PACE Trial: Recovery Rates and Positive Outcome Rates (repeat request)

The request was refused by Queen Mary, University of London.

The PACE Trial.

"Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial"

Dear Queen Mary, University of London,

This is a new FOI request for information previously requested and declined. Please treat this as a new FOI request. (FOI legal procedures require me to repeat a previous request, if I am to follow-up the request.)

For all the therapy groups (APT, CBT, GET, SMC), I would like the 'recovery' rates, and the 'positive outcome' rates (the 'primary efficacy measure'), as defined in the published trial protocol for the PACE trial.

Full details as follows...

Recovery Rates.

I would like the proportion of participants, in each therapy group, who achieved a 'recovery', as defined in the published trial protocol.

A 'recovery' is defined as follows:

"Recovery" will be defined by meeting all four of the following criteria:
(i) a Chalder Fatigue Questionnaire score of 3 or less [note, that the relevant questionnaires should be scored using the bimodal scoring method],
(ii) SF 36 physical Function score of 85 or above,
(iii) a CGI score of 1, and
(iv) the participant no longer meets Oxford criteria for CFS, CDC criteria for CFS or the London criteria for ME.

Positive Outcome rates.

I would like the proportion of participants, in each therapy group, who achieved a 'positive outcome' (including the proportion of 'overall improvers'), as defined in the published trial protocol.

A 'positive outcome' is defined as follows:

"The 11 item Chalder Fatigue Questionnaire measures the severity of symptomatic fatigue, and has been the most frequently used measure of fatigue in most previous trials of these interventions. We will use the 0,0,1,1 item scores to allow a possible score of between 0
and 11. A positive outcome will be a 50% reduction in fatigue score, or a score of 3 or less, this threshold having been previously shown to indicate normal fatigue.
[Note, that the relevant questionnaires should be scored using the bimodal scoring method.]

"The SF-36 physical function sub-scale measures physical function, and has often been used as a primary outcome measure in trials of CBT and GET. We will count a score of 75 (out of a maximum of 100) or more, or a 50% increase from baseline in SF-36 sub-scale score
as a positive outcome.

"Those participants who improve in both outcome measures will be regarded as overall improvers."

Details of the trial protocol:
Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy.
Peter D White et al.
8 March 2007
BMC Neurology 2007, 7:6
doi:10.1186/1471-2377-7-6

Yours faithfully,

Mr Courtney

Mr Courtney left an annotation ()

This is a repeat FOI request. The previous request can be found here:
https://www.whatdotheyknow.com/request/p...

QM FOI Enquiries, Queen Mary, University of London

We acknowledge receipt of your request and will respond as soon as we can.

QM FOI Enquiries, Queen Mary, University of London

1 Attachment

Our ref. 2013/F257
 
Dear Mr. Courtney

Thank you for your e-mail of 29^th October.

As you have stated, this request is identical to a request you submitted
to QMUL on 26^th October 2012. As we replied then, the information you
have requested is not held. Nevertheless, since your original request a
paper on recovery rates in the PACE trial, attached, has been published.

If you are dissatisfied with this response, you may ask Queen Mary to
conduct a review of this decision.  To do this, please contact the College
in writing (including by fax, letter or email), describe the original
request, explain your grounds for dissatisfaction, and include an address
for correspondence.  You have 40 working days from receipt of this
communication to submit a review request.  When the review process has
been completed, if you are still dissatisfied, you may ask the Information
Commissioner to intervene. 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/

Dear Queen Mary, University of London,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Queen Mary, University of London's handling of my FOI request: 'PACE Trial: Recovery Rates and Positive Outcome Rates (repeat request)'.

I requested the 'recovery' analysis and 'positive outcome' analysis, as defined in the PACE trial’s published protocol.

For all the therapy groups (APT, CBT, GET, SMC), I would like the 'recovery' rates, and the 'positive outcome' rates, as per the criteria defined in the published protocol.

Please note that the trial protocol specified that these analyses would be carried out at 12 weeks, 24 weeks, and 52 weeks. As such, I require the analyses to be carried out at these time frames.

Please also note that the 'positive outcome' analysis was also referred to as the 'primary efficacy measure' and was the main primary outcome analysis proposed in the final published protocol.

Full details and a full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/p...

On a separate but related matter, Queen Mary's policy is to make trial data public. For example Queen Mary's trial data policy from 2012 states: "publicly funded research data should be made openly available in a timely manner". The PACE trial was a publicly funded medical trial. As such, it seems that a FOI request should not be necessary to gain access to anonymised data relating to this FOI request, but that the trial data should be made public (i.e. 'openly available'), as per Queen Mary's policy.

If Queen Mary wishes to release the data relating to the PACE trial, then that would be a welcome addition to this FOI request. Otherwise, an explanation as to why Queen Mary has so far declined to release any PACE trial data to the public, except for the very limited data that has been published in peer reviewed papers, would be welcome.

Also, a time frame, in relation to plans for releasing the trial data to the public, would be welcome, along with a description of the data that will be released.

Below, I quote relevant extracts from Queen Mary's data policy from 2012, which as far as I am aware, is the current data policy:

Queen Mary, University of London. Research Data Management Policy

http://www.arcs.qmul.ac.uk/policy_zone/r...

"Policy ...
Where possible publicly funded research data should be made available for access and re-use.
...
"Most grant applications for research which will generate digital data sets require a data management plan that meets the 2011 Research Councils UK (RCUK) policy; this states that: ‘Publicly funded research data are a public good, produced in the public interest, which should be made openly available with as few restrictions as possible in a timely and responsible manner that does not harm intellectual property:’...
...
"RCUK now require all funded universities to have a data management policy and road map that will meet their expectations for data sharing in place by 1 May 2012 with full implementation by 2015. This is to ensure we make it clear how publicly funded data can be accessed for at least ten years after publication. Our policy should deliver the following criteria:
• publicly funded research data should be made openly available in a timely manner;
• data with acknowledged long term value should be made accessible;..."

Many thanks in anticipation for your cooperation.

Yours faithfully,

Mr Courtney

QM FOI Enquiries, Queen Mary, University of London

Dear Mr. Courtney
 
We acknowledge receipt of your internal review.
 
I note that there is a separate request in your reply to us viz. ‘If Queen
Mary wishes to release the data relating to the PACE trial, then that
would be a welcome addition to this FOI request. Otherwise, an explanation
as to why Queen Mary has so far declined to release any PACE trial data to
the public, except for the very limited data that has been published in
peer reviewed papers, would be welcome.
 
Also, a time frame, in relation to plans for releasing the trial data to
the public, would be welcome, along with a description of the data that
will be released.’
 
With regards to the first part, please can you clarify what data you are
requesting of Queen Mary? Where you have asked for an explanation, this
does not constitute a request for recorded information under s.1 of the
Freedom of Information Act. On the last part relating to plans to release
data, we will deal with this as a request, although please clarify what
trial data exactly you are enquiring about.
 
However, I am not sure how the whatdotheyknow.com website will accommodate
this request within an internal review request, as the deadline for
response will not be set by its system. You may wish to resubmit this as a
new request separately.
 
Yours sincerely
 
Paul Smallcombe
Records & Information Compliance Manager
 
 

Dear Mr Smallcombe,

I should have clarified my intentions. The request for additional information, that you have quoted, was not intended to be treated as a formal FOI request. It was an informal request for information. I will consider submitting it as a separate formal FOI request at a future date.

In terms of the formal FOI proceedings, please ignore my requests for any additional information, and please refer only to the details in my original FOI request.

However, I did include one clarification that should be considered as part of the formal FOI request, as follows:

Please note that the trial protocol specified that the requested analyses (the recovery rates and positive outcome rates) would be carried out at 12 weeks, 24 weeks, and 52 weeks. As such, I require the analyses to be carried out at these time frames.

Thank you for your prompt request for clarification.

Yours sincerely,

Mr Courtney

QM FOI Enquiries, Queen Mary, University of London

Dear Mr. Courtney
 
We have conducted a review of your request. The decision is that the
information you have requested is not held. Insofar that it could be
possible to calculate the data from what is held, your request would be
refused under s.12 of the Freedom of Information Act 2000. This means that
we estimate that to produce the particular data would exceed the
appropriate limit as defined by the Freedom of Information and Data
Protection (Appropriate Limit and Fees) Regulations 2004. Your request is
therefore refused under s.12 of the FOIA.
 
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 makes 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.
 
The interim Research Data Management Policy to which you referred has been
superseded, please see:
[1]http://www.arcs.qmul.ac.uk/docs/policyzo...
However, you will see that this is not applicable to research data such as
that from the PACE trial anyway: “access to data that is associated with
medical research will be governed by the relevant funder’s policies on
datasharing”. Therefore, I refer you to the Medical Research Council’s
Data Sharing Policy at:
[2]http://www.mrc.ac.uk/Ourresearch/Ethicsr...
 
If you remain dissatisfied you have the right to complaint to the
Information Commissioner's Office; please see [3]www.ico.org.uk for
details.
 
Yours sincerely
 
Paul Smallcombe
Records & Information Compliance Manager
 
 

References

Visible links
1. http://www.arcs.qmul.ac.uk/docs/policyzo...
2. http://www.mrc.ac.uk/Ourresearch/Ethicsr...
3. http://www.ico.org.uk/

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