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Placebo on Prescription: Hepatitis C Transplants, Genes and Back Pain

If you're on the transplant waiting list would you accept a life-saving organ from a donor with hepatitis C? Such organs will soon be on offer and Dr Mark Porter finds out why now

Until recently it was assumed that placebo pills would only produce a therapeutic benefit if patients didn't know that's what they had been given. But there are early suggestions that patients can still get symptom relief even when they're told that there is no active ingredient at all in the pills they've been given. So should placebo pills be openly prescribed to patients? Ted Kaptchuk, Professor of Medicine at Harvard University tells Mark he believes open-label placebo could, if evidence continues to accumulate, form part of the physician's therapeutic toolbox. But Inside Health's Dr Margaret McCartney urges caution. She says there is insufficient evidence about the long-term impact on symptoms.

Nearly 500 people died on the transplant waiting list last year and if you're one of the 7,000 waiting for a life-saving organ, how would you feel if the organ on offer came from a donor infected with hepatitis C? Such organs are about to be available on the NHS and this radical change has come about because of the revolution in treatment for this potentially-serious blood borne viral infection. Yes recipients of Hepatitis C positive organs will be infected by the virus after transplant, but a short course of treatment, direct acting antivirals, will then cure them. Consultant kidney and transplant specialist Dr Adnan Sharif from Queen Elizabeth Hospital in Birmingham explains why patients on the waiting list should have this option available to them and Professor James Neuberger from the UK government's advisory committee on the Safety of Blood, Tissues and Organs, tells Mark why SaBTO have recommended this policy change and are now keen to see it implemented.

Back pain is common but most of us recover in a matter of weeks. For 10-20% of people though, the pain and discomfort doesn't go away and they suffer chronic pain throughout their lives. What many people don't know is the extent to which genes feature in back pain - it runs in families. Frances Williams is Professor of Genomic Epidemiology at Kings' College, London and a consultant rheumatologist at Guy's and St Thomas' NHS Trust. She tells Mark about the genetic clues that emerged from the world's largest ever study of 500,000 individuals with chronic back pain across five countries.

Producer: Fiona Hill

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28 minutes

Programme Transcript - Inside Health

Downloaded from www.bbc.co.uk/radio4

 

THE ATTACHED TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT.  BECAUSE OF THE RISK OF MISHEARING AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS, THE BBC CANNOT VOUCH FOR ITS COMPLETE ACCURACY.

 

 

INSIDE HEALTH – Programme 3.

 

TX:  09.10.18  2100–2130

 

PRESENTER:  MARK PORTER

 

PRODUCER:  FIONA HILL

 

 

Porter

Hello.  We’ve an eclectic mix for you this week.  Transplants – surgeons in the UK will soon be allowed to use organs from donors infected with hepatitis C.  But would you be happy to receive an infected liver, heart or kidney?  And what does a transplant specialist think?

 

Clip

I would, on the balance of evidence just now, I would go for the Hepatitis C kidney because it would be a better kidney and the evidence suggests within 12 weeks of the treatment the Hepatitis C will be cured.  For me it’s a no brainer.

 

Porter

And the genetics of back pain, apparently, it’s neither or all in the back nor all in the mind.

 

Clip

The surprise to me was that these are genes that are not chronic pain genes but that they’re structural spine genes and we’ve also found a surprising overlap with genes for anxiety and depression.

 

Porter

But first, placebos.  They’re all over the news recently thanks to the latest episode of the Horizon TV documentary series – The Placebo Experiment, which got us thinking here at Inside Health about the mysteries of the placebo effect.  What does the evidence actually tell us?  How might placebos be working?  And should we do more to harness their power?

If you missed the programme, it was a BBC experiment to assess the impact of placebos in people with chronic pain.  One hundred and seventeen volunteers were told they were taking part in a trial to test a new type of powerful painkiller.  In fact, the pills were dummies that contained nothing but powdered rice.  Yet, just three weeks later, the response, at least from some of the volunteers, was dramatic.  As the programme’s presenter, Michael Mosley, explained on The Today Programme.

 

Clip – Today Programme

Mosley

These were people who were on everything, many of them were wheelchair bound, they had been disabled for a long period of time, some young, some old.  And literally people getting out of their wheelchairs and able to walk and to do things, play with their grandchildren in ways they hadn’t.  Some people didn’t but around half, just under half, got what you’d term clinically significant improvement.

 

Porter

Dr Margaret McCartney is in our Stirling studio.  Margaret, we’ve known about the power of placebos for some time.

 

McCartney

Well actually it’s been running since the 16th century.  There were in fact placebo-controlled exorcisms attempted in the 16th century where men of religion would attempt to use either holy water or special controlled non-holy water to see which one worked for an exorcism for a supposedly possessed person or not.  So, the story of placebos really is pretty ancient.

 

Porter

And it’s a pretty potent effect, if you look at some of the evidence that’s out there.

 

McCartney

Well certainly that was what a doctor called Henry Beecher thought in 1955.  He wrote an essay called The Powerful Placebo which I think really set up medicine from the 1950s onwards to be looking for and searching for this very potent placebo effect.  And certainly, by the 1970s there were trials coming in saying that if you gave medical students red placebo pills they felt energised and full of life but if you gave them blue placebo pills they would feel calm and sedated when actually they didn’t contain any active ingredient at all.  And at that time there were trials going on showing that branded headache medication was more effective than unbranded plain headache medication, that two pills were more effective generally than one, so there were all kinds of interesting stuff being done.  But of course, these were quite short-term trials and it wasn’t really until the 1980s and ‘90s that we started to get really quite sophisticated trials going on looking at placebo effects.

 

Porter

You talked about the history of the placebo effect, I mean do we still think of it in the same way today, knowing what we now know?

 

McCartney

Not the same way at all.  In 2010 there was a Cochran Review and it kind of reversed what Henry Beecher had reported in 1955 and said that actually placebo effects seemed to be much smaller than perhaps had been reported till now and perhaps weren’t as big or important as doctors had believed.  And this is really fascinating because one of the things that needs to be accounted for is whether sometimes things get better by themselves.  And what they really arguing for was three arm trials.  So, you have an intervention in one group, what you want to test; you have your placebo in the second group, to give a placebo response of what might be generated by a fake tablet or operation but you had another group where nothing happened at all, so you could see what the natural course of events would be and then you would know what the placebo effect was and what the intervention effect was as well.

 

Porter

So, it might be that doing nothing or a sham treatment people are just getting better anyway with time?

 

McCartney

That’s exactly right.  Regression to the mean – things in general improving no matter what you do or what you don’t do.  And it’s always very tempting to ascribe someone getting better to what you’ve offered as a doctor or what you’ve taken as a patient.  Whereas it might have actually improved all by itself and the mechanism of action was nothing to do with the operation or the tablet being taken.

 

Porter

Thank you, Margaret.

 

The British Medical Journal has recently devoted an editorial to prescribing placebos.  It was written by Ted Kaptchuk, Professor of Medicine at Harvard, and he joins us on the line from Cambridge, Massachusetts now.

 

Ted, your article talks about open label placebo – telling a patient that they are getting a dummy pill, rather than pretending it is an active drug?  Does that still work?

 

Kaptchuk

Well until now everyone believed that was impossible because everyone had a theory of placebo that it’s all in your conscious or awareness, you have to believe in it.  And until we did the first experiments on this it was considered totally ridiculous.  We decided to do those experiments because we said it had never been tested.  And we’ve given placebos in randomised control trials to many different conditions at this point, there are many studies going on now, that demonstrate that people can still have a placebo response even if they know it’s placebo.  This is if it’s prescribed by a physician in a medical context, I should emphasise.  And I think what this shows is that our previous theories about placebo – that it’s what you believe makes you better, positive thinking, mind cure – are actually not necessarily true. 

 

Porter

So, what is going on?

 

Kaptchuk

To be honest I don’t know.  That’s the bottom line.  But I think what’s going on is that it’s become very clear with some research in the last five, seven years that responses to placebo are activated by non-conscious processes.  My team, other teams, has demonstrated that different areas in the brain are activated even when you’re not aware you’re getting a placebo and that neurotransmitters are released, even when you’re not aware.  It’s a kind of embodied cognition, a kind of knowing without being aware, that actually has become more and more plausible in neuroscience.  I think that’s what’s going on but again this is still pretty cutting edge.

 

Porter

Do we actually need the placebo component, could it just simply be the interaction with a healthcare professional of some sort and we’re giving the pill to complete the deal?

 

Kaptchuk

Absolutely a good question.  In all our experiments we controlled for the doctor/patient relationship, both arms – the one with placebo and usual care or just usual care had the same interaction, the same time, with the physician, the same words until the last minute we opened up the envelope.  Both groups got better but the people taking placebo got much better.  I assume that a doctor/patient relationship is important and helpful but these experiments demonstrate that was not sufficient or did not make a placebo response as big as the arm that was taking openly [indistinct word] prescribed placebos.

 

Porter

One of the main advantages, from my perspective as a clinician of using open label placebos, is that there’s no deception involved, you’re not using a sham treatment, you’re not conning the patient if you like.  But how do the patients respond themselves to being told that they’ve been given the dummy treatment?

 

Kaptchuk

First, I believe that the open label placebo is probably one of the most radically honest treatments even given to human beings.  There’s an honesty that patients respect deeply because all our patients are refractory – I mean they’ve been to doctors before, there has been a treadmill of despair and hope.  So, if someone’s told you’re going to get better, they know that’s not true.  Hearing the doctor say, you know, let’s try and see what happens is a radical statement of honesty and most doctors don’t believe – including myself, this is crazy.  So how do patients react – they laugh, they giggle, they say you must be kidding do you really think that this could work – and our physicians never say it’s going to work, they say let’s see what happens.  When we started this, we said we have no idea if it’s going to work, radical uncertainty, and now we can say it sometimes seems to work.  So, our patients think it’s interesting, it’s novel.  We’ve recruited patients for these trials and had much less trouble recruiting patients than in drug trials that we’ve performed.

 

Porter

And in terms of degree of response, I mean looking at some of the more spectacular cases that you must have seen, what sort of response are you seeing?

 

Kaptchuk

Well you know a good drug, many good drugs really, get about a third of people get sufficient benefit, one third not sure and one third nothing happens.  We’re getting similar kinds of results.  On the average people have significant and clinical meaningful response to open label placebo in the trials that we’ve done so far.

 

Porter

What would you like to see happen next?

 

Kaptchuk

Well I think we need more evidence.  This is really proof of principle research.  We need to treat people for longer, larger samples, we need some mechanistic studies but I really think that underneath it all there’s a possibility that we have the potential to honestly ethically transparently harness something that we’ve been neglecting for a long time – the placebo effect.  I think if – I think patients are willing to try it.  I’m not sure the medical community is ready to try it.  People have been trained to look for very good drugs and very good procedures but if there’s courage and compassion I think this is really a unique way of offering patients with subjective complaints, complaints of self-appraisal, another option that might relieve many of them.

 

Porter

Well it’s certainly a very different approach to what’s currently offered.  Professor Ted Kaptchuk, thank you very much.  And there is more information on placebos on the Inside Health page of the Radio 4 website, where you can also subscribe to the podcast service so you need never miss another episode.

 

Now, imagine this, you’re desperately ill due to a failing heart or on dialysis because your kidneys don’t work anymore.  Your only hope of a cure is a transplant but a shortage of donors means you may not get one in time.  Then a suitable organ becomes available, but it is from a donor who has Hepatitis C – a potentially serious, blood borne viral infection that will go on to attack you after your operation.

 

It may sound like the cruellest of gifts but recent advances in antiviral therapy mean it is anything but, and such donations – which are currently banned on safety grounds – could soon be commonplace.  And, given that nearly a quarter of million people in the UK are currently thought to carry Hepatitis C, such a move could significantly improve the supply of organs, meaning fewer people die on the waiting list, something that happened to nearly 500 last year alone.

 

Dr Adnan Sharif is consultant kidney and transplant specialist at Queen Elizabeth Hospital in Birmingham.

 

Sharif

We’re actually talking about being able to cure Hepatitis C, the new drugs, which are now available, have over a 95% success rate of curing Hepatitis C with 12 or 16 weeks of treatment.  It’s only because of this revolution that we’ve had in the treatment of Hepatitis C that we are actually now talking about whether we can use these donors.  And what we have to remember are that these organs which are declined from these donors, these donors tend to be younger, they tend to have less other health issues such as high blood pressure or diabetes or significant heart disease, so they would otherwise be very good organs. 

 

Porter

So, these are good quality organs and what you’re saying is that with the advent of modern antivirals the recipient would be put on medication and the Hepatitis C unlikely ever to cause a problem?

 

Sharif

Absolutely and there’s been studies which have been done in the United States and they’ve taken kidneys from people who had Hepatitis C, they’ve transplanted them into people who do not have Hepatitis C and they’ve simply just given them 12 weeks of treatment and what they found is that they essentially eradicate the Hepatitis C, so they’re cured.  And even if you go beyond the early period, up to six months and even 12 months, there’s no recurrence of the Hepatitis C and these individuals have excellent kidney function because they’ve received fantastic organs.

 

Porter

So, this is not a lifelong therapy for the recipients, it could be as short as three months?

 

Sharif

Absolutely, I mean the studies which have been done in the United States, they’ve simply just had to use 12 or 16 weeks of treatment and that’s it and essentially for the published work 100% of people have been cured of the Hepatitis C.  Now some people may say well we’ve only got one year data, what’s going to happen in five years and 10 years and so we will need to have some long-term data.  But I think what people have to remember is where would these individuals be if they hadn’t received those organs, they’d either still be on dialysis or may they have died waiting for that transplant.

 

Porter

How do the patients themselves feel, if you’re talking about someone who’s at end stage renal failure, kidney failure, I mean they’re pretty poorly, they’ve having regular dialysis, they’re desperate for a transplant, along comes a new organ and they say but it’s from a patient who has Hepatitis C – how are they likely to react?

 

Sharif

Well I mean I think it’s all a question of how we counsel these patients.  I mean especially when we get kidneys from the waiting list, so these are people who have died in a variety of circumstances and we normally always have to counsel our patients with regard to the risk of transmitting infections or cancers.  We have to remember we already take organs from individuals who may have died from infection or people may have died from meningitis and we will normally counsel people who are getting those kidneys that we will have to treat them with some antibiotics for the first few hours.  So, we already do that for a variety of infections and this, to me, just seems like a natural extension, we essentially give them that choice.

 

Porter

Do you have patients that you look after that die waiting for a transplant because an organ never becomes available?

 

Sharif

Absolutely and I think all of us who look after patients with organ failure, whether it’s kidney failure or liver failure, we will all have patients who we know who have been on the waiting list and have either died waiting for that transplant or have simply just become too frail to undergo the rigours of transplantation.  And for those individuals the faster you can get a transplant the better the likely outcomes and people have to appreciate that, I mean especially from my perspective looking after people on dialysis it can be a very miserable existence and some patients will describe it as a very slow death sentence.  And if you can give those individuals the option of having these kidneys with the caveats and the risks that come with it I think a majority of patients, once they’ve been counselled, will be happy to take that chance.

 

Porter

Adnan, if you were in the position where you or a member of your family needed an organ would you accept from a donor who’d had Hepatitis C?

 

Sharif

Absolutely, knowing the trend with organ donation we do seem to be getting organ donors who are now older, they’re heavier, they seem to have more health issues and if I had the choice of one of those organs versus one of these Hepatitis C donors, who tend to be younger with less health issues, I would on the balance of evidence just now I would go for the Hepatitis C kidney because it would be a better kidney and the evidence suggests within 12 weeks of the treatment the Hepatitis C will be cured.  So, for me it’s a no brainer, I would go for the Hepatitis C donor.

 

Porter

Dr Adnan Sharif.

 

Well the government’s expert committee, SaBTO, the advisory committee on the Safety of Blood, Tissues and Organs, endorsed the change back in 2016.  Professor James Neuberger chairs the committee.

 

Neuberger

Our committee said that patients should be offered organs from donors with Hepatitis C subject to two caveats.  Firstly, that they should be given fully informed consent and the information needs to be given not at the time of offer but beforehand, so they have time to consider the options, consider the implications and make the right decision.  And the second caveat is that treatment must be guaranteed to be available for them after transplantation.

 

So, with those two caveats we recommended that such donors should be offered to patients.  And based on a retrospective analysis that we did of the potential donors we looked at potential donors in the 15 year period from 2000 and we found that there were 244 donors with Hepatitis C, we’ve also looked at the people for whom consent wasn’t asked and again there was about 780 patients who could have been asked for consent and potentially many of their organs could have been used for transplantation to save and improve lives. 

 

So, there is a small but significant group of donors and against that, during that period, nearly 1500 people died on the waiting list.

 

Porter

It’s been two years or thereabouts from your recommendation to now, when is the first person going to be offered an organ from someone who’s Hepatitis C positive?

 

Neuberger

As a practising clinician who looks after people waiting for transplants and seeing the stresses they go through whilst on the waiting list I have a certain frustration that this is not already in place.  There are ongoing discussions with NHS England to ensure that antiviral therapy will be made available but I find it frustrating that this isn’t in place yet.

 

Porter

Is the cost of the antiviral drugs, which runs into tens of thousands of pounds, is that an obstacle in this because I would imagine that the cost of looking after someone who’s desperately ill with liver disease or kidney disease or whatever it is, is also very high?

 

Neuberger

The cost is an issue and the health service has a finite budget.  But for renal transplant patients the cost is recouped within three years of dialysis.  So, within five years you’re saving the NHS money by taking this option as well as improving the lives of your patients.

 

Porter

How confident are you in the effectiveness of the antiviral drugs that are being used?  There has been some concern that a lot of the evidence we have is quite short term, they do seem to be very effective in the short term, does that mean that they work well in the long term too?

 

Neuberger

You’re absolutely right.  The evidence is in two, three years, although the clinical trials perhaps give greater experience, and there’s always concern about this 98% cure rate experience from the States and other countries, again show that in liver transplant recipients Hepatitis C treatment is very effective.  You’re absolutely right of course we’re still uncertain about the long-term.  We think it’s positive but again this is a decision for the patient and if you’re waiting for that phone call for that liver if you’re potentially dying because there isn’t a suitable organ then I think at least you have the opportunity of making a decision, the patient has the choice – do they want to take that risk or take a risk of waiting for another offer.

 

Porter

We know what you hope, you’d like to see this implemented soon.  What do you think is going to happen realistically, for people who are listening who are on the waiting list now?

 

Neuberger

I think if there are people on the waiting list who are listening to this what I would recommend is they talk to their transplant coordinator or their clinician and put it to them and ask them what is the situation and if they want to be considered they need the information, they need to digest it and then come up with a decision.

 

Porter

Given that we seem to be lagging slightly behind here in England, might this happen in Wales, Scotland or Northern Ireland first?

 

Neuberger

It may well do.  There are ongoing discussions with NHS England, I think quite frankly within the pressures on NHS England this is a tiny factor.  But in a way that’s the frustration because this is maybe what a second or two seconds of the annual budget so why not just say yes, just JFDI.

 

Porter

Professor James Neuberger.   JFDI standing – obviously – for Just Focus, Do It.

 

And it is happening.  Changes are imminent in Scotland and Wales with England, I am told, likely to follow suit early next year.

 

Now if I asked you to list the causes of back pain, I doubt genes would feature prominently, if at all, yet a tendency to long term back pain does run in families.  But why?  One of the questions a huge international study, examining the genetic make-up of nearly 160,000 people, led by teams from King’s College London and the University of Washington, was hoping to answer.

 

Frances Williams is Professor of Genomic Epidemiology at King’s.

 

Williams

Low back pain’s a huge problem.  It’s a huge problem both within medical services with seeing people on a day to day basis in the clinic who have low back pain and it’s also recognised to be a really big problem globally.  So, recent studies from the Lancet have shown that the global burden of disability from back pain is just going up and up.

 

Porter

But when you think of back pain and people might think of injuries, painkillers, genetics doesn’t feature highly on the list.

 

Williams

Well it doesn’t but actually it’s very important.  It’s important in a number of ways.  Firstly, we know that back pain itself is heritable, around 40%, so that means that genetic factors influence about 40% of expression of back pain.  And I’ve spent the last 15 years looking at degeneration of the spine, which is one of the main contributors to back pain and surprisingly that’s even more heritable at between 70 and 80%.

 

Porter

So, there is an important genetic component.  Are we talking about a particular type of back pain here because it’s an umbrella term for a myriad of problems?

 

Williams

It is an umbrella term and I think that’s partly one of the difficulties that we have with this.  So, there are a few important causes of back pain that are relatively rare, that it’s important to spot, such as inflammatory spine disease or cancer.  But we know that most back pain is caused by mechanical factors in the spine.  And we’ve given it this term simple mechanical back pain which actually has not served us well, it hasn’t served the population well and it hasn’t served the medical community well either.

 

Porter

Now for most people that’s hopefully relatively short lived, they might tweak their back, have a problem for 10 days, couple of weeks but there’s a significant proportion who have ongoing problems and these are the group that you were most interested in.

 

Williams

So, I think these are the group that contribute to this global burden of disability, these are the folk whose acute back pain, this short-lived back pain, doesn’t settle down it goes on to be a chronic problem with associated disability and possibly loss of job and real big social factors involved.

 

Porter

So, what did you do and what did you find?

 

Williams

So, we looked across in a very large study across the US and Europe.  We studied 450,000 people who’d reported on whether or not they had long term chronic back pain, this might have lasted three, six or 12 months.  And we were able to look for links between the genes that people have and the complaint of chronic back pain.  And to our surprise we found only three highly significant genes associated with chronic back pain.  And when we set off on this work we were expecting to find the sorts of genes that would implicate the chronic pain mechanisms, so central nervous system or peripheral nervous system mechanisms that might be involved in pain transmission.

 

Porter

Something in the sensing side of things.

 

Williams

Exactly, exactly, so something that was taking the pain from being a short-lived pain, which normally would resolve to a sort of failure of resolution and moving on to the chronic phase.  But in fact, what we found were genes that look very much more like the sorts of genes that are involved in spine development, in bone and in intervertebral disc.  And the interesting thing about that is that this is very much allied to our previous work which has shown that actually the amount of degeneration on the spine is one of the single biggest predictors of episodes or severe and disabling low back pain. 

 

Porter

So, the suggestion from the genetic side is that these people have very real problems with their backs, that there are positive mechanical triggers going on here.

 

Williams

I’m sure there are positive mechanical triggers but we also have shown that the genes involve overlap with other important and largely psychological genetic influences, such as anxiety and depression.  And so, I think the overall message from this is that we should be taking a very much more holistic approach to managing back pain and not focusing on the precise anatomical trigger through imaging and x-rays but actually looking much more broadly at the whole individual and at their occupation and lifestyle and psychological factors.

 

Porter

Well to many people listening to this it won’t come as a surprise that if you look at people with chronic back pain that you find something wrong with their backs, which is effectively what you found, so how does understanding the genes take us forward in any way?  I mean it won’t come as a surprise that these people are more likely to have degenerative conditions in the back.

 

Williams

For me the main message is that we need to be telling folk that actually degeneration of the spine is a normal part of ageing and that’s partly the problem that we have with people going off and seeking imaging.  When you image the spine in somebody who’s over 20 frankly you see abnormalities…

 

Porter

That’s the cause of your problems when in fact it’s…

 

Williams

And people get fixated – exactly…

 

Porter

…it’s normal.

 

Williams

…exactly, it’s normal for age.  So, I’ve looked at thousand MRI scans across the twins, in Twins UK, and there’s just a clear demonstration of age and genetic influence.  And those are things we’re not going to be able to change.  But we need to accept that the changes that you see on the imaging are part of the normal human condition, it’s how you respond to the pain that matters.

 

Porter

So, what does it tell you?  I mean what have you learnt personally from this that was perhaps a surprise that you didn’t know before?

 

Williams

So, the surprise to me was that these are genes that are not chronic pain genes but that they’re structural spine genes and we’ve also found a surprising overlap with genes for anxiety and depression.

 

Porter

And that might have implications on how we manage this because if we don’t manage the psychological aspect of the pain properly we’re unlikely to give them much relief.

 

Williams

Exactly, exactly, so instead of sort of homing in on the precise anatomical trigger to the problem that’s based in the spine again I think we should look at the whole person and manage the whole problem considering the effects on mood, on sleep, on people’s anxiety around their occupation or on day to day issues, activities of daily living that they’re not managing to complete.

 

Porter

Frances Williams, and there is a link to that new study on our website.

 

Just time to tell you about next week when I will be in Oxford to meet the team behind new research into the huge toll exacted by hip fractures – the biggest single cause of serious injury in older people – and finding out what really matters to recovering patients.

 

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