"Another request for data from the PACE trial" 36 more scientists join request for PACE data

[BurnA]

It is interesting to observe that the only additional signatories from the UK (in addition to Prof Edwards) are Doctors Shepherd, Speight and Weir of whose independence of mind and professional integrity we were already assured.

Yes it's very telling.
I thought I'd at least see Ben Goldacres signature there.

 

[eafw]

the Trustees will carefully consider the issues and our position at the forthcoming Board meeting and action will be taken following this.

Time for a full on boycott I think.

 

[Stewart]

"We have also received requests from people who were involved in the Trial as participants to support them to ensure that their data should not be released, anonymised or otherwise, as this is a breach of their consent."

I thought that anonymised data was by definition NOT personal data, and that consequently consent wasn't needed to disclose it. Have I misunderstood, or has AfME?

 

[Aurator]

It'll be interesting to see what happens in UK NHS ME clinic provision while the NICE guidelines are quibbled over after PACE falls.

GET may get sidelined and the psychiatrists be called on by NICE and the DWP to play an even bigger role in treatment than they are doing at present; I can see certain persons right now rubbing their hands at the prospect.

 

[SilverbladeTE]

Another nail in the coffin.

I prefer to think of it as a "corkscrew coated in chili sauce, being screwed up their arses, one turn at a time"

 

[Mrs Sowester]

Bear in mind that it's an interim statement from AfME. Their official position should follow after the next Board meeting.

Still time to for anyone to make their opinion known to AfME if you haven't already done so.

Call me cynical, but I'm pretty certain that's a gentle warning/prelude to AfME announcing they can't support the release of PACE data without the consent of the trial participants.
I think we'd do better to lobby the trial participants (TPs) with the details of how GET is disabling pwME and how children are being forced into treatment.
We also need to remember that the TPs did not all have ME, a substantial subgroup will have had mood disorders and probably benefited from the treatment - then there is the placebo effect from having someone sympathetic take an interest in personal suffering (mental or physical). The care some TPs received during the study was possibly the only attention they received to help them with their mood disorder excepting pills - this subgroup will feel indebted to and allied with the PACE team.

 

[BurnA]

It's worth remembering as stated previously, that the trial participants dont have a say in whether anonymised data is released to others.

 

[Scarecrow]

Call me cynical, but I'm pretty certain that's a gentle warning/prelude to AfME announcing they can't support the release of PACE data without the consent of the trial participants.

But the consent form didn't have a data sharing clause. So the PACE participants who have already contacted AfME may have misunderstood what they were consenting to, unless there was another form that we haven't yet seen.

 

[Mrs Sowester]

GET may get sidelined and the psychiatrists be called on by NICE and the DWP to play an even bigger role in treatment than they are doing at present; I can see certain persons right now rubbing their hands at the prospect.

Blimey! You're more cynical than me!

 

[Mrs Sowester]

It's worth remembering as stated previously, that the trial participants dont have a say in whether anonymised data is released to others.

I'm not sure AfME want to be seen as forcing the hand of TPs who don't want their data released.

 

[Mrs Sowester]

But the consent form didn't have a data sharing clause. So the PACE participants who have already contacted AfME may have misunderstood what they were consenting to, unless there was another form that we haven't yet seen.

Are we absolutely sure of that now? If so that's good news, means that can be argued in next appeal when patient confidentiality is raised as an excuse.
But if that really is the case why has the issue of patients not wanting their anonymised data released been such a sticking point?
Something isn't adding up...

 

[Stewart]

Are we absolutely sure of that now? If so that's good news, means that can be argued in next appeal when patient confidentiality is raised as an excuse.
But if that really is the case why has the issue of patients not wanting their anonymised data released been such a sticking point?
Something isn't adding up...

I think the problem is that neither the patient information sheet nor the consent form explained the distinction between personal data and anonymised data, leaving participants with the distinct impression that *no* data of any kind would be shared.

The Patient Information Sheet stated:

"Will you keep my details confidential?
Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research.

Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study.

The data and recordings we collect will be securely stored for 20 years after the end of the trial, for your protection and to follow good clinical practice (GCP). The same applies to other records gathered for our study, including your medical notes and the database holding the collected data for this trial. ​

Your name, address, and telephone number will be on only one database. This will be held securely at St Bartholomew’s Hospital, in London, and it will be used only to monitor recruitment. You will not be named in any published results from our study." ​

The consent form stated:

"I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records."​

The PACE team seem to be taking the line that they can't release any data - even anonymised - because the participants only gave permission for it to be accessed by individuals involved directly with the trial.

(The reason that the participants gave only this limited permission is of course because that's all the trial investigators asked them for - it's almost as if they didn't want anyone else to be able to access the data, regardless of what the MRC guidance on data sharing might say...)

(And of course Kings College has publicly claimed that they *have* released data to independent investigators, so obviously this is less of a stumbling block than they claim it is when they're refusing FOI requests)

My understanding (which may be wrong) was that you don't need patient consent to release anonymised data, as it can't be considered personal data any longer (as participants aren't identifiable).

 

[Valentijn]

I thought that anonymised data was by definition NOT personal data, and that consequently consent wasn't needed to disclose it. Have I misunderstood, or has AfME?

AfME has misunderstood. They habitually misunderstand many simple things. Perhaps they find it advantageous to appear to misunderstand, to avoid taking a stand on important issues.

 

[Scarecrow]

Are we absolutely sure of that now? If so that's good news, means that can be argued in next appeal when patient confidentiality is raised as an excuse.
But if that really is the case why has the issue of patients not wanting their anonymised data released been such a sticking point?
Something isn't adding up...

I answered on the other thread:
http://forums.phoenixrising.me/inde...st-release-pace-data.42767/page-5#post-695711

 

[Scarecrow]

AfME has misunderstood. They habitually misunderstand many simple things. Perhaps they find it advantageous to appear to misunderstand, to avoid taking a stand on important issues.

That's possible but it also could be that they are considering the wellbeing of their members who were trial participants. I think we all know that whatever the participants believe they consented to is irrelevant and that AfME should consider the wellbeing of all their members, and indeed all pwME/CFS. The ME/CFS community as a whole has a clear interest in the data being released.

 

[Valentijn]

That's possible but it also could be that they are considering the wellbeing of their members who were trial participants.

That would be better achieved by AfME reassuring those members that no personal data is involved, and that anonymous trial data is always shared. AfME doesn't seem to be attempting to correct the misconception, and are instead citing it as an excuse to not call for the release of the trial data.

It's completely illogical for AfME to even consider allowing the undeniable misconceptions of others to decide their actions.

 

[Scarecrow]

That would be better achieved by AfME reassuring those members that no personal data is involved, and that anonymous trial data is always shared. AfME doesn't seem to be attempting to correct the misconception, and are instead citing it as an excuse to not call for the release of the trial data.

It's completely illogical for AfME to even consider allowing the undeniable misconceptions of others to decide their actions.

That's just what I hope they will do after they have had their Board meeting.

 

[Chrisb]

One must presume that the major players in the PACE trial approved of and consented to the publication of the paper in Plos One on conditions, which they must be presumed to have understood, of open access to the data relating to that paper.

How could they have acted in this way if they were, all the time, prevented by the terms of the consent from providing such free access? It must be presumed that all the consent forms are standardised and without differences between them. One would expect these matters to have been resolved before that publication and the fact that they proceeded to publish should be regarded as an indication that this defence is spurious.

 

[Mrs Sowester]

Yes Chrisb, its a weasely stalling tactic.

 

[SilverbladeTE]

Blimey! You're more cynical than me!

You can NEVER be cynical enough when it comes to the British "Establishment".
Their duplicity, perverseness, malignity, stupidity and cowardice are such that I'm quite sure they are some kind of undead blood sucking demons, because obviously, the Devil wouldn't want them in Hell as they'd give the place a bad name and put him out of a job...

Seriously, there is NOTHING you could past those bastards.
A fave example is the way they exported orphans and kidnapped children from the UK to be slaves to "repopulate the Colonies with good white stock to keep the wogs out" (the actual words and belief of the UK's Establishment at the time when doing these awful crimes, not my words or beliefs!) and fact they kidnapped many of those children, telling their mothers they'd died at birth, especially if "single mothers" who of course were branded with "moral turpitude" and other crap.
that happened up to the 1960s
PEOPLE ARE PEOPLE, then, now, here, there, everywhere...they don't magically change and become better Human Beings, they repeat the same bullshit time after time until someone stops them...and repeat it again if they aren't continually watched and kicked in the nuts! :/

Human Beings in groups, alas, tend towards the very worst of the group's mentality, as they all to often rise to the top of the group's hierarchy:
gassy turds always float to the top of the toilet bowl