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

[Dolphin]

I just started a thread:

Recovery from CFS after treatments given in the PACE trial - unpublished letters
http://forums.phoenixrising.me/inde...-in-the-pace-trial-unpublished-letters.22258/

 

[Esther12]

Just saw this clarification pop up on list serv. I've seen a few things which indicate that lots of questions are now being interpreted as FOI requests (not just related to PACE). I wonder if there's an attempt to claim that they're being overwhelmed with harassing FOI requests, when equivalent requests sent to other researchers are just answered easily by e-mail. To me, it seems that psychosocial CFS researchers are really emphasising how victimised they are since PACE showed that their 'treatments' are so much less effective than had been claimed.

https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1303b&L=co-cure&F=&S=&P=9738

Dear Mr. Kindlon

Thank you for your email of 2nd February, which has been dealt with
under the Freedom of Information Act 2000.

The information you have requested is effectively available in the
paper published in Psychological Medicine (available at:
http://journals.cambridge.org/psm/White - please see top-right of page
3).

This means that having a score of 70 or more on the SF-36 sub-scale
would mean that the participant did not meet Oxford criteria.
Similarly having a score of 5 or less on the Chalder fatigue
questionnaire would mean that the participant did not meet Oxford
criteria.

If you are dissatisfied with this response, you may ask the College to
conduct a review of this decision. To do this, please contact the
College in writing (including by fax, letter or email), describe the
original request, explain your grounds for dissatisfaction, and
include an address for correspondence. You have 40 working days from
receipt of this communication to submit a review request. When the
review process has been completed, if you are still dissatisfied, you
may ask the Information Commissioner to intervene. Please see
www.ico.gov.uk for details.

Yours sincerely

Paul Smallcombe
Records & Information Compliance Manager


-----Original Message-----
From: Tom Kindlon [mailto:[log in to unmask]]
Sent: 02 February 2013 22:05
To: [log in to unmask]
Subject: Re: Recovery from chronic fatigue syndrome after treatments
given in the PACE Trial

Dear Prof. White,

I read your paper, “Recovery from chronic fatigue syndrome after
treatments given in the PACE Trial”, with interest.

I have a couple of quick questions that would help me help inform
members of the Irish ME/CFS Association about the trial (e.g. in our
newsletter) as well as help inform any comments I might make in other
fora e.g. were I to submit a letter to Psychological Medicine, it
would be better for everyone if it was based on good information (you
may recall that I have had some letters published in medical journals
in the past, including in reply to the Lancet paper on the PACE
Trial).

(i) What score would somebody need to score on the SF-36 PF subscale
to not meet the Oxford criteria (and hence have the possibility of
being classed of "clinical" recovery at 12 months). Is it a SF-36 PF
score of greater than 65? Or something else? A lot of people have said
it's greater than or equal to 60 but I'm not so sure.

(i) What score would somebody need to score on the Chalder Fatigue
scale to not meet the Oxford criteria (and hence have the possibility
of being classed as having "clinical" recovery at 12 months). Is it a
Chalder Fatigue bimodal score of less than 6? Or something else?

Thanking you for your time.

Tom Kindlon
Information Officer/Assistant Chairperson
Irish ME/CFS Association

 

[Graham]

Thanks Tom and Esther. So just one twitch away in the questionnaire on fatigue OR in the one of physical activity, covering only the previous week, and you are "recovered"? It is as appalling as we thought.

 

[Firestormm]

Charles Shepherd
I will now be working away for a couple of days and won't be dealing with any comments or queries on MEAF till Friday morning. On another matter I have been told that Psychological Medicine will be publishing some responses to the paper on PACE trial recovery rates.

ME Association Facebook 13 March 2013

Looks like some publication of letters is imminent then.

 

[Valentijn]

Looks like some publication of letters is imminent then.

Yup, I submitted one and it should be getting published. I'm waiting for their final approval of the revisions I made at their request.

 

[Dolphin]

I've just noticed that there is no reference to the McCrone et al. (2012) paper (and hence its findings) in this paper.

 

[Bob]

Here's an inconsistency that I've just spotted. I don't know if this has been picked up before. They've got themselves in a muddle again!

Quote from the recovery paper from page 3:

CFS case definition : Oxford criteria
[...]
To satisfy the third criterion for severity of fatigue and disability, participants had to meet trial entry thresholds for fatigue (a binary score of ≥6 out of 11 on the CFQ) and abnormal levels of physical function (a score of ≤65 out of 100 on the SF-36 physical function subscale) (White et al. 2007).

So a SF-36 PF score of 65 is 'normal', 'recovered', 'abnormal' and 'significantly disabled' etc. etc.!

The mind boggles!

 

[Mark]

So a SF-36 PF score of 65 is 'normal', 'recovered', 'abnormal' and 'significantly disabled' etc. etc.!

The mind boggles!

Perhaps someone could collate (with page references) the various quotes where they allow a score of 65 to be classified in those ways? That would be a powerful little fragment of text...

 

[Bob]

≤65 is the entry criteria, described as 'significantly disabled', by White et al. in the Lancet [1].

For the main trial 'recovery' a participant can have an SF-36 PF score as low as 60. (≥60.)

A score of ≥60 is in the 'normal range'.

A score of ≤65 is described as 'abnormal', in the recovery paper, as quoted above. (Although, I doubt if this is included intentionally, but is an oversight, caused by the confusion that they created with such a messed up, and continuously changing, set of thresholds.)


[1] White PD, Goldsmith KA, Johnson AL, Walwyn R, Baber HL, Chalder T, Sharpe M (2011). The PACE trial in chronic fatigue syndrome — Authors' reply. The Lancet, Volume 377, Issue 9780, Pages 1834 - 1835, 28 May 2011. doi:10.1016/S0140-6736(11)60651-X
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60651-X/fulltext
"PACE trial participants represented typical secondary-care CFS patients: young to middle-aged, significantly disabled, and ill for a mean of 2·7 years."

 

[Dolphin]

One of the two authors of this study is one of the PIs of the PACE Trial, incl. one of the co-authors of the PACE Trial recovery paper:

BMJ Case Reports 2011; doi:10.1136/bcr.01.2011.3716
• Novel treatment (new drug/intervention; established drug/procedure
in new situation)
Adolescents with severe chronic fatigue syndrome can make a full recovery
1. Mary Burgess1,
2. Trudie Chalder2

OUTCOME AND FOLLOW-UP
At discharge, after 23 home-based sessions over 19 months, George was back at school full-time but was not participating in sports. At 3-month follow-up, his parents felt that he was ‘back to normal’. Gains were maintained at 6 and 12 month follow-up. At 36 months post discharge, treatment questionnaire scores revealed that gains previously made had been maintained ( fi gure 1 ). He had achieved good grades in his GCSE’s and was studying for A levels. By 54 months after the end of treatment, (September 2010), his mother informed me that he had achieved good A level results and had won a sports scholarship to a top university in the UK ( figures 1 and 2 ).

Figure 1 shows:

Chalder fatigue questionnaire (bimodal i.e. 0-11):
0 at 12 follow up
0 at 36 months

The Work and Social Adjustment Scale (0-8):
just above 0 (0.2 perhaps as average of 5 questions) at 12 follow up
0 at 36 months

Figure 2 shows:

School attendance:
Post: at 80% (or so)
At 6 months follow-up: 100%
At 12 months follow-up: 100%
At 36 months follow-up: 100%

I'd still like to know if he reached his academic potential before saying full recovery, but would certainly accept it for "recovery"* unlike the joke recovery definition Trudie Chalder and co use in Psychological Medicine.

* presuming a sports scholarship means playing sports, which I presume it does mean. This is how they started the case presentations:

George, a previously healthy 11-year-old boy who played tennis at a national level,

 

[Valentijn]

I'd still like to know if he reached his academic potential before saying full recovery, but would certainly accept it for "recovery"* unlike the joke recovery definition Trudie Chalder and co use in Psychological Medicine.

Yes, instead of relying on him saying he's slightly less fatigued, they're looking at attendance and (presumed) current sports ability. And simply asking him (or his parents in this case) "Are you fully recovered, as healthy as you were before you got sick?" seems like something of an improvement over feeling "much better" but not "very much better".

Not sure why they're talking to his mom instead of him, though. Sounds like he's pretty much an adult.

Also seems like the BPS crowd is getting a bit desperate, if they're back to the stage of case studies on adolescents (who usually recover without any "help" anyhow).

 

[Bob]

One of the two authors of this study is one of the PIs of the PACE Trial, incl. one of the co-authors of the PACE Trial recovery paper:

BMJ Case Reports 2011; doi:10.1136/bcr.01.2011.3716
• Novel treatment (new drug/intervention; established drug/procedure
in new situation)
Adolescents with severe chronic fatigue syndrome can make a full recovery
1. Mary Burgess1,
2. Trudie Chalder2

http://www.ncbi.nlm.nih.gov/pubmed/22696706

Just to point out that the treatment they used was 'pragmatic rehabilitation', which was the intervention investigated in the FINE Trial (2010), and proved to be ineffective for adults with CFS/ME.

From the Burgess & Chalder paper:
"This case report illustrates how recovery can occur with pragmatic rehabilitation combined with a committed compassionate family based approach."

 

[Dolphin]

http://rheum.med.ufl.edu/2013/03/27/is-recovery-from-chronic-fatigue-syndrome-possible/

Is Recovery from Chronic Fatigue Syndrome Possible?


Published: March 27th, 2013

Category: Slider News

Meriem Mokhtech, BS
UF Center for Musculoskeletal Pain Research

Most of this article seems to be very similar to info one might get from the press release or abstract.

However, here are the last two paragraphs (only the second last one is that interesting I think):

After the release of these findings, several key criticisms came to light. First, the results of the PACE study used the Oxford selection criteria as opposed to the CDC criteria, meaning that some of the participants might not qualify as having ME/CFS according to internationally accepted CDC criteria. Second, the protocol was changed during the trial. Third, the Chandler Fatigue Scale, designed by one of the researchers, was used by participants to rate fatigue, but it has not yet been accepted as an objective and scientific method for measuring fatigue. All of these factors could confound the results.

In conclusion, despite yielding positive outcomes for around a quarter of the study population participating in CBT and GET, we would like to see higher recovery rates in patients with ME/CFS. More research needs to be done to understand this multifaceted condition in order to best predict what patients would succeed with which therapies. It is important to keep in mind that everyone is different and to consult your physician before starting any new treatments.

 

[Simon]

More issues with Physical Function "Recovery" Threshold in the Real Word

According to the recent paper on CFS/ME treatment outcomes in Clinical practice (NOD), around 25% of patients had physical function SF36 scores in thePACE 'Recovery' range (60+) at baseline.

They give Interquartile Range (IQR = range of scores withi 25% of the median, so 25% are above this range) at baseline for patients with and without outcome data (they only have outcome data on half of all patients):

IQR for SF36 at baseline:
Patients without follow up data: 20-60 (25% above 60)
Patients with follow up data: 25-55 (25% above 55

 

[Bob]

I'd completely forgotten about the info in the following thread, so I'm just posting this as a reminder, and to make sure that everyone has seen the info...

(PACE Trial) Response to FoI request: Numbers within normal ranges for CFQ and SF36 PF at baseline
http://forums.phoenixrising.me/inde...ranges-for-cfq-and-sf36-pf-at-baseline.22366/

 

[Enid]

"Recovery" with PACE - are they so ignorant, simple, out of ducking chair mentality, turning their backs on modern science - we've met it before - witches - this time not burned at their stake. Pity they have no experience of the errors of history. Are you firestorm Shephard influenced - a psychiatrist - driven at last to basic medicine - so should you too ( this time bugger the spelling) you clever dicks. Get your facts first. We have all gone through (often without help) this disease - stick to the facts.

Oh and family all Docs - Profs - Neurology, Radiology, Paediatrics.

 

[Dolphin]

6 letters have been published.
They're up at: https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1307c&L=co-cure&F=&S=&P=18139 along with the authors' response and a short editorial note.

 

[Firestormm]

PACE Trial: letters and reply | Journal of Psychological Medicine | August 2013

Posted by The ME Association: Tony Britton 22 July 2013

From the Journal of Psychological Medicine, August 2013.
CORRESPONDENCE

Editorial note
Unusually for Psychological Medicine, we publish below six letters concerning the paper by White et al (2013) on the PACE Trial. The UK Office of the Journal received 15 letters criticising asspects of this paper, but it seemed unlikely that all of these letters originated entirely independently since a number arrived on consecutive days and reiterated the same points. Nevertheless, in the spirit of scientrific openness, we have published six of the letters which cover the main criticisms, and invited Professor White to reply to them.

Am reading through them now myself...

Letter published were from:

SUSANNA AGARDY

SAMUEL CARTER

ROBERT COURTNEY

DUNCAN COX

CARLY MARYHEW

CHARLES SHEPHERD

Reply from Professor White. All the above appear to have been in relation to objective measures for recovery:

REPLY

The definition of recovery from any chronic illness is challenging. We therefore agree with Cox (20I3) and Courtney (2013) that no single threshold measurement is sufficient; this is why we measured several domains of improvement and combined them into a composite measure of recovery (White et al. 20l3).

Shepherd (2013) suggests asking patients whether they recovered as a result of [our italics] receiving a treatment; we did not ask this since it is not possible for individuals to ascribe change to one particular source in exclusion from all others, such as regression to the mean or external factors.

Maryhew (2013) suggests self-ratings may be biased when participants cannot be masked to treatment allocation; this may be true, but is inconsistent with cognitive behaviour therapy (CBT) being more effective than adaptive pacing therapy (APT) when treatment expectations were significantly lower before treatment (White et al. 2011).

We dispute that in the PACE trial the six-minute walking test offered a better and more `objective’ measure of recovery, as suggested by Agardy (2013), Maryhew (2013), and Shepherd (2013).

First, recovery from chronic fatigue syndrome (CFS), which is defined by a patient’s reported symptoms, is arguably best measured by multiple patient-reported outcome measures, rather than a single performance test.

Second, and importantly, there were practical limitations to our conduct of the walking test. Due to concerns about patients with CFS coping with physical exertion, no encouragement was given to participants as they performed the test, by contrast to the way this test is usually applied (Guyatt et al. I984; American Thoracic Society, 2002).

Rather than encouragement, we told participants, `You should walk continuously if possible, but can slow down or stop if you need to.’ Furthermore we had only 10 metres of walking corridor space available, rather than the 30-50 metres of space used in other studies; this meant that participants had to stop and turn around more frequently (Guyatt et al. I984; Troosters et al. I999; American Thoracic Society, 2002), slowing them down and thereby vitiating comparison with other studies.

Finally, we had follow-up data on 72% of participants for this test, which was less than for the self-report measures (White et al. 2011).

Economic data, such as sickness benefits and employment status, have already been published by McCrone et al. (2012). However, recovery from illness is a health status, not an economic one, and plenty of working people are unwell (Oortwijn et al. 2011), while well people do not necessarily work.

Some of our participants were either past the age of retirement or were not in paid employment when they fell ill. In addition, follow-up at 6 months after the end of therapy may be too short a period to affect either benefits or employment. We therefore disagree with Shepherd (2013) that such outcomes constitute a useful component of recovery in the PACE trial.

We agree with Carter (2013) that there is a difference between sustained recovery and temporary remission; this is why we were careful to give a precise definition of recovery and to emphasize that it applied at one particular point only and to the current episode of illness (White et al. 2013).

Despite the complexities of measuring recovery, we believe that our approach of using multiple self-report measures provides a reasonable approach to inform clinicians’ and patients` choice between available treatments.

The findings from the PACE trial are clear; however we measured recovery, CBT and graded exercise therapy (GET) were more likely to lead to recovery, when added to specialist medical care (SMC), compared to either adding APT or SMC alone.

Recovery after SMC alone, using our composite criteria, was only 7% – the same as that without treatment (Cairns & Hotopf, 2005) – whereas three times as many (22%) recovered after receiving CBT or GET.

The PACE trial has shown that both CBT and GET are moderately effective, safe, cost-effective, and are more likely to lead to recovery (White et al. 2011, 2013; McCrone et al. 2012). These treatments should now be routinely offered to all those who may benefit from them (Crawley et al. 2013].

I added some paragraph breaks to the reply to aide readability (hopefully).

 

[Esther12]

Even with six letters, at that length, they still don't come close to covering al the problems, and those that are mentioned can only be briefly referred to. If Psych Med are going to publish such poor papers, they need to make more room for responses.

 

[Valentijn]

Pretty pathetic reply from White & co. ... "Objective measurements don't matter 'cause the diagnosis is based entirely on self-reported symptoms!!!" and "We didn't have a long enough corridor to do a proper walking test!!!!!" and "Maybe 'recovered' fatigue patients just don't want to work!!!111!!!1!111"

Also gotta love their psychobabble math: "three times as many recovered!" Just think what they could've claimed if 11% 'recovered' according to their BS definition, compared to 1% of their half-assed 'control' group

I think they've backed themselves into a corner, and don't have anywhere left to go.