PACE trial data

JohnTheJack said:
I did try a similar line with the ICO who was sympathetic but rejected that approach: an FOIA request is for public release of data and so must be to the world at large and not to, for example, a researcher who would then make the information available.

The appeal with QMUL has been going reasonably and I think there is a chance, no more, that the Tribunal will order release.
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All the best :thumbup:
 
JohnTheJack said:
I did try a similar line with the ICO who was sympathetic but rejected that approach: an FOIA request is for public release of data and so must be to the world at large and not to, for example, a researcher who would then make the information available.

The appeal with QMUL has been going reasonably and I think there is a chance, no more, that the Tribunal will order release.
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But could that person not be commissioned by a public body, and simply do that work on their behalf. The person doing the work would have no exclusive entitlement to the data they extracted, they simply do the extracting?
 
Daisymay said:
Thank you very much JTJ for all your work on this. Can you please remind my addled brain what data you are requesting, is it LTFU for employment?
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The original request is outlined in the first post of this thread. https://www.s4me.info/threads/pace-trial-data.2337/
https://www.s4me.info/threads/pace-trial-data.2337/
TL;DR version:
1. The pre-trial protocol states the essence of Graded Exercise Therapy is that planned physical activity, and not symptoms, determines what patients are asked to do. Please provide any data collected on GET-group patients' compliance with planned activity.

Please provide for the following patient-level data for baseline, 24-week and 52-week assessments, where available.
2. EuroQOL (EQ-5D) scores.
3. Hospital Anxiety and Depression Scale scores in both anxiety and depression sub-scales.
4. Work and Social Adjustment scale scores.
5. Borg Scale scores
6. Physical Health Questionnaire 15 items (PHQ15) scores.
7. Client Service Receipt Inventory scores. (Please also include the 6-months-prior assessment.)
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JohnTheJack said:
1. The hearing of the First Tier Tribunal for the QMUL request has been set for next Tuesday afternoon. On Friday, QMUL, with the support of the ICO, asked for a full-day hearing. The Tribunal refused this request, but the matter has now been referred to a judge. I await the decision.

2. The ICO has upheld KCL's claim it doesn't hold the data in terms of the FOIA. I got this decision a couple of weeks ago and sent off my appeal to the FTT yesterday. The ICO's decision is here https://ico.org.uk/media/action-weve-taken/decision-notices/2018/2260044/fs50735928.pdf
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Are the meeting notes stating they would make preparations to make the data available for approved researchers a factor here? They may insist that it's onerous to prepare the data but we know they already did that and had planned for it, as they should. Are they still arguing it's too much of a burden despite this argument being false?

Are they still arguing some wild speculations about nefarious intent with the data? I'd sort of assume that a defendant who keeps lying to a tribunal would start feeling the heat.
 
rvallee said:
Are the meeting notes stating they would make preparations to make the data available for approved researchers a factor here? They may insist that it's onerous to prepare the data but we know they already did that and had planned for it, as they should. Are they still arguing it's too much of a burden despite this argument being false?

Are they still arguing some wild speculations about nefarious intent with the data? I'd sort of assume that a defendant who keeps lying to a tribunal would start feeling the heat.
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They're not really a factor, though I am using them in evidence.

The questions are really quite technical and somewhat legalistic, so in a sense what may or may not have been said in a meeting doesn't really matter.

There has been no such speculation and it's not part of the case.

I think we should be careful about making allegations of lying to a Tribunal.
 
I'm most interested in what they said about point 1, i.e. that they did not 'hold' the data on compliance:

1. The pre-trial protocol states the essence of Graded Exercise Therapy is that planned physical activity, and not symptoms, determines what patients are asked to do. Please provide any data collected on GET-group patients' compliance with planned activity.
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It sounds like they didn't even collect any data on what activity participants were being asked to do week by week, and whether they met those targets, at least not in an analysable format. To me it seems odd not to collect compliance data on such a key aspect of GET, particularly if successful therapy is to get participants up to 30 mins of exercise a day before increasing intensity further. If the aim of therapy is to reverse physical inactivity, surely they should have been measuring how much activity participants were actually achieving.

However, we know from the GET manuals that they did use planned activity worksheets (GET Plans and Progress sheets) and exercise diaries (Exercise Record), so this must have been recorded at least somewhere. I can only guess that if they say they did not hold it, that they did not hold this information in an anonymised format, or that it was never transferred to the main dataset.
 
JohnTheJack said:
They're not really a factor, though I am using them in evidence.

The questions are really quite technical and somewhat legalistic, so in a sense what may or may not have been said in a meeting doesn't really matter.

There has been no such speculation and it's not part of the case.

I think we should be careful about making allegations of lying to a Tribunal.
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I find it hard to otherwise describe the claims they made. The most generous interpretation is that they misled the tribunal, which the ruling of "grossly exaggerated" and "wild speculations" agrees with.

Their claims were false. Lying is a determination of intent. The released data proved them wrong in re-analysis. They knew it would. That's a very good reason to lie. But I understand the particulars of UK libel laws make this problematic. I have no such fears being outside UK jurisdiction.

Anyway, misleading a tribunal is certainly a problematic choice in itself.
 
Lucibee said:
I'm most interested in what they said about point 1, i.e. that they did not 'hold' the data on compliance:



It sounds like they didn't even collect any data on what activity participants were being asked to do week by week, and whether they met those targets, at least not in an analysable format. To me it seems odd not to collect compliance data on such a key aspect of GET, particularly if successful therapy is to get participants up to 30 mins of exercise a day before increasing intensity further. If the aim of therapy is to reverse physical inactivity, surely they should have been measuring how much activity participants were actually achieving.

However, we know from the GET manuals that they did use planned activity worksheets (GET Plans and Progress sheets) and exercise diaries (Exercise Record), so this must have been recorded at least somewhere. I can only guess that if they say they did not hold it, that they did not hold this information in an anonymised format, or that it was never transferred to the main dataset.
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I don't think they ever expected to be held accountable, or even face any scrutiny. There is likely a lot more missing data.

They took great pains to make it look like a clinical trial, but it was anything but. It was a confirmation exercise with a predetermined outcome from the start. Aside from the underlying data contradicting the conclusions they boasted about, that is likely one cause for their fierce reaction to the FOIs.
 
Lucibee said:
I'm most interested in what they said about point 1, i.e. that they did not 'hold' the data on compliance:



It sounds like they didn't even collect any data on what activity participants were being asked to do week by week, and whether they met those targets, at least not in an analysable format. To me it seems odd not to collect compliance data on such a key aspect of GET, particularly if successful therapy is to get participants up to 30 mins of exercise a day before increasing intensity further. If the aim of therapy is to reverse physical inactivity, surely they should have been measuring how much activity participants were actually achieving.

However, we know from the GET manuals that they did use planned activity worksheets (GET Plans and Progress sheets) and exercise diaries (Exercise Record), so this must have been recorded at least somewhere. I can only guess that if they say they did not hold it, that they did not hold this information in an anonymised format, or that it was never transferred to the main dataset.
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Interesting. From their response, it seems they don't consider they hold this information at all. They'd have to say if they held it but couldn't anonymize it and nor it would it matter if it were part of the main dataset or not.

They just must never have collated the information from sheets and diaries. Extraordinary, really.
 
JohnTheJack said:
From their response, it seems they don't consider they hold this information at all.
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What's in the filing cabinets then? Bricks? ;)

The shame of this is that they did seem to do the trial very thoroughly. They do seem to have collected lots and lots of really useful data, and then just let it gather dust. Shameful waste of patient data.
 
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Lucibee said:
What's in the filing cabinets then? Bricks? ;)

The shame of this is that they did seem to do the trial very thoroughly. They do seem to have collected lots and lots of really useful data, and then just let it gather dust. Shameful waste of patient data.
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Hehe. Bricks and coasters.

Yes, I agree. There is so much more that could be done with everything they collected. It is a real waste.
 
Lucibee said:
Copious notes:
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I wonder whether they would say all this copious record keeping was for the purpose of helping therapist and patient complete all the required steps to carry out the therapy properly, so were only intended as part of the therapeutic process and for supervisors to check to ensure all the therapists were following the same procedures, and were never intended to be used as data to be analysed in any external way.
 
Lucibee said:
What's in the filing cabinets then? Bricks? ;)

The shame of this is that they did seem to do the trial very thoroughly. They do seem to have collected lots and lots of really useful data, and then just let it gather dust. Shameful waste of patient data.
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As they put it in Liar, liar: because it would have been devastating to their case.

Although how interesting would it be if they could somehow be questioned and unable to say anything but the whole truth?
 
I suspect the problem they encountered early on was that any systematic differences in records between the trial arms could never be recorded in the main dataset without breaking the analysis blinding.

As far as I can tell, the only record of compliance they had was the exercise diary. And it then only had to agree with what was planned. There was no objective back-up - such as actigraphy. Ultimately, it was the therapist who decided whether they had complied or not.

How much they actually managed to do is really important - because if everyone did something slightly different, the results are uninterpretable. Because how do you know if it was actually those who did the least who were best able to walk the furthest in the 6mWT at the end of the trial.
 
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