PACE Trial: Recovery Rates and Positive Outcome Rates

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,

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 full protocol: Final Protocol, Version 5.0, 1st February 2006, ISRCTN54285094.

Details as follows:

Recovery Rates.

I would like the proportion of participants, in each therapy group, who achieved a 'recovery', as defined in the trial protocol, version 5.0.

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 trial protocol, version 5.0.

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."

Yours faithfully,

Mr Courtney

Queen Mary University of London

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

Queen Mary University of London

1 Attachment

Dear Mr. Courtney

Thank you for your email of 26th October requesting information from the
PACE Trial.

The information you have requested is not held. The requested data
relating to the recovery rates and positive outcomes do not exist. That is
to say that such analyses have not been done and there is no intention to
do so. The reason for this is that the analysis strategy has changed from
the original protocol as described below.

In the original protocol, which was published in 2007 and which is
attached for your convenience, it was stated that it was intended to do
the analysis to produce the data you have requested. As is the normal
process in any clinical trial, a far more detailed analysis plan was
written before any analysis of outcomes, positive or negative. This is
what was said would be done in the original published protocol (page 15).
It was decided not to use the composite measure of positive change in
primary outcome, to which you refer, because this would not properly
answer the Trial’s question of comparing the efficacy of the treatments
and would be hard to interpret. Instead it was decided to compare absolute
values of the two primary outcomes across treatments, a method which was
approved by the two independent committees of the Trial: the Data
Monitoring and Ethics Committee and the Trial Steering Committee. The
final statistical analysis plan, which gives more detail about these
changes, has been submitted to a peer-reviewed journal and will be made
public soon.

Positive changes in the primary outcomes, to which you refer, were
compared in three different ways (by absolute differences between
treatments, by proportions of participants meeting a minimal clinically
important threshold, and by proportions of participants being within
population normal ranges) in the PACE Trial’s main paper, published in The
Lancet in 2011. Therefore, these relevant data are already available in
the public domain.

With regards to the recovery rates: the criteria thresholds for measuring
recovery in the Trial were changed in the light of more detailed
consideration of previous published studies (making the Trial’s analyses
either consistent with these studies or more stringent) and in the light
of newly published work (on the normal range of fatigue in the U.K.
population). These changes were made before analysing any data.  A paper
that includes all analyses on recovery is currently under review by a
peer-reviewed journal. This was submitted for publication two months ago
and we expect to know whether this has been accepted for publication by
the end of this year. If accepted, we would expect this to be published in
the first three months of 2013.

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 [1]www.ico.gov.uk for details.

Yours sincerely

Paul Smallcombe
Records & Information Compliance Manager

References

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

TP Kindlon left an annotation ()

I think it is important to point out that just because the investigators had not seen the full data before making some of the changes, does not mean that they did not have an idea how the trial was going from, for example, their involvement in the trial. What was being measured such as people’s functioning is not something that is hidden away and can only be seen under a microscope (say).

Also, two of the measures Queen Mary, University of London refer to: "proportions of participants meeting a minimal clinically important threshold, and by proportions of participants being within population normal ranges" were actually post-hoc analyses, according the Lancet paper [1], performed after the researchers had seen the data.

References:

[1] White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36. Epub 2011 Feb 18.

TP Kindlon left an annotation ()

The positive outcome data that Mr. Courtney is looking for is actually one of the primary outcome measures [1]. Reporting primary outcome measures (as set out in the trial protocol) is particularly important.

As I mentioned in the last comment, the investigators can have an idea of how the results are going before seeing the full data because what is being measured is not something that is hidden away in a blood test.

The third part of the positive outcome criteria is a measure that combines the two scales (SF-36 and Chalder Fatigue Questionnaire). The only data that has been released that combines the two scales are data from post-hoc analyses, performed after seeing the data (the Minimal Important Change and the percentage in the normal range) [2]. The information for the percentage in the normal range is not particularly interesting as participants could actually deteriorate in the trial on the measures and be counted as being in the normal range. So it is clearly not a good measure of improvement if one can deteriorate and be counted in the group. The other measure of improvement, minimal important change, which was a post-hoc measure (as I pointed out), was extremely broad; for example, by this measure, 65%, 76%, 80% and 65% of people in each of the four trial arms improved with regard to fatigue. This criteria is very lax. The information promised in the protocol is more interesting: it uses a validated definition for the presence/absence of fatigue [3].

References:

[1] White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; PACE trial group. 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. BMC Neurol. 2007 Mar 8;7:6.

[2] White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O'Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36. Epub 2011 Feb 18.

[3] Chalder T, Berelowitz G, Hirsch S, Pawlikowska T, Wallace P, Wessely S, Wright D: Development of a fatigue scale. J Psychosom Res 1993, 37:147-153.

TP Kindlon left an annotation ()

I thought I would point out that this trial cost in the region of £5.0 million of taxpayers' money [1,2].
It would not take much time to look at the data and get these particular answers. The cost of doing this would be minuscule in comparison to the overall cost of collecting the data.

References:
Source 1:

http://tinyurl.com/ydsv857
i.e.
http://www.rae.ac.uk/submissions/ra5a.as...

You are in: Submissions > Select unit of assessment > UOA 9 Psychiatry, Neuroscience and Clinical Psychology > University of Edinburgh > RA5a UOA 9
-
Psychiatry, Neuroscience and Clinical Psychology University of Edinburgh

[..]

"the PACE trial (7 UK centres) of chronic fatigue syndrome (CFS) treatments (MRC; £5.0M);"
--------

Source 2

From figures below:
£2,076,363
£1,800,600
£702,975
£250,000
------
£4,829,938 + DWP money (unknown)

(Yes, this is the same web page as source 1 but it is a summary of a different entry)

http://tinyurl.com/ydsv857
i.e.
http://www.rae.ac.uk/submissions/ra5a.as...

You are in: Submissions > Select institution > Queen Mary, University of London > UOA 9 - Psychiatry, Neuroscience and Clinical Psychology > RA5a Queen
Mary, University of LondonUOA 9 - Psychiatry, Neuroscience and Clinical Psychology
RA5a: Research environment and esteem
[..]
White showed that recovery from CFS is possible following CBT (Knoop et al, 2007). The MRC funded PACE trial, led by White , evaluates CBT, graded exercise, adaptive pacing and usual medical care in the treatment of CFS, and is over half-way completed (http://www.pacetrial.org/) (PACE trial MRC 04-09 £2,076,363, DH Central Subvention 04-09 £1,800,600; MRC PACE trial extension 09-10 £702,975).
=========

SCOTTISH PARLIAMENT - WRITTEN ANSWER

2 December 2005

Health Department

Janis Hughes (Glasgow Rutherglen) (Lab): To ask the Scottish Executive what funding it has awarded for chronic fatigue syndrome/myalgic encephalomyelitis
(CFS/ME) services or research since the CFS/ME short-life working group reported in 2002.

(S2W-20924)
Lewis Macdonald:

NHS Boards are given unified budgets, increased by an average of 7.6% in the current financial year, from which they are expected to meet the costs of services for people with CFS/ME and all other chronic conditions. It is for NHS Boards to decide how their unified budgets should be distributed, based on their assessments of local needs.

The Chief Scientist Office (CSO), within the Scottish Executive Health Department, has responsibility for encouraging and supporting research into health and health care needs in Scotland. CSO is currently contributing £250,000 to the Medical Research Council project 'Pacing, Activity and Cognitive behaviour therapy: a randomised Evaluation (PACE)' which compares
different approaches to the clinical management of patients with CFS/ME.

TP Kindlon left an annotation ()

The recovery data that Mr. Courtney has requested is very important. The form of CBT [1,2] and GET [3,4] that was tested do not simply assume that they can help ME/CFS but actually are based on the theory that the symptoms and problems with functioning are reversible. It is important to know for how many people such a result was achieved.

It appears likely from previous data that the investigators have released that what will be published will be less strict criteria for recovery than what they said they were going to publish in the trial protocol. The more strict the criteria for recovery, the more useful it is in terms of telling us how effective CBT and GET were in terms of doing what they claim to do. It gives us an idea for how many people the model fits.

As I have pointed out, with a trial like this, it is possible for investigators to have an idea how participants are doing even before formally seeing all data. That is why it is so important that the pre-defined outcome measures are published.

References:

1. CBT therapist manual http://www.pacetrial.org/docs/cbt-therap...

2. CBT participant manual http://www.pacetrial.org/docs/cbt-partic...

3. GET therapist manual http://www.pacetrial.org/docs/get-therap...

4. GET participant manual http://www.pacetrial.org/docs/get-partic...

Epson left an annotation ()

The ME Association, with some others, requested this data previously:

"(4). “Recovery” will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less [27], (ii) SF-36 physical Function score of 85 or above [47,48], (iii) a CGI score of 1 [45], and (iv) the participant no longer meets Oxford criteria for CFS [2], CDC criteria for CFS [1] or the London criteria for ME [40].

Our comment: Not Given

We would therefore be interested in receiving the data for ‘recovery’ as defined in the protocol paper and how many participants in each arm of the trial met the criteria specified above after completing treatment?"

http://www.meassociation.org.uk/?p=6171

In their response, Queens Mary claimed that this information is exempt under section 22, as the authors intend to publish these in the future.

http://www.meassociation.org.uk/wp-conte...

It would be good to have some patient organisations pushing to have this data release. If a paper is currently under peer review expressions of public concern could even lead to the peer reviewers requesting that the info on recovery as it was defined in the protocol be included.

Action for ME have previously been involved with PACE, so it would be good if they were now to try to help get access to the data from the trial.

Epson left an annotation ()

It is important that we have access to the data on recovery, to help cut through some of the spin and manipulation of results which has enveloped the presentation of the PACE trial.

We have already seen how a number of researchers and publications took the post-hoc definition for 'normal', and try to class that as recovery, even though it over-lapped with the trials criteria for 'severe and disabling fatigue'. When the protocol indicated that an SF-36 PF score of 85 should indicate recovery, while a score of 65 was part of the inclusion criteria that required severe disability, it is deeply misleading to then try to claim that a score of 60 can be taken to indicate recovery, or what would conventionally be viewed as a normal level of disability. Trying to define normal levels of disability for working age patients by taking the mean - 1 sd for data from of population 25% of whom were aged over 65, included all those with disabilities and short-term ill health, and thus had highly skewed distribution, and a long tail unsurprisingly led to a definition of 'normal' which included the seriously sick and disabled, and over 90% of the working age population.

PACE protocol:

http://www.biomedcentral.com/1471-2377/7/6

Here the Lancet editorial wrongly claim that a score of 60 is the mean minus 1 sd of a healthy person's score:

“PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person's score. In accordance with this criterion, the recovery rate of cognitive behaviour therapy and graded exercise therapy was about 30%” Gijs Bleijenberg, Hans Knoop Chronic fatigue syndrome: where to PACE from here? The Lancet, Volume
377, Issue 9768, Pages 786 - 788, 5 March 2011
doi:10.1016/S0140-6736(11)60172-4 Published Online: 18 February 2011
http://www.thelancet.com/journals/lancet...

Here Trudie Chalder makes claims to the press about getting patients 'back to normal', without making it clear that this definition of 'normal' includes those she earlier classed as suffering from severe and disabling fatigue:

“Trudie Chalder, professor of cognitive behavioural psychotherapy at King's College, London, said that "twice as many people on graded exercise therapy and cognitive behaviour therapy got back to normal" compared with those in the other two treatment groups.” Study finds therapy and exercise best for ME The Guardian, Thursday 17 February 2011 http://www.guardian.co.uk/society/2011/f...

Here the BMJ classed these patients as cured:

"Less than a third of patients were cured by either treatment (30% (44/148) after CBT and 28% (43/154) after graded exercise therapy)."

http://www.bmj.com/content/342/bmj.d1168

Esther Crawley was the corresponding author on a paper which further spun these results, claiming that PACE showed a recovery rate of 30-40%:

“Evidence from a recent evidence trial of cognitive behavioral therapy and graded exercise therapy indicated a recovery rate of 30-40% one year after treatment.”

http://www.biomedcentral.com/1472-6963/1...

Given the willingness of researcher making money from these treatments to spin their results in ways which published protocols were supposed to counter, FOIs seem to be the only way that we are likely to gain access to an accurate understanding of the results from this medical research.

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'.

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

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 full protocol: Final Protocol, Version 5.0, 1st February 2006, ISRCTN54285094.

It should be noted that the requested analyses (the 'positive outcome' data, and the 'recovery' data) were all proposed in the published protocol, as well as in the final protocol described above.

The details of the published protocol are as follows:

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

It should also be noted that the requested 'positive outcome' data, was the main 'primary outcome' analysis that was proposed in the final and published protocol.

Full details of my FOI request and all correspondence is available on the Internet at this address:
http://www.whatdotheyknow.com/request/pa...

Yours faithfully,

Mr Courtney

J. Mitchell left an annotation ()

QMUL's reply to the current FOI request states that "In the original protocol, which was published in 2007 and which is attached for your convenience, it was stated that it was intended to do the analysis to produce the data you have requested. As is the normal process in any clinical trial, a far more detailed analysis plan was written before any analysis of outcomes, positive or negative. This is what was said would be done in the original published protocol (page 15)". This is not what the trial protocol said would be done however, as what the trial protocol actually says is that "A full Analysis Strategy will be developed, independently of looking at the trial database, and before undertaking any analysis. This paper summarises the analysis plan". By stating that the trial protocol summarizes the analysis plan, this means that the trial protocol is simply a condensed version of what would occur in the full analysis plan. This does not mean that every single one of the outcome measures which were set forth in the trial protocol would be abandonded in favor of substantially reduced outcome measures, in fact such an assertion raises the question of what would even be the purpose of publishing a trial protocol to begin with if every single one of the outcome measures set forth in that published protocol were simply to be abandoned in favor of substantially reduced measures.

As for QMUL's other assertion that abandoning every single outcome measure which was set forth in a published trial protocol, ie both primary and secondary outcome measures, reporting of harms, etc, being part of the 'normal process in any clinical trial', this also does not seem to be the case. Contrary to QMUL's assertion, such behaviour in fact seems positively contradictory to sound practice, at least according to what Fiona Godlee, current editor in chief of the BMJ, had to say in a 2001 editorial on the subject- “In 1999, Iain Chalmers, director of the UK Cochrane Centre, and Doug Altman, of the ICRF Statistics Group in Oxford, called for journals to play a more radical role in the prevention of poor medical research. Most useful, they suggested, might be the publication of protocols for proposed or ongoing research, and in particular, protocols of randomised controlled trials…A protocol is a crucial part of any study. It is a statement of intent. It provides a detailed account of the hypothesis, rationale, and methodology, and is a plan for all the investigators to follow…Protocol publication allows easier comparison between what was originally intended and what was actually done. It reduces the potential for ‘data dredging’ - where associations are sought or stumbled upon during data analysis rather than hypothesised a priori. It also reduces the potential for unacknowledged or post-hoc revision of the study aims, design, or planned analyses. Such practices are not only detrimental to the advancement of medical research, they are ethically unsound since they may result in patients receiving inappropriate care." (1) Seeing as how several of the outcomes which have been widely reported in the media concerning PACE's supposed efficacy arose from such post-hoc analyses it is hard to imagine a better real-world example of what Dr. Godlee was writing about.

Furthermore, the editors of BioMedCentral, the online journal in which the PACE trial protocol was published, also did not seem to think that changes would be made to the protocol since they explicitly stated such in their Editor's comment on the PACE trial protocol on the BioMedCentral website- “This study protocol was not peer reviewed by the journal because it had already received "ethical" and funding approval by the time it was submitted. These processes of approval usually involve peer review. Also, once approved, the authors/investigators are unlikely to be able to make revisions to their protocol. On balance, then, the editors of this journal have accepted the protocol because the authors were able to supply evidence of both types of approval... We strongly advise readers to contact the authors or compare with any published results article(s) to ensure that no deviations from the protocol occurred during the study.”

Finally, in the PACE authors' request for Substantial Amendment 5.1 made to the West Midlands Research Ethics Committee dated 20th Febuary 2006, Peter White, Co-Principle Investigator (PI) of the PACE trial, requested that PACE's entry criteria be raised from a SF-36 PF score of 60 to a 65 'in order to increase recruitment'. As part of the justification given for this request for substantial amendment, Prof. White assured the MREC that "This would mean the entry criterion on this measure was only 5 points less than the categorical positive outcome of 70 on this scale. We therefore propose an increase of the categorical positive outcome from 70 to 75, reasserting a 10 point score gap between entry criterion and positive outcome. The other advantage of changing to 75 is that it would bring the PACE trial into line with the FINE trial, an MRC funded trial for CFS/ME and the sister study to PACE." (3) With QMUL acknowledging in their response to the current FOI request that there is no intention to do these analyses and since there is no record of the authors asking for or receiving approval from the MREC for any subsequent alterations to PACE's entry criteria or positive outcome measures, it would appear that this means that the West Midlands MREC was given false information by PACE's Co-PI in support of making this substantial amendment to PACE. It is also questionable whether these requested changes to PACE would have been approved by the WMREC had such assurances not been made.

Given that every single one of the numerous changes made thus far to PACE's planned analysis have had the direct impact of either making it easier for the authors to report improvements and/or making it harder for participants to report being made worse, perhaps QMUL will be understanding if its claims from Nov. 1st that the recovery criteria which were set out in PACE's trail protocol are to be made more strict rather than less are met with some degree of skepticism by those who have been following the trial's progress.

1. Fiona Godlee ‘Publishing study protocols: making them visible will improve registration, reporting and recruitment’ BMC News and Views 2001, 2:4 http://www.biomedcentral.com/content/pdf...

2. Editor's comment- Title: 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 standardized specialist medical care alone for patients with the chronic fatigue syndrome / myalgic encephalomyelitis or encephalopathy
http://www.biomedcentral.com/imedia/2095...

3. Request for Substantial Amendment 5.1 to the PACE Trial, 20th February, 2006

Epson left an annotation ()

I will include a link to the cost-effectiveness PACE paper. Although not much is made of it, it does include data which shows that adding CBT and GET to SMC did not bring about an improvement in employment rates. Were a significant portion of patients to truly be recovering as a result of these interventions, or just gaining truly meaningful improvements in their health, one would expect this to lead to some improvements in their levels of employment too.

http://www.plosone.org/article/info%3Ado...

Queen Mary University of London

2012/148

Dear Mr. Courtney

We have responded previously that the information you have requested is
not held, in line with Section 1(1) of the Freedom Of Information Act
2000, as the final analysis strategy changed from that proposed in the
protocol. Positive primary outcome data were published in 2011 and
recovery data is currently under review, having been submitted for
publication to a peer reviewed journal.

Effectively this is a repeated request and is refused under s.14(2) of
FOIA.

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

Yours sincerely

Paul Smallcombe
Records & Information Compliance Manager

References

Visible links
1. file:///tmp/www.ico.gov.uk

TP Kindlon left an annotation ()

I don't accept the information isn't held. The values can be easily calculated: it would not take much time.

The outcome measures were changed years after the trial started when many, probably most, patients had completed all their treatment. As I have mentioned, it is quite possible that people involved in the trial had a sense of how the trial was going and this could have influenced the change.

Outcome reporting bias is the term that comes to mind. Such a change would be frowned on if a pharmaceutical company did this. It is unclear why it should be acceptable in a trial that cost around £5 m of taxpayers' money: perhaps because the therapies are nonpharmacological, some people are less vigilant about such issues, but that is not a good approach especially when nonpharmacological therapies are promoted as primary therapies for ME/CFS and in effect could be said to be in competition with pharmacological therapies. Also, there can be conflicts of interest, both intellectual and financial, with nonpharmacological therapies just as there can be with pharmacological therapies.

Mr Courtney left an annotation ()

This FOI request will now be taken forwards as a formal complaint to the Information Commissioner.

J Stone left an annotation ()

Today a request for the raw PACE trial data has been submitted to the Queen Mary, University of London, and the Department of Health.

J Stone left an annotation ()

Not knowing how this site operates the FOI has been made separately. Therefore others may wish to also put in an FOI through "What do they know?".

A request for the raw data has been submitted to the Department of Health, who have already replied to say they do not hold this information. As well as the MRC, Lancet and Queen Mary, University of London.

Mr Courtney left an annotation ()

I was unable to take this FOI request forward as a complaint to the ICO because of timing issues. So I have had to re-submit the FOI request. The new (identical) FOI request can be found here:
https://www.whatdotheyknow.com/request/p...