Time for a Patient Revolution

July 10, 2013

by Simon McGrath

revolutionary-woman2Let 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 saysThe 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

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

omiAs 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, 11% 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. Surely the prime arbiters of what counts as recovery should be patients, who live the real-world consequences of the illness, not researchers who might be more concerned with making their study look good.

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 impossible for anyone to deteriorate seriously in the second 6 months of the trial. They also published the proportion of patients improving by a ‘clincially useful difference’ in their 2011 paper but failed to provide the corresponding proportion of patients deteriorating by the same amount. Following a Freedom of Information request it appears they will now be publishing the data – more than 2 years later. 

As well as ‘no decision about me without me’, perhaps we also need a firm commitment from the Government there should be ‘no research about me, without me‘.

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 particpants:

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

meandyouPatients 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

 

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60 comments

{ 60 comments… read them below or add one }

Sasha July 10, 2013 at 12:54 pm

Fascinating, Simon – great article. Lots to think about there and plenty of opportunities seem to be in the pipeline for the ME/CFS community. As you say, we've seen big successes in fundraising with MEandYou and Ryan Prior's film project. We're also winning most online voting contests we enter and there's plenty more we could be doing. Anyone who still thinks their small donation or their mouse-click or any small action that they could take doesn't matter because no-one else will do it hasn't been paying attention to how things have changed – and how fast they're still changing. It's all to play for.

Simon July 10, 2013 at 1:31 pm

Thanks, Sasha

As I wrote the blog I was amazed myself how much seems to be changing at the moment and how many opportunities are coming up. I think there will be a gulf between some of the fine words from the UK government, the BMJ etc, and reality on the ground, but it's going to be easier to advocate for change when the principle that patients need to be centre-stage has been conceded.

And in the nearly 2 decades I've been ill there have never been such signs of radical change at the top. Interesting times. Or maybe just blind optimism from me :) .

Jarod July 10, 2013 at 1:35 pm

Glad somebody had enough energy to follow through on my crowd funding idea. Hope it gets run well. :D

http://forums.phoenixrising.me/index.php?threads/crowd-sourced-advocacy-concept.14836/#post-242573

Sasha July 10, 2013 at 1:45 pm


Simon

I think there will be a gulf between some of the fine words from the UK government, the BMJ etc, and reality on the ground, but it's going to be easier to advocate for change when the principle that patients need to be centre-stage has been conceded.

Nothing like being able to quote somebody back at themselves, though. :cool:

Sasha July 10, 2013 at 7:01 pm

Superb TED Talk by e-patient Dave, there, by the way – just watched it and he got a well-deserved standing ovation at the end.

taniaaust1 July 10, 2013 at 7:45 pm


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,

I think people are only just starting to understand the huge advantages there is in an internet age thou I think things could still be taken far further. The things I see being done using internet eg using competitions to gain funding, to use crowdfunding, making the knowledge known of the poor studies throu support sites, I see as just a start to things to come.

In this day and age with the use of the internet, we should be able to set up patient ME/CFS research studie and then make the patient research known (just like it comes now to our attention the info on the bad studies being down out there.. If someone does a good study of 1000-2000 ME/CFS patients even if its an unoffical study.. I believe it will gain attention throu our sites etc. The new found knowledge from such studies would get out).

I personally dont think there is a major necessarity to be needing to be going throu medical journals anymore when there are large ME/CFS interacting communities all over the place and patients who can set up unoffical studies and be doing better studies then currently being done in the medical journals!!! We have all became great analysers of bad studies, they stand out like sore thumbs and Im sick of seeing bad studies done,, even many of the better studies arent comparing the different subgroups in whatever they are studying. I think we need to be running our own studies (always comparing the subgroups while we are at it ..hence being research which wont go out of date when ME/CFS definitions change as it would then still be relevent) and we could do them far more cheaply too if we worked together and used the test results patients are getting back now.

Im very interested in setting up an unoffical study to help answer questions we have about ME/CFS which arent currently being researched. If anyone else is interested in being involved in something like this (I do have an easy thing to research in ME/CFS which hasnt been researched yet in mind to do with the methylation cycle) but maybe someone else has other easy to research things we could focus on if we formed a patient research group), please message me. Im looking for others who'd be serious interested in setting up a patient ME/CFS research group to research various things in ME/CFS (looking at things in both ME and CFS subgroups).

If you'd be a willing volunteer as a ME/CFS study guinea pig (only kidding thou I guess we could also do things like test out supplements or medications people get from their doctors which they want to trial anyway and not just look at peoples test results which is along the lines of what Im thinking about researching and analysing first being simple and without possible bad issues)… please contact me to with your email and I'll start making up a list of those who would be willing volunteers to be subjects in ME/CFS research studies done by a patient group once set up ( (No need to report me for a rule breach as Ive spoken to Mark and thou PR isnt involved at all at what I want to set up, he said its ok to try to do this off my own back).

It is my belief that with the power of the internet we (those who have ME/CFS) as a large patient group, could do something like this which would help us all and have it succede. Maybe it would even make todays ME/CFS research community turn to us to find out how to better run ME/CFS studies! (without all the study disputes which go on now) once it came known the patients themselves were doing very well run studies. We could set a new ME/CFS research standard.

Firestormm July 11, 2013 at 1:25 am


10 July 2013
Cut to the core

Fiona Godlee, editor, BMJ
fgodlee@bmj.com
The costs and quality of hospital care are under scrutiny as never before. How should we decide which types of secondary care represent value for money, how should we pay for them, and which treatments should be included in a tax funded service, free at the point of care (as the NHS still purports to be)?

In the first of a two part BMJ investigation, Gareth Iacobucci lifts the lid on England’s clinical commissioning groups (CCGs) as they take control of the purse strings for hospital care (doi:10.1136/bmj.f4351). Through freedom of information requests, he finds that CCGs are taking a range of different approaches to managing the money. Many have tightened existing restrictions on referrals for elective surgery; some have introduced new "gateways" and triage services to limit referrals and admissions to hospital; some have not implemented recent NICE guidance that would increase cost—for example, provision of IVF to older women and single sex couples. But a few have taken a very different route. Instead of tightening restrictions they have removed them, relying instead on improved dialogue between clinicians in primary and secondary care to deliver efficiencies.

Of course, such variation in local decision making is key to the government’s plan. Given time and good data we will be able to see which approach is better. And the government wants doctors, rather than politicians and managers, to decide which treatments to provide. Despite doctors’ concerns, NHS England is unapologetic about the idea that good clinical practice must encompass effective use of resources.

So should we mind the inevitable return of postcode prescribing, with patients being "at the mercy of CCG finances"? Or should the government, in the form of NHS England, draw up a list of core services for the NHS so that individual doctors are not asked to decide between their responsibilities to their patient and the need to help their CCG stay within budget?

In their replies to Iacobucci’s investigation, all the CCGs said that their decisions were being driven by clinical evidence rather than cost. But unlike their predecessors, the primary care trusts, CCGs have a legal duty to break even. In the words of one GP who recently stepped down as a CCG clinical director, "CCGs can run out of services but they cannot run out of money."

These pressures will only get worse as the finances tighten. Jon Ford, head of the BMA’s Health Policy and Economic Research Unit, concludes that the NHS is being required to create efficiency savings equal to a quarter of its budget by 2016, something he believes to be "totally unrealistic" (doi:10.1136/bmj.f4422). It can only be achieved, he says, by slashing pay and staffing levels, which would make the service unviable. Yet by most accounts the NHS is still one of the most cost efficient health services in the world. Why would the government want to dismantle it?

Shame the articles being referred to are behind paywalls. Surely such topics should be open-access in the spirit of 'patient power' :)

Simon July 11, 2013 at 7:25 am


taniaaust1

In this day and age with the use of the internet, we should be able to set up patient ME/CFS research studie and then make the patient research known (just like it comes now to our attention the info on the bad studies being down out there.. If someone does a good study of 1000-2000 ME/CFS patients even if its an unoffical study.. I believe it will gain attention throu our sites etc. The new found knowledge from such studies would get out).

… I think we need to be running our own studies (always comparing the subgroups while we are at it ..hence being research which wont go out of date when ME/CFS definitions change as it would then still be relevent) and we could do them far more cheaply too if we worked together and used the test results patients are getting back now

Now that is a revolutionary idea. And it makes great sense to use test results patients already have.

However, I wouldn't underestimate just how difficult it is to do good research. There are a thousand different ways to mess up a study, and only a few ways to get it right. Just getting the data in the right format is hard enough, and doing robust statistical analysis is fiendishly difficult.

To a large extent, something like OMI's OpenMedNet is providing the perfect platform to collect the information you want and to oganise experiments. A couple of things occur to me that might be easier to pull off, and achieve the same, are:

  • Bring together patients to agree priority research questions that need answering, and maybe suggesting experiments that would provide the answers
  • Approach OMI about using OpenMedNet to tackle said experiments. I don't know if they would be willing to play ball, but it could be interesting to ask. They may even be able to suggest researchers who would be willing to collaborate with patients on studies.

I personally dont think there is a major necessarity to be needing to be going throu medical journals anymore when there are large ME/CFS interacting communities all over the place and patients who can set up unoffical studies and be doing better studies then currently being done in the medical journals!!! We have all became great analysers of bad studies, they stand out like sore thumbs and Im sick of seeing bad studies done,, even many of the better studies arent comparing the different subgroups in whatever they are studying..

There are certainly plenty of bad studies out there, and probably most in the scientific community would agree that the current system doesn't work very well. I do think it's important to have an independent view of any study write-up before it's published as that spots errors at least (if not all of them).

On top of improving the current patchy peer-review system, people like James Coyne have argued that Post-publication review/critiques are enormously helpful – because it extends scrutiny to a much wider group of people. He is campaigning against the practices of limiting critiques to just a few hundred words, or of authors blocking any critiques of their studies. Another issue is that even if critics make good points that undermine a study, someone paying for access to the original study won't usually get access to any correspondence or critiques. This sort of thing is easy to organise through the internet and drives up standards, but there is a lot of resistance to it from authors who like to feel that once published their study becomes an unchallenged beacon of light, rather than something to be debated. Overall, I believe journals are better reformed than abandoned.

Esther12 July 11, 2013 at 4:36 pm

Thanks for tying together all those different sources Simon. It does seem like lots of different sources of power are pushing a similar agenda at the moment, and one that has particular significance for CFS patients (although I don't thikn that the BMJ will want to recognise this).

Firestormm July 12, 2013 at 5:22 am

Apologies Simon, but I've finally now cleared some time to properly read your article and wanted to comment a little further about our local action in relation to the GP Commissioners down here in hot and sunny Cornwall.

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.

Whilst the problems facing our ME Service had become apparent prior to the publication of this Bill, it certainly did serve to provide the impetus for Kernow Clinical Commissioning Group, the outgoing Primary Care Trust and indeed the Hospital Trust (who are responsible for the Service); to sit-up and take notice of what we as patients and representatives had to say.

N.B. For anyone wishing to discover who their commissioners are. Try this if you are in England. :)

I am a committee member of MESHcornwall. A small volunteer organisation (soon to become charity) that liaises frequently with the NHS ME Service. Professor Tony Pinching is our Patron, and it was his retirement that actually brought all the financial problems to light.

And before any asks – I am responsible for the 'new' website information. So blame me for the fact that it isn't all perfik at the moment. I am working on it with my 'technical advisor' who is unpaid also and busy running his company at the moment. [Sigh] The 'third sector' can suck :zippit:

Essentially, the Service was operating without any formal model and was costing far more than the amount allocated by the PCT. Generally, each new patient is allocated £X in the NHS. This however is often inadequate when dealing with a chronic condition – as I suppose we can all imagine.

We became involved properly in 2011 and our principal concern at that time was a replacement clinician for the Professor. But we became embroiled in the controversy of funding vs. performance and it became apparent that the Service itself was under threat of closure.

The overspend was being picked up by the Hospital Trust and they were themselves in financial deficit. So what to do? The Cornwall ME Service was very highly regarded by patients and in a 2011 Neurological Services report commissioned by CAN-DO (another group I had been assisting with and another project I helped to produce); the Service was highlighted as a 'good integrated working model' of care (page 26).

That Report from CAN-DO actually draws on much of the 'no decision about me…' ethos of the Governments plans – although again the Bill had not been published and the Commissioners had not taken office at the time.

So, while the Service – with Tony Pinching at it's head as Service Lead – was seen as something worth saving; it was costing more than was available and the Hospital Trust were desperate for a solution.

Incidentally, Tony did not cost anything really. His salary and time were picked up as a part of his contract with another part of his professional role. So losing him was not a financial benefit to the Trust. It was felt as a loss all round.

But what can you do? We are so desperate for clinicians to come onboard. We as patients could only protest the need and indeed, we still are. We have gone from Tony, and 2 GPs with special interest working part-time; to a single GPwSI and a Neurology Specialist.

In terms of medical manpower we are down. And our remaining GP might indeed be considering his role – he has to travel from Torbay to Truro to attend clinic. The ethos extends you see to having GPs in Primary Care carrying a greater share of the 'burden' and then Secondary Care i.e. the ME Service: complementing them.

Our Neurology Specialist I have yet to meet. It took some effort by our current Service Lead (Carol Wilson) to snag Julie's interest I think. A case of bypassing the system of advertising, and bureaucracy, and knocking on her door! Not ideal perhaps, and Julie is new to ME, but – seriously – what can you do?

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.

So. Once we knew that Kernow Commissioners had come on-line. We also discovered that GPs generally wanted – some quite desperately – the ME Service to continue. Had this ground-swell not been there then perhaps things might have been different.

Point here is that we had already established the infrastructure locally. We had the networks. Alongside MESHcornwall we have Seven Community Support Groups across the county – Cornwall is very large and rural. We had CAN-DO a recently new organisation; and we had national input and awareness – principally with the ME Association. But much was done by MESHcornwall and especially by our Chairman.

Through our Newsletter we kept our 200 members in touch with what was happening. We have formal quarterly meetings with the ME Service and the Hospital Trust decision-makers; and these meetings were increased to monthly almost throughout the 18-24 months this dragged on.

Letters were written of course, phone calls, etc. with the Trust executives, PCT, and Commissioners; all made through our Chairman. It helped to keep things streamlined and enable relationships to be established. I was a background bod, offering support and writing crap :lol:

We also negotiated a BBC Radio Cornwall feature. Our Chairman read the letters from patients pleading for the Service to remain open and better funded. Relating their experiences of help and support. This feature ran throughout the morning show. And believe me – almost everyone in Cornwall listens to this radio. It IS very influential.

Our meeting with the Kernow I remember very well. I had actually reviewed the NICE Guideline with the aim of trying to impress upon them how the remaining Service was not fulfilling the expressed need. Accompanying the Guideline by the way is a rather useful 'costing template'.

The link there is to the pdf. but there is also an Excel document that enables you to add your own population data and it will compute a cost estimate for their ideal of a 'model' service. It's extremely useful I found for comparisons – its the only one I came across.

When it came to the meeting, there I was armed with my nicely typed – taken forever – reports and the five of us were ready to rock n' roll. Only they had overrun with – of all people – CAN-DO!! Still we got our points across succinctly – and presented the reports. I never knew if they'd read them but when I got home I followed them up with emails – damned if I was going to see all my efforts wasted!! :zippit:

Oh there were moments of panic on the journey and we aren't out of the woods yet by any means. At one point the suggestion from the Hospital Trust was to provide a Liaison Psychiatrist to oversee our Service and the Pain Management Clinic. But we sidestepped, and dodged, and ducked and dived; and punched a few noses… you get the point :)

Main thing was to keep talking. Keep engaged. And try to make sense and not talk with emotion. Although emotion is very useful at times – like the radio for example.

Another aspect to all of this has been the development of the Referral Management System. Not sure if other parts of the country have similar systems for GPs to use? It is intended to streamline referrals. There is some bumf on there as you can read about ME.

Our Service is now formally taking Moderate, Severe, and Very Severe. It is better funded than it was. The system still has flaws and these we will be hoping to address next week and at our next Liaison meeting in August. Home visits are made – I should know because I get them. The medical side has been downscaled but this might be corrected if we can recruit someone new.

Am in danger of losing the plot now… and have written enough for everyone to turn off I suppose. One final point. In Cornwall we now have these people: Healthwatch Cornwall

I haven't really had time to look into them very closely but they are I think another aspect of the Bill. My overriding concern with all of these changes and with the ethos is one of EFFECTIVENESS and MEASUREMENT.

How can any patient feel that their expensive efforts have been effective? How can we as patients measure our efforts?

I mean we are able to have our say; they are told they have to take notice – but how can we be reassured that all this effort and energy has been worth it?

If we can't be assured of something – then the 'carrot' (the hope of better services) may not be enough to overcome the 'stick' (the cost to us as people who are sick in stretching our resources to get involved constructively).

Sasha July 12, 2013 at 5:33 am

Firestormm – my brain went 'pop' partway through your very interesting account there so apologies if I'm now talking rubbish – will try to reread later – but I wonder if this isn't a great case for telemedicine (another new direction that the NHS is trying to head in).

The benefits to PWME of telemedicine would in general be huge. Who among us bedbound/housebound patients get adequate care? We desperately need the NHS to take advantage of even the phone (!) in dealing with us, rather than requiring us to visit surgeries and hospitals or do the impossible and get a housecall (difficult for GPs, impossible for specialist care).

Can ME be a leader in this field? And led by patients? It would be a good way of emphasising to the NHS and the public in general that we are so physically disabled that we're incapable of accessing care in the normal way.

Firestormm July 12, 2013 at 5:40 am

Thanks Sasha for the 'like'. Hope it bloody makes sense. Have been editing. I always hit the return button too soon. Anyway, that's me done for the day. You have a good one :)

Re: Tele-medicine. Yes. Carol is trialling a system for people with ME. I am struggling now but it had to do with the telephone and a black box :ninja: Something about pain management and advice and medication. I believe she said – this was last year – that it held recordings or it might have also been a 'hot-line' for people who became rather desperate for advice and couldn't get to the GP. I shall endeavor to follow-up on this. Thanks for the reminder :)

Sasha July 12, 2013 at 5:57 am


Firestormm

Thanks Sasha for the 'like'. Hope it bloody makes sense. Have been editing. I always hit the return button too soon. Anyway, that's me done for the day. You have a good one :)

Re: Tele-medicine. Yes. Carol is trialling a system for people with ME. I am struggling now but it had to do with the telephone and a black box :ninja: Something about pain management and advice and medication. I believe she said – this was last year – that it held recordings or it might have also been a 'hot-line' for people who became rather desperate for advice and couldn't get to the GP. I shall endeavor to follow-up on this. Thanks for the reminder :)

Better to hit the return button often than not at all, I think!

Take it easy! Sounds like you need a rest. :sleep:

MeSci July 12, 2013 at 6:40 am


Firestormm

I am a committee member of MESHcornwall. A small volunteer organisation (soon to become charity) that liaises frequently with the NHS ME Service. Professor Tony Pinching is our Patron, and it was his retirement that actually brought all the financial problems to light.

Wow – you sure have been doing a lot! :)

Firestormm

We are so desperate for clinicians to come onboard. We as patients could only protest the need and indeed, we still are. We have gone from Tony, and 2 GPs with special interest working part-time; to a single GPwSI and a Neurology Specialist.

I couldn't find names for your clinicians on the MESH site. I recall seeing that a researcher on a recent article posted here was based in Devon – can't find it again or remember his name but it was a 'double' surname without a hyphen. Whom do you have?

Firestormm

We also negotiated a BBC Radio Cornwall feature. Our Chairman read the letters from patients pleading for the Service to remain open and better funded. Relating their experiences of help and support. This feature ran throughout the morning show. And believe me – almost everyone in Cornwall listens to this radio. It IS very influential.

Not sure about this but I'm sure you will reach a lot of people who wouldn't come across the issue otherwise through that station. I don't listen to Radio Cornwall – my radio is almost permanently tuned to Radio 4, Radio 4 Extra and occasionally BBC World Service, Radio 3 and Planet Rock! I don't think my best friend listens either, nor another close friend.

MeSci July 12, 2013 at 6:46 am


Sasha

Firestormm – my brain went 'pop' partway through your very interesting account there so apologies if I'm now talking rubbish – will try to reread later – but I wonder if this isn't a great case for telemedicine (another new direction that the NHS is trying to head in).

The benefits to PWME of telemedicine would in general be huge. Who among us bedbound/housebound patients get adequate care? We desperately need the NHS to take advantage of even the phone (!) in dealing with us, rather than requiring us to visit surgeries and hospitals or do the impossible and get a housecall (difficult for GPs, impossible for specialist care).

Can ME be a leader in this field? And led by patients? It would be a good way of emphasising to the NHS and the public in general that we are so physically disabled that we're incapable of accessing care in the normal way.

Agree 100%. I think there has been at least one trial of telemedicine in Cornwall, but only for certain conditions. With the long distances, the low car ownership and the poor public transport system it can be hard for many people in Cornwall to access health services. The volunteer driver services are overwhelmed, and those using them often claim back the cost as they are on low incomes. This must cost the NHS a fortune.

I visited my GP recently, taking the best part of the afternoon to get there and back on the bus, just to check my blood pressure! I have my own BP monitor so it was really unnecessary and inconvenient.

taniaaust1 July 12, 2013 at 2:43 pm


Simon
taniaaust1

In this day and age with the use of the internet, we should be able to set up patient ME/CFS research studie and then make the patient research known (just like it comes now to our attention the info on the bad studies being down out there.. If someone does a good study of 1000-2000 ME/CFS patients even if its an unoffical study.. I believe it will gain attention throu our sites etc. The new found knowledge from such studies would get out).

… I think we need to be running our own studies (always comparing the subgroups while we are at it ..hence being research which wont go out of date when ME/CFS definitions change as it would then still be relevent) and we could do them far more cheaply too if we worked together and used the test results patients are getting back now

Now that is a revolutionary idea. And it makes great sense to use test results patients already have.

However, I wouldn't underestimate just how difficult it is to do good research. There are a thousand different ways to mess up a study, and only a few ways to get it right. Just getting the data in the right format is hard enough, and doing robust statistical analysis is fiendishly difficult.

To a large extent, something like OMI's OpenMedNet is providing the perfect platform to collect the information you want and to oganise experiments. A couple of things occur to me that might be easier to pull off, and achieve the same, are:

  • Bring together patients to agree priority research questions that need answering, and maybe suggesting experiments that would provide the answers
  • Approach OMI about using OpenMedNet to tackle said experiments. I don't know if they would be willing to play ball, but it could be interesting to ask. They may even be able to suggest researchers who would be willing to collaborate with patients on studies.

I personally dont think there is a major necessarity to be needing to be going throu medical journals anymore when there are large ME/CFS interacting communities all over the place and patients who can set up unoffical studies and be doing better studies then currently being done in the medical journals!!! We have all became great analysers of bad studies, they stand out like sore thumbs and Im sick of seeing bad studies done,, even many of the better studies arent comparing the different subgroups in whatever they are studying..

There are certainly plenty of bad studies out there, and probably most in the scientific community would agree that the current system doesn't work very well. I do think it's important to have an independent view of any study write-up before it's published as that spots errors at least (if not all of them).

On top of improving the current patchy peer-review system, people like James Coyne have argued that Post-publication review/critiques are enormously helpful – because it extends scrutiny to a much wider group of people. He is campaigning against the practices of limiting critiques to just a few hundred words, or of authors blocking any critiques of their studies. Another issue is that even if critics make good points that undermine a study, someone paying for access to the original study won't usually get access to any correspondence or critiques. This sort of thing is easy to organise through the internet and drives up standards, but there is a lot of resistance to it from authors who like to feel that once published their study becomes an unchallenged beacon of light, rather than something to be debated. Overall, I believe journals are better reformed than abandoned.

"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.

taniaaust1 July 12, 2013 at 3:07 pm

I was just thinking.. maybe OMI would allow a patient group to work with them to collect info on certain test results and then pass them on the info so they can put out the info??? (this may be worth at least asking them about). I know they have their own set focuses but I wonder if they would allow a group of others to do the work for them on other ME/CFS things? (and take on the costs of that research).

Im wondering if anyone has a contact email for Andreas Kogelnik? (founder/director of OMI If so, could you please pm it to me as I'd like to ask him about my idea of a patient group gathering up info on other ME/CFS research things and if that info them could be passed on to OMI. I'd like to start up a research patient group which could work with OMI

Simon July 12, 2013 at 4:10 pm

Thanks for explaining som much about your battles, Firestormm, think you wrote an article there! Think you deserve a medal too, both for perserverance and effectiveness (sorry, only balloons available :balloons:) . Congrats to all at MESHCornwall.

I've highlighted what I thought were some of your key points below, but it's still a lot! So, mainly for my benefit I've summarised what struck me as key issues in all this at the end- you can let me know how i did

Firestormm

Essentially, the Service was operating without any formal model and was costing far more than the amount allocated by the PCT. Generally, each new patient is allocated £X in the NHS. This however is often inadequate when dealing with a chronic condition – as I suppose we can all imagine.

We became involved properly in 2011 and our principal concern at that time was a replacement clinician for the Professor. But we became embroiled in the controversy of funding vs. performance and it became apparent that the Service itself was under threat of closure.

The overspend was being picked up by the Hospital Trust and they were themselves in financial deficit. So what to do? The Cornwall ME Service was very highly regarded by patients and in a 2011 Neurological Services report commissioned by CAN-DO (another group I had been assisting with and another project I helped to produce); the Service was highlighted as a 'good integrated working model' of care (page 26).

That Report from CAN-DO actually draws on much of the 'no decision about me…' ethos of the Governments plans…

So, while the Service – with Tony Pinching at it's head as Service Lead – was seen as something worth saving; it was costing more than was available and the Hospital Trust were desperate for a solution.

…But what can you do? We are so desperate for clinicians to come onboard. We as patients could only protest the need and indeed, we still are. We have gone from Tony, and 2 GPs with special interest working part-time; to a single GPwSI and a Neurology Specialist.

So. Once we knew that Kernow Commissioners had come on-line. We also discovered that GPs generally wanted – some quite desperately – the ME Service to continue. Had this ground-swell not been there then perhaps things might have been different.

Point here is that we had already established the infrastructure locally. We had the networks.
We also negotiated a BBC Radio Cornwall feature… And believe me – almost everyone in Cornwall listens to this radio. It IS very influential.

Our meeting with the Kernow I remember very well. I had actually reviewed the NICE Guideline with the aim of trying to impress upon them how the remaining Service was not fulfilling the expressed need. Accompanying the Guideline by the way is a rather useful 'costing template'.

The link there is to the pdf. but there is also an Excel document that enables you to add your own population data and it will compute a cost estimate for their ideal of a 'model' service. It's extremely useful I found for comparisons – its the only one I came across.

…Oh there were moments of panic on the journey and we aren't out of the woods yet by any means. At one point the suggestion from the Hospital Trust was to provide a Liaison Psychiatrist to oversee our Service and the Pain Management Clinic. But we sidestepped, and dodged, and ducked and dived; and punched a few noses… you get the point :)

Our Service is now formally taking Moderate, Severe, and Very Severe. It is better funded than it was. The system still has flaws and these we will be hoping to address next week and at our next Liaison meeting in August. Home visits are made – I should know because I get them. The medical side has been downscaled but this might be corrected if we can recruit someone new.

Key points (I think)

  • The 'No decision about me, without me' principle helped the discussion
  • Money and budgets were hugely important but you spent a lot of time addressing this and that seems to have paid off
  • Showing how valued the service was by GPs was a very smart move
  • Tying up Cornwall's radio waves for ME was a cool
  • That liaison pyschiatry option must have been alarming – it's what happened in Leeds.

Fantastic you have home visits. Amazingly, my consultant came out to see me at home when I was very ill but have used phone and letters since, which has worked well. I didn't even meet my new GP for 6 years until I was able to see them this spring – everything was done by phone.

Erik Johnson July 12, 2013 at 7:24 pm

Dr Cheney and Dr Peterson are awesome, but what happened to us in Incline Village was so unbelievable…
that frankly, neither of them could believe it.

There was more going on, but you had to be there to feel it.

http://www.cfsuntied.com/toxicmold.html

GcMAF Australia July 13, 2013 at 1:32 am

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.

David Egan July 13, 2013 at 1:49 pm

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.

Simon July 13, 2013 at 4:08 pm


taniaaust1

"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.

alex3619 July 14, 2013 at 12:57 am

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.

Erik Johnson July 27, 2013 at 12:28 am

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.

alex3619 July 27, 2013 at 1:56 am


Erik Johnson

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.

Erik Johnson July 27, 2013 at 3:21 pm

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.

knackers323 July 27, 2013 at 3:57 pm

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.

alex3619 July 27, 2013 at 4:57 pm


Erik Johnson

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.

Erik Johnson July 27, 2013 at 6:08 pm

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.

Mark July 27, 2013 at 6:31 pm

"Newton's law has since been superseded by Einstein's theory of general relativity, but it continues to be used as an excellent approximation of the effects of gravity"

http://en.wikipedia.org/wiki/Newton's_law_of_universal_gravitation

Erik Johnson July 27, 2013 at 6:55 pm

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.

Mark July 27, 2013 at 8:00 pm


Erik Johnson

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.

Erik Johnson July 27, 2013 at 8:43 pm

‘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.

Erik Johnson July 27, 2013 at 10:17 pm

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.

alex3619 July 28, 2013 at 5:02 am


Erik Johnson

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.

alex3619 July 28, 2013 at 5:04 am


Erik Johnson

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.

Simon July 28, 2013 at 5:21 am


alex3619

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.

Erik Johnson July 28, 2013 at 9:14 am

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.

alex3619 July 28, 2013 at 9:20 am


Simon

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.

alex3619 July 28, 2013 at 9:27 am


Erik Johnson

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.

Nobody has said that patient selection for scientific studies does not matter. Please reread the prior posts. Patient selection is important for studies into ME. So is the selection of controls, and decisions made about standards of testing.

Selection bias is not so important in an OMI style database. Its the studies that determine criteria, create matched controls etc.

Its the sad reality that doctors being unable to handle uncertainty in medicine and diagnosis that makes them want certainty. The only "certain" diagnosis for ME in many doctors eyes is a psychosomatic one. This is dangerous. Medicine needs to embrace uncertainty, or these mistakes will be driven by their need for certainty. which makes them vulnerable to latching on to half-baked theories such as that deconditioning, depression or the wrong ideas about their illness can cause ME, or actually be ME. Once they have the wrong ideas firmly entrenched, then work committments, confirmation bias and cognitive dissonance make looking at contrary data difficult. It gets dismissed. Why should they look at data about ME? They already know its psychosomatic, or not a real illness or whatever their view is.

What needs to happen is that false hypotheses, false claims about ME, are disproved. Then we have to find a way to break through the political and economic structures that make current BPS models so appealing.

Meanwhile studies like the phase 3 clinical trials into Rituximab may yet present us with a reliable cure for many of us, and a treatment for most. At that point we will need to push for treatment, and lobby for government support in every country and acceptance by the insurance industry. It was patient demand that got antibiotics accepted for use in peptic ulcers, the medical profession resisted it.

Other studies include possible biomarkers, novel pathogens etc. Lots of interesting research may come out in the next few years.

MeSci July 28, 2013 at 10:59 am


alex3619

Meanwhile studies like the phase 3 clinical trials into Rituximab may yet present us with a reliable cure for many of us, and a treatment for most. At that point we will need to push for treatment, and lobby for government support in every country and acceptance by the insurance industry. It was patient demand that got antibiotics accepted for use in peptic ulcers, the medical profession resisted it.

Other studies include possible biomarkers, novel pathogens etc. Lots of interesting research may come out in the next few years.

I agree as long as no compulsion is brought to bear on patients to agree to treatments (let's use Rituximab as a theoretical example) or else lose welfare benefits.

Few, if any, new medicines are both safe and effective for all sufferers of a given illness, and different treatments are likely to benefit different patients, as indeed is currently accepted for things like hypertension. Hopefully this kind of level of uncertainty over which treatment is suitable for which patient, which most doctors acknowledge, will also be acceptable to them with regard to treatments for ME, with the patient being the final decision maker after being given all necessary information.

alex3619 July 28, 2013 at 12:59 pm

Yes MeSci , compelling people to comply in the call of it being in their own good is legitimization of authoritative control of so very much. Its a very bad idea. However patients should be given the evidence and the option. I am not sure that in the case of Rituximab it will be a problem though – its very expensive. I think it more likely they will try to disuade people from using it.

Rituximab currently has a fail rate of 30% (though I am sure it is now less than that, the actual figure is not public). So up to 30% of patients who try Rituximab are taking a risk on a drug that can cause sudden death, or viral infections from viruses that only attack the severely immune compromised, and so on. Nobody should be compelled to take such risks.

What we really need is biomarkers that predict a very high level of success. I hope they can come out of the phase 3 study, or at least some study in the next five years, which is my expected time frame before we have an answer on whether Rituximab is highly useful as a treatment or not.

One thing that is a big concern with many of us is we react very badly to so many things. Rituximab is a class of drugs that induces massive allergic reactions anyway. So how can somone who is highly drug intolerant cope with using Rituximab? Its a concern, and nobody has real answers yet.

Simon July 28, 2013 at 3:27 pm


alex3619

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.

The fact that it's still accurate enough to be used to put a man on the moon and to build the human world is the point; the Law holds in most circumstances, which is all science Law claims to do. That's different from, say, the notion that the earth is flat, which could be said to be wrong, debunked or disproved – as you were suggesting applies to Newton's Law of gravity.

Anyway dont' know quite how we got from 'A Patient Revoulution' – how patients need to be centre-stage for the good of both healthcare and research – to Newton's Law of gravity and whether or not science can prove anything. How about pursuing this instead on a new thread?

Meanwhile, I thought it timely that there is going to be a research study into the value of Phoenix Rising, given this in the Patient Revolution blog:

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]

Erik Johnson July 28, 2013 at 4:54 pm

For this biobank, proper selection is critical.

—————————————————————————-
THE OMI-MERIT INITIATIVE—CHANGING THE GAME FOR ME/CFS
OMI-MERIT (ME Roundtable on Immunology and Treatment) is a strategic initiative of OMI and its collaborators to bring together leading clinicians and researchers to tackle this debilitating but underserved disease. The MERIT group is focused on developing and applying a multi-factorial approach to the discovery of new diagnostic and treatment solutions for ME/CFS.

OMI-MERIT Priority Projects

An International Neuro Registry and Biobank
Goal: Supporting and expanding the largest and most comprehensive longitudinal ME/CFS information source for research and collaboration will be the result of this project. We will collect longitudinal data and biological specimens from ME/CFS patients and controls, and characterize the ME/CFS population by patient symptoms and laboratory and molecular profiles through crowd-sourced informatics and cutting-edge tools in immunology, genomics, and molecular biology. Comprehensive, standardized sampling will include blood, cerebrospinal fluid (CSF), urine, stool, brain/CNS, and other tissues. Samples will be available for additional studies in the MERIT list and beyond.
Importance: There has been no large-scale, chronologic characterization effort across the ME/CFS population. The Registry and Biobank will help establish clinical and biologic clusters in the population, paving the way for diagnostic biomarkers and cluster-specific treatments. In addition, this will provide a community resource for patients and is central to additional collaborative projects.

Sushi July 28, 2013 at 5:02 pm

Erik Johnson

If you use the quote function at the end of the bar above it will make posts easier to read. It will save the "head-scratching" factor of trying to figure out which part is yours and which quoted.

Thanks,
Sushi

alex3619 July 28, 2013 at 5:11 pm

Patients often drive change. According to one medical conference report that I blogged on, it was patients who made the medical profession use antibiotics to treat peptic ulcers. They forced the issue. When the science changes, when a treatment is available, ultimately its we who have to ensure the change goes through, especially given the huge resistance we have already faced for even minor acknowledgement of research into ME.

Nielk July 28, 2013 at 5:21 pm


alex3619

Patients often drive change. According to one medical conference report that I blogged on, it was patients who made the medical profession use antibiotics to treat peptic ulcers. They forced the issue. When the science changes, when a treatment is available, ultimately its we who have to ensure the change goes through, especially given the huge resistance we have already faced for even minor acknowledgement of research into ME.

This is what Dr. Munos was presenting at the FDA meeting. here

“We need more and better data. We need tools to go along with the data. We need partners, we need money and lastly, we need leadership and passion. I should stress we have quite a bit of that already, but we need to, [perhaps], connect it a little bit better than it is connected today.”

Our community already have the patient registry in America for CFS, but he felt it would be better if this data could be collected from sources across the world. This would lead to a much broader and more variable array of information, producing a better understanding of the disease differentials. Note: this is something that might be achieved by the OMI-MERITinitiative and their International Neuro Registry and Biobank.

"If you think about the scientific revolutions in history, they’ve been driven by one thing: the availability of data. From Copernicus to quantum mechanics: it is data that drives innovation."

We could just sit back ad complain that nothing is being done, that there is a lack of funding, that the research out there is flawed or we can take matters in our own hands and advocate for change.

user9876 July 29, 2013 at 5:27 am


alex3619

One thing that is a big concern with many of us is we react very badly to so many things. Rituximab is a class of drugs that induces massive allergic reactions anyway. So how can somone who is highly drug intolerant cope with using Rituximab? Its a concern, and nobody has real answers yet.

I believe it is often given with a quite high dose antihistamine premed given by IV.

user9876 July 29, 2013 at 5:30 am


alex3619

Patients often drive change. According to one medical conference report that I blogged on, it was patients who made the medical profession use antibiotics to treat peptic ulcers. They forced the issue. When the science changes, when a treatment is available, ultimately its we who have to ensure the change goes through, especially given the huge resistance we have already faced for even minor acknowledgement of research into ME.

The drug companies have cottoned onto the idea of patient power and are funding groups that try to get drugs approved.

alex3619 July 29, 2013 at 6:37 am

In the case of drug companies they were funding things so that antibiotics would not be used for peptic ulcers. The antacid industry was huge. At least in our case there is no established market for highly useful drugs. Currently nobody is going to lose a fortune if some other drug is used.

alex3619 July 29, 2013 at 6:38 am


user9876

I believe it is often given with a quite high dose antihistamine premed given by IV.

Yes, to avoid anaphylactic shock.

Simon August 11, 2013 at 10:18 am

Update on CFIDS and OMI proposals re $1 million grants for ME/CFS patient-powered research databases, by Jennie Spotilla:
Occupy CFS » Need to Reality

Jennie points out that CFIDS are partnering with PatientsLikeME, an organisation that already allows patients with other illnesses to share data with researchers:

my Patient Revolution blog

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.

Conclusion of her new blog

Jennie Spotilla

So what’s next? Full proposals for PCORI [Patient Centered Outcome Research Centre, with $350m budget] funding are due September 27, 2013 and funding would begin in January 2014. Let’s hope that at least one of the ME/CFS proposals is successful. One million dollars would go a long way towards building what Munos said we needed: a patient-powered network of data that can be shared with researchers and form the basis of treatment trials and biomarker identification. If there is any disease cohort that needs this kind of jumpstart funding, it is the ME/CFS community.

Dolphin September 16, 2013 at 11:27 am


Finally, and most importantly, clinicians and patients should complain to trialists and publishers if trials are published with inadequate descriptions of their interventions. Clinicians and patients are the last line of defence against poor reporting.

From:

Descriptions of non-pharmacological interventions in clinical trials.BMJ. 2013 Sep 11;347:f5212. doi: 10.1136/bmj.f5212.

Cook A, Douet L, Boutron I.
Source

Wessex Institute, University of Southampton, Southampton SO16 7NS, UK.

—-
Shows a recognition of the value of patients' input.

Bob October 12, 2013 at 8:58 am
Firestormm January 30, 2014 at 5:29 am


30 January 2014
Editor's Choice
Towards the patient revolution
Fiona Godlee, editor, BMJ

fgodlee@bmj.com

In an editorial last year we called for a patient revolution (doi:10.1136/bmj.f2614). We said that patients, far more than clinicians, understand the impact of disease and treatment. We said that clinicians and patients therefore needed to work in partnership if we are to improve healthcare. We talked about corruption in the mission of healthcare and the need to challenge deeply ingrained practices and behaviours. We said that we wanted to develop a strategy for patient partnership at the BMJ, that we planned to establish a panel of patients and clinicians to help us with this work—and that we would report back on progress.

Well, last week we held our first patient partnership workshop, and as Tessa Richards explains in her blog (bmj.com/blogs) we were humbled and inspired by the enthusiasm of the patients and patient advocates who came to help us advance the quest to make patient partnership a reality.

We expected to be challenged by the panel, and we were. Was this just eye candy for the BMJ, we were asked, a form of tokenism to help the journal look and feel good? Or were we serious in our commitment to change things at the BMJ so that we can campaign for a cultural shift in medicine? I hope we managed to convince those present that we are indeed serious.

We have made a small start by adding expert patients to the peer review process for selected research papers. And we plan to publish our draft strategy on patient partnership in the next three months. I expect this will incorporate many of the recommendations from the workshop. These included having a patient voice on all the committees that make decisions about the BMJ’s content and strategy, asking authors of research articles to explain how they involved patients in the design of their study, and having an expert patient as a coauthor on every clinical review.

Our hope is that these changes to our own policies and practice will provide us with a sturdier platform from which to advocate change. Our panel wants the BMJ to campaign for patients to be equal partners in the design and delivery of healthcare and in clinical research and to tackle the power imbalance between patients and the "medical industrial complex."

I wonder, though, whether our main challenge will be just keeping up with the speed of change. As Paul Wicks and colleagues explain (doi:10.1136/bmj.g368), when it comes to clinical trials some patients are already well ahead of the game. By sharing their own data and analyses through social media, trial participants are breaking the cultural and actual codes of clinical trials. This "disobedience" shows that participants know they are statistically and literally the "power" in trials. Wicks and colleagues, all from the patient network PatientsLikeMe, warn of tragic outcomes unless we forge a new social contract. "With the new tools at their disposal patients will hold us all accountable in new and necessary ways," they conclude.

Cite this as: BMJ 2014;348:g1209

Dolphin January 30, 2014 at 12:00 pm


These included having a patient voice on all the committees that make decisions about the BMJ’s content and strategy, asking authors of research articles to explain how they involved patients in the design of their study, and having an expert patient as a coauthor on every clinical review.

If I'm reading this correctly, this refers to the writers of reviews, rather than reviewers appointed by the journal. This could be interesting in terms of CFS when the CBT school have organised reviews which have been published by the BMJ group e.g. I recall a review done by a KCL team.

Bob January 30, 2014 at 12:30 pm

We should keep an eye on what the BMJ are doing.
I didn't know that they were planning to hold a 'patient partnership workshop'.
And I didn't know that they have added "expert patients to the peer review process for selected research papers."
And we should find out about their plans for "having a patient voice on all the committees that make decisions about the BMJ’s content and strategy."

Bob January 30, 2014 at 2:20 pm

This is the BMJ blog that is referenced in the editorial that @Firestormm posted above…

Tessa Richards: The rise and reach of expert patients
17 Jan, 14 | by BMJ
http://blogs.bmj.com/bmj/2014/01/17/tessa-richards-the-rise-and-reach-of-expert-patients/

As the BMJ gears up for its first patient partnership workshop next week we have been humbled and inspired by the enthusiasm of the many patients and patient advocates who have come forward to work with us. We see their insights, and those of an army of patients who we should all listen to, as crucial to developing a strategy to help doctors, and the health systems in which they work realise the challenging goal of partnership.

Our initial steps include patient peer review of research papers (randomised controlled trials) and some analysis papers, and we are actively seeking patients to join our growing database of patient reviewers to help us do this. We will also be getting the patient’s voice into the journal more often and seeking their input into educational articles.

Patients bring an expertise to the table that can’t be found in the corridors of academia or the manager’s office. Many of those who live with chronic disease slowly and painfully acquire knowledge which over time exceeds that of many of the health professionals they intermittently meet. A recent, much tweeted (553 times) paper in BMJ Open entitled, “What happens when patients know more than their doctor?” explores this issue.

Bob January 30, 2014 at 2:22 pm

And this is the BMJ webpage (which is linked to in the blog above) that provides info re their patient reviewer program…

It includes instructions about how to register as a patient reviewer, and instructions re how to review a paper…

http://www.bmj.com/about-bmj/resources-reviewers/guidance-patient-reviewers

MeSci January 31, 2014 at 5:44 am


Bob

This is the BMJ blog that is referenced in the editorial that @Firestormm posted above…

Tessa Richards: The rise and reach of expert patients
17 Jan, 14 | by BMJ
http://blogs.bmj.com/bmj/2014/01/17/tessa-richards-the-rise-and-reach-of-expert-patients/

A recent, much tweeted (553 times) paper in BMJ Open entitled, “What happens when patients know more than their doctor?” explores this issue.

That paper is discussed here.

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