PACE trial TSC and TMG minutes released

For me, that cuts to the chase and sounds right to me.

 

> While I understand that trust in the charity remains an issue for some, I strongly refute the statements I have seen about individual researchers having any role, including a decision-making one, in the charity

it seems pwme do not fully know who/what donates or effectively controls afme?

 

The bit of Sonya Chaudhury's message that concerns me greatly is this:

The ME community need to wake up and recognise what it would mean to have people from the CMRC acting as the lead figures in a James Lind Alliance "Priority Setting Partnership" (PSP) for ME/cfs.
In doing so, they could act as enablers for the BPS brigade, allowing them to gain an unwelcome and unwarranted position on the list of research priorities for this illness.

http://www.jla.nihr.ac.uk/about-the-james-lind-alliance/about-psps.htm

 

@Action for M.E.
Can you respond please re PSP and James Lind Alliance- clarification as to the objectives, defined outcomes and clinicians involved would be appreciated. This may help put minds at ease.

 

Or it could enable the new biomedical focus that the CMRC seems to be adopting to really take hold and for a new age of biomedical research to happen in the UK.

 

The MEA have found the article and have said that I can post it here:

 

That would be a trusting and optimistic viewpoint.
However, we all know where trust and optimism has led to in the past.

Personally, I would much prefer to see people who were put forward by Invest in ME Research taking the lead on this.

 

Are Esther's fitnet and magenta using objective measures?

 

incredibly ironic as a lot of teenagers will use Fitbit type devices and be used to them. For the cost of a number of identical devices there could be data on sleep, activity, heartrate.... not difficult.
My daughter also uses an app to track activity etc on her phone - not as comprehensive as Flaredown - different coloured emojiis - but very effective.
It is sometimes hard to believe we are in the 21st Century.

 

Having looked at the full trial protocol, and with reference to the TMG minutes, I can sort of understand why they ended up ditching actigraphy.
I don't think they really understood why they were measuring it (it certainly wasn't to help participants to pace or track activity). They didn't really know how to go about recording it effectively. I suspect they data they did obtain were a mess (there were 5 pages of data that needed to be filled in by RN), and they didn't know how to analyse it or even obtain a summary measure. When they started to run out of ActiWatches (they only had a max of 3 per centre), and probably failed to download the data properly a few times, I guess the "measurement burden" really did prove to be too much - but it was probably never that much of a burden for the patient, but was for them (too much incomplete or missing data).

There were so many measures that they used that they clearly hadn't trialed properly for feasibility. The fact that there were 60 pages of questionnaires, many of them overlapping, indicates that they simply didn't know what they were doing or what they were measuring things for. AfME were probably right to be concerned about that!

With the STEP test, they referenced Petrella et al., but that paper gives no clear instructions on how to do the test. And the test itself wasn't even validated until 2014. And then not in the target population. One review even states that such tests are inappropriate for those who are unable to sustain moderate exercise. There is no instruction of how to obtain a score or of what equation they used for this purpose. The results that appear in the mediation paper bear no relation to the sort of results they should have obtained anyway - the range on the fitness graph is from 0-3, when the test gives a proxy for VO2 max (one would expect a score of 20-30 ml/kg/min).

But this is all supposition. I guess we'll never know what really went on.

 

On p.1 of the supplemental material that accompanied the Chalder paper (where the fitness test results were 'reported', barely) there's this info about the test they actually used (which wasn't Petrella but apparently similar):

http://www.thelancet.com/cms/attachment/2081116809/2072376618/mmc1.pdf

Self-paced step test of physical fitness The self-paced step test of fitness involves timing participants while they do 20 step-ups and stepdowns (of two steps each), as well as gathering resting and post-exercise heart rates (10). A measure of fitness was calculated as [Body Mass (in kilograms) x 9.81 x total step height (in metres) x 20] / time (in seconds) / %HRR, where %HRR = [(highest measured HR - resting HR) / (predicted max HR - resting HR)] x 100 (11) .​

Ref 11 is given as:

11. James D. Formula for fitness. University of Gloucestershire: Research Faculty of Sport, Health & Social Care 2012.​

In other words, not something that appeared in a peer-reviewed journal (not that PACE is any advert for what can appear in a peer-reviewed journal).

 

So they used Petrella's Step Test, but then used someone else's unvalidated formula? It just gets better, doesn't it!

 

I am sorry if the cardigan references touch a nerve. It is all my fault, I admit.

However, although I may reduce references to cardigans here if that is what people prefer, I am probably not going to drop the reference altogether because I think it may be useful.

So I need to justify that and am happy to be shot down.

I worked in rheumatology alongside women in blue and green cardigans of the sort you mention. Our speech therapists wore mufti but I can imagine that red was their colour. The few men in the therapy professions did not wear cardigans.

Right from the start as a trainee I saw these cardigans as symbols of a male doctor-run hierarchy. Doctors could wear what they liked but were able to wear a macho white coat on top. I went on the wards without my white coat at Bart's as a registrar and a coat was immediately ordered by the consultant from sister. For a doctor not to wear his badge of authority was unthinkable. I would be only too happy to make white coat jokes. Over the years people came to realise that my original reason for not wearing the coat was right. It is better to wear fitting clothes you put in the laundry bin every night than a coat you might wear for a fortnight that sweeps past every infected object in a ward of cancer patients with no immune defences.

But in fact the cardigan joke does not refer to uniforms. It comes from a more subtle social pattern, I think. Clinical psychologists, like psychiatrists and GPs (interestingly) never wore uniform. The blue cardigan I envisaged was based on young clinical psychologists who we had in the department in the 1990s, who mostly lasted about six months. They wore mufti but always a slightly cuddly dressed down mufti (no suits) that indicated inferiority to doctors but a 'caring' role for patients. Their cardigans were fluffy and a bit more expensive and usually pale blue or maybe charcoal. Cardigans were worn at work then because a lot of hospitals had poor heating and you had to go outside to get to the ward or lunch. I doubt many people wear them now. But if you were a young doctor you wore a suit. If you were a skivvy nurse you wore starchy uniform. Everything was tuned to 'persona'. As I saw it the cardigan was a sign of a position in a hierarchy that was not top but not bottom and coded for a particular 'human' role.

I have been reading through the document 'The bastards do not want to get better' and I think this highlights what I am trying to get at. The nurses felt uncomfortable with the 'new persona' of being a therapist. As a doctor I have lifted patients, carried bedpans, put up drips, told people they are dying, written prescriptions and God knows what and it never struck me that I might need a 'new persona'. But it seems that to deliver CBT and GET you need to put on some strange mask that makes you a different person. I see the cardigan in medicine as part of that charade.

So my main point is that I am absolutely not suggesting that people who wear cardigans rather than white coats are dim or uncritical or rationalising or disingenuous. The villains of this piece come in all dress codes. And the heroes and heroines may have to wear the same. I am suggesting that the cardigan as symbol of role playing, of charade playing, is at the heart of the problem. The results of PACE are literally the results of this charade playing and the cardigan role seems to me to be pretty much what gets the results.

 

Yes

 

Absolutely not !