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

[Hutan]

I think it's pretty clearly research. It is aiming to answer a question about treatment efficacy, the researcher had direct contact with the subjects, generating new data as they did so. There was no existing knowledge about the question.

 

[hibiscuswahine]

My head exploded and heart sank this morning reading this paper and so have had to put all my thoughts down here in the forum to start to process this. I don't do quotes so all things in the paper are quoted in italics. I may have misinterpreted things as my cognition was failing writing this.

Ethics approval is not required in New Zealand for audits of clinical practice.

This was in the the Journal of Family Practice and Primary Care - this is a journal for GP's and other medically trained practitioners in primary care eg nurses

They have not audited "clinical practice" i.e. clinical practice of a GP or a nurse. so this statement makes no sense to me.

Although Jenny Oliver is probably certified as a non-regulated health provider as per the HDC (not that I have bothered rummaging around on her website to find this, but all I can say- it was not on her entry page, which is pretty odd, wouldn't you want to be identified as a HDC registered non regulated health provider just to boost your credibility like all the other quack practitioners that are allowed to use this title (eg Mel Abbott of the Switch and other LP/NLP heath coaches like ex rugby league star Richie Barnett? )

Jenny Oliver is not a medically trained health provider in Family Practice and Primary Care. So I do not consider Jenny is doing "clinical practice" and why should her "practice audit" be in the Journal of Family Practice and Primary Care? (Most likely because Bruce is a Professor of General Practice).

Interesting they didn't audit Bruce Arroll's clinical practice where he uses LP techniques and his own theories on helping people become "unstuck" in their health journey and what he teaches to GP's at his Goodfellow CME conference.

I would like to point out that Bruce has no formal training in any psychological therapy, belongs to no professional organisations related to counselling or psychological therapy and no advanced psychiatric training. GP's have training in psychiatry as part of their GP training. It is fairly basic around DSM diagnosis and treatment and their practice remit is to treat anxiety and depression of the mild severity. Some of their clients will also have other major mental health disorders diagnosed by a clinical psychologist or psychiatrist (private or public) and liase with registered mental health providers who provide psychological treatments (so not Jenny and her fellow part-time LP practitioners) and follow up clients discharged from care by the Mental Health Service.

"The LP practitioner agreed to participate in an independent audit of patients completing treatment and obtained permission to provide the study team with names, email addresses and mobile phone numbers. Our interviewer followed up with participants who were not initially contactable to avoid responder bias. The sample size was determined by the number of participants the interviewer could do during her student vacation"

This study was funded by the University of Auckland Research Fund for Professor Bruce Arroll.

But I note the study was a joint effort by the University of Auckland's 1) General Practice Department, Bruce the Professor, Fiona Moir is a senior lecturer in General Practice and 2) the Department of Psychological Medicine. David Menkes is a psychiatrist and Associate Professor there. It would be very interesting to know what David Menkes contributed to the writing of this paper as this sounds mostly to be from the mouth of Bruce but who knows what they are cooking up in these two departments.

The other author is Eloise Jenkins who does not have a profile of the University of Auckland Website. (the only Eloise Jenkins on google is a private psychotherapist in the UK who I doubt would be involved in this NZ paper masquerading as research) so I gather Eloise is the student interviewer. She could be a medical student or any other discipline pertaining to these two departments. She was likely on summer scholarship during her summer break, which is normally from November to February after the academic year finishes. Often students will be allowed to have their name on the paper due to the work they did. I doubt the professionals would allow this paper to be released for publication without authorising the content but they should have proof-read the sentence structure better, it is not up to standard I would expect from a journal or these authors.

The bolded statement above is odd to me, does it read in its entirety - that the LP practitioner did some of the audit of her patients? so it was not independent? if the interviewer had to follow up the ones uncontactable, how were they uncontactable i.e. by email? So did the interviewer phone them and then do the questionnaire. I think the methods should have been much more clearer and transparent. It is quite easy to write a methods for a study like this so there is no question for a reader. i.e we were given the emails of the "participants" from Jenny Oliver and we emailed them the questionnaire.

Also Jenny does not have patients as reported in the study, in my opinion, I would call them customers/clients but maybe she can call them patients under HDC law or Bruce decided to call them patients)

6/20 were self diagnosed (It is not difficult to get a official diagnosis of PASC otherwise known as Long Covid in NZ, many GP's I know are willing and able to diagnose it and it can also be done online via zoom for people living in remote areas, or if they don't have a GP or who has a GP who "doesn't believe" in long covid).

So a third of the participants cannot be considered case subjects for a scientific journal case series as they do not have "caseness" as per the requirement for being considered a case (reference for the term for those interested.https://en.wiktionary.org/wiki/caseness) i.e the participants have to have met the full diagnostic criteria for PASC.

Including self diagnosed people is a big red flag to be included in a scientific paper (but now they and others will quote the paper as "LP does no harm and is safe and effective".)

So perhaps Jenny did this audit in her "practise" with ? her questionnaire or the questionnaire provided by these Joint Authors (excluding Eloise until her credentials are clearer). They give examples of the questions but not the whole questionnaire. Why did they not provide the questionnaire as a supplement? So who was independent and who was the reviewer? Maybe it was just the student... I am not sure the student is independent, she got a summer scholarship to do this work for the University of Auckland and she has two professors as the lead authors, no pressure then.

So the student then has to follow up the patients not initially contactable by ?email ?phone and within the roughly four month period, but to be fairer, lets say 2-3 months because of the xmas/new year break for uni staff. So the interviewer had 2-3 months to contact people and they only got 12/20 to respond, so that is 8 people who were uncontactable, 40 % chose not to answer their email/follow -up phone call after agreeing to take part in the audit. Does not look good....If the LP was so good and effective why wouldn't they respond to an agreed to study? Of course their illness could have got much worse and they were incapable of responding. Why did they not theorise about the non-responders lack of response - big red flag.

The quotes of the consumers/clients were all pretty cherry-picked to be positive - one would expect some negative responses to any questionnaire and a good study would provide their readers with all responses. (But as we know LP only takes people who align to alternative psychological therapies or just haven't done the research to know this is quackery, the fact these doctors don't think this is quackery is deeply troubling but they seem to want to make a name for themselves...)

Their quotes of "10/12 patients said they had previously heard negative things about the LP, such as “it is witchcraft”, ”it does not work”,” “it is a waste of money,” and “it is dangerous.”. This was likely to have come from the Long Covid and ME/CFS forums we have in NZ where most people are well aware of how LP practitioners operate here and very vocal on calling LP and Mel out.

These authors claims that "This emphasizes the need to reshape conversations about medically unexplained symptoms and new evidence‑based approaches" is patently ridiculous - to be aiming this sort of study at primary health practitioners as an evidenced based approach when there is a self selected group by an alternative healthpractitioner, of people with undiagnosed and diagnosed LC. taking part in a study Professors biased towards a psychosomatic and CBT-ME/CFS approach and funded by his university. No bias then (ironically said). No conflict of interest - False.

This is not an audit of clinical practise, it is a targeted approach by Bruce (and now David and Fiona) and the worldwide LP movement to legitimise a pseudoscientific alternative psychological therapy and hopefully gain funding for a randomised control trial and after reading the below quotes I am not surprised Garner is promoting it as they are also aligned with the Oslo Fatigue Consortium's "statements"

If they wanted to audit clinical practise, they should ask a group of GPs to ask their patients with LC what alternative therapies they have had and what they thought of them. It should go through an unbiased Department of General Practice, the only one I can think of would be in Wellington as the Otago Professor of General Practice is also in the grip of another LP/NLP devotee Mel Abott who also wants a clinical trial but so far hasn't got one (as far as I know). I don't see why the Dept of Psych Medicine needs to be involved, but clearly in Auckland, they believe in a newly minted CBT for LC (which they think is MUS), that Garner wrote about in his meta-analysis recently.

Although I can read the CBT constructs they are pinning the new CBT for LC on, as they are mentioned in the italicised quote below. From what I have read, there is yet to be a manualised CBT treatment for LC so it could be anything they want to include, bits of all sorts of CBT (eg CBT for depression/anxiety and health anxiety), so none of this has been properly studied and using CBT for ME/CFS is not supported by NICE UK due to weak evidence. (Unfortunately our NZ clinical guidelines have not been updated since before this, it is the remit of the Ministry of Health and no one knows why, probably not on their list of priorities) Also clinical practise is different throughout the country as GP's are private practitioners and most care for people with ME/CFS is done in primary care as we have no hospital clinics here like in the UK or private clinics like the US. Most (but a not all) GP's would contact ANZMES for clinical support as they have GP's that are willing to advice on the basis of their own clinical practice of seeing many people with ME, all of them would follow NICE as this is the latest guideline of special note that does not to support pwME having GET, CBT-ME/CFS or LP.

"Compared with the current standard care, physical and respiratory training interventions have improved functional exercise capacity, dyspnea, and quality of life. For example, an intervention study found benefits in both physical and psychological outcomes.[10] Taking another approach, a study of cognitive–behavioral therapy (CBT) for long COVID found benefits in reducing fatigue among patients who were mainly nonhospitalized and self-referred[11]; the positive effect was sustained at the 6-month follow-up.

The intervention was not aimed at depressive symptoms as patients with depression or other significant mental health issues were excluded. The cognitive–behavioral model of fatigue assumes that a disease (in this case, COVID-19) triggers fatigue, while cognitive–behavioral variables can perpetuate it.[12] Seven perpetuating factors were identified: 1) disrupted sleep–wake pattern, 2) unhelpful beliefs about fatigue, 3) low or unevenly distributed activity level, 4) perceived low social support, 5) problems with psychological processing of COVID-19, 6) fear and worries regarding COVID, and 7) poor coping with pain.

All participants experienced debilitating fatigue. All participants made significant improvements; some had cures after performing the LP and did not experience any harm and was congruent withthe Oslo Consortium Statement.[ ] This is the first study to report outcomes for patients with long covid with the lightning process. Primary care clinicians can be assured that this is likely to be a safe and effective intervention. Randomized trials are indicated."

And to top it off, @Deanne NZ has found that Bruce and Fiona have endorsed Phil Parker on his commercial website. No bias then. Appalling behaviour.

edited for all the cognitive errors I could find...

and to add - using the term witchcraft is interesting, I have never heard anyone talking about LP in our NZ forums and saying it is like witchcraft. It is a sort of inflammatory word to make people with ME suggesting LP it not an appropriate treatment look like crazy activists throwing out assertions with no basis, something BPS people are quite good at doing whenever they feel threatened by the clear biological evidence in LC and ME.

 

[Nightsong]

Huh. "Audit or research?" - Arroll as one of the two authors (NZ Med J 2001; 114: 499-500-2) (p20+ of the PDF):

https://nzmj.org.nz/media/pages/journal/vol-114-no-1143/9cb67b3606-1696470765/vol-114-no-1143.pdf

We wish to bring the vexed question of differentiating ‘audit’ and ‘research’ to the attention of colleagues, and to stimulate debate within our profession regarding the need for ethical appraisal of any study of clinical data. This issue arose in the context of a study we conducted where the decision as to whether this was ‘audit’ or ‘research’ is not clear-cut.

We therefore sought the opinion of the Ethics Committee of the Health Research Council (HRC). This committee endorsed the decision that it is not appropriate for ethics committees to give retrospective ethics approval. After some deliberation, they determined that there are three criteria which define audit that is exempt from ethics committee review:

1 “The audit is undertaken by or under the supervision of senior members of the health care or disability team directly responsible for the care of that group of health and disability support service consumers;
2 “There is no access to confidential medical information by persons who do not owe a professional duty of confidentiality to those consumers;
3 “Audit can be defined as examining practice and outcomes in a particular time and place to see whether they conform with expectations, with a view to informing and improving management rather than adding to general knowledge.”

The Committee determined that our study met the first two criteria but not the third. The study ‘was not examining procedures or outcomes of the abortion service’ but was contributing to new knowledge and hence was research, conducted on the basis of information given by patients for treatment purposes, without consent for research use.

 

[dave30th]

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.

Audit seems like "service evaluation," which is different from research and doesn't require ethical approval. But service evaluation, at least in UK health research, is defined as analysis of anonymous databases to see if service benchmarks were met. No conclusions or anything beyond that is allowed in "service evaluation," so if you make conclusions, then it's not service evaluation. I think here it really depends upon the operative New Zealand research policies and definition of "audit." I think these defintions are geographically specific, to a degree.

 

[dave30th]

There must be some sort of ethics guidance in NZ that governs this and specifically outlines what the distinction is and what qualifies as an "audit." I'm not sure if the three items outlined in the previous Arroll article are the prevailing, but certainly it doesn't sound like "auditing" involves making conclusions like doctors should feel comfortable prescribing LP and that it's completely safe. That's a general conclusion being widely extrapolated and certainly would be defined as an effort to "add to general knowledge."

 

[Hutan]

There must be some sort of ethics guidance in NZ that governs this and specifically outlines what the distinction is and what qualifies as an "audit."

Yes, there is. I quoted it above.

 

[Hutan]

Huh. "Audit or research?" - Arroll as one of the two authors (NZ Med J 2001; 114: 499-500-2) (p20+ of the PDF):

Another excerpt:

One distinction offered is that audit is ‘whether you are doing what you ought to be doing’, whereas research is ‘finding out what you ought to be doing’.5 The objective of an audit may be to improve service against a standard. Research may include the objective of defining best practice. BMJ editor Richard Smith writes that audit might be defined as ‘collecting data on routine clinical practice with the intention of improving that practice’, whereas research is ‘testing a new hypothesis’.6

Where audit findings pose no harm to individual subjects, we consider that the public good should take precedence over the argument that patients have not given explicit consent for their anonymised clinical information to contribute to new health knowledge.

Clearly, Arroll knows the difference between audit and research, he just feels that he doesn't need to follow the rules. And this case isn't even in the grey zone. It is research.

 

[Utsikt]

the researcher had direct contact with the subjects, generating new data as they did so

I don’t believe that this particular aspect disqualifies it as an audit. An audit will always generate some kind of data, and I don’t believe that it can’t include patient contact. The important part is what the data is about - that’s where they stuck to research-approaches.

edit: do they follow the guidelines? Is new data. What’s the efficacy of X? Is new data and knowledge (pertaining to the intervention), and therefore research.

 

[Sean]

but the much bigger problem with this "audit" is that self-reports of improvement due to LP can't be taken at face value, because LP teaches participants to misreport.

THIS!

It is unbelievable that any clinicians or researchers take this obviously cruel drivel seriously. But here we are, some do.

LP quacktitioners

'quacktitioners'

 

[Sean]

So basically, they are handpicking those that already believe it will work. And making them pay an enormous sum which will induce sunk cost fallacy.
Then doing their voodo magic.
Then asking the people if it worked.
Bearing in mind some of the voodo magic instructions include pretending it worked even if it didn’t.
Then suprise, the handpicked people told to say it worked say it worked!

Basically standard cult manipulation techniques.

 

[Utsikt]

It is unbelievable that any clinicians or researchers take this obviously cruel drivel seriously. But here we are, some do.

That’s because they believe that positive reports are worth something. If they can make someone happy or make them believe that they no longer need help, that’s a win. Actually helping is less important than being perceived as helping (either by patients, stakeholders or even themselves).

 

[forestglip]

Interesting they didn't audit Bruce Arroll's clinical practice where he uses LP techniques and his own theories on helping people become "unstuck" in their health journey and what he teaches to GP's at his Goodfellow CME conference.

I don't know what the rules are. Are doctors who prescribe a treatment in their practice supposed to disclose that as a conflict of interest if they're involved in research about that treatment?

 

[rvallee]

he just feels that he doesn't need to follow the rules

He's certainly right about that. Because those rules aren't enforced as written and he will never be in trouble for it. They have secret exemptions, although not so secret that anyone is unaware of them. This is about as close as it all gets to unaccountable secret societies with secret proceedings making secret decisions about people they know nothing about and couldn't care less about.

And I'm about 99% certain that nothing we could do would get anyone to care about it, even if every single point were acknowledged. Worst case they'd just do it again, coloring between the lines this time. Because it doesn't matter what the rules say. What matters is how they are enforced, and when it comes to the many failures of medicine where psychosomatic ideology operates, there is a full de facto exemption that no one challenges, in fact would be career suicide to challenge.

All of which shows how these 'scientists', who no doubt believe themselves to be seeking the truth, even when it's uncomfortable, especially when it's uncomfortable, believe in none of this. They're just stories they tell about themselves. In the last few years, medicine has revealed itself to not only comply with bad politics, but to comply in advance, never even needing any pressure exerted. Hell, many of them will outright fabricate total bullshit, because it's such an easy way to game the system. They even explicitly ignore even using facts they know are scientifically sound, and will invent complete nonsense to match the politics. Their self-image is a lie, there is so much cowardice out there, especially at the institutional level. The whole system is built on lies.

 

[Hutan]

For what it is worth @rvallee, it appears that the very reason that Arroll wrote that 2001 article bleating about his 1999 paper on women getting frightened by media reports about oral contraceptives contributing to deep vein thrombosis, the 'panic-stopping' of oral contraceptives and subsequently needing abortions is because the system did eventually work and the rules were enforced.

Huh. "Audit or research?" - Arroll as one of the two authors (NZ Med J 2001; 114: 499-500-2) (p20+ of the PDF):
https://nzmj.org.nz/media/pages/journal/vol-114-no-1143/9cb67b3606-1696470765/vol-114-no-1143.pdf

In December 2000 a complaint was made to us and to our local ethics committee that we were publishing work which had not received prior ethical approval and which had had no external evaluation for scientific validity. We felt that the NZ Med J peer review process adequately addressed the latter criticism. Inherent in the former criticism was the premise that our study was research, not audit. We immediately embargoed publication of our NZ Med J paper and sought clarification from the Auckland Ethics Committee. The committee members were divided in their view as to whether our study was audit or research, and they declined to conduct a retrospective ethics review.

We therefore sought the opinion of the Ethics Committee of the Health Research Council (HRC). This committee endorsed the decision that it is not appropriate for ethics committees to give retrospective ethics approval.

It seems that the medical journal and the peer review process didn't catch the problems with the paper, but a complaint led to an ethics committee deciding that the work should have been reviewed by an ethics committee. And then, when that was appealed, another ethics committee upheld that decision. Presumably the paper was never published.

(Although of course Arroll still managed to get the results of the 'panicking women' study published in the medical journal by writing a paper complaining that he was not allowed to publish the results. In fact, possibly it is worse, in that the conclusion of the abortion clinic study is presented, along with the recommendation that the Ministry of Health could somehow embargo information that might frighten women until their doctors had had a chance to talk to them, without any of the details such as the numbers of women who were supposedly so panicked ...)

 

[hibiscuswahine]

I don't know what the rules are. Are doctors who prescribe a treatment in their practice supposed to disclose that as a conflict of interest if they're involved in research about that treatment?

No, not specifically a conflict of interest, though this is debatable. Some doctors have done medication trials as part of research and the drug company paid for the medication but the trial was run by their publicly funded department or an academic department through a university. If the medication is proven safe and effective that doctor could recommend and use the drug without declaring they took part in the research.

In the Medical Council of NZ's "Good Medical Practice" which is a lengthy guideline for doctors practising in NZ. https://www.mcnz.org.nz/assets/standards/b3ad8bfba4/Good-Medical-Practice.pdfI
It states:

"56. Be honest and open in any financial or commercial dealings with patients, employers, insurers or other organisations or individuals.

57. Act in your patients’ best interests when making referrals and providing or arranging treatment or care. You must not allow any financial or commercial interests to affect the way you prescribe for, treat or refer patients."

Of course you need to prove the Bruce, Fiona or David have a commercial interest in LP.

Bruce, if I recall correctly has had LP training and likely uses these beliefs and techniques in his practice but we would have to prove that categorically to be a fact. He will say he has no financial interest in Jenny's LP business. Endorsing Phil Parker on his website is different to having a commercial interest in it, of course.

These three will probably say on the second clause that they do feel they are providing best care as they believe LP is helpful, sometimes "curative" and seem to have developed psychological theories that they say proves their position. It is appalling that they consider a pseudoscientific alternative "treatment" as in a patients best interest and to be recommending it to other primary care practitioners as safe and effective. But Bruce has being doing this for several years at the GP CME conference and got away with it. GP's think they are "helping" a pwME/LC because there are no scientifically proven treatments for ME. But those GP's would have to believe there is a psychological causation for LC and ME and many believe it is biological.

GP's may say, if their patient is enquiring about any sort of "treatment" - that one of their patient's has had "x treatment" and they found it helpful but that is not a formal recommendation to have an alternative therapy. They are also likely to say there is no evidence base that this treatment is helpful. That is a problem as one has already influenced the patient by mentioning it.

Also part of NZ medical practice is to respect the right of people to seek alternative treatments, especially cultural ones (eg. Rongoa Maori and Samoan massage) and GP's are often asked about alternative treatments.

I personally think this is not acting in the patients best interest, but it is often done here, another example being supplementation advised by integrative GPs. As long as they do not have financial involvement in the alternative practitioners business or supplement company they can recommend what they like.

 

[forestglip]

If the medication is proven safe and effective that doctor could recommend and use the drug without declaring they took part in the research.

I think you're answering about disclosing to patients. I'm curious about the Conflicts of Interest section of the research paper. I would think if you write a paper saying a treatment is "safe and effective" and you also make money from patients who come to your practice for that treatment, that should be disclosed to readers. Though I don't know what Bruce does in his practice, I was just going by your suggestion that he might be doing LP-like things.

On the document you linked, it says:

If you have a conflict of interest, you must be open about the conflict, declaring your interest. You should also be prepared to exclude yourself from related decision making.

It cites "the Council’s statement on Doctors and health related commercial organisations" and I found a document with that name that says:

Publication and dissemination of research results
35. The reliability and integrity of scientific literature is affected by research findings and conclusions, the identity of the authors, their affiliations, and any support or funding they receive. When submitting articles to an academic journal or a public forum, you must:

d. disclose all sources of funding received, and any financial and non-financial interests and associations that influenced the research.

This is the policy of the journal they published in (linked from the About page of the journal:

At the point of submission, policy requires that each author reveal any financial interests or connections, direct or indirect, or other situations that might raise the question of bias in the work reported or the conclusions, implications, or opinions stated - including pertinent commercial or other sources of funding for the individual author(s) or for the associated department(s) or organization(s), personal relationships, or direct academic competition.

 

[hibiscuswahine]

yes,@forestglip there is a more extended version of guidance around the doctors and health-related commercial organisations as you have linked to. I have copy and pasted just a few paragraphs in this document.

Bruce clearly has conflicts of interest, potentially in his private practice which I believe patients are mostly being referred to him by other GP's, where he does his what I would loosely term as a psychological intervention. This is his webpage https://www.brucearroll.com/ He developed FACT "Focussed Acceptance and Commitment Therapy" You can download his manual of this off his website. There is no indication he has formal training in ACT like psychologists have, he may have read a book and decided to start using the model. The manual is a copyrighted output for other "therapists" . He is also a practising GP at a medical centre in Auckland. That is separate from his work for the University of Auckland.

But he also has a clear conflict of interest, in my mind, with his work for the University of Auckland. He runs the Goodfellow Unit, out of the General Practice Department at Auckland University, which provides CME for GP's and specifically does symposium on" Chronic Fatigue" and openly shows LP techniques to the GP's who have signed up for the conference (they would have to pay for the conference, usually as part of their employment at a GP practice they would get some money towards attending such conferences). CME is a requirement for being a specialist in General Practice as NZ GP's are required to do continued medical education for specialty registration with the Royal NZ College of GP's & NZ Medical Council.

These conferences also include talks by Jenny Oliver and Mel Abbott. Local ME advocacy groups have complained to many parties involved in these CME Conferences. They have ignored their letters, openly declared that ME advocacy groups who have questioned him on his evidence base to be teaching LP as is a suitable treatment for ME to primary care practitioners, as per the NICE guidelines, are ME activists to the whole assembled group of GP's. The only concession by one chairperson of the CME was not to allow Mel Abbot a spot to lecture GPs (but she has on one previous occasions lectured on her remix of LP (The Switch) as a treatment for CFS/Fatigue/MUS using derogatory terms about these people i.e. "heart sink patients etc")

This chairperson, (I think was a representative of the NZ Medical Association, sorry it was a few years ago so I may be wrong) changed it so Mel Abbot could only talk in a break between CME modules for those interested, which is during the tea break between sessions. I don't know what other alternative practitioners are allowed to speak to a room of GPs as part of the RNZCGP continued medical education conferences.

"24. If you are organising, endorsing or presenting at an educational event, you must ensure there is a clinical/scientific basis for the event

the purpose of the event is educational rather than commercial

information is presented in a balanced and unbiased manner, especially where there are references to a commercial organisation’s products or to the support and funding provided by a commercial organisation

if presenting, include a statement that your presentation is not an endorsement or promotion of any products referred to

that you use generic rather than trade names wherever possible

that you disclose any relationship with a health-related commercial organisation

there is no obligation, or sense of obligation, to buy or prescribe any goods, services or medications associated with any sponsoring organisation

The extended guidance states very clearly about conflicts of interest in recommending treatment and research but it appears by doing an audit of an alternative health practitioner he thinks he has managed his conflict. I don't think he has.

"What to consider when you interact with health-related commercial organisations

5. Clinical decision-making must be free of actual or perceived bias towards an organisation, device, product, person or service. The following pointers will help you to identify, assess and manage bias
or conflicts of interest that may arise in the course of your interactions with health-related commercial organisations.

Integrity is a key aspect of your professionalism as a doctor

6. Integrity (being honest and trustworthy) is vital to your professionalism as a doctor. You should recognise the inherent power and knowledge imbalance in a doctor-patient relationship, and ensure that, at all times, your conduct and decisions justify your patients’ trust in you and the public’s trust in the profession.2

Do not allow your own interests to influence your clinical decisions

7. Interactions with health-related commercial organisations can create a duality of interests. This can lead to a conflict of interest between your obligations to your patients and your obligations to
the commercial organisation(s) you are associated with. The interests and welfare of patients must be your primary concern and take priority over any commercial, personal or other interests you may have.

8. If you are unsure whether your interactions with a health-related commercial organisation create or result in a conflict of interest, you should err on the side of caution and act as though a conflict exists.

Be open and transparent about your relationships and interactions with health-related commercial organisations

9. Managing conflicting interests effectively includes being open and transparent, and having appropriate processes in place to identify and address specific issues and conflicts. While
disclosure alone may not necessarily resolve the conflict of interest, open communication is a vital part of managing that conflict.

10. Your patients must be able to trust that you will be open and transparent with them. Ensure that you fully disclose any financial or personal interests you may have with a health-related commercial organisation where they affect (or could be perceived to affect) your actions as a doctor. You should also document these disclosures.

1 There is extensive literature on how health related commercial organisations can influence doctors and the clinical decisions they make. See, for example, the Royal Australasian College of Physicians’ Guidelines for ethical relationships between health professionals and industry for a comprehensive list of references.

2 See also Good Medical Practice.

Critically appraise information from health-related commercial organisations

11. Health-related commercial organisations may be selective about what information they share and who they share that information with. For that reason, it is vital that you critically appraise the information that health-related commercial organisations publish about new treatments, devices, products or services. This is particularly important if you provide patients with any materials issued by health-related commercial organisations.

12. Avoid relying on health-related commercial organisations for key information and, instead, actively seek unsponsored objective information about treatments, devices, products or services. Engage regularly with your colleagues to ensure that your knowledge and care is consistent with current best practice"


For Research, the guidance is

"When engaging in research

30. Advances in medical care depend on sound clinical research. However, support provided by health-related commercial organisations can influence the design, conduct, outcomes, and findings from the research and how those findings are interpreted and published. For example, a doctor whose research is funded by a health-related commercial organisation may be inclined to report results in a more favourable manner to facilitate future research opportunities.

31. If you engage in research, you must manage conflicts of interests appropriately. Failure to do so could compromise the integrity of your study and affect public confidence in medical research. To
manage and reduce conflict of interest in research, you must:

act with honesty and integrity when designing, organising, conducting, and reporting findings from the research

ensure there is a written agreement that outlines your level of involvement, what services you will provide, and the nature and duration of the research

obtain approval from a research ethics committee before conducting the research (unless the type of research does not require this) and additional approval for any material changes to the
scope once the research is underway."

edited for typos

 

[Nightsong]

A few more thoughts:

* Of the 12 contactable, all agreed to be interviewed. Such an agreement rate is unusual in research. And by the time of interview the median interval since undergoing the intervention was 8.5 mo & the median duration of LC symptoms prior to the intervention was 9.5 mo, so participants were on average interviewed well over a year after their initial COVID infection?

* I didn't see mention of clarifying what they meant by "harm" to the participants: one wonders how they interpreted this - patients might think of harm quite narrowly. Also one patient is reported as 15 years of age - usually involving children brings additional ethical scrutiny in research. The authors mention STROBE, but did they adhere to it? And they state that the interviewer "knew nothing about the conditions or persistent fatigue before starting", presumably implying neutrality, but inexperienced interviewers might also not pick up on salient details from interviewees.

* The sample size is very small, but worth noting that they didn't attempt to examine if those with, say, shorter illness did better; they didn't consider confounders. (And self-diagnosed patients may differ from those medically diagnosed; perhaps they might have shorter or milder illnesses.)

* The 85% back-to-normal metric: how was it chosen? Was it a specific question, or were they asked to rate on a scale and then the researchers picked 85% as a cut-off? Table 4 seems to show one patient did not reach it.

* I'm no statistician, but the authors use a within-subject paired t-test to compare worst vs. current work hours.. but many participants reported 0 hrs at worst (7/12 = 0) - there's a cluster at zero - and compute a mean despite the skew. Also, look at those unlikely SDs compared with the ranges (mean duration of LC symptoms 9.5mo range 1.5-16.5 mo but SD 1.2; mean time since LP 7.9 mo range 2-12 SD=1.1; mean hours of work at follow-up 32.3 but SD=1.0..?) Not sure this [the authors' reported results] is right; hopefully someone can give a statistical opinion.

* Patients were asked to recall the "worst point" of their illness - each patient is compared to their sickest point, not to how they felt on average during LC. Some may have been - and probably were, given the usually self-limiting nature of post-viral fatigue states - on an upward trajectory prior to the intervention.

Arroll also seems to have a history of interest in, & sympathy to, NLP. From 2017, from an NLP magazine - "NLP research, equipoise and reviewer prejudice":

https://web.archive.org/web/2023062...h_Phobia_NZ_SuzanneHenwood_Rapport_Report.pdf

[minor edits for clarity]

 

[petrichor]

Small-ish detail, but the question asked was "Did you experience any harm while doing the LP?", not "Did you experience any harm as a result of LP?", or "Did you experience any harm during or after LP?". If LP does cause harm, you'd expect it to probably mostly occur afterwards, not during the LP, which only goes for three days

 

[forestglip]

mean hours of work at follow-up 32.3 but SD=1.0..?) Not sure this is right; hopefully someone can give a statistical opinion.

Hmm, I'm not sure this is possible. Here is the data it gives for that measure:

Hours per week at the time of the interview
Mean: 32.3
Median: 30
Standard deviation: 1.0
Range: 16 - 50

I'm not an expert, but I think to minimize the standard deviation, you should try to cluster as many as possible as close together as possible. We know there is at least one value of 16 and one value of 50, so the most clustered possible, and with a median of 30 is: [16, 30, 30, 30, 30, 30, 30, 30, 30, 30, 30, 50]

The sd of these is 7.34.

If I instead spread the values apart like so: [16, 17, 18, 19, 20, 30, 30, 46, 47, 48, 49, 50]

sd = 14.41