/apamonitor/201410#pg70
---
Note that cognitive behavioural stress management is not the same as graded activity-oriented CBT.

Includes the following on the PACE Trial:


ETA:
Here's more - what came next:

Jason promoting good sense and showing that not all Mental health professionals buy into the hype.

 

[Graham]

It's my belief (based on very little evidence) that possibly the majority of psychiatrists and psychologists do not go along with the Wessely crowd, simply because they are so few in number, and the few that I have come across personally have had a much more open and balanced attitude. I came across an ex-Indian army psychiatrist a few years back, and was a bit apprehensive. Just showed how wrong I was to be prejudiced! He was really good. I have also heard from others in the profession with family members or friends with the illness, who know it is not a psychological illness. The trouble is, of course, that most of the ones we come across are at ME/CFS centres, and are picked or trained in the Wessleyan tradition.

 

[Graham]

The big question to me is what is it that allows a supposedly intelligent person to ignore good evidence, and to accept poor quality evidence in its place? Is peer pressure and the need for approval really that strong an influence? The ironic thing is that the psychologists should be only too aware of that, as they have been doing experiments on peer pressure for ages. Or do the ones holding the disbelieving views think that it only applies to the rest of the human race?