PACE trial TSC and TMG minutes released

[TiredSam]

Speaking as someone who is currently wearing a blue cardigan, I am not offended.

I do not own a cardigan, a white coat, or a starchy uniform. I feel totally excluded. Can we have some blue dressing-gown references please?

 

[Robert 1973]

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.

It might be wise to link to this post when referencing cardigans in future. Similarly, I winced when I first read one of your references to “the girlies”. It was only later, when I read something else you’d written that I realised you were parodying those with sexist views rather than being sexist yourself. But not everybody who reads your posts will be so familiar with your views or sense of humour, and there is a danger of getting what Ricky Gervais has referred to as the “wrong laugh”.

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.

This reminds me of when I was in hospital in 1999. We were told that we couldn’t use mobile phones in the ward because it would interfere with heart-monitoring equipment or something. But for some reason this never seemed to be a problem for doctors’ phones.

I don't think it matters who the researchers blame. They are the researchers, and are responsible for their research.

(With regard to AfME I'm far more interested in what they do now and going forward)

Agreed. As I said above, I believe that @Action for M.E. made an error judgment, but that in no way mitigates the responsibility of the PACE authors. They are responsible for the trial design and they are to blame for its failures.

I just feel that it would help AfME and everybody else to move forwards if it were to apologise for the mistakes it has made in the past.

 

[Woolie]

Haha, in my line of work, the dress code is "wear clothes, preferably clean ones". Actually, the clean part is optional for a lot of academics.

Dressing down is a mark of quality in academia. Wearing a suit makes you look like a phony, like a used car salesman. It is a no-no (except perhaps in commerce and law where the lecturers are often professionals in that area who just do a bit of teaching on the side).

 

[Skycloud]

I just feel that it would help AfME and everybody else to move forwards if it were to apologise for the mistakes it has made in the past.

I don't disagree with this Robert. It would be very helpful. However I think I've already concluded this will never happen and have moved on. Probably due to a lot of cynicism on my part.

 

[Snow Leopard]

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).

The step test is well established (in healthy people at least) and I believe that formula is an empirical one from a linear regression comparing VO2Max with step counts.

 

[Sasha]

The step test is well established (in healthy people at least) and I believe that formula is an empirical one from a linear regression comparing VO2Max with step counts.

I wonder why a more solid reference isn't given for it?

 

[Snow Leopard]

I wonder why a more solid reference isn't given for it?

Probably that it's achieved "textbook status". (not always a good thing )

 

[Lucibee]

The step test is well established (in healthy people at least) and I believe that formula is an empirical one from a linear regression comparing VO2Max with step counts.

But that's not the one they used. Here are the Petrella equations:


Compared with the equation quoted by @Sasha:

Self-paced step test of physical fitness
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) .

 

[Sasha]

@Lucibee, is it possible that they're measuring something other than VO2max (sorry if that's a stupid question - I can't remember much about this stuff!).

 

[Lucibee]

@Lucibee, is it possible that they're measuring something other than VO2max (sorry if that's a stupid question - I can't remember much about this stuff!).

But why would they reference Petrella, and then use a more ambiguous measure of fitness?

This is one of the main problems with trials using tests that they don't then provide details for. Often they can't, because the tests they use have been copyrighted, but it clobbers any attempts at replication, and any validation trails are hard to find.

And I don't know enough about exercise physiology to know what they should have used.

 

[Sasha]

Often they can't, because the tests they use have been copyrighted, but it clobbers any attempts at replication, and any validation trails are hard to find.

That's weird (that a test could be copyrighted). But you'd think that they could at least reference the equation and that the equation (and how it was derived, etc.) would be in a peer-reviewed journal - or at least something that people could access and read.

All very odd.

 

[Sasha]

On the one hand, I'm pleased that they were thinking in terms of submaximal testing (presumably to protect patients) but how illogical to put patients through this kind of fitness testing at all (and have them do the six-minute walking test) and not 'burden' them with actimeters.

 

[Karen Kirke]

Hi everybody! This has led to a useful discussion, I think. Thanks to @Jonathan Edwards for the thoughtful response. The good news is that we agree on what matters; we only differ on just how useful we find the cardigan metaphor.

I should explain that I get the joke! I don’t post much anywhere, because my ME skewers my cognition in a way that scuppers that. If I want to write a letter to the Lancet once a year, I have to not post much and sometimes at all. But I read a lot on S4ME and used to on PR, and was, I believe, possibly even present at the birth of the cardigan metaphor on PR. You just couldn’t see me.

I totally agree that clothing ends up mirroring the power (im-)balance in hospitals. And that imbalance is gendered, as you said, because historically most doctors have been male, and most of those considered lower-ranking, like nurses, have been female. So the clothing ends up being gendered too.

If I understand you correctly, for you, cardigan came to be a symbol for anyone in a more caring or therapeutic role, and those people were lower-ranking than docs. I get that.

Here’s where I think we agree:

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.

If I understand what you’re saying here, it’s that the increases in Chalder Fatigue scores and SF-36 Physical Function scores reported in PACE and similar trials are likely due to the effect of the therapeutic relationship on the patients’ self-reporting rather than the effect of the therapy on the patients’ ME. I agree. I’m not sure what bringing cardigans into it adds, but we are in complete agreement about the substance here.

I think where we start differing in how useful we see the cardigan metaphor to be might be here:

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.

I don’t think delivering CBT and GET involves adopting a new therapeutic be-cardiganned persona. I think that when activity-increasing therapies are used with people with ME, the health professional delivering them often, not always, but often, becomes a-therapeutic or anti-therapeutic in terms of the effect on the patient’s ME. But the health professional delivering them may simultaneously be therapeutic by virtue of their basic therapist skills of listening, caring, encouraging etc.

When you read of the experiences of many people with ME when they did GET or activity-increasing CBT (as opposed to adapting-to-chronic-illness-CBT), as in the ME Association's 2015 survey report, there is often a stark lack of caring, lack of empathy, lack of therapeutic relationship, lack of altering the programme flexibly to suit the needs of the patient. A distinct lack of what you would call cardigan. So this is where the metaphor falls down for me.

To deliver activity-increasing CBT and GET to people with ME, you need to swallow the deconditioning and/or faulty illness belief model. No therapist should ever swallow a model whole. It goes against everything a therapist should be. In my view, to be a good therapist of any kind, you have to begin, middle and end with the patient, not with a bleeping model. You’re informed by models, just as you’re informed by scientific findings, but you don’t blindly adhere to them.

A therapist of any kind, occupational, physio-, speech, psycho-, needs to be free to draw on various models to fit the needs of their patient/client flexibly, and needs to have the clinical judgement to throw any and all of them out when they’re not helping the patient. If you find yourself butting heads with your patient over whether they want to get well or not because you’re so welded to a model that you’ve stopped seeing the patient, you’ve failed horribly.

No health professional should ever swallow anything whole. You have to be constantly questioning everything, checking in with the patient, checking what they're saying and what you're thinking against multiple more objective measures, checking that what you believe to be true is being borne out in response to treatment, very quickly responding when that is not the case.

So for me, if you want cardigan to mean therapist/therapeutic, then it can’t be used to refer to activity-increasing CBT or GET or LP for most people with ME. There is nothing cardiganny about how these are used for most people with ME. Or probably more accurately, the therapeutic and anti-therapeutic elements fight each other out and for a minority of patients, result in increased scores on self-report measures in trials. In your terminology, they’ve been cardiganned. (I also think it’s possible that actual change happens in some cases, but we haven’t seen evidence of this, because it would reside in objectives measures being used and robust literature on spontaneous change over time in ME and CFS.)

For me, the metaphor has just been stretched too far. It has turned into cardigan being used as a byword for poor care, or anti-care. And because cardigan is gendered, since they’re mostly worn by women, this gets a bit more problematic.

Would like to have been able to express this in a more succinct manner, but...brain fog. I hope that what I mean comes through.

 

[Trish]

Hi @Karen Kirke, I enjoyed reading your thoughtful post. I agree with you that the problem with the directive CBT/GET/'changing false illness beliefs' model is nothing to do with good therapy if followed blindly, as the PACE 'therapists' appear to have been instructed to do.

The label CBT is a misnomer in this case - directive CBT like this is actually more like brainwashing, as is LP - trying to persuade the patient to disbelieve their symptoms and 'act well'. There is nothing therapeutic about this.

 

[TiredSam]

So is a therapist wearing a blue cardigan delivering PACE-style CBT, GET or LP a wolf in sheep's clothing?

 

[Jonathan Edwards]

So is a therapist wearing a blue cardigan delivering PACE-style CBT, GET or LP a wolf in sheep's clothing?

I think they were mostly cashmere (goat) or angora (rabbit)

 

[Amw66]

But why would they reference Petrella, and then use a more ambiguous measure of fitness?

This is one of the main problems with trials using tests that they don't then provide details for. Often they can't, because the tests they use have been copyrighted, but it clobbers any attempts at replication, and any validation trails are hard to find.

And I don't know enough about exercise physiology to know what they should have used.

Formula looks like a work rate
Gravitational potential energy is mass x gravity x height, adding time and heart rate looks as though it' s trying to link heart rate to work done. Sort of like heart monitoring ?

 

[Barry]

It might be wise to link to this post when referencing cardigans in future. Similarly, I winced when I first read one of your references to “the girlies”. It was only later, when I read something else you’d written that I realised you were parodying those with sexist views rather than being sexist yourself. But not everybody who reads your posts will be so familiar with your views or sense of humour, and there is a danger of getting what Ricky Gervais has referred to as the “wrong laugh”.

Must confess I also felt very uncomfortable with that, but had not appreciated until your post here that it was parodying; humour can be really tricky to get across without the body language backup to spot when it's being misunderstood.

 

[Barry]

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,

I can fathom some of this.

1 kg => 9.81 newtons of force (at earth gravity, before someone reminds me).
1 N x 1 m = 1 Nm = 1 joule of energy
1 j/s = 1 Nm/s = 1 watt of power.

i.e. Needs a steady 9.81 watts of power to lift 1 Kg at constant speed by 1m in 1s.

So the above seems to rationalise to ...

( [9.81 x Body Mass (kg) x total step height (m) / time (s)] (W) ) x 20 / %HRR

applied power x 20 / %HRR

Does that make any sense?

 

[BruceInOz]

applied power x 20 / %HRR

Yes, it's definitely power divided by change in heart rate (maximum - resting). For two people with the same power (same number of steps in the same time), the number will be higher for the person with the lowest change in heart rate from resting to maximum. For two people with the same heart rate change, the person with the greater power will have higher score. I guess I can see how that may correlate to fitness.