NHS workforce and the reality distortion field.

The process of designing the first Apple Macintosh computer in the early 1980s was an arduous one. The exacting demands of Apple co-founder Steve Jobs resulted in his employees and colleagues describing a ‘reality distortion field’ around him and the people who came into his orbit, within which the impossible became possible. Rectangles with rounded corners when the processor couldn’t draw a circle? No problem. A device with a footprint smaller than a phone book when everything else was three times this size? OK. Shave half a minute off an already streamlined boot process? Yeah, we can do that.

Jobs was able to bridge the gulf between expectation and reality by the clarity of his idea assisted by the sheer force of his personality, his drive, his obsession and a large dose of behaviour one might describe as bullying.

In today’s NHS we see a huge gulf between expectation and reality. Amongst other laudable aspirations NHS England [NHSE] expects to eliminate elective waits of over 65 weeks by March 2024 and increase diagnostic activity to 120% of pre-pandemic levels by April 2023. There will be improved cancer waiting times and outcomes, delivery of 50 million more GP appointments, upgraded maternity services and more, all delivered within a balanced budget.

And yet as I write, emergency departments are full to overflowing and secondary care is snarled up as social care cannot take discharges. High cost resources like theatres stand idle as hospitals grind to a halt. Primary care is drowning in demand. Much infrastructure is ageing. Estate is frequently tired, cramped and unfit for purpose. In this context, a reality distortion field with the metaphorical power of a black hole is required to make NHSE’s objectives seem even remotely achievable.

There are things that can be done: waste can be reduced and unnecessary bureaucracy eliminated; skill mix can be improved and workforce better deployed; estate can be upgraded flexibly to allow for new ways of working; services can be made more responsive to the needs of the people the NHS serves. Perhaps demand or public and political expectation can be managed. Maybe artificial intelligence or other technocratic solutions can finally deliver on their promise. We can refresh our NHS and make it comparable again with the best of our neighbouring nations.

To achieve all this requires money. This is necessary but insufficient. It also requires people.

Without a motivated, engaged, enthusiastic, driven workforce, recovering from the current crisis will be impossible. It’s the staff of the NHS and social care sector who identify the blockages and inefficiencies and create the solutions needed to improve at all levels: from district nursing team to quaternary hospital service, from clinic to Integrated Care Board. This is not a new concept: Kaizen methodology with continuous improvement driven by all staff is well established in business and healthcare. It is the staff who deliver.

Jobs recognised the importance of people in delivering his vision. He surrounded himself with people he described as his ‘A’ team. They achieved what they did because while he was a martinet character, difficult to work with, prone to bouts of anger, rudeness and extreme condescension he was also inspiring, he imbued loyalty and belief. People wanted to work for him, to deliver for him.

Given the strong vocational ethos in the NHS workforce, it should be easy to motivate its staff. But instead I perceive a disillusionment and learned helplessness that I have never known before. This is corrosive to initiative and problem solving. Motivating the workforce means paying people appropriately, recognising that pay and compensation have a salient effect on morale and on the recruitment of new colleagues and the retention of old ones. It means publishing a long overdue workforce strategy. It means listening, and understanding the daily frustrations that erode professionalism and vocational drive. It means appreciating that working in ageing buildings with ageing equipment will inevitably breed apathy. It means transformative investment.

But more than this the NHS needs a transformative vision, akin to that seen at its inception. This means having the bravery and honesty to start a public discourse on how to fund the NHS and social care long term: what we can (or choose to) afford as a country and what we cannot (or choose not to). It means confronting difficult policy decisions about cost-effectiveness and service rationing with public, professionals and industry. It means addressing both demand for- and supply of- healthcare. Everyone I know in the NHS recognises the fact that we cannot go on as we are spending more and more on increasingly marginal outcomes.

And this is where the reality distortion field can help: because with the development of a transformative vision and a clear commitment to transformative investment I believe the NHS’s staff will deliver the solutions required. It has happened before and can happen again. Even before the money flows, the idea that the government understands and is committed to action will empower the workforce. It will allow the distortion field to develop and the gulf between expectation and reality to be bridged. But until the vision is developed and the investment begins there will be no reality distortion in the NHS. Just a grim reality.

Where might the vision come from? It’s clear not from our current government who seem to only have a wish-list of near-future outcomes expedient to help with their prospects at the next general election. To me, the only option seems to be a long term collaborative effort across successive Parliaments and political ideologies and involving all public, private, patient and professional stakeholders to co-create it. Whether there is the political will, executive structure or inspiring leader to facilitate this remains to be seen. Steve Barclay is not Steve Jobs.

Values, guidance, NICE and the ESVS.

This is a transcript of a 7 minute talk I was invited to give at the Cardiovascular and Interventional Society of Europe’s [CIRSE] annual conference in Barcelona, as part of a session on “Controversies in Standard Endovascular Aneurysm Repair [EVAR] within IFU” [indications for use].

This talk: “NICE guidelines best inform clinical practice”, was one side of a debate: my opponent’s title was “European Vascular Society [ESVS] guidelines should be the standard of care”.

If you have on-demand access to CIRSE2022 content, you can view a recording of the session here.

Barcelona. Spain. 13th September 2022. 15:00h

Thanks. My name is Chris Hammond, and I’m Clinical Director for radiology in Leeds. I was on the NICE AAA guideline development committee from 2015-2019.

I have no declarations, financial or otherwise. We’ll come onto that in a bit more detail later.

This talk is not going to be about data. I hope we are all familiar with the published evidence about AAA repair. No. This talk is about values. Specifically, the values that NICE brings to bear in its analysis and processes to create recommendations and why these values mean NICE guidelines best inform clinical practice. What are those values?

Rigour, diversity, context.

Let’s unpick those a little.

NICE’s is known for academic rigour. Before any development happens, the questions that need answering are clearly and precisely identified in a scoping exercise. A PICO question is created, the outcomes of interest defined, and the types of evidence we are prepared to accept are stipulated in advance. 

The scope and research questions are then published and sent out for consultation – another vital step.

After the technical teams have done their work, their results are referred explicitly back to the scope. Conclusions and recommendations unrelated to the scope are not allowed.

This process is transparent and documented and it means committee members cannot change their mind on the importance of a subject if they do not like the evidence eventually produced. 

It’s impossible to tell from the ESVS document what their guideline development process was. A few paragraphs at the beginning of the document are all we get. ESVS do not publish their scope, research questions, search strategies or results. How can we be assured therefore that their conclusions are not biased by hindsight, reinterpreting or de-emphasizing outcomes that are not expedient? 

We can’t.

For example, data on cost effectiveness and outcomes for people unsuitable for open repair are inconvenient for EVAR enthusiasts. I’ll let you decide the extent to which these data are highlighted in the ESVS document.

More, in failing to define the acceptable levels of evidence for specific questions ESVS ends up making recommendations based on weak data. Recommendations are made based on the European Society of Cardiology criteria which conflate evidence and opinion. Which is it? Evidence or opinion? 

Opinions may be widely held and still be wrong. The sun does not orbit the earth. An opinion formulated into a guideline gives the opinion illegitimate validity.

Finally, there is the rigour in dealing with potential conflicts of interest. These are the ESVS committee declarations – which I had to ask for. The NICE declarations are in the public domain on the NICE website. Financial conflicts of interest are not unexpected though one might argue that the extensive and financially substantial relationships with industry of some of the ESVS guideline authorship do raise an eyebrow. 

The question though is what to do about them. NICE has a written policy on how to deal with a conflict, including exclusion of an individual from part of the guidance development where a conflict may be substantial. This occurred during NICE’s guideline development.

The ESVS has no such policy. I know because I have asked to see it. Which makes one wonder: why collect the declarations in the first place.

How can we then be assured these conflicts of interest did not influence guideline development, consciously or subconsciously.

We can’t

What about diversity? 

This is the author list of the ESVS guideline. All 15 of the authors, all 13 of the document reviewers and all 10 of the guideline committee are medically qualified vascular specialists. They are likely to all have had similar training, attended similar conferences and educational events and have broadly similar perspectives. It’s a monoculture. 

Where are the patients in this? The ESVS asked for patient review of the plain English summaries it wrote to support its document, but patients were not involved in the development of scoping criteria, outcomes of importance or in the drafting of the guideline itself.

Where is the diversity of clinical opinion? Where are the care of the elderly specialists to provide a holistic view? Where is anaesthesia? Primary care? Nursing?

Where is the representation of the people who pay for vascular services:  infrastructure, salaries, devices? And who indirectly pay for all this, maybe for your meal out last night, for the cappuccino you’ve just drunk? Where is their perspective when they also have to fund the panoply of modern healthcare?

NICE committees have representation of all these groups, and their input into the development of the AAA guidance was pivotal.  The NICE guidance was very controversial, but the consistency of arguments advanced by diverse committee members with no professional vested interest was persuasive.

Finally, we come to context.

An understanding of the ethical and social context underpinning a guideline is essential.

We cannot divorce the treatments we offer from the societal context in which we operate. We live in a society which emphasises individual freedom and choice and are comfortable with some people having more choices than others, usually based on wealth. Does this apply equally in healthcare? In aneurysm care? What if offering expensive choices for aneurysm repair means we don’t spend money on social care, nursing homes, cataracts or claudicants.

To what extent should guidelines interfere with the doctor-patient relationship? Limit it or the choices on offer? What is the cost of clinical freedom and who bears it?

NICE makes very clear the social context in which it makes its recommendations. It takes a society-wide perspective, and its social values and principles are explicit. You can find them on the NICE website. Even if you don’t agree with its philosophical approach, you know what it is.

We don’t know any of this for the ESVS guideline. We don’t know how ESVS values choice over cost, the individual over the collective. Healthcare over health. This means that the ESVS guideline ends up being a technical document, written by technicians for technicians, devoid of context and wider social relevance.

The ESVS guideline is not an independent dispassionate analysis, and it never could be, because its development within an organisation so financially reliant on funding from the medical devices industry was not openly and transparently underpinned by NICE’s values of rigour, diversity and context. 

Rigour. Diversity. Context

That’s why NICE guidelines best inform clinical practice.

Thanks for your attention.

Decisions, QALYs and the value of a life

Here’s a well known thought experiment:

A runaway train is on course to collide with and kill five people who are stuck at a crossing down the track. There is a railway point and you can pull a lever to reroute the train to a siding track, bypassing the people stuck at the crossing but killing 2 siding workers.

What would you do? What is the ethical thing to do? Why? What if one of the siding workers was related to you? What if the people stuck at the crossing were convicted murderers on their way to prison? What if the people on the crossing were not killed but permanently maimed?

Have a think about it before reading on.

Unless you answered that you did not accept the situation at face value (like Captain Kirk and the Kobayashi Maru simulation), or refused to choose, you will have made some judgements about the relative value of the choices on offer and perhaps the relative value of the lives at risk. You are not alone in this: in a 2018 Nature paper, nearly 40 million people from 233 countries were prepared to make similar choices. On average there were preferences to save the young over the old, the many over the few and the lawful over the unlawful, though with some interesting regional and cultural variations.

Making value judgements about people in a thought experiment is one thing, but making them in the real world with impacts on real people and their lives is another. Ascribing value to a persons life has grim historical and moral connotations. If someone is deemed somehow less valuable than someone else there is a risk that this is used to justify stigmatisation, discrimination, persecution and even genocide. We therefore need to be extremely careful about the moral context in which such judgements are made and the language we use to discuss them. Human rights, justice and the fundamental equivalence of the life and interests of different people must be central. 

Decisions which affect the health, livelihoods and welfare of citizens are (and need to be) made all the time. In some cases decisions affect length or quality of life, or liberty.  Decision making during the pandemic (whether locking down, opening up, isolation, mask wearing or travel restriction) is a potent recent example. Few people would argue that no decisions were necessary even if they may disagree with the details of some (or all) of the actual decisions made.

But if everyone’s life and interests are equivalent, how do we avoid becoming paralysed when faced with choices which inevitably will have (sometimes significant) consequences for different individuals? We do this by understanding that the values we ascribe to the people affected by a decision are not absolute measures of their worth, but merely tokens which allow us to undertake some accounting. If the process by which we allocate these tokens is transparent, just and humane then their use to inform a decision is morally defensible. Choosing to switch the points because this results in the least worst outcome on average is morally very different from choosing to switch them because you have a seething hatred of railway engineers.

What tokens can we use in healthcare to help us make decisions?

There have been attempts to provide a quantitative framework for measuring health. The most commonly recognised token of health is the Quality Adjusted Life Year (QALY) though there are others (eg. Disability Adjusted Life Years [DALY]). One QALY is a year lived in full health. A year lived in in less than full health results in less than one QALY, as does less than one year lived in full health. How much we scale a QALY for less than full health is determined by studies asking members of the public to imagine themselves ill or disabled and then enquiring (for example) how much length of life they’d trade to be restored to full health (time trade-off) or what risk of death they’d accept for a hazardous cure (standard gamble). 

The QALY is a crude and clumsy tool. It has been criticised for relying on functional descriptions of health states (like pain, mobility and self care) rather than manifestations of human thriving (stability, attachment, autonomy, enjoyment), for systematically biasing against the elderly or the disabled and for failing to take into account that health gains to the already healthy may be valued less than health gains to the already unhealthy (prospect theory). The scalar quantities contributing to a QALY (‘utilities’) reflect the perceptions of those surveyed during QALY development, validation and revalidation. These perceptions may be clouded by fear or ignorance and may have little relation to the real experiences of people living with a health impairment or handicap. Some have argued that QALYs have poor internal validity and are therefore a spurious measure.

These are important, though arguable, technical criticisms and to some extent explain the marked international variation in the use of the QALY: they are used in the UK and some Commonwealth countries, but have been rejected as a basis for health technology assessment in the US and Germany. And yet, decisions need to be made. If not QALYs then what else?

But the most emotionally charged criticism of QALYs is that they somehow inherently rank people’s value according to how healthy they are or that the health of people who gain fewer QALYs from an intervention is somehow worth less than the health of those who gain more. This is a misunderstanding. QALYs (like the assessments you made of the lives at risk from the runaway train) are accounting tokens. When fairly, justly and transparently allocated (and technical criticisms might be important here) they merely allow a quantitative assessment of outcome. The rationale underlying QALY assessment is explicit that the value of a QALY is the same no matter who it accrues to: there is no moral component in the calculation. And nor is there the requirement that efficiency of QALY allocation be the sole (or even most important) driver of decision making.

A QALY calculation is fundamentally contingent on the interaction of the intervention with the people being intervened on. Someone’s capacity to benefit (which is what QALYs measure) depends not just on their characteristics but also those of the intervention. Absolute ranking of QALYs as an empirical assessment of someone’s ‘value’ based on their health is therefore meaningless: a different intervention on the same set of people can result in a totally different estimate of outcome.

Consider if rather than five people on the crossing there was only one (and still two siding workers). A pure utilitarian consequentialist would switch from ploughing the train into the siding to smashing it into the crossing. But this doesn’t mean she has suddenly changed her mind about the value of the lives of the people involved, merely that the situation and therefore the most efficient outcome, has changed.

QALYs don’t ascribe a value to someone’s life. They are accounting tokens, providing a (perhaps flawed) quantitative estimate of health outcome in a specific circumstance – usually that of evaluation of an intervention relative to an alternative in an identifiable group of people. This is not to say that some people might not be harmed by a decision based on a QALY assessment, but that, of itself, does not make the decision unfair or unjust.

Alongside utilitarian efficiency and QALYs, egalitarian considerations of fairness and equity, distributional factors, affordability, and political priorities may (and often do) feed into the decisions that are ultimately made. 

Cost-effectiveness, art and science in medicine

I’m consulting with a man in his mid 70s: a retired teacher in an inner city secondary school. He used to smoke, but quit several years ago. He’s otherwise pretty fit: he has never learned to drive so walks everywhere and uses public transport. He is married, and his wife and he are still independent. They have grown up children who live a long way away. They go out to the theatre when they can and enjoy going to the local pub together and with friends. He’s got high blood pressure which is well controlled. He also has an abdominal aortic aneurysm (an AAA). It’s large. And he is worried about it. We talk about the options for repair. He is anxious about a major abdominal operation. He’s not dead set against it, but is concerned about the recovery, the impact it will have on his wife. On balance he is minded to have an endovascular repair, for which the AAA is anatomically suitable. We discuss the long term outcomes of open and endovascular repair. The need for secondary procedures and surveillance. He leaves the consultation undecided and plans to discuss it with his family.

I have spent the last 5 years on the NICE Guideline Development Committee, developing a guideline for the management of people with AAA. The results of several large trials comparing open and endovascular repair of AAA are consistent that while endovascular repair and open repair are safe (meaning very few people die from them), endovascular repair is safer by a small margin and gets people out of hospital and back to normal substantially more quickly than open surgery. However the longer term outcomes are not as good and beyond about 7 years, more people are dead after endovascular repair than after open repair. Because of this, endovascular repair is not cost effective, meaning the opportunity cost of providing it is too great and at a population level offering endovascular repair causes harm. Putting aside arguments about the contemporary relevance or methodological detail of the evidence, the only possible conclusion is that endovascular repair should not be undertaken if someone can have an open operation.

There are several problems with accepting this analysis. One is that it requires a belief that savings made in one place in the healthcare economy will be realised in a benefit elsewhere: something called Pareto efficiency. This might be an intellectual leap too far for some in the NHS of 2020. But perhaps the biggest issue that it is a cold joyless analysis – a faceless functional accounting, the reduction of individual encounters to marks on a Kaplan-Meier chart. It is the science in medicine, but medicine is more than science. It’s an art. For me some of the joy of practicing medicine is in this art: the ability to synthesise the evidence into a narrative a patient can engage with, helping them work out the best option. What do I do then, when having done this, my patient’s preferred option is not cost effective, when the art and the science collide? How do I decide between the interests of a real person sitting before me, vulnerable, perhaps anxious, who trusts me to make decisions with them, for them and in their best interests and the interests an unknown person (or group) with whom I have no relationship – the people who will theoretically benefit if I choose the science over the art. How do I decide between my patient and society?

Since the publication of the draft NICE guidance on AAA, which recommended against endovascular repair partly on the basis of cost effectiveness arguments, I have defended and explained the decisions the guideline committee made at conferences, in conversations and in print. I have posed questions to conference panellists who were challenging the guideline about whether they think cost effectiveness is an important consideration when deciding a therapy and received frequently unconvincing responses. But in the back of my mind, I’m questioning: are they right? Are the unseen consequences of my clinical decisions (for unknown people) my responsibility or are these too distant from me to consider. 

Within the contexts by which NICE asks its committees to make decisions, the answer is clear: they are not too distant, and must be taken into account. But while it may be the right thing to do, to follow the science and deny treatments that are not cost effective, it can feel wrong. It’s a depressing analysis to frame the future for individual people in terms of population outcomes. Individual characteristics, ambitions, concerns and expectations, love, beauty and hope are subordinated to the inevitable logic of the data. This feels like a betrayal of the doctor-patient relationship which is ultimately a personal one: and guidelines are implemented at a personal level, patient by patient. 

This is not a new dilemma, either in medicine or in economics in general. It is a version of ‘the tragedy of the commons’. To some extent patients, the public and physicians understand it, in the general acceptance of triage in emergency departments, or waiting lists for elective treatment. But the idea of not offering treatments at all, solely on the basis of a cost effectiveness calculation, seems to be too much for many people in their role as clinicians or patients, even if it makes sense in their role as taxpayers. In fact it is probably impossible (and certainly not desirable) for clinicians to make bedside judgements on the basis of cost effectiveness, not only because of how it makes them feel, but also because it would undermine the trust central to the relationship with their patient. Solutions to the dilemma attempt to constrain the options available to clinicians either by incentivising certain therapies, or by limiting choice to cost effective options only (by either not funding the alternatives or by creating guidelines). In order to allow these solutions, clinicians need to accept that some decisions are taken out of their hands. But in doing this, it can seem as if the art in their practice is reduced to a near irrelevance. Perhaps this, then, is one of the reasons for the criticism, even resentment, of some of NICE’s draft AAA guidance.

Where does this leave us? We are caught in the cleft stick of increasingly costly technological advances in healthcare, wanting to offer them to our patients where appropriate, but understanding that ultimately resources are finite. We will need to face this as a society and as individual clinicians sooner or later unless healthcare costs are to escalate uncontrollably. We surely need to understand that the technical advances that interest us may not be in the best interests of society at large, and accept this where it is the case. We need to allow trusted organisations to make these decisions for us, within an open and transparent process, and we need to allow that the art in medicine (and our joy in practising it) is retained but refocussed to help our patients navigate their therapy choices within the constraints imposed on us by those trusted organisations. NICE’s failure to stand firm on its principles in respect of this aspect of the AAA draft guidance sets an unfortunate precedent and makes these issues more difficult, not less.

My patient returns to clinic. He has spoken with his family and his wife. He wants an endovascular repair. Cognitive dissonance rages within me. I take a deep breath in, and begin….