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"News" 8 Sep 2016: PACE trial team analyse main outcome measures according to the original protocol

BruceInOz

Senior Member
Messages
172
Location
Tasmania
......there were statistical methods for defining "improvers" in the protocol and in the PACE paper and we can now clearly see the difference using the different methods, with far fewer people improving using the protocol method.

But what about what I'll call "worsers"?

I'm not thinking here of those who suffered some major adverse event, those were recorded, I'm thinking of those whose score worsened with CBT/GET to a comparable degree to how the "improvers" improved!

...

Were they "worsers" or did their score stay static before and after treatment?

IF their subjective scores are normally distributed, I would think that, since the mean score has improved, any sensible definition of improvers and "worsers" will show more improvers than worsers. That is, if we look at the area under the distribution curve of the 52 week results and compare the area above the baseline mean plus some constant with the area below the baseline mean minus the same constant, the first area must be bigger if the curves are normal distributions and the 52 week mean is higher than baseline.

So what is interesting is seeing if the scores are NOT normally distributed, which can be analysed with the data. Ceiling and floor effects will change the picture I outlined above but so also would a double humped curve. Of course, the 95% confidence level error bars probably also rely on a normal distribution.

But, at the end of the day, these scores are subjective measures from an unblinded trial so any conclusions drawn from them don't really mean much.
 

Hip

Senior Member
Messages
17,874
I would like to add that it's important to serially remember (burn it into your synapses) the PACE trial study participants of the trial did not meet Fukuda CDC criteria CFS, which is the established criteria in use today.

They met psychiatric criteria F48.0 Chronic Fatigue.

F48.0
is a code used in the psychiatric industry, in contrast, ME & CFS, is G93.3.
(For example, Somatization disorder is also F48.0).

F48.0 is a disease code found in the ICD-10, which refers to neurasthenia. It is not really a set of diagnostic criteria for ME/CFS.

The PACE trial authors used the Oxford definition of ME/CFS. See here:
Several published definitions or criteria can be applied to decide if a person has CFS. We used the Oxford definition (see below) to define CFS in the PACE trial.
 
Messages
42
Location
USA
"Diagnosed" is a laugh -- in the US all it takes is for a GP to nod wisely and say, "I think s/he has depression." No specialist required, just eyeball the person and you'll know. ;)
-J

I had a neurologist do just that, because I "looked sad", even though I wasn't sad at the time and rarely get sad! So you are spot on that doctors in the US will "diagnose" a person with depression just on the eyeball test.
 

PennyIA

Senior Member
Messages
728
Location
Iowa
Ah, thanks JohnCB, I see what you mean, I remember now Dolphin talking about the ceiling effect.

How very convenient that the testing methodology doesn't allow for assessment of "worsers"!


But then if a paper is peer reviewed by those who use the same flawed methodology......

I know when I participated in a US-based similar study - I was a 'worser' - BUT DROPPED FROM THE STUDY as a result of my condition worsening. Convenient, huh? Interestingly, the study I was in never published anything. I'm assuming because it didn't pan out - but wouldn't it have been good to publish a study that contradicted PACE?

sigh
 

BruceInOz

Senior Member
Messages
172
Location
Tasmania
I know when I participated in a US-based similar study - I was a 'worser' - BUT DROPPED FROM THE STUDY as a result of my condition worsening. Convenient, huh? Interestingly, the study I was in never published anything. I'm assuming because it didn't pan out - but wouldn't it have been good to publish a study that contradicted PACE?
And that's why the results of all studies should be published, whether they support the hypothesis or not. If only the "good" results are published, science is lead up the garden path.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
And that's why the results of all studies should be published, whether they support the hypothesis or not. If only the "good" results are published, science is lead up the garden path.
Its why so many false results go unchallenged.

Seriously though, it has been commented on several times by researchers that they will not conduct a study to replicate PACE because they regard it as unethical to do so, given the potential harm to patients.
 

TiredSam

The wise nematode hibernates
Messages
2,677
Location
Germany
This study is a major step for The Optimum Health Clinic, and our long-term vision of making integrative medicine treatment for ME/CFS available to all. We really do need your support to make this happen, so if you are able to support us with fundraising in anyway, please do get in touch.

Well that shows what their priorities are. No mention of benefits to patients, just a major step forward for them, and what their goal is irrespective of where the evidence leads, and a request for money. Lovely people.
 

trishrhymes

Senior Member
Messages
2,158
fear that CBT/GET therapy is now so embedded in the UK health system, (not just for ME) that it's going to be a tough order to achieve any change..............then you've also got The Optimum Health clinic waiting in the wings...

Eeek! :eek:, another version of Lightening process, Gupta retraining, etc. Horrendous. And they're doing clinical trials.:aghhh:
How on earth do they get away with it. (Answers self - probably by taking clients who are rich, a bit tired and bored and giving them a nice time doing yoga and stroking their egos).

The sooner we refuse to use the name Chronic Fatigue for ME the better, so all these 'treatments' can be consigned to the rich and tired, and we can get proper biomedical research and treatment for a genuine physical illness.