BMJ: Rapid response to 'Updated NICE guidance on CFS', 2021, Jason Busse et al, Co-chair and members of the GRADE working group

I watched a documentary about Jack Nicholson and his eyebrows.... and his ensuing behaviour and excesses! I would suggest any eyebrow work up will be asking for trouble!? I wish I had his energy to even think about an eyebrow raise let alone an excess.....

 

Presumably one of the reasons it was introduced? In order to make money out of healthcare, there has to be a way of disposing of patients who keep needing interventions but just stay obstinately ill anyway.

It won't be long before it's grading more apps than medicines...until they can grade themselves, of course.

 

There is an interesting response from a GP / PCP to Schünemann's article:

 

new ME stock photo?

 

Especially as it systematically leads to:

Deliberately. In fact they use it to justify themselves doing more denying research, which itself further stifles relevant research. It creates a cycle of failure, demonstrably. Problem is some failures have a very high approval rating and happen to be very convenient in making for easy career advancement. People always forget that people will people no matter what and just err.

 

This is especially relevant given the weird boasts in BPS about personalized this and holistic that. Treatment that is fully unique to the person, which cannot be standardized, and this is something they are finally having to deal with, is essentially useless. At the very least it cannot scale in the same way as an artisanal industry that manufactures everything by hand simply cannot meet the needs of a large population.

By definition treatment that requires mostly judgment and is wholly personalized (even if it actually isn't and people are pretending, like psychics and astrologers do) is too unreliable to use in practice, for reasons that include economics but also go to the fact that people are simply too flawed to do this reliably. It is precisely because individual judgment tends to be poor, largely because it is uninformed, that standardized treatments are valuable.

There is a whole range between holistic-woo-stuff and one-size-fits-all and this is clearly where most treatments should be. Ironically both are happening, applying generic CBT-GET to everyone while pretending there are customized elements that make them unique to every individual. In reality the people behind this know very well that lengthy sessions with therapists who received "advanced training" have the exact same outcomes as a 10-minute pamphlet and that their thing is fully generic, the "customization" is strictly a matter of branding.

It's frankly hard to even give proper context to how irrelevant physician discomfort is, especially as they have to do far more uncomfortable things on a daily basis anyway. Another cheap excuse.

 

Did Roger Moore suffer from ME?

 

Hopefully NICE will recognise that the pressure being applied to them is no different to that which has been applied down the years to anyone disagreeing with them, be they ME/CFS patients, scientists, whoever. They respond with a mixture of poor-science flimflam, and/or attacks against their critics to cover their lack of scientific counter argument.

 

Exactly. When people whose modus operandi is to fight from the shadows start coming out into the light, it often signals desperation to prevent their control slipping away. I see it as recognition their game is up. Hopefully NICE will see through them.

 

Yes, if you mash too many variables together that are supposedly similar but in reality have nuanced but significant differences, then in a way all bets are off. End up with too many unknowns, whose existence are potentially not even realised and presumed not to exist.

 

Nail. On. Head.

 

Suss's letter seems to be saying something a bit different as a whole - which I agree is very sensible. He is against recommendation where evidence is weak. I think in this sentence he is just saying if evidence is weak do not give a strong recommendation, say we are pretty uncertain.

To me the whole idea of grading is phoney. I think a guideline committee can helpfully give their opinion on the strength of the evidence - in whatever words are applicable to that situation. Any concession to a grade is by definition a blunting of meaning because the grade can only approximate to some clear words.

I don't see any value in grading recommendation though, at least in most cases. The prescribing doctor and the patient should decide whether the evidence justifies using the treatment. If it is considered too expensive to provide on public funds or insurance over that is a different issue, which can get decided by the body paying.

 

Finally emailed my MP i.e. to try to raise the change in the methodology (outcome indicators - objective to subjective) in the PACE protocol. If there's revised NICE guidance, which (at least in part) undoes the mistake, then this may be an opportune time to remind Government of the need to learn lessons.
Probably a lot of flaws in this*!

*"My MP,
there's a Government funded study on the use of Graded Exercise Therapy [GET] and Cognitive Behavioural Thereapy (CBT) in Myalgic Encephalomyelitis (ME)
- the study is called PACE. PACE was used for the current NICE guidance for ME.

The original protocol for the PACE study used objective monitoring of activity levels - actmetry - think of a Fitbit type device. However, the study protocol was revised to use subjective outcome measures (questionnaires). The reasons given for the change to the study protocol differed and were not convincing. Subjective measurement of activity consistently overestimates activity levels [https://www.sciencedirect.com/science/article/abs/pii/S0022399921000623]. In this case the use of subjective outcomes led to a policy [NICE guidance] which caused harm to people with ME/CFS.

The NICE guidance is currently being revised, and the review panel have downgraded studies, like PACE, which used subjective outcome measures.

I think the change to the study protocol, i.e.to replace objective outcome measures with (biased) subjective outcome measures, should be raised through the relevant oversight committee in Westminster - the public accounts committee?

I would be grateful if you would advise how to raise the issue of the change to the PACE study protocol to subjective (biased) outcome measurements.

Thank you for your assistance & happy to discuss
Francis

 

Unfortunately, I think the inadequate HRA report whitewashed PACE to a great extent and will make it hard to get official and legitimate concerns about misconduct to stick. The dropping of the actimeters was clearly based not on concern about it being a burden but because they learned that it didn't match subjective results. The whole study is bogus because they didn't have informed consent, given that they violated their promise to observe the Helsinki Declaration. But getting people to act on that has also been a challenge.

 

There's also this really important point that @Mithriel has just made on the general PACE thread (https://www.s4me.info/threads/a-general-thread-on-the-pace-trial.807/page-48#):

 

"Although we originally planned to use actigraphy as an outcome measure, as well as a baseline measure, we decided that a test that required participants to wear an actometer around their ankle for a week was too great a burden at the end of the trial."
I find this interesting. If it was not too great a burden at the beginning of the trial, why was it too great a burden at the end of the trial, when people were supposedly improved?

Moreover, if it was a burden, then the very act of removing that burden would have inevitably resulted in improved subjective impressions of how participants would have felt. If I went on a hike with a backpack, and then the backpack was removed, any subjective impressions I gave would be improved because I could not help but feel more positive, given the lightened burden.

 

From pages 81~82 of the PACE GET Participant Manual:

"Example of a setback plan: (your plan might have some differences)

1. Setbacks are a normal part of recovery: it is the overall trend that is important
2. Setbacks are likely to become less severe and last for less time than previously as I get stronger
3. I should try to maintain as much physical activity as I can, even though this may feel more difficult than normal
4. I need to remember that there is no evidence to suggest that my symptoms are causing me any harm, even though they feel very uncomfortable
5. I should try to keep to my physical activity or exercise plan as much as possible, in order to maintain my physical health during this time
6. Resting too much may feel like the right thing to do now, but in the long run is likely to worsen my condition
7. Resting for a week could lead to my muscles weakening by 10% - this will
   make it much harder to get back to the activity I was doing
8. I can reduce activity if I absolutely have to, but should try to avoid this
   where possible and build up again as soon as I can
9. I should try to get back into any activity I have avoided as soon as I can"

[my underline/italics]

This, in a trial supposedly trialling the efficacy and safety of the very treatment the participants are being told is safe! Talk about expectation bias! Scientific disaster on every level.

 

Thanks @dave30th could you explain what "HRA" is? If I can get this moving (unlikely) then it may be useful to have details of the project/study protocol (links etc.).