Cognitive behavioural therapy in chronic fatigue syndrome: RCT of group programme (O'Dowd et al, 200

[barbc56]

@Tom Kindlon

Thanks for the analysis. I haven't had a chance to read all of it but something caught my eye. The dropout rate.

I'm surprised, unless I missed it, that the study doesn't mention people dropping out because they were too sick and exhausted to continue.

I wanted to be a participant in three different studies. The Baraniuk study where I didn't have the energy to fill out the questionanaire which I think was about 50 pages. The second one was close to where my dad lives. I made it to his place but not the study. The third was here in town about exercise (not GET), and after thinking about it realized it just wasn't feasible.

All this simply to say, I think this is a big factor with these studies. You most likely will get a healthier group and that can skew the results.

I'm not sure how/if a study can get around this issue.

Barb

 

[Valentijn]

I question in particular excluding the high scores. 60 and 75 are normal scores for healthy people - if somebody recovers, one would expect such scores. It is different from excluding a score like on a blood test that looks like an error. These scores don't look like errors.

It looks like academic dishonesty - manipulating the results until they find something which is statistically significant, even if they to ignore their own data to do it.

What they omit to say in the abstract is that initially the groups were at 37%, 16% and 38% so there is virtually little difference in the increase across groups: 9%, 10% and 6%.

There's that question answered ... I was wondering what they were trying to hide by showing baseline scores for the patients as a whole, but then showing outcome scores based on groups to suggest CBT is teh awes0me. These sorts of tactics do not belong in academia, and should not be tolerated or published. Ditto for their dishonest reporting of the SF-36 scores.

It is somewhat interesting to see all those in the normal range at baseline given the definition of recovery in the PACE Trial, etc.

Isn't it nice when 30% of participants are already cured at the beginning of the trial

These claims (regarding mood, fatigue and physical fitness) are pretty debatable when one looks at the figures closely and sees the number of measures for which there was not a statistically significant difference. Saying something is "effective" for these measures, given the final values, could be said to be somewhat misleading (although other researchers seem to use this phrase too).

And that they pretty much admit that the one "borderline significant" HADS result probably isn't significant if they would correct for multiple outcome measures. Another failure to take all of the data properly into account. And "borderline significant" does not exist, and does not excuse them from calculating those corrections.

 

[Dolphin]

The shuttle lengths were 10m. So the test looks like it is the one that is often called the six minute walking test (6MWT).

 

[Tom Kindlon]

I just posted this quick comment on PubMed Commons http://www.ncbi.nlm.nih.gov/pubmed/17014748#cm17014748_3673:

Additional information on/context for the walking test results (from the full text):
The abstract doesn't put the walking test results in context.

In the full text, the authors say:
"The ISWT, used as a physical performance measure, has normative reference data described by Taylor and colleagues.7 Their sample of 122 healthy subjects (mixed gender and age) walked a mean of 67 × 10-m shuttles."

Contrast this figure of 67 with the results achieved:

The CBT group started at: 24.3. After six months, were at 28.5 and at 12 months were 28.9.

The changes are thus minimal compared to normal functioning.

The full text also refers to outliers being excluded:

"Five clear outlying observations were omitted from the analysis of shuttles walked. Three were very low values (0 or 2) and two were amongst the highest values (60 and 75), but were from a patient with a low baseline score (9). If these outliers were retained, the SEs increased and difference between CBT and SMC was no longer statistically significant (p = 0.17)."

Whatever about excluding the low values, I question excluding the values of 60 and 75 which are the type of scores one sees in the normal population. It is not widely accepted that nobody with CFS ever gets back to normal functioning (I don't even think the authors believe this either). It is understandable to exclude scores that don't look like they represent the real values, but there is no evidence that the scores of 60 and 75 are anything other than the real, or valid, values.

Also, the wording, "two were amongst the highest values", suggests that there were other high values but these weren't excluded.

 

[Esther12]

I thought this would be an appropriate place to post this article on O'Dowd discussing her results:

What works when treating chronic fatigue syndrome?

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Cognitive behavioural therapy (CBT) could benefit patients experiencing extreme fatigue, Congress delegates heard. Hazel O'Dowd, consultant clinical psychologist at North Bristol trust, presented the preliminary results of a four-year trial looking at the use of CBT for people with chronic fatigue syndrome (CFS).

The trial randomised 153 patients into three treatment groups: one offering CBT and ungraded activity, an education and support (EAS) group, and a standard medical care group in which patients were cared for by their GP. Patients were assessed at six, 12 and 18 months, using a range of outcome measures. These included quality of life scores, fatigue tests, hospital and anxiety scales, shuttle test or walking speed, and mental distress. Although not always statistically significant, the CBT group showed improvements at 12 months. However, the EAS group also showed some improvements, albeit at a lower level.

The trial measured 14 different scales and 'without exception, every single scale showed the same trend,' Dr O'Dowd said. 'We had to set a level of success and we chose a 15 per cent improvement in SF-36 [a quality of life measure] over baseline for 50 per cent of the sample. In this study 54 per cent made this change.

'However, there is a big difference between clinical and statistical significance. I think we demonstrated that CBT did something above and beyond the other groups, but there were improvements in the EAS groups.' The team in Bristol has received funding to continue to offer CBT, Dr O'Dowd revealed. 'People were very keen to take part in the trial, which may say something about how desperate people were, and we had a very small drop-out rate,' she added.

One of the most difficult aspects of the trial to manage was the EAS group, whose treatment involved 'sitting down and being nice', Dr O'Dowd noted. 'We would sit down and talk about how to manage their illness in a very non-directive way. However, patients very often came up with good ideas [for treatment] and we were constantly in the position of people coming up with ideas about how to manage the condition, but when they asked "What do you think?", we had to reflect it back on them and ask "Well, what do you think?".' Estimates for the number of people with CFS in the UK vary between 172,500 and 1.5 million. Many of these patients have a poor prognosis.

lol at clinical significance requiring less of a change than statistical significance. In a non-blinded trial. Where the control sounds rubbish.

Also, a little thing, but this is O'Dowd on PACE:

The effectiveness of CBT and GET is moderate (30% recovery, 60%
significant improvement)

www.avongpeducation.co.uk/handouts/2012/neurology/CFSME.pdf+&cd=6&hl=en&ct=clnk&gl=uk

Apparently she is:

Clinical Champion for CFS/ME
services Avon, Somerset, Wiltshire and
Gloucestershire Dr O’Dowd

Certainly not a champion of patients.

 

[Revel]

This is my local CFS Clinic. I say "local", it's a 3 hour round trip. My GP is perplexed as to why I refuse to attend .

 

[ruben]

This is my local CFS Clinic. I say "local", it's a 3 hour round trip. My GP is perplexed as to why I refuse to attend .

Up until last summer I spent around 5 years attending an NHS me/cfs clinic every 6 months.This is in suffolk. I was working all that time but very much struggling. It's disappointing at these places that you don't see a doctor specialising in me/cfs, but an occupational therapist. The people I saw there were perfectly ok with me and sympathetic. She did compile a letter for me which she said I should give to my employer requesting me to have some additional tea breaks. I never did hand this in though as I knew it just wasn't practical. She was honest with me in that said she had nothing to offer me except CBT/GET. If these interventions really had anything to offer surely I would have been strongly pushed in that direction. You could tell the way she very briefly mentioned it she never had any faith in it herself. These approaches are probably there just as an attempt to get people off benefits. Also, I may have missed it, but has anyone ever said on these forums that their health has been significantly improved by CBT/GET