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Recruiting Adolescents With [CFS/ME] to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial, 2020, Knoop, Crawley et al

Discussion in 'PsychoSocial ME/CFS Research' started by Andy, Aug 14, 2020.

  1. Andy

    Andy Committee Member & Outreach

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    Full title: Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial
    Open access, https://www.jmir.org/2020/8/e17768/
     
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  2. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    They won't give up will they
     
  3. Trish

    Trish Moderator Staff Member

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    So in the first 12 months which they are calling an internal pilot, whatever that is, they recruited far fewer than they expected, and used their data to adjust the methodology.
    This appears to be now rolled into the full trial, just as they did with the SMILE LP trial.
    @dave30th, something to look into?
     
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  4. dave30th

    dave30th Senior Member (Voting Rights)

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    They don't want to let me have a vacation, obviously. seems they're rushing out a lot of stuff to impact NICE
     
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  5. Amw66

    Amw66 Senior Member (Voting Rights)

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    This
     
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  6. rvallee

    rvallee Senior Member (Voting Rights)

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    OK this is reaching total madness levels. They could not recruit enough participants for their trials, pretend to be doing a partial feasibility trial that will be rolled into a fully-powered trial, but are instead calling it an "internal pilot". This "treatment" modality has been tested many times already, including by Crawley herself, so the idea that they need to do a feasibility study on something that's been done many times before is genuinely insane.

    So putting aside the fact that this has already been tried many times before, they could barely reach 50% of their recruitment target and still report that they met their target. Seriously at this point the people who enable, fund and oversee this are bordering on criminal misconduct themselves.

    The Dutch FITNET experiment's results were published in 2012. It defined "recovery" post hoc, because of course. The results were not in the slightest bit "promising".
    So promising that years later they only feel they can just try the same feasibility study again? And fail? And still argue it warrants a full trial for which they will clearly not be able to recruit? This is completely insane, these people are out of their damn minds.

    FITNET-NHS's target is 734 participants. They could not even recruit 60% of a target of 156 despite using completely invalid biased methodology. This clearly shows the full trial is unfeasible.
    When did 734 turn into 229? The numbers are all over the damn place.
    So clearly it failed on its primary outcome.
    They actually used a fraction of a fraction. What in the actual HELL? That's not how statistics work. They can't even recruit their target for a feasibility, how is it even invalid to do analysis on incomplete data when the primary outcome is meeting the recruitment target? Again even putting aside the fact that this exact same experiment has been done multiple times before and still manages to get funding.

    There is no crisis of replicability, the crisis is validity. This is invalid unresearch. Real people, real human lives are just being toyed with by mediocre ideologues and it still manages to get funding, approval and gets published despite completely misrepresenting everything. This is insane.
     
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  7. NelliePledge

    NelliePledge Moderator Staff Member

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    Hopefully all they are doing is making the pile of tripe so huge that NICE can’t ignore the smell.
     
  8. Amw66

    Amw66 Senior Member (Voting Rights)

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    This is where critical analysis and statements from charities is needed.
    It is not difficult when faced with studies this bad, but it does not seem to happen.
    I would love to be proved wrong on this occasion especially.
     
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  9. MEMarge

    MEMarge Senior Member (Voting Rights)

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    I'm not sure which charities have the capacity to do this.
     
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  10. Amw66

    Amw66 Senior Member (Voting Rights)

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    To me this should be an inherent part of their remit. If not challenged via bodies which purport to support and represent the patient group then the narrative simply continues and the endless loop goes on with revisionist name changes.

    If after all these years they do not have persons who can dissect and explain with some authority then we have have to ask why not.

    I understand that getting it into mainstream narrative is difficult but social media is a gamechanger for this - we can see this repeatedly.
    Perhaps I am just being incredibly naive
     
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  11. alktipping

    alktipping Senior Member (Voting Rights)

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    not like you to be so generous "mediocre" really that would be a vast improvement on the blatant fraud that these people commit in every psuedo scientific piece of trash they produce .
     
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  12. dave30th

    dave30th Senior Member (Voting Rights)

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    I'd have to look again. Did they actually mention any pilot study in the protocol? I can't remember that.
     
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  13. Trish

    Trish Moderator Staff Member

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    Here's our thread on the protocol:
    FITNET-NHS Esther Crawley - 5th protocol out now

    Here's the version of the protocol from February 2018
    https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3
    My bolding.

    And an announcement of amendment December 2019:
    https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3895-1

    They then go on to talk about the larger proportion than expected with comorbid mood disorders, and then about getting approval from the funding body for the revised recruitment target.

    So, despite being way below recruitment target, they have managed to get approval to continue with a half size trial and a time extension.

    Oh, and by the way, the trial budget is over £1 million. And I haven't seen anywhere mention of cutting that budget in half for their half sized trial.
     
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  14. rvallee

    rvallee Senior Member (Voting Rights)

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    That "and" is way too flexible, allows for any BS argument to be used, which of course it was. That they lowered their recruitment target by half, which they clearly will not meet after having failed to meet half of that to begin with, is proof that they cannot improve recruitment. This is as clear as it gets, no amount of interpretation over what "data suggests" can change that.
    So that's it then. End of story. What is there even to discuss here? Why continue to spend money when this weird aberration of an "internal pilot", a feasibility study in all but name, has failed to meet its objectives? What is this, Mulligan research? Just keep trying until you get the results you want, change your targets, redefine your goals, cheat about everything?

    The steering group and funders have failed miserably. Why even have a steering group if they allow everything and don't bother with the registered objectives? Now that the practice was normalized with PACE it's just become normal to them. Complete corruption of the very system of medicine.

    And where is £1M even going towards? This is a copy-paste experiment, the substance is the same as every other identical trial. It's been done many times before, does not require any specialists or technology. Extremely poor fiscal responsibility here. This is blatant misuse of funds they were entrusted with.
     
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  15. Trish

    Trish Moderator Staff Member

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    And of course the whole trial is based on comparing two different versions of on line 'treatment', both of which involve encouraging kids to find a baseline and then increase activity, as far as I can see.. So it's a win win for the researchers and therapists. Whichever version does a bit better than the other will be declared the definitive treatment, and they will claim they have proved it works.
     
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  16. dave30th

    dave30th Senior Member (Voting Rights)

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    I'm actually perplexed at offering essentially two related interventions. I don't see how you can show much difference between them. It's not likely activity management has been 'proven' to do anything.
     
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  17. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    just like MAGENTA
     
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  18. Cheshire

    Cheshire Moderator Staff Member

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    Trial By Error: FITNET-NHS Falls Short in Recruitment Drive

    https://www.virology.ws/2020/08/18/trial-by-error-fitnet-nhs-falls-short-in-recruitment-drive/
     
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  19. Snowdrop

    Snowdrop Senior Member (Voting Rights)

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    I've decided belatetly that it might be worth exposing and highlighting who the people are who are funding these endless same old same old trials that show nothing except to conclude that 'more research is needed'.

    So NIHR, health technology assessment programme is responsible for handing out money for this useless trial.

    The person behind this unit is here:

    So someone new is now heading this unit since June 2020 and the former person (who doled out the cash would have been Hywel Williams the previous head.

    I think that the funders need to start being held accountable for this endless wasting of taxpayer resources.
     
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  20. Sean

    Sean Senior Member (Voting Rights)

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    Yep. It isn't just the researchers who carry the blame, it is the whole system that supports them. The researchers could not have got so far on their own. They needed substantial sustained material and political support and protection. And they have had it for 30 years.

    Not to mention patients' lives.
     
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