CFS - a small % of the objective physical and physiological data from PACE trial

Kathryn Dickenson made this Freedom of Information request to Queen Mary University of London

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was refused by Queen Mary University of London.

Kathryn Dickenson

Dear Queen Mary, University of London,

I refer to FOI 2017/F158, which details why I am requesting the release of some of the objective, physiological and physical raw data from the PACE trial and contains links to letters/articles written by expert scientists, about the misleading claims made by PACE trial authors.

I have amended my request in response to your claim that it would cost more than 450 pounds to provide the objective data requested in FOI 2017/F158, and hence refusal of the request.

In this amended request, I have reduced or removed, the following items:
(a) the number of time points;
(b)exercise and activity scale data;
(c)physical and physiological data specified in version 7 of the PACE manual, but not directly specified, in the 2007, published protocol
(d) data that separates patients with depressive or psychiatric disorders from those without mental health issues , who "just" have CFS.
(e) VO2 max test results (which you advise were not obtained)

My amended information request is as follows:
i/ Actometer results (BMC reference 18) – raw data actometer, baseline measurements.
ii/ 6 minute walk objective measure of recovery (BMC reference 31).
iii/ Self-paced step. Test of fitness (BMC reference 43), including the Borg test (scale of perceived exertion) and end heart rate.

This information is requested for two of the specified time periods:
iv/ Baseline
v/ Final assessment – 52 week/39 week time point

Yours faithfully,

Kathryn Dickenson

Kathryn Dickenson

Dear Queen Mary, University of London,

To clarify this request is a narrowing of FOI 2017/F158, which QMUL refused on the basis that:
i) the PACE trial authors did not obtain the data from all the objective outcome measures specified in the PACE manual (version 7),
ii) it would cost more than 450 pound, to provide a copy of the raw data from the objective outcome measures, that PACE authors did collect.

I have marked FOI 2017/F158, as refused, as per QMUL's advice. I was advised that it was prudent to start afresh, in order to avoid any legal debate about whether a refused request could be subsequently, narrowed and restarted.

Note the reasons for requesting this data (i.e. non vexatious) and links to relevant research and expert comment detailed in FOI 2017/F158, also relate to this narrowed request.

I look forward to your response.

Yours faithfully,

Kathryn Dickenson

Kathryn Dickenson

Dear Queen Mary, University of London,

I am writing to remind QMUL that it has a legal obligation to respond promptly to a request and that a response to this request is due by 11 July 2017, at the latest.

Yours faithfully,

Kathryn Dickenson

Kathryn Dickenson

Dear Queen Mary, University of London,

I am writing to remind QMUL that by law, public authorities must respond promptly to requests for information, requested under the FOI Act and that legally you must respond within 20 working days.

Your response to this request is overdue.

Please advise when a response will be forthcoming.

Yours faithfully,

Kathryn Dickenson

Kathryn Dickenson

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 'CFS - a small % of the objective physical and physiological data from PACE trial'.

QMUL has not responded to my request for this data that was collected by the PACE trial principal investigators Micheal Sharpe, Peter White and Trudi Chaldler, under the guidance of the principal adviser Simon Wessley. Nor has QMUL responded to my emails chasing up a response.

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

Note that this request for a small % of the objective data from the 5 million pound PACE trial, was drafted after my request for all of the objective trail data was refused on the basis of cost.
Yours faithfully,

Kathryn Dickenson

Kathryn Dickenson

Dear Queen Mary, University of London,

I am concerned that your failure to respond this request and to my original request for all the objective physical and physiological data, promptly and within 20 days, is putting the health of CFS patients at risk UK wide.

QMUL must be aware of the dichotomy between UK mental health "experts" proclaiming CFS to be a mental health disease and graded exercise therapy (GET) to be safe and the USA , patients and exercise physiologists who on the basis of objective research findings, patients and patient carers reports have found GET to be extremely harmful.

The USA Centre for Disease Control's is so concerned about the negative impact of GET on the health of patients with CFS (and its lack of effectiveness) that it has removed all reference to GET from its website.

The requested information is required urgently, as the time frame for stakeholders to make a submission substantiating why NICE should overturn its decision not to up date its guideline for CFS is only a few days.

I will bring the fact that QMUL's failure to comply with its legal obligations to respond to requests as required by law has serious health implications for patients and hence tax payers to the attention of the Information Commissioner and hold QMUL responsible for all legal costs associated with this matter.

Yours faithfully,

Kathryn Dickenson

Kathryn Dickenson left an annotation ()

Cognitive behaviour therapy and objective assessments in chronic fatigue syndrome

Graham McPhee

Abstract Most evaluations of cognitive behavioural therapy to treat people with chronic fatigue syndrome/myalgic encephalomyelitis rely exclusively on subjective self-report outcomes to evaluate whether treatment is effective. Few studies have used measures appropriate to assessing whether cognitive behavioural therapy changes in more objective measures. A review of studies incorporating objective measures suggests that there is a lack of evidence that cognitive behavioural therapy produces any improvement in a patient’s physical capabilities or other objective measures such as return to work. Future studies of chronic fatigue syndrome/myalgic encephalomyelitis should include some objective assessments as primary outcomes. If this is to include activity monitors, we first need a sound baseline dataset.
Journal of Health Psychology 1-6
2017
DOI:10.1177/1359105317707215
Journals.sagepub.com/home/hpo

Kathryn Dickenson left an annotation ()

Graham McPhee requested the objective data from PACE via a FOI request, QMUL responded advising that his request was vexatious. QMUL's response to my original request for all the objective data was to say the provision of the data would cost more than 450 pounds.

Kathryn Dickenson

Dear Queen Mary, University of London,

I have referred your no response to this request for Internal Review as you will be aware.

I will lodge a complainant with the Information Commissioner in relation to the failure of QMUL to comply with its legal obligations under the FOI Act, i.e. the requirement to response promptly and within 20 days of the request.

Yours faithfully,

Kathryn Dickenson

Queen Mary, University of London FOI, Queen Mary University of London

Dear Kathryn Dickenson

We are planning to respond to this request and apologise for the delay.

Yours sincerely

Queen Mary University of London

Kathryn Dickenson

Dear Queen Mary, University of London FOI,

I have previously detailed why delays in the provision of the objective raw data from the PACE trial, may adversely affect chronic fatigue syndrome (CFS) patients ie the data is required for a submission to NICE.

The use of graded exercise therapy (GET) and cognitive behavior therapy (CBT) as described in the PACE trial as "treatments" for CFS, have been rejected by the USA Centre for Disease Control (CDC). It is expected that the objective raw data will substantiate the view of the CDC.

The non-release of the objective raw data from the UK tax payer funded the 5 million pound study enables the PACE authors, to continue to peddle their false belief that GET and/or CBT result in improved health in patients with CFS throughout the UK.

QMUL appear to be complicit in perpetuating the PACE authors misleading claims.

Since your apology appears to be merely a delaying tactic, I need to proceed with lodging a complaint to the Information Commissioner.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson left an annotation ()

Another ‘False Start’ in ME/CFS Clinical Trials: The GETSET Study by Todd Davenport, Associate Professor and Program Director, Department of Physical Therapy, University of the Pacific.

I am a physical therapist, and movement is my medicine. Some people might need more movement, in the
form of an exercise program, while some people might need less movement, in the form of a pacing program.
I rely on scientific studies to help me decide who might benefit from which kind of treatment. Science helps
me assign probabilities to outcomes, which I can then use to work with my patients collaboratively to
establish the best possible treatment program to help them meet their goals. Reliable data from valid
scientific studies can help me be more confident as a clinician that the decisions I make together with my
patients actually will help them.

After starting my research career conducting clinical studies related to other fatiguing health conditions, I’ve
now worked in the field of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) for over 10 years.
During that time, I’ve been fortunate to work with a caring and dedicated group of scientists and advocates.

To say that the body of intervention studies in ME/CFS has involved disappointingly (and sometimes
breathtakingly!) poor science is an understatement. The trend of poorly designed intervention studies, most
recently headlined by the PACE trial, has just led to reinforcement of erroneous perceptions about ME/CFS
without providing the tools necessary for clinicians like me to help ameliorate the devastating impact of
ME/CFS on real peoples’ lives. So, it was with great interest that I read the GETSET study, which was recently
published in the Lancet.

All the things that made me uneasy as a physical therapist about the PACE trial are back, now in the form of a
study involving a slick self-help guide. It’s the same confirmation bias of telling folks to move in the context of
a graded exercise program, and then having them parrot back the study hypothesis on standardized
questionnaires. It’s the same absence of objective activity measures that result in the same self-fulfilling
prophecy of telling people to move more, and then declaring victory when some of them are actually able to
do it. It’s the same disregard for foundational scientific evidence of aerobic system compromise, immune
activation, and other forms of organic pathophysiology in favor of a behavioral approach to ‘tell the tired
people to move more.’

http://www.workwellfoundation.org/wp-con...

QM FOI Enquiries, Queen Mary University of London

1 Attachment

FOI 2017/F158

 

Dear Kathryn Dickenson

 

Thank you for your email. We have not treated this as a new request but
rather as a narrowing of your request received on 08/05/2017, which was
initially refused on 05/06/2017. I apologise for the slight delay in
responding.

 

You have requested:

i/ Actometer results (BMC reference 18) – raw data actometer, baseline
measurements.

ii/ 6 minute walk objective measure of recovery (BMC reference 31).

iii/ Self-paced step. Test of fitness (BMC reference 43), including the
Borg test (scale of perceived exertion) and end heart rate.

 

This information is requested for two of the specified time periods:

            - Baseline

            - Final assessment – 52 week/39 week time point

 

The 6 minute walking test measures are attached as these are already in
the public domain.

 

I am afraid that the rest of your request remains impossible to fulfil
without exceeding 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. The extraction and analysis required
must be done by a statistician and QMUL does not employ one for PACE.

 

If you are dissatisfied with this response, you may ask QMUL 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/

Kathryn Dickenson

Dear QM FOI Enquiries,

My original request, (your reference number FOI 2017/F158) was made on 5 May 2017 - refused on 8 June 2017, due a claim that it would cost more than 450 pounds to provide the information.

On 13 June 2017, I submitted a narrowed request, which I will refer to as FOI 2017/F158 (b) - refused on 25 July 2017, due a claim that it would cost more than 450 pounds to provide the information.

None of the information, that was not already in the public domain, has been provided, nor has QMUL responded promptly to the request/s.

I contend that some of the 5 million pounds of tax payers money, spent on the PACE trial, would have included putting the actometer and the self paced STEP test results into a table.
As illustrated by the table of the 6 minute walking test data, (that QMUL provided as it was already in the public domain), the information requested is not onerous, and is merely the content of two small tables.
I contend that locating, retrieving and extracting the table of results, will not cost more than 450 pounds i.e. take more than 18 hours.
I contend that the claim QMUL by staff that they can not find these tables in less than 18 hours is preposterous.
I contend that a willing person, could find the data in minutes, if not seconds.
I suggest that a search entry such as "Peter White", "PACE trial", "actometer results" "STEP test results" in the QMUL database would quickly locate the data.

I request that QMUL, complies with its legal obligation to the UK tax payers, and promptly provides the following information:
i/ Actometer results (BMC reference 18) – raw data actometer, baseline
measurements.

ii/ Self-paced step. Test of fitness (BMC reference 43), including the
Borg test (scale of perceived exertion) and end heart rate.
This information is requested for two of the specified time periods:
- Baseline
- Final assessment – 52 week/39 week time point

As detailed in previous correspondence, the non-provision of objective data from the PACE trial is harmful to people with chronic fatigue syndrome (CFS) and the release of this data is in the public interest.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson left an annotation ()

No confidence’: Charities reject NICE ‘no update’ proposal for ME/CFS guideline
Support for CBT and GET, the treatments in question, is largely due to the claimed results of the UK PACE Trial. However, 42 experts wrote an open letter accusing the researchers of that trial of bias and misrepresentation.

‘The investigators violated their promise in the PACE protocol to adhere to the Declaration of Helsinki, which mandates that prospective participants be ‘adequately informed’ about researchers’ “possible conflicts of interest.” The main investigators have had financial and consulting relationships with disability insurance companies, advising them that rehabilitative therapies like those tested in PACE could help ME/CFS claimants get off benefits and back to work. They disclosed these insurance industry links in The Lancet but did not inform trial participants, contrary to their protocol commitment. This serious ethical breach raises concerns about whether the consent obtained from the 641 trial participants is legitimate,’ says the letter published at Virology.

Invest in ME Research also rejects the trial’s claims, saying, ‘The PACE Trial is null science, bad science, discredited science, its worth is only to demonstrate how research should not be conducted.’

After a Freedom of Informational tribunal ruled that the authors of the PACE Trial had to publish their raw data, unusual changes to trial outcome measures were discovered, and the data was reanalysed by a number of different parties. Critics of the PACE Trial and GETSET trial have pointed out that only a small number of patients seem to improve with these treatments, and that a significant number report getting worse, especially after GET.

An open critique of the PACE Trial was also published by Rebecca Goldin, the director of Stats.org and Professor of Mathematical Sciences at George Mason University. Goldin writes, ‘The question of how all this happened and how the criticism is being handled have sent shockwaves through medicine. The results from PACE (including these) have been published in prestigious journals and influenced public health recommendations around the world; and yet, unraveling this design and the characterization of the outcomes of the trial has left many people, including me, unsure this study has any scientific merit. How did the study go unchallenged for five years?’

ME Action wrote, ‘We would like to make clear that our concerns about methodology extend beyond the PACE trial to include the entire body of GET/CBT research, where it relies on the flawed combination of unblinded randomisation and subjective outcomes (Helmfrid, 2016). We ask that such clinical trials be excluded or downgraded.’

http://vadamagazine.com/news/no-confiden...

Kathryn Dickenson left an annotation ()

The NICE guideline for CFS/ME is not fit for purpose and needs a complete revision

“I think that the single most damaging misconception perpetrated on ME patients is
the idea that deconditioning is the problem and that exercise is the antidote.
“I have seen many people now, well-motivated, who have made themselves much
worse with exercise, often on the advice of their GPs who have been gullible enough to
swallow the deconditioning hypothesis.
“I think this needs to be properly emphasised with NICE, otherwise their advice
concerning graded exercise will always be assumed to be "exercise to fitness" which
is always destructive.
“Sadly, the people who get worse with exercise, because they exceed their anaerobic
threshold on multiple occasions with further reduction of the latter, are then assumed
to be imagining their disability and treated accordingly. It would be farcical if it wasn't
so serious.”
Dr Weir has asked if his comments might be added to the evidence that has already been
submitted by the ME Association for the consultation.
Finally, could I draw your attention to the submission from the Countess of Mar and
members of the Forward ME Group of charities:
http://www.forward-me.org.uk/Reports/10%...
This response focusses on the important issues of ethics and informed consent.
The NICE guideline was published in 2007 and it has not been changed in 10 years despite
advances in our knowledge-base and its testing on many thousands of people with ME/CFS.
In our opinion, it is fundamentally failing to serve the need of patients and we call on you to
help us work with NICE to achieve something demonstrably better.
I would welcome the opportunity to come and discuss the situation outlined by the petition
and in our submission to NICE with you at your earliest opportunity.
In the meantime, I look forward to hearing your response to the petition so that I might pass
your words on to our supporters.
Yours sincerely,
Dr Charles Shepherd
Hon Medical Adviser, ME Association.

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

Kathryn Dickenson

Dear QM FOI Enquiries,

To avoid future confusion if the case goes to the First Tribunal, I've been advised to mark this request refused as per the advice from QMUL and submit an amended request, without the request for the 6 minute walking test as that information is in the public domain.

Yours sincerely,

Kathryn Dickenson

Linked to:

FOI 2017/F158
Links to previous requests, annotations and history:
https://www.whatdotheyknow.com/request/c...
https://www.whatdotheyknow.com/request/c...

A Baldwin left an annotation ()

In a response to Anna Wood's FoI concerning the mean 6mwt distances for people who they claimed were recovered QMUL claimed that it would take them over 18 hours to calculate.

After the release of data for Mr Matthees's FoI it tool me about an hour to calculate these values. Most of that time was taken working out how they had changed the Oxford definition within the recovery paper to include additional thresholds.

Point being I would not believe their work estimates.

Kathryn Dickenson

Dear QM FOI Enquiries,

I am not sure which is the most appropriate way forward with this request and have submitted a narrowed request given that some of the 6 minute walking test data is in the public domain. I am also detailing the need for an internal review here.

The claim by QMUL that it would take more than 18 hours and cost more than 450 pounds to provide the information requested in FOI 2017/F158 (b), is at odds with reality.

The volume of information requested is less than one gigabyte and is most likely located in a file adjacent or near the 6 minute walking trial data.

My interest in the objective data, is because patients are using bio feed back such as continuous heart rate monitoring, and following the Workwell video's to improve their quality of life.

I want to see how the PACE trial objective outcomes compare to the scientific and physiologically based methods being used successfully by patients worldwide.

The PACE trial for all its flaws and faults did collect some objective data from 640 patients with CFS. This data does not appear to be being collected by NHS clinics hence is not able to be obtained elsewhere.

The 6 minute walking test data showed that after a year of the PACE GET, the patients could walk on average an extra 30 metres, this result appears to be significantly less than the results being obtained by individualised, physiologically based programs.

It is not onerous for QMUL to produce the requested data , it might take a couple of minutes to locate the file and a couple more minutes to upload the data to this website.

It is in the tax payers and patients interests to facilitate open and honesty in scientific research and to cease protecting those whose agenda is at odds with scientific progress, regardless of the human cost of their false belief systems.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

Dear QM FOI Enquiries,

The Information Commisioner's office advises that it is reasonable to expect a response to a request for an internal review within 20 days of the request being made.

It is now over 3 months since I first lodged a request for the release of objective data from the PACE trial with QMUL.

It is nearly 2 months since I lodged this narrowed request with QMUL.

Does QMUL intend to respond to this request for an internal review? If so when? If not why not?

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

Dear Queen Mary, University of London,

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

I refer to my request an internal review of Queen Mary, University of London's handling of my FOI request 'CFS - a small % of the objective physical and physiological data from PACE trial' , submitted 13 June 2017.

I refer QMUL to the What do you know website:
"Internal reviews should be quick. If one takes longer than 20 working days then the authority should write and let you know, and it should never take longer than 40 working days (see this good practice guide). You will then either get the information that you originally requested, or you will be told that the review upholds the original decision."

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

Yours faithfully,

Kathryn Dickenson

Kathryn Dickenson left an annotation ()

PACE authors are not the only ones who drop objective measures of the trial participants physical functioning ( actometer /actigraph results). The PACE authors colleagues in the Netherlands did the same and this paper details how subjective results are over inflated and no borne out by the objective findings.

http://www.mdpi.com/2076-328X/7/3/52/htm
Open Access
Behavioral Sciences 2017, 7(3), 52; doi: 10.3390/bs7030052
Review
FITNET’s Internet-Based Cognitive Behavioural Therapy Is Ineffective and May Impede Natural Recovery in Adolescents with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. A Review
Simin Ghatineh 1 and Mark Vink 2,*
1 Biochemist, London TW11, UK
2 Soerabaja Research Center, 1096 HH Amsterdam, The Netherlands
* Correspondence:
Received: 6 April 2017 / Accepted: 2 August 2017 / Published: 11 August 2017
Abstract: The Dutch Fatigue In Teenagers on the interNET (FITNET) study claimed that after 6 months, internet based cognitive behaviour therapy in adolescents with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), led to a 63% recovery rate compared to 8% after usual care, and that this was maintained at long term follow up (LTFU). Our reanalysis shows that their post-hoc definition of recovery included the severely ill, the unblinded trial had no adequate control group and it used lax selection criteria as well as outcomes assessed via questionnaires rather than objective outcomes, further contributing to exaggerated recovery figures. Their decision not to publish the actometer results might suggest that these did not back their recovery claims. Despite these bias creating methodological faults, the trial still found no significant difference in recovery rates (“~60%”) at LTFU, the trial’s primary goal. This is similar to or worse than the documented 54–94% spontaneous recovery rates within 3–4 years, suggesting that both FITNET and usual care (consisting of cognitive behaviour and graded exercise therapies) are ineffective and might even impede natural recovery in adolescents with ME/CFS. This has implications for the upcoming costly NHS FITNET trial which is a blueprint of the Dutch study, exposing it to similar biases.

Queen Mary, University of London FOI, Queen Mary University of London

Dear Kathryn Dickenson

Please clarify that you wish QMUL to carry out an internal review of this request despite the fact that you have subsequently submitted a new request, which narrows the original.

We have presumed that the latter request superseded this one, with the effect that this one has been withdrawn.

Yours sincerely
Paul Smallcombe
Queen Mary University of London

Kathryn Dickenson

Dear Queen Mary, University of London FOI,

I apologise for any confusion, I would like all the information requested.

The reason that, I narrowed the request was to obtain at least some of the information, within a reasonable time frame.

To date, I have not received any information.

We are talking about a few tiny tables of data of only a few hundred kilobytes.

Yours sincerely,

Kathryn Dickenson

QM FOI Enquiries, Queen Mary University of London

FOI 2017/F248
 
Dear Kathryn Dickenson
 
Thank you for your reply. It is not altogether clear when overlapping
requests are received before we have had an opportunity to respond.
 
Given your reply, please confirm that you wish to withdraw the request
made in your email of 7^th August at 1.30a.m. Or do you wish us to refuse
that under s.14(2) of the Freedom of Information Act 2000, since it
repeats in part what you have requested in the present request, in order
to close that one? We have received at least 16 emails from you since May
and in some cases you have requested internal reviews only to put in a
narrowed request, or before the time for compliance has been reached. We
currently have two open requests from you: this one due on 25^th August
and the one of 7^th of this month due on 5^th September.
 
Please clarify that by 'all the information requested' you are referring
to your email of 27^th July, which QMUL has assigned the reference above,
if you wish for us to deal with this one.
 
Yours sincerely
 
Paul Smallcombe
Queen Mary University of London
 

Kathryn Dickenson

Dear QM FOI Enquiries,

I request all the information that I have asked for. I apologise for the confusion, I am profoundly ill with ME/CFS and have the physical and physiological abnormalities detailed, in the International Consensus Criteria 2011 and the Canadian Consensus Criteria 2003, this adversely impacts on my cognition, especially after exertion.

In my opinion instead of prevaricating and debating the semantics of my request, if QMUL was acting in good faith. you would take a few minutes, to upload the requested information, to this website.

It would be much appreciated if the broadest list of information was provided.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

Dear QM FOI Enquiries,

As QMUL is aware I have narrowed this request down further this is because as explained to QMUL, in previous correspondence, I require the data urgently as information for a submission to NICE regarding their decision not to update their 2007 Guideline for CFS.

The QMUL claim that it has not had "an opportunity to respond", is at odds with its legal obligation to respond promptly. On 5 June 2017, QMUL advised that it had ascertained that it holds the data requested, when responding to my original request of 6 May 2017.

It is now more than 70 days since this narrowed request, of data that QMUL has determined that it holds, was lodged on 13 June 2017. In my opinion is ample time for QMUL, to comply, with its legal obligation to provide information to the public.

It is not as if the volume of data I have requested is onerous. I estimate the data to be around 2-4 (at most) pages of information, less than 100 kB, as per the 6 minute walking test data was a 17 kB file, a 3 column table that bleed onto a second page.

I have attached a summary of the information regarding my request for objective data from the PACE trial. The full information e.g working links to the annotations are available on the What do they know? website.

Yours sincerely,

Kathryn Dickenson

FOI requests for PACE objective raw data.

Summary
Reference numbers and links to the website, What do they know?
FOI 2017/F158 - 6 May 2017-KD Submitted an FOI request via What do they know? QMUL gave it the reference number FOI 2017/F158.
Request entitled: CFS - PACE trial objective data enable comparison with patients own objective data. https://www.whatdotheyknow.com/request/c....
6 June 2017 KD narrowed the request and removed the information that QMUL stated that they did not hold most of the information and that given the time already taking ascertaining what they held it would be to onerous for QMUL to provide the information.
8 June 2017 KD narrowed the request yet again.
QMUL refused the request.
FOI 2017/F158 (b) 13 June 2017-KD Submitted a narrowed, FOI request via the website What do they know?
Request entitled: CFS - a small % of the objective physical and physiological data from PACE trial
Link to the request:
https://www.whatdotheyknow.com/request/c...
QMUL said that they were treating it as a continuation of the previous request. KD refers to it by the reference number FOI 2017/F248 (b). The request was refused currently with internal review
FOI 2017/F158 (c) 27 July 2017 KD submitted a narrowed, FOI request via What do they know?
Entitled: CFS - a small % of the objective physical and physiological data from PACE trial (6 minute walk test already in public domain).
Link to the request:
https://www.whatdotheyknow.com/request/c...
KD refers to this request as FOI 2017/F158 (c)
No response to this request was received from QMUL. The request was withdrawn on 19 August 2017, as it did not fufil its intended purpose of clarifying the FOI status.
FOI 2017/F158 (d) FOI 2017/F255 7 August 2017, KD submitted a narrowed FOI request via What do they know?
Entitled: CFS- a request for even less objective info from the PACE trial just the STEP test results at baseline and 52 weeks
Link to the request:
https://www.whatdotheyknow.com/request/c...
KD has used the reference number FOI 2017/F158(d) to refer to this request, however on 17 August 2017 QMUL gave the narrowed request a new reference number i.e. FOI 2017/F255. QMUL refused the request on the basis that the request is a narrowing of the request FOI 2017/F158(b), and hence overlaps with it. The refused request is with QMUL internal review
--------------------------------------------------------------------------------------------------------------
Timeline
FOI request lodged via the website, What do they know?
6 May 2017- FOI 2017/F158
CFS - PACE trial objective data enable comparison with patients own objective data. https://www.whatdotheyknow.com/request/c....
“Dear Queen Mary, University of London,
I am writing to request the release of the objective physiological and physical data, collected during the PACE trial, and at follow up. This data was collected according to the procedures detailed in the PACE trial manual and the trial protocol published in the BMC in 2007 and follow up papers.
It is appropriate to release this data since, the State, and taxpayers, ultimately fund clinical research for the benefit of patients, so it’s important patients are provided with accurate, reliable information on the effectiveness of any proclaimed treatments.
This is particularly imperative in cases such as the PACE trial, where the beliefs and claims made by the authors, their colleagues and the insurance industry appear to be at odds, with the patient experience of living with the disease, biomedical research findings, physiological findings and those of CFS clinicians based outside the mental health field.
There is no evidence that the disclosure of the trial’s objective raw data will prejudice to QMUL’s research programme, reputation, or funding streams. In the contrary, it could be claimed, that the non-release of the data, may look like an attempt to hide scientific findings from scrutinty and be harmful to the universities reputation.
I request this data so that myself and other independent researchers may determine the effect of PACE-style GET, CBT, APT and SMC on reducing physiological/physical dysfunction in patients with CFS.
I request, that the data is provided in a manner that enables me to distinguish between data from patients with CFS and those with mental health disorders, since these 3 patient cohorts were included in the PACE trial:
(i) Patients diagnosed with CFS and no mental health disorders
(ii) Patients diagnosed with psychiatric disorder
(iii) Patients diagnosed with depressive disorder
This separation of patient streams is necessary as the mixing of patients diagnosed with psychiatric and depressive disorders and “pure” CFS patients, may severely affect the results and compromise the conclusions. Other, authors have found that CFS and mental health disorders respond very differently and in opposite directions to exertion and exercise and in fact this difference may be used, in part, to distinguish between the disease CFS and mental health disorders [1]. In addition, the recent Centre for Disease Control multi-site clinical study, found severe physiological and biological abnormalities in patients with CF, yet these very ill patients had good mental and emotional health [2].
QMUL is aware that the objective raw data, may be anonymised to the extent that the risk of identification is remote. The release of some of the subjective PACE trial raw data and the raw data from PACE’s sister trial, the FINE trial has not led to the identification of any patient/s.
In contrast to the subjective observations favoured by the PACE authors, patients are documenting objective improvements in their health and the release of the objective data will enable them to compare their progress using other management techniques such as flexible pacing and pacing assisted by a heart rate monitor to the PACE trial findings.
Patients appear to be benefiting from findings of the Workwell Foundation [3], the International Consensus Criteria [4] and exercise physiological principles used for other categories of severely ill patients, such as those with congestive heart disease. These ideas are largely consistent with the ideas of the UK CFS doctors achieving positive outcomes such as Dr. Nigel Speight, Dr. Sarah Myhill, Dr. Peter Smith.
Ironically one of the PACE authors Peter White, published a paper on the successful use of a physiologically based exercise program in 1997 [5]. It is not clear why physiologically guided programs were dropped. Replacement of physiologically based programs, with uncontrolled programs where CFS patients are told to ignore their symptoms, and exercise despite worsening health appears to have been detrimental to CFS patients. Patients report worsening of health and unsustainable increases in activity that lead to a severe worsening of health, on these programs.
Many patients are now wearing continuous heart rate monitors and are identifying and quantifying severely abnormal heart rate drops and rises, in response to everyday activities. Many patients find that they need to REDUCE their activity levels, in the first instance to enable sustainable health improvements in the longer term.
The release of the objective data from the 5 million pound PACE trial will enable independent researchers and patients to compare their own findings and data with that measures during the trial.
In order to ease the burden of staff and not requiring them to do any calculations themselves once the relevant data is located and retrieved. I would like to request the data on the following selection of assessments, as detailed in the published protocol [6] and the PACE, GET manual version 7, MREC Version 2; 16/11/04 [7].
I seek the data for all 640 individual PACE Trial participants, for which the requested data exists, in a spreadsheet or equivalent file with separate columns for each variable/descriptor and the three clinical groups of patients as described above be provided separately.
MEASURE
Actometer results (BMC reference 18)
VO2 max (manual page 40)
TUAG (timed up and go. Chair-stand-walk 3 metres-turn- walk back -sit down (manual page 88)
Sit-stand test (count number in one minute – manual page 88))
2-minute walk (manual page 88)
6 minute walk objective measure of recovery (BMC reference 31)
Self-paced step. Test of fitness (BMC reference 43)
Exercise and activity scale (BMC reference 36)
For each physiological measure I require, The time, End heart rate and Borg measure. (Borg Scale of perceived physical exertion [BMC reference 44], is used to measure effort with exercise.)
I request, the information for each of the time periods, that the PACE authors specified they would collect, objective measurements of physical functioning, as follows:
Baseline (PACE manual)
After randomisation (BMC)
10 weeks
12 weeks (authors response to review)
Mid assessment (PACE manual)
24 weeks
Final assessment (PACE manual)
39 weeks
One year follow up
2.5 year follow up”
8 May 2017 - QMUL Acknowledge receipt of the request of 6 May.
(A number of PACE related annotations added to the What do they know site)
21 May 2017 annotation FOI 2017/F158
Cite this as: BMJ 2015;350:h227
Tom Kinlon

Tackling fears about exercise is important for ME treatment, analysis indicates. Objective measures found a lack of improvement for CBT & GET in the PACE Trial: subjective improvements may simply represent response biases or placebo effects in this non-blinded trial
21 May 2017 annotation FOI 2017/F158
http://journals.sagepub.com/doi/full/10....

PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome – true or false?

It’s time for an independent review of the methodology and results
Charles Bernard Shepherd
First Published April 9, 2017

21 May 2017 annotation FOI 2017/F158
http://www.virology.ws/2017/03/13/an-ope...

An open letter to Psychological Medicine about “recovery” and the PACE trial
13 MARCH 2017
Sir Robin Murray and Dr. Kenneth Kendler
Psychological Medicine

21 May 2017 annotation FOI 2017/F158
http://www.thelancet.com/pdfs/journals/l...

Correspondence
www.thelancet.com/psychiatry Vol 3 February 2016

PACE: CBT and GET are not rehabilitative therapies
22 May 2017 annotation FOI 2017/F158

http://journals.sagepub.com/doi/pdf/10.1...

David Tuller on the PACE trial authors failure to address flaws in the trial.

https://doi.org/10.1177/1359105317703788
Journal of Health Psychology 1–5

24 May 2017 annotation FOI 2017/F158
The USA Centre for Disease Control

https://www.cdc.gov/features/cfsawarenes...

24 May 2017 annotation FOI 2017/F158

The Invest in ME Research 2017. IIMEC12 Pre-conference dinner. David Tuller will be our guest presenter.

David Tuller DrPh, is academic coordinator of University of California Berkeley's joint masters program in public health and journalism. He was a reporter and editor for 10 years at the San Francisco Chronicle, served as health editor at Salon.com and frequently writes about health for The New York Times.

David's presentation - #TearItUp - will include his work in exposing the flaws in the PACE Trial.
1 June 2017 annotation FOI 2017/F158
Key websites:
Press & research
Added in 2017

TED TALK: Jen Brea describes the obstacles she’s encountered in seeking treatment for her condition: What happens when you have a disease doctors can’t diagnose

2 June 2017 annotation FOI 2017/F158
http://journals.sagepub.com/doi/10.1177/...

Relevant article regarding PACE

Once again, the PACE authors respond to concerns with empty answers
David Tuller
Abstract
In their response to Geraghty, the PACE investigators state that they have “repeatedly addressed” the various methodological concerns raised about the trial.
While this is true, these responses have repeatedly failed to provide satisfactory explanations for the trial’s very serious flaws.
This commentary examines how the current response once again demonstrates the ways in which the investigators avoid acknowledging the obvious problems with PACE and offer non-answers instead—arguments that fall apart quickly under scrutiny.
2 June 2017 annotation FOI 2017/F158
David Tuller - podcast regarding the flaws and faults with PACE and the FOI release ordered by the First Tribunal and International and Worldwide concern about the trial.

No statistical recovery and subjective outcome only. No verifiable objective data released.

http://www.microbe.tv/twiv/twivs-tuller3/
3 June 2017 – KD sent a reminder. FOI 2017/F158
5 June 2017 - QMUL refused the request and issued a refusal notice under s.17.FOI 2017/F158
“Firstly, not all of the information you have requested is held. Many of
the measures specified seem to be based on being listed in the trial’s
manuals. However, this has no bearing on what was measured in the trial
and you should refer to the protocol. We do not hold data on VO2 max,
TUAG, sit-stand test, 2 minute walk. We hold the actometer measures, but
only at baseline, not at the other time points requested. The only measure
for which we hold Borg and end heart rate is the step test. There are no
data measured direct after randomisation, at 10 weeks, separately at mid
assessment (this is the 12 week data), separately at the final assessment
(this is the 52 week data) or 39 week time points. No exercise data were
measured at long term follow-up, so these data are not held.”
“With regards to the rest of the data that we do hold, we estimate - given
the time already expended ascertaining what is held as well - that to
provide all of the information would exceed the appropriate limit.”

Narrowed the request, 6 June 2017 FOI 2017/F158– KD narrowed the request and removed the information that QMUL stated that they did not hold.
“I note your advice that the protocols described in the PACE manual, have “no bearing on what was measured in the trial”.
“On the basis of your advice I have modified my information request to the information that QMUL states was measured, and make the following amendments, to my request for objective physiological/physical data :
1/ Actometer results (BMC reference 18) – QMUL advise that the actometer results were only measured at baseline. Request raw data actometer, baseline measurements.
2/ VO2 max (manual page 40) - QMUL advise this is not held.
3/ TUAG (timed up and go. Chair-stand-walk 3 metres-turn- walk back -sit down (manual page 88) - QMUL advise this is not held.
4/ Sit-stand test (count number in one minute – manual page 88)) - QMUL advise this is not held - QMUL advise this is not held.
5/ 2-minute walk (manual page 88)- QMUL advise this is not held.
6/ 6 minute walk objective measure of recovery (BMC reference 31) – Request raw data.
7/ Self-paced step. Test of fitness (BMC reference 43) - QMUL advise have Borg test (scale of perceived exertion) and end heart rate – Request raw data.
8/ Exercise and activity scale (BMC reference 36) – Request raw data.
9/ For each physiological measure I require, The time, End heart rate and Borg measure. (Borg Scale of perceived physical exertion [BMC reference 44], is used to measure effort with exercise.) QMUL advise that the “only measure for which we hold Borg and end heart rate is the step test” – Request raw data for the heart rate and Borg measure for the step test.
Time periods, that the PACE authors specified they would collect, objective measurements of physical functioning:
10/ Baseline (PACE manual) – request the raw data
After randomisation (BMC) – QMUL advise this measurement did not take place.
10 weeks - QMUL advise this measurement is the 12 week data.
11/ 12 weeks (authors response to review) – request the raw data
Mid assessment (PACE manual) - QMUL advise was not measured
12/ 24 weeks - request the raw data
13/ Final assessment (PACE manual) – request the raw data
14/ 39 weeks - QMUL advise data was not measured at this time point.
15/ 52 week data - QMUL advise this measurement time point is the same as the 39 week time point and the final assessment time point.
16/ One year follow up - request the raw data.
17/ 2.5 year follow up - QMUL advise that data was not obtained at long term follow up.
Hence my modified request is as follows:
i/ Actometer results (BMC reference 18) – raw data actometer, baseline measurements.
ii/ 6 minute walk objective measure of recovery (BMC reference 31).
iii/ Self-paced step. Test of fitness (BMC reference 43), including the Borg test (scale of perceived exertion) and end heart rate.
iv/ Exercise and activity scale (BMC reference 36).
At the specified time periods, that the PACE authors specified they would collect the data:
v/ Baseline
vi/ 12 weeks
vii/ 24 weeks
viii/ Final assessment – 52 week/39 week time point
ix/ One year follow up
I request, that the data is provided in a manner that enables me to distinguish between data from patients with CFS and those with mental health disorders:
(i) Patients diagnosed with CFS and no mental health disorders
(ii) Patients diagnosed with psychiatric disorder
(iii) Patients diagnosed with depressive disorder”

8 June 2017 FOI 2017/F158 – QMUL clarified that the refusal applied to the modified request
“Where we do hold data, this has been refused under s.12 of the Freedom of Information Act.”
8 June 2017 FOI 2017/F158– KD thanked QMUL for responding
KD narrowed the request, FOI 2017/F158– reducing the number of time points requested, and removing the separation of patients into mental health and non-mental health patients requested, the third version of the request
“I have reduced my information request to asking for even less information.
I have reduced the number of time points, removed the request for the exercise and activity scale data and removed, the request for a copy of the data in a format that separated the patients without depressive or psychiatric disorders from those with the mental health issues.”
My reduced information request is as follows:
i/ Actometer results (BMC reference 18) – raw data actometer, baseline measurements.
ii/ 6 minute walk objective measure of recovery (BMC reference 31).
iii/ Self-paced step. Test of fitness (BMC reference 43), including the Borg test (scale of perceived exertion) and end heart rate.
At the specified time periods, that the PACE authors specified they would collect the data:
iv/ Baseline
v/ Final assessment – 52 week/39 week time point
13 June 2017 FOI 2017/F158 – KD chased up an acknowledgement that QMUL had received the narrowed request
13 June 2017 FOI 2017/F158– QMUL
“We are proceeding with this request now that it has been narrowed. We will be in touch in due course.”
14 June 2017 – KD advises FOI 2017/F158
…“After I didn't receive a response to my reduced request for information. I submitted a fresh request. In part as it appears quite likely that this FOI could follow the footsteps of Alem Mattews one and end up before the Information Commissioner, in which case it might be clearer to have the request as a "fresh start".
Hence, I refer you to my request entitled:
"CFS - a small % of the objective physical and physiological data from PACE trial"

13 June 2017 lodged a new request via the website, What do they know? FOI 2017/F158(b)
Entitled: CFS - a small % of the objective physical and physiological data from PACE trial.
The link to the website is:
https://www.whatdotheyknow.com/request/c...
“I have amended my request in response to your claim that it would cost more than 450 pounds to provide the objective data requested in FOI 2017/F158, and hence refusal of the request.”…
…“My amended information request is as follows:
i/ Actometer results (BMC reference 18) – raw data actometer, baseline measurements.
ii/ 6 minute walk objective measure of recovery (BMC reference 31).
iii/ Self-paced step. Test of fitness (BMC reference 43), including the Borg test (scale of perceived exertion) and end heart rate.
This information is requested for two of the specified time periods:
iv/ Baseline
v/ Final assessment – 52 week/39 week time point”
15 June 2017 – KD advises FOI 2017/F158 (b)
...“To clarify this request is a narrowing of FOI 2017/F158, which QMUL refused on the basis that:
i) the PACE trial authors did not obtain the data from all the objective outcome measures specified in the PACE manual (version 7),
ii) it would cost more than 450 pound, to provide a copy of the raw data from the objective outcome measures, that PACE authors did collect.
I have marked FOI 2017/F158, as refused, as per QMUL's advice.”…
11 July 2017 – KD advises FOI 2017/F158 (b)
..”I am writing to remind QMUL that it has a legal obligation to respond promptly to a request and that a response to this request is due by 11 July 2017, at the latest.”…
12 July 2017 – KD advises FOI 2017/F158 (b)
..”I am writing to remind QMUL that by law, public authorities must respond promptly to requests for information, requested under the FOI Act and that legally you must respond within 20 working days.
Your response to this request is overdue.”…
13 July 2017 – KD request for internal review FOI 2017/F158 (b)
..”I am writing to request an internal review of Queen Mary, University of London's handling of my FOI request 'CFS - a small % of the objective physical and physiological data from PACE trial'.
QMUL has not responded to my request for this data that was collected by the PACE trial principal investigators Micheal Sharpe, Peter White and Trudi Chaldler, under the guidance of the principal adviser Simon Wessley. Nor has QMUL responded to my emails chasing up a response.”…
…“Note that this request for a small % of the objective data from the 5 million pound PACE trial, was drafted after my request for all of the objective trail data was refused on the basis of cost. ..

13 July 2017 – KD details the need for the objective data for a submission regarding the NICE Guidelines FOI 2017/F158 (b)
…”I am concerned that your failure to respond this request and to my original request for all the objective physical and physiological data, promptly and within 20 days, is putting the health of CFS patients at risk UK wide.
QMUL must be aware of the dichotomy between UK mental health "experts" proclaiming CFS to be a mental health disease and graded exercise therapy (GET) to be safe and the USA , patients and exercise physiologists who on the basis of objective research findings, patients and patient carers reports have found GET to be extremely harmful.
The USA Centre for Disease Control's is so concerned about the negative impact of GET on the health of patients with CFS (and its lack of effectiveness) that it has removed all reference to GET from its website.
The requested information is required urgently, as the time frame for stakeholders to make a submission substantiating why NICE should overturn its decision not to up date its guideline for CFS is only a few days.
I will bring the fact that QMUL's failure to comply with its legal obligations to respond to requests as required by law has serious health implications for patients and hence tax payers to the attention of the Information Commissioner and hold QMUL responsible for all legal costs associated with this matter.”…

16 July 2017 -annotation added)
Future studies of chronic fatigue syndrome/myalgic encephalomyelitis should include some objective assessments as primary outcomes. If this is to include activity monitors, we first need a sound baseline dataset.
Journal of Health Psychology 1-6
2017
DOI:10.1177/1359105317707215
Journals.sagepub.com/home/hpo
16 July 2017 -annotation added)
Graham McPhee requested the objective data from PACE via a FOI request, QMUL responded advising that his request was vexatious. QMUL's response to my original request for all the objective data was to say the provision of the data would cost more than 450 pounds.

20 July 2017 – KD advises FOI 2017/F158 (b)
…”I will lodge a complainant with the Information Commissioner in relation to the failure of QMUL to comply with its legal obligations under the FOI Act, i.e. the requirement to response promptly and within 20 days of the request.”..

20 July 2017 – QMUL advises FOI 2017/F158 (b)
“We are planning to respond to this request and apologise for the delay.”
20 July 2017 – KD advises FOI 2017/F158 (b)
..”I have previously detailed why delays in the provision of the objective raw data from the PACE trial, may adversely affect chronic fatigue syndrome (CFS) patients ie the data is required for a submission to NICE.”..
“The non-release of the objective raw data from the UK tax payer funded the 5 million pound study enables the PACE authors, to continue to peddle their false belief that GET and/or CBT result in improved health in patients with CFS throughout the UK.
QMUL appear to be complicit in perpetuating the PACE authors misleading claims.
Since your apology appears to be merely a delaying tactic, I need to proceed with lodging a complaint to the Information Commissioner.”…

21 July 2017 -annotation added)
Another ‘False Start’ in ME/CFS Clinical Trials: The GETSET Study by Todd Davenport, Associate Professor and Program Director, Department of Physical Therapy, University of the Pacific.

25 July 2017 – QMUL advises FOI 2017/F158 (b)
- 6 minute walking test results provided as QMUL has already put them in public domain.
“We have not treated this as a new request but
rather as a narrowing of your request received on 08/05/2017, which was
initially refused on 05/06/2017. I apologise for the slight delay in
responding.”..

…”your request remains impossible to fulfil without exceeding 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”
QMUL advised that
“ The extraction and analysis required
must be done by a statistician and QMUL does not employ one for PACE.
However, at no time have I requested any analysis to be carried out, I have merely sought raw data. In fact, my request specifically states that “in order to ease the burden of staff and not requiring them to do any calculations themselves once the relevant data is located and retrieved”

25 July 2017 – KD advises FOI 2017/F158 (b)
…”I contend that some of the 5 million pounds of tax payers money, spent on the PACE trial, would have included putting the actometer and the self paced STEP test results into a table.

As illustrated by the table of the 6 minute walking test data, (that QMUL provided as it was already in the public domain), the information requested is not onerous, and is merely the content of two small tables.

I contend that locating, retrieving and extracting the table of results, will not cost more than 450 pounds i.e. take more than 18 hours.

I contend that the claim QMUL by staff that they can not find these tables in less than 18 hours is preposterous.

I contend that a willing person, could find the data in minutes, if not seconds.
I suggest that a search entry such as "Peter White", "PACE trial", "actometer results" "STEP test results" in the QMUL database would quickly locate the data.
I request that QMUL, complies with its legal obligation to the UK tax payers, and promptly provides the following information”…

27 July 2017 annotation FOI 2017/F158 (b)
No confidence’: Charities reject NICE ‘no update’ proposal for ME/CFS guideline
Support for CBT and GET, the treatments in question, is largely due to the claimed results of the UK PACE Trial. However, 42 experts wrote an open letter accusing the researchers of that trial of bias and misrepresentation.
27 July 2017 annotation FOI 2017/F158 (b)
The NICE guideline for CFS/ME is not fit for purpose and needs a complete revision

“I think that the single most damaging misconception perpetrated on ME patients is
the idea that deconditioning is the problem and that exercise is the antidote.
“I have seen many people now, well-motivated, who have made themselves much
worse with exercise, often on the advice of their GPs who have been gullible enough to
swallow the deconditioning hypothesis.
“I think this needs to be properly emphasised with NICE, otherwise their advice
concerning graded exercise will always be assumed to be "exercise to fitness" which
is always destructive.
“Sadly, the people who get worse with exercise, because they exceed their anaerobic
threshold on multiple occasions with further reduction of the latter, are then assumed
to be imagining their disability and treated accordingly. It would be farcical if it wasn't
so serious.”

27 July 2017 – KD advises FOI 2017/F158 (b)
…To avoid future confusion if the case goes to the First Tribunal, I've been advised to mark this request refused as per the advice from QMUL and submit an amended request, without the request for the 6 minute walking test as that information is in the public domain.”..
30 July 2017 A Baldwin left an annotation FOI 2017/F158 (c)
In a response to Anna Wood's FoI concerning the mean 6mwt distances for people who they claimed were recovered QMUL claimed that it would take them over 18 hours to calculate.

After the release of data for Mr Matthees's FoI it tool me about an hour to calculate these values. Most of that time was taken working out how they had changed the Oxford definition within the recovery paper to include additional thresholds.
27 July 2017 Narrowed request lodged via the website, What do they know.
FOI 2017/F158 (c)
CFS - a small % of the objective physical and physiological data from PACE trial (6 minute walk test already in public domain) https://www.whatdotheyknow.com/request/c...
“I refer to:
1/ My original request: (your reference number FOI 2017/F158) which was made on 5 May 2017 and refused on 8 June 2017, due a claim that it would cost more than 450 pounds to provide the information.
2/ My second request for small % of the information: (my reference FOI 2017/F158 (b)) made on 13 June 2017 and refused on 25 July 2017, due a claim that it would cost more than 450 pounds to provide the information.
3/ This third request: (my reference FOI 2017/F158 (c)), it is largely the same as request 2/ however I am not requesting the 6 minute walk test results, as these results are in the public domain.
I request that QMUL, complies with its legal and moral obligation to UK tax payers and CFS patients, and promptly provides the following information from the PACE trial:

27 July 2017 annotation FOI 2017/F158 (c)

THE PACE TRIAL: THE MAKINGS OF A MEDICAL SCANDAL

Special issue on the PACE trial, Vol 22, No 9, Aug 2017.
Publication date 31 July 2017
http://journals.sagepub.com/toc/hpqa/cur...

28 July 2017 annotation FOI 2017/F158 (c)
PACE-gate Papers

http://journals.sagepub.com/action/doSea...
29 July 2017.. KD advises FOI 2017/F158 (c)
“I am writing to put on record the small size of the file/s containing the objective actometer and STEP test results from the PACE trial as detailed in requests FOI 2017/F158, FOI 2017/F158 (b) and FOI 2017/F158 (c).
Depending on how the data has been tabulated there may be 1-4 tables of data.
It is estimated that these files will be less than 20 Kb in size each and hence easily copied and transposed digitally.
The size of the data files is estimated, based on the fact that the table for the PACE trial 6 minute walking test data, is is 1.7 kB in size.
The information is likely to be stored, in files near the PACE trial 6 minute walking test data and easy to locate.
The claim made in response to FOI 2017/158 (b) that it would take more than 18 hours to locate and provide copies of this information is rejected.
For clarity I have resubmitted this request, with the request for the 6 minute walking test data deleted, since this data is in the public domain.
I refer this narrowed request as FOI 2017/158 (c).
It is nearly 3 months since my request for objective information from the 5 million pound, PACE trial, was first made.”
31 July 2017 annotation FOI 2017/F158 (c)
PACE-gate

Last ditch attempt to block publication of special issue of Journal of Health Psychology foiled

by James C Coyne July 30, 2017

Publication of the special issue of Journal of Health Psychology will go forward as planned on Monday July 31.
31 July 2017 annotation FOI 2017/F158 (c)
Journal of Health Psychology

David F Marks First Published July 31, 2017 Editorial

Download PDFPDF download for Special issue on the PACE Trial Article information

Abstract
We are proud that this issue marks a special contribution by the Journal of Health Psychology to the literature concerning interventions to manage adaptation to chronic health problems. The PACE Trial debate reveals deeply embedded differences between critics and investigators. It reveals an unwillingness of the co-principal investigators of the PACE trial to engage in authentic discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5million) on what is a textbook example of a poorly done trial.
31 July 2017 annotation FOI 2017/F158 (c)
https://jcoynester.wordpress.com/2017/08...

QUICK THOUGHTS
One of James C. Coyne's Blogs

The unfolding story of removal of data from a PLOS One article
31 July 2017 - KD advises FOI 2017/F158 (c)
“Please advise if QMUL intends to respond to this request and if so by what date.
As per the previous FOI requests, I am adding comments on and publications relating to the PACE-gate trial, in the annotations section of my request.
When adding an annotation to this request, I noticed a typo...the size of the file containing the 6 minute walk test data is actually 17 kB.”
1 August 2017 FOI 2017/F158 (c)

Scientists trade insults over myalgic encephalomyelitis (ME) study

1 August 2017 – KD advises FOI 2017/F158 (b)
..”I am not sure which is the most appropriate way forward with this request and have submitted a narrowed request given that some of the 6 minute walking test data is in the public domain. I am also detailing the need for an internal review here.”…
..”The volume of information requested is less than one gigabyte and is most likely located in a file adjacent or near the 6 minute walking trial data.”..
My interest in the objective data, is because patients are using bio feed back such as continuous heart rate monitoring, and following the Workwell video's to improve their quality of life.
I want to see how the PACE trial objective outcomes compare to the scientific and physiologically based methods being used successfully by patients worldwide.”..
..“The PACE trial for all its flaws and faults did collect some objective data from 640 patients with CFS. This data does not appear to be being collected by NHS clinics hence is not able to be obtained elsewhere.”…
“The 6 minute walking test data showed that after a year of the PACE GET, the patients could walk on average an extra 30 metres, this result appears to be significantly less than the results being obtained by individualised, physiologically based programs.
It is not onerous for QMUL to produce the requested data , it might take a couple of minutes to locate the file and a couple more minutes to upload the data to this website.
It is in the tax payers and patients interests to facilitate open and honesty in scientific research and to cease protecting those whose agenda is at odds with scientific progress, regardless of the human cost of their false belief systems.”..
The Information Commisioner's office advises that it is reasonable to expect a response to a request for an internal review within 20 days of the request being made.
10 August 2017 – KD advises FOI 2017/F158 (b)
“It is now over 3 months since I first lodged a request for the release of objective data from the PACE trial with QMUL.
It is nearly 2 months since I lodged this narrowed request” FOI 2017/F158 (b) “with QMUL.”
Does QMUL intend to respond to this request for an internal review? If so when? If not why not?”
7 August 2017 KD submitted a further narrowing of the information request via the website What do they know?
FOI 2017/F158 (d)
Entitled: CFS- a request for even less objective info from the PACE trial just the STEP test results at baseline and 52 weeks
Link to the website: https://www.whatdotheyknow.com/request/c...
“In support of this request refer to:
1/ My original request: (your reference number FOI 2017/F158) which was made on 5 May 2017 and refused on 8 June 2017, due a claim that it would cost more than 450 pounds to provide the information.
2/ My second request for small % of the information: (my reference FOI 2017/F158 (b)) made on 13 June 2017 and refused on 25 July 2017, due a claim that it would cost more than 450 pounds to provide the information.
3/ My third request: (my reference FOI 2017/F158 (c)), made on 27 July 2017, is largely the same as FOI 2017/F158 (b) however I excluded the 6 minute walk test results, as these results are in the public domain. I've not received a response to this request.
4/ This is my fourth request: (my reference FOI 2017/F158 (d). I have removed the request for the actometer data. This data is of limited use. QMUL only measured the physical activity of the trial participants at baseline and not, as is normal scientific practice, also at the end of the trial. From memory, the reason given by Peter White, Trudi Chaldler, Micheal Sharpe and Simon Wessley, for this omission is that it was too onerous, for the trial participants, to wear a 28g actometer for a week, post "treatment". This claim is at odds with the fact that the participants, were healthy enough to wear a 28g actometer for a week pre-"treatment". This claim is also at odds with the fact that surveyed patients have stated that GET (74%) and CBT (14%) made them sicker, some severely, yet none appear to have ever stated that the wearing of a 28g actometer, adversely affects their health.”…
…”The provision of the data requested will help patients who are using heart rate based monitoring to pace effectively, as touched on in the NICE Guidelines. Given the lack of guidance in UK literature many patients are relying on the work of USA exercise physiologists such as Prof. Mark Van Ness, Todd Davenport, Staci Stevens (Workwell Foundation and associated Universities) to manage their activity levels, and to ensure that they rest adequately. Many patients struggle with staying below 50% of their age predicted maximum heart rate, doing their activities of daily living e.g. rolling over in bed, walking to the toilet, dressing etc...but are improving by ensuring that they spend most of their day in the "resting heart rate zone".
For these patients the provision of the objective data will enable them to compare their progress from following USA protocols, with the treatment regimes carried out by the 4 arms of the PACE trial.”
8 August 2017 annontation FOI 2017/F158 (d)
Trial by Error: Retired PACE Investigator Peter White and Swiss Re
7 AUGUST 2017
By David Tuller, DrPH

On November 17, 2015, a few weeks after publication of my 15,000-word investigation of the PACE trial, I posted a blog about a talk Peter White gave to Swiss Re employees on the findings from his bogus study. Professor White, of course, was the lead PACE investigator and also served–and apparently still serves–as “chief medical officer” for the insurance company.

11 August 2017 KD requests an internal review of the FOI 2017/F158 (b)
“ pass this on to the person who conducts Freedom of Information reviews.
I refer to my request an internal review of Queen Mary, University of London's handling of my FOI request 'CFS - a small % of the objective physical and physiological data from PACE trial' , submitted 13 June 2017.
I refer QMUL to the What do you know website:
"Internal reviews should be quick. If one takes longer than 20 working days then the authority should write and let you know, and it should never take longer than 40 working days (see this good practice guide). You will then either get the information that you originally requested, or you will be told that the review upholds the original decision."

11 August 2017 annotation FOI 2017/F158 (b)
PACE authors are not the only ones who drop objective measures of the trial participants physical functioning ( actometer /actigraph results). The PACE authors colleagues in the Netherlands did the same and this paper details how subjective results are over inflated and no borne out by the objective findings.

http://www.mdpi.com/2076-328X/7/3/52/htm
Open Access
Behavioral Sciences 2017, 7(3), 52; doi: 10.3390/bs7030052
Review

15 August 2017 – QMUL advises FOI 2017/F158 (b)
“Please clarify that you wish QMUL to carry out an internal review of this request despite the fact that you have subsequently submitted a new request, which narrows the original.
We have presumed that the latter request superseded this one, with the effect that this one has been withdrawn”

15 August 2017 – KD advises FOI 2017/F158 (b)
“I apologise for any confusion, I would like all the information requested.
The reason that, I narrowed the request was to obtain at least some of the information, within a reasonable time frame.
To date, I have not received any information.
We are talking about a few tiny tables of data of only a few hundred kilobytes.”

16 August 2017 – QMUL advises FOI 2017/F158 (b)
...” It is not altogether clear when overlapping requests are received before we have had an opportunity to respond.

Given your reply, please confirm that you wish to withdraw the request
made in your email of 7^th August at 1.30a.m. Or do you wish us to refuse
that under s.14(2) of the Freedom of Information Act 2000, since it
repeats in part what you have requested in the present request, in order
to close that one? We have received at least 16 emails from you since May
and in some cases you have requested internal reviews only to put in a
narrowed request, or before the time for compliance has been reached. We
currently have two open requests from you: this one due on 25^th August
and the one of 7^th of this month due on 5^th September.

Please clarify that by 'all the information requested' you are referring
to your email of 27^th July, which QMUL has assigned the reference above,
if you wish for us to deal with this one.”…

16 August 2017 – KD advises FOI 2017/F158 (b)
“I request all the information that I have asked for. I apologise for the confusion, I am profoundly ill with ME/CFS and have the physical and physiological abnormalities detailed, in the International Consensus Criteria 2011 and the Canadian Consensus Criteria 2003, this adversely impacts on my cognition, especially after exertion.
In my opinion instead of prevaricating and debating the semantics of my request, if QMUL was acting in good faith. you would take a few minutes, to upload the requested information, to this website.
It would be much appreciated if the broadest list of information was provided.”…
16 August 2017 – QMUL advises FOI 2017/F158 (d) [QMUL advises reference number FOI 2017/F255 is allocated to this request)
“FOI 2017/F255

Thank you for your email of 7th August where you requested:
‘Self-paced step. Test of fitness (BMC reference 43), including the Borg
test (scale of perceived exertion) and end heart rate.

This information is requested for two of the specified time periods:
- Baseline
- Final assessment – 52 week/39 week time point’

As per the correspondence here:
[1]https://www.whatdotheyknow.com/request/c...,
for the sake of completeness this request is refused under s.14(2) of the
Freedom of Information Act 2000 as it is a repeat of part of the request
made on 27th July, found at the previous link.

Please accept this as a refusal notice.”
18 August 2017- KD seeks an internal review of the decision to refuse FOI 2017/F158 (d)- FOI 2017/F255
“I am writing to request an internal review of Queen Mary, University of London's handling of my FOI request 'CFS- a request for even less objective info from the PACE trial just the STEP test results at baseline and 52 weeks'.
I request a review of the decision, to refuse the release of the information request.
I agree that the request is a narrowing down of the information sought in the previous request.
QMUL refused to release the accelerometer and STEP test results, on the basis that the 2 pages of data sought were too onerous and would take more than 18 hours to find, locate and upload to this website.
I narrowed the request to just the STEP test results as any objective data would be better than none. To date the only objective data released by QMUL is the 6 minute walking data and 28% of the final test results are missing.
I put it to QMUL that given the misleading claims made by PACE authors, the flaws and faults in the trial that they have refused to address in any meaningful manner that it is negligent to continue to hide objective data, from the UK tax payer, independent researchers and patients.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/c...
I trust that QMUL will comply with its legal obligation to respond promptly and provide the 2 pages of data sought (estimated).”

19 August 2017 – KD withdraws FOI 2017/F158 (c)
“I sent this request to QMUL with the intent of clarifying the status of my "narrowing" of requests for objective data from the PACE trial.
I now think it clearer to leave FOI 2017/F158 (b) and FOI 2017/F158 (c) standing.
Please withdraw this request.”
19 August 2017 KD Error correction
“Requests FOI 2017/F158 (b) and FOI 2017/F158 (d) are still standing.”
20 August 2017
Summary provided to QMUL.
FOI 2017/F255 (originally referred to as FOI 2017/F158 (d) by KD, prior to QMUL allocating it it’s own reference number) and FOI 2017/F158 (b)

Kathryn Dickenson

Dear QM FOI Enquiries,

I note the advice received from QMUL provided in response to the narrowed request, i.e. actometer data not requested (QMUL reference FOI 2017/F255), that it will respond to this request for the actometer and STEP data, by the end of this week i.e. Friday 25 August 2017.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

Dear QMUL FOI Enquiries,

I refer to my request of 5 May 2017 requesting the objective data from the PACE trial and subsequent correspondence.

On 13 June 2017-KD, I submitted a narrowed, FOI request to QMUL, via the website. "What do they know?".

The request is entitled: CFS - a small % of the objective physical and physiological data from PACE trial

Link to the request:
https://www.whatdotheyknow.com/request/c...

QMUL said that they were treating this request as a continuation of the request submitted on 6 May 2017. I refer to it by the reference number FOI 2017/F248 (b), as on the website it appears in a separate thread to the original request. The request was refused and I was advised that a response from the internal review panel, would be provided by 25 August 2017.

No response has been received.

Please provide the response from QMUL's internal review team to this request by return.

Yours sincerely,

Kathryn Dickenson

Kathryn Dickenson

Dear QM FOI Enquiries,

I am writing to remind QMUL that the reply to this internal review is long overdue and QMUL has not complied with its undertaking to respond by 25 August 2017.

I trust that QMUL will respond by return.

Yours sincerely,

Kathryn Dickenson

Queen Mary, University of London FOI, Queen Mary University of London

1 Attachment

Dear Kathryn Dickenson

It appears that you are confused as to our reply of 21st August 2017 in which reference was made to a response being made by 25th August to a request. That response was made on 23rd August (with our ref. FOI 2017/F248) here: https://www.whatdotheyknow.com/request/c.... It is not clear to us why you marked this as withdrawn.

The attached will hopefully clarify for you the requests we have received from you related to the PACE trial, with dates, reference numbers and responses. We do not believe that any have been late or are currently
outstanding because we have taken the view that new requests submitted have superseded previous ones. Please confirm the request on which you would like QMUL to carry out an internal review.
Yours sincerely

Paul Smallcombe
Queen Mary University of London

Kathryn Dickenson

Dear Queen Mary, University of London FOI,

What caused the confusion is that QMUL gave separate requests the same FOI reference number and treated them as the same request.

This resulted in QMUL "seeing" the FOI requests differently from how they are recorded on the "What do you know?" website.

QMUL has been persistently, tardy and failed to comply with its legal responsibility to respond promptly.

I note your refusal.

Yours sincerely,

Kathryn Dickenson