Request for raw data from the PACE Trial

Mr Courtney made this Freedom of Information request to Queen Mary, University of London

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

From: Mr Courtney

9 June 2011

Dear Queen Mary, University of London,

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

I would like access to the full raw data from the PACE Trial.

I particularly require the data relating to the changes measured
for each individual participant (i.e. not just the average
measurements), at baseline and at 52 weeks for the primary outcomes
for each of the measured groups in the Trial (The SMC, GET, CBT and
APT groups.)

The same measurements for the secondary outcomes is also required.

I also require the data relating to the changes measured for
individual participants, and the average changes, in each subgroup
in the study (i.e. subgroups under each of the different diagnostic
criteria.)

Yours faithfully,

Mr Courtney

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Mr Courtney left an annotation ( 9 June 2011)

Quote-marks This FOI request follows a previous request to the MRC:
http://www.whatdotheyknow.com/request/re...

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Queen Mary, University of London

9 June 2011

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

Queen Mary, University of London
On 09/06/2011 3:35 PM, Mr Courtney wrote:

Dear Queen Mary, University of London,

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

I would like access to the full raw data from the PACE Trial.

I particularly require the data relating to the changes measured
for each individual participant (i.e. not just the average
measurements), at baseline and at 52 weeks for the primary outcomes
for each of the measured groups in the Trial (The SMC, GET, CBT and
APT groups.)

The same measurements for the secondary outcomes is also required.

I also require the data relating to the changes measured for
individual participants, and the average changes, in each subgroup
in the study (i.e. subgroups under each of the different diagnostic
criteria.)

Yours faithfully,

Mr Courtney

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Queen Mary, University of London

14 June 2011

Dear Mr. Courtney

I am writing to you for clarification on part of your request. Please can
you define more precisely what is meant by "full raw data"?

Please note that we will be unable to process your request further until
we have received a response from you; the 'clock will be stopped' in the
meantime.

Yours sincerely

Paul Smallcombe
Records & Information Compliance Manager
On 09/06/2011 3:35 PM, Mr Courtney wrote:

Dear Queen Mary, University of London,

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

I would like access to the full raw data from the PACE Trial.

I particularly require the data relating to the changes measured
for each individual participant (i.e. not just the average
measurements), at baseline and at 52 weeks for the primary outcomes
for each of the measured groups in the Trial (The SMC, GET, CBT and
APT groups.)

The same measurements for the secondary outcomes is also required.

I also require the data relating to the changes measured for
individual participants, and the average changes, in each subgroup
in the study (i.e. subgroups under each of the different diagnostic
criteria.)

Yours faithfully,

Mr Courtney

-------------------------------------------------------------------
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[1]http://www.whatdotheyknow.com/help/offic...

Please use this email address for all replies to this request:
[2][FOI #74816 email]

Is [3][Queen Mary, University of London request email] the wrong address for Freedom of
Information requests to Queen Mary, University of London? If so
please contact us using this form:
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If you find WhatDoTheyKnow useful as an FOI officer, please ask
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From: Mr Courtney

14 June 2011

Dear Queen Mary, University of London,

Thank you for your reply.

To clarify my request, I would like the individual measurements and
questionnaire scores which were determined during the PACE Trial
(at baseline, 12 weeks, 24 weeks and 52 weeks), for each, and
every,(anonymised) individual participant, for all of the Primary
and Secondary Outcomes. The data much indicate to which of the
treatment groups (APT, CBT, GET and SMC) each set of participant's
data corresponds (i.e. which treatment group the individual
participants were designated to.)

I would also like information which identifies which specific
subgroups each of the participants (i.e. their corresponding
individual measurements) are aligned to: including 'International
CFS criteria', 'London ME criteria', 'Depressive disorder', and
'any psychiatric disorder'.

I would also like the 'duration of illness' information for each
participant, which should identify which treatment group, subgroup
and other categories the participants and their measurements can be
attributed to.

I would also like to know exactly how many participants dropped out
of each group (APT, CBT, GET and SMC) during the PACE trial, when
counted from the very beginning of the trial.

Thank you very much for your cooperation.

Yours faithfully,

Mr Courtney

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Queen Mary, University of London

7 July 2011

Dear Mr. Courtney
Thank you for your emails of 9th and 14th June about the PACE Trial where
you requested data and other information from the trial. I am pleased to
provide a response to your request.

 “I would like the individual measurements and questionnaire scores
which were determined during the PACE Trial (at baseline, 12 weeks, 24
weeks and 52 weeks), for each, and every,(anonymised) individual
participant, for all of the Primary and Secondary Outcomes. The data much
indicate to which of the treatment groups (APT, CBT, GET and SMC) each set
of participant's data correspond (i.e. which treatment group the
individual participants were designated to.)

 “I would also like information which identifies which specific
subgroups each of the participants (i.e. their corresponding individual
measurements) are aligned to: including 'International CFS criteria',
'London ME criteria', 'Depressive disorder', and 'any psychiatric
disorder'.

“I would also like the 'duration of illness' information for each
participant, which should identify which treatment group, subgroup and
other categories the participants and their measurements can be attributed
to.”

Where you have requested results for each individual I can confirm that we
hold this information but cannot supply you with it. This information is
exempt under S.41 of the Freedom of Information Act 2000 (FOIA) as the
information was medical data provided in confidence by participants and
S.43 of FOIA as we believe its release would prejudice our (and others’)
commercial interests.

When participants consented to taking part in the trial, they consented
that the data collected was for limited purposes i.e. for disclosure only
to individuals associated directly with the PACE study for use in this
trial and they were given assurances of confidentiality. The second
principle of the Data Protection Act 1998 does not allow data controllers
to process personal data for further purposes. Since we do not have
consent in order to re-use their data, which may occur if we were to
release the data to members of the public, and the data was provided in
confidence , we are unable to release it to you. Section 41 is an absolute
exemption.

In addition, formal analysis of the data at individual-participant level
is still being undertaken by the trial team. We believe releasing data at
the individual-participant level would prejudice publication of future
study papers. It would also inhibit Queen Mary from maximising the output
from the information obtained and could set a precedent that may affect
our ability to attract research funding and participants in the future.
Like most institutions, Queen Mary depends a great deal on its continued
capability to perform in the Research Excellence Framework and attract
funding from all sources. Higher education institutions face an
increasingly competitive environment. Since disclosure would be likely to
prejudice publication of future papers it could affect Queen Mary and all
the other institutions which contributed to the trial.

Summarised data (primary outcomes, secondary outcomes, sub-group analyses
and duration of treatment per treatment group) have already been published
and is therefore accessible to you by other means (exempt under S.21 of
the FOIA). Other data will be published in future as analysis continues
and so are exempt under S.22 of the FOIA.

 “I would also like to know exactly how many participants dropped out
of each group (APT, CBT, GET and SMC) during the PACE trial, when counted
from the very beginning of the trial.”

This information is exempt under S.21 of the Freedom of Information Act 2000 as it has already been published in the Lancet paper and is therefore accessible to you by other means.
Information on how to do this is available at: [1]http://www.pacetrial.org/ Section 21 is an absolute exemption.

If you are dissatisfied with this response, you may ask the College 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 [2]www.ico.gov.uk for
details.

Yours sincerely

Paul Smallcombe
Records & Information Compliance Manager

S.21 Information reasonably accessible to the applicant by other means
S.22 Information intended for future publication
S.41 Information provided in confidence
S.43 Commercial interests

On 14/06/2011 7:01 PM, Mr Courtney wrote:

Dear Queen Mary, University of London,

Thank you for your reply.

To clarify my request, I would like the individual measurements and
questionnaire scores which were determined during the PACE Trial
(at baseline, 12 weeks, 24 weeks and 52 weeks), for each, and
every,(anonymised) individual participant, for all of the Primary
and Secondary Outcomes. The data much indicate to which of the
treatment groups (APT, CBT, GET and SMC) each set of participant's
data corresponds (i.e. which treatment group the individual
participants were designated to.)

I would also like information which identifies which specific
subgroups each of the participants (i.e. their corresponding
individual measurements) are aligned to: including 'International
CFS criteria', 'London ME criteria', 'Depressive disorder', and
'any psychiatric disorder'.

I would also like the 'duration of illness' information for each
participant, which should identify which treatment group, subgroup
and other categories the participants and their measurements can be
attributed to.

I would also like to know exactly how many participants dropped out
of each group (APT, CBT, GET and SMC) during the PACE trial, when
counted from the very beginning of the trial.

Thank you very much for your cooperation.

Yours faithfully,

Mr Courtney

-------------------------------------------------------------------
Disclaimer: This message and any reply that you make will be
published on the internet. Our privacy and copyright policies:
[3]http://www.whatdotheyknow.com/help/offic...

Please use this email address for all replies to this request:
[4][FOI #74816 email]

If you find WhatDoTheyKnow useful as an FOI officer, please ask
your web manager to suggest us on your organisation's FOI page.
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