McMaster University LP Trial - "Fatigue in Long COVID (FALCON)", Jason Busse

rvallee

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Fatigue in Long COVID (FALCON)
Study registration: https://clinicaltrials.gov/study/NCT07697261
Lead researcher: Jason Busse

Long COVID affects about 6 in 100 people after a COVID-19 infection. It can cause ongoing problems like ongoing tiredness, muscle pain, and "brain fog." We know very little about which treatments might be helpful for long COVID.

The goal of this trial is to compare two treatments for people with long COVID to try to manage their symptoms. The main question is to assess whether the Lightning Process is effective for people living with long COVID compared to activity pacing. Each person will be placed into one of the two groups randomly (by chance, like flipping a coin). Activity pacing helps people balance rest and daily activities. The Lightning Process teaches ways to change thought patterns and body responses to symptoms. We will include 100 adults with long COVID. Everything will be done online, including filling out surveys about health and daily life. The goal is to find out which approach helps people feel better and improve their daily activities.
 
Exact same traditional reasoning as usual:
Emerging evidence suggests that gradually re-engaging long COVID patients in physical activation and modifying unhelpful beliefs may promote recovery.
No information on who is funding this. It's really telling how McMaster University is both a major center for evidence-based medicine in Canada, as well as one of our quackiest institutions. EBM seems to be converging to be most quackery.
 
The main question is to assess whether the Lightning Process is effective for people living with long COVID compared to activity pacing.
The goal is to find out which approach helps people feel better and improve their daily activities.

Note the equivocation.

What does it mean to 'be effective compared to' when you don't know if what you are comparing to is effective under the conditions of the test? And why the asymmetry. What about activity pacing being 'effective compared to'?

The second sentence is bad English. It sounds even handed but the equipoise is busted long ago.
 
Is this him?

Rapid Response to 'Updated Nice Guidance on Chronic Fatigue Syndrome' 16th Feb 2021


'As the commentary authors note, the guidelines have chosen to downplay the evidence supporting graded exercise therapy. An appropriate application of GRADE would have come to a very different conclusion, as did a recent Cochrane review of exercise in chronic fatigue syndrome using GRADE methodology: “Exercise therapy probably reduces fatigue at end of treatment (SMD −0.66, 95% CI −1.01 to −0.31; 7 studies, 840 participants; moderate‐certainty evidence)”.'

16 February 2021
Jason W. Busse
Associate Professor
Per Olav Vandvik, Elie A. Akl, Philipp Dahm, Marina Davoli, Signe Agnes Flottorp, Paul Garner, Joerg J. Meerpohl, Reem Mustafa, Maria X. Rojes, Gordon H. Guyatt
McMaster University



Jason Busse's links with the insurance industry:



.
 
I’m not surprised that McMaster University is doing this. When discussing the evidence of neuroplasticity/brain retraining, I was pointed to this page from Dynamic Neural Retraining Systems. I’m too tired to point out all of the misleading things and copious bias on this page, but it seems to be a paper that was never published. I’m surprised McMaster never asked them to remove it. I wonder if they even know about it. But yeah, they have a history of doing this research even if it never goes anywhere.
 
Jason Busse's qualifications
  • McMaster University. PhD Clinical Epidemiology. 2004 - 2009.
  • CMCC. DC Chiropractic. 1995 - 1999.
  • University of Toronto. MSc Molecular & Medical Genetics. 1993 - 1996.
  • University of Toronto. BSc Microbiology. 1990 - 1993.
 
OT students are going to be responsible for the pacing arm.
Other: Activity Pacing
  • Activity Pacing, a self-management strategy that balances activity and rest to manage fatigue, allowing individuals to maintain consistent energy levels throughout the day. The aim of activity pacing is to avoid symptom exacerbations whilst achieving as much as possible with limited energy. Pacing focusses on developing awareness not only of the symptoms but also more subtle indicators that herald a future exacerbation of symptoms (listening to your body) and becoming aware of effect of activity or lack of rest on disability. Senior occupational therapy students will deliver activity pacing remotely and individually by videoconference.
Patients assigned to the pacing intervention complete 15 sessions over 24 weeks-four weekly sessions, then sessions every two weeks until week 26.
 
It's all being done on line and says its international.

Participant group:

Experimental: Lightning Process
Lightning Process is a mind body intervention that focusses on identifying and interrupting negative thoughts that may affect fatigue.

Behavioral: Lightning Process
  • LP is a mind body intervention which is delivered over 3 consecutive days to individuals or in groups via video technology. The sessions are approximately 4 hours long. Experienced LP practitioners will deliver the LP intervention remotely and individually. The intervention is comprised of a preparation phase, core sessions, and follow-up. Preparation consists of an audio home-study module (about 4 hours total) and about 1 hour of preparatory coaching by telephone or videoconference in the days to weeks before delivery of the LP intervention to orient participants to the approach and address any questions.

Problems with this approach:

I didn't find any information about how participants will be recruited. Given that it's international, I assume it will be via social media and word of mouth. I can imagine people already persuaded to try LP signing up in order to get it free, and possibly dropping out if allocated to the pacing group instead.

Preparation consists of an audio home-study module (about 4 hours total) and about 1 hour of preparatory coaching by telephone or videoconference in the days to weeks before delivery of the LP intervention to orient participants to the approach and address any questions.

I find this part highly suspicious, given what we already know about LP only allowing participants willing to not question anything and who are deemed 'ready' in a preliminary interview. I can imagine lots of people either dropping out at this stage if they realise it's a scam, or being quietly dropped for spurious reasons and not recorded as participants if the LP practitioner thinks they are likely to be non responders, ie not susceptible to brainwashing.
 
DNRS feature McMaster on their website, as far as I know this study was never done, not published, and you cannot find it:


I wonder what makes McMaster an easy target for these scams. I had an MD reference this website to me as proof it works. Seriously the MD didn’t even google if this study exists. They still stand by it.

Edit: this just brought back so much frustration I emailed that MD’s office the studies they are presenting do not exist.
 
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Study overview -

'The purpose of this trial is to establish the efficacy and safety of LP vs. activity pacing in adults living with long COVID. We hypothesize that in our trial, people randomized to LP will report greater improvement in fatigue compared to those receiving activity pacing. Our trial will enroll people living with long COVID who are motivated and show willingness to change their condition through intervention.'


Not loaded with positive expectation of Lightning success then. Enrolling 'people living with long COVID who are motivated and show willingness to change their condition through intervention'
- is that study code for 'susceptible and pre-primed to accepting the "do as we say and say what we tell you - AND NO Negativity!' MO of Lightning Process.
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The purpose of this trial is to establish the efficacy and safety of LP...
Yep

Busse and McMaster will be being paid plenty to do this study. The interesting things are 'paid by who' and 'how'.

There is a tag for Jason Busse at the top of the thread (also one for McMaster University). He has a long association with CFS quackery as well as Cochrane. And Cochrane is of course closely tied to the insurance industry, with their Insurance Medicine group in Switzerland one group that survived Cochrane cutbacks. At one point, possibly still, Jason Busse was co-director of the Cochrane Insurance Medicine Group.

I'm inclined to think this is less about LP and more about the insurance industry, because the promoter of an LP look-alike programme in NZ which does not pay royalties to Phil Parker seems to be linked into the same support network.

I do wonder what Crawley (who ran a terrible trial of LP in children and started the failed trial of GET in children (MAGENTA) and who since seems to have vanished from medical practice and research) could tell us about who is behind these sorts of trials, if she ever were to speak up.
 
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From other threads about Busse:
Dr. Jason Busse has established multiple connections to the insurance industry through his clinical practice, research, and advisory roles:

Consultant to Prisma Health Canada: Dr. Busse serves as a consultant for Prisma Health Canada, a private company funded by employers and insurers that consults on disability claims. (PMC)

Clinical Director at Prisma Health Canada: In addition to his consultancy, Dr. Busse holds the position of Clinical Director at Prisma Health Canada, where he oversees the management of chronic disability claimants referred by private disability insurers. (http://orthohub.xyz)

Former Director at ATF Canada: From 2001 to 2010, Dr. Busse was the Director of the Complex Claims Division at ATF Canada, a private company that provided assessment and treatment for patients receiving long-term disability benefits. (http://orthohub.xyz)

Research in Insurance Medicine: Dr. Busse's research encompasses insurance medicine, focusing on areas such as disability benefits and workers' compensation. (Insurance Journal)

Collaborator with Cochrane Insurance Medicine: He is listed as a collaborator with Cochrane Insurance Medicine, an organization dedicated to evidence-based research in insurance medicine. (http://insuremed.cochrane.org)

Research on Impairment Ratings: Dr. Busse has conducted studies comparing editions of the American Medical Association's Guides to the Evaluation of Permanent Impairment, which are utilized in workers' compensation systems. (Insurance Journal)

These roles and research endeavors highlight Dr. Busse's active engagement with the insurance industry, particularly concerning disability assessment and management.

Gordon Guyatt, Jason Busse, both from McMaster University, both associated with "evidence-based medicine" and Cochrane. Regina Kunz leads Cochrane Insurance Medicine and is based in Basel, Switzerland - Switzerland of course having a lot to do with the insurance industry and the insurance industry having deep pockets.
 
How depressing.
I pay a monthly health insurance fee to a company that pays frauds to keep me from getting healthy.
They don't give a d*** about my health.
And those that are paid for blocking disability claims are even worse.
That's why I'm stuck with ME/CFS for 35 years and had to fight in court over my disability.

I knew this for a long time, but seeing it spelled out by @Hutan in black and white is a very good reminder.
 
Fatigue in Long COVID (FALCON)
Study registration: https://clinicaltrials.gov/study/NCT07697261
Lead researcher: Jason Busse

Long COVID affects about 6 in 100 people after a COVID-19 infection. It can cause ongoing problems like ongoing tiredness, muscle pain, and "brain fog." We know very little about which treatments might be helpful for long COVID.

The goal of this trial is to compare two treatments for people with long COVID to try to manage their symptoms. The main question is to assess whether the Lightning Process is effective for people living with long COVID compared to activity pacing. Each person will be placed into one of the two groups randomly (by chance, like flipping a coin). Activity pacing helps people balance rest and daily activities. The Lightning Process teaches ways to change thought patterns and body responses to symptoms. We will include 100 adults with long COVID. Everything will be done online, including filling out surveys about health and daily life. The goal is to find out which approach helps people feel better and improve their daily activities.
What is it with McMaster University?

Is it just the one in Canada or are there more of them that aren't like this (ie is McMaster a bigger brand or just the local name)

I note it tends to be the same individuals including this chiropractor guy but there are a few more there and they seem heavy on the propaganda and trying to get involved in groups that are linked to psychosomaticists and influence things with articles.

Who funds this department?

Does LP head like Parker do donations to places (or equivalent) for example that we know of?
 
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