PACE Trial and PACE Trial Protocol

[A.B.]

The mean walking test distance at the end was slightly below patients with heart failure.

But PACE authors can still say "trust us, there were some people who really improved".

Without the data this cannot be disproved.

The released fitness graph doesn't seem to show that there were a few people for whom this really worked, but relying on that alone could be misleading.

This is how I see it (and I'm just an amateur).

The release of the data could be the torpedo the finally makes PACE sink.

 

[Jonathan Edwards]

The fear was that the online patient community would take this successfully de-anonymized data and publish it online:

“…must further consider this greater risk presented for identification with this data set from the highly motivated requestor who will likely publish it on a CFS/ME group website, such as Phoenix Rising, where it will be available to all CFS/ME activists seeking to discredit the PACE trial and its researchers, as has been demonstrated, since they do not agree with the PACE trial outcomes.

R Horton:
“I think this is where one sees a real fracture in the patient community. One is seeing a very substantial number of patients very willing to engage in this study, desperate to get good evidence on which to base their future treatment but one sees a fairly small, but highly organised, very vocal and very damaging group of individuals who have I would say actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients,”.
This community actively seeks to identify and attack those who are associated with the PACE trial.”

I hope to have the opportunity to redress this imbalanced account.

 

[Cheshire]

The University informed the Commissioner that it believed that section 43(2) applied to the withheld information as disclosure would be likely to prejudice its commercial interests because it might affect its ability to conduct research and attract the necessary funding to carry this out. It believed that this would have a kn
ock-on effect of damaging its reputation and thus its ability to recruit high quality staff and students, which would also affect funding from both tuition fees and from the Research Excellence Framework, participation in which would be adversely affected as a further consequence.

So the information they're trying to block has the potential to "damage their reputation".

Sounds like a confession.

 

[Sidereal]

How can raw data damage your reputation unless you've done something dodgy with it in your publications?

 

[Tyto alba]

Sounds like the ICO was wondering the same thing

Not that it would even be possible to identify anyone based on the info requested. Though the authors do sound like they're worried about trial participants identifying themselves I can't even find their explanation for that being any concern whatsoever, though I haven't read it all and just did a search. Maybe they're just throwing in every objection they can think of?

I was half expecting there to be mention of a kitchen sink at the end of it....

 

[Valentijn]

How can raw data damage your reputation unless you've done something dodgy with it in your publications?

Hrm, looks like they forgot to explain that bit in their objections

My best guess is: "Actual results don't matter, because CFS. CBT/GET only works if they believe it does, so we just have to keep saying it over and over. Contrary data is harmful!"

 

[Gijs]

The reasons they give are very unprofessional and are extremely suspicious. These are arguments used by someone who has something to hide without a valid reason. Let the data speaks for itselves. Why demonize a group of patiënts? Redherring? Remarkable!

 

[Scarecrow]

So the information they're trying to block has the potential to "damage their reputation".

Sounds like a confession.

Careful not to take things out of context. With respect to 43(2), they argue that damage will be caused by people not enrolling in trials if QMUL don't safeguard personal data.

Edited to add: not to mention it would be more difficult to attract high quality staff and students.

 

[Gijs]

Let me say one thing more; their reputation will be destroyed eventually by the advance of science itself. These so-called researchers go down in history as clowns in a major medical scandal of the 21st century. Trying to convince sick people and telling them they are not ill is a crime!

 

[Cheshire]

Careful not to take things out of context. With respect to 43(2), they argue that damage will be caused by people not enrolling in trials if QMUL don't safeguard personal data.

I know, but very tempting to be ironic about all this.

 

[BurnA]

Let me say one thing more; their reputation will be destroyed eventually by the advance of science itself. These so-called researchers go down in history as clowns in a major medical scandal of the 21st century. Trying to convince sick people and telling them they are not ill is a crime!

Worse than clowns. Persecution of sick people reminds me of something a lot more sinister

 

[Dolphin]

The mean walking test distance at the end was slightly below patients with heart failure.

But PACE authors can still say "trust us, there were some people who really improved".

Without the data this cannot be disproved.

The released fitness graph doesn't seem to show that there were a few people for whom this really worked, but relying on that alone could be misleading.

This is how I see it (and I'm just an amateur).

The release of the data could be the torpedo the finally makes PACE sink.

Technically, we only have the average fitness scores, not the individual scores. But on average, they were no better than the Specialist Medical Care-only group.

 

[Dolphin]

Careful not to take things out of context. With respect to 43(2), they argue that damage will be caused by people not enrolling in trials if QMUL don't safeguard personal data.

Edited to add: not to mention it would be more difficult to attract high quality staff and students.

But just to remind people that the personal data isn't very personal (and doesn't even include people's ages, gender, location, etc.):

In order to help ease the burden of staff having to perform the required calculations themselves once the relevant data is located and retrieved, I would like to request the following selection of baseline and 52-week followup data on all 640 individual PACE Trial participants for which the data exists, in a spreadsheet or equivalent file with separate columns for each variable:
• SF-36 physical function scores (range 0-100 points) [baseline and 52-week followup];
• CFQ fatigue Likert scores (range 0-33 points) [baseline and 52-week followup];
• CFQ fatigue bimodal scores (range 0-11 points) [baseline and 52-week followup];
• Oxford criteria CFS caseness (does participant meet criteria, yes or no) [52-week followup only];
• Participant-rated CGI scores (range 1-7) [52-week followup only];
• Doctor-rated CGI scores (range 1-7) [52-week followup only];
• 6MWT walking distances (in meters) [baseline and 52-week followup];
• The group which each participant was allocated to after randomisation (i.e. either to APT, CBT, GET, or SMC).

If I was in a trial, I would want this data to be released so that a true record of the findings was available rather than spin from a particular research team that were known to be biased.

 

[Sean]

If the raw data supported their claims, it would have been released it years ago.

 

[Sean]

If the raw data supported their claims, it would have been released it years ago.

Especially objective data.

 

[Simon]

The University informed the Commissioner that it believed that section 43(2) applied to the withheld information as disclosure would be likely to prejudice its commercial interests because it might affect its ability to conduct research and attract the necessary funding to carry this out.

It believed that this would have a knock-on effect of damaging its reputation and thus its ability

• to recruit high quality staff
  
• and students
• which would also affect funding from both tuition fees
  
• and from the Research Excellence Framework, participation in which would be adversely affected as a further consequence.

Whoa, the whole university would collapse, basically because of a 'might'? And that's in relation to releasing anonymised trial data from a study that completed in 2010?

Don't they have lawyers, or anyone really, to check the submission for basic levels of plausibility? I can't imagine the commissioner found that a very convincing argument.Or even a slightly convincing one.

 

[Large Donner]

Whoa, the whole university would collapse, basically because of a 'might'? And that's in relation to releasing anonymised trial data from a study that completed in 2010?

Don't they have lawyers, or anyone really, to check the submission for basic levels of plausibility? I can't imagine the commissioner found that a very convincing argument.Or even a slightly convincing one.

It is very revealing however that the university is worried that the release of this information would bring the whole Uni into questioning and damage their credibility. Are they actually saying they know the study is so appalling that they cant admit to having supported it all these years?

Kind of like when something very bad the government has done in the passed is locked away under the official secrets act for years because "it could be very embarrassing for the government". Which basically means the people involved may still be very influential in the governing process and we don't want the public knowing.

Maybe people have been scratching each others backs and turning blind eyes from top to bottom as long as the cash and prestige rolls in.

 

[Sidereal]

The University informed the Commissioner that it believed that section 43(2) applied to the withheld information as disclosure would be likely to prejudice its commercial interests because it might affect its ability to conduct research and attract the necessary funding to carry this out. It believed that this would have a kn
ock-on effect of damaging its reputation and thus its ability to recruit high quality staff and students, which would also affect funding from both tuition fees and from the Research Excellence Framework, participation in which would be adversely affected as a further consequence.

Come on, bro.

 

[A.B.]

Technically, we only have the average fitness scores, not the individual scores. But on average, they were no better than the Specialist Medical Care-only group.

The fitness graph also shows the upper and lower bounds for each group. The spread is not large. It doesn't give the impression that within those groups there were people who had substantial improvements in fitness. Of course we need the data to be able to really understand what happened. And the fitness test is also just one part of the picture... but still it doesn't look good for the PACE.

 

[Dolphin]

The fitness graph also shows the upper and lower bounds for each group. The spread is not large. It doesn't give the impression that within those groups there were people who had substantial improvements in fitness. Of course we need the data to be able to really understand what happened. And the fitness test is also just one part of the picture... but still it doesn't look good for the PACE.

Those lines aren't bounds for the individual scores. They're 95% confidence intervals.