PACE trial data

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?

 

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?

 

The original request is outlined in the first post of this thread. https://www.s4me.info/threads/pace-trial-data.2337/

TL;DR version:

 

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.

 

Many thanks Lucibee x

 

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.

 

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.

 

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.

 

Maybe they just threw the diaries away when they realised they didn't fit their ideas? What? Me doubting researchers?

ETA 'researchers' to comment.

 

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.

 

Copious notes:

 

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.