An audit of 12 cases of long COVID following the lightning process intervention examining benefits and harms, 2025, Arroll

Discussion in 'Psychosomatic research - ME/CFS and Long Covid' started by Dolphin, Feb 24, 2025.

  1. Utsikt

    Utsikt Senior Member (Voting Rights)

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    @forestglip you can also add: feeling of ‘guilt and blame’ when not getting better, ref. YP1 case study and last paragraph on page 14:
    Later, however, her symptoms got worse and she started to think differently about the whole programme. Her experience was that the Lightning Process programme placed the full responsibility for recovery on her; if she didn’t do what she was taught at the seminar, it was her own fault that she didn’t experience any improvements.
     
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  2. Hutan

    Hutan Moderator Staff Member

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    I think this is a point well worth investigating more.

    I also think that a letter to the funders of this study is another advocacy possibility.
     
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  3. rvallee

    rvallee Senior Member (Voting Rights)

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    Exact same thing as "free speech warriors" who are always aggressively censoring everyone they disagree with.

    Dude is out there throwing rocks out of a glass house, lecturing people about the dangers of doing that. When they do that, it's always fine. It's only when people they disagree with do it that's a problem.
     
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  4. Utsikt

    Utsikt Senior Member (Voting Rights)

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    It can’t be an audit of clinical practice because LP isn’t a medical treatment delivered by medical practitioners. But they sure try to make it seem that way:
    How could one frame an argument that says ‘this is a study, not an audit’? What’s the core of that argument?
     
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  5. Utsikt

    Utsikt Senior Member (Voting Rights)

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    They contradict themselves here:
    Is it an audit or a study?
     
    Last edited: Feb 24, 2025
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  6. Deanne NZ

    Deanne NZ Senior Member (Voting Rights)

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    Digging around for clues, I found this post from Phil Parker about a recent LP success article by Bruce Arroll, in replies Paul Garner asks for access to open version link. Phil Parker offers "I can hook you up with the author..."
    https://www.facebook.com/share/p/1Bjb7K41We/


    upload_2025-2-25_11-43-7.png
     
  7. Deanne NZ

    Deanne NZ Senior Member (Voting Rights)

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  8. Utsikt

    Utsikt Senior Member (Voting Rights)

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    Anything that resembles formal English is way outside my comfort zone, but here’s an effort to make an argument about the audit/study situation:

    «The authors claim that they describe an audit, and that it therefore is excempt from ethical approval. Yet, they seem to have forgotten this convenient and salient point when they wrote their own paper. They repeatedly refer to the paper as describing a ‘study’, and claims that it ‘is the first study to report outcomes for patients with long covid with the lightning process’. According to their declaration, it was also funded as a study. If the authors themselves believe that they are writing about a study, it was funded as a study, and they use this study to make claims about the efficacy of an intervention, it follows that it is in fact a study, and that the authors should have sought ethical approval. The authors can’t have their cake and eat it too.»
     
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  9. forestglip

    forestglip Senior Member (Voting Rights)

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    What are the actual rules though? Is an audit a type of study?
     
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  10. Utsikt

    Utsikt Senior Member (Voting Rights)

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    No, at least not according to this:
    WHAT IS CLINICAL AUDIT
    “Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria…Where indicated, changes are implemented, and further monitoring is used to confirm improvement in healthcare delivery.”

    Principles for Best Practice in Clinical Audit (2002, NICE/CHI)

    https://www.uhbristol.nhs.uk/files/nhs-ubht/1 What is Clinical Audit v3.pdf
     
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  11. Utsikt

    Utsikt Senior Member (Voting Rights)

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  12. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    My understanding is that an audit is an evaluation of something you already are doing, whereas as a research study is asking about something new.

    One question might be is the object of study something you are doing already or something that you are doing for the purpose of this study.

    So on this interpretation if the LP for Long Covid was already happening independently of this study, then attempting to evaluate its outcomes is an audit rather than research or an experiment. So doing this, even ignoring the selection bias and drop out, means there are important research questions you can not answer, the most significant here being you can not provide any control so have no idea if what you have done is any different to doing nothing or even doing any random activity with no LP content.

    However what we see in the write up is a post hoc pretence that this audit can answer research questions, which it does not, indeed can not.
     
    Last edited: Feb 24, 2025
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  13. Nightsong

    Nightsong Senior Member (Voting Rights)

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    I have no New Zealand specific knowledge, and my own knowledge of ethics in academia is now quite dated and was never extensive to begin with. Nonetheless, a few brief thoughts on audits vs research - I'd be interested to know what others think:

    This doesn't compare practice to established Long COVID guidelines or established benchmarks; the purpose is not quality improvement (well, on my brief skim I saw no mention of quality-improvement elements?). The question isn't how one clinic functions compared to how clinics should optimally function; the authors generalise somewhat from it, saying that "primary care clinicians can refer patients for treatment with a high chance of benefit without fear of harm". The purpose is surely that of collecting outcome data to generate new knowledge, not to improve an internal practice or compare it to a guideline, a benchmark, a standard, or ideal practice. And would this have been done anyway if there were no prospect of publication? (I suspect not, but audits are often done when there is no such prospect.)
     
    Last edited: Feb 25, 2025
  14. Hutan

    Hutan Moderator Staff Member

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    Here are the standards that govern health research in NZ
    https://neac.health.govt.nz/national-ethical-standards/part-two/18-quality-improvement
    Under 'National Ethical Standards'
    (they aren't great, but they are something)



    https://neac.health.govt.nz/national-ethical-standards/part-two/18-quality-improvement
    Even quality improvement can pose sufficient risks that ethical approval is needed.




    I think it is possible to argue that this study was research, it is intended to find information about how well a treatment works and it is intended to be generalisable, and in fact the results are generalised. And, even if it was quality improvement, it required ethical approval.
     
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  15. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    I am thinking that if it was an audit it failed singularly and if it was research it never had any prospect of answering the questions the authors claimed it did.
     
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  16. Hutan

    Hutan Moderator Staff Member

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    Here's the definition of research, Section 1 of the standards:
     
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  17. Utsikt

    Utsikt Senior Member (Voting Rights)

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  18. Nightsong

    Nightsong Senior Member (Voting Rights)

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    One more point. From NG206:
    I think one could make a good argument based on that that even in the case where it was definitively audit and not research that the LP is something of a special case in terms of requiring ethical review and approval.
     
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  19. Utsikt

    Utsikt Senior Member (Voting Rights)

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    A project with the same name as the title and by Arroll was declined by the REC in 2016.
    https://ethics.health.govt.nz/asset...onal-ethics-committee-annual-report-2016.docx

    It is listed as a 2015 project here:
    https://whaufoundation.org.nz/success-stories/

    Yet the page talks about ‘long covid’, so there must have been an update post-2019
     
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  20. Utsikt

    Utsikt Senior Member (Voting Rights)

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    Something like ‘previous reports of harm from this intervention means that ethical clearance is required’?

    Are there examples of this reasoning for approved or declined ethics applications?
     
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