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United Kingdom: Multiple Symptoms Study 3 (ScHARR) - NIHR funded MUS treatment trial

Discussion in 'Health News and Research unrelated to ME/CFS' started by rvallee, Jan 17, 2021.

  1. rvallee

    rvallee Senior Member (Voting Rights)

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    https://www.sheffield.ac.uk/scharr/research/centres/ctru/mss3

    I don't see a thread on this. The list of contributors imply a very expensive price tag for doing copy-paste research that's been done many times before. No idea if ME is an exclusion criteria, very few details.

    Obviously not a controlled study but I guess words have no meaning anymore.

    Contributors include: Burton, Deary, Greco. With this many involved it looks like a PACE-scale trial.
    Not even sure this is actually a trial, let alone controlled. Reducing health care utilization appears to be the goal, but I can't find protocol so don't know what are the outcomes used. There's a video but it's generic fluff.

    Another one to follow, @dave30th.
     
  2. Trish

    Trish Moderator Staff Member

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    Professor Chris Burton, the leader of this study, is on the ME/CFS guideline committee. Science for ME wrote a letter expressing serious concerns about his suitabillity for the role and his conflicts of interest. These included the fact that he is running this trial while on the guideline committee, and his own methodology has the same flaws as the research being reviewed by the Guideline committee.

    https://www.s4me.info/threads/s4me-letter-to-nice-concerning-chris-burton.7774/
     
  3. Hutan

    Hutan Moderator Staff Member

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    This sounds awful. There's a short video at the link. 'Common syndromes' are mentioned, with IBS and fibromyalgia given as examples. The closest the list on the accompanying slide comes to ME/CFS is 'fatigue'.

    It makes no sense to look retrospectively at the patients who were sent for tests and had no medical cause identified for their symptoms and say 'there was no benefit and only a cost to the health care system'. It ignores that fact that many of the patients who have tests do have a medical cause identified and treatment can start to cure or reduce life-limiting symptoms.

    It's just like saying that when people who participate in a screening program, for bowel cancer or whatever, and are subsequently found to not have bowel cancer that there was no benefit and only a cost to the health-care system.

    (I bet if Chris Burton suddenly developed a condition that prevented him from earning a living and doing many of the things he enjoys, or his child developed a condition that prevented them from going to school and required him to stay home to provide care, he might want some tests done to rule out possible diagnoses.)

    And, if you accept that the medical system should in fact test to rule out other conditions, and the PPS clinic only gets people after they have been through an effective diagnosis system, then there really isn't any basis to suggest that vast sums of money are going to be saved in avoided testing.

    I wonder if someone in the UK could sign up to get the screening questionnaire, or even participate?
     
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  4. Amw66

    Amw66 Senior Member (Voting Rights)

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    Is this England and Wales only ?
     
  5. dave30th

    dave30th Senior Member (Voting Rights)

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    Interesting point. has this just popped up again now because they've relaunched recruitment for it?
     
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  6. Trish

    Trish Moderator Staff Member

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    I had the impression from my memory of reading about this when we were preparing the letter to NICE about Burton, that recruitment is via referral from GP's in the Sheffield area. I dont think it's one asking for volunteers.

    The patients would have to be selected by their GP as fitting the category of MUS, having been through whatever diagnostic process the GP had ordered, and still returning to the GP with symptoms.
     
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  7. NelliePledge

    NelliePledge Moderator Staff Member

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    Be interesting to see how they get consent from people to be involved and whether the thinking behind MUS is made explicit.
     
  8. It's M.E. Linda

    It's M.E. Linda Senior Member (Voting Rights)

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    I wonder whether we have any members of the Sheffield ME&Fibro Group here?

    I joined just because I have really appreciated their monthly webinars, but am completely out of area.

    I will send an email so the committee can keep a careful eye on what is happening in the City.
     
  9. cassava7

    cassava7 Senior Member (Voting Rights)

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    @Hutan picked up important fallacies about testing. Though, on the point that the "Symptoms Clinic" wouldn't save the expense of tests done prior to patients' referrals, it actually might once it is set up. GPs could be asked to redirect their patients to this clinic after only one inconclusive blood test and/or one specialist consultation. Those who do not want to take on the burden of patients with "unexplained" symptoms may be happy to do so as it seems like an easy solution.

    The description of this intervention/clinic highlights does not fail to highlight that its purpose is cost saving:
    - A "telehealth clinic" is much cheaper to set up and to run than a physical one
    - The intervention is a short-term intervention (4 consultations), after which the patients are left on their own -- much cheaper than long-term care
    - Only 1 long consultation is provided, the other 2-3 follow-ups not being longer than a standard GP appointment and so not more expensive per se (they might be if they're considered as a "specialist" consultation)
    - I suspect the intervention itself revolves around telling patients not to focus on their symptoms and thus to avoid consulting their GP for their PPS, saving costs again down the line.

    If only this money could go towards biomedical research.
     
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  10. NelliePledge

    NelliePledge Moderator Staff Member

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    @Gecko i think
     
  11. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    found the project here:

    https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/1513607/#/

    It started in 2018.
    Cost: £1,466,568.27

    https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/1513607/#/abstract
     
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  12. Trish

    Trish Moderator Staff Member

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    So basically the doctor spends 50 minutes telling the patient they symptoms are not symptoms.
     
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  13. Simbindi

    Simbindi Senior Member (Voting Rights)

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  14. MEMarge

    MEMarge Senior Member (Voting Rights)

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    In the video he talks about doing a larger trial to see if improvement in wellbeing is sustained for a longer period alongside reduced healthcare use/costs.

    They are now recruiting in 3 areas: Sheffield, Tyneside and Manchester/Lancashire
     
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  15. rvallee

    rvallee Senior Member (Voting Rights)

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    Looks identical to FINE. More FINE than PACE anyway.

    FINE had null results. It formed the basis of an NHS training module for what they called "chronic fatigue". Obviously because it's nonsense.

    What is it called to do the same thing over and over again expecting different results? Too bad it's not something these people should be aware of.
     
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  16. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    ah but thats the thing; they don't expect different results, and do everything they can to make it so.
     
  17. Gecko

    Gecko Senior Member (Voting Rights)

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    Yep I'm a member and sometimes volunteer. And yes keeping an eye but do always feel welcome to drop our communications officer Elyane a line on info@sheffieldmegroup.co.uk

    I would guess NICE won't consider this a major conflict of interest for Chris Burton as it's not studying ME/CFS...

    This has been on our radar a while, unsure why it has just popped up again now. I thought there was an old thread on here about it somewhere but I can't find it - possible it was just discussed in relation to the NICE ctte.

    As others have said tho - this will provide no good evidence on anything much.
     
  18. Hutan

    Hutan Moderator Staff Member

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    Cara Mooney, the trial manager has replied to my emailed questions about recruitment and scope. Here are the answers:

    Yes we are still recruiting participants to the study however their GP practice does need to be signed up to take part in the study and be willing to run the searches and send the invitation letters. So yes referral from a GP practice is required. We are currently recruiting GP practices in Yorkshire, Greater Manchester and Newcastle/Gateshead.

    Would people with a diagnosis of CFS potentially be eligible? We do not include CFS in our search criteria so if this is the primary diagnosis it is unlikely that they would be eligible.
     
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  19. Sarah

    Sarah Senior Member (Voting Rights)

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    In the MSS3 trial protocol, the selection and inclusion criteria do not I believe refer to chronic fatigue or chronic fatigue syndrome. However, a paragraph in the protocol introduction gives three examples of MUS syndromes, one of these examples is 'chronic fatigue'. I don't know whether this may be an indication that 'chronic fatigue' may be a search term.

    My recollection is there is a list of amendments towards the beginning of the protocol, in which it was stated that the word 'syndrome' was removed from the term 'chronic fatigue syndrome' in this general introductory paragraph.

    In this para, the term 'chronic fatigue' was listed with the MUS syndromes fibromyalgia and IBS. (Fibromyalgia and IBS are listed as examples of eligible syndromes in the section on selection criteria.) So even though the word 'syndrome' was removed, the sentence describes 'chronic fatigue' (a single symptom) as a syndrome:
    This appears to be the sole mention of 'chronic fatigue [syndrome]' in the trial protocol.

    The selection and inclusion criteria does not exhaustively list MUS syndromes that would be included (or excluded), beyond giving examples of fibromyalgia and IBS, and does not, I believe, refer to chronic fatigue [syndrome] at all.

    A third version of the protocol was apparently published on 18 Jan 2019.

    I think it is the case that the MSS3 trial builds on a couple of other papers on the development of this 'Symptoms Clinic Intervention' under evaluation, and that for one of those, 'chronic fatigue syndrome' was explicitly mentioned in the inclusion criteria.

    Regardless of whether 'chronic fatigue' is a search criterion in the MSS3 trial, it would seem from the selection criteria that ME/CFS patients may be picked up due to other criteria re negative investigation:
    I also wonder if long covid will now be included in search criteria, or if people with long covid that have not had a positive test result may be picked up.
     
  20. rvallee

    rvallee Senior Member (Voting Rights)

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    Non-answer. What even is a "primary diagnosis"? That's not a real thing.
     
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