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Breaking News: PLOS One issues Expression of Concern for PACE trial paper

Yogi

Senior Member
Messages
1,132
Great news!!

Thanks to everyone and Dr Coyne.

@Valentijn linked in the other thread to the original article 'Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis' which now gives the Expression of Concern in a background of a beautiful shade of red!

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0040808

Also check out the warning sign on the article!
images


Big day for pwme!!

PACE authors, DWP and insurance industry (and AFME) > :devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil::devil:

Everyone with ME >:):):):):):):) :):balloons::balloons::balloons::balloons::balloons::balloons::):):):):balloons::balloons::balloons::balloons::balloons::balloons::balloons:

 

user9876

Senior Member
Messages
4,556
Authors of PACE:
"We have shared data from the PACE trial with other researchers previously".......

Does anyone know who?
And if ,say, IiME researchers were to request the data would they have grounds for access?

The only ones we know of is the Cochrane collaboration when they were involved in writing the analysis protocol. The fact they have shared means and will share under their policy means that there is no data protection reason for not sharing.
 

RogerBlack

Senior Member
Messages
902
Authors of PACE:
"We have shared data from the PACE trial with other researchers previously".......

Does anyone know who?
And if ,say, IiME researchers were to request the data would they have grounds for access?

This is - not quite - a lie.

They do in fact have a data sharing policy.
It (paraphrasing) runs 'We require a pre-specified plan as to what you are going to do with the data, and will then decide if we will give you data. We will usually expect to be co-authors on the work, and only rarely if we really trust you're going to be nice will we not be.'

They do not share with people they believe will be critical of them.
It is quite likely any data sharing request will first be refused after a lengthy delay, then need appealed through the university, which will again refuse after a lengthy delay, and then go to the data protection tribunal.
This is likely to take 5 years.
 

Yogi

Senior Member
Messages
1,132
During negotiations with the journal over these matters, we have sought further guidance from the PACE trial REC. They have advised that public release, even of anonymised data, is not appropriate. As a consequence, we are unable to publish the individual patient data requested by the journal. However, we have offered to provide key summarised data, sufficient to provide an independent re-analysis of our main findings, so long as it is consistent with the REC decision, on the PLOS ONE website. As such we are surprised by and question the decision by the journal to issue this Expression of Concern.


Utter nonsense. The English courts have listened to these bogus arguments and declared anonymised individual data is appropriate and should be released in the public interest.

Who is on the REC?
 

user9876

Senior Member
Messages
4,556
Utter nonsense. The English courts have listened to these bogus arguments and declared anonymised individual data is appropriate and should be released in the public interest.

Who is on the REC?

I think it is a research ethics committee who approved the trial in the first place and I think they have claimed that the REC also approved protocol changes but not sure on that one. We should remember that the head of governance at the MRC who dismissed concerns about the PACE trial and protocol changes appeared at the information tribunal to try to block the release of data.

It is an appeal to authority with out explaining the case presented to the REC and the advice they gave and any conflicts of interest they may have due to their approval of PACE and PACE protocol changes.
 

Stewart

Senior Member
Messages
291
The QMUL response is weird. Are they suffering from memory loss. Surely they already accepted the FOI tribunal ruling that they should release some of the PACE data. So what's different about this data?

There's nothing different about the data - I think it's just that QMUL has judged that that they couldn't get away with defying the Information Tribunal, but they probably can get away with defying PLOS. I guess the question now is whether PLOS considers the matter closed now they've highlighted the concerns or whether there are any further steps they're prepared to take.

I wonder if there's any way of getting the MRC to respond to the claim that the PACE data sharing policy is consistent with the MRC's policies. That statement seems a bit of a stretch to me.
 

Cheshire

Senior Member
Messages
1,129
Data sharing in clinical research: challenges and open opportunities
Posted May 2, 2017 by Iratxe Puebla and Joerg Heber

Request for data from PLOS ONE publication related to the PACE trial



At the time we approached QMUL, a Freedom of Information (FOI) request for the data from the main PACE trial [2] was ongoing. Upon completion of the evaluation of the FOI request, the Tribunal ruled that the data for the main outcomes of the trial should be released, based on their position that the identification of patients was a remote possibility. Following this decision and in line with the Tribunal’s ruling, QMUL released data for some of the primary outcomes.



In parallel to these developments, we pursued contacts with QMUL regarding the dataset for the PLOS ONE article. We also sought advice from members of the PLOS Data Advisory Board and COPE.



Expression of Concern



From our follow up with the authors and QMUL, we understand that a framework is in place to consider requests for data from the PACE trial. This framework entails direct involvement by the authors on considerations on whether the data can be shared, and imposes other restrictions that we view as incompatible with the relevant data sharing policy.

At this point, PLOS has not yet received confirmation that QMUL has established a mechanism, compatible with the relevant data policy, that would allow independent evaluation of requests to access data underlying the PLOS ONE article. Since we feel we have exhausted the options to make the data available responsibly, and considering the questions that were raised about the validity of the article’s conclusions, we have decided to post an Expression of Concern [5] to alert readers that the data are not available in line with the journal’s editorial policy. It is our intention to update this notice when a mechanism is established that allows concerns about the article’s analyses to be addressed while protecting patient privacy.



http://blogs.plos.org/everyone/2017/05/02/data-sharing-in-clinical-research/#.WQiy0rGY39o.twitter
 

user9876

Senior Member
Messages
4,556
I wonder if there's any way of getting the MRC to respond to the claim that the PACE data sharing policy is consistent with the MRC's policies. That statement seems a bit of a stretch to me.

The MRC's head of governance supported the PACE data being kept secret but then she also dismissed concerns over outcome switching and other methodological issues.

The question for the MRC may be if PACE is wrong to share why are others sharing.
 

Kati

Patient in training
Messages
5,497

Also check out the archived tweets on this link from 2012. How prescient pwme were in 2012. And the PACE authors could not see the problems?
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0040808

In other words PACE = MAJOR RESEARCH FRAUD
This was an image created using @ballard 's artwork when the tribunal ordered to release the data. I may just have to update the text to reflect what just happened today.

@ballard if you are working on a new cartoon I will be more than happy to share widely.