O'Dowd-Crawley early intervention study

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/

 

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.

 

Oh dear. Heaven help the ME patients in her area if she doesn't know the difference between fatigue and ME/CFS. A psychologist, ie someone with NO medical training should not be in charge of ME/CFS services.

 

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.

 

@Action for M.E. are you considering removing the ODowd video from your website as part of your presumably extensive overhaul to remove support and promotion of behavioural approaches?

 

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:

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.

 

Well done and thank you @JohnTheJack.

 

As I thought, they haven't posted the patient-level data.

This is what they have uploaded: 'basic results'.

Any thoughts? Worth going after the patient-level?

 

The 6 month results are not impressive.