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O'Dowd-Crawley early intervention study

Discussion in 'PsychoSocial ME/CFS Research' started by JohnTheJack, Mar 13, 2018.

  1. JohnTheJack

    JohnTheJack Moderator Staff Member

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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.
     

    Attached Files:

  2. Trish

    Trish Moderator Staff Member

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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.
     
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  3. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    @Action for M.E.
    any comment?
     
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  4. Amw66

    Amw66 Senior Member (Voting Rights)

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    How much other research is still unfinished/ unpublished and how does this bode for the scrapping of CNT/ GET?
    If the basic diagnostic criteria is wrong, change becomes more difficult.
     
  5. Amw66

    Amw66 Senior Member (Voting Rights)

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    CBT/ GET.
     
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  6. Robert 1973

    Robert 1973 Senior Member (Voting Rights)

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    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:
    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:
    https://webcache.googleusercontent....fs-m-e-cme-webinar/+&cd=1&hl=en&ct=clnk&gl=uk
     
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  7. Trish

    Trish Moderator Staff Member

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    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.
     
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  8. MEMarge

    MEMarge Senior Member (Voting Rights)

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  9. dangermouse

    dangermouse Senior Member (Voting Rights)

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    I really find AfME disappointing.
     
  10. Esther12

    Esther12 Senior Member (Voting Rights)

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    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"
     
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  11. Esther12

    Esther12 Senior Member (Voting Rights)

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    That Action for ME continue to promote O'Dowd is just shameful.
     
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  12. Solstice

    Solstice Senior Member (Voting Rights)

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    It shows what they were all about and what they continue to be all about. Small hint, they're not about helping patients.
     
  13. JohnTheJack

    JohnTheJack Moderator Staff Member

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    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.
     
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  14. JohnTheJack

    JohnTheJack Moderator Staff Member

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    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.
     
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  15. NelliePledge

    NelliePledge Senior Member (Voting Rights)

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    @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?
     
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  16. JohnTheJack

    JohnTheJack Moderator Staff Member

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    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.
     
  17. Trish

    Trish Moderator Staff Member

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  18. JohnTheJack

    JohnTheJack Moderator Staff Member

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    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?
     

    Attached Files:

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  19. seanpaul

    seanpaul Established Member

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    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
     
  20. Cheshire

    Cheshire Moderator Staff Member

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    The 6 month results are not impressive. upload_2019-4-1_15-6-31.png
     
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