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CBT for CFS in Adults: Face to Face versus Telephone Treatment-A RCT (Burgess et al)

Dolphin

Senior Member
Messages
17,567
Re: the Cochrane review, I'm having trouble finding the 'improvement over 12 months' employment data from 'Sharpe 1993'.
The employment data wasn't published. The first Cochrane review of CBT highlighted this. This mysteriously disappeared from the second Cochrane review i.e. it wasn't mentioned that the employment data was missing. I wrote to the authors saying I wasn't happy with it and that I expect any update to include it. I got a reply. We shall see what happened.

It is interesting that it wasn't reported as at least one of the (Sharpe et al) authors has worked for insurance companies. They know it is important data.

----------
This details the point I'm making above:
I would like an answer to the following question.

The previous Cochrane Review [Cognitive behaviour therapy for adults with
chronic fatigue syndrome. Price JR, Couper J.
Cochrane Database Syst Rev. 2000;(2):CD001027] contained the following:

"Data reporting

Two studies (Lloyd 1993, Sharpe 1996) did not report standard
deviations. The authors of Sharpe (Sharpe 1996) have kindly provided
the missing standard deviations for this review. Missing data
from Lloyd (Lloyd 1993) are still awaited. It was, therefore,
difficult to interpret the results of Lloyd (Lloyd 1993), as the
absence of standard deviations makes the calculation of effect sizes
impossible.

There were some other deficiencies in published data, such as
Sharpe (Sharpe 1996) not reporting improvement in employment
status despite stating the intention to use this as a subsidiary
measure of functioning. These data are still awaited."


However in the updated review, [Cochrane Database Syst Rev. 2008 Jul
16;(3):CD001027.
Cognitive behaviour therapy for chronic fatigue syndrome in adults.
Price JR, Mitchell E, Tidy E, Hunot V.
Full free text at: http://tinyurl.com/PriceMitchelletal i.e.
http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001027/frame.html ]

despite employment status being one of the outcome measures being
investigated (e.g. page 5) and despite
giving the impression that your review investigates thoroughly
"assessment of risk of bias in included studies" and in particular "5) Selective
outcome reporting: Are reports of the study free of suggestion of selective
outcome reporting?", on page 15, there is no mention that the data was not
reported.


Of course, it could be the case that at some stage Sharpe et al could have
given the data but the data isn't included either.


As I'm sure you understand, the issue of employment status in the area of
CFS is an important one. Arguably it's the most important outcome measure
investigated.


If it was an error, will you get back to me to let me know that it has
been noted for when the review is being updated in the future.


Thanking you,
 

Snow Leopard

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The 2008 review summary is ambiguously worded - when doing the other comparisons, they say which group it favoured, but for "improvement in work status", (page 21) they simply state there was a significant difference. Strange...
 

Dolphin

Senior Member
Messages
17,567
The 2008 review summary is ambiguously worded - when doing the other comparisons, they say which group it favoured, but for "improvement in work status", (page 21) they simply state there was a significant difference. Strange...
Where is that? I can't see it and it is not showing up when I search for "work".

This is on page 17 (page 21 of pdf) in what I have:
9) Occupational outcomes:

Short/medium term follow-up (Graph 01 17)

One traditional CBT study (61 participants) contributed data to
this outcome, in which the number of days of absenteeism was
measured during the 12-month follow-up period. The difference
between the CBT group and usual care group was not significant
(MD 4.35, 95% CI -50.06 to 58.76).

Also (page 23 of pdf, printed page 19):

(from: COMPARISON O2: COGNITIVE BEHAVIOURAL THER-
APY vs OTHER PSYCHOLOGICAL THERAPIES)

9) Occupational outcomes
No studies contributed to this outcome at post treatment or followup.
 

biophile

Places I'd rather be.
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8,977
PACE data isn't all that encouraging either

I deleted a post that essentially had the same data (p74) as what Dolphin posted about employment status (p17).

So the only study in Cochrane 2008 (Huibers 2004) which looked into employment status found no significant difference between CBT and usual care. [EDIT: A later version of the same Cochrane 2008 review includes data from Sharpe 1993 which found a significant difference between CBT and usual care.]

As for the PACE Trial, the 2007 protocol states that:

Secondary outcome measures Secondary efficacy measures:

6. The Work and Social Adjustment scale provides a more comprehensive measure of participation in occupational and domestic activities.

11. The Client Service Receipt Inventory (CSRI), adapted for use in CFS/ME, will measure hours of employment/study, wages and benefits received, allowing another more objective measure of function.

Economic costs:

The CSRI will retrospectively record service utilisation for the six months prior to the baseline assessment, for the period between baseline and 24 weeks, and then for the period from 24 weeks to 52 weeks. A comprehensive range of services will be included so that in addition to being able to determine the resource implications to the NHS, we will also have information on the impact that treatment has on other parts of the care system as well as on informal carers. The ability to engage in employment, education and work in the home are frequently affected by CFS/ME and the CSRI will collect data on these activities. Service use will be valued by attaching appropriate unit costs from national sources (e.g. Netten et al, 2003) as well as intervention costs specifically calculated for the study.

Long term follow-up:

Permission will be sought from the participant to be contacted annually for follow-up information regarding the participant's health and employment status. The participant will also be invited to remain in contact so that the results may be disseminated to them once published.

The 2011 Lancet paper only reports data from The Work and Social Adjustment Scale (WSAS) and showed a small advantage for CBT and GET over SMC and APT, one that is a self-rated subjective measure about how limited one feels, so we don't know how well it correlates with actual employment status in CFS, which the CSRI would provide better detailed data for. Some of the PACE authors published a study which included data from the PACE Trial to investigate "psychometric" correlates of the WSAS with CFS (http://www.ncbi.nlm.nih.gov/pubmed/21843745):

BACKGROUND: Disability is a defining feature of chronic conditions, and it is an increasingly used measure of therapy effectiveness. The Work and Social Adjustment Scale (WSAS) is a simple and clear measure of disability. Although the scale is widely used, no study has yet investigated its psychometric properties in patients with chronic fatigue syndrome (CFS).

METHODS: Data from two samples of patients were used, one from a multicenter randomized controlled clinical trial of treatments for CFS (n =639) and the other from a clinic that specializes in CFS (n=384). All patients completed the WSAS as well as other measures.

RESULTS: Internal consistency and the Spearman-Brown split-half coefficient values indicated that the scale is reliable. CFS patients who had comorbid diagnoses of depression, anxiety or fibromyalgia had higher WSAS scores. High levels of disability were associated with high number of physical symptoms, severe fatigue, depression, anxiety, poor sleep quality and poor physical fitness, with correlation coefficients ranging between 0.41 and 0.11. Lower scores on the WSAS were modestly associated with better physical functioning as well as higher levels of physical capacity as assessed by a walking test. Sensitivity to change was evaluated in a subgroup of patients who had undergone a course of cognitive behavioral therapy. Disability significantly decreased after therapy and remained stable at follow-ups.

CONCLUSION: The WSAS is a reliable and valid assessment tool for disability in patients with CFS.

I haven't seen the full text so I don't know "reliable and valid" the WSAS data is when compared to actual employment status, the abstract only talks about clinical symptoms and physical function and the walking test. And whatever happened to the CSRI data from the PACE Trial? Will this be in a future paper or did PACE once again prefer to report the more optimistic subjective scales about how impaired one feels instead of the more objective data about how much one actually worked etc?

It is odd that the PACE Trial was co-funded by the UK Department of Health and Work and Pensions but the employment outcomes weren't included or promoted like the patients "getting back to normal" (cough), I guess these figures aren't too encouraging? At this stage it would not surprise me if a large proportion of patients within "normal" range (cough again) for both fatigue and physical function are still actually unemployed or at least underemployed due to CFS related impairments. Looking at the 2007 protocol, they intend on annual followups, so it isn't too late for them to take actigraphical measurements as well (which hopefully would not be too affected by reactivity bias)?
 

biophile

Places I'd rather be.
Messages
8,977
alex3619 wrote: Lol biophile, the gyroscope theory of CF? Maybe it should be their logo. Bye, Alex

Feel free to use the gyroscope theme for your book, hehe! A spinning top is more obvious but a gyroscope symbolizes the layers of spin.
 
Messages
13,774
Sorry to hear that. Coming up to 23 years myself.

Nightmare - sorry it's been so long for you. The first few years I was ill (probably longer) it seemed unfathomable that anyone could be ill for a long time with 'Chronic Fatigue Syndrome'. As time when by, the quackery around CFS became reassuring: "No way a condition would be treated like this if it could be serious." Now I've realised it's just that different standards are held for those diagnosed with CFS.

If they start excluding people who have been ill for over ten years, it will give them more positive prognosis figures! "Thanks to our work, everyone now recovers from CFS."
 

biophile

Places I'd rather be.
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"One of our inclusion criteria was having CFS for less than 10 years as we were concerned that a longer duration raised concerns over the accuracy of the diagnosis. However, this may have meant that some patients were excluded who could have benefited." (http://www.kcl.ac.uk/innovation/groups/projects/cfs/publications/assets/2011/Burgessface2face.pdf)

They do not explain the reason behind this "concern". If it isn't CFS after 10 years then what is it? Would a revised Oxford criteria state that "fatigue" must last a minimum of X months but no longer than 10 years? They probably wanted to exclude such long-term (ie presumedly "recalcitrant") patients from interfering with their results. I thought some biopsychosocialists were proud that in one or two studies the duration does not predict response to CBT, although average duration in such studies is usually only several years rather than decades. Perhaps now they have caught on that prognosis becomes worse over time and are fear-avoidant about including such patients in their studies because the statistical advantages of CBT in research are fragile.
 

Snow Leopard

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Location
South Australia
This is on page 17 (page 21 of pdf) in what I have:[...]

The very next paragraph is:
The other study (60 participants) reported improvement in work status at 12 months. The difference between the CBT group and the usual care group was significant (RR 3.17, 95% CI 1.47 to 6.81).

Note that graph 1.18 suggests it is in favour of the control group.

The study that you quoted was the Dutch GP delivered CBT study (Huibers et al. 2004). Their conclusion was that GPs cannot deliver CBT effectively, but I never felt their reasoning was satisfactory... http://www.ncbi.nlm.nih.gov/pubmed/14990522
 

biophile

Places I'd rather be.
Messages
8,977
More smoke and mirrors from Chalder et al

biophile wrote: I haven't seen the full text so I don't know "reliable and valid" the WSAS data is when compared to actual employment status, the abstract only talks about clinical symptoms and physical function and the walking test.

I had a quick look at the full text of the WSAS study (http://www.kcl.ac.uk/innovation/gro...2011ThereliabilityofWASAinCFSpatientsJoPR.pdf) and my initial assessment based on the abstract seems correct. They also make this claim which I investigated and discovered was nothing more than smoke and mirrors:

(after describing how poor occupational outcomes are for untreated CFS patients)

"However, occupational outcomes tend to improve substantially for CFS patients who receive treatment such as cognitive behavioral therapy and graded exercise therapy [6]."

[6] Rimes KA, Chalder T. Treatments for chronic fatigue syndrome. Occup Med (Lond) 2005;55:328.

However, the cited paper does not appear to discuss work/employment/occupational related outcomes for CBT but only for GET (http://occmed.oxfordjournals.org/content/55/1/32.full.pdf):

"RCTs evaluating GET have found an overall beneficial effect on fatigue and functional work capacity compared to control groups [1013]."

10. Fulcher KY, White PD. Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome. Br Med J 1997;314:16471652.

11. Powell P, Bentall RP, Nye FJ, Edwards RHT. Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome. Br Med J 2001;322:15.

12. Powell P, Bentall RP, Nye FJ, Edwards RHT. Patient education to encourage graded exercise in chronic fatigue syndrome. Two-year follow-up of randomised controlled trial. Br J Psychiatry 2004;184:142146.

13. Wearden AJ, Morriss RK, Mullis R, Strickland PL, Pearson DJ, Appleby L, et al. Randomised, double-blind, placebo controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome. Br J Psychiatry 1998;172:485490.

Furthermore, these claims appear to be unsubstantiated even for GET ...

* Fulcher & White 1997 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2126868/pdf/9180065.pdf) : comparison of occupational status was uncontrolled at followup because it was a crossover study and did not account for dropouts etc, the authors ackowledge this weakness but then try to dismiss it by claiming that spontaneous improvement was an unlikely explanation because it didn't occur in a "similar sample" in another study.

* Powell et al 2001 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC26565/pdf/387.pdf) : reports work status at baseline but not post-treatment.

* Powell et al 2004 (http://bjp.rcpsych.org/content/184/2/142.full.pdf) : followup of Powell et al 2001, did not report occupational status at any point.

* Wearden et al 1998 (full text not easily available but a Cochrane 2004 systematic review appears to refer to this study as "Appleby 1995" because of multiple publications - http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003200.pub2/pdf) : the improvement in "functional work capacity" in the GET group compared to the control group at 12 weeks and at 26 weeks was not statistically significant.

So all in all, no good evidence for the statement that "occupational outcomes tend to improve substantially for CFS patients who receive treatment such as [CBT] and [GET]".
 
Messages
13,774
Thanks a lot for that biophile. Something I find is that when their references are checked, they often do not support the claims being made - I know it can be a lot of work to do so though.

Thanks to all the people digging in to this paper actually - I've been a bit too tired to follow the discussion properly, but I'm definitely planning to come back to it when I've got a bit more energy.
 

biophile

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@ Snow Leopard and Dolphin re work status in the Cochrane 2008 CBT systematic review. It appears the older versions of the same paper do not contain the relevant data from the 2nd study (Sharpe 1993) but the current online PDF file does.

@ Esther12. Yes, this seems to happen frequently when I decide to investigate their claims, enough that I can't take what they say at face value anymore.
 

Dolphin

Senior Member
Messages
17,567
The 2011 Lancet paper only reports data from The Work and Social Adjustment Scale (WSAS) and showed a small advantage for CBT and GET over SMC and APT, one that is a self-rated subjective measure about how limited one feels, so we don't know how well it correlates with actual employment status in CFS, which the CSRI would provide better detailed data for. Some of the PACE authors published a study which included data from the PACE Trial to investigate "psychometric" correlates of the WSAS with CFS (http://www.ncbi.nlm.nih.gov/pubmed/21843745):



I haven't seen the full text so I don't know "reliable and valid" the WSAS data is when compared to actual employment status, the abstract only talks about clinical symptoms and physical function and the walking test.
Full text available at: http://www.kcl.ac.uk/innovation/groups/projects/cfs/publications/index.aspx
ETA: (after reading on) I see you have it now

Thread discussing paper at: http://forums.phoenixrising.me/show...FS-reliability-and-validity-of-the-WSAS-(PACE
 

Dolphin

Senior Member
Messages
17,567
I have it filed in my mental filing cabinet that the PACE Trial authors said they would be publishing the employment data.

I'm not sure if it is just based on this reply: http://www.meassociation.org.uk/wp-content/uploads/2011/06/FOI+from+Queen+Mary.pdf which is a bit vague or something more definite.
As for the PACE Trial, the 2007 protocol states that:



The 2011 Lancet paper only reports data from The Work and Social Adjustment Scale (WSAS) and showed a small advantage for CBT and GET over SMC and APT, one that is a self-rated subjective measure about how limited one feels, so we don't know how well it correlates with actual employment status in CFS, which the CSRI would provide better detailed data for. Some of the PACE authors published a study which included data from the PACE Trial to investigate "psychometric" correlates of the WSAS with CFS (http://www.ncbi.nlm.nih.gov/pubmed/21843745):



I haven't seen the full text so I don't know "reliable and valid" the WSAS data is when compared to actual employment status, the abstract only talks about clinical symptoms and physical function and the walking test. And whatever happened to the CSRI data from the PACE Trial? Will this be in a future paper or did PACE once again prefer to report the more optimistic subjective scales about how impaired one feels instead of the more objective data about how much one actually worked etc?

It is odd that the PACE Trial was co-funded by the UK Department of Health and Work and Pensions but the employment outcomes weren't included or promoted like the patients "getting back to normal" (cough), I guess these figures aren't too encouraging? At this stage it would not surprise me if a large proportion of patients within "normal" range (cough again) for both fatigue and physical function are still actually unemployed or at least underemployed due to CFS related impairments. Looking at the 2007 protocol, they intend on annual followups, so it isn't too late for them to take actigraphical measurements as well (which hopefully would not be too affected by reactivity bias)?
 

oceanblue

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biophile

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I wouldn't hold my breath either, especially if the results were minimal. It might be based on this ...

Michael Sharpe :

16 Apr 2011 6:12:59pm

I would just like to respond to the comment about data from measures listed in the protocol not being reported in the Lancet paper. This is simply because there is too much data to adequately report it in a single paper (the Lancet like most other journals has a strict word limit of 4000 words). There is a publication plan for this, so far unpublished, data which includes papers on: 'recovery' (careful reading will make it clear that recovery is not reported in the Lancet paper), longer term outcome, mediators and moderators of response, and economic aspects including employment. I hope this is helpful.

Michael Sharpe

Co-PI PACE trial

http://www.abc.net.au/radionational...son-of-treatments-for-chronic-fatigue/2993296

I smirked at this statement though, "careful reading will make it clear that recovery is not reported in the Lancet paper". Why should it require careful reading? They certainly didn't make it clear enough at face value in the paper itself (especially with the editorial erroneously reporting normal as "a strict criterion for recovery") and during the press conference when promoting the participants "getting back to normal" lives. How else was normal supposed to be interpreted by the audience? In their authors' reply, they state "It is important to clarify that our paper did not report on recovery; we will address this in a future publication." Apparently it wasn't important enough to prevent medical journals and newspapers alike from falling for the spin about "normal" range.

Even if there are small improvements to occupational status, without actigraphy it would be more difficult to know whether activity substitution occurred.
 

Snow Leopard

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It certainly makes you wonder why they wouldn't/didn't publish recovery data (as per the protocol) in their big Lancet paper. But then again, I don't expect much scientific honesty from these guys anymore.
 

Dolphin

Senior Member
Messages
17,567
Somebody asked me about this post of mine and the missing SDs.

http://forums.phoenixrising.me/show...Burgess-et-al)&p=234483&viewfull=1#post234483
--
I thought I'd re-post my reply here for what it is worth.

----
It's good you are interested in these things.

The Lloyd point is certainly bad. I'm not sure how bad the issue is with the Sharpe paper.

The Sharpe et al paper can be seen at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2349693/pdf/bmj00523-0026.pdf .
So they do give CIs for the difference. And they did at least give the necessary data when the Cochrane reviewers asked.

However, Lloyd and Hickie are still very active in the field so it is pretty bad that, as well as not reporting the SD in the original paper, they haven't provided it for later meta-analyses.

This came up in another meta-analysis:
Clin Psychol Rev. 2008 Jun;28(5):736-45. Epub 2007 Nov 1.
Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: a meta-analysis.
Malouff JM, Thorsteinsson EB, Rooke SE, Bhullar N, Schutte NS.
In this paper the authors said:

"We also contacted or attempted to contact the corresponding authors of each relevant article we found and asked whether the person
knew of other relevant articles not yet published. When an article provided insufficient information to determine an effect size or
to enter data for a moderator analysis, we wrote to the corresponding author asking for the needed information."
But they obviously didn't get a reply because they said:
"One study was excluded because we were unable to obtain the information necessary to determine an effect size (Lloyd
et al., 1993)."

Given that the results in Lloyd et al weren't good for CBT
Neither dialyzable leukocyte extract nor CBT (alone or in combination) provided greater benefit than the nonspecific treatment regimens.
this means the effects of CBT look better than they actually are because their data hasn't been included. Lloyd and Hickie are CBT/GET fans so this would suit them.

Bye,

Dolphin
 

biophile

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biophile wrote:

* Powell et al 2001 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC26565/pdf/387.pdf) : reports work status at baseline but not post-treatment.

* Powell et al 2004 (http://bjp.rcpsych.org/content/184/2/142.full.pdf) : did not measure occupational status at any point.

Note that Powell et al 2004 is a followup of the same patients from Powell et al 2001, so they did "measure" occupational status at baseline as reported in the first paper but did not mention this in the second paper. Obviously the authors thought about the issue of occupational status and decided to either not take followup measurements or not report them if they did take them.
 

Snow Leopard

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* Wearden et al 1998 (full text not easily available but a Cochrane 2004 systematic review appears to refer to this study as "Appleby 1995" because of multiple publications - http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD003200.pub2/pdf) : the improvement in "functional work capacity" in the GET group compared to the control group at 12 weeks and at 26 weeks was not statistically significant.

What exactly is "functional work capacity" in this context? (Wiley site is down at the moment due to maintenance)