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Peter Denton White/Queen Mary, University of London again refuse to release data from £5m PACE Trial

snowathlete

Senior Member
Messages
5,374
Location
UK
The rule is there to protect their costs from spiraliing out of control. I don't believe it for a second in this case....but why don't we offer to pay the excess - whatever the cost is beyond £450.
 

cigana

Senior Member
Messages
1,095
Location
UK
What a horrible man Peter White is :(

Does anybody know if Dr Sheridan is prepared to pay (assuming she could raise the money)?
I would certainly contribute if someone could start a crowdfund.
 

Scarecrow

Revolting Peasant
Messages
1,904
Location
Scotland
The rule is there to protect their costs from spiraliing out of control. I don't believe it for a second in this case....but why don't we offer to pay the excess - whatever the cost is beyond £450.
I think Dr Sheridan would have to take this on since she(?) made the original request.

Queen Mary could still refuse to provide the information. I guess at that stage Sheridan could try to involve the ICO.

Alternatively, she could try appealing directly to Queen Mary again about the calculation of the number of hours. As the great Sean Connery would say "Shurely shome mishtake".

Or a piss take?
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
I think Dr Sheridan would have to take this on since she(?) made the original request.

Queen Mary could still refuse to provide the information. I guess at that stage Sheridan could try to involve the ICO.

Alternatively, she could try appealing directly to Queen Mary again about the calculation of the number of hours. As the great Sean Connery would say "Shurely shome mishtake".

Or a piss take?

I think it would be worth her while to consult a few statisticians who are familiar with dealing with data from this kind of trial, and ask them to give an estimate of how much time it should take, and present that evidence as part of her appeal. I'd be astonished if the consensus was even remotely anywhere near 18 hours.
 

shahida

Senior Member
Messages
120
maybe in a case like this political pressure in the form of contacting our MP's might help?-it often causes embarrassment
 

snowathlete

Senior Member
Messages
5,374
Location
UK
I think Dr Sheridan would have to take this on since she(?) made the original request.

Queen Mary could still refuse to provide the information. I guess at that stage Sheridan could try to involve the ICO.

Alternatively, she could try appealing directly to Queen Mary again about the calculation of the number of hours. As the great Sean Connery would say "Shurely shome mishtake".

Or a piss take?

Yes I'm sure it's up to Dr Sheridan but we could help provide funding perhaps. I'm sure that even if we offered to foot the bill they would still decline because I believe the reality is that it isn't truly about the cost, it's about avoiding sharing of data that exposes the truth about non recovery under this trial.
But it's worth asking because we want to see the data to see if that is correct or not. Without the data we can only guess but we want facts not guesses.
If they did still refuse then that would perhaps add weight to what I suspect are the true motives behind this refusal.
 

Seven7

Seven
Messages
3,444
Location
USA
Do you guys have something similar here like the lady who requested via court for the new IOM contract?? Can you start legal action somehow??? IF a study that is going to rule our treatment, then we have the right to scrutinize as much as possible.
 

Sam Carter

Guest
Messages
435
White et al wrote that "The data has been entered and checked during the course of the trial in a customised Microsoft Access [78] database. Once the database is locked, the data will be transferred into Stata". (1)

The FOIA stipulates that public bodies should "provide advice and assistance, so far as it would be reasonable to expect the authority to do so, to persons who propose to make, or have made, requests for information to it." (2)

Dr Sheridan could ask QMUL for assistance in formulating a query to execute against the Stata file holding the trial data to identify the required subset and then transfer this to a comma separated value file (i.e. a spreadsheet file.) QMUL's IT services offer support for "our enterprise applications such as Guassian, Stata and Matlab"(3), and given the simplicity of the task, a competent user of Stata could export the data in a matter of minutes.

I've never used Stata, but after a bit of googling, the query would look something like the following (and obviously I've had to guess at the label of each data-column).

First, filter the data to keep the details only of the participants who recovered:

``(keep if (
CFQ_likert_52_weeks <= 18
& SF36PF_52_weeks >= 60
& CGI <= 2
& CDC_criteria_met_52_weeks == 'No'
& Oxford_criteria_met_52_weeks == 'No'
& London_ME_criteria_met_52_weeks == 'No'))``

Second, save the filtered data in memory:

``save part``

Finally, use the "outsheet" command to output the trial arm, the 6 minute walking distance at baseline and the 6 minute walking distance at 52 weeks to a CSV file called "six_minute_walk_data_for_recovered.csv", which could be emailed to Dr Sheridan who could then open it in Excel or OpenOffice Calc.

``outsheet trial_arm 6_min_walk_baseline 6_min_walk_52_weeks using six_minute_walk_data_for_recovered.csv , comma``

No personally identifiable data would be released, and QMUL couldn't argue that it would take more than 18 hours to complete.

It's also worth bearing in mind that, when evaluating the claim that it would take more than 18 hours to fulfil the request, only 87 people recovered according to the post-hoc criteria, and that White et al must have identified this small group of participants (and have tabulated their Patient Identification Numbers) before writing "Recovery from chronic fatigue syndrome after treatments given in the PACE trial." (4)


(1) A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan
Trials 2013, 14:386 doi:10.1186/1745-6215-14-386

(2) http://ico.org.uk/~/media/documents...eness_guidance_23_-_advice_and_assistance.pdf

(3) http://www.its.qmul.ac.uk/research/

(4) Recovery from chronic fatigue syndrome after treatments given in the PACE trial.
White PD1, Goldsmith K, Johnson AL, Chalder T, Sharpe M.
Psychol Med. 2013 Oct;43(10):2227-35. doi: 10.1017/S0033291713000020.
 
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user9876

Senior Member
Messages
4,556
Dr Sheridan could ask QMUL for assistance in formulating a query to execute against the Stata file holding the trial data to identify the required subset and then transfer this to a comma separated value file (i.e. a spreadsheet file.) QMUL's IT services offer support for "our enterprise applications such as Guassian, Stata and Matlab"(3), and given the simplicity of the task, a competent user of Stata could export the data in a matter of minutes.

It should be pointed out that QMUL is the public body responsible for the FoI not just those who are involved in the PACE trial so the fact they have IT services to support Stata suggests they have the ability to process the data.

First, filter the data to keep the details only of the participants who recovered:

``(keep if (
CFQ_likert_52_weeks <= 18
& SF36PF_52_weeks >= 60
& CGI <= 2
& CDC_criteria_met_52_weeks == 'No'
& Oxford_criteria_met_52_weeks == 'No'
& London_ME_criteria_met_52_weeks == 'No'))``

It might be slightly more complex in that the columns could be the individual questionnaire answers rather than the composite scores but they should have functions to deal with these. I wrote something to do the SF36 scores from questionnaire answers in matlab once and it took less than an hour to code and test. The only slight complexity is in interpolating when there are up to two questions unanswered.

I also think the test could be done as an SQL query in MS Access then exported as a comma separated list.

It's also worth bearing in mind that, when evaluating the claim that it would take more than 18 hours to fulfil the request, only 87 people recovered according to the post-hoc criteria, and that White et al must have identified this small group of participants (and have tabulated their Patient Identification Numbers) before writing "Recovery from chronic fatigue syndrome after treatments given in the PACE trial." (4)
If they haven't got a table they should at least have the code to regenerate it. They would have needed to keep this in case they were asked to do revisions to the paper.
 

user9876

Senior Member
Messages
4,556
Do you guys have something similar here like the lady who requested via court for the new IOM contract?? Can you start legal action somehow??? IF a study that is going to rule our treatment, then we have the right to scrutinize as much as possible.

There is a whole legal process. The next stage is to complain to the information commissioner. But I would expect QMUL so then it goes to a court. The guardian (A national newspaper) took a FoI request they had made for prince Charles' letters to government ministers as far as the highest court of appeal.
 

ukxmrv

Senior Member
Messages
4,413
Location
London
There is a whole legal process. The next stage is to complain to the information commissioner. But I would expect QMUL so then it goes to a court. The guardian (A national newspaper) took a FoI request they had made for prince Charles' letters to government ministers as far as the highest court of appeal.

We don't have lawyers willing to help us get to court in the UK for ME matters in general and when they do it can be a disaster (see the NICE Judicial Review)

It would depend on PWME finding a lawyer willing to do this and a group probably paying an off-front fee even to look at this as a possibility even if there hoping for pro-bono or legal aid (as this has been the case previously)

http://www.meactionuk.org.uk/MH_JR_Statement_2.htm
 
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Dolphin

Senior Member
Messages
17,567
I was just reflecting on this:

PACE: A trial & tribulations
Prof Peter White, Barts and the London School of Medicine and Dentistry


[..]
“The PACE trial has also played a small role in helping to amend the FOI Act for the better. From 1 October, current research will be exempt from the FOI Act so long as it can be shown that release of that data will be prejudicial to the conduct of the research.

I wonder what they mean by current research.

There can be long-term follow-up of research participants.

PDW/QMUL previous said:

For your information the appropriate limit is £450, calculated as the
estimated cost of one person spending 18 hours in determining whether the
information is held, then locating, retrieving and extracting the
information. Section 12 of FOIA therefore make provision for public
authorities to refuse such requests.

The processes would include work of a statistician to perform the various
programming and data file operations as well as the calculations to
produce accurate data. Moreover, as there is no longer a statistician
employed by the PACE trial, one would need to be recruited for this
operation and trained.

https://www.whatdotheyknow.com/request/6min_walking_test_data_recovered#incoming-454571

This sort of reasoning could mean people might never get data:

if the statistician is employed, it's current research and so perhaps exempt.

Once the statistician finishes, people can make requests, but they'll be refused because there's no one working on the project?
 
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Esther12

Senior Member
Messages
13,774
This sort of reasoning could mean people might never get data: if the statistician is employed, it's current research and so perhaps exempt.

Once the statistician finishes, people can make requests, but they'll be refused because there's no one working on the project?

lol- I wouldn't put it past them.

Also, after claiming that they had no statistician, weren't they then asked to make revisions to one of their shortly due papers? If a peer reviewer had asked for re-working involving stats, I doubt that QMUL would have decided it needed to hire and train a new statistician.
 
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user9876

Senior Member
Messages
4,556
lol- I wouldn't put it past them.

Also, after claiming that they had no statistician, weren't they then asked to make revisions to one of their shortly due papers? If a peer reviewer had asked for re-working involving stats, I doubt that QMUL would have decided it needed to hire and train a new statistician.
But Whites argument is flawed in that QMUL is the institution responsible of the FoI not his PACE project. QMUL have people capable of working out simple results. White may not want them to see the data.
 

Dolphin

Senior Member
Messages
17,567

Dolphin

Senior Member
Messages
17,567
(In case anyone missed it)
The journalist, David Tuller DrPH, has today posted a substantial piece on the PACE Trial:

TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
http://www.virology.ws/2015/10/21/trial-by-error-i/

There's an introduction and summary at the start if you don't want to take on the whole thing.

It's being discussed in this PR thread:
http://forums.phoenixrising.me/inde...he-pace-chronic-fatigue-syndrome-study.40664/

ME Network have also posted their own summary piece:
http://www.meaction.net/2015/10/21/david-tuller-tears-apart-pace-trial/
 

worldbackwards

Senior Member
Messages
2,051
Hey, we're officially evil!
The fear was that the online patient community would take this successfully de-anonymized data and publish it online:

Richard Horton - “…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. The risk is maximised by the fact that the CFS/ME patient community is a very small percentage of the population (e.g. estimates at less than 1%) and the PACE trial population already known to be part of that is relatively large and possibly including members of the above. The risk that additional information could be combined with the individual level data to allow identification must be considered not at all far-fetched, although QMUL need not be expected to know exactly what additional information there is presently.”

the request is merely one of a series of requests for similar access to this same medical treatment information, upheld by the ICO on several occasions, including a request by the complainant found vexatious (see FS50558352) as part of a campaign by a small group of CF/MSE activists to discredit research and researchers whose results they do not agree with.