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"QMUL releases the PACE data" (news piece with commentary from #MEaction)

trishrhymes

Senior Member
Messages
2,158
Sam Carter just put this on another thread. I think this means QMUL have to publish the data!


Freedom of Information: New Rules on Datasets
...
3. Obligation to pro-actively publish datasets

Where a dataset is requested under FOIA, a public authority must now make it available to the public via its "publication scheme" (i.e. publish the dataset on its website) – unless it is "not appropriate" to do so.
""" [source]


"""
The question of course is – what can be considered “not appropriate” in this context?

examples where publication might be “not appropriate” include:
• where there is no wider interest or value in publishing the dataset;
• where it would be expensive to publish the dataset;
• where there are technical issues with publishing the dataset
""" [source]


"""
In deciding whether it is appropriate to publish a dataset under its publication scheme, the public authority should also take account of the public interest in transparency and accountability.
""" [source]


"""
If you are a public authority (as defined in FOIA) making a dataset available in response to a FOIA request, you must, so far as is reasonably practicable, make it available in a re-usable, electronic form. You must also make requested datasets available in your publication scheme in a re-usable form unless you are satisfied that it is not appropriate to do so.
""" [source]
 

Marco

Grrrrrrr!
Messages
2,386
Location
Near Cognac, France
• 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).

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

Looks like the bare minimum to allow recovery rates to be calculated, and 6mwt as an extra.

Thanks Esther
 
Messages
65
Location
UK
Re the question of what they will release. They MUST release what has been ordered under the Tribunal's decision and elsewhere IF the decision falls within any law about what happens next (like the extract Trish quoted above). So if that is to fulfill Alem's request, it will be that, and if it falls within any law about what happens next, it will be that too.

The following is pure supposition on my part (and I'm happy to be corrected, I've never been involved in actual litigation, but a lot of what I used to do - private client tax accountancy, mostly troubleshooting where the risk is suddenly real and liabilities are looming say for trustees - needs a general knowledge of the law around what happens next and where the burden of risk lies where there are disputes. So that's where I get my suppositions from).

I very much doubt they would release MORE than that ordered under the Tribunal's decision, at this stage, maybe at all, because that may lead to unforseen complications legally. If they just stick to fulfilling the Tribunal's Order, then they don't get subsequent legal headaches. So from a 'risk' perspective any lawyers they have taken advice from, I feel, would say, only release what's in the Order - because that's a legal obligation so they can't be criticised for it/held to account for it. Sometimes a party has to go to court to get the protection from liability they might otherwise (remotely sometimes) risk, because the existence of teh Court Order removes that risk. It's a sensible approach in legal terms (even if very annoying for the other party who just wants some stuff that isn't particularly risky in itself).

[Edited to add: I'll never actually know, and don't need to, but it may be that QMUL went to Tribunal not only to challenge the FOI because they didn't want to release it, but also to get ironclad permission from the Court to release the data. Given they previously only released it where confidentiality agreements and pre-agreed statistical plans were in place. The FOI request is a different animal to that in legal terms in the realm of permission or data handling. If they had just shrugged and given in without the Tribunal, but it later turned out they were wrong in data protection and handling terms, the consequences for them could be grave. So in taking it to Tribunal, either way, they 'won' in terms of covering their arses in legal terms (which is necessary for businesses of which the University is one) - either the Court said they couldn't release the data into the 'wild', or alternatively they could. Either way it removed the risk of doing one or the other and being mistaken in law - which is a key part of running a business - obtaining certainty as to acts or omissions - going to Tribunal, no matter what the result, release or retain the data, it gave them certainty. No idea if that makes sense to anyone, it does to me, but that's not saying much!]

{Further edit to add: This approach of allowing the Court to decide whether or not data release is appropriate in terms of legal risk, is of course more in point where, as with the PACE Trial, it covers such a relatively huge length of time from inception to completion and then to publication of results in various journals.

As the phrase goes - the past is another country, they do things differently there. The PACE Trial was created at a time when 'best practice' and 'industry standards' were differnt to now, there's an article somewhere where someone says the PACe Trial shows the break between the 'old' style of doing things with friends and influences, as opposed to now which is far more open. I think PLoS will only publish papers where the data is freely available for example - that's a relatively 'new' thing in the sense that it wasn't as widespread back when PACE was being put together.

As a result of the length/period of time covered, and the deficiencies of the Permissions requested from Participants (see David Tuller's Virology articles, I think he points out issues with them in there?) - the legal risk is higher to QMUL for PACE data, than say it would be if it was a Trial that was put together last year, was run this year, and is published now - because, one hopes, more 'modern' practices as to the Trial admin like Permissions and expecting the dataset to be required to be public for any papers to be published, for example, because if it was a new 'modern style' form of Trial, there wouldn't be any risk, the need for public dataset would be built in from the start.}

They may at a later date decide to release more data of their own volition, if only because that gives a more complete set from which statistics may be drawn. But I imagine that will only be after they've worked out if they have already come to their own conclusions & published them, or if it's as yet 'unmined' data (if that makes sense).

There are apparently other FOI requests for other data in the pipeline. I would imagine QMUL are now taking advice as to whether to refuse those and risk further litigation, or whether the Tribunal Order sets a precedent that they can safely follow with regards to 'similar' requests albeit by different legal entities or individals - cos the Order applies specifically to Alem's request. So a request by say myself (not that I have, but I'm not Alem) isn't covered by the Order itself specifically, but the Order MAY be strong enough in law to mean that all other similar requests if taken to Tribunal again would come out with the same result. Once you've got legal advice (that you can sue on cos you paid for it)on that point - that's when QMUL would decide their 'policy' of either challenging ongoing or subsequent similar requests, what they would regard as similar, what they would regard as necessary to challenge and last but not least, that if sufficiently similar they wouldn't challenge, but feel it was similar enough that the Tribunal would find the same result, so they'd agree to the FOI request and save themselves the time and money.

At least, those are the issues that would usually be considered in such circumstances. Whether they are or not, or whether there's specific complexities or wrinkles attached to medical trial data of which I am unaware that would complicate their considerations, is something I can't speculate on.

{{Final edit (I promise) - I know many people won't be interested in the legal considerations behind the data release, however I do feel that an understanding of the legal side of it (although it's supposition on my part) helps to explain why QMUL have been 'dragging their feet' to a certain extent. Not totally obviously, but some way towards it. I contend that it's not entirely that White et al have been reluctant to release data because they feel it's theirs, so much as an uncertainty at the wider University level as to what commercial or economic or reputational consequences may accrue (to the University itself).}}
 
Last edited:
Messages
65
Location
UK
These days it is a very small dataset. I think 12 variables were requested over 640 patients. In these days of big data that is very small. No need for a hadoop cluster!. Excel will deal with that with no problems (but not a great tool)

R offers a free stats package that is good and widely accepted by statisticians. I tend to like octave which is an open source version of matlab but that just reflects my technical background.

Assuming one line per patient and a minimum of 12 columns (one per variable) - that's not big enough to break Excel cos it can go up to 200 columns I think now? Mind you know nothing about statistics and I've no idea what's involved in terms of calculations/ functions and how much of Excel's capacity they take up.

All I know is that Excel can take a lot of cross linked across work sheets and work books data without breaking these days (having broken it by accident on a project that involved about 800 lines and a ridiculous number of columns (and therefore worksheets) for a period of 10 years (so 10 workbooks in theory, in practice many many more)). That did break Excel 2000 (despite using macros to make certain calculations static rather than constantly recalculating), but shouldn't break it from Excel 2007 onwards from recollection.
 

Dolphin

Senior Member
Messages
17,567
Re the question of what they will release. They MUST release what has been ordered under the Tribunal's decision and elsewhere IF the decision falls within any law about what happens next (like the extract Trish quoted above). So if that is to fulfill Alem's request, it will be that, and if it falls within any law about what happens next, it will be that too.

The following is pure supposition on my part (and I'm happy to be corrected, I've never been involved in actual litigation, but a lot of what I used to do - private client tax accountancy, mostly troubleshooting where the risk is suddenly real and liabilities are looming say for trustees - needs a general knowledge of the law around what happens next and where the burden of risk lies where there are disputes. So that's where I get my suppositions from).

I very much doubt they would release MORE than that ordered under the Tribunal's decision, at this stage, maybe at all, because that may lead to unforseen complications legally. If they just stick to fulfilling the Tribunal's Order, then they don't get subsequent legal headaches. So from a 'risk' perspective any lawyers they have taken advice from, I feel, would say, only release what's in the Order - because that's a legal obligation so they can't be criticised for it/held to account for it. Sometimes a party has to go to court to get the protection from liability they might otherwise (remotely sometimes) risk, because the existence of teh Court Order removes that risk. It's a sensible approach in legal terms (even if very annoying for the other party who just wants some stuff that isn't particularly risky in itself).

[Edited to add: I'll never actually know, and don't need to, but it may be that QMUL went to Tribunal not only to challenge the FOI because they didn't want to release it, but also to get ironclad permission from the Court to release the data. Given they previously only released it where confidentiality agreements and pre-agreed statistical plans were in place. The FOI request is a different animal to that in legal terms in the realm of permission or data handling. If they had just shrugged and given in without the Tribunal, but it later turned out they were wrong in data protection and handling terms, the consequences for them could be grave. So in taking it to Tribunal, either way, they 'won' in terms of covering their arses in legal terms (which is necessary for businesses of which the University is one) - either the Court said they couldn't release the data into the 'wild', or alternatively they could. Either way it removed the risk of doing one or the other and being mistaken in law - which is a key part of running a business - obtaining certainty as to acts or omissions - going to Tribunal, no matter what the result, release or retain the data, it gave them certainty. No idea if that makes sense to anyone, it does to me, but that's not saying much!]

{Further edit to add: This approach of allowing the Court to decide whether or not data release is appropriate in terms of legal risk, is of course more in point where, as with the PACE Trial, it covers such a relatively huge length of time from inception to completion and then to publication of results in various journals.

As the phrase goes - the past is another country, they do things differently there. The PACE Trial was created at a time when 'best practice' and 'industry standards' were differnt to now, there's an article somewhere where someone says the PACe Trial shows the break between the 'old' style of doing things with friends and influences, as opposed to now which is far more open. I think PLoS will only publish papers where the data is freely available for example - that's a relatively 'new' thing in the sense that it wasn't as widespread back when PACE was being put together.

As a result of the length/period of time covered, and the deficiencies of the Permissions requested from Participants (see David Tuller's Virology articles, I think he points out issues with them in there?) - the legal risk is higher to QMUL for PACE data, than say it would be if it was a Trial that was put together last year, was run this year, and is published now - because, one hopes, more 'modern' practices as to the Trial admin like Permissions and expecting the dataset to be required to be public for any papers to be published, for example, because if it was a new 'modern style' form of Trial, there wouldn't be any risk, the need for public dataset would be built in from the start.}

They may at a later date decide to release more data of their own volition, if only because that gives a more complete set from which statistics may be drawn. But I imagine that will only be after they've worked out if they have already come to their own conclusions & published them, or if it's as yet 'unmined' data (if that makes sense).

There are apparently other FOI requests for other data in the pipeline. I would imagine QMUL are now taking advice as to whether to refuse those and risk further litigation, or whether the Tribunal Order sets a precedent that they can safely follow with regards to 'similar' requests albeit by different legal entities or individals - cos the Order applies specifically to Alem's request. So a request by say myself (not that I have, but I'm not Alem) isn't covered by the Order itself specifically, but the Order MAY be strong enough in law to mean that all other similar requests if taken to Tribunal again would come out with the same result. Once you've got legal advice (that you can sue on cos you paid for it)on that point - that's when QMUL would decide their 'policy' of either challenging ongoing or subsequent similar requests, what they would regard as similar, what they would regard as necessary to challenge and last but not least, that if sufficiently similar they wouldn't challenge, but feel it was similar enough that the Tribunal would find the same result, so they'd agree to the FOI request and save themselves the time and money.

At least, those are the issues that would usually be considered in such circumstances. Whether they are or not, or whether there's specific complexities or wrinkles attached to medical trial data of which I am unaware that would complicate their considerations, is something I can't speculate on.

{{Final edit (I promise) - I know many people won't be interested in the legal considerations behind the data release, however I do feel that an understanding of the legal side of it (although it's supposition on my part) helps to explain why QMUL have been 'dragging their feet' to a certain extent. Not totally obviously, but some way towards it. I contend that it's not entirely that White et al have been reluctant to release data because they feel it's theirs, so much as an uncertainty at the wider University level as to what commercial or economic or reputational consequences may accrue (to the University itself).}}
Given how vehemently they challenged freedom of information act requests for summary data for which there was no risk of identification, I'm not convinced they were specifically concerned with the risk of identification.
 

Esther12

Senior Member
Messages
13,774
Given how vehemently they challenged freedom of information act requests for summary data for which there was no risk of identification, I'm not convinced they were specifically concerned with the risk of identification.

I'm not yet entirely convinced myself. I have a few lingering doubts about their entirely implausible attempt at an excuse.
 

user9876

Senior Member
Messages
4,556
[Edited to add: I'll never actually know, and don't need to, but it may be that QMUL went to Tribunal not only to challenge the FOI because they didn't want to release it, but also to get ironclad permission from the Court to release the data. Given they previously only released it where confidentiality agreements and pre-agreed statistical plans were in place. The FOI request is a different animal to that in legal terms in the realm of permission or data handling. If they had just shrugged and given in without the Tribunal, but it later turned out they were wrong in data protection and handling terms, the consequences for them could be grave. So in taking it to Tribunal, either way, they 'won' in terms of covering their arses in legal terms (which is necessary for businesses of which the University is one) - either the Court said they couldn't release the data into the 'wild', or alternatively they could. Either way it removed the risk of doing one or the other and being mistaken in law - which is a key part of running a business - obtaining certainty as to acts or omissions - going to Tribunal, no matter what the result, release or retain the data, it gave them certainty. No idea if that makes sense to anyone, it does to me, but that's not saying much!]

Prior to the trial they claimed to have released data to independent researchers but during the trial they had to admin that the Cochrane researchers they released data to were not independent as they were involved in (and helping to fund) the protocol design. I know of no other researchers who have got data but 3 groups of academics who were turned down without explanation or even a request for an analysis plan.

The tribunal also noted that personal data cannot be shared with a confidentiality agreement as the Data protection act does not allow this. Personal data can only be shared when consent for sharing is given by the subject. But most of the trial data is anonymised in that it would be hard (or impossible) to reidentify the subject from the data.

The tribunal only covered a very limited data set so it doesn't cover them for sharing more data. I think they had spun their results and hence didn't want to share. They were part of a campaign to try to exempt universities from the FoI.

As the phrase goes - the past is another country, they do things differently there. The PACE Trial was created at a time when 'best practice' and 'industry standards' were differnt to now, there's an article somewhere where someone says the PACe Trial shows the break between the 'old' style of doing things with friends and influences, as opposed to now which is far more open. I think PLoS will only publish papers where the data is freely available for example - that's a relatively 'new' thing in the sense that it wasn't as widespread back when PACE was being put together.
PLOS always demanded data sharing but I think it was becoming hard to enforce so now they demand data is shared at the time of publication. There is though as you say a growing movement towards open data.


As a result of the length/period of time covered, and the deficiencies of the Permissions requested from Participants (see David Tuller's Virology articles, I think he points out issues with them in there?) - the legal risk is higher to QMUL for PACE data, than say it would be if it was a Trial that was put together last year, was run this year, and is published now - because, one hopes, more 'modern' practices as to the Trial admin like Permissions and expecting the dataset to be required to be public for any papers to be published, for example, because if it was a new 'modern style' form of Trial, there wouldn't be any risk, the need for public dataset would be built in from the start.}
Pace had already shared some individual patient data in the form of adverse events within the original lancet paper (in the appendix). There are many medical papers that publish individual data for small trials as it is useful to understand what is going on. So I do think consent forms are not clear but I'm not sure they have improved with a high degree of clarity about what will be shared.

{{Final edit (I promise) - I know many people won't be interested in the legal considerations behind the data release, however I do feel that an understanding of the legal side of it (although it's supposition on my part) helps to explain why QMUL have been 'dragging their feet' to a certain extent. Not totally obviously, but some way towards it. I contend that it's not entirely that White et al have been reluctant to release data because they feel it's theirs, so much as an uncertainty at the wider University level as to what commercial or economic or reputational consequences may accrue (to the University itself).}}

I think many people believe they have been slow to release data because of the way the spun results. I think they have a pretty low opinion of patients (not unusual as I think when people get a patient label they have other labels about their education, abilities etc removed) so I think they thought they would get away with spin. I think QMUL's reputation has been harmed much more by them holding onto data than any release especially since they spent so much public money on it.