Information Commissioner's Office orders release of PACE trial data

[worldbackwards]

The PACE trial was quite different to how CBT and GET are often provided. It would not surpris me if there were genuinely few harms related to CBT and GET within the PACE trial.

This is true, I suppose. In my experience, a real world GET would never let you back off if symptoms got worse. Shows a lack of character, apparently.

 

[jimells]

Actometers would have gone a long way to doing that. Except of course they dropped them halfway through the trial.

Does that suggest there should be data for the first half? Or would they have been allowed to delete it?

 

[BurnA]

Dear aforementioned visitors. I hope you like our little community. Feel free to join and engage us directly to discuss any concerns you might have. Contrary to what you might have heard, we don't bite.

We may not bite but we want our lives back.
You've lived it up and milked the system for long enough, looks like your time might finally be up.
You will sail into the sunset knowing you denied patients proper research into a devastating disease, while your 'research' was worse than worthless. Your spin and manipulations have convinced many that pwme just need to exercise more. How do you sleep at night ? I hope you enjoyed your careers, was it worth ruining thousands of patients lives ?
Don't make it any worse by lingering. Goodbye.

 

[Graham]

@Jonathan Edwards

They say she was Annie Gsample,
zose on ze English zey like to trample.
But if you speak posh
It doesn't rhyme ...
like in Limerick, as an example.

Before, when I used to teach maths,
They'd chide me for how I said "graphs":
I thought I'd escaped,
But see how life's shaped!
I'm back to providing some laughs.

(and if it doesn't rhyme for you, just remember that it does for the geographically greater part of the UK!)

 

[Sidereal]

James C.Coyne ‏@CoyneoftheRealm

More pummeling of PACE coming. IOC order releasing data next. Why'd investigators think they could say 'no'?

 

[Research 1st]

Two important fundamental study design flaws of PACE will always remain unanswered, irrespective of the release of the data. (Which is why it doesn't matter if the data is unreleased for political reasons).

1)
CFS and ME are not coded as mental illnesses.
Meaning F48.0 Chronic Fatigue (which is in the DSM) was the INCORRECT diagnostic criteria for CFS ME used in PACE.

Gathering up people with unexplained tiredness that include those with active depression and using the media to class these patients as 'ME' or 'CFS/ME' or 'CFS' (knowing full well the participants are F48.0 CF) is not scientific or ethical.

So to make the study ethical, (if it's to steer medicine into psychiatry), we must screen the patients first for explained reasons of fatigue to make as sure as we can, what we 'think' is happening, probably is happening. Right? That's a common sense approach.

Yet...

2)
None of the PACE participants had MEDICAL SCREENING to investigate biomedical reasons for their CHRONIC FATIGUE.

Pituitary MRI/IGF-1/Stimulation tests to rule out Adult Growth Hormone Deficiency.
TILT table test to rule in or out Autonomic Dysfunction/POTS
Blood volume assessment
Sleep Disorder Screening
Nutritional Status Screening
Cardiac Output/VO2 Max
Hormonal Levels
Infection including Throat/Groin/Nasal swab and Mycotoxins
Immune activation/Inflammation
Supine/Erect Heart Rate/Blood Pressure pre and post activity.
24hr ECG and 24hr blood pressure monitoring.

NB: The above can be altered in organic CFS and ME, which are explained reasons for sufferers symptoms.

So even if PACE had a 100% response rate to CBT/GET and the F48.0 patients are all somatizing, the results are irrelevant to organic CFS and ME, because the patients never had medical screening for EXPLAINED FATIGUE and weren't medically assessed for any signs of ME, (Unexplained Chronic Fatigue is not a sign of ME) either!

Thus we don't know who the PACE particpants really are, medically.

Ultimately, this why the PACE idea of F48.0 failed, even in the psych patient criteria cohort.

If you gather up tired people and don't extensively screen them, you'll get it wrong they might/probably/do have/ 'faulty illness beliefs' leading to 'activity avoidance'.

On that basis, PACE data needs to be released in full and analysed. Yet even if it was oddly favourable, it doesn't matter, as the PACE patients were diagnosed with the incorrect diagnostic criteria for both CFS and ME.

 

[Sidereal]

James C.Coyne ‏@CoyneoftheRealm
Wish I had more protected time to write about PACE as example of how many things can go wrong in clinical trial.

Damn day job.

 

[Sidereal]

James C.Coyne ‏@CoyneoftheRealm

More pummeling of PACE coming. IOC order releasing data next. Why'd investigators think they could say 'no'?

davidtuller ‏@davidtuller1
@CoyneoftheRealm Maybe because until now they did say no and it kept working for them?

Too true.

 

[ScottTriGuy]

Two important fundamental study design flaws of PACE will always remain unanswered, irrespective of the release of the data. (Which is why it doesn't matter if the data is unreleased for political reasons)...
...

On that basis, PACE data needs to be released in full and analysed. Yet even if it was oddly favourable, it doesn't matter, as the PACE patients were diagnosed with the incorrect diagnostic criteria for both CFS and ME.

Wow - the evidence keeps piling that PACE is a real shit show.

 

[Ecoclimber]

Wow - the evidence keeps piling that PACE is a real shit show.

This is why in the IOM report, they stated that the oxford criteria must be retired

I've been saying this to SW, TheLancetPsych,TheLancent for well over a year now - not on here, (PR) but directly to them the info in the tweet below by Coyne that goes to the heart of the issue. It threatens the research in all trials for replication. You need the critical data to reproduce especially if the research is spun as the gold standard and final authority on the subject. As I mentioned before, this was one of the reasons that the xmrv paper was retracted in Science. If Science can retract their paper on xmrv, then it follows flawed research surrounding the PACE trial can be equally retracted for the same reason! ( the withholding of information critical for replication )

James C.Coyne ‏@CoyneoftheRealm 9h9 hours ago
I ask @bengoldacre if investigators refusing to share trial data threatens #ALLTRIAL requirement for data being available for reanalysis.

 

[Ecoclimber]

Interesting article concerning this topic concerning Canada.

Take the muzzle off federal scientists: Editorial

It’s now well-established that reporters in this country face daunting obstacles when seeking information from government scientists. Too often, the process is like something out of Kafka. Journalists’ questions are either rerouted to communications staffers who provide inexpert, politically massaged responses, or the queries disappear in a bureaucratic maze, only to emerge well past deadline.

This so-called muzzling problem became so widespread and controversial that by 2012 the world had taken notice. Nature, a leading science journal, called on our government to “set its scientists free.” The Guardian and the Economist made similar pleas. And in the summer, researchers from around the country gathered in Ottawa to mourn what they called “the death of evidence.”...

...“Our findings are concerning because current media policies could prevent taxpayer-funded scientists from sharing their expertise with the public on important issues from drug safety to climate change,” said Katie Gibbs, one of the report’s authors and a scientist..

Scientists, ministers get green light to speak under Trudeau

For nearly a decade, the Canadian Prime Minister's Office has exercised tight control over the release of information, but reporters are hopeful they can now do a better job of telling Canadians what's happening in government.

I'm not aware of this issue. Not being knowledgeable on UK politics nor the Tory government, is this an aspect that perhaps is behind the reluctance of the researchers releasing the raw data sets? DWP Disability benefits or such?

What we need is for a the courageous act of a whistleblower to come forth and help this patient community.

 

[Dolphin]

Regarding harm from GET in the PACE Trial:
One person in the GET leg of the trial on another forum posted these:

For what it's worth, my physio told me that if I felt myself crashing due to something other than the GET, I should cut back to 50% and definately not keep going at the same rate. If I felt that the GET was too much, I cut back to a previous baseline that hadn't caused any side-effects.

How does one know what is causing a crash? This isn't in the normal descriptions of GET (exceptions are if you have infections you can reduce exercise).

"If your physio won't listen to you, the easiest thing to do is lie . For example, if 10 minutes of housework uses the same amount of energy as a 10 minute walk, then remove that amount from your set exercise and claim you just did the walking."

"Look up the term Active Pacing, I think it has been discussed here a few times. It was what I aimed for with my physio and we used things I wanted to do like housework to count towards my daily "exercise". She realised that these things use up energy too, and that energy had to be accounted for."

Counting housework as exercise shouldn't count. Most people unless they're bedbound (who would have been ineligible for a trial) do some sort of housework. The idea of graded exercise therapy is that it is supposed to be extra exercise (and proponents have explicitly said before it should be exercise rather than simply activity). Also, it is supposed to be a set intensity for a set duration which can then gradually be increased. It would be close to impossible to do this with housework.

Because adverse events were being monitored more closely in the PACE Trial than usual, I think many/most of the staff involved were more worried about adverse effects than in general practice.

 

[SOC]

"If your physio won't listen to you, the easiest thing to do is lie . For example, if 10 minutes of housework uses the same amount of energy as a 10 minute walk, then remove that amount from your set exercise and claim you just did the walking."
.
.
.
"Look up the term Active Pacing, I think it has been discussed here a few times. It was what I aimed for with my physio and we used things I wanted to do like housework to count towards my daily "exercise". She realised that these things use up energy too, and that energy had to be accounted for."

There was a Active Pacing arm, right? So am I reading this correctly that therapists in the GET arm were encouraging patients to use a more effective therapy in another arm if the GET was proving harmful? And not reporting this divergence from the research plan?

If so, this is a huge flaw in the study. Using APT and counting the results in the GET arm to judge the effectiveness of GET is definitely fraudulent. The only excuse the authors have here is that they can claim the therapists they trained violated the rules of the study without telling the principal investigators. It still leaves them in the unpleasant spot of having to admit to poorly training, managing, supervising those they had doing the clinical end of the research. It also shows extremely poor research design if they can't manage to keep the arms of their treatment study separate.

 

[RustyJ]

Regarding harm from GET in the PACE Trial:
One person in the GET leg of the trial on another forum posted these:



How does one know what is causing a crash? This isn't in the normal descriptions of GET (exceptions are if you have infections you can reduce exercise).




Counting housework as exercise shouldn't count. Most people unless they're bedbound (who would have been ineligible for a trial) do some sort of housework. The idea of graded exercise therapy is that it is supposed to be extra exercise (and proponents have explicitly said before it should be exercise rather than simply activity). Also, it is supposed to be a set intensity for a set duration which can then gradually be increased. It would be close to impossible to do this with housework.

Because adverse events were being monitored more closely in the PACE Trial than usual, I think many/most of the staff involved were more worried about adverse effects than in general practice.

I agree, I think, if I understand you. There is very little attempt to quantify the mechanisms of prioritizing output or activity in ME/CFS literature. A reduction in an activity such as housework as a result of increased output in another activity such as exercise should be regarded as a harm.

 

[Dolphin]

I agree, I think, if I understand you. There is very little attempt to quantify the mechanisms of prioritizing output or activity in ME/CFS literature. A reduction in an activity such as housework as a result of increased output in another activity such as exercise should be regarded as a harm.

Not disagreeing with you. Activity substitution is an important issue i.e. it's not that interesting if somebody does more exercise if they have reduced other activities to allow them to do it. And like you say, not being able to do important activities in one's life could be considered a harm.

But my point was this person might not be doing any exercise per se (e.g. x minutes walking at a certain speed, cycling, etc.); instead he/she could have been doing x minutes of housework and be seen as compliant. Doing a bit of housework now and again and not getting worse doesn't tell one much about how safe it would be to be going out and doing x minutes of a specific type of exercise most days each week on top of one's normal activities.

 

[Dolphin]

There was a Active Pacing arm, right? So am I reading this correctly that therapists in the GET arm were encouraging patients to use a more effective therapy in another arm if the GET was proving harmful? And not reporting this divergence from the research plan?

If so, this is a huge flaw in the study. Using APT and counting the results in the GET arm to judge the effectiveness of GET is definitely fraudulent. The only excuse the authors have here is that they can claim the therapists they trained violated the rules of the study without telling the principal investigators. It still leaves them in the unpleasant spot of having to admit to poorly training, managing, supervising those they had doing the clinical end of the research. It also shows extremely poor research design if they can't manage to keep the arms of their treatment study separate.

That's one way of looking at it, all right. "Treatment contamination" is a jargon term that is sometimes used.

 

[Large Donner]

T

If so, this is a huge flaw in the study. Using APT and counting the results in the GET arm to judge the effectiveness of GET is definitely fraudulent. The only excuse the authors have here is that they can claim the therapists they trained violated the rules of the study without telling the principal investigators.

Good point.

I am sure their defense would not wash either, it was their responsibility to monitor the ongoing trial and supervise it. If they didn't bother to have a tool to measure the swapping of activities of daily living with "exercise therapy" the trial is a joke on that front alone.

If they did monitor it (the fluctuating levels of ADL) where are the charts and graphs. If there's an obvious possibility people were doing a two minute walk everyday as part of GET but forfeiting bathing and cooking meals why hasn't it been observed and reported?

 

[RustyJ]

Should it have been so easy to work out who the complainant was? I am reluctant to mention the name of the person, but the ICO practically gave the game away.

 

[Large Donner]

Should it have been so easy to work out who the complainant was? I am reluctant to mention the name of the person, but the ICO practically gave the game away.

Was it that bloody Annie Gsample?

 

[RustyJ]

Was it that bloody Annie Gsample?

Ha! Seriously tho, does anyone have some thoughts on this? I have already had to go back and edit an earlier post, and am fearful that I may have compromised the complainant.