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The NHS

Individualised and Personalised QALYs in Exceptional Treatment Decisions

28 Jul, 16 | by BMJ

Guest Post by Warwick Heale

When NICE decides whether to make a treatment available on the NHS it considers both clinical effectiveness and cost effectiveness.  Cost effectiveness is based on population-level QALY data, as is appropriate for a population-level policy.  However, this can cause problems for exceptional individual patients.

When a doctor wants to offer an individual patient a treatment that has been deemed by NICE not to be cost-effective, the doctor can make an Individual Funding Request (IFR) to NHS England or a Clinical Commissioning Group.  The doctor must convince the IFR Panel that the patient is exceptional and that it is worth spending the money on this patient, leaving less to be spent on others.  The Panel’s presumption, based on the population-level data, is that the treatment will not be cost effective, and this stacks the cards against the individual patient, however extreme the patient or their condition may be compared to the population average.

One solution to this might be to consider individualised cost or response (individualised QALYs) or personalised valuations of health states (personalised QALYs).  Applying these concepts might protect the patient from a treatment being refused even if he or she is markedly different from the population average.  In doing this, we would actually promote utility and effective use of resources which is one aim of the IFR process, but one which I think it fails to achieve as effectively as it might.

Consideration of personalised QALYs also offers a justification for offering a Jehovah’s Witness a more costly alternative to blood transfusion, on the basis that this would actually maximise the utility we gain from our limited resources – in contradiction to the more obvious view that this would compromise utility.  Furthermore, in doing this we don’t need to give any special status to religious considerations – the Jehovah’s Witness, the patient of a different faith and the atheist should all be subject to the same principles of personalised QALYs.  Personalised QALYs also allow us to think about patient choice alongside utility rather than as independent principles.

Read the full paper here.

Event: Courting Controversy?

3 Jul, 16 | by Iain Brassington

This might be of interest to some readers:

Courting Controversy?  Recent Developments in Health Care Law

21 July 2016

Chancellors Hotel, Chancellors Way, Moseley Road, Fallowfield, Manchester M14 6NN

This afternoon seminar examines some controversial recent developments in health care law and introduces two new books on law and medicine:

  • Margaret Brazier and Emma Cave Medicine, Patients and the Law (6th Edn) (Manchester UP, 2016)
  • Catherine Stanton and Hannah Quirk (eds), Criminalising Contagion: Legal and Ethical Challenges of Disease Transmission and the Criminal Law (Cambridge UP, 2016)

Participants will have the opportunity to discuss developments in the law and meet the authors and researchers from the Centre for Social Ethics and Policy (CSEP) informally.

Programme

13:30 – 14:00  Registration

14:00 – 14:30  Overview of recent developments (Margot Brazier and Emma Cave)

14:30 – 15:00  Protecting Vulnerable Patients (Emma Cave)

15:00 – 15:30  Criminalising Disease Transmission: Demands, Difficulties and Dangers (Hannah Quirk)

15:30  Tea

16:00 – 16:30  Patient Autonomy: Clinical Compulsion?  An Analysis of Montgomery and Doogan – Margot Brazier

16:30 – 17:00  Law Commission Recommendations on Deprivation of Liberty Safeguards – Neil Allen

17:00  Open Discussion

17:30  Reception

This event is free and offered by the CSEP and the School of Law, University of Manchester.  Registration, however, is required.  Please reserve your place here.  For more information, email maureen.barlow[at]manchester.ac.uk

Should Junior Doctors Strike?

25 Jan, 16 | by Iain Brassington

Guest Post by Mark Toynbee, Adam Al-Diwani, Joe Clacey and Matthew Broome

[Editor’s note: Events in the real world have moved more quickly than David or I have; the facts of the junior doctors’ strike have moved on since the paper was published and this post submitted.  Still, the matters of principle remain. – IB]

A strike by junior doctors is planned for January 2016 following failure of the last-ditch ACAS (Advisory, Conciliation and Arbitration Service) mediated talks between the BMA and the Department of Health (via NHS Employers) – see media reports here, here, and here.  Industrial Action had previously been planned for December last year but was suspended at the last minute when both sides agreed to the now failed mediation.  The current regrettable position has resulted from over two years of formal negotiations between the BMA and NHS Employers regarding a new junior doctor contract.  The BMA went to its junior doctor members for a mandate for industrial action last autumn as the talks stalled and received an almost unprecedented mandate with 98% indicating they would be prepared to strike.

Subsequently, many well-known figures voiced their concerns about the ethical and practical implications of industrial action (here and here).  Strikes by doctors are not common, with only one example in the UK in the last generation, but far from unprecedented.  The overwhelming recent ballot result raises many interesting issues, foremost among them the ethical legitimacy of industrial action by doctors, specifically junior doctors.

The term ‘junior doctor’ is often misunderstood.  It applies to all doctors from graduation until completion of specialist training – over 50,000 individuals.  Their roles and responsibilities have evolved significantly over many years; their pay and hours have reduced whilst their debts, costs and responsibilities have increased.  The patient-doctor relationship has also changed with increased emphasis on patient involvement and the promotion of autonomy.

We have looked at arguments proposed during previous instances of doctor industrial action, often from this journal (see this, this, and this) and considered them in the current context.  Absolute ethical objections to doctor industrial action appear old-fashioned, especially when applied to junior doctors.  Concerns about harms caused by doctors withdrawing their labour also seem less sustainable in the light of recent evidence than perhaps would be expected.  Indeed, the ethical responsibilities of doctors may require them to take action if they believe patient care, or the well-being of their colleagues’, is being compromised.

So far there has been strong support for the junior doctors from the Consultant bodies of many Trusts, and the Royal Colleges.  The modern NHS asks more of its junior doctors than ever before, placing ever increasing responsibilities on their shoulders, with ever more challenging working conditions.  With industrial action by junior doctors now likely to go ahead, claims that it would be unethical appear to us to be increasingly hard to justify.

Read the paper here.

R-E-S-P-E-C-T

24 Dec, 15 | by Iain Brassington

Here’s an intriguing letter from one John Doherty, published in the BMJ yesterday:

Medical titles may well reinforce a clinical hierarchy and inculcate deference in Florida, as Kennedy writes, but such constructs are culture bound.

When I worked in outback Australia the patients called me “Mate,” which is what I called them.

They still wanted me to be in charge.

Intriguing enough for me to go and have a look at what this Kennedy person had written.  It’s available here, and the headline goes like this:

The Title “Doctor” in an Anachronism that Disrespects Patients

Oooooo-kay.  A strong claim, and my hackles are immediately raised by the use of “disrespect” as a verb – or as a word at all.  (Don’t ask me why I detest that so; I don’t know.  It’s just one of those things that I will never be able to tolerate, a bit like quiche.)  But let’s see…  It’s not a long piece, but even so, I’ll settle for the edited highlights: more…

Homeopathy, Blacklisting, and the Misuse of Choice

15 Nov, 15 | by Iain Brassington

It seems that homeopathy might at last be facing some serious opposition from within the NHS, with the prospect of its being blacklisted being considered.

There’s any number of people who’ll be entirely on board with that. Homeopathy doesn’t work.  Of course, a lot of medicines turn out not to work, or not to work well.  But the difference between homeopathy and unsuccessful drugs is that the latter are at least more likely to have a plausible mechanism – roughly, one of throwing molecules at other molecules, or coaxing the body to throw molecules at molecules.  Homeopathy doesn’t even have that.  It relies on water having a memory.

At the very best, it contributes nothing. But it does cost money – not much, but more than none, and in the end, the taxpayer has to pony up for it.  Money is being wasted every time the NHS pays for homeopathic treatment, and that looks to be unjust.  (It’s not the most unjust thing in the world, but that’s neither here nor there.  Wrongs are wrongs, even if harms might vary.)

It might even get in the way of effective treatments, if patients use it rather than them.  That might mean that they’re worse off than they could otherwise be.  At the outside, it might mean that they’re a danger to others – they might be spreading illness by dint of not getting treated properly for it.

To that extent, Simon Singh strikes me as being bang on the money: more…

Should Doctors Strike?

9 Nov, 15 | by bearp

 

Should doctors strike?

Is it ethical for doctors to go on strike, potentially putting their patients at risk of getting inadequate treatment?

As the BBC reports, ministers and junior doctors are currently “locked in a dispute.” One possible outcome of this disagreement is a physicians’ strike, which raises a number of tricky ethical questions. But before we get into those questions, it might be helpful to take a look at a quick sketch of what the problem is all about (from the BBC article):

Junior doctors’ leaders are objecting to the prospect of a new contract. The government has described the current arrangements as ‘outdated’ and ‘unfair,’ pointing out they were introduced in the 1990s. Ministers drew up plans to change the contract in 2012, but talks broke down last year. The government has indicated it will impose the new contract next year in England. The BMA has responded by initiating the industrial action process. …

The latest information provided by the government, which is the most detailed so far, includes an 11% rise in basic pay for doctors. But that comes at a price. Other elements of the pay package are being curbed.

The prospect of a strike appears to be firmly on the table: “Doctors can take strike action but only if it affects non-emergency care. The last time this happened was during [a] pensions dispute in 2012, but that was the first time such action had been taken for almost 40 years. Doctors still attend work – so they are ready for urgent and emergency cases.”

The Journal of Medical Ethics has tackled this issue before. Writing for the journal in 2013, John Park and Scott Murray gave an analysis of the 2012 “pensions dispute” just mentioned.

Last year in June, British doctors went on strike for the first time since 1975. Amidst a global economic downturn and with many health systems struggling with reduced finances, around the world the issue of public health workers going on strike is a very real one. Almost all doctors will agree that we should always follow the law, but often the law is unclear or does not cover a particular case. Here we must appeal to ethical discussion.

The General Medical Council, in its key guidance document for practising doctors … claims that ‘Good doctors make the care of their patients their first concern.’ Is this true? And if so, how is this relevant to the issue of striking? One year on since the events, we carefully reflect and argue whether it was right for doctors to pursue strike action, and call for greater discussion of ethical issues such as the recent strikes, particularly among younger members of the profession.

In light of the current turmoil, the Journal of Medical Ethics welcomes submissions on the ethics of physicians striking, including papers which build on, critique, or respond to the work of Park and Murray. Their 2013 paper can be accessed here. As Associate Editor Dominic Wilkinson stated in an interview:

In their submissions, authors should focus on ethical questions and put their discussion in the context of ongoing international debate and existing literature. Possible questions include, for example: what is a fair level of remuneration for public sector healthcare workers, including doctors? Should all doctors be paid equally? Should antisocial hours be rewarded financially? In a financially constrained environment, should doctors’ pay go down in order to protect funding for health care provision?

Papers can be submitted to the Journal of Medical Ethics here. Author instructions are here.

The Journal of Medical Ethics remains the top-ranked journal in bioethics for 2015 according to Google Scholar Metrics, with an impact factor of 1.511 and an h5-index of 28. We look forward to seeing your submissions.

Check out the current issue by clicking here.

Stop What You’re Doing: This is Important.

14 Oct, 15 | by Iain Brassington

I’d not realised it, but the latest iteration of the erstwhile Medical Innovation Bill – colloquially known as the Saatchi Bill – is up for debate in the Commons on Friday.  This is it in its latest form: to all intents and purposes, though, it’s the same thing about which I’ve blogged before.

In a nutshell, the Bill does nothing except remove protections from patients who would (under the current law) be able to sue for negligence in the event that their doctor’s “innovative” treatment is ill-founded.

Much more articulate summaries of what’s wrong with the Bill can be found here and here, with academic commentary here (mirrored here on SSRN for those without insitutional access).  There have been amendments to the Bill that make the version to be discussed on Friday slightly different from that analysed – but they are only cosmetic; the important parts remain.

Ranged against the Bill are the Medical professional bodies, the personal injuries profession, patient bodies, and research charities.  In favour of the Bill are the Daily Telegraph, a few people in the Lords who should know better (Lord Woolf, Lady Butler-Sloss: this means you), and Commons MPs who – understandably – don’t want to be seen as the one who voted against the cure for cancer.

Gloriously, Christ Heaton-Harris, who introduced the Bill, did so only after winning the ballot for Private Members’ Bills.  In a nutshell, he was allotted Parliamentary time, and then began the process of wondering what to do with it – which suggests that even the Bill’s sponsor doesn’t have a burning commitment to the cause – or, at least, didn’t when he took it on.

Still, the Bill has the support of Government; as it stands, there’s a good chance that it’ll pass.

SO: Take a few minutes to look up your MP’s email address – you can do that by following this link – and drop him/ her a line to encourage them to vote against the Bill.

Do it.

Assisted Dying’s Conscience Claws

11 Sep, 15 | by Iain Brassington

Aaaaaaaand so the latest attempt to get assisted dying of some sort onto the statute books in the UK has bitten the dust.  I can’t say I’m surprised.  Watching the debate in the Commons – I didn’t watch it all, but I did watch a fair chunk of it – it was striking just how familiar the arguments produced by both sides were.  It’s hard to shake the feeling that, just as is the case with the journals, the public debate on assisted dying has become a war of attrition: noone has much new to say, and in the absence of that, it’s simply a matter of building up the numbers (or grinding down the opposition).  The Nos didn’t win today’s Parliamentary debate because of any dazzling insight; the Ayes didn’t lose it because their speakers were measurably less impressive than their opponents’.  If the law does change in the UK, I’d wager that it’ll be because of demographic brute force rather than intellectual fireworks.

(Every now and again I hear a rumour of someone having come up with a new approach to assisted dying debates… but every now and again I hear all kinds of rumours.  I live in hope/ fear: delete as applicable.)

Still, I think it’s worth spending a little time on one of the objections that’s been raised over the last couple of days to this Bill in particular; it’s an objection that was raised by Canon Peter Holliday, the Chief Executive of a hospice in Lichfield:

In an interview with the Church of England, Canon Holliday said: “If there is no possibility within the final legislation for hospices to opt out of being a part of what is effectively assisted suicide, then there is nervousness about where our funding might be found in the future. Would the public continue to support us and indeed would the NHS continue to give us grants under contract?”

Canon Holliday said the Assisted Dying Bill also contains no opt out for organisations opposed to assisted suicide in spite of high levels of opposition to a change in the law amongst palliative care doctors. Where hospices did permit assisted suicide the potential frictions amongst staff could be ‘enormous’ with possible difficulties in recruiting doctors willing to participate, he said.

“The National Health Service requires us, in our contracts, to comply with the requirements of the NHS. Now if the NHS is going to be required to offer assisted dying there is of course the possibility that it would require us or an organisation contracting with the NHS also to offer assisted dying. If we as an organisation were able, and at the moment under the terms of the bill there is no indication we would be able, but if we were able to say that assisted dying was not something that would happen on our premises, would that prejudice our funding from the NHS ?”

Is this worry well-founded? more…

On the other hand…

20 Jul, 15 | by Iain Brassington

… the phenomenon of apologising for the wrong thing comes alongside people taking umbrage at the wrong thing.  Last week, the BMJ ran a head-to-head feature on the “question” of whether doctors should recommend homeopathy.  This was the latest in a series of articles in which a question is posed, apparently strictly on the understanding that it’ll accommodate a polarised debate, and one person is invited to give a “yea” response, and another to give “nay”.  I won’t bother here with a screed about homeopathy: Edzard Ernst does a good job in the BMJ piece, as have many others across the blogosphere.  (You could do worse, for example, than to have a wander through the Anomalous Distraction blog, which is written by an ex-schoolmate of mine, and which also has lots of pretty pictures of proteins and things.)  Since it’s a nice day, and I’m in a reasonably good mood, I’ll even admit that when Hahnemann was working, something like homeopathy was probably as good a punt as anything else that medicine had to offer.  But… y’know.

Aaaaaanyway…  A rather angry letter appeared.  I think it’s worth examining, because it makes a number of normative and value claims; and if norms and values aren’t the meat and veg of an ethicist’s life, then we might as well go home. more…

The Death of Sidaway: Values, Judgments and Informed Consent

15 Mar, 15 | by BMJ

Guest post by Kirsty Keywood (University of Manchester)

On 11th March Nadine Montgomery won her case before the UK Supreme Court to gain compensation for the failure of her obstetrician to warn her of risks associated with the vaginal delivery of a large infant – a risk which she would have averted by requesting a caesarean section.[1] Shortly after his birth, her son was diagnosed with cerebral palsy and a brachial plexus injury, resulting from the occlusion of the placenta during a “very stressful” vaginal delivery.

Nadine Montgomery had diabetes, which increased her chances of giving birth to a larger than average-sized baby. This, in conjunction with her small stature (she was 5 feet tall), indicated a risk that a natural delivery would bring with it a 9-10% chance of shoulder dystocia. Were dystocia to occur, attempts to dislodge the infant’s shoulders through mechanical manoeuvres would generate a risk of occlusion of the umbilical cord resulting in death or cerebral palsy of 0.1%. According to the obstetrician, Dr McLellan, the risk of shoulder dystocia did not merit specific mention in discussions with diabetic patients, because the risk of an adverse event associated with shoulder dystocia was very small indeed.

Mrs Montgomery’s case before the UK Supreme Court hinged on the question of the nature of the obstetrician’s duty to the patient. more…

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