How guidelines can fail usBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5448 (Published 04 September 2014) Cite this as: BMJ 2014;349:g5448
All rapid responses
The health sector is dependent on innovative suppliers to develop and supply for fair reward validated products in many sectors, including pharmaceuticals but also health informatics applications. But whereas in pharmaceuticals there are guidelines on how to moderate commercial interest so as to ensure credible scientific evidence, and the exceptions rightly cause concern [1,2], in health informatics there is no such universal evidence-based ethos or framework.
Health informatics in its various e-health applications clearly has much of benefit to offer a modern health sector, and indeed arguably this sector is lagging behind other fields of commerce in the constructive exploitation of modern information and data management systems. Yet health informatics policy is too often set by aspiration and a generic but unsubstantiated desire for ‘modernisation’, and applications selected not least by provider promises. Hard underpinning evidence bases, and proof in use, are not considered the absolute standard that they would be in other health delivery innovations. New systems are by nature and purpose disruptive innovations; they are usually imposed on health professional users by higher policy decision, despite information being a vital tool of every clinician, and despite most systems being based on a ‘black box’ approach which the clinical user cannot verify. Evidence of clinical appropriateness and safety should thus be paramount.
The cost of failure or sub-optimal results is not just high in monetary terms . Poor informatics systems can not only cause delay and frustration, but can have iatrogenic or fatal effects [4,5], as well as affecting professional liability. Individual sub-optimal informatics products may not cause the scale of iatrogenic harm that a pharmaceutical or medical device can, but this overall culture of seeing evidence as subservient to belief and hope can clearly cause widespread waste, frustration, and patient harm, and should have no place in modern health care.
Academic informaticians have highlighted the need for evidence-based informatics. Randomised trials may be difficult, but other forms of robust evidence gathering, based in scientific evaluation, are possible . The same call for scientific review has been made in England by 23 senior computer scientists in an Open Letter to the House of Commons Health Select Committee , and most recently in a UK-US context by Sheikh et al , while a group within the International Medical Informatics Association (IMIA) has worked for a decade to further progress , including devising an EQUATOR-recognised studies reporting framework .
Health informatics systems rightly are ubiquitous in health care delivery, and should become more so. It is vital that they are implemented in a context of trust, based on evidence, and open debate. Instead, policies seem too often to be driven by hope with those responsible able to divert blame to the implementation process, while at system level commercial confidence, and pressure on development and implementation resources, can often be used to hide the lack of evidence or to stifle criticism. This then becomes a breeding ground of mistrust. A prime example of such an unhappy situation started in Australia, and necessitated a full post-implementation independent review, and subsequent commentaries which showed an unacceptable barrage of negativity [12,13], but spilled over to the UK where the system was also to be implemented. There should be no place in healthcare operational systems for this kind of deviousness and antagonism, whether in pharmaceuticals , health informatics, or indeed any other aspect.
So, sadly, to pick up your editorial question about distorted priorities, in the important field of health informatics affecting all professionals and patients in modern health care, there is a significant lack of an evidence-based culture, of evidence-based policy or implementation, or of open discussion of issues. Too often commercial confidentiality and partnership are, as with the statins case, allowed greater weight than scientific fact. Of course, not all systems, suppliers, or implementations are bad, and there are conspicuous successes. But the scientific ground rules and guidelines are not so much deficient as absent. And while a vibrant supplier industry is vital, it should expect to operate within the open and evidence-based culture of the health domain.
1. Cole GD, Frances DP. Perioperative β blockade: guidelines do not reflect the problems with the evidence from the DECREASE trials; BMJ 2014;349:g5210 .
2. Godlee F. How guidelines can fail us; BMJ 2014;349:g5448.
3. Report by the Comptroller and Auditor General HC 888. Session 2010–2012. The National Programme for IT in the NHS: an update on the delivery of detailed care records systems. London; National Audit Office, 2011.
4. Ammenwerth E, Shaw NT. Bad health informatics can kill - is evaluation the answer? Methods Inf
5. Web list “Bad Health Informatics can Kill” (accessible via the ‘Bad Health Informatics’ link at http://iig.umit.at/efmi) (accessed 10 September 2014).
6. Ammenwerth E, Brender J, Nykänen P, Prokosch H-U, Rigby M, Talmon J, et al. Visions and strategies to improve evaluation of health information systems. Refl ections and lessons based on the HIS-EVAL workshop in Innsbruck. Int J Med Inf 2004 Jun 30;73(6):479-91.
7. Andersen R et al. the National Programme for IT in the NHS; Open Letter to the Health Select Committee, http://scholar.googleusercontent.com/scholar?q=cache:TGXa7Q6qlMkJ:schola... (accessed 10 September 2014)
8. Sheikh A, Atun R, Bates DW. The need for independent evaluations of government-led health information technology initiatives; BMJ Qual Saf 2014;0:1–3. doi:10.1136/bmjqs-2014-003273
9. Rigby M, Ammenwerth E, Beuscart-Zephir M-C, Brender J, Hyppönen H, Melia S, Nykänen P, Talmon J, de Keizer N. Evidence Based Health Informatics: 10 Years of Efforts to Promote the Principle - Joint Contribution of IMIA WG EVAL and EFMI WG EVAL; in Sérousi B, Jaulent M-C, Lehmann CU (eds.). Evidence-based Health Informatics – IMIA Yearbook of Medical Informatics 2013; 34-46.
10. http://www.equator-network.org/reporting-guidelines/stare-hi-statement-o... (accessed 10 September 2014).
11. Deloitte. NSW Health: Independent Review of Cerner FirstNet (available on http://www.ecinsw.com.au/sites/default/files/Deloitte%20Report%20FirstNe... ) (accessed 10 September 2014)
12. http://www.computerweekly.com/blogs/public-sector/2009/11/claim-of-censo... (accessed 10 September 2014)
13. http://www.zdnet.com/academic-claims-nsw-health-censorship-1339299731/ (accessed 10 September 2014)
Competing interests: MR is retired from employment, but undertakes periodic pro bono activities for International Medical Informatics Association and European Federation of Medical Informatics groups, and contributions to funded research projects.
Dear Fiona Godlee,
Writing in the International Journal of Evidence-based Health Care, (2006; 4: 180-186), Dave Holmes, Stuart J Murray, AméliePerron RN, Genevieve Rail argued that evidence based health system is “outrageously exclusionary and dangerously normative with regards to scientific knowledge. As such, we assert that the evidence-based movement in health sciences constitutes a good example of micro-fascism at play in the contemporary scientific arena.” They went on to show “how health sciences are colonised (territorialised) by an all-encompassing scientific research paradigm - that of post-positivism - but also and foremost in showing the process by which a dominant ideology comes to exclude alternative forms of knowledge, therefore acting as a fascist structure.”
The statistical science of medicine tries to base all evidence on their pet RCTs where a heterogeneous group is being tested and the data is then applied to individual patients on the bedside. While I agree with the authors of the above paper, I go a step further to say that this seems to be close knit fraud on gullible patients to make money between the researchers, drug lobby, the medical world and also the watchdog bodies. Human physiology is so unique and individualised that “one-size-fits-all” theory cannot fit into the system.
In systems biology the human body is not an open system as envisaged by modern western medical science where every minor deviation in human physiology needs external intervention. The human body, on the contrary, is a closed system with its own in-built repair mechanism. Outside intervention, especially in the asymptomatic stage of any illness, could do more harm than good. I have been writing about this for decades but to no avail. Giving peri-operative beta-blockers has been foolishly conceived and executed. In 1962 when beta-blockers were introduced they were trying to sell the idea that with the advent of propranolol all cardiovascular problems would be solved. Again in the late '80s and early '90s when alpha-blockers came the story repeated. I opposed alpha blockers, arguing that they could bring on heart failure, and I was outnumbered in a meeting in Dubai where Norman Kaplan opposed my theory. One year later what I had predicted came true! When I write something on those lines your team would ask for a reference. If there are references the thought does not become original thought from “Gadenkenexperiment”. If Werner Heisenberg had to give references for his “Uncertainty Principle” physics would not have progressed at all.
“Medicine is not science,” wrote Clifford and Donald Miller from Washington University, Seattle, and London, UK, in their article by the same name in the European Journal of Person Centred Health Care 2014; 2:.... They go on to state that “science, in the sense of the conventional conception of the scientific method applied in chemistry and physics, is not the only route to and is limited in the extent to which and the fields in which it and it alone can deliver, reliable knowledge. There is an urgent need for a fundamental reappraisal of the nature of knowledge and how it is and can better be obtained. The practice of medicine is largely observational and functions without the level of certainty essential to science.
Evidence-based medicine has serious crippling flaws. We need “evidence-informed” individualized care. Cohort studies like RCTs do not apply to individuals. Statistically significant changes in a heterogeneous cohort cannot and should not be applied to a unique dynamic human being. That is where modern western medicine has lost its track, resulting in the medical establishment becoming one of the leading causes of death and disability.
“If scientific knowledge cannot be distinguished from other knowledge we cannot prohibit use of unscientific and non-scientific knowledge in medicine. Science addresses narrow closely defined questions (hypotheses) in closely controlled conditions by carefully designed experiments to elicit a narrow range of evidence of high reliability, adopting the highest standards of proof. Science proves cause and effect by intervention demonstrating regularity of outcome. Universal generalisation by theory enables accurate and reliable prediction in existing previously observed and unobserved cases and in wholly new cases. Neither the practice of medicine nor medical research is science. A fundamental limit to universal generalised theorisation is medical research’s inability to test by rigorous scientific experiment. This is an inevitable consequence of treating individuals in heterogeneous populations of complex biological organisms,” they add. As I had written many times in the past RCTs are not science and meta-analysis of RCTs is unscientific while medicine can only be non-science. Science as conceived in the west is not the exclusive owner of all knowledge in this universe.
You are still groping in the dark about RCTs and trying to juggle the data to either suit your argument or otherwise but you are missing the bus as your basic data on which you base your arguments are questionable. Simple logic tells us that giving Beta-blockers peri-operatively can only be foolish; forget the RCT results being misunderstood. Surgery, even in normal human beings, is a great stress. Our only strength under stress is our autonomic nervous system, which helps us to survive in the fight-flight-fright situations. Blocking such a protection in a “closed systems human biology” could be inviting disaster. No wonder thousands of lives are lost in this bargain. But deaths are only statistic for the pharma lobby, profit being their God. Industry “seems to have sold its soul to the devil, a sordid boon.” I have a gut feeling that giving beta-blockers in heart failure does not stand logical scrutiny. In a closed system if you block the beta receptors in the heart, they are immediately replaced by the body’s wisdom to keep the heart going. In case the patient misses the doses for a day or so the suppressed receptors get reactivated making too many receptors active. The tired horse, the heart, gets whipped up to bring on arrhythmias! I know the “wise” people will say that the RCTs have shown otherwise! Luckily, I do not think RCTs are science.
Competing interests: No competing interests
Recent guidelines on hypertension (JNC) are so confusing and in the end the onus is on the practising physician--in this case GPs bear the brunt. Till last year I was very aggressive in treating high blood pressure in all my patients. Very particularly in diabetics, young hypertensives and patients with a bad cardiovascular family history. I was just going after the values and trying to educate the patients about blood pressure target values. New guidelines have put me in great embarrassment, at times I have to behave like a moron! Beta blockers have their role in hypertension but everyone seems to be condemning it. Do we have to believe the guidance and evidence or the eminence and experience? I agree with the other responder that GPs should be involved in making guidance since we see an entirely different picture in practice!
Competing interests: No competing interests
What part do Research Ethics Committess play in all this? Do they in a sense have any role in ''Duty of Care"?
Competing interests: No competing interests
I have long become disenchanted with the 'guideline' and 'evidence based' movement. All one has to do is find the conflicts of interest, (usually buried deep in the document), to realize many guidelines are the product of pharmaceutical companies and their academic sycophants. The reality is, if you put a bunch of 'experts' in a room and tell them to come up with 'guidelines', they will, whether they have any evidence or not. These will then be touted far and wide as based on 'the best evidence available' even if the evidence is weak or non-existent.
I have come to the conclusion the only guideline committee that could be trusted would consist of a family doctor, an epidemiologist, a statistician, a patient, and a specialist. None should have any ties to industry. Unfortunately, since none would be members of the university-pharmaceutical complex, none would be in a position to afford to sit on such committees and the evidence based movement would become moribund.
Competing interests: I have researched guidelines critically, and am presently attempting to get the results published. Unsuccessfully, so far......
Of course this revelation is outrageous and evidence of sociopathy among medical leadership. The Mafia maintains control by extracting the pledge of Omertà from its members. Maybe it's time for medical journals to impose sanctions that go far beyond current practice. Criminalization of research fraud lacks a constituency, so the politicians will not pass legislation to do so. On the other hand, medical journals can adopt a policy of publishing manuscripts on condition that the authors pledge to give access to anonymized original data and code books on demand. If published authors renege on the pledge, the medical journal can act on an accompanying policy of retracting the published report on the basis of a rebuttable presumption that the authors had committed research fraud. Government funding agencies can also up the ante by imposing a life-time ban on researchers who have been found guilty of research fraud. But why is any of this necessary? Don't medical societies take action in cases of unethical practice, as they claim? I guess not.
Competing interests: No competing interests