A Mock strawberry: No it’s not poisonous, despite what you may have heard. Just tasteless.
Here is my opinion: For ME/CFS, this tribunal case is one of the most important things that will happen in the whole of 2016. It’s outcome will affect millions of us for years to come. So I consider this important. Very important.
I’m not sure all ME/CFS patients realise how much PACE affects their lives. PACE is the cornerstone of the behavioural model that dominates how ME/CFS is perceived by government agencies including the NHS, the media and the public. It dominates how the disease is treated, not only in the UK but in many other countries around the world. It dominates how research money is spent (more behavioural studies rather than biomedical studies that might actually lead somewhere). It dominates social security policy that ultimately affects whether you get the support you need to live when you are crippled by the disease.
If you think that as PACE was studying those diagnosed with the Oxford criteria and therefore it doesn’t affect you, think again. The authors use the term myalgic encephalomyelitis in their protocol, their paper, and media statements, alongside chronic fatigue syndrome, and this important limitation to the study (uselessly broad criteria that mean people with other diseases are included in the study) has not held it back from being used to blight the lives of those with ME or CFS defined by a stricter set of criteria. So this matters to all of us no matter what we think of the names, or whether more than one disease is represented by these labels.
The study has been fraught with problems, the design was a shocker, there have been concerns over safety, reporting of results and misrepresentation of data, and the hiding of data that does not support the authors pet-theory of a behavioural model of disease. Without visibility of the data the authors conclusions cannot be put to test and undergo normal scientific scrutiny. So it is essential that we get to see the de-identified data.
In relation to this case, QMUL have said that they are “seeking….advice of patients…” No details are given of how QMUL is seeking this advice of patients. We have not been told how patients are being selected, how QMUL are presenting their request and what information they are providing the patients with, or how patients wanting to provide advice (me, for instance) can do so. This concerns me greatly as the authors of the PACE trial have repeatedly attempted to set themselves up as an unofficial mouthpiece for patients; they tell government agencies and the public what we apparently want and think, they have huge influence in this area, and yet none of them, to my knowledge actually formally represent any patient organizations – and given their research positions it would be inappropriate if they did. These are researchers who give treatment in clinics and in trials to patients. They do not formally speak for patients. And it’s just as well, as they make all kinds of statements without foundation:
QMUL and the PACE authors have repeatedly misled and propogated misinformation with regard to FOI requests for data from the trial, painting a picture of requesters are harassers and of individual patient’s personal data being at risk (click here for a list of examples that I have just started putting together – please leave a comment there if you have spotted others), but this is nothing more than a tactic designed to avoid transparency. Even if we trusted them to follow a transparent and appropriate process when contacting patients for advice, the statements they have already made are highly likely to have biased much of that patient feedback already.
I think it essential to ensure everyone knows exactly what data was requested. These are the data points, below – and only this data – that will be released should the tribunal reject QMUL’s appeal.
• Total SF-36 physical function scores at baseline and 52 weeks. Patients filled in a 10-item questionnaire and their answers were summed to give a total score between 0 and 100 points: it’s this total score that has been requested.
• Total Chalder Fatigue Questionnaire Likert scores at baseline and 52 weeks. Patients filled in an 11-item questionnaire and ‘Likert’ scoring yields a total score between 0 and 33 points.
• Total Chalder Fatigue Questionnaire bimodal scores at baseline and 52 weeks. The “bimodal” method of scoring this questionnaire yields a total score between 0 and 11 points.
• Whether the participant met the Oxford definition of CFS at 52 weeks (yes/no).
• Participant-rated Clinical Global Impression score. This is a rating from 1 to 7 of how the participant saw their health as having changed at 52 weeks, ranging from “very much worse” (7) to “very much better” (1).
• Doctor-rated Clinical Global Impression scores. As above, but rated by the doctor, not the patient.
• Meters walked in six minutes (the “six-minute walking test“) at baseline and 52 weeks.
• The group to which each participant was randomly allocated (i.e. APT, CBT, GET, or SMC).
As you can see, the data being talked about contains no personal information whatsoever. Personal details of participants such as name, gender, age, locality, will NOT be disclosed.
For more detail on these questionnaires, HERE is an excellent detailed explanation
A spreadsheet containing only the above data would be released. Here is a made up example of what a few rows of that data might look like with each row being the de-identified results from each patient:
Click here for a larger image in a new window. As you can see this is data is handy if you want to analyse whether or not the PACE treatments were as effective as its authors claimed, it is entirely useless if you wanted to track down the patients from the trial (not that there is any evidence anyone would want to do that anyway).
If you have read, or been told, that the data is more than this, then you have been lied to. If you have been told that patients who took part in the trial can be identified from this information then you have also been lied to. It is patently ridiculous to suggest that anyone could be identified from this set of data, as there are no personal details whatsoever. With over 600 patients having taken part in the trial there is simply no way to pick anybody out, even if someone knew who had been in the PACE trial; and with over 250,000 CFS patients in the UK, there’s no way of picking out PACE trial patients with the sort of data that has been requested.
Something QMUL and the PACE authors have never explained is why anyone would want to identify and track down the patients from the trial. Without a suggested motive, it’s hard to see why the PACE data should be higher out of reach than other studies which release their de-identified data (quickly becoming the norm nowadays). What has been the experience of patients from the PACE trial who have chosen to reveal that they took part in the trial, I wonder?
I have seen several patients who took part in the PACE trials say so on social media and I have never seen anyone respond negatively at all. Rather, I have seen fellow patients thank them for taking part in research, I have seen fellow patients offer support if they are still sick, and I have seen fellow patients respect their privacy unless they want to talk about it more. The most common response I have seen is a “Like” on Facebook with many patients from the PACE trial who reported their participation getting double figure “Likes”. We are all patients who share this diabolical disease, and I think it is very unethical of the PACE authors to manufacture the illusion of some kind of wedge between us when there is not one.
To reinforce the point that the release of the PACE trial data would not lead to any patients being harassed, I want to remind everyone that the PACE trial had a sister trial called FINE that was conducted at the same time. Whereas the PACE trial was for mild to moderate patients, the FINE trial was intended for severe patients and those who could not get to their local ME/CFS clinic due to distance, but similar data was collected. The FINE trial failed just as badly as the PACE trial did, but unlike the PACE trial, the authors of FINE, to their credit, released several pieces of data equivalent the data requested of PACE. In fact they released a whole bunch of other de-identified fields as well, and did so without even being asked and anyone can go access it without any problems. No patients who participated in the FINE trial have been identified, no one has even tried. What would possibly be the motive to do so? I’ve noticed that QMUL and the PACE authors sometimes like to say things which lack any logical foundation to justify them, and that seems to reflect their overall effort to simply hide the PACE study from scrutiny at all costs.
I hope patients, including those who took part in the study, are not fooled by this scaremongering, but I understand some will be. It is not their fault if they are, they should be able to trust the people running the trial, but clearly if you question what they are saying you can see they are misleading patients. I hope this article adds a little clarity to what data is really being asked for and leads people to think about the true motives behind QMUL’s extreme attempts to deny release of the annonymized trial data. If you want to follow this topic as it progresses over the coming months I suggest following James Coyne, David Tuller, and myself and keeping an eye on our blogs.
Within the next week I will be publishing another blog post focusing on how ME/CFS charities are responding to the PACE trial scandal and this specific appeal case, and what patients might be able to do to ensure their views are heard.
The Self-Taught Author 
Another great blog Clark. Well done my friend.
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Thank you kind sir
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really good. I have this fear that in the appeal these sensible arguments might not reach the panel of people who take the hearing…but the PACE PI and Wessely school will get their side in…is there a way Ian to lobby these points?
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Officially I don’t know, but I think the ME charities should be voicing their concerns about the trial and calling for the data to be released. Otherwise they are letting patients down. Of course they may be being misled also, which may complicate matters. But I will be writing about this issue and will suggest ways I think patients can ensure their views are heard by the charities they are members of.
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sorry I mis-read ‘Iam’ as Ian lol…I mean – Clark!
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The following is a rebuttal to the denial by QMUL to the FOI request for the PACE trial data by Racaniello, Davis, Tuller and Levin, described on another page on this site, but that page doesn’t allow comments. The part about QMUL citing the General Medical Council ‘Confidentiality’ guidance seems like a Hail Mary attempt to me.
On 17 December 2015 a group of senior academics and research scientists reported that they had made a FOI request for anonymized research data from the PACE trial, specifically consisting of the following- “…We would like the raw data for all four arms of the trial for the following measures: the two primary outcomes of physical function and fatigue (both bimodal and Likert-style scoring), and the multiple criteria for “recovery” as defined in the protocol published in 2007 in BMC Neurology, not as defined in the 2013 paper published in Psychological Medicine. The anonymized, individual-level data for “recovery” should be linked across the four criteria so it is possible to determine how many people achieved “recovery” according to the protocol definition.” (1)
On 19 January 2016, Queen Mary University London responded with a refusal, citing the exemptions of s.41 and s.22A of the UK Freedom of Information Act 2000. (2)
Information provided in confidence (section 41)
As justification for their refusal based on exemption s.41, ie. Information provided in confidence, (3) QMUL stated that “The data consists of (sensitive) personal data which was disclosed in the context of a confidential relationship, under a clear obligation of confidence. This is not only in the form of explicit guarantees to participants but also since this is data provided in the context of medical treatment, under the traditional obligation of confidence imposed on medical practitioners. See generally, General Medical Council, ‘Confidentiality’ (2009) available at http://www.gmc-uk.org/guidance/ethical_guidance/confidentiality.asp The information has the necessary quality of confidence and release to the public would lead to an actionable breach.”
The GMC guidance cited by QMUL specifically deals with personally identifiable information about patients, not anonymized research data. Furthermore, the guidance cites numerous “important secondary uses made of patient information”, each of which “can serve important public interests.” For instance, the guidance not only states that “For many secondary uses, it will be sufficient and practicable to disclose only anonymised or coded information”, but also that “You should consider whether the work needed to anonymise or code the information or to seek patients’ consent is reasonably practicable in all the circumstances. Only if unreasonable effort is required should you go on to consider whether disclosure of identifiable information is justified in the public interest.” (4) Clearly there is no ‘unreasonable effort’ required as not only has the requested data already been coded and anonymized, but in fact has already been ruled to not constitute personal data as described below.
While it is true that PACE trial participants were asked as part of the trial for potentially sensitive information including, but not limited to- a) their current wages/salary before tax, b) whether they currently receive income protection benefit or private medical/retirement pension and if so, how much, c) details of all jobs they have had in the past six months, d) which ethnic group that they identify as, and e) whether they currently are a member of a local self-help group for CFS/ME or national CFS/ME patient organization, and if yes, to which organisation(s) do they belong, (5) for the PACE investigators to claim that such basic information as anonymized SF-36 and Chalder Fatigue Scale scores constitute ‘sensitive personal data’ is ridiculous on its face.
The GMC guidance also specifically tell readers that “You should follow the technical guidance of the Information Commissioner’s Office”, yet the Information Commissioner’s Office has recently ruled against QMUL on a very similar request for data from the trial, stating that “[QMUL] has not provided any evidence as to how [an individual] might be able to actually identify participants from the trial from the information contained in the requested information and other information that may be available to such an individual”, and that “There is no indication in the University’s submissions to the Commissioner as to what means are reasonably likely to be available to…facilitate re-identification”.
The Information Commissioner concluded that “It is not clear to the Commissioner what prior knowledge an individual might have which might allow them to identify one or more of the participants in the PACE trial from the information requested, particularly given the large number of participants. In addition, he is not convinced that there is a sufficient basis for him to determine that it might be possible for a motivated intruder to identify any of the participants in the trial. Consequently, he has decided that the withheld information does not constitute personal data and that the exemption in section 40(2) is not applicable”. (6)
Information intended for future publication and research information (sections 22 and 22A)
QMUL’s second refusal dealt with exemption s.22, ie. Information intended for future publication and research information, (7) stating that “The primary outcomes requested are also exempt under s.22A of FOIA in that these data form part of an ongoing programme of research.” However Section 22 does not provide for an all-encompassing exemption for ‘ongoing programmes of research’, which would necessarily consist of the gathering of new data. Instead s. 22 specifically provides an exemption for information that is intended to be published in the future. Perhaps more importantly, s.22 also explicitly states that “The exemption can’t apply post-publication- Once information has been published, the exemption in section 22 will no longer apply to any of the same information contained in either earlier draft versions or in other documentation.”
Regarding the first criteria of s.22, ie Information intended for future publication, PACE Co-PI Peter White has gone on record stating that the PACE investigators have no intention of publishing the trial protocol definition of recovery, which is the data being requested. In an interview in Slate magazine on Nov. 15, 2015, which was published approximately one month before the request was made, PACE Co-PI Peter White stated that, in his opinion, the changes to the original protocol “improved the science and interpretation” and that “We see no reason why we should do a further analysis based on an inferior method.” (8) In fact, it is the PACE trial investigators’ persistent refusal to publish virtually any analysis that conforms to the original published trial protocol that is the impetus for many of the past and present FOI requests in the first place. Seeing as how Prof. White explicitly stated that the PACE investigators have no intention of even performing the analyses in question, much less of publishing the results in the future, this goes very much against the stated purpose of the claimed exemption. Furthermore, as to the explicit caveat in s.22 that the exemption cannot apply post-publication, the two requested primary outcomes of physical function and fatigue were published in the original PACE Lancet paper in 2011,(9) with the ‘recovery’ criteria being published in the journal Psychological Medicine in 2013. (10) Therefore again, the s.22 exemption would appear to have no justifiable relevance to the request, even without taking the considerable public interest in making said data available into consideration.
References
1. A request for data from the PACE trial – 17 December 2015
http://www.virology.ws/2015/12/17/a-request-for-data-from-the-pace-trial/
2. At least we’re not vexatious – 19 January 2016
http://www.virology.ws/2016/01/19/at-least-were-not-vexatious/
3. Information provided in confidence (section 41)
Click to access information-provided-in-confidence-section-41.pdf
4. General Medical Council guidance – Confidentiality (2009)
Click to access Confidentiality___English_1015.pdf_48902982.pdf
5. PACE trial protocol: Final version 5.0, 01.02.2006 ISRCIN54285094
Click to access PACE_Protocol.pdf
6. Freedom of Information Act 2000 (FOIA) Decision notice FS50565190
Click to access fs_50565190.pdf
7. Information intended for future publication and research information (sections 22 and 22A)
Click to access information-intended-for-future-publication-and-research-information-sections-22-and-22a-foi.pdf
8. Hope for Chronic Fatigue Syndrome – Nov. 13 2015
http://www.slate.com/articles/health_and_science/medical_examiner/2015/11/chronic_fatigue_pace_trial_is_flawed_should_be_reanalyzed.html
9. Prof PD White, MD, KA Goldsmith, MPH, AL Johnson, PhD, L Potts, MSc, R Walwyn, MSc, JC DeCesare, BSc, HL Baber, BSc, M Burgess, PhD, LV Clark, PhD, DL Cox, PhD, J Bavinton, BSc, BJ Angus, MD, G Murphy, MSc, M Murphy, FRCP, H O’Dowd, PhD, D Wilks, FRCP[Ed], Prof P McCrone, PhD, Prof T Chalder, PhD, Prof M Sharpe, MD, on behalf of the 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
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960096-2/abstract
10. P. D. White, K. Goldsmith, A. L. Johnson, T. Chalder and M. Sharpe, PACE Trial Management Group
Recovery from chronic fatigue syndrome after treatments given in the PACE trial
http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=8988741&fileId=S0033291713000020
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Just discovered your excellent blog, and it is now bookmarked. 🙂
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Great!
And thank you for pointing out those typos. I have now edited the article so it should now read correctly.
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Reblogged this on The Halflife of ME.
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Excellent, yet again. Very clear. Thank you.
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