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Time for a Patient Revolution

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by Simon McGrath



'Let the Patient Revolution begin'. A militant cry from those difficult, demanding ME/CFS patients unwilling to listen to doctors and researchers who only have patients' best interests at heart? No, this dramatic call comes from a pillar of the medical establishment, the British Medical Journal (BMJ). Its recent editorial argues that the healthcare system as a whole is, far from being benign, actually badly broken and can only be fixed by an active partnership with patients:


[Most patients face] tests and treatments whose merits are hyped and harms underplayed...

Practice is informed by an incomplete research base bedevilled with selection and reporting bias, and at worst fraud. The preservation of institutional bureaucracies, as well as professional and commercial vested interests, have consistently trumped the interests of patients. The healthcare industrial complex stands accused of losing its moral purpose...

How better to [fix this] than to enlist the help of those whom the system is supposed to serve—patients?

BMJ Editorial: Let the patient revolution begin, May 2013


The BMJ may not have had ME/CFS in mind specifically, but their comment "Far more than clinicians, patients understand the realities of their condition, the impact of disease and its treatment on their lives, and how services could be better designed to help them" sums up the ME/CFS predicament perfectly.

Some patients have good constructive relationships with their physicians - Dan Peterson's patients are practically queuing up to praise him. Yet many have had nightmares, with doctors who want to dictate to patients without listening to the reality of their condition, and who sometimes seem to think this illness isn't much more than an attitude problem. It varies a lot - I've experienced both sides of the coin myself - but there are way too many examples of patients having horrific experiences at the hands of the health service. And for those severely-affected, there is often nothing on offer at all.

Things should be changing in the UK, at least in theory. The Government's new Health and Social Care Act aims for there to be “no decision about me, without me” for patients and their own care. How well these high ideals translate into better patient care remains to be seen.


'Healthcare won’t get better until patients play a leading role in fixing it'

That quote comes from the BMJ editorial, again - but, of course, patients across diseases have been calling for change for years. One of the leading advocates for putting patients centre-stage is e-Patient Dave, (Dave deBronkart) who says "The most underutilized resource in all of healthcare is the patient". While the BMJ said "Patient engagement is seen as a way to help health systems become sustainable. Some have argued that it is the “blockbuster drug of the century” and will deliver equivalent dividends."

Patients Rising: TED talk from e-Patient Dave
http://embed.ted.com/talks/dave_debronkart_meet_e_patient_dave.html



The e-patient (and how the web changed everything)

Dave says that a key figure in the development of patients who were partners in their own treatment was Tom Ferguson, medical editor of the hippy Whole Earth Catalogue. Tom pointed out in the 1970s that most healthcare consists of healthy people looking after themselves, but somehow when people become ill, their healthcare is all down to someone else. So he coined the word e-patient, who he called Equipped, Enabled, Empowered and Engaged (to which others have added Equals and Expert), to describe patients actively engaged in treating their disease.

Then the web changed everything - Dave emphasised how the Internet lets patients not only find information but also connect with one another. This makes new things possible, including in his case patients finding doctors in his region that were experienced in using a new and aggressive treatment for his terminal-diagnosed cancer. The patients said it probably wouldn't work, but it might - and in his case it did (see his BMJ article: "How the e-patient community helped save my life"). This isn't to suggest that there is a miracle cure for ME/CFS out there waiting to be found online, but it does show how online patients can provide well-informed, highly relevant information that wouldn't otherwise be available. The BMJ too emphasise the value of patient communities:

Online patient communities where patients meet, talk, support, inform, and coach each other are empowering patients... They also provide a rich and as yet largely untapped learning resource for health professionals. Examples include [not Phoenix Rising, sadly!] There are salutary lessons in the gulf between conversations in the clinic and the concerns patients share with their peers. [BMJ editorial]

Unfortunately, not all doctors see patient forums so positively.


Clinics that give patients what they want?

As the BMJ said, "Far more than clinicians, patients understand the realities of their condition and how services could be better designed to help them" and this is probably nowhere more true than for ME/CFS.

The UK Government says the 'no decision about me without me' approach also applies to the design of health and social care services. Firestormm, for example, found the new GP Commissioners in Cornwall were willing to listen to patients when the NHS CFS/ME Service was under threat in 2011/12, and that these talks led to the preservation of a much needed service and actually saw funding increase: I'm hoping he'll post more in the comments section. However, it is early days for the new system of GP Commissioners, so it's not yet clear if this new initiative from the Government - to give decision-making and funding responsibility to local GP experts - will translate to better, more responsive ME/CFS services right across the country.


Putting patients at the heart of research



As well as medical care itself, medical research needs to change too, so that it really does serve the interests of patients. The United States government has set up a new agency, Patient-Centred Outcomes Research Institute (PCORI), to focus on outcomes that matter most to patients. This is serious work: last year they had a budget of $150m. This year both CFIDS and the Open Medicine Institute (OMI) are applying for a share of $12 million to establish patient networks of individuals who (choose to) provide their own clinical and self-reported data for research studies that promise to improve outcomes for patients. Phoenix Rising is supporting the OMI application, so if it's successful we could be part of that network, helping to power better research. More about the OMI initiative below.

In the UK, groups of patients, carers, and clinicians are focusing on the questions about treatment outcomes - good and bad - that researchers need to answer. The results is DUETS, a database of uncertainties about the effects of treatment. Unfortunately, such an enlightened approach has yet to reach ME/CFS, as was shown by the world's largest CFS clinical trial, the £5 million PACE study, which defined success and failure without consulting patients.

Not everyone wants to collaborate with patients…
The PACE Trial’s recent paper claimed that 22% of patients ‘recovered’ with CBT or Graded Exercise (compared with 7% without). However, they had abandoned their original protocol definition of recovery and created a new version with much looser criteria. To give an idea of how far-fetched some of the new ‘recovery’ criteria are, 13% of patients met the fatigue or function ‘recovery’ criteria at the start of the trial – while simultaneously meeting criteria for ‘severe and disabling fatigue’. And a quarter of patients seen in wider clinical practice had physical function scores that met PACE recovery criteria.

Patients were not consulted about what should define recovery, not were participants asked if they considered themselves recovered. Surely the prime arbiters of what counts as recovery should be patients, who live the real-world consequences of the illness?

When it came to measuring treatment ‘Harms’, the PACE trial did go further in collecting data than any previous study of CBT and graded exercise. But they revised the original protocol definition of ‘Harms’, making it harder to for problems to count as ‘harm’, and made it technically almost impossible for anyone to deteriorate seriously in the second 6 months of the trial.

As well as ‘no decision about me without me’, perhaps we also need a commitment from the Government there should be ‘no research about me, without me‘. There is progress here, and the National Institute of Health Research, one of the biggest UK funding bodies for clinical research, now actively encourages researchers to involved patients in all stages of research, as partners rather than simply as trial participants.

It's also worth noting that ME/CFS patient surveys - based on patients receiving normal clinical services rather than the highly controlled therapy of research trials - consistently find high levels of adverse reactions with CBT and graded exercise. This information hasn't always been taken very seriously by researchers and clinicians.

Elsewhere, The Cochrane Collaboration has raised standards in medicines by producing systematic reviews of evidence on a topic, so that doctors can see the whole picture rather than relying on cherry-picked studies for information. Every Cochrane Review has a plain language summary aimed at patients, and they've gone further with the creation of the Cochrane Consumer Network, ccnet, that involves patients and patient advocates in preparing reviews - to make sure that Reviews address the issues that matter most to patients. Sadly there is no patient involvement in the forthcoming review on exercise therapy for CFS. There will, though, be an opportunity for patients to publish comments on the review - and hopefully patients will be involved in the future Reviews.

Other organisations show new signs of being willing to listen too. The recent FDA workshop gave over much of the first day to patients talking about their experiences. It quickly became clear that many at the FDA had no idea of the level of suffering of ME/CFS patients, but the often-moving testimony from sufferers did sem to make a difference.


Give us our data!

It's pretty hard to be an engaged e-patient if you can't even read the research, and most CFS papers are currently locked away behind a paywall. Ironically, even the 'Let the patient revolution begin' BMJ editorial initially couldn't be read by patients as it was paywalled, but credit is due to the BMJ who made it open access when the problem was pointed out to them. Nonetheless, its series of patient essays, including e-patient Dave's, remain paywalled despite their obvious value for patient engagement.

Fortunately, most new publicly funded research both in the UK and the US has to be made open access, though compliance is not enforced and that still leaves decades-worth of research locked away from patients. There is also a new movement for 'Open Data' that believes all scientific data (suitably anonymised as needed to protect patient confidentiality) should be available for anyone to analyse, even patients. Not all researchers are keen on having their data scrutinised, but the UK government is backing calls from the Wellcome Trust to make research funded by the government and charities freely available.


Patients doing it for themselves

Patients are increasingly becoming a driving force in research, rather than simply being consumers or participants:


Crowd-sourcing to speed up research

The Open Medicine Institute's OpenMedNet gives patients the chance to share their clinical data, biological samples or both - sharing as much or as little as they wish with researchers who will suddenly have the chance to conduct studies with thousands of patients. There are plans to let patients add data from devices such as Fitbit that monitor activity levels and sleep, to give researchers an unparalleled opportunity to study patients 'in the wild' rather than just in the lab. PatientsLikeMe is another site that lets patients network and share data with other patients and researchers, though not specifically for ME/CFS.


Crowd-funding too

Patients aren't just giving researchers data now, they are starting to directly fund research themselves too. Maria Gjerpe's incredible MEandYou initiative raised $430,000 in 90 days for the planned Norwegian multi-centre trial of the potential ME/CFS drug Rituximab. But MEandYou achieved far more than that. The fact that patients were resorting to funding their own research generated huge media and political interest, especially in Norway where, as Maria says, it changed attitudes and helped prompt the Norwegian Research council into funding a large chunk of the Rituximab trial, having earlier turned it down.


Crowdfunding is catching on: Ryan Prior turned to patients to fund his 'Blue ribbon' documentary exposing the terrible neglect of ME/CFS - and reached the $12,000 target in half the planned 36 days.


Patients Rising

There are a raft of opportunities coming together that could help tackle the major problems faced by ME/CFS patients. The medical establishment is finally beginning to wake up to the need for radical change, no doubt prompted by years of advocacy from patients pointing out that their needs are being ignored in healthcare and research. And there is recognition too that patients are central to fixing the system. Legislation in the UK will, at least in theory, give patients a much greater say. Research is being opened up to patients, while new technology and a can-do spirit from people like the Open Medicine Institute creates brand new ways for patients to contribute.

Not everyone will welcome a patient revolution, and I suspect that the medical establishment will resist more when it comes to ME/CFS than with most other diseases. It's crucial that ME/CFS patients keep up the pressure and exploit these new opportunities, but I believe there has never been such a promising time to get a better deal for ME/CFS patients.



Credits: Thanks to OCAL at clickr.com for the revolutionary woman icon, and to those who contributed ideas including Esther12 (who set up the thread that sparked this off) and Tom Kindlon.



Simon McGrath tweets about ME/CFS Research Follow @sjmnotes




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Comments

Thanks
The Australian Federal Government has formed a committee to address Lyme disease. This resulted from conumer action.
In the last few days consumer actions have resulted in 3 Australian bodies undertaking investigations into medical bodies using inadequate testing and other possible illegal and misleading activities.
this is highlighted in this article
http://www.bendigoadvertiser.com.au/story/1630359/victorian-doctor-goes-to-accc-with-lyme-disease-concerns/?cs=80
There is also a call for a federal commission enquiry which is the highest legal enquiry in Australia.
 
while many ME patients are working hard to improve diagnostics and treatments for ME, build ME clinics, there are some patients who criticise, belittle and insult them. Recently, one person in north ireland issued some very nasty and offensive insults against a group working for an ME clinic. And he managed to get a few others to support him in these insults, which led to a lot of trouble on the Internet. Yet for 20 years this man sat on his arse and did very little, while ME patients died and suffered and worsened over time. Shame on him for insulting and mocking other ME patients working hard to build an ME clinic, and move forward with diagnostics and treatments. Thats we are all up against, a small minority of patients who wish to attack and undermine the good work of others.
 
"Now that is a revolutionary idea. And it makes great sense to use test results patients already have."

The issue with this if one used the test results of tests the patients already had, is that it would only be accurate if patients were enrolled BEFORE they had the test done as otherwise if they knew a certain thing was being looked at, those who know already that they have this issue may be more likely to join, which would then not give accurate population rates of the issue. Hence I was thinking people would have to be enrolled before the test (which they were planning to get done anyway) was done (and then everyone who had the test, would have to be followed up both positive and negative results).

Of cause if a large group of patients were enrolled as test participants and all their test results were looked at rather then focus on just a certain area, then one wouldnt have biases towards certain results (I guess the OMI works like that?) . If a patient group thou collected things in such a way (unless OMI allowed a patient group to access all their info which I doubt it would), it would be too hard thou for a patient group to be looking at ALL the test results at once and hence I think just a few things at the most should be focused on at a time (one cant go and try to answer all the questions at once unless one had technology at ones fingertips to be analysing everything)..

I also think something like OMI is limited as does it ask for ALL tests the patients have had, all abnormal findings found? Ive found that data collections of things esp in the field of ME/CFS.. certain things are never asked or looked at . and if they arent, well they arent in the data base. Is OMI giving out what subgroup ME/CFS patients are, along with the data? or just data?. (thou i do think I read somewhere that OMI does look at gene stuff.. but how could a patient group or someone who wants to find out what percentage of ones with ME/CFS in certain definitions, have certain polymorphisms access the info from there?. Unless those who want questions answered can get the info from there, OMI is unfortunately useless to them.

"OpenMedNet streamlines data collection"

And what about data which hasnt been collected yet? (Im interested in looking at things in ME/CFS which havent been looked into yet.
Not sure you always need purely representative samples, eg studying POTS ME patients would only generalise to other ME POTS patients (and maybe only those that had been tested) but could still provide valuable info. In any case, good luck with your amibitous plans.

When I've contacted OMI before, I've just used the contact email on their website so might be worth trying.
 
The point of OMI patient database is not to prove anything, so selection bias in what it contains should not be an issue ... unless we forget that no amount of supporting data is sufficient to prove anything. What this kind of thing does is create a basis for developing hypotheses about ME, and therefore leading to more focussed research. As a tool for hypothesis generation, and for doctors looking for case by case comparisons so they can better treat patients, it will be invaluable.
 
What strange words.
OMI patient database not out to prove anything? What's the point then?

Selection bias should not be an issue? Why do it, if nothing is being selected?

No amount of supporting evidence is sufficient to prove anything:
What then, can ever be proven?

It would be as "invaluable" as a rubber hammer when trying to pound a nail.
 
What strange words.
OMI patient database not out to prove anything? What's the point then?

Selection bias should not be an issue? Why do it, if nothing is being selected?

No amount of supporting evidence is sufficient to prove anything:
What then, can ever be proven?

It would be as "invaluable" as a rubber hammer when trying to pound a nail.
Hi Eric, we disagree again. No surprise there.

OMI patient database is not a scientific study in itself, so is not about proving hypotheses.

Selection bias is not just about selecting. Your comment makes no sense.

No scientific hypothesis can ever be proven. This is a long established principle in the philosophy of science. This is discussed in Sir Karl Popper's work. So very much of science, and indeed nonscientific hypotheses, had so much supporting data many never doubted them. Yet they were then disproved. This includes even basic things the Newton's "law" of gravity. Things cannot be proved, only disproved. What you can do is verify facts and replicate data and show that data is consistent with an hypothesis - and even more important, you can test an hypothesis against new data collected in a way that is designed to show problems in the hypothesis. Proof primarily exists as a valid concept only in abstract mathematics. In other contexts "proof" typically means only "provide evidence for" and the hypothesis can still be wrong. For example, lots of people have been "proved" guilty of a crime in a court of law, yet were later shown to be innocent.

If the OMI database is as useful as a rubber hammer, then please explain why it cannot be used for hypothesis generation, and why it cannot be used to assist doctors in treating patients.

Alex.
 
You've managed to twist virtually every sentence completely out of recognition, including the analogy for the uselessness of a rubber hammer.

It is your perspective that nothing can be proven that obviates the point of even trying...
if your assertion were accurate.

Thank goodness it is not.
I imagine science will go on creating hypothesis and proving them, despite your doubts.
 
Hi guys how do you think we would go pleading our case and trying to get some help and/or donations to someone like Dick Smith or some other philanthropic organisation? Clive Palmer may be a good one. If he is running for politics he could just about ensure himself 100% of the PWCFS vote.
 
You've managed to twist virtually every sentence completely out of recognition, including the analogy for the uselessness of a rubber hammer.

It is your perspective that nothing can be proven that obviates the point of even trying...
if your assertion were accurate.

Thank goodness it is not.
I imagine science will go on creating hypothesis and proving them, despite your doubts.
Its not doubt, crtical rationalism is an almost universally accepted scientific practice, and taught to almost all science students, and represents the main philosophic position in science for over half a century. Almost any book on scientific philosophy, or methodology, or practice will say the same. Science has never proved anything, it tries to create best possible explanations, which frequently get overturned as we learn more.

There are special types of scientific research in which proof is not important though, nor is falsifiability. Some research is just out to explore in the hope of building enough data to make a more rigorous hypothesis.

Or do you think things like Newton's law of gravity were and still are proved?

Those vestiges of "scientific" research that do not embrace critical rationalism are responsible for things like psychogenic medicine ... as far as they are concerned they "proved" ME is psychosomatic. Nobody in modern science, from physics or chemistry to biology, would agree. Researchers who do not use critical rational methods are not scientists, and the concept of proof in science was the hallmark of nineteenth century science. Then they woke up. Large chunks of psychiatry, and smaller chunks of medical research, have yet to catch up to the twentieth century advances in scientific thinking.

Critical rationalism does have problems though, none of which is insurmountable - pancritical rationalism resolves the issues that lie within critical rationalism, though at the expense of some precision. Critical rationalism can be considered a special case of pancritical rationalism.

The whole idea of evidence based medicine arose because "proven" treatments were not working, or even killing people. It has its own set of problems, but it was a start. One of the issues is that it blurs medical management and practice with medical science ... they should be kept separate.

When someone argues that a whole lot of evidence proves some scientific hypothesis, then they risk making the inductive fallacy. Even the ancient Greek philosophers knew better. Inductive inference is great for making hypotheses, and sometimes for practical situations when fast responses are required, but those scientists doing this would not claim their conclusions are proven, or shouldn't if they want to have credibility.

There is some suggestion that statistical methods can provide proof, but this is hotly debated and not considered sound by many.
 
So you think Newtons's Law of Gravity is unreliable and can never be proven.

The only thing that keeps you from floating off into outer space is that it is just statistically unlikely because it doesn't happen very often?
"But this is hotly debated and not considered sound by many"... so watch out.

You could fly away any second.
 
Some of us were under the impression that the OMI patient database was out to "prove" the reality of the disease, and develop effective treatments.

This can only be accomplished by proper selection.
 
Some of us were under the impression that the OMI patient database was out to "prove" the reality of the disease, and develop effective treatments.
Where did you get that from? From the Open MedNet page:


OpenMedNet is an online community for patients, doctors and researchers to share and accelerate medical research and help deliver the highest quality patient care. It features the latest in Web and mobile technology; can be tied to home monitoring devices. New features will be added regularly.

The OpenMedNet is a service of the Open Medicine Institute and includes a longitudinal clinical data registry and repository, de-identified research database and a clinical biobank. OpenMedNet is enabling a new era in medicine today.

Patients can share data, biological samples or both. Patients control their data - they can be as restrictive or open as they wish. Online tools allow patients to manage medications, set reminders, track disease parameters, review labs, summarize their status to their providers (and researchers) as well as additional functions.
https://www.openmednet.org/registry/cfs_about


This can only be accomplished by proper selection.
The Open MedNet approach seems to me to be to gather a wide range of detailed longitudinal data across a broad range of conditions into one database. Such data might reveal subgroups or treatment effects through data mining. The database should contain any 'proper selection' of patients within it and such subgroups should be searchable. Assuming that's the case, I don't see why 'proper selection' would be relevant to such a project.
 
‘Let the Patient Revolution begin‘. A militant cry from those difficult, demanding ME/CFS patients unwilling to listen to doctors and researchers who only have patients’ best interests at heart?
----------------------------------------------------------------------
To have "ME/CFS" bests interests at heart, they would be properly selecting to study ME/CFS instead of a broad range of conditions.

It is clear you don't find this relevant.
 
When I first heard about Dr Kogelnik's datacrunching project, it was to solve ME/CFS.

I had assumed that was still the goal, and hadn't looked to see that the mission had changed.

I suppose datamining a broad range of de identified conditions then throws the burden of making sure they know what ME/CFS is on whoever is doing the analyzing.
 
So you think Newtons's Law of Gravity is unreliable and can never be proven.

The only thing that keeps you from floating off into outer space is that it is just statistically unlikely because it doesn't happen very often?
"But this is hotly debated and not considered sound by many"... so watch out.

You could fly away any second.
Hi Erik, look at my avatar? Recognize him? Why is he famous? He disproved Newton's law of gravity. Its called the theory of relativity ... and its not proven either. Or do you think Einstein was wrong? Einsteins predictions about gravity were shown to be accurate (so far) and so they debunked Newton whose law could not predict the observed phenomenon involving light bending and planets.
 
I suppose datamining a broad range of de identified conditions then throws the burden of making sure they know what ME/CFS is on whoever is doing the analyzing.
That is very much the case. As definitions change, or study focus changed, criteria for datamining will change. Its a resource, and its very likely that there will be a variety of medical conditions present in the patients.
 
Hi Erik, look at my avatar? Recognize him? Why is he famous? He disproved Newton's law of gravity. Its called the theory of relativity ... and its not proven either. Or do you think Einstein was wrong? Einsteins predictions about gravity were shown to be accurate (so far) and so they debunked Newton whose law could not predict the observed phenomenon involving light bending and planets.
Newton's Law was neither disproved or debunked, which is handy as most of the human-made world relies on it. A Law in science simply describes observations - usually mathematically - and no claims are made that it applies in all circumstances. And a Law explains what happens, not WHY it happens. Einstein's theory reveals a deeper truth about why gravity works, and can explain observations that Newton's Law cannot (though Newton's does a pretty good job with planetary motion, as well as most of the world we see). The two are not incompatible.
 
We'll never get a ME/CFS patient revolution going by insisting that patient selection doesn't matter, and nothing can be proven.

Those are the very words ME/CFS patients are struggling to overcome.
 
Newton's Law was neither disproved or debunked, which is handy as most of the human-made world relies on it. A Law in science simply describes observations - usually mathematically - and no claims are made that it applies in all circumstances. And a Law explains what happens, not WHY it happens. Einstein's theory reveals a deeper truth about why gravity works, and can explain observations that Newton's Law cannot (though Newton's does a pretty good job with planetary motion, as well as most of the world we see). The two are not incompatible.
Newton's law made predictions which were shown to be wrong. Under standard conditions on Earth its accurate enough that its still used, but thats because its a close approximation. Its not correct.