(UK) "Frenchay to lead 250,000 study into the effects of early intervention for ME"

[Esther12]

Just noticed that it's been 18 months since this was classed as completed, and no sign of it yet.

Also I just posted this in the thread linked above, but it seems just as relevant here:

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?

Tweet

0 Comment 0
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.

 

[Esther12]

Just noticed that it's been 18 months since this was classed as completed, and no sign of it yet.

Over a year since I posted that... anyone heard anything?

 

[alex3619]

If it failed we might hear nothing. If it cannot be hyped as success, it might also not appear. It took the PACE authors years to figure out how to twist a failure on fitness into a positive claim.

 

[Dolphin]

https://www.whatdotheyknow.com/request/results_for_trial_id_isrctn72645

Results for trial id ISRCTN72645894

A Baldwin 20 July 2016
Delivered


Dear North Bristol NHS Trust,

I noted that in 2011 North bristol trust (Dr Hazel O'Dowd) was given a research grant from the NIRH's RfPB programme where the contract number is PB-PG-1010-23253

https://data.gov.uk/data/contracts-finde...

This lead to a trial being registered under the identifier ISRCTN72645894

The trial was registered to run from 05/05/2012 until 31/10/2014

I cannot find any publications associated with the trial even though it was finished over a year ago. I believe normal practice is now considered to be publication of trial results within a year.

So I would like to request a copy of the trial report, any papers published and a publication schedule associated with outcomes of the trial

Yours faithfully,

A Baldwin

---

Freedom of Information, North Bristol NHS Trust 21 July 2016


Dear Sir / Madam

Thank you for your request for information under the terms of the Freedom of Information Act 2000. Your request has been forwarded to the appropriate department for consideration and will be responded to within 20 working days.

Your ref: 3627-07-16

Kind Regards

Helen

Helen Williamson
Head of Information Governance & IT Security
North Bristol NHS Trust
Information Management & Technology
Data Centre
Southmead Hospital

Tel: (0117) 41 44767
Email: [email address]

www.nbt.nhs.uk

Advanced Notice:
I will be on leave from Wednesday 27th July 2016 to Tuesday 16th August 2016 inclusive.

---

Dear Sir / Madam

Thank you for your request for information of 20th July 2016. In compliance with the Freedom of Information Act 2000, our response is below.

With regards to the publication plan, the research team has thus far presented the findings at two conferences (below) and are now preparing the manuscript for publication of the results in a scientific journal. The plan is to submit the manuscript in September and it is hoped therefore that results will be accessible in early 2017 (reliant on the manuscript being accepted for publication).

Title: Early Intervention in Fatigue: A Feasibility study
Authors: O’Dowd, H, Crawley, E, Hollingworth, W, Sterne, J, CollinS, Ingram, S, Montgomery;A, MacLeod, J.
Conference: British Association for CFS/ME (BACME) conference, October 2013

Title: Randomised controlled trial investigating the feasibility and acceptability of early intervention for fatigue in primary care
Authors: O’Dowd, H, Crawley, E, Hollingworth, W, Sterne, J, CollinS, Ingram, S, Montgomery;A, MacLeod, J, Beasant, LA
Conference: UK CFS/ME Research Collaborative Scientific conference, September 2014

Your request has been fully discharged, but I should be pleased to offer any further assistance that you may require.

We should advise that you have the right to complain about this response by reference to the complaints procedure of the North Bristol NHS Trust, in which case you should write to:

Complaints Manager
North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB

If you remain dissatisfied with the decision of North Bristol NHS Trust following your complaint, you may write to the Information Commissioner, whose address is:

Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire SK9 5AF

The Trust asks that you note, that the information you have been supplied may be subject to the Copyright, Designs & Patents Act 1988. You may re-use the information provided for personal use, (not including logos), free of charge in any format or medium. However, you must re-use it accurately and not in a misleading context. You must acknowledge the information as North Bristol NHS Trust copyright and give the title of the document/publication. Where we have identified any third party copyright material you will need to obtain permission from the copyright holders concerned.

Kind Regards

Helen

Helen Williamson
Head of Information Governance & IT Security
North Bristol NHS Trust
Information Management & Technology
Data Centre
Southmead Hospital

Tel: (0117) 41 44767
Email: [email address]

www.nbt.nhs.uk

Advanced Notice:
I will be on leave from Wednesday 27th July 2016 to Tuesday 16th August 2016 inclusive.

Early Intervention in Fatigue – A Feasibility Study

National Institute for Health Research RfPB

Ref. PB-PG- 1010-23253

Study Summary

Chronic Fatigue Syndrome (CFS/ME) is quite common and can be severe. Patients with CFS/ME have

felt ill for more than 4 months, this stops them working or taking part in other activities.

Patients with CFS/ME told us that with early information on sleep and managing activities, they

might not have become so ill. We developed a package of advice and support that could be offered

early on when patients had only had fatigue for 1 to 4 months. We wanted to find out if GPs could

identify patients with a short history of fatigue; whether it was possible to provide support; whether

patients would take part in the study and whether they found the support helpful.

GPs identified patients with fatigue and gave them information about the study. Eligible patients

were randomised (like tossing a coin) to receive either standard GP care or standard care plus the

package of support which we called “Early intervention (EI)”. The EI included a one hour

appointment with a fatigue specialist, an information booklet and three 20 minute telephone

support sessions. We contacted those taking part at 6 and 12 months to collect information on

fatigue, pain, mood and disability.

We talked to participants and asked them about the process and support they received (early

intervention and standard GP care). We talked to those who took part in the intervention and those

who dropped out. We also interviewed GPs to find out what they thought about early fatigue, the

study and what they offered as standard medical care.

Results: 44 participants were randomised, 28 had the intervention and 16 had usual care from their

GP.

Feasibility: We aimed to recruit 100 participants to this study, but were only able to recruit 44. In

addition, 9 (32%) who should have received EI did not have all the sessions offered.

Acceptability: Although 12 of the participants told us that some of EI was useful, 11 of these

participants also found some parts unacceptable. Four participants were still experiencing fatigue

after completing EI and two felt they wanted more help at the end. Four of those we talked to did

not find EI acceptable and withdrew. Reasons included: not liking the treatment model, or the way it

was delivered.

Fatigue, pain, mood and work status were no different between the two groups at the end of the

study however the study was not large enough to show an effect.

Our results show that this type of study is not feasible and EI was not acceptable to a lot of

participants

EARLY INTERVENTION IN FATIGUE:

A FEASIBILITY STUDY

THANK YOU!

We are writing to thank you for taking part in this study and tell you some of the findings.

Fatigue is a big problem that GP’s try to help people with, and patients with CFS/ME had told us that if they had received early information on sleep and managing activities, they might not have become so ill. The study wanted to see if we could find the people with new fatigue and the right intervention to test this idea out.


Did the study answer the questions?

Yes, we wanted to know if GP’s could get 100 people to see if we could compare those that had specialist sessions to those with GP care alone.




What did you find out from GP’s?


GP’s couldn’t recruit enough patients in the timeframe. They often thought there was an explanation for the fatigue that would sort itself out.



What did you find out from patients?


Results were very mixed. A third didn’t complete all the sessions and while some people felt it was really useful, some didn’t think the approach applied to them.



Was it worth doing?


Definitely! We have lots of new information about fatigue at this early stage from a patient and a GP point of view.



What happens now?

We are developing guidelines with GP’s and patients to provide more consistent, tailored help for patients who go to their GP with early fatigue.

Thank you for taking part.

 

[Kati]

If only these investigators saw clearly. Someone give them glasses and a microphone that tells the truth...

 

[Esther12]

There don't seem to be as many press articles about their terrible results as there was about the great news that they were being given a lot of money.

 

[user9876]

It seems slow to me for them to be writing an article for September when the trial was some time ago.

But then their results are poor in that they failed to recruit enough patients. 11 out of 12 who said that their early intervention was useful also said parts of it were unacceptable. So even those who had positive things to say were unhappy.

At the end they had a null result

Fatigue, pain, mood and work status were no different between the two groups at the end of the study

Given the null result I doubt if it will ever be published.

 

[A.B.]

Some observations:

- They had difficulties recruiting patients because GPs thought the fatigue would resolve over time.

- Of 28 patients in the intervention group, 12 thought that the intervention was useful, but 11 of them also thoughts some parts were unacceptable. There was only one patient who found it useful and fully acceptable! We don't know how many patients that didn't find it useful considered it unacceptable, but probably the majority.

- Of 28 patients in the intervention group, only four were still experiencing fatigue at the end, and there was no difference between the groups in terms of fatigue. This suggests that the way they picked patients resulted in a sample with very strong regression to the mean, in other words, those GPs were on to something. I suspect that the more severely ill were not even referred to this study because the GPs were busy continuing to exclude alternative diagnoses.

It seems the authors didn't realize that a diagnosis of ME is rarely made within 4 months of symptom onset.