In progress: Rehabilitation Therapy for Post COVID 19 Chronic Fatigue Syndrome, 2022 -

[PACE 2.0: Cairo Comeback!]

The aim of this study is to investigate the effect of intensive combined rehabilitation therapy in form of Graded Exercise Therapy (GET) , Cognitive Behavioral Therapy (CBT) to treat patients with post COVID19 chronic fatigue syndrome .

....

Outcome Measures

Primary Outcome Measures :

1. The fatigue severity level [ Time Frame: 12 weeks ]
   The fatigue severity level will be measured via the Arabic version of the Fatigue Severity Scale (FSS)
   
   
2. aerobic capacity and endurance [ Time Frame: 12 weeks ]
   Aerobic capacity and endurance will be measured via The 6 Minute Walk Test. The test will be performed at Modern University for the technology and information rehabilitation center corridor.
   
   
3. Maximal hand grip strength and fatigue resistance [ Time Frame: 12 weeks ]
   Maximal hand grip strength and fatigue resistance will be measured using the Handgrip dynamometer
   
   
4. the Fall risk [ Time Frame: 12 weeks ]
   Fall risk will measure via the Biodex Balance System (BBS) (Biodex Medical Systems Inc, Shirley, NY).

....

Inclusion Criteria:

• 60 post covid patients (6 months recovery after last negative PCR diagnosis)
• Patients will be selected using the Oxford diagnostic criteria for CFS which required disabling fatigue to be the primary problem, in the absence of an exclusionary medical or psychiatric diagnosis. Patients will fulfil the following criteria for CFS :
  
  
  • fatigue as a principal symptom.
  • fatigue definite onset that is not life long.
  • fatigue should have been present for a minimum of 6 months during which it was present for more than 50% of the time.
  • Other symptoms may be present, particularly myalgia, mood and sleep disturbance.

https://clinicaltrials.gov/ct2/show/NCT05534997

 

Is this a freaking joke?

 

This bit is

sadly the rest isn't.

 

“Patients will be selected using the Oxford diagnostic criteria for CFS…”

Truly a PACE 2.0.

 

Weird setup. The researcher who listed the trial is Samar Hosny from Cairo University.

 

This is a major issue. How is it that someone can still be allowed to do research under the name of ME, CFS or any combo of the two and use inaccurate criteria still? There needs to surely be something which puts a line out there saying ethics, funding committees - whatever hoops there are - should not sign off studies where the cohort of the sample is not of the condition being studied.

Things like this can then either use proper methodology or they - and the clinics who refuse to update themselves and are playing games claiming it's OK because it is 'CFS/ME' in order to undermine ME/CFS - should be required to use an utterly different term for whatever it is they are actually studying condition-wise. This is vital for funding surely that it is upfront about the numbers and debility associated with the very condition they are studying.

It's so naughty using ME/CFS stats for that (which they will because there are no 'chronic fatigue' stats, and they likely are not as convincing), whilst studying a different condition that necessarily excludes the very condition being described , I cannot believe this is the state of the situation.

 

How does this even get on a to do list? Let alone get past an ethics committee?

Is it April Fools day?

Jaw drop or joke?

 

'The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.'

A bit like Twitter then?

 

Merged thread

Cairo researchers posted a RCT of CBT and GET in post-COVID CFS in CliniclalTrials.gov in Sept 2022. https://clinicaltrials.gov/ct2/show/NCT05534997

Participants: 60 post COVID CFS patients selected using Oxford

Brief Summary: The aim of this study is to investigate the effect of intensive combined rehabilitation therapy in form of Graded Exercise Therapy (GET) , Cognitive Behavioral Therapy (CBT) to treat patients with post COVID19 chronic fatigue syndrome .

Description of therapy: The intervention group (below) compared to no intervention group

24 sessions of combined rehabilitation exercise program in the form of Graded exercise therapy (GET) and cognitive behavioral therapy (CBT). Patients will attend two sessions per week for 12 weeks....A home exercise program will be prescribed on at least five days a week. ​

Outcomes measured at 12 weeks

Fatigue Severity Scale
6 minute walk test
Maximal hand grip strength and fatigue resistance
Fall risk will measure via the Biodex Balance System​

 

We do not know if any study, so far as I am aware, other than the PACE trial, is intentional fraud. I suspect many studies copying the methodology do so because its easier to copy other apparently successful studies. Its biased, its bad or non-science, even pseudoscience, but some percentage will not be intentional fraud. Some are probably just copycat studies. Someone did it, it succeeded, we didn't examine the scientific merit of the study, we just copied it with some additional bells and whistles to make it a tiny bit different.

To my way of thinking every study using SD on population SF36PF data needs to be retracted. Studies without objective outcome measures as a primary measure need to be downgraded. Studies using the 6 minute walking test need to be retracted if they do not use the proper protocol that mitigates the bias in this method, a protocol not used in the PACE trial. Any study using Oxford criteria should be discounted as irrelevant on any ME patient. Every major study needs a long term follow up, and if it fails to show a significant difference like in PACE it needs to be downgraded.

Now the deliberate use of SD on SF36PF data in the PACE trial, after PDW published a paper in 2007 demonstrating he knew it was a biased method, and ignoring the statistical preconditions for the use of SD, shows intentional improper manipulation of data. Copycats may or may not know. My guess is most in the field are well aware of the problems, but some will just be demonstrating ineptitude. Some will just be additional victims, where researchers are led down a path of deliberate pseudoscience. The problem is I cannot tell who is intentionally manipulating data, or exploiting bias, and who is just ignorant of the requirements, there is too much guesswork involved. I have no way of knowing, except of course for PDW in the PACE trial. Publishing a paper showing you know the issue, and then making use of that bias, should be a slam-dunk on showing data manipulation.

This study apparently does not use SF36PF, so it may or may not be as problematic.

However if the 6 minute walk test is used just once it risks the known bias, in that patients need to be familiar with the test to get accurate results. It will also not show what they think it will. Any patient with any kind of real pacing strategy, even intuitively, just working within their limits, might well do worse on this test than patients who are not using that strategy. If all patients were followed for daily activity we might know more. Oh, wait, every study that followed actual activity levels has failed. Every. Single. One. Unless of course there is some obscured study I am not aware of. If so, the BPS CBT/GET research community need to make everyone aware of it, so we can scrutinize it.

Methodology matters, and so far as I am aware every study using sound methodology has been a fail with respect to the efficacy of CBT and GET on ME or CFS.

 

I have not much doubt that many with idiopathic fatigue will improve with exercise. There are lots of studies in the past that show this. I am less familiar with depression and exercise, or the use of CBT. I am aware there are different CBT methodologies, and you cannot just equate CBT studies unless they use the same methodology.

To my understanding the methodologies in this field consist of cramming biased methods together, that somehow by accident show bias in one particular direction, and then sitting back and claiming success when the biases add up. It then gets promoted with extensive rhetoric.

 

It is. But depression is even less well-defined than ME, or even generic chronic fatigue, and the vast majority of MDs believe it's all depression anyway, so it's consistent to them. It's consistently wrong, but it's consistent.

The tells that no one cares are all over the place. In their recent comments, the BPS ideologues argue that PEM can't be important because it's subjective, even though they made everything about fatigue, incorrectly, which is not only subjective, but the fact that it is has been used to argue this is why it's OK for them to do open label trials with subjective outcomes. Because fatigue is subjective anyway. Even though it's an invalid definition of ME. They don't even care about contradicting their own arguments because no one else cares about what's right or wrong, zero attention to details.

It's clear that medicine has chosen pseudoscience over reason, that this isn't an isolated fringe thing. The failure is at the very core of medicine, about the fact that they don't treat people, only lab results and diagnostic codes, and the very nature of what is valid evidence. We are defying the very nature of medicine, built on eminence and arrogance wherever science doesn't give easy answers.

I don't know how we challenge this, but it's the real underlying issue: the fact that most of medicine is more art than science and that most medical evidence is of a far lower grade than any other profession. Of all the professions to use the arrogance of their perfect knowledge to declare that things they don't know cannot exist, that it's the medical profession is basically too absurd to fix, because no one can believe it can be as dysfunctional as it really is, thanks to operating largely in secrecy without any actual oversight.