How medicine is broken, and how we can fix it
BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h3397 (Published 23 June 2015) Cite this as: BMJ 2015;350:h3397
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I applaud last week's editorial on this subject and agree with the points made about the need to clean up the act when it comes to the evidence base for modern medical practice. If medicine is, as I hope, to have its roots in science and ethics then it is vital we pursue this agenda. One thing worries me greatly though. Most of the research agendas seem to be set by a brigade whose basic science has not taken into account what has happened in biology since the turn of the millennia. It is as if we are still practising Newtonian mechanics to model a quantum universe. And just as physicists struggled with weird new realities it's time for medicine to open to the new biology. Several areas of paradigm changing science prompt me to make the point. And they are all potential game changers when it comes to our conception of the pathological basis of disease.
According to the prevailing models when I was a student, one gene equals one protein and one mutated gene one faulty protein one disease. It's emerging that this is ridiculously simplistic and, although getting dealt a duff hand genetically is bad news, it's perhaps how the cards are played which is more important. Epigenetics is being increasingly factored into evidence based mechanistic reasoning, and ways are being developed to accommodate this into epidemiology. At the cellular level it's gene expression that governs function and factors which govern expression now seem a lot more complex and modifiable than previously imagined thought. It's even the case that DNA methylation due to environmental exposures can create heritable changes (1) a small vindication of Lamarkism in a sense. Quests for simple gene coding solutions to complex health problems abound but seem unlikely to bear real fruit.
We learnt about Koch's postulates with reference to microbial causes of disease. You need to isolate and culture the culprit and prove infectivity. The Human Microbiome project is uncovering astonishing things about the degree of symbiosis with microbes in our bodies. How much of our metabolism is done and controlled by bugs and they swap genes with each other and us? Some disease may well be down to dysbiosis a faulty ecology rather than an infection.(2)
The hypothalamic – pituitary – adrenal axis is a big player in health at every level and the vagus nerve and important purveyor of sensory as well as afferent signals. Practitioners of hypnotherapy, mindfulness and yoga have something to teach us about the applied science here.
Investigations such as heart rate variability measures provide interesting inroads into ways to harness these practices as effective therapies. (3)
Physiological mechanisms of placebo effects are a fascinating area of study and as well as yielding powerful therapeutic benefits are illuminating mechanisms of healing.(4)
And then of course there is food. We have looked endlessly and confusingly at single changes in micro and macro nutrients when real people eat whole diets. Whole diets are hard to study but not impossible and there is already a body of evidence pointing to a diet based mainly on a huge variety of whole plants being a very good starting point.(5). Since it seems to be poor people in rich countries who suffer most in this regard the implications for primary care cannot be ignored.
I am not suggesting we abandon the prospective double blind placebo controlled trial of single interventions, just recognise its limitations. If we remain blind to the concept of synergy and doggedly ignore the reality that humans are evolved and evolving creatures rather than assembled mechanisms, we cannot approach a systems view in both research and practice and will cease to be of service. The goal of turning medicine into a science will remain as illusive as ever.
In my own practice I feel I am already failing because of my inability to apply my conceptual knowledge of synergy and ecology. “Why do none of the painkillers work doctor?” “I have tried every diet why can I not lose weight?” . I feel what I teach people in consultations is far more important than what I do to or for them. But I need better knowledge based on, as Goldacre and Heneghan aptly describe - more than speculations derived from superficially plausible narratives. On good days this feels exciting! The future of medicine will certainly be fascinating but we need to very clever about how and what kind of knowledge we invest in in order to reap meaningful rewards.
1. Carey,N. (2011) The Epigenetics revolution. Faber and Faber.
2. Enders,G. (2014) Gut. Scribe publications.
3. Morrice, A. (2015)The Mind -Body Connection course notes book. Human Givens College
4. Benedetti, F. (2008) Placebo effects: understanding the Mechanism in Health and Disease
5. Campbell, TC. (2014) Whole . Rethinking the Science of Nutrition. BenBella Books.
Competing interests: No competing interests
You cannot "fix" it.
Randomised controlled trials and meta-analyses are fine in principle. But, as fellow readers know, there are constant controversies about every trial.
As for NICE. - it was a good idea, until , instead of merely looking at the value of a drug to the individual patient, this worthy body started to consider the cost to the exchequer. Also, the Ministers over-ruled NICE, at least once, if newpaper reports were correct.
Now the CMO is appealing to the Academy. Yet another parliament of GREAT (WO)MEN. More committee meetings, more money spent on cheese and pickle sandwiches washed down with a pint of bitter, and more clinical time away from the patients ( I almost said, "away from the coal-face).
Peer reviews? Are the peer reviewers free from biases, conflicts of interest?
No, there cannot be a real fix. We can try. If the doctor is given the time to discuss with the patient the illness, the cause, the cure, the amelioration.
And finally, if the doctor offers to the patient just what (s)he would offer himsels ( herself).
Competing interests: Old. Might need medicine, preferably unbroken
“What we need to do is change the nature of the contact we have between health professionals and the public. This can only be done by encouraging their natural urge to self diagnose and is best started as early as possible” and it will immediately put an end to the myth of “Shaken Baby Syndrome.”
Competing interests: No competing interests
This is not so much a specific response to Ben Goldacre and Carl Heneghan's editorial as a general comment on the fact that we are looking in the wrong place to find where medicine is broken. It is broken because we have failed to analyse and challenge the often simplistic contract we have with patients. Increasingly the public are being fed an unhealthy diet of quick fixes (witness the almost daily headlines in the Mail about another pill to cure everything), medical consumerism, rights based medicine, wonder pills all washed down with relatively tiny amounts of advice about diet and exercise. We are constantly regaled by patients who have decided on their diagnosis and who 'want it sorted'. Seven day working will probably fuel this need for immediate answers to problems for which there is often no solution or which will resolve spontaneously. People's sense of normal has narrowed so much that it could easily be replaced by perfection.
What we need to do is change the nature of the contact we have between health professionals and the public. This can only be done by encouraging their natural urge to self diagnose and is best started as early as possible. So, we should not chastise this who use google doc but encourage them and act as educators and explainers. Alongside that we need to educate a new generation of youngsters to understand that normal includes birth, death, illness, woe, setbacks, periods of feeling low and also great joy. Most of these things do not need a diagnosis, a pill or a visit to a GP or emergency department. They are normal. Until we can replace patient's narrow perception of normal with 'Life' we will be beset with increasing demand.
At facts4life we are pioneering a project aimed at harnessing children's natural interest in their bodies and illness to drive a cross-curricluar approach to illness and health which allows them to see illness in its social, geographical and historical setting (amongst others). Our recent pilot with Gloucestershire CCG and the University of the West of England with 180 children using a resource about illness has shown we can alter 8 and 9 year olds' attitudes to illness (personal communication from UWE colleagues - data in process of analysis*) and whether they need medicine of doctors for minor ailments. Hopefully in our next roll-out - we have funding from Gloucestershire CCG for three years aiming to reach 128 schools - we can tackle attitudes to mental health and more significant illnesses. It works because we give children the permission and save forum in which to ask these questions. Surely, this is the way to go?
Why isn't the education of children (everyone?) about illness seen a pressing need by the medical profession and a human right by the public, media and politicians. Have we been lazy or irresponsible in allowing so many to feel that so much can be cured by so little (a pill)? The information is out there (it's known); it's possible with some thought to pre-package the knowledge (it's knowable); people self-diagnose anyway (they want to know more) and it would help if they knew more about illness so we could have a more collaborative approach to healthcare and so our interactions were more meaningful and useful for all.
* below pre-pilot results showing shift in attitudes over six weeks of the course - not analysed statistically
Competing interests: No competing interests
The authors suggest, "If we incentivise shared decision making then—for the same financial outlay—best practice will be recognised, rewarded, and laid down in the everyday templates of what doctors do"
Shared decision making (SDM) is just one aspect of patient (or person/ relationship) centred care and it involves the integration of clinical evidence and patient preferences. There is little doubt that medicine would be better for being more patient-centred [1].
In general practice decisions are made continually, with and about patients, all the time. Only some decisions are about treatment and the NHS SDM website has SDM aids for only 36 out of the thousands of conditions that GPs see.
The first problem with the authors’ proposal is ‘which decisions should be incentivised: only those for which decision-aids exist, all decisions, or something in between?’ Some decisions are more important than others and SDM making is more important for some decisions and for some people, than others [2].
The second problem is, ‘who is able to judge whether shared-decision making has taken place?’ Patients and doctors are both poor judges compared with objective assessments which involve experts observing the consultation, which is not feasible in practice [3].
A third problem is how to record shared-decision making. The use of electronic templates to gather data for QoF have shifted consultations from being patient-centred to computer-centred [4]. The more time we spend recording SDM, the less time we have to actually do it.
A skilful consultation is an act of improvisation, in which the doctor explores the patient’s story, responding to cues, context and prior knowledge [5]. A patient-centred consultation may uncover a great deal that is of profound importance but may involve no decisions [6].
What patients want, and need is doctors who are flexible and can improvise, adapting to their needs, including their need for shared decision making. Better training, including on-going support and supervision, more time with patients, less computer-centred demands and better continuity of care can all help, but I doubt very much that SDM can be incentivised in general practice.
1 Wood S, Collins A, Taylor A. Is the NHS becoming more patient-centred? 2015. http://www.health.org.uk/public/cms/75/76/313/5549/IsTheNHSBecomingMoreP...
2 Ford S, Schofield T, Hope T. Are patients’ decision-making preferences being met? Health Expect 2003;6:72–80.http://www.ncbi.nlm.nih.gov/pubmed/12603630 (accessed 25 Jun2015).
3 Ford S, Schofield T, Hope T. Observing decision-making in the general practice consultation: who makes which decisions? Health Expect 2006;9:130–7. doi:10.1111/j.1369-7625.2006.00382.x
4 Swinglehurst D, Greenhalgh T, Roberts C. Computer templates in chronic disease management: ethnographic case study in general practice. BMJ Open 2012;2:e001754 – . doi:10.1136/bmjopen-2012-001754
5 Haidet P. Jazz and the ‘art’ of medicine: improvisation in the medical encounter. Ann Fam Med 2007;5:164–9. doi:10.1370/afm.624
6 Launer J. Patient choice and narrative ethics. Postgrad Med J 2014;90:484. doi:10.1136/postgradmedj-2014-132866
Competing interests: No competing interests
Ben Goldacre’s and Carl Hengan’s points are well made [1]. However, a major cause of the problem is that current EBM methods are inadequate [2]. The conventions of evidence for identifying patients who benefit from treatment need to be strengthened, so that there is less scope for opinion affected by conflicts of interest. The way that current EBM assesses diagnostic tests is flawed, usually based on misapplication of concepts such as ‘specificity’. This index should be used only for the preliminary assessment of screening tests.
Tests also need to be assessed and compared for their ability to predict treatment benefit (and harm), for their performance as necessary and sufficient diagnostic criteria, for their use as diagnostic leads (short lists of differential diagnoses are best) and by their ability to differentiate between such differential diagnoses (with ratios of ‘sensitivities’). They should also be assessed for their ability to monitor disease progress and predicting patients’ well being. Many of these methods are explained to students (some hopefully will become more mathematically literate than current seniors) in the Oxford Handbook of Clinical Diagnosis [3].
The necessary research to collect such ‘practice-based evidence’ can be done during day to day care by the intelligent use of clinical guidelines and treatment cut-off points [2]. The required software is already available in primary care. It could be used to assess new tests and treatments (and less of doctors). The research would be independent of commercial organisations, but supported indirectly by them, reducing dramatically their research costs.
References
1. How medicine is broken, and how we can fix it. 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h3397 (Published 23 June 2015) Cite this as: 2015;350:h3397.
2. Llewelyn H. The way forward from “rubbish” to “real” EBM in the wake of Evidence Live 2015. http://blogs.bmj.com/bmj/2015/04/28/huw-llewelyn-the-way-forward-from-ru...
3. Llewelyn H, Ang HA, Lewis K, Al-Abdullah A. Oxford Handbook of Clinical Diagnosis 3rd edition. Oxford University Press, 2014, pp 615-642.
Competing interests: No competing interests
Goldacre and Heneghan make some good points, and important pleas for better independent and unbiased research. They state "Such trials can practically be delivered only by reducing the expensive and disproportionate regulatory burden, embedding them in everyday clinical care and gathering follow-up data from existing electronic health records." But where will the funding come from ?
As is the current fashion, they attack aspects of the current GP Quality and Outcomes Framework (QOF) especially their bete-noir (12) - mass Statinisation. "If instead we incentivise shared decision making then—for the same financial outlay—best practice will be recognised, rewarded, and laid down in the everyday templates of what doctors do." Much easier said than done !!
McShane and Mitchell (3) continue the extensive critique of QOF but fall very short on practicable proposals. Criticism of GP pay-for-performance is easy. Most GPs hate it, and would rather be paid a lump sum and trusted to do a caring curing job. They want to be 'patient-centred' and not be 'ticking boxes'. But QOF has considerably improved reported measures of an agreed set of evidence-based health interventions (processes). It is very difficult to come up with measurable outcomes by which to judge GP performance as opposed to population disadvantage. QOF has always permitted exceptions on grounds of patient unsuitability, and informed dissent.
McShane and Mitchell claim that "Although the difference in performance on the QOF between least and most deprived GP practices has narrowed considerably, no evidence shows that this has led to a reduction in health inequalities." This is perverse reading of the referenced King's Fund paper. Deprivation is clearly a major determinant of disease and health inequality. And outcome improvements are easier to achieve in the English Shires, than the Welsh Valleys or Inner Cities. Tudor-Hart's Inverse-Care Law still rules. For example, the QOF prevalence adjustment initially rewarded the Shires and penalised the deprived valleys. Reviewing the King's Fund paper ( the reference quoted) has clearly shown that once the perverse prevalence adjustment was abandoned, inequalities have narrowed. More importantly, this King's Fund study shows that health outcomes have improved in most of the incentivised domains, but the improvement was slower in deprived areas. With the incoming tide all floatable boats rise, but some quicker than others. The paper also makes it clear that well-resourced practices in deprived areas do better, and deprived practices in healthy areas do worse, when it comes to avoidable admissions. QoF COPD care correlates particularly well, but Asthma management does not. The likely reasons are clear.
The rate of improvement has plateaud, argued McShane. Necessarily so , as all practices approach the ceiling !
We need to praise and improve QoF successes, not bury it. Here are two proposals
Improved Exception reporting.
eg: in the case of statin prescription , we could record allergy, side-effects etc under 'unsiutability', and 'person-centred care' under informed dissent.
Improved reporting of Outcomes.
eg: trends in CHD, Stroke etc could be mapped against the process measures, practice by practice.
Thus, QoF funding could quickly provide us with the unbiased reliable and credible information needed on Statins, within a year or two. NICE could agree a list of important, relevant and answerable research questions, with our GP negotiators. GPs could get some steer on what matters in practice.
references
1. How medicine is broken, and how we can fix it. 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h3397 (Published 23 June 2015)
Cite this as: 2015;350:h3397
2. Goldacre B, Smeeth L. Mass treatment with statins. BMJ2014;349:g4745.
Cite this as: 2014;349:g4745
3. Person centred coordinated care: where does the QOF point us? 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h2540 (Published 11 June 2015)
Cite this as: 2015;350:h2540
4. Dixon A, Khachatryan A, Wallace A, Peckham S, Boyce T, Gillam S. Impact of quality and outcomes framework on inequalities. Apr 2011. www.kingsfund.org.uk/publications/impact-quality-and-outcomes-framework-....
see http://www.kingsfund.org.uk/audio-video/anna-dixon-impact-quality-and-ou...
Competing interests: No competing interests
Re: How medicine is broken, and how we can fix it
I agree with Ben Goldacre but I do not agree with the statement "medicine is broken", nor do I agree that medical research (Publication bias..., Independent trials..., Cost of trials..., Better evidence..., Shared decision making..., Declare conflicts of interest...) flawed as it is, is the most important shortcoming in medicine. Far more important, in terms of global health, is the continuing lack of availability and use of reliable, appropriate secondary reference and educational materials to guide health care at the front lines in low- and middle-income countries.
Competing interests: No competing interests