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

[Esther12]

Presumably that makes all of us vexatious then.

Only if you're interested in the truth, and being able to make informed decisions about your health care.

QMUL also claimed this request was vexatious: https://www.whatdotheyknow.com/request/timing_of_changes_to_pace_trial#incoming-522615

It looks like they're just treating requests from CFS patients about PACE as vexatious for no reason other than their own prejudices.

 

[Scarecrow]

This following is a list of indicators of 'vexatiousness' from the Information Commissioner's Office's document 'Dealing with Vexatious Requests (Section 14); Freedom of Information Act',

http://ico.org.uk/~/media/documents...st_guides/dealing-with-vexatious-requests.pdf

Abusive or aggressive language

The tone or language of the requester’s correspondence goes beyond the level of criticism that a public authority or its employees should reasonably expect to receive.

Burden on the authority

The effort required to meet the request will be so grossly oppressive in terms of the strain on time and resources, that the authority cannot reasonably be expected to comply, no matter how legitimate the subject matter or valid the intentions of the requester.

Personal grudges

For whatever reason, the requester is targeting their correspondence towards a particular employee or office holder against whom they have some personal enmity.

Unreasonable persistence

The requester is attempting to reopen an issue which has already been comprehensively addressed by the public authority, or otherwise subjected to some form of independent scrutiny.

Unfounded accusations

The request makes completely unsubstantiated accusations against the public authority or specific employees.

Intransigence

The requester takes an unreasonably entrenched position, rejecting attempts to assist and advise out of hand and shows no willingness to engage with the authority.

Frequent or overlapping requests

The requester submits frequent correspondence about the same issue or sends in new requests before the public authority has had an opportunity to address their earlier enquiries.

Deliberate intention to cause annoyance

The requester has explicitly stated that it is their intention to cause disruption to the public authority, or is a member of a
campaign group whose stated aim is to disrupt the authority.

Scattergun approach

The request appears to be part of a completely random approach, lacks any clear focus, or seems to have been solely designed for the purpose of ‘fishing’ for information without any idea of what might be revealed.

Disproportionate effort

The matter being pursued by the requester is relatively trivial and the authority would have to expend a disproportionate amount of resources in order to meet their request.

No obvious intent to obtain information

The requester is abusing their rights of access to information by using the legislation as a means to vent their anger at a particular decision, or to harass and annoy the authority, for example, by requesting information which the authority knows them to possess already.

Futile requests

The issue at hand individually affects the requester and has already been conclusively resolved by the authority or subjected to some form of independent investigation.

Frivolous requests

The subject matter is inane or extremely trivial and the request appears to lack any serious purpose. The request is made for the sole purpose of amusement.

The next extract deals with time limits.

The cut off point for evidence that a request is vexatious

128. The authority may take into account any evidence it has about the events and correspondence which proceeded or led up to the request being made.

129. An authority has a set time limit (normally 20 working days) in which it must respond to a request. As long as the authority keeps to this time limit then it may also take into account anything that happens within the period in which it is dealing with the request (for example if the requester sends in further requests).

130. However, an authority cannot take into account anything that happens after this cut off point. This means that if a public authority breaches the Act and takes longer than 20 working days to deal with a request, or if it makes a late claim of section 14(1) after a complaint has been made to the ICO, then
it will need to be very careful to disregard anything that only happened after the time limit for responding had expired.

So if we have seen full correspondence, it's hard to understand how the request could be vexatious unless Sheridan's 2nd, clarifying, request counts as 'Frequent or overlapping requests' or as a 'Scattergun approach'.

That would be harsh.

 

[Sasha]

It would be interesting if the writer of the letter could respond to the university quoting those regulations and ask in exactly what manner the request was considered to be vexatious. I think White may have addressed the issue (if memory serves) of why they didn't use the planned analysis (not to any of our satisfaction) but that doesn't mean he's addressed the issue of why it's OK to withhold data on the planned analysis on this £5 million trial that we all paid for. I think the situation would make a good letter to the BMJ (or as an add-on to that rapid response thread).

 

[MeSci]

The definitions of what constitutes 'vexatious' seem very subjective and open to (mis)interpretation.

 

[Esther12]

I don't think that they're open enough to allow them to get away with classing a request like as vexatious though!

 

[Min]

http://www.sophiaandme.org.uk/collusion.html


Prof White is listed as working for the health insurance firm Swiss Re and the UK's Department of Work and Pensions. Surely there is a conflict of interest here?

The Parliamentary Gibson report of 2006 advised that the psychiatrists involved in myalgic encephalomyelitis in the UK be investigated for their links to the health insurance industry.

We are still waiting for this to happen. Instead, they are inappropriately being handed more and more money that should go to biomedical research into our physical illness.

 

[MeSci]

http://www.sophiaandme.org.uk/collusion.html


Prof White is listed as working for the health insurance firm Swiss Re and the UK's Department of Work and Pensions. Surely there is a conflict of interest here?

The Parliamentary Gibson report of 2006 advised that the psychiatrists involved in myalgic encephalomyelitis in the UK be investigated for their links to the health insurance industry.

We are still waiting for this to happen. Instead, they are inappropriately being handed more and more money that should go to biomedical research into our physical illness.

and a knighthood.

 

[Dolphin]

Latest response now up.
Not sure whether Queen Mary, University of London should be chosen to do important research if such a task would take them over 18 hours!

From: QM FOI Enquiries
Queen Mary, University of London

25 September 2014
PACE White 2011.pdf
308K Download View as HTML

Dear Dr. Sheridan



Queen Mary has been conducting its internal review on this request and we
apologise for the delay. The review has determined that the request is not
vexatious.



In the light of this we have reassessed your request.



We do not hold the precise data you have requested i.e. for recovered
patients. To provide this would exceed the appropriate limit as defined by
the Freedom of Information and Data Protection (Appropriate Limit)
Regulations 2004. For your information this 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 the Freedom of Information Act 2000 therefore
makes provision for public authorities to refuse such requests.



Data relating to the six minute walking test has been published in summary
form in the original Lancet paper of 2011 in Table 6, please see attached.



If you remain dissatisfied you have the right to appeal to the Information
Commissioner's Office. Please see [1]www.ico.org.uk for details.



Yours sincerely



Paul Smallcombe

Records & Information Compliance Manager



References

Visible links
1. http://www.ico.org.uk/

 

[Sasha]

Good grief. Are they really arguing that the people who ran a trial costing £5 million of taxpayers' money didn't store their data where they can instantly lay hands on it and in a form in which further analysis (especially such an obvious, easy one) would be possible?

This is ridiculous. Finding the data and running that kind of analysis should take a couple of hours, tops (less if they've got their original statistician to hand). I hope Dr Sheridan appeals.

 

[Sasha]

...or, if they really want to argue that cost is the issue, let them say what the cost is and we'll crowdfund it. We'd raise the money in seconds.

 

[Esther12]

The review has determined that the request is not
vexatious.

After you were told that the ICO had recommended the request?

Would love to hear the reasoning for initially classing the request as vexatious.

 

[Wildcat]

.
Sasha wrote : "Good grief. Are they really arguing that the people who ran a trial costing £5 million of taxpayers' money didn't store their data where they can instantly lay hands on it and in a form in which further analysis (especially such an obvious, easy one) would be possible?".


So why on earth should such people (ie Prof Peter White) have been invited onto the Executive Board of the UK Research Collaborative?

The inviting of Professor White into the Collaborative, and his status within it, does nothing but undermine confidence in the accountability of the Collaborative.

.

 

[snowathlete]

They should cough up. They've had huge huge funding from the public and this data surely exists. It would probably take ten minutes to locate but even if the true cost was £450 which seems ludicrous, it's obviously in the public interest that this information is made available. They're just stonewalling because they don't want us to see the data as it no doubt shows failure to recover, or worse, a deterioration.

The idea that's it's vexatious is just an unfounded avoidance tactic on their part.

 

[Scarecrow]

...or, if they really want to argue that cost is the issue, let them say what the cost is and we'll crowdfund it. We'd raise the money in seconds.

Great idea!

Some more extracts from the extremely informative ICO website:

http://ico.org.uk/for_organisations...t_of_compliance_exceeds_appropriate_limit.pdf

Section 12 of FOIA allows a public authority to refuse to deal with a request where it estimates that it would exceed the appropriate limit to: - either comply with the request in its entirety or; - confirm or deny whether the requested information is held.

The estimate must be reasonable in the circumstances of the case.

The appropriate limit is currently £600 for central government and £450 for all other public authorities.

Where a public authority claims that section 12 is engaged, it should, where reasonable, provide advice and assistance to help the requestor to refine the request so that it can be dealt with under the appropriate limit.

and

10. All public authorities should calculate the time spent on the permitted activities at the flat rate of £25 per person, per hour.

11. This means that the appropriate limit will be exceeded if it would require more than 24 hours work for central government, legislative bodies and the armed forces, and 18 hours work for all other public authorities.

and

Fees Notices

If it would exceed the appropriate limit to comply with a request, a public authority is not obliged to comply with it. The authority should however issue a refusal notice stating that it is relying on section 12.

As a matter of good practice, if a public authority is offering to provide the information for a fee then it should issue a fees notice. There is no statutory requirement to do this, because there is no obligation on the authority to comply with a request when section 12 applies. However, it will normally be the easiest way of letting the requestor know that they have the option of receiving information upon payment of a fee.

As a matter of good practice a public authority should also aim to provide a fees notice as soon as possible and at least within the 20 working day period for responding to the request.

Queen Mary are absolutely entitled to refuse the request under section 12 and they do not have to offer to provide the information for a fee.

But if Dr Sheridan offered to cover the costs, how far would Queen Mary persist in their refusal?

 

[user9876]

Great idea!

Some more extracts from the extremely informative ICO website:

http://ico.org.uk/for_organisations...t_of_compliance_exceeds_appropriate_limit.pdf


and

and


Queen Mary are absolutely entitled to refuse the request under section 12 and they do not have to offer to provide the information for a fee.

But if Dr Sheridan offered to cover the costs, how far would Queen Mary persist in their refusal?

If they cannot get simple information within the 18 hours then this casts a huge doubt on how they are handling and storing information which in turn should add concerns about their results. If they don't have systematically stored and well managed data and access processes then how can we trust the quality of their results.

 

[Min]

I do not understand why the ME Association and Action for ME are not vigorously demanding the release of the data. Instead, they have chosen to be part of the Collaborative with Peter White.

 

[Scarecrow]

If they cannot get simple information within the 18 hours then this casts a huge doubt on how they are handling and storing information which in turn should add concerns about their results. If they don't have systematically stored and well managed data and access processes then how can we trust the quality of their results.

I don't disagree but I don't think impugning them is the correct path to take.

 

[Sasha]

If they cannot get simple information within the 18 hours then this casts a huge doubt on how they are handling and storing information which in turn should add concerns about their results. If they don't have systematically stored and well managed data and access processes then how can we trust the quality of their results.

Data management and quality of results are two entirely separate issues.

Clinical trial data in this day and age should be held in a single computer file and data field names should have been chosen by the trial statistician to be rational and easily understood by any statistician who comes along later (or an easily accessible explanation of field names should have been included with the data files. This data should be extremely easy and quick to access and analyse. 18 hours is simply ridiculous.

 

[user9876]

Data management and quality of results are two entirely separate issues.

Clinical trial data in this day and age should be held in a single computer file and data field names should have been chosen by the trial statistician to be rational and easily understood by any statistician who comes along later (or an easily accessible explanation of field names should have been included with the data files. This data should be extremely easy and quick to access and analyse. 18 hours is simply ridiculous.

My point was that if the clinical data is not clearly labelled with semantically meaningful labels for each column and for each of the access functions then there is an increased chance of errors. That is the wrong data being processed or the wrong result being quoted.

If it will take them over 18 hours to access the data that suggests they have not have an adequately labelled data schema and hence my comment that this casts doubt on the accuracy of their results (and I mean that they are error free rather than methodologically sound which is a whole different subject).

Since they use a stats system its not enough to have an adequately labelled schema they need to have a QA process for any data processing/statistics functions/methods they have to ensure they are doing the right thing. These functions also need to be well described and labelled.

I was alarmed a while ago hearing a statistician (nothing to do with PACE) recommending using numbered rather than labelled data columns in R. That's just poor practice.

I have big doubts about the quality assurance processes applied to a lot of academic research especially having looked at code written by PhD students!

I would add I believe that stats systems should include preconditions for each function that describe any expected data distributions etc but we are a very long way from that.

 

[biophile]

Data management and quality of results are two entirely separate issues.

Clinical trial data in this day and age should be held in a single computer file and data field names should have been chosen by the trial statistician to be rational and easily understood by any statistician who comes along later (or an easily accessible explanation of field names should have been included with the data files. This data should be extremely easy and quick to access and analyse. 18 hours is simply ridiculous.

http://www.trialsjournal.com/content/14/1/386 ...

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 [79]. It is anticipated that the analyses will be carried out primarily within Stata [79], although MLwiN [80] and other statistical packages may be used as necessary. The most up-to-date version available will be used in each case.

https://www.whatdotheyknow.com/request/raw_data_for_6mwt ...

We do not hold the precise data you have requested i.e. for recovered patients. To provide this would exceed the appropriate limit as defined by the Freedom of Information and Data Protection (Appropriate Limit) Regulations 2004. For your information this 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 the Freedom of Information Act 2000 therefore makes provision for public authorities to refuse such requests.

Why doesn't a university have any qualified staff to do basic data operations? Dr Sheridan didn't ask for any statistical testing so they wouldn't need to use Stata. Shouldn't be too difficult to convert or import a Microsoft Access database into a spreadsheet file and just create a cell formula in Microsoft Excel to get a list of 6MWD values for the "recovered" in each treatment group. 18 hours or £450 sounds difficult to believe even if they have to train someone or bring in outside help.

https://twitter.com/TomKindlon ...

Tom Kindlon ‏@TomKindlon

.@QMUL refuse to release 6-minute walking distances of "recovered" in £5m #PACEtrial saying it'd take them over 18 hrs #LowQualityUniPerhaps

Tom Kindlon @TomKindlon

Details of @QMUL's refusal to release 6MWDs for so-called recovered in what the PIs claimed was a "definitive" trial https://t.co/dAuuKTpaPZ

Michelle B @MichelleBull4

@TomKindlon @QMUL makes you wonder about the quality of their data control if it takes that long to sort it. #feebleexcuse or #poorquality

uab9876 ‏@uab9876

@TomKindlon Maybe @QMUL could find a bit of data in less than 18 hours but are just trying to cover up that they mislead patients.

Tom Kindlon ‏@TomKindlon

.@uab9876 Either way, it doesn't look taxpayer-money should be going to research conducted by @QMUL.

uab9876 ‏@uab9876

@ TomKindlon If @ MRC withdrew funding till @ QMUL until they published data as defined in the #PACEtrial protocol it would be found in minutes