PACE and the interests of trial participants

disabled courtA tribunal has recently ruled that anonymous data from the controversial PACE trial must be released, rejecting an appeal from Queen Mary University of London (QMUL).

The data in question has been discussed on this blog before and you can read here to understand exactly what data we are talking about. It includes no personal identifiers.

The release of this data would allow for a reanalysis of the primary outcome measures according to the thresholds pre-specified in the researcher’s own published protocol. The recovery analysis in their published papers diverged from their own protocol, and included them lowering the recovery thresholds – this had the effect that more patients appeared to “recover” than if they had stuck to the planned thresholds for recovery. It’s possible that against the original recovery thresholds PACE may fail to demonstrate any significant recovery in patients – which would make the trial a failure.

QMUL can potentially appeal the tribunal’s decision and try again to block the release of the data that would allow this analysis. QMUL have already spent over £200,000 on legal fees on this tribunal case alone, which seems extraordinary considering they are a public institution. Following the tribunal’s decision they released this statement on their website: Disclosure of PACE trial data under the Freedom of Information Act

Prior to the tribunal, QMUL released a similar statement in which they said they were “seeking…the advice of patients”: Release of individual patient data from the PACE trial which led me to write to ME/CFS charities asking them to speak on behalf of patients. I asked patients to do the same, and you did! The effort was a success with 29 charities across the globe writing to QMUL on the request of patients to call on them to release the data and drop their appeal. This was submitted to the tribunal as evidence of the public interest in the data being released. Regarding the clear public interest in the release of the data, the tribunal stated:

“There can be no doubt about the Public Interest in the subject matter which is evident throughout the course of this appeal, and beyond, and we are grateful for the assistance that has been given to us in this regard.”

It was surprising that QMUL chose to ignore such strong public interest in the release of the data, which included thousands of patients, patient organizations, and academics. It appears they were not sincere in their wish to take account of the advice of patients, after all and I note that in their most recent statement, this time they do not invite the views of patients. But their most recent statement does say this (my emphasis added):

“We are studying the decision carefully and considering our response, taking into account the interests of trial participants and the research community.”

Perhaps QMUL will be consulting with participants then. QMUL surely do not mean to decide what is in the interests of participants without consulting them? To not consult participants would seem quite remarkable to me, but for all I know QMUL have been keeping participants informed and are seeking their views following the tribunal decision.

Given the Judge has ruled that they “…are satisfied that the risk of identification has been anonymised to the extent that the risk of identification is remote”, and that there is “…a strong public interest in releasing the data…” it is hard to see how QMUL could claim the interests of participants could be furthered by another appeal.

It must never be forgotten that trial participants are also patients, and members of the public too. However, this has not stopped QMUL in its various submissions from making a number of accusations of harassment from patients. In a separate FOI case, under a section they entitled “Harassment,” QMUL have pointed to the 12,000 strong petition calling for PACE claims to be retracted – most of those signatures are patients and some may be from patient participants in the PACE trial.

QMUL has accused patients in their “further skeleton” submission to the tribunal, where they claim “’highly critical’ and ‘vitriolic’ patient/activist groups” have tried to discredit the research.

One such activist group, according to QMUL, is the patient forum Phoenix Rising. Professor Jonathan Edwards, a member of the Phoenix Rising Board of Directors, appears to have been displeased with this accusation, as evidenced by his submission to the tribunal, referred to in the tribunal’s decision:

“Professor Edwards takes issue with the assertions that Phoenix Rising is allowing inappropriate behaviour, and further takes issue with the  term  ‘activist’ being used for its audience. He distinguishes highly motivated data requesters from those acting inappropriately or unreasonably. He accepts that certain individuals have expressed their frustrations with the misinterpretation of the PACE trial on the website in abusive terms, but this pales  in  comparison with four years of “intelligent and measured critique” provided by the other patients. Rather, the campaign to discredit or hijack the issue has come from the PACE authors and their colleagues in a series of attacks in review articles in the national press, online and in public presentations.”

The tribunal decision notice shows that one of QMUL’s arguments against disclosure of the anonymous PACE data was that “It would cause unwarranted distress to participants and open them to criticism or harassment.”

One document submitted by Alem Matthees as part of the evidence to the tribunal was a document collating the publicly available comments from PACE trial participants who had voluntarily come forward to express their views in public. A copy can be found here. It was submitted to dispute the claims of QMUL that patient participants were in danger of being harassed, and shows that in all cases where patient participants have come forward they have not been harassed, but rather have been praised, thanked and supported. This is no surprise, as we are all patients and we all just want to get better.

The Judge, considering this, and other evidence, found QMUL’s assessment of activist behaviour to be “grossly exaggerated” and QMUL were forced to admit at the hearing that “no threats have been made either to researchers or participants.”

But understandably, patients – including patient who are participants in the PACE trial – may feel rather upset with QMUL about their negative stereotyping of patients.

The tribunal decision includes a sentence about the responsibility of QMUL to participants when it comes to information about the anonymous data, the Information Commissioner pointing out that ” It would be up to QMUL to explain to participants that their data has been anonymised so that they could not be identified from it so as to allay fears that they themselves [QMUL] seem to be attempting to stoke up.”

Again, this makes you wonder what QMUL have been telling patient participants, if anything.


 

 

image credit: welsnet
creative commons licence
changes made to original image

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Magna Carta’s 800th Birthday

800 years ago, king John, put his seal to The great charter. His barons demanded this of him; they had had enough of his tyranny.

No longer would they allow him to lock them up without charge, to hold their families hostage, murder who he liked,  steal their lands and possessions, extort them with taxes and have control over who was appointed in the powerful church.

Stephen Langton, the Archbishop of Canterbury had just returned from exile in France, and was instrumental in Magna Carta coming about. He was there when it was sealed.

800 years ago today it was either agree to the charter or have civil war. And the French were waiting in the wings to invade if given half a chance.

Stephens brother Simon (briefly Archbishop of York at the time of Magna Carta) also played a key part, and would later be Chancellor in France and encourage an invasion  of England by the French Prince when king John reneged on Magna Carta.

It seems we have a lot to thank the Langtons for. And yet the history books wrongly state they were born in Langton by Wragby, in Lincolnshire.

The mistake comes from Powicke who in 1928 gives a reference to a manuscript talking of a mill at Langton which he claims is Langton by Wragby. However, manuscripts of this time rarely identified the specific village as the context (the names involved, the other places mentioned) made it clear which Langton village was being written about. In this case, you have a mill (which of course, requires water) which cannot have been at Langton by Wragby as it has no river.

The brothers actually came from Langton by Horncastle where there is a river and a mill as seen in other deeds in relation to the Langtons, including one in 1236 in which Simon Langton is sorting out the dowrie of his brother Walter’s widow. And other deeds exist showing their father Henry Langton, also at Langton by Horncastle. 

There appear to be no deeds which talk of any Langtons at Langton by Wragby in the time period (1100-1300) which is no surprise as it was very small at the time of Domesday and probably was not a significant settlement in the following centuries.

History books should not be taken at face value. Mistakes are often made and it’s important to use your own brain to evaluate the evidence and see if you agree with the conclusions reached. Much like scientific research, such as the PACE trial in chronic fatigue syndrome, that concluded graded exercise therapy (GET) leads to recovery in patients, when in face the opposite is true, as shown in the recently published survey conducted by the ME Association which found the majority of patients had a decline in health following GET.

Thankfully, we are free to challenge erroneous conclusions, in large part due to the work of the Langtons and the Barons in opposition to king John 800 years ago, though with our rights ever being eroded in this modern age, and the voices of individuals increasingly drowned out, you have to wonder if it isn’t time for a new Magna Carta. As was the case 800 years ago though, people have to be pushed very hard before they finally say, enough is enough.

Millions of Fantastic Free Images Added to the Internet

Creative Commons Image by Jonas Tana.

Creative Commons Image by Jonas Tana.

Adding an appropriate, quality image to your blog post can make the world of difference.

But where do you source them? You can’t just help yourself to what you fancy; it belongs to someone – or at least it might. When someone creates an image it is by default copyrighted to them. It is there’s and unless they allow it, no one else can use it. If therefore, you find yourself in need of free images to use alongside your crafted words then this post is for you.

A while ago I put together a list of resources where you can find free images and I had it in mind to tidy up my list and publish it. I hate those “Ten best places to get free images” type posts though, so thought I’d wait until there was an excuse to write about it properly.

Well, today I read about the recent addition of millions of copyright-free images to the internet and the guy who made it happen is Kalev Leetaru. Good on you sir. If he can do that then the least I can do is put my list up on here.

One of my favourite websites is archive.org, the free access on-line library also called the internet archive. I first became aware of this some years ago when I became interested in genealogy – a lot of very important records, including parish records and older deeds are freely available on there and it is well worth a look if you are interested in family history, rather than stumping up for a membership to somewhere like Ancestry or FindMyPast. There is also a wealth of free music there and even better – BOOKS!
Lots and lots of digitized books, which you can read on-line, print off, or even download to your Kindle.

William Tyndale, who died to give the Bible in English to the common man

William Tyndale, who died to give the Bible in English to the common man

Most of the books on archive.org come from libraries from all over the world which have been scanned and read by specialist software, which used optical character recognition to identify printed text and turn it into digital text which can then be adapted into a variety of formats. When it identified an image it ignored it. What Mr Leetaru has done is adapted the software to specifically find those images in the archives database and scan each one as a jpeg. The result is several million new images available to everybody. Works of art (some of which are the only surviving record as the original has been lost), illustration, sketches of this and that, coats of arms, photographs, even library stamps and scans of the book bindings themselves, are available.

Answers on a postcard to...

Answers on a postcard to…

These images become part of the Commons database on Flickr which includes images from additional free sources.

In addition, many photographers upload their pics to Flickr and make them available under the creative commons licence, meaning they can be used without charge so long as the author/creator of the image is attributed. What you can do with each image varies and you’ll need to check in each case.
You can search these via the creative commons area of Flickr.
As well as your search terms, scroll down the page and click the “Only search within Creative Commons-licenced content” and optionally any of the other Creative Commons search options and then hit “search”. When you find an image you want to use, click on it and check what it says below the image about usage.

There will be a “Some rights reserved” along with some icons, and the link can be clicked opening a new window making it clear what you can and cannot do with the image in question. Sometimes you can adapt the image in any way you want and sometimes that right is not given, and sometimes the rights do not extend to commercial use. In either case, they – the author/creator – retain the copyright of the image (they are just letting you use it for free).

When you use an image you need to provide an attribution statement on your post and ideally a link back to their page. See the caption below the image I’ve used above? That tells people who the image rights belong to and if you click on the image it will take you to the owner Flickr profile.

Another large source for creative commons images is Wikimedia Commons: A very good source for images and they make clear where permissions are required on their images. Simply search for the image you wish to use and scroll down, it will outline the image copyright status; you can also click the’use on the web’ link and copy and paste any required citation from here.

It’s also worth checking out Wikipedia’s image resources list.

A few more sources worth checking out

Microsoft Office: All free, photos and good clip art. Most of the clipart is in their own wmf format, which needs converting (it appears weird in most pc viewers):
– open with Office Picture Manager if you have any version of Office installed, File>Export>options inc png formats
– or convert on-line with zamzar.

Pixabay: the vast majority of images are free. Great selection of photographs and Clipart and Vector. Selecting an image will inform you in there is a charge. No requirement to quote source upon reproduction and images may be re-used for any purpose i.e. even commercial.

Clker: uploaded clip art vouched as public by those that upload.

Getty Museum Art Images: this site contains 4600 high-resolution images of artwork, and they can all be used for commercial and non-commercial purposes so long as they’re properly attributed to the museum. When downloading an image, the site also asks for you to share why you’re using it — information the museum wants to see the many reasons that people have for downloading its content.

Free Digital Photos.net: all you need do – where required – is credit the author and site. http://www.freedigitalphotos.net/

Medical journals/papers are another great source of good quality images, especially when an article is about a medical topic. Most journals have a policy already, so check their website. Some have a blanket policy where images can be used unchanged, and without specific formal request, so long as they are correctly attributed to the journal/authors in the way they specify. Other journals have an email address where you can contact them to ask specifically for permissions to use images from one of their papers. Journals get asked this often, so you’ll likely get a reply. Make sure you point out that it is for use by a non-profit charity if you are one.

If you cannot find an image suitable on the aforementioned sites it may be worth doing a google search specifying only images with no copyright on them.

Google’s advanced image search allows you to specify usage rights to find free to use content. Simply scroll to the bottom of the page and under the ‘usage rights’ tab select ‘free to use or share, even commercially’ But beware that sometimes Google screws up and the images aren’t really free to use, so check each source carefully to make sure you really can use them.

Fair Usage

Here is an example of an image used by wikipedia that is under copyright along with their statement for why it is fair usage:
Oetzi the Iceman
Do be aware, however, that the application of this rule is a matter of opinion and someone with a commercial stake in an image may try to stop you using it, even if you claim fair usage rights. You’ll have to make your own judgement what to use, as well as what to do if the owner asks you to stop.

In the spirit of free usage, if anyone wants to use the image I created for my ghost writer article, go ahead, I grant a Creative Commons licence on it. Just remember to attribute it to me when you do.

Know any more good sources? Tell us about them in the comments section!

EDIT: 04.09.2014, Yale University have a cool, interactive, searchable archive of 170,000 free photographs from the Depression era. Worth checking out.

What is an Autodidact?

I am an autodidact. (Ancient Greek: αὐτός “self” and διδακτικός “teaching”, pronounced: au·to·di·dact).

An autodidact is someone who is self taught. This sometimes means that the person may be very knowledgeable on a subject but lack the formal qualifications that evidence this, but not always so. An autodidact will often utilise whichever learning platforms are available to him, which can include formal learning at school or university as well.
Either way, they are probably well read, Their name on their library card all but worn away from overuse, and they probably live in houses full of books. Of course the modern day autodidact, myself included, is just as likely to have a worn out keyboard from all that internet research they do as well.

Now, I suspect that some people consider it a desirable quality and aspire to be one and therefore chose to label themselves this way when perhaps it does not belong, but I am not such a one. I have been an autodidact as far back as I can remember, and it was only as an adult that I came across the term and there was an instant moment of gleeful recognition… Oh, there are others out there like me!

Why I think I became an autodidact is a topic for a future post, but I think people tend to romanticize it, much like the overused cliché of the protagonist in both fiction and non-fiction stories being impoverished orphans who rise above their limited existence by the strength of their intellect alone.

Leonardo Di Vinci was autodidactic, as was the late Ray Bradbury and the fictional character Will Hunting played by Matt Damon in the film “Good Will Hunting” alongside the very recently late Robin Williams, who deservedly won an Oscar for his performance.
Leonardo Di Vinci was also a polymath which to me seems a desirable quality (though I am not a polymath myself) but I’m sure it has its drawbacks as well and my view of being a polymath is somewhat skewed by my outside perspective. But in terms of autodidactism, I always knew I ticked differently to other around me; although I was not strictly academic, not gifted at mathematics for instances, and terrible at spelling and grammar, I possessed a keen interest in a very broad range of topics and had a strong tendency to take up new hobbies or get absorbed in new things, saturating myself in them until there was nothing more to absorb.
And later on, seeking out and engaging true experts in those topics, focusing obsessively on details, striving for perfection and new ground and even ignoring basic needs like water, food and sleep because I was busy learning something new.

As a teenager I had great trouble deciding what to study at university. I looked at all the prospectuses and I thought they all sounded so fantastic I didn’t know which to choose. My parents and teachers mistook this for procrastination but it wasn’t. The model out there in society just didn’t fit me. Eventually I went to Art College at Falmouth University, but only because that was what I was thought gifted in at that time and I could start on a foundation course which covered all aspects of art from advertising and photography to ceramics, fine art and textiles – in other words, I could put off making a final decision for another year while still experiencing a lot of diversity.

Then I did the obvious thing: I left Art College after that foundation year was complete  and applied for a job in computer software, an industry I knew nothing about. Zilch. The agency gave me an exam and I failed all 50 questions. I was good looking (back then as a 19-year-old) and so I convinced the agency girl put me through anyway but I knew the real boss would reject me the next day at the second interview when he saw my test results. So what did I do? What any autodidact would do of course: I stayed up and studied!

Armed with a copy of the exam questions I learned the answers to all of them that night and the next day at the interview the first thing the boss said, with a perplexed expression on his face was, “why are you hear? You failed.” To which I said, “Ask me any question; today I’ll give you the correct answer.” He looked a little reticent at first, but he went along with it and ten minutes later after I had given perfect answers to all the questions he read to me, he gave me the job.
He even put my starting salary on more than I asked him for.

And so began my first career in software, though I went on to specialise in quality and efficiency management because of its wide remit and varied work. I am now a writer. I am finishing an epic fantasy series, a sci-fi thriller and an allegorical dystopian novel, all of which I plan to publish when able and which I will feature on my blog.

I sometimes absorb myself in a new topic for a day, or even a month or so, before dropping it when there isn’t much more to be sucked out of it, but the core fabric of my interest is writing. I also write occasionally for PhoenixRising and ProHealth on topics relating to myalgic encephalomyelitis, which I suffer from. I suffer as well from ulcerative colitis and may write something about that too.

You can expect a post or two about growing flowers and vegetables, an interest that has stayed with me, and the odd film review, but autodidactism seemed a fitting post to start with as I won’t be able to help writing about a few other things as they kidnap my thoughts along the way, such posts as “how to fix your laptop keyboard” when the S letter stops working unless you really whack it hard, for instance (I expect that post will come up in a week or two).