O'Dowd-Crawley early intervention study

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JohnTheJack

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I thought it would be worth checking what was happening with this study.
https://doi.org/10.1186/ISRCTN72645894

The following are attached:

1. A copy of the trial protocol.

2. A copy of the approval by Multicentre Research Ethics Committee (MREC), 19/01/2012, ref: 11/SW/0301.

3. A copy of the patient information sheet.

I asked for the patient-level data. They say:

A paper entitled 'The feasibility and acceptability of an early intervention in primary care to prevent Chronic Fatigue Syndrome (CFS) in adults: randomised controlled trial' has been accepted for publication in the BMC journal, Pilot and Feasibility studies, but we have not been advised of the actual date of publication.

They did send the study consort diagram.

I'll give them a while and if there's nothing published ask again for the data.


Mod note: Forum thread on the study publication, published after JTJ asked for study data:
https://www.s4me.info/threads/the-f...ndomised-controlled-odowd-crawley-2020.15114/
 

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I notice it's a feasibility trial with primary outcomes relating to whether it's actually feasible and acceptable to patients to run such a trial. The secondary outcomes are CFQ, SF36 etc.

And no real surprise that they are conflating chronic fatigue after 4 months with CFS/ME.

The NHS seems prepared to fund a steady stream of this sort of junk on the justification that it will save money by reducing doctors visits and other demands on the NHS. And AfME were heavily involved.

Presumably if they manage to show it's 'feasible' they will get a whole load of cash to run a much bigger trial.

I can't see a copy of the patient leaflet or of the plans for what actually happens in the sessions with the therapist, among the documents, but I gather it's basic advice on sleep hygiene and activity management through keeping diaries, with a taste of GET and CBT.

The recruitment process sounds like it will pick up people with all sorts of reasons for being fatigued. In other words it's Oxford definition with the 6 month requirement reduced to 1 month. Whether such a sample will actually catch anyone who may develop ME is a complete unknown.

Thanks @JohnTheJack for digging up all this stuff and chasing up the outcomes.
 
For those who are unaware, the psychologist Dr Hazel O’Dowd is one of the PACE trial authors who is sponsored by Action for M.E. to give webinars about “CFS/ME”.

From the Action for M.E. 2016-2021 strategy document:
“In July 2015 we sponsored Webinars for GPs to run a pilot webinar on M.E., led by Dr Hazel O’Dowd, Clinical Champion for CFS/M.E. Services for Avon, Gloucester, Wiltshire and Somerset. This attracted more than 150 GPs and had its running time extended by an hour to accommodate the many questions they asked.”
Click to expand...

https://www.actionforme.org.uk/uploads/pdfs/2016-2021-strategy.pdf


In 2017 AfME sponsored Dr O’Dowd’s webinar: “Meeting the challenge of CFS/ME”. The webpage seems to have been deleted but I found this in the google cache:
On Thursday 12 January 2017 at 8pm GMT, Dr Hazel O’Dowd, Consultant Clinical Psychologist, will be presenting on “Meeting the Challenge of Chronic Fatigue Syndrome (CFS)/M.E.” Chronic Fatigue Syndrome / M.E. is often a significant challenge for both patients and their GPs. In a recent survey CFS /M.E. was rated in the top three most difficult conditions for GPs to manage.

Expected Learning Outcomes:

1.Gain knowledge to help your confidence in diagnosing CFS/M.E
2. Learn more about the management of CFS/M.E
3. Have a better insight and understanding of treatments available
4. Obtain a more detailed understanding of the services available and how to access them
5. Tips for managing the condition in primary care

This webinar is equivalent to 1 CPD credit.

About the Speaker: Dr Hazel O’Dowd, Consultant Clinical Psychologist

Dr Hazel O’Dowd qualified as a clinical psychologist in 1994. She has been continuously employed by the NHS since qualifying. She has worked in general medicine for 15 years and in the field of CFS/M.E. for 10 years. Dr O’Dowd was appointed as Clinical Champion for CFS/M.E. Services for Avon, Gloucester, Wiltshire and Somerset in 2004. The service at Cossham Hospital is one of 12 specialist centres in England that was funded by the Department of Health in programme of 2004/2005. It is now one of the biggest teams in the country and in a recent trial, demonstrated the best outcomes.

Dr O’Dowd is currently the Deputy Chair of the British Association of CFS/M.E. and the lead for the national conference each year.

This webinar is sponsored by Action for m.e
Click to expand...

https://webcache.googleusercontent....fs-m-e-cme-webinar/+&cd=1&hl=en&ct=clnk&gl=uk
 
JohnTheJack said:
I thought it would be worth checking what was happening with this study.
https://doi.org/10.1186/ISRCTN72645894
Click to expand...

Thanks John.

I note that the registration says

"Editorial Notes
16/01/2017: No publications found, verifying study status with principal investigator."

Actually - here's an FOI release on this study already:

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

"Our results show that this type of study is not feasible and EI was not acceptable to a lot of
participants"
 
Esther12 said:
Thanks John.

I note that the registration says

"Editorial Notes
16/01/2017: No publications found, verifying study status with principal investigator."

Actually - here's an FOI release on this study already:

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

"Our results show that this type of study is not feasible and EI was not acceptable to a lot of
participants"
Click to expand...

Thanks. That's interesting. I was reading through the stuff yesterday evening, and the study was a disaster. They couldn't get participants. The whole thing is a massive misadventure.
 
I was told that this trial was going to be published in 6 months' time, which was last week. Since it hadn't, I contacted them asking for an update. They then asked the researchers and this is the result:

I have heard back from the study team

The study has been submitted to Pilot and feasibility. (https://pilotfeasibilitystudies.biomedcentral.com/)

I gather the reviewers have asked for a third revision but promised this would be the last, and it should therefore be published by the end of the calendar year.
 
I have continued working on this and had a long (friendly) exchange with the FOI department at North Bristol NHS Trust. The researchers have clearly tried to get the paper published but haven't been able to, despite some interest a year ago.

The latest I have came today:

Just to let you know the team have submitted the data to ISRCTN for upload and release on Friday.

I have just checked the system and it is not showing yet but hopefully during this week we will have finally got there.

I am so very grateful to you for helping highlight the issue and as a result we are undertaking a much wider programme of work to update registries. The programme will probably take most of the year but I think you can take the credit for helping me and the team secure the resources and political will to address this problem.

I’ll check during the week and let you know when it is up.
Click to expand...

I don't know whether the full patient-level data will be included, but the person I have been in contact with says they will be.
 
ODowd got almost 240k of NIHR money to research CBT-GET via GPs - Crawley was involed ----- no paper has ever been published nor has study results.

ODowd stuck in further requests for research money years after - turned down by the looks of it.

No money for ME-CFS research - except CBT
 
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