Consent for medical research comes under scrutiny yet again: time for ethics committees to stop second-guessing the public?

This is a really interesting study published in PLOS ONE today.  Eessentially it’s a survey of the attitudes of 2300 participants in TwinsUK (a national biobank) to giving their consent to medical research.  The full paper can be found here.

The results of the survey would seem to highlight what has been a growing theme in the debate about ‘consent’ over many years now: that participants actually have a more flexible and pragmatic attitude to giving their consent than is assumed in the current regulations and regulatory framework.

They certainly want to know the researchers who want (in this case) their data; but they are happy to consent online, and to give an extended warranty for its multiple use over a good period of time.

You could say this is just one study. But the recent Health Research Authority (HRA) public dialogue exercise that I Chaired and which will be published later this year yet again found that the public are remarkably chilled about the things that exercise policy-makers and campaigners most.  Which suggests we probably need to trust our fellow citizens a lot more than we do at the moment.

When I wrote about the latest INVOLVE/NRES study of public involvement in research applications a few weeks ago I was surprised by the response. In the main it was not about which funders were worse at doing public involvement.  No, most people vented their  frustrations about the attitude of ethics committees to proposals for getting consent, public involvement or public engagement in research applications.

They (both researchers and lay people) reported that often these were sent back with a request that they ‘do it again.’ Even though the public have been involved in their design.  And in spite of ethics committees having lay people as members.  Which suggests a certain mindset has taken hold in these local fiefdoms.  A mindet which is not about ‘right touch’ regulation but about ‘always being right’

I know the HRA is on the case of this issue and has indeed been working hard on educating and training ethics committees members.  But iIt’s an area ripe for reform.  In the meantime perhaps ethics committees need to chill out more and, at the very least, stop second-guessing the public in whose interest they are supposed to be acting.

 

Stop ticking the box (disarming a bureaucrat) #tokenism #NHS #bureaucracy

It’s world poetry day today and, as you may know, I try to publish a verse or two to mark the occasion each year. I was going to read this at the East Midlands Academic Health Science Network (AHSN) event ‘Stop ticking the box’ event last Monday.  But time did not allow.

This is for all patients, carers and their families – and for that matter our health professional colleagues – contending with meaningless ‘tick box’ bureaucracy and tokenism in health nod social care.

I hope you’ll the poor formatting.

Stop ticking the box (disarming a bureaucrat)

Please!
Put your pencil down
Slowly.

Now your clipboard
Slowly.

In front of you.
Where I can see them.

Now put your hands
Where I can see them

And listen.

II

A pox on your crosses
Your ticks in your boxes.
Take a hammer to your computer
Take a flame to your procedure.

Stop it with your bar codes
Your jargon and your data.
You look like a robot, roaming the floor
One like you, has asked me this before.

In bed, drip fed, flat on my back,
I might be. But I’m not a flat-pack
Patient made-to-order, with whom to go through the motions
Who has no emotions.

Don’t ask me to do your survey
To join your panel or committee
That’s just tokenism for you to parade
In front of your masters, what a charade!

Stop watching the clock
Tick tock, tick tock.
Stop ticking the box.
Get out of your box.

III

My name is [….]
And I’ll tell you anything you need to know

But don’t consign it
To a box.
It doesn’t fit
In a box.
You won’t find what you need
In a box.
You certainly won’t find me
In a box.
Stop ticking
The box.

IV

Let’s stop for a moment
And forget your instructions
Let’s think for a moment
And work on some solutions

For I think you’ll find
That once we’re talking
We’ll tick all the boxes
Both yours and mine.

NIHR turns to public for help with defining research priorities in alcohol-related liver disease

17 Mar 2015


This week sees the official launch of an important Priority Setting Partnership (PSP) set up by the James Lind Alliance (JLA) to identify and prioritise unanswered questions about alcohol-related liver disease (ARLD). 

ARLD can be a range of liver damage varying from simple fatty liver, through fibrosis, to cirrhosis, portal hypertension and chronic liver failure, frequently accompanied by sudden episodes of acute or chronic cholestatic liver failure (termed alcoholic hepatitis). The Office for National Statistics suggests that in 2012, ARLD was responsible for the majority of alcohol-related deaths, most of which were among those aged 50-59 years.

Professor Dame Sally C. Davies FRS FMedSci, Chief Medical Officer and Chief Scientific Adviser at the Department of Health, said:
“The number of people with alcohol-related liver disease has been increasing over the last few decades: death rates have risen considerably in this time and alcohol is now one of the most common causes of death in the UK, so this is an important area for research. It’s vital that we bring together patients, carers and clinicians to decide jointly what the priorities for research are in this area, and the NIHR is pleased to support the James Lind Alliance in doing so.”

Set up through the JLA and funded by the NIHR and the British Society of Gastroenterology (BSG), the new JLA PSP is guided by a steering group and supported by a number of organisations including The British Liver Trust, and Alcohol Health Alliance UK. The PSP will complete in 2016, publishing a list of ‘top ten’ questions that will present opportunities for high-quality research to help tackle the disease.

The project encourages members of the public to get involved by completing an online survey. The survey will be available on our survey page later in the spring and is designed to collect questions from patients, carers and clinicians about ARLD to inform the ‘top ten’ priorities for treatments.

If people wish to be notified when the survey becomes available, they can do so by joining our mailing list by emailing us at jla@southampton.ac.uk.

To help put ARLD research in the spotlight and to get involved, visit 
www.psp.nihr.ac.uk/alcohol-related-liver-disease or email jla@soton.ac.ukwith any questions.

Public involvement in health research: that’s another country right? #diversityandinclusion

When you live abroad you get used to neighbours and friends saying things to you like ‘I’ve got a relative in Rugby do you know them?’ Less so their palpable disappointment that, try as they might, you can’t place their next of kin in a country going on for 65 million people. When I lived in America I used to feel so guilty at times that it crossed my mind to pretend that I did.

More perplexing were those occasions when language differences would come into their own. One time I told a cashier I was from the ‘UK’ only to find myself talking at cross-purposes with her. She clearly thought I had said I was from the Ukraine.

Who can blame our friends from across the water. Or anywhere else for that matter? We are a comparatively small island half-way across the world. And however worldly-wise we would like to think we are as a nation, we are equally naive about our fellow global citizens.

Being in public involvement is not dissimilar.

How many times have you been asked the following question: ‘Do you know someone?’ Or even worse: ‘I am looking for someone with…?’ This is then followed by a very precise description of someone who has the intellect of Stephen Fry, the athletic prowess of Kelly Holmes and charisma of Barack Obama or Mary Berry. All rounded off with the immortal phrase: ‘We don’t want the usual suspects!’

To which a very good friend has suggested I always reply: ‘If you don’t like the usual suspects, wait until you’ve seen the unusual suspects.’

I don’t know about you but I positively groan at the question. More so because it’s usually just a few days before they need people even though they’ve known for months. Also it assumes you have all the time in the world to start emailing and ringing those people you know. And boy is it a time-consuming task.

Yes, to some of our colleagues, we are a small island.

That would not be so bad were it not for the fact that recruiting people for public involvement through personal referral only affirms our misshapen profile as a community. Our informality as a movement is fertile ground for advancing mono approaches to public involvement.

However man-for-all-seasons I would like to think I am, when asked to help I naturally tend to go searching in my predominantly white and Middle-class network.

This is not just a problem for public involvement. It’s also a problem for the NIHR and our health research system. In the US there is a vibrant and at times angry debate about the lack of diversity among people being recruited into clinical trials – minority ethnic communities, women, older people.

Here in the UK the Health Research Authority (HRA) published figures showing ongoing and strong public support for clinical research. http://www.hra.nhs.uk/news/2015/03/10/strong-public-support-for-health-research/ .

The story within this good news story is the more wary view taken of clinical research and issues like sharing data among minority ethnic communities. It’s a problem and the diversity and inclusiveness of our public involvement movement is fundamental to addressing it.

The soon-to-be published report of the Breaking Boundaries review will highlight the need for us all to prioritise diversity issues in future months and years. But there is already much we can do to make things better.

More open recruitment methods, active outreach into communities that must matter to us all, using the People in Research website more, and sharing approaches that work. I was very struck by the comment a young researcher made to me at the NIHR Trainees event last year. She said to me (and I paraphrase): ‘We know how to do it but no one shares what they have learnt more widely.’

We may be another country to some. A small one? No. A diverse one? We have much still to do.

Government pushes forward with review to speed up availability of innovative medicines and treatments

Two posts in one day!  Ah, those were the days when we got two Post Office deliveries a day….

Just to say the Government has published the full terms of reference for its Innovative Medicines and MedTech Review to be headed up by Sir Hugh Taylor who is currently Chair of Guy’s and St Thomas’s.  Yes, that’s the very same review I said this morning would be out any time soon.  Only it happened yesterday!

The remit is comprehensive and the door is very much open to patients and patient groups to give their views.  The specific para of relevance here is as follows:

‘Consider how to ensure patient trust in the regulation and assessment of medicines and medical technology, and recognise the importance of the patient voice and role of medical research charities as both sponsors and beneficiaries of innovation.’

The review is being supported by the Wellcome Trust – in other words they are doing the legwork – and there is a short blog on their website here.  They haven’t announced the other members of the review panel nor details of how it will work. We will learn more in due course.

I think Hugh Pym at the BBC has written a good piece here on the significance of the review for the future of medical research and speedier access to medicines for patients.

Also this from law firm Pinsent Masons which highlights the review focus on digital technologies.

 

Old rules need not apply – Is Apple tearing up the rule book with #ResearchKit?

‘Purdah’ will very shortly fall over Whitehall as the General Election looms.

At the end of March the airspace over government will be closed for six weeks or so. No new flights of Ministerial fancy can take off. Those already in the air may continue on their way but must do so in radio silence.

Still, we have a few weeks to go yet. And a number could still get off the ground in that time.

The Budget is always an opportunity for pre-election give aways. We await the publication of more details of George Freeman’s innovation and medtech review. The report and recommendations of the Breaking Boundaries may well get clearance to leave its holding pattern.

All perfectly proper and natural of course, albeit frustrating.

The big news in research this week has not come from the UK Government. It has come from the United States. Apple – in its annual showcase of new offerings – launched ResearchKit. https://www.apple.com/researchkit/

This technology will allow researchers to build apps to recruit Apple consumers to research as well as to use their data and activity to answer scientific questions.

I say ‘will’ but actually five projects are already underway including ones in asthma, heart health and Parkinson’s. Last night, one of the research teams involved said over 10,000 people had signed up to their project in the days since ResearchKit was launched. It would have taken them many, many months to have achieved the same recruitment through traditional routes, they say. http://www.bloomberg.com/news/articles/2015-03-11/apple-researchkit-sees-thousands-sign-up-amid-bias-criticism . That’s quite something.

As you might expect, Apple’s foray into this arena has divided opinion. Some say revolution. Others wag their finger. Thousands of column inches have already been written about the ethics, potential bias in the research because of the narrow profile of Apple’s iPhone customer base, and why they haven’t teamed up with other companies such as Google to expand its reach.

All of these are valid questions that need answers. But, I for one, can’t help but feel genuinely excited by what Apple have launched. And perhaps the early impact tells us something about the different ‘contract’ consumers feel they have with the Apples of this world versus their Government.

Use of data, new technology platforms for its analysis, furthermore its use to engage consumers, has been the talk of the town for years. It’s been the ‘apple in the eye of the health research system.’

However, this week, it feels as though that Apple has stepped out of this eye – in the manner of 007 in those opening titles to any James Bond movie – fired the gun and completely changed our field of vision.

Y’know I think Apple will be quite happy to have ignited the ensuing debate. It will not worry too much about the criticisms. It will expect its partners to help them address these. It recognises that this is an area where old rules need not apply and some rules need to be broken. It has the relative freedom to do this while others review reviews and wring their hands. It also knows it’s consumers better than researchers perhaps know their participants?

There is perhaps one criticism or disappointment I would level at ResearchKit. It may very well be premature. But, for a company which has built its reputation consumer-led innovation, I would like to see this sort of platform also opened up to patients to share their data, inquire and innovate as PatientsLikeMe has shown is possible.

That would also be true to one of its seven founding principles – empathy. I’ve been using the following J.K.Rowling quote in some of my talks lately. It’s worth pondering by all those in the business of innovation:

Imagination is not only the uniquely human capacity to envision that which is not, and therefore the fount of all invention and innovation. In its arguably most transformative and revelatory capacity, it is the power to that enables us to empathize with humans whose experiences we have never shared.

Have a good day.

Forget the General Election, cast your vote for public understanding of science NOW! #A2Ucomp

Cast your vote now!

This is the third year running that I have been involved in the Access to Understanding awards run by EuropePMC, eLife and the British Library.

It’s a great initiative that has gone from strength to strength. And this is the part of the competition where you get to have a say by voting in the People’s Choice Award.

‘Access to Understanding’ seeks to make the science presented in jargon-heavy research articles accessible to a wider audience. Early career researchers are invited to write plain-English summaries of scientific research articles for a public audience.

Each summary needed to explain why the research was done, what was done and why it was important. Entrants could write about one of 12 articles, each covering fascinating cutting-edge science including: a potential treatment for tinnitus, the effects of disrupted sleep on the human body and the effects of social interactions on flu transmission

The 12 best summaries have already been shortlisted by a panel of judges (Chaired by me). Now we want to know what the public make of them. Are they interesting? Are they easy to understand? Since the entries are written for the public, we think they should be judged by the public.

The website is now live and open for you to place your votes: http://www.access2understanding.org/competition/peoples-choice/

The deadline to vote for the People’s Choice award is 1200 GMT on 27 March 2015; the award winner will be announced at the award ceremony that evening at The British Library. Tickets are still available for the event.

Please do vote. But, above all, enjoy the articles. Each of their authors has gone a great job of making some very complex science not only understandable but also invigorating and exciting.

Blog: £6bn health tremors in Greater Manchester shake up national debate

It happens more regularly than the startled headlines suggest.  An earthquake somewhere in England rattles the crockery and wakes up citizens in the middle of the night. Later, many miles away, we read our newspapers, shake our heads in that ‘well I never’ sort of way, and get on with our day.

But something truly seismic would appear to be happening in Manchester. The tectonic plates of our health service are on the move again. Yesterday, we learnt that responsibility for the £6bn NHS health and social care budget is going to be devolved to the civic leadership of Greater Manchester. This is no BACS transfer that’s for sure!

Truth be told those plates have been grinding along for years. I have a faint recollection of being on a fascinating study visit to Manchester about ten years ago as part of an otherwise underwhelming leadership course. Civic leader after leader trouped in to tell the largely skeptical audience of a long-term vision for dealing with their own affairs at last. Free from the constraints of Whitehall micromanagement. Also, how it was re-discovering the innovative edge that made it the centre of our industrial revolution in the 19th century. And more recently there has been a public consultation on its Healthier Together intitiative.

Well, now those ambitions and collective vision would seem to be one huge step nearer.

There are much more intelligent, well-informed and insightful commentators than I – Roy Lilley, Nigel Edwards at Nuffield, Chris Ham at the King’s Fund - that you should follow and read over the next few months if you want to learn what the new landscape might look like and understand the policy and politics behind it. It is also at times like this that our local media is wont to come into its own.  No more so than the Manchester Evening News which, I for one, will be following closely: http://www.manchestereveningnews.co.uk/news/health/opinion-piece-dr-kailash-chand-8722506
What it might mean for health and social care research is an interesting question? Understandably the issue may not be top of everyone’s minds this morning. But it’s an important one to ask. If these changes are to lead to real improvements in health and wellbeing for the citizens of Greater Manchester then research must be at the heart of the enterprise.
I am a fairly regular visitor to Manchester; as a speaker and as a Board member of the NIHR Greater Manchester Primary Care Patient Safely Translational Centre . I do not know the place well although I lived there as a boy in the late seventies.  But I have formed some impressions of this wonderful City and the research opportunities and challenges that it faces in meeting the needs of a diverse population with complex health needs.
The Government’s strong and very public backing for Manchester as a ‘Northern Powerhouse’ in science and research – most recently expressed in the Autumn Statement with the Chancellor of the Exchequer, George Osborne’s, announcement of a £235 advanced material science institute – will be important.  Celebrated research initiatives such as the Salford Lung Study demonstrate its innovative edge in clinical research.  It’s capability and capacity to lead research is encapsulated in its success in winning grants and awards like the aforementioned Primary Care Research Centre – one of only two of its type in the country.  The leadership across key organisations including the Greater Manchester Academic Health Science Network (AHSN),  and the recently launched Clinical Research Network (North West Coast) is strong.  And it has one of the best run and most influential regional citizen forums in research in the shape of the North West People in Research Forum.

And yet, and yet, my experience is also that getting engagement in research across social care and primary care in Greater Manchester is difficult to say the least and the resulting picture patchy.  This fact alone takes on greater significance when you realise that health and social care, lock, stock and barrel, will be run out of the Town Hall.  Will the new Board get the importance of research to the success of their new venture and see it as an opportunity to build on their innovative heritage?  Or will they pass it down the corridoor to some forgotten office open between the hours of 9 and 12, and 2 and 4.30, where the door has frosted glass and the receptionist even frostier?

One other passing thought about what the events in Manchester might mean for the rest of us in England.  Ever since the Health and Social Care Act 2012 was passed – if not before! – there have been active campaigns beseeching us all to rise up against the privatisation of the NHS.  In looking so hard at it this way, perhaps we have missed the fact that what we have really been entering is an era of creeping provincialism in how our health service is run.  Whether you think this is good or bad will depend on your political standpoint I guess.  But we should take note of the experience of countries such as Canada in trying to ensure consistency, continuity and viable networks across such strong geo-political borders.
Whether the seismic activity in Greater Manchester results in an idyllic spa-like island or sink hole through which £6bn will disappear is going to be the health story of the year ahead.
Have a good day.

Sign-up to help step-up research into dementia: new service enables people to volunteer for research studies #joindementiaresearch @beatdementia

Of all the dementia initiatives announced by the Prime Minister, David Cameron, this weekend it may prove the pivotal one.  It may not grab headlines in the same way as £ commitments to research or new institutes (although it is doing pretty well). But, without it, this expenditure will be worthless.

For other patient populations it will undoubtedly be a model to be copied in galvanising their effort behind similar research of patient benefit.

Fact is, as regular readers of this blog will know, research that could possibly make a difference to health and wellbeing can not happen without the involvement, and in particular the willingness of those people to step forward and volunteer to take part in clinical trials and research studies.  As was amply demonstrated by Fergus Walsh’s excellent Panorama programme a few weeks ago.

Today a new online and telephone service launches to enable people with dementia, carers, family – as well as members of the public wanting to support research – to sign-up to participate in future dementia research. The service also enables researchers to identify potential participants for their studies.

Called JoinDementiaResearch you can access the (mobile friendly) website here: https://www.joindementiaresearch.nihr.ac.uk

The service has been in development for over 2-3 years with people with dementia and their carers fully involved in the design of every aspect.   When the Lay Champions Group began its work all that time ago it is difficult to convey the daunting nature of the task that lay ahead of us or its complexity.  Giving people a safe and secure way of signing up for research in this way has felt like building a skyscraper on a small plot of land in a crowded city.  But the determination was always there and it is in no small part due to the commitment of those champions (many of whom will be speaking to the media today) and also the commitment of the organisations involved, to working in partnership with them,

Today’s  launch follows a pilot in North East London which has already demonstrated its exciting potential to enable studies to get up and running.  I notice that just in the last twent minutes or so that I have been editing this blog another 200 people have signed-up and the total number has just passed 2000.

So, what can I say, other than: JoinDementiaResearch Now!

Have a great day.

Here’s the full news release…..

Ground-breaking new national service empowers public to take part in vital dementia research

A new nationwide online and telephone service that helps people to take part in dementia research studies launches today (24 Feb 2015). Join Dementia Research promises to accelerate the pace of dementia research by allowing people with and without dementia to register their interest in studies, helping researchers find the right participants at the right time. Join Dementia Research is a collaboration between the National Institute for Health Research (NIHR), Alzheimer’s Research UK, Alzheimer’s Society and Alzheimer Scotland and has been funded by the Department of Health.

Dementia affects over 850,000 people in the UK, with 25 million of the UK population having a close friend or family member affected. A new national poll* has shown that almost two thirds of the general public (62%) would be willing to take part in dementia research, but more than four out of five people (81%) wouldn’t know how to volunteer. Join Dementia Research is designed to overcome these barriers and give everyone the opportunity to play a role in changing the outlook for people with dementia now and in the future.

The lack of access to willing volunteers is holding back critical research into the condition with government figures showing that less than 5% of people with dementia take part in research studies. The first of its kind in the UK, this innovative new service will boost research participation by connecting people interested in research to suitable dementia studies across England, Scotland and Wales. After piloting the service in a small region for six months, more than 1,800 people have signed up and already over 200 of them have participated in studies through Join Dementia Research.

The joindementiaresearch.nihr.ac.uk website offers a secure and easy way for someone to register their interest, discover studies that interest them, and ultimately connect with researchers to take part in their studies.

Anyone aged 18 years or over can sign up themselves, or on behalf of someone else, either by registering online or by contacting the helplines of Alzheimer’s Research UK (0300 111 5 111) and Alzheimer’s Society (0300 222 1122). By signing up to the service, people give permission for researchers to contact them with details of studies in their area that match their profile. People can then decide if they would like to participate in those studies on a case-by-case basis. By registering, people do not have to take part in any studies and can opt-out at any time.

Prof Martin Rossor, the NIHR National Director for Dementia Research, said:

“The government and charities have increased funding for dementia research over the last few years, meaning more studies are being done than ever before, but it’s often difficult to find willing volunteers at the right time.

“Join Dementia Research offers a way of ‘match-making’ – linking volunteers to researchers. The system also helps us plan future studies. It’s important that everyone should be able to find out about research that is happening near to where they live and get the opportunity to be part of that research. People can register with Join Dementia Research without being obliged to take part in a particular study, but we hope that the service will expand the pool of willing participants. Growing the number of willing research volunteers will help push forward research to make advances in treatment, prevention and care.”

Secretary of State for Health, Jeremy Hunt, said:

“New research is desperately needed to help the growing numbers of people who live with dementia, which is why we’re doubling the size of the funding pot. This is an important initiative, and I encourage anyone who is interested to visit the website or call the charity helplines to find out more about how they can help us tackle dementia.”

Sue Boex, one of the carers who helped design Join Dementia Research, said:

“This is a very exciting initiative, and one we really need people to get behind. Everyone can sign up, whether you have dementia or not, and there are lots of different types of studies to take part in. But because studies have very specific criteria, we need lots of people signing up in order to find the right people for the right study at the right time. I hope that 100,000 people will join the service in the first year. Its an ambitious target, but dementia is a massive problem and we’re ambitious to help make a difference through research.”

Speaking about this new service, Hilary Evans, Director of External Affairs at Alzheimer’s Research UK, said:

“As a charity focused on dementia research, we’re acutely aware of the tremendous impact volunteers make on research progress in dementia. We know there is a strong appetite from the public to play a role in dementia research, but until now there hasn’t been an easy and coordinated way for people to register their interest. We’re proud to be supporting Join Dementia Research to give people with dementia and their families the opportunity to be part of pioneering research to improve the lives of everyone affected by this heartbreaking condition.”

Dr Doug Brown, Director of Research and Development at Alzheimer’s Society said:

“We and others are increasing our investment in research to develop better treatments and ultimately a cure for dementia, but finding suitable volunteers to take part in these research studies is a difficult and costly task. This can slow research progress which is unacceptable given the urgent need of the hundreds of thousands of people affected by dementia.

“We’re thrilled to be supporting Join Dementia Research as it will overcome many of these barriers and speed up the ongoing research effort. For people with an interest in dementia research, this innovative new service gives them the best possible chance of finding and taking part in a suitable research study, empowering them to be part of the crucial search for better care today and a cure for the future.”

Professor Dame Sally Davies was appointed Chief Medical Officer:

“This superb initiative was developed to help ensure we can meet the ambitious targets for recruitment to high-quality research studies, set by the Prime Minister in his challenge on dementia. Join Dementia Research is a potential pathfinder for other fields, showing how to boost patient and public participation in research.”

Current research studies range from clinical trials of new treatments to surveys identifying what works in improving the quality of life of people with dementia.

 

Let’s get animated about public involvement in health research: new film by @NIHRINVOLVE

It’s film awards season. Did you watch the BAFTAs a few days ago?

I did and I was thrilled that ‘Boyhood‘ directed by Richard Linklater took home a lot of the trophies including ‘Best Film.’  It’s a wonderful movie about growing up, as well as a film-making feat; it was shot over twelve years.  Do go and see it if you can.

Use of film as a means of public engagement is on the increase across health research.  NIHR is running a new-media competition at the moment in which it is looking for the best short-films about research.  The closing date is 31st March 2015.  It even has its own TV channel on Youtube.

A trend within this trend is the use of animation or cartoons to tell a story. I have been involved in a number over the years.

Now, INVOLVE – the national advisory group for the promotion and advancement of public involvement – has produced a short cartoon (actually the technical term in this case is ‘whiteboard animation} entitled: ‘This is my story, what will yours be?’ It tells Tom Grew’s story of being involved in research following his diagnosis with Hodgkin’s Lymphoma at the age of 18 and it really is splendid. If you click here, you can view the film and find out more about the story behind it.

It’s the Oscars on 22nd Feb. Who knows, one day patients and the public might get to walk on the red carpet?

Patient charter on genome sequencing is a call to arms to the NHS, charities and researchers

It is one of the boldest and most exciting initiatives in UK health research and care that I have witnessed.  It’s also happening at lightning speed.

In the eighteen months since the Prime Minister announced the 100,000 Genomes Project to coincide with the NHS’s 65th birthday in 2013, we have gone from almost a standing start to being on the eve of patients with rarer diseases and some of the commonest forms of cancer being recruited to take part.  By 2017 the aim is to have sequenced 100,000 genomes from patients which will lead to better diagnosis, insights into disease and hopefully new interventions and therapies.

For those who think that the NHS does ‘lacklustre’ all too well, they should have heard the Life Sciences Minister, George Freeman  MP, speak this morning.  Reflecting on his recent visit to the US he was adamant that the UK is stealing a march on its international competitors when it comes to genome sequencing.  Having myself been out to Canada in the last few weeks, I can vouch for this.  They might have the technology.  But not the infrastructure or people or co-ordination.

I am not sure what politicians mean when they say they want to ‘weaponise’ the NHS.  What I do know is that, in terms of embedding research in patient care and making it part of a high quality health system, the NHS IS a weapon that few if any other countries can emulate.

The focus being brought to bear on the 100k Genomes Project has meant some innovative solutions being adopted to get things off the ground, away from the clutches of the bureaucrats.  Symbolic of this is Genomics England itself which was set up as a company owned by the Department of Health to spearhead the work.  Prior to Christmas NHS England appointed 11 centres around England where patients will be recruited.  I am involved in developing the PPI strategy for one of these, the North Thames GMC. It is a daunting but thrilling challenge.

But one can only feel that this is just the beginning.  Alastair Kent, CEO of Gentic Alliance UK today talked about genomics eventually permeating and penestrating the whole of healthcare.  I think he might just be right.  It is worth adding that Scotland, Wales and Northern Ireland also have similar initiatives in the pipeline.

So what of patients and their families in this venture?

Today, Genetic Alliance UK which has been holding a week-long series of public engagement events on genome sequencing #GenomeSeqWeek, published a Patient Charter entitled ‘Genome Sequencing: what do patients think?’  Based on the views of 144 patients recruited through the members of Genetic Alliance UK, Rare Disease UK and SWAN UK, the Charter puts forward 15 recommendations grouped under four statements:

  • Patients want the option to receive as much information about health as possible from genome sequencing
  • Patients value genetic counselling and are keen for the support of genetic counsellors before and after genome sequencing
  • Patients welcome the sharing of their genomic data for research purposes
  • Patients think that the NHS needs to make more progress towards preparing for the integration of genome sequencing into clinical practice

George Freeman launched the charter today by stating that whole genome sequencing would lead to a revolution in patient empowerment leading to greater choice over how their information is used in care and research.  Listening to the discussion afterwards it was compelling to hear the sense of urgency reflected by the rare disease community – patients, clinicians and health professionals – in the room.  This is not just a charter, I thought, but a call to arms.

93% of patients who took part in the ‘Charter’ exercise said they wanted their sequenced genome to be made available for research.  The vast majority wanted to see it happen across the NHS and would be likely to give their consent for it to take place.  80% trusted the NHS with their data, but charities and private companies were trusted by only 63% and 31% respectively.  Perhaps it has something to do with how people perceive these sectors behaving toward patients.  At the very least, it suggests these sectors have a lot more to do to ‘get with the programme’ and demonstrate their trustworthiness.

As Rachel Jeffares (SWAN UK Parent representative), said at the meeting: ‘knowledge is power.’  Rachel talked eloquently about the importance of information to patients in giving them some sense of control over a situation where often they felt none.  The perception that somehow this information is being withheld or used against their permission is disempowering at the least and potentially harmful to the relationship we wish to build with users of our health service, I would add.

Before I had to leave the meeting I was struck by the ensuing conversation that about the need for more genetic counsellors in the UK.  Also for there to be better training and resourcing of these colleagues, and for them to have accreditation as professional body.  There are only 300 genetic counsellors across the nation and it would seem terribly important for us to grow and better support this important group of professionals if we are going to really facilitate patient choice as a result of genome sequencing.

 

 

 

A&E to the rhythm of Casabianca: Our Bubb stood on the crowded ward

News reaches these parts that Stephen Bubb, CEO of the charity umbrella group ACEVO, has cut a deal with the Government to unleash hundreds of charity volunteers on the NHS to alleviate pressures on A&E.
http://www.theguardian.com/society/2015/feb/05/charity-a-and-e-hospital-age-uk-red-cross-royal-voluntary-service-nhs-england-budget

I genuinely do not know how I feel about this.

Clearly, Sir Stephen and his colleagues are right to pitch the expertise of our charities as important agencies in providing health and social care.

And you would expect them to offer their services to help at a time like this when things are going awry in our hospitals.

But when in crisis…….

Such actions can set a precedent. Or set in train change that takes on its own momentum with little thought being given to the long-term consequences.

Anyway, it’s Friday and it’s worthy of a poem. To the rhythm of Casabianca (c’mon, you know it: ‘The boy stood on the burning deck’).

Our Bubb stood on the crowded ward
As all around him spelt disaster
Fear not, he cried, above our heads,
Us charities have the answer.

Like Temporal Knights they set about,
Their task like great crusaders.
We’re to help our NHS
Its nurses, staff and doctors.

But when the hubb-Bubb has gone away
And A&E has gone much quieter
Will our gallant friends be left to hold
The baby ever after?

So when you hear Sir Stephen now
I say let’s shout together
‘Let’s not make these special measures
Our thinking of the future.’

Have a good weekend. X

Medical research can not ignore the wishes of the dying forever

study published in the Annals of Internal Medicine on Monday has been causing quite a stir in the United States this week.

It has concluded that, despite national efforts there to improve end-of-life care: ‘proxy reports of pain and other alarming symptoms in the last year of life increased from 1998 to 2010.’

In other words, things would appear to have got worse since a US Institute of Medicine report in 1997 pointed to the suffering of many Americans at the end-of-life and urged a change in practice and attitudes.  There is now much debate about the reasons for this lack of progress.

One of the common discussion threads emerging is that people feel medicine cares more about keeping you and I alive at all costs, than helping us to die well.  One of the study authors Dr Lynn said, is quoted as saying in this NPR blog that: “We throw more medical treatment at patients who are on their way to dying, which keeps them in a difficult situation for much, much longer,” she said. “We’ve increased the number of people put on ventilators and kept in hospitals, and we simply have more treatments that are possible to offer.”

You could argue that this debate has most recently manifested itself over here in campaigns like the Medical Innovation ‘Saatchi’ Bill which continues to make its way through the Houses of Parliament. For it is essentially a measure which is intended to legalise one last, desparate throw of the dice. My worry about this Bill is not how the dice may land but who is throwing them and why.  However, this blog is not intended as an entree into the well-worn debates about this proposal or about issues such as assisted suicide. More what will happen for the vast majority of us when it is time for us to die.

Another theme is that the medical research agenda is dominated by priorities that are focused on finding a ‘cure’ rather than providing ‘care.’ Which is true.  UK research funders must surely act on the final report of the Palliative Care and End-of-Life Priority Setting Partnership which was launched at the Palliative and End of Life Care Research Summit last month, if patients and their families are to experience a good death in the future?  It lists 10 priorities for research identified by the dying, their families and carers and by physicians; no magic pills, instead things that would make a real difference to dying such as 24 hour care, access to palliative care services and pain management.

The report states that only 0.7% of the total budget spent on cancer research in the UK has been spent on palliative care since 2002.  It is a shameful amount.  Especially so given the latest figures Cancer Research UK put out this week saying 1 in 2 of us will get cancer.  When will we learn?  Or is this simply a conspiracy against dying?

However, as one respondent to the NPR blog rightly pointed out it’s not all medicine’s fault.  In fact, I was rather affected by this piece in the New York Times from Ira Byock, a well-known palliative care physician, author and director of the US Institute for Human Caring of Providence Health and Services.  He calls for a citizen uprising on the issue and a Safe Dying Act.  And you will know I am a sucker for citizen action.  You might also read this piece from the US National Pain report to gain a sense of the frustration now being felt with the lack of clear progress in the US.

In the UK we have had the controversey about the Liverpool Care Pathway and then the Government’s announcement in June 2014 of a new approach to care for the dying which puts the emphasis on enabling people to plan well in advance of death.  The Health Select Committee has finished taking written evidence as part of its ongoing inquiry into the  area.  Meanwhile, just a few weeks ago, we had news about the development of a ‘Death test (Daily Telegraph).’  But as the Age UK spokesperson in the Daily Telegraph says the utility of such a tool will be rendered meaningless if we are not all well-prepared for the moment its results are known.

As a society we are clearly struggling with the notion of death and how to care for people who are dying.  But the priorities identified by those for whom death is closest would be a good starting point don’t you think?  Frankly, cost of leaving it to the last minute is too high for all concerned.

 

 

Nuffield report underlines importance of public participation if people are to trust how their medical records are used for research

The Nuffield Council on Bioethics have today published their report: ‘The collection, linking and use of data in biomedical research and health care: ethical issues’ following months of inquiry by an expert working group Chaired by Professor Martin Richards.  Here’s a copy of the actual report.

There is much coverage in the media already including the Financial Times, The Guardian, Science 2.0, and The Independent.  Given the report makes a number of interesting and sometimes pointed observations on a number of data intitiatives including care.data, the 100k Genome Initiative and Biobank I am sure it will continue to generate a great deal more comment.

The overriding message of the report is pretty clear: public participation in the governance of initiative using data for medical research and health care is essential to building and maintaining public trust.  One of the panel members, Susan Wallace is widely quoted as saying: “Any data project should first take steps to find out how people expect their data to be used and engage with those expectations through a process of continued participation and review.”

The report has an interesting section on participant-led research (Page 146 onwards).  But the key bit of the report is Chapter 5 which looks at ‘Ethical Governance.’  It puts forward four principles for guiding future governance on the use of data including: respect for persons, human rights; participation and accounting for decisions.  It summarises the principle of participation as:

Principle 3 – Participation
The set of expectations about how data will be used (or re-used) in a data initiative, and the appropriate measures and procedures for ensuring that those
expectations are met, should be determined with the participation of people with morally relevant interests. This participation should involve giving and receiving public accounts of the reasons for establishing, conducting and participating in the initiative in a form that is accepted as reasonable by all. Where it is not feasible to engage all those with relevant interests – which will often be the case in practice – the full range of relevant values and interests should nevertheless be fairly represented.

The report has laid down an important and powerful principle here which – alongside the other three – should be a benchmark forr how all data access and sharing is governed and managed.

Some people are not going to like this report, that’s for sure. But, in my view, it’s spot on about public involvement being essential to building public trust.

Churches’ late showing on ‘three-person baby’ issue is based on a wing and prayer not evidence

I hope those MPs who have yet to decide how to vote in tomorrow’s parliamentary debate on the statutory instrument on mitochnodrial donation – ‘three-person babies’ – will take a few minutes to listen to Sharon Bernardi in this BBC News report from the weekend.  Sharon has lost seven children to mitochonria disease and her appeal for this legislation to be passed is measured and dignified.

In contrast, the Church of England and Catholic Church has made a less than dignified late showing in the debate calling on MPs to block the measure because of the lack of evidence and the need for greater debate about the ehthical considerations.

Quite where the churches have been for the last three years is beyond me.

The Human Fertilisation and Emryo Authority has conducted a comprehensive scientific inquiry including reports in 2012, 2013, and 2014 and a public consultation in 2012.   The Academy of Medical Sciences responded in 2013.  And you can read the report from the meeting of the All-Party Parliamentary Group on Medical Research about this issue which took place just a few weeks ago and included medical research charities.  For more, you may wish to read this Guardian interview with two of the leading scientists pioneering this work, Professors Douglas Turnbull and Alison MurdochOr the Wellcome Trust blog.

Contrary to what the churches would have you wish to believe, this is an issues where the ethics and science have been explored to an arguably unparalleled breadth and depth.  Naturally, they have every right to participate in the this debate but to do so, so late and in such an ill-informed way renders their intervention almost redundant in my view. It certainly does not do justice to their respective congregations.

 

 

 

 

INVOLVE launches new benefits advice service for public involvement in NIHR research @NIHRINVOLVE #ppibenefitsadvice

This is an important and timely intervention by INVOLVE to ensure people get the right advice and support about how payment of fees and expenses for their public involvement in NIHR might affect their receipt of state benefits.  Please read the following for more information on how this service will operate. With thanks to our partners in helping to make this happen.

New confidential service launched today 29 January 2015

  • a new service offering personal advice and support on how payment of fees and expenses for public involvement might affect people in receipt of state benefits
  • National Institute for Health Research (NIHR) in partnership with others is offering a service that covers advice on payment of fees and expenses for public involvement in health or social care research, service design or service delivery
  • the service will be provided by Bedford Citizens Advice Bureau, initially as a pilot for one year.

Who is the Benefits Advice Service for?

The National Institute for Health Research (NIHR) is offering this confidential service to:

  • members of the public involved with NIHR organisations or NIHR funded research projects.
  • staff within NIHR organisations who are supporting members of the public to get involved.

INVOLVE is funding this service on behalf of, and for the NIHR. Other partners who are also part of the service are:

  • NHS England
  • Health Research Authority(HRA)
  • Involving People (Wales)
  • Social Care Institute for Excellence (SCIE) and Think Local, Act Personal (TLAP)

Further information is available on the INVOLVE websitewww.invo.org.uk/resource-centre/benefits-advice-service/