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

[JohnCB]

QMUL is not appealing.

www.qmul.ac.uk/media/news/items/smd/181216.html

In complying with the Tribunal’s decision, we remain mindful of the interests of trial participants and acknowledge the assurance given by the Tribunal that participants will be adequately protected from personal identification by the disclosure of this information. No names or addresses of any participants have been released. We will continue to engage with other universities and bodies to debate the broader implications of the decision for clinical research.

It's still all spin. Names and addresses were never asked for. Neither did the tribunal assure them that " participants will be adequately protected from personal identification by the disclosure of this information". The tribunal ruled that QMUL had not shown such a risk. The tribunal ruling did not change the level of risk.

They are still playing the tune that they are protecting participants when all they are doing is protecting their own arses. They are still peddling misinformation.

 

[Adelle Lee]

1st, I just want to say how proud I am of all the CFS/ME sufferers fighting for justice over this unjust treatment of true CFS/ME patients. 2nd, I have a question about the trial's criteria. I feel this could apply to many others as well. Having had CFS for 20 years, I have seen many doctors, including psychiatrists. I did not feel a need to see the psychiatrists or psychologists, but I did because I didn't know what else to do, when regular drs. and my family were telling me that's what I needed to do. Therefore, I have had the diagnosis of depression. Would this exclude me, and others like this, from participating in a potentially helpful scientific study where the criteria is to not have mood disorders? This feels totally unfair, where a wrong diagnosis could prevent further knowledge, and potential treatment, for our condition. Thanks

 

[Keela Too]

Good point. How many have been wrongly diagnosed with depression.

 

[Esther12]

Therefore, I have had the diagnosis of depression. Would this exclude me, and others like this, from participating in a potentially helpful scientific study where the criteria is to not have mood disorders? This feels totally unfair, where a wrong diagnosis could prevent further knowledge, and potential treatment, for our condition. Thanks

It really depends on the study. I think that those with a diagnosis of CFS and depression can still benefit from CFS research that excludes those with a diagnosis of depression, as it can help reduce the risk of the symptoms of depression interfering with the study of the symptoms of CFS. It's not saying some people's CFS is less important than others, so much as trying to get the most reliable data we can for a difficult to study condition.

PACE included patients who had been diagnosed with depression, and some are concerned that this could mean (along with other possible problems with the way patients were selected) that some patient were suffering primarily from depression rather than CFS. It's very difficult for anyone to know whether that was the case or not.

 

[PennyIA]

I only found this thread after finding the QMUL releasing the data thread.

So basically - THE DAY BEFORE THEY RELEASED THE DATA... they 're-analyze' it and find that the results weren't as good as originally reported.

Huh. Funny that.

WOW... this just pokes me wrong. So basically, this way they can PROVE that in their re-analysis they were still *right* with what they reported (well, not really, but more right than they were before).

Can't say as I blame them, it's a good strategy for keeping their names as clean as can be from any fallout.

 

[PennyIA]

Just had a chance to read a little more. I did end up getting treated with a little bit of CBT/GET here in the states as part of a 'pain rehabilitation clinic'... and to be honest, getting away from stress at home and getting to spend the whole day with new people and trying to increase my walking time from 2 minutes to 3 minutes to 4 minutes... stopping pain medication that really wasn't working (even if it seemed like it did) but was adding to tiredness did help.

In the short term.

Until I exceeded my energy envelop and crashed.

And then I got written off as not being included in the study any longer.

So, even if we see a 10% or 20% improvement in the short term? That can easily fit the model of pushing past your limits is a problem and CBT/GET are not the right treatment for something that has limits on physical activity..

 

[Mark]

Regrettably I don't have the time to read the whole of this thread, so I'm sorry if this has already been discussed, but it seems to me that this (rather desperate) re-analysis is based on (carefully selected parts of) the original protocol is only about the percentage who have improved to varying degrees...I would be interested to know more about the percentage in each of the groups who deteriorated, or who deteriorated a lot.

 

[BurnA]

No, strangely not - even though the protocol clearly specified how to calculate recovery.

But it's worth noting that fewer "improved" according to the protocol than "recovered" according to the authors' revised recovery criteria. And the gap with SMC was smaller. (2013 recovery paper claimed 22% for CBT/GET, 8% for SMC).

Could someone explain or point me in the right direction for what recovery means? And what the implications of this analysis is on previous claims ?
Did they actuallyy use the term recovery because I thought I heard David Tiller say they didn't actually say that ( but that might have been in relation to something else ) Tks.

 

[Dolphin]

Could someone explain or point me in the right direction for what recovery means? And what the implications of this analysis is on previous claims ?
Did they actuallyy use the term recovery because I thought I heard David Tiller say they didn't actually say that ( but that might have been in relation to something else ) Tks.

The analysis they released doesn't cover recovery.

4.
"Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less [27], (ii) SF-36 physical Function score of 85 or above [47, 48], (iii) a CGI score of 1 [45], and (iv) the participant no longer meets Oxford criteria for CFS [2], CDC criteria for CFS [1] or the London criteria for ME [40].

 

[JES]

I didn't think they would appeal but at the risk of being a party pooper, they've not actually said that they won't be appealing (although reading between lines it's highly unlikely that they will take this any further) but the phrase "certain PACE trial data" sticks in my mind.

Given that they've played hardball over this (and Sharpe's tweet last night), watch them like a hawk. I know people will, and rightly so.

In complying with the Tribunal’s decision, we remain mindful of the interests of trial participants and acknowledge the assurance given by the Tribunal that participants will be adequately protected from personal identification by the disclosure of this information.

I think the above quoted part is phrased clear enough to interpret it such that they will accept the decision of the tribunal and share (or already have shared) the data to Alem. It was no surprise to me really after yesterday's suspiciously urgent release of the corrected trial outcomes.

 

[Woolie]

"We know we did the right thing, but since so many of you fools insist..."

Yea, the wording is designed to communicate "we've already explained all this... you people just don't listen "

 

[Woolie]

Add in the FINE patients who didn't improve at all and this shows that well above 90% of ME Chronic Fatigue patients get no effect whatsoever from these treatments. It's hardly a shop window.

Nice point, @worldbackwards. Good way of correcting for the selection of only mildly-moderately impaired patients.

 

[Woolie]

Just some minor exploratory analysis. nothing of interest here. no one forced our hand on this. Honest.

Yea, that's funny, given that the "peer reviewed" stuff was actually the "exploratory" analysis, and this is the genuine protocol-specified analysis.

You can see from the protocol how very confident they researchers were of getting an effect. They really, genuinely believed in their treatments. What a shock they must have got when the data started coming in!

Plus, I think they still probably believe they work and that the data themselves are just a bit off. A lovely illustration of how belief can lead people to override the evidence.

Its just so easy for our own preconceptions to blind us to the facts.

Still, hard to feel sorry for these researchers. If they'd only listened to us in the first place, they would never have gotten themselves in this mess!

I'm reminded of the cautionary tale of Freud's case "little Hans". The wee boy with a phobia of horses? Freud went to town on this kid, theorised about his oedipal complex (after all, horses have big penises, right?) Turned out, the kid had recently seen a horse collapse on the street turning over a carriage full of people, and it made a frightening loud crash.

A lesson to all health care professionals out there. Listen to your patients, folks. If you ever reject a patient's own testimony in favour of some elaborate (and seductive) psychological theory, you'd better have a darned good reason!

 

[Woolie]

One effect that comes to mind is that the medical textbook entry, I think written by Peter White, which said that around 60% improved in the PACE Trial with CBT or GET would need to be significantly altered.

Hmmm... White et al have recently published an article calling out us "naughty" CFS patients for not believing in "what the textbooks say"!

 

[Woolie]

This makes CBT a tough sell, because apart from a small and transient improvement in subjectively reported fatigue, the published data indicate that six months of CBT is no better than usual medical care alone.

Nicely, put @Sam Carter!

 

[Jenny TipsforME]

@Woolie yes it is fascinating to the public if you create elaborative psychological theories. Freud went out of fashion in Psychology because his theories are unfalsifiable. This doesn't mean there's nothing of truth in them, but you need good evidence to treat ill people, not imaginative stories. If people seem physically ill and don't report psychological symptoms the chances are it is not a psychology based illness.

It seems to me that False Illness beliefs share heritage with Freud's imagination and need to be put in the category of 'quirky things people used to think'.

 

[Jenny TipsforME]

BTW what time point are these % for?

SMC only: 16 (10%)
SMC+CBT: 32 (20%)
SMC+GET: 33 (21%)
SMC+APT: 15 (9%)

Is the 52 week follow up based on original protocol available?
When I click the link I don't seem to be able to get the information

 

[Woolie]

If people seem physically ill and don't report psychological symptoms the chances are it is not a psychology based illness.

Quite so, @Jenny TipsforME. How did it ever become possible for a condition whose definition does not require any actual psychological features at all to be classed as "psychological"? How did this kind of lazy thinking start and when will it end?

BTW at what time point are these % for?

52 weeks after they allocated the patients to their treatment conditions.

 

[A.B.]

How did it ever become possible for a condition whose definition does not require any actual psychological features at all to be classed as "psychological"? How did this kind of lazy thinking start and when will it end?

 

[JaimeS]

Good point. How many have been wrongly diagnosed with depression.

"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.

Plus, I think they still probably believe they work and that the data themselves are just a bit off. A lovely illustration of how belief can lead people to override the evidence.

Definitely. The initial protocol was very confident. These researchers just knew their treatments helped. But how can you help that, when one of the treatments is literally convincing the patient they are already well. You MUST strongly believe that, yourself, in order to do any of this convincingly. You are convincing yourself as you work to convince them.

-J