Sustainability and Transformation Plans in the English NHS

Sustainability and Transformation Plans (STPs) are the latest in a long line of approaches to strategic health care planning over a large population footprint. These latest iterations were based on a one million plus population, looked at a five year timescale, were led by local partners (often acute trusts, but sometimes, as in Birmingham and Solihull, by the Local Authority), and focused inevitably on financial pressures. The plans were published in December 2016 and now the challenge to the STP communities is further refinement of the plans and, of course, implementation.

The Health Service Journal (HSJ) reviewed the content of the STPs in November 2016 and highlighted three common and unsurprising areas of focus: further development of community based approaches to care (notably aligned to the New Models of Care discussed in the CLAHRC WM News Blog of 27 January; see also https://www.england.nhs.uk/ourwork/new-care-models/); reconfiguration of secondary and tertiary services; and sharing of back office and clinical support functions. More interestingly, the HSJ noted an absence of focus on social care, patient/ clinical/ wider stakeholder engagement and on prevention and wellbeing.

The King’s Fund has produced two reviews of how STPS have developed in November 2016 and February 2017. These have been based on interviews with the same sub set of leaders , as well as other analyses. Both have reached similar conclusions. Recommendations have included the need to: increase involvement of wider stakeholders; strengthen governance and accountability arrangements and leadership ( including full time teams ) to support implementation; support longer term transformation with money, e.g. new models of care, not just short term financial sustainability; stress-test assumptions and timescales to ensure they are credible and deliverable, then communicate with local populations about their implementation honestly; and finally, align national support behind their delivery, e.g. support, regulation, performance management and procurement guidance.

A specific recommendation relates to the need to ensure robust community alternatives are in place before hospital bed numbers are reduced. The service has received strong guidance about this latter point from NHS England in the last few weeks. Various other Thinktanks have also produced more or less hopeful commentaries on STPs, such as Reform, The Centre for Health and Public Interest and the IPPR; they all say they cannot be ignored.

Already, in March 2017, the context is shifting: yet again, ‘winter pressures’ have been high profile and require a NHS response; the scale of the social care crisis has become even more prominent; there is a national push to accelerate and support change in primary care provision.

Furthermore, the role of CCG is changing in response: some are merging to create bigger population bases which may or may not be the same as STP geography; some GP leaders are moving into the new primary care provider organisations; the majority of CCGs will be ‘doing their own’ primary care commissioning for the first time just as the pace of primary care change is increasing; some commissioning functions may shift to new care models such as accountable care arrangements. It is clear that for some geographies and services the STP approach could work, but more local and more national responses to specific services and in specific places will continue to be needed. All these issues will influence how the STPs play out in the local context.

— Denise McLellan

Clinical Research Stands Out Among Disciplines for Being Largely Atheoretical

A recent paper in the BMJ (see our recent Director’s Choice) described the (null) result in a RCT of physiotherapy for ankle injury.[1] The broader implications of this finding were discussed in neither the discussion section of the paper itself, nor in the accompanying editorial.[2] The focus was confined entirely on the ankle joint, with not a thought given to implications for strains around other joints. The theory by which physiotherapy may produce an effect, and why this might apply to some joints and not others, did not enter the discourse. The ankle joint study is no exception, such an atheoretical approach is de rigour in medical journals, and it seems to distinguish clinical research from nearly everything else – most scientific endeavours try to find out what results mean – they seek to explain, not just describe. Pick up an economics journal and you will find, in the introduction, an extensive rationale for the study. Only when the theory that the study seeks to explicate has been thoroughly dealt with do the methods and results follow. An article in a physics journal will use data to populate a mathematical model that embodies theory. Clinical medicines’ parent discipline – the life sciences – are also heavily coloured by theory – Watson and Crick famously built their model (theory) entirely on other researchers’ data.

The premise that theory features less prominently in medical journals compared to the journals of other disciplines is based on my informal observations; my evidence is anecdotal. However, the impression is confirmed by colleagues with experience that ranges across academic disciplines. In due course I hope to stimulate work in our CLAHRC, or with a broader constituency of News Blog readers, to further examine the prominence given to theory across disciplines. In the meantime, if the premise is accepted, contingent questions arise – why is theory less prominent in medicine and is this a problem?

Regarding the first point, it was not ever thus. When I was studying medicine in the late 1960s / early 1970s ‘evidence-based medicine’ lay in the future – it was all theory then, even if the theory was rather shallow and often implicit. With the advent of RCTs and increased use of meta-analysis it became apparent that we had often been duped by theory. Many treatments that were supported by theory turned out to be useless (like physiotherapy for sprained ankles), or harmful (like steroids for severe head injury). At this point there was a (collective) choice to be made. Evidence could have been seen as a method to refine theory and thereby influence practice. Alternatively, having been misdirected by theory in the past, its role could have been extirpated (or downgraded) so that the evidence became the direct basis for practice. Bradford Hill, in his famous talk,[3] clearly favoured the former approach, but the profession, perhaps encouraged by some charismatic proponents of evidence-based medicine, seems to have taken the second route. It would be informative to track the evolution of thought and practice through an exegesis of historical documents since what I am suggesting is itself a theory – albeit a theory which might have verisimilitude for many readers.

But does it matter? From a philosophy of science point of view the answer is ‘yes’. Science is inductive, meaning that results from one place and time must be extrapolated to another. Such an extrapolation requires judgement – the informed opinion that the results can be transferred / generalised / particularised across time and place. And what is there to inform such a judgement but theory? So much for philosophy of science, but is there any evidence from practice to support the idea that an atheoretical approach is harmful? This is an inevitably tricky topic to study because the counterfactual cannot be observed directly – would things have turned out differently under an imaginary counterfactual where theory was given more prominence? Perhaps, if theory had been given more weight, we would have extrapolated from previous data and realised earlier that it is better to treat all HIV infected people with antivirals, not just those with supressed immune systems.[4] Likewise, people have over-interpreted null results of adjuvant chemotherapy in rare tumours when they could have easily ‘borrowed strength’ from positive trials in more common, yet biologically similar, cancers.[5] [6]

In the heady days of evidence-based medicine many clear cut results emerged concerning no treatment versus a proposed new method. Now we have question inflation among a range of possible treatments and diminishing headroom for improvement – not all possible treatments can be tested across all possible conditions – we are going to have to rely more on network meta-analyses, database studies and also on theory.

Richard Lilford, CLAHRC WM Director

References:

  1. Brison RJ, Day AG, Pelland L, et al. Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial. BMJ. 2016; 355: i5650.
  2. Bleakley C. Supervised physiotherapy for mild or moderate ankle sprain. BMJ. 2016; 355: i5984.
  3. Hill AB. The environment and disease: Association or causation? Proc R Soc Med. 1965; 58(5): 295-300.
  4. Thompson MA, Aberg JA, Hoy JF, et al. Antiretroviral Treatment of Adult HIV Infection. 2012 Recommendations of the International Antiviral Society – USA Panel. JAMA. 2012; 308(4): 387-402.
  5. Chen Y-F, Hemming K, Chilton PJ, Gupta KK, Altman DG, Lilford RJ. Scientific hypotheses can be tested by comparing the effects of one treatment over many diseases in a systematic review. J Clin Epidemiol. 2014; 67: 1309-19.
  6. Bowater RJ, Abdelmalik SM, Lilford RJ. Efficacy of adjuvant chemotherapy after surgery when considered over all cancer types: a synthesis of meta-analyses. Ann Surg Oncol. 2012; 19(11): 3343-50.

 

Physiotherapy – No Use in Ankle Sprain Injury

As touched upon in the main Director’s Blog, Robert Brison and colleagues recently conducted a randomised controlled trial of physiotherapy for ankle sprain injury.[1] The result is entirely null. The paper concentrates only on the ankle, not mentioning potential implications beyond this single joint. This broader picture is also ignored in the accompanying editorial.[2] So solipsistic is the attention on the ankle that the broader question about the role of physiotherapy in sprains is not discussed. The interesting question now is to evaluate the role of physiotherapy across a wide range of joint injuries – this is an excellent opportunity for a multiple indication review.[3] I am looking for collaborators who might want to take on such a task.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Brison RJ, Day AG, Pelland L, et al. Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial. BMJ. 2016; 355: i5650.
  2. Bleakley C. Supervised physiotherapy for mild or moderate ankle sprain. BMJ. 2016; 355: i5984.
  3. Chen Y-F, Hemming K, Chilton PJ, Gupta KK, Altman DG, Lilford RJ. Scientific hypotheses can be tested by comparing the effects of one treatment over many diseases in a systematic review. J Clin Epidemiol. 2014; 67: 1309-19.

Worm Wars Continued

We have discussed results of deworming before and argued that it is important to treat at cluster level because of rapid re-infection from reservoirs in soil. A recent important meta-analysis compares deworming targeted at children versus a community-wide intervention.[1] It finds that community-wide approaches are more effective than treatment targeted at children for roundworms (Ascaris) and hookworms (Ancylostoma), but not whipworms (Trichuris). This finding is consistent with the much greater efficiency of the medicine in the former two worm types. The relative effect was greater in roundworms (odds ratio >16) than the more dangerous hookworms (OR >4), consistent with the shorter life-span of hookworm eggs than of roundworm eggs. These are important findings, but there is a worry that resistance may emerge with mass treatment. It would be interesting to see whether any studies have been done in slum populations specifically.

— Richard Lilford, CLAHRC WM Director

Reference:

  1. Clarke NE, Clements ACA, Doi SA, et al. Differential effect of mass deworming and targeted deworming for soil-transmitted helminth control in children: a systematic review and meta-analysis. Lancet. 2017; 389: 287-97.

A Device for Failing Hearts

Back in 2005 I was approached by Sally Davies, then languishing as deputy director general of Research and Development, and asked to evaluate the utility of a trial of left ventricular assist devices (LVADs) for heart failure. We elicited a Bayesian prior from a chapter of surgeons from the American Society of Heart Surgeons. This prior was the basis for a value of information study,[1] which suggested that expensive LVAD technology might be a bridge too far for the hard-pressed NHS. Anyway, the world moves on and the New England Journal of Medicine has recently carried out a trial comparing two different LVADs, one more sophisticated (type 3) than the original version we studied (type 2).[2] The latest version had less problems with clotting up of the device, but survival free of a serious stroke at six months was similar, at over 80% in both groups – quite high considering how sick these patients were. The article has some extremely good diagrams explaining the devices. These devices are sometimes used to rest the heart, for example in a case of inflammation of the heart muscle. Most often they are used when the heart muscle packs up permanently, say as a result of heart attacks. In that case LVADs can be used to keep a person alive until a match can be found for a heart transplant, so called ‘bridge to transplant’, or as a permanent solution. However, I think the devices are themselves a bridge to a more subtle regenerative medicine approach based on stem cells.

— Richard Lilford, CLAHRC WM Director

References:

  1. Girling AJ, Freeman G, Gordon JP, Poole-Wilson P, Scott DA, Lilford RJ. Modeling payback from research into the efficacy of left-ventricular assist devices as destination therapy. Int J Technol Assess Health Care. 2007; 23(2): 269-77.
  2. Mehrea MR, Naka Y, Uriel N, et al. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. New Engl J Med. 2017; 376: 440-50.

Keeping a Child Back at School

We have often talked about Hattie’s work on evidence-based education.[1-4] Now we turn to retention (pages 97-99) – the act of keeping a child back and having them repeat a year of school on the grounds of poor performance.[5] Numerous papers, including a meta-analysis of 20 studies,[6] have shown retention to be associated with negative effects for the retained student. In subsequent years they have lower scores for a whole range of subjects: language, arts, reading, mathematics, work-study skills, and social studies, as well as social and emotional adjustment and behaviour, self-concept, and attitude to school. So a picture is starting to emerge – remember streaming is also unhelpful.[7] So any act that demeans a child or destroys her self-confidence is bad, while bright children are not held back by having less bright peers in the classroom. See also our News Blog on the Michelle Obama effect.[8]

— Richard Lilford, CLAHRC WM Director

References:

  1. Lilford RJ. Evidence-based Education. NIHR CLAHRC West Midlands News Blog. 24 February 2017.
  2. Lilford RJ. The School, the Teacher of the Pupil – Which is Most Important? NIHR CLAHRC West Midlands News Blog. 28 October 2016.
  3. Lilford RJ. Ask Not to Whether, But Why, Before the Bell Tolls. NIHR CLAHRC West Midlands News Blog. 29 July 2016.
  4. Lilford RJ. Education Update. NIHR CLAHRC West Midlands News Blog. 2 September 2016.
  5. Hattie J. Visible Learning: A Synthesis of Over 800 Meta-Analyses Relating to Achievement. Oxon, UK: Routledge, 2009.
  6. Jimerson SR. Meta-analysis of Grade Retention Research: Implications for Practice in the 21st Century. School Psychol Rev. 2001; 30(3): 420-37.
  7. Lilford RJ. Evidence-Based Education (or How Wrong the CLAHRC WM Director Was). NIHR CLAHRC West Midlands News Blog. 15 July 2016.
  8. Lilford RJ. More on Education. NIHR CLAHRC West Midlands News Blog. 16 September 2016.

Scientists Should Not Be Held Accountable For Ensuring the Impact of Their Research

It has become more and more de rigour to expect researchers to be the disseminators of their own work. Every grant application requires the applicant to fill in a section on dissemination. We were recently asked to describe our dissemination plans as part of the editorial review process for a paper submitted to the BMJ. Only tact stopped us from responding, “To publish our paper in the BMJ”! Certainly when I started out on my scientific career it was generally accepted that the sciences should make discoveries and journals should disseminate them. The current fashion for asking researchers to take responsibility for dissemination of their work emanates, at least in part, from the empirical finding that journal articles by themselves may fail to change practice even when the evidence is strong. Furthermore, it could be argued that researchers are ideal conduits for dissemination. They have a vested interest in uptake of their findings, an intimate understanding of the research topic, and are in touch with networks of relevant practitioners. However, there are dangers in a policy where the producers of knowledge are also held accountable for its dissemination. I can think of three arguments against policies making scientists the vehicle for dissemination and uptake of their own results – scientists may not be good at it; they may be conflicted; and the idea is based on a fallacious understanding of the normative and practical link between research and action.

1. Talent for Communication
There is no good reason to think that researchers are naturally gifted in dissemination, or that this is where their inclination lies. Editors, journalists, and I suppose blog writers, clearly have such an interest. However, an inclination to communicate is not a necessary condition for becoming an excellent researcher. Specialisation is the basis for economic progress, and there is an argument that the benefits of specialisation apply to the production and communication of knowledge.

2. Objectivity
Pressurising researchers to market their own work may create perverse incentives. Researchers may be tempted to overstate their findings, or over interpret the implications for practice. There is also a fine line to be drawn between dissemination (drawing attention to findings) and advocacy (persuading people to take action based on findings). It is along the slippery slope between dissemination and advocacy that the dangers of auto-dissemination reside. The vested interest that scientists have in the uptake of their results should serve as a word of caution for those who militantly maintain that scientists should be the main promotors of their own work. The climate change scientific fraternity has been stigmatised by overzealous scientific advocacy. Expecting scientists to be the bandleader for their own product, and requiring them to demonstrate impact, has created perverse incentives.

3. Research Findings and Research Implications
With some noble exceptions, it is rare for a single piece of primary research to be sufficiently powerful to drive a change in practice. In fact replication is one of the core tenets of scientific practice. The pathway from research to change of practice should go as follows:

  1. Primary researcher conducts study and publishes results.
  2. Research results replicated.
  3. Secondary researcher conducts systematic review.
  4. Stakeholder committee develops guidelines according to established principles.
  5. Local service providers remove barriers to change in practice.
  6. Clinicians adapt a new method.

The ‘actors’ at these different stages can surely overlap, but this process nevertheless provides a necessary degree of detachment between scientific results and the actions that should follow, and it makes use of different specialisms and perspectives in translating knowledge into practice.

We would be interested to hear contrary views, but be careful to note that I am not arguing that a scientist should never be involved in dissemination of their own work, merely that this should not be a requirement or expectation.

— Richard Lilford, CLAHRC WM Director

More on Brain Health in Young Children and Effect on Life Course

Brain health in early childhood is a recurring theme of your News Blog. Peter Chilton referred me to an interesting article in Nature Human Behaviour published at the end of last year.[1] This study was based on a prospective study of children in the South Island of New Zealand. The investigators wanted to determine the prognosis for the 20% of the population with the worst brain health indicators at age three. These indicators include single parent family; low socioeconomic group; poor self-control; and low IQ. Outcome variables covered a range of important economically burdensome outcomes, such as obesity, cigarette smoking, and crime. These variables were harvested from various databases where health and crime statistics are recorded. A 20% ‘segment’ of this young population could be defined which predicted 80% of crime, and similar high rates on other outcomes. This 20:80 ratio, called the Pareto ratio, is often encountered in social science – for example, wealth distributes itself roughly in this proportion across many societies (about 20% of people control 80% of wealth). The authors say that their study shows plenty of ‘headroom’ for preventive interventions. That is to say, society could achieve massive gains if health and social outcomes among the highest risk segment could be improved to average levels. We have discussed interventions, such as early childhood education, before.[2-4] Many studies show statistically significant and economically worthwhile results for such interventions, but the gains come nowhere near the theoretical headroom defined here. Likely this is because brain health at age three is only partly the result of remediable factors.

— Richard Lilford, CLAHRC WM Director

References:

  1. Caspi A, Houts RM, Belsky DW, Harrington H, Hogan S, Ramrakha S, Poulton R, Moffitt TE. Childhood forecasting of a small segment of the population with large economic burden. Nature Hum Behav. 2016; 1: 0005.
  2. Lilford RJ. Pregnancy before age 16 – dropping quite rapidly from a peak in 1997. NIHR CLAHRC West Midlands News Blog. February 10, 2017.
  3. Lilford RJ. If you want to reduce partner violence or teenage pregnancy, then teach algebra and history? NIHR CLAHRC West Midlands News Blog. December 9, 2016.
  4. Lilford RJ. Evidence-based education (or how wrong the CLAHRC WM Director was). NIHR CLAHRC West Midlands News Blog. July 15, 2016.

The Increasing Codification and Transparency of Hospital Practice

Ah the halcyon days, when at the age of 26 I was the most senior obstetrician on site in a huge high-risk hospital. How times have changed. Now a fully accredited specialist must be on hand, she must follow check-lists, and cognitive aids will try to pre-empt errors.[1] And now we hear that she will be under video-surveillance for a substantial portion of her working life.[2] Of course all of this is a good thing – codification reduces error in all industries. And we must also realise that codification does not mean that the need for judgement is vitiated, or that medicine cannot still be fun and even heroic, as we have argued before.[3] And transparency is also no bad thing; as it punishes those who transgress so it exonerates the many who are falsely accused.

— Richard Lilford, CLAHRC WM Director

References:

  1. Merry AF, Mitchell SJ. Advancing Patient Safety Through the Use of Cognitive Aids. BMJ Qual Saf. 2016; 25(10):733-5.
  2. Joo S, Xu T, Makary MA. Video transparency: a powerful tool for patient safety and quality improvement. BMJ Qual Saf. 2016; 25: 911-3.
  3. Lilford RJ. Can We Do Without Heroism in Health Care? NIHR CLAHRC West Midlands News Blog. March 20, 2015.

Stem Cells for Stroke – Still a Long Way Off

The Lancet recently reported the results of stem cell therapy given six months or more after a hemiplegic stroke in eleven subjects.[1] A small degree of functional improvement was noted but in the absence of contemporaneous controls no firm cause and effect conclusion is possible – no dramatic effect here, such that such controls are not needed. An interesting question concerns the design of a proper trial – should the controls undergo a sham procedure? I am opposed to sham surgery trials involving more than minimal risk of harm for reasons spelled out elsewhere.[2] In the meantime, acute embolectomy is a highly effective treatment and the NHS needs to urgently reconfigure services to accommodate this new technology, as argued previously.[3] [4]

— Richard Lilford, CLAHRC WM Director

References:

  1. Borlongan CV. Age of PISCES: stem-cell clinical trials in stroke. Lancet. 2016; 388: 736-8.
  2. Wolf BR & Buckwalter JA. Randomized Surgical Trials and “Sham” Surgery: Relevance to Modern Orthopaedics and Minimally Invasive Surgery. Iowa Orthop J. 2006; 26: 107-11.
  3. Lilford RJ. Meta-analysis of emergency embolectomy for acute thrombotic stroke. NIHR CLAHRC West Midlands News Blog. September 2, 2016.
  4. Lilford RJ. First the heart, now the brain. NIHR CLAHRC West Midlands News Blog. April 10, 2015.