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David A Henry, Professor of clinical pharmacology and physician University of Newcastle, New South Wales, Australia
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Peter Rothwell is correct to point to the need for observational clinical research, which is undervalued compared with basic research and randomised clinical trials. Can I add a plea that granting bodies and journal editors provide room for well researched and representative clinical case series. Our capacity to describe diseases and their natural history changes over time, with better diagnostic tests and improved understanding of disease mechanisms. It is important that we have contemporary descriptions of diseases and their outcomes. I am sure that I am not the only physician who uses Google Scholar when I am on call. Finding summmaries of treatment trials and meta-analyses is straightforward when I am confident of the diagnosis. But when I am faced with a diagnostic problem I sometimes resort to entering the symptoms and signs into Scholar. It is not always helpful but sometimes I hit a thoughtful case description that expands my thinking about the problem I am struggling with. This will only work if clinicians have a medium in which to share their clinical observations. Competing interests: None declared |
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Mike Thomas, Asthma UK Research Fellow Department of General Practice, University of Aberdeen
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In his editorial highlighting the current neglect of basic observational clinical research by academia (1), Professor Rothwell makes pertinent points illustrated from his research field of neurology, and considers some of the reasons why this state of affairs has occurred. A further possible explanation may lie in the perception of many scientists, particularly those involved in the evidence-based medicine ‘industry’, that observational research is intrinsically inferior. This attitude is reflected in the hierarchical evidence structure that underlies evidence- based assessments (2), which positions observational research in a lowly place and implies that evidence coming from other research methodologies is intrinsically more trustworthy and reliable. As a consequence clinical researchers wishing to make an impact on how medicine is practiced in the real world tend to avoid observational methodologies and concentrate on basic science research and randomised controlled studies of interventions. We have argued in a different clinical area (respiratory medicine) that evidence from different research methodologies can give complementary information on a research question (3), and that an alternative structure to a rigid hierarchy of evidence would be to recognise that all research methodologies have strengths and weaknesses, and can provide overlapping information. For instance, observational research is able to utilise large clinical databases of whole populations treated in real-world settings, and so potentially can confirm that the findings of a randomised controlled trial are generalisable to the populations and pragmatic constraints of every-day clinical practice. The lack of randomisation inherent in observational research will of course always allow the possibility of confounding factors and biases to influence observed outcomes, and such research will not be conclusive in isolation. However, when the evidence from different research methodologies is consistent, we can be reassured that the messages are likely to be robust and generalisable; when they seem to point to different conclusions, rather than rejecting the results of observational research as being inevitably inferior, further research and investigation should be instigated to understand why a discrepancy has occurred. Rothhwell is to be applauded in highlighting the plight of observational research; possibly academia needs to re-examine the value it affords to evidence from different sources and recognise that good quality observational data can play an important part in answering relevant questions. Dr Mike Thomas Asthma UK Research Fellow Department of General Practice, University of Aberdeen References: 1. Rothwell PM. Medical academia is failing patients and clinicians by neglecting basic observational research. BMJ 2006;332:863-4. 2. Evidence-based medicine: a new approach to teaching the practice of medicine. Evidence-based medicine working group. JAMA (1992) 268(17):2420-2425. 3. Thomas M, Clealand J, Price D. Database studies in asthma pharmacoeconomics: uses, limitations and quality markers. Expert Opin. Pharmacother. 2003 (3); 3 Competing interests: None declared |
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Patrick J Morrison, Professor & Consultant in Clinical Genetics Belfast City Hospital Trust, Belfast BT9 7AB
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Peter Rothwell [1] argues that academia is failing patients and clinicians. As one of the authors of the paper he cites demonstrating ‘enormous value’ (the first reliable data on risk of major malformations due to antiepilepsy drugs in pregnancy [2]), he may be interested to know that none of the co-authors (a varied mixture including Consultants, a General Practitioner and specialist epilepsy nurses), have academic contracts and are paid purely by the NHS. The research was enjoyable – the difficult parts came mainly from the tedious ethical applications, and NHS beurocracy, and apart from the epilepsy register co-ordinator, was done mainly in our spare time. Herein lies the problem - the ‘post new-consultant contract NHS’ is primarily interested in seeing patients, not in research or education. I spend large amounts of time outside my paid NHS contract on education and research, but in my draft job plan, was recently presented with research sessions scheduled from 08.00 – 09.05 on every 5th Friday – the three hours and 15 minutes per year thus allocated is insufficient for trust governance paperwork let alone organising or doing any research! None of my colleagues were offered any research time at all. The NHS needs to maintain a vision for the future [3], and if it were a business, would regularly invest heavily in education and research, rather than as an afterthought. It is not just academia (driven by a research assessment exercise that rewards grant income and high impact factor science papers and therefore unlikely to do clinical research) that is failing patients and clinicians. Clinical research requires time and NHS clinicians may be best placed to do it if they were given more. References: 1. Rothwell PM. Medical academia is failing patients and clinicians. BMJ 2006;332:863-4. 2. Morrow JI, Russell A, Guthrie E, Parsons L, Robertson I, Waddell R, Irwin B, McGivern CR, Morrison PJ, Craig J. Malformation risks of anti- epileptic drugs in pregnancy: A prospective study from the UK Epilepsy and Pregnancy Register. JNNP 2006;77:193-8. 3. Morrison PJ. Colour vision. Ulster Med J 2006;75(1):1-2. Competing interests: PJM has 2 honorary personal chairs and an honorary readership from three UK universities but is paid by the NHS and not by any of the 3 universities. |
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David Kingdon, Professor of Mental Health Care Delivery University of Southampton, Royal South Hants Hospital, Southampton SO14 oYG
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Medical academia may be failing patients and clinicians but this reflects the environment in which it operates and which determines its research direction. Funding agencies, including Government, use unscientific mechanisms such as the Research Assessment Exercise and peer review. These favour basic sciences and maintenance of the status quo with scientists who cite their colleagues and even themselves benefiting rather than those who attempt to reflect the needs of those who ultimately use and fund their research and those who disseminate their findings so that they can have greatest impact. The RAE has been subject to criticism since its inception and the Chancellor has now stated that its days in its present form are numbered. The 2008 exercise may go ahead if no better agreed alternative emerges. Such an alternative should include users of services as now occurs with most evaluations in other areas. Patient and carer representatives are frequent members of policy and management bodies and now often involved lower down in the research process, indeed increasingly this is a requirement for grant funding. It seems therefore eminently appropriate that they become members of RAE and all research funding panels. It may also be reasonable to include clinicians and industry representatives. Selection of those to be involved in panels needs to be transparent and equitable but this would not involve excessive expense or additional time. Brief but accessible explanations of research, from individual researchers, would need to be provided to most effectively involve them with added assistance from technical members of the panels. This would also probably mean greater involvement by all members of panels rather than just those with immediate proximity to and vested interests in a specific area. The RAE and Research funding bodies have to move from being self- perpetuating oligarchies to becoming responsive to patient and clinician needs using equitable principles with appropriate representation. It may well be that an important contribution of impact factors for theoretical work will remain but other important reasons for supporting research be included, e.g. contribution to NICE guidelines or to medical practice and training. Applied research by clinicians and academics may then be valued commensurate with its significance. Competing interests: My academic contribution is assessed under the RAE and funding applications by a range of organisations. |
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Roger Jones, Wolfson Professor of General Practice King's College London School of Medicine, London, SE11 6SP
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Let us hope that the cogent arguments advanced by Peter Rothwell in support of more and better clinical research in the UK begin a serious dialogue which will correct the asymmetries in research funding, kudos and leadership that have developed over the last 5-10 years. The examples from clinical neurology can, undoubtedly, be matched by analogies from other fields of internal medicine and from psychiatry. Rothwell’s arguments apply with even greater force to the need for a clinical research effort in primary care and in community-based health services research on topics such as the natural history of common diseases, the value of interventions, both therapeutic and preventive, and critically, as Rothwell points out, the difficulties of individualising risk and benefit in a single patient, on the basis of large-scale trials. For many important interventions, these trials have not been conducted in primary care, creating the added problem of attempting to extrapolate from data collected in secondary care settings. The newly-launched NHS R&D Strategy includes welcome proposals for new primary care research networks across the UK and also for a School of Primary Care Research. The general practice registration system within the NHS, coupled to research networks, provides an unrivalled opportunity for the identification of patients with conditions of interest and long- term follow up to study natural history and outcomes after interventions and a sampling frame for the enrolment of patients into trials. The costs of the infrastructure to support this research should not be underestimated – the ‘well-found community laboratory’ – and it is essential that adequate project and programme funding is also available to support the kinds of research that Rothwell identifies as being needed. Apart from trials, these studies should include follow-up studies of large cohorts of patients after the completion of therapeutic trials, adequate health economic evaluations of interventions, careful evaluation of the success or otherwise of getting newly-proven interventions into practice, studies aimed at improving our understanding of patients’ willingness to accept therapeutic and preventive interventions and high-quality health services research aimed at establishing the optimum ways of providing new services. There is an urgency about this. Swept along by the wave of anxiety surrounding the next Research Assessment Exercise, so-called clinical academia has increasingly focused on quick-fix solutions, including playing the ‘research star’ transfer market and re-distributing clinical academic funding to support laboratory-based research, which is thought to have a shorter research cycle time and a higher likelihood of publication in desirable journals. Rothwell is, I believe, right to say that non- clinical and non-practising researchers underestimate the need for clinical research, partly because they simply can’t see it and partly because it is likely to be uncomfortable in terms of their own priorities. Non-clinical researchers need to understand that ‘translational’ doesn’t simply mean getting the protein out of the test tube into the zebra fish, but getting the therapeutic intervention into the patient and the population. Competing interests: None declared |
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Christine Bundy, Senior Lecturer in Psychological Medicine/Health Psychology University of Manchester, Medical School
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I read with interest Rothwell's views on the failure of academia to support clinical research. In particular his conclusions regarding the loss of capacity of the NHS to facilitate research and the increased bureaucratising of clinical research particularly resonated with me. Unless we reverse this trend it is my belief that things are going to get worse. As the numbers of medical students increase and the numbers of staff to educate and train them decrease, one of the casualties of this phenomenon is a reduction in the provision of opportunities for medical students to learn about research methods. This, coupled with the ever increasing bureaucracy associated with obtaining ethics approval to conduct research means students will be lucky if they ever get to appreciate the highs and lows and the complexity of real world research. This is a big mistake; the next generation of clinical researchers will not have had the basic training or experience to pursue the research questions arising out of their everyday clinical observations. Neither will they have had their research curiosity stimulated. If research concentrates on basic biomedical questions and clinical research issues continue to be viewed as of secondary significance this seriously compromises the evidence base of everyday clinical medicine and the status of medicine as a profession. One of the hallmarks of a first class health professional is one who applies robust scientific methodology gained through training to everyday observations of common problems encountered. For medicine to abandon this or entrust it to the few who are motivated to pursue it as a hobby will reduce capacity even further and devalue clinical medicine. In the larger medical schools now ever fewer students are being offered opportunities to conduct supervised research and many are being offered literature searching as an alternative to hands on research. While I support the need to have students able to conduct detailed literature searches this is no substitute for being actively involved with applied research. As medical educators we have a moral obligation to the next generation of clinical researchers to ensure they are educated in all aspects of research from the page to the patient. Competing interests: None declared |
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Des Spence, GP Glasgow
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I was taught by rote and humiliation. I learn clinical signs, symptoms and treatments. These were delivered in unquestioning way and I assumed they to be fact. These guided my practice for some years which lead to investigation, interventions and treatment. I also applied research data in general practice with the certainty and arrogance of science. I observed, however, that many of these signs and symptoms were in common in the healthy. With no sensitivity or specificity for the disease that I was told they detected. Likewise re-reading the summary statements of much of the research seemed the stuff of 50’s style science fiction. This mix of myth and half truths have seen widespread over diagnosis and unnecessary intervention that defines our medical culture. Long maligned observational data is fundamental to change and has a key role is assessing the value our modern invention. General Practice equally ignored for many years has a enormous potential in this area. Thanks to the continuity of NHS records systems - many GP practices have complete electronic records dating back over a decade with large stable populations. Case finding is quick, easy and robust . What are the long term outcome of chlamydia?, what are the long term outcome with antidepressants? The answer to these questions and all the rest are in the Gold mine of data in General Practice. General Practice research needs top stop simply aping the hospital sector but be creative and thoughtful with observational studies. Medicine has the greatest capacity to do harm but observational studies can protect the public and preserve medicine. Competing interests: None declared |
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Jeffrey C McILwain, Consultant, Clinical Risk Management St Helens & Knowsley NHS Trust
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I am neither a Professor nor University personage, but a humble academic type in NHS Clinical Risk Management . (Yes we do exist !). I read the leading paper "Medical Academia is failing patients and clinicians" with interest. I wonder where the fault lies ? In 1986 as an SR in ENT I did my year away in Toronto as a Charlie Conacher fellow. From this I produced my MD on the basic sciences of the Posterior Glottis (definition, embryology, physiology, anatomy and pathology) which was accepted by Queens Belfast and published in two parts by the Canadian ENT journal as a paper and a supplement. The final message was that both the UICC and AJCC were wrong in their definitions and approach to staging cancer in this area. Did anyone take an interest or give a toss ? Only one reprint request and about three citations (Google Scholar). This was about the first MD in ENT circles at the time. So why no interest ? I can only offer several conjectures. 1. basic sciences are presumed
to have been thrashed out in the 19th Century and nothing changes. Retesting of evidence, even old accepted evidence, with new techniques or with a virgin unpolluted mind, can sway established opinion, if the established opinion is prepared to be receptive to change and more keen thought. I believe the leader is timely, however, whether clinicians or researchers get sexed up on the viagra of basic science research remains to be seen ! Jeff McILwain MD FRCS Competing interests: None declared |
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David G Taylor, GP principal Birmingham B31
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In 1928, in his introduction to Sceptical Essays, Bertrand Russell wrote: "The extent to which beliefs are based on evidence is very much less than believers suppose." As a generalist I read Prof Rothwell’s paper with great interest. It seems to me that the two examples he gives in neurology can be matched by many others in all the medical disciplines. It is not only that we do not have the bedside research to inform us however. It is also that other common problem; we do not act on what we already know. I will give three examples from different aspects of medicine. We are urged to rush to make a diagnosis in chest pain; though we know the predictive value of the subsequent tests are poor, as is the outcome for those caught up in the process.(1) Screening still seems to be uncritically accepted, and the suggestion that in breast screening two women will have an unnecessary mastectomy to save one life go without remark.(2) In treatment we are still over-influenced by drug company relative risk studies (BHS, ASCOT etc – the list is endless) and, in heart disease, overestimate the risk by roughly three times and the benefits of treatment by five to eight times.(3) Primary care is a territory characterised by uncertainty, and yet the public – and many doctors - seem to believe that certainty is just a further test away. We all need to understand much more about risk estimation, and grapple with communicating that to out patients. It is not easy(4), but is vitally important. 1) BMJ 2001;323:1319-1320 ( 8 December ). Opening Pandora's box: the unpredictability of reassurance by a normal test result 2) BMJ 2005;331:973 (22 October). Over-diagnosis in breast cancer screening 3) Ann Intern Med 1996; 124: 414-421. Differences in generalists' and cardiologists' perceptions of cardiovascular risk and the outcomes of preventive therapy in cardiovascular disease. 4) BMJ 2003;327:757 (27 September). Personal View; Risk, statistics, and the individual Competing interests: None declared |
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Alfredo D. Espinosa-Brito, Professor of Internal Medicine Hospital Dr. Gustavo Aldereguía Lima, Ave 5 de Septiembre and Calle 51A, Cienfuegos 55 100, Cuba, Orestes M. Álvarez-Fernández, and Ángel J. Romero-Cabrera
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Dear Sir: Almost two year ago, Smith signed an editorial in the BMJ: “Doctors are not scientists” (1) By that time, there were a lot of Rapid Responses with very different points of view about this topic, including one of us. There, we wrote: “We think that clinical medicine is art and science. So, clinical doctor has to be, at the same time, artist and scientist if we want to fulfill both characteristics of our profession”. (2) Why we started that? Because “the scientific method is not only related with the biomedical research or clinical trials in Medicine, but also, and especially, with the clinical method applied to the patient care… Clinics is a practical science, which is expressed in the final result of the medical care of one sick person. (research study n = 1)”. (2) We agree that “a scientist is somebody who constantly questions, generates falsifiable hypotheses, and collects data from well designed experiments” (1) Precisely, this is the way of the clinical method when we study in a comprenhensive way, case by case, our patients. It is the correct thinking process for diagnosis, prognosis and treatment of a sick person, when we actively intervene in the always new and natural “experiment” that represents the health-disease process of one person”. (2) Now, we agree with Rothwell who wrote that although it is widely recognised “the need to facilitate clinical research -particularly translational "bench-to-bedside" research and randomised controlled trials of interventions, there is another even more neglected field of clinical research, which arguably has greater potential to improve clinical outcomes, certainly in the short term: basic observational research necessary for effective clinical practice”. (3) Nowadays, case study is a very common approach to study many problems, not only in medical field, but in many other academic scenarios. However, it is rare to find “classical” clinical reseach based on old and new descriptions of clinical pictures. Furthermore, it is assumed that the better clinical illustrations are in the texbooks of medicine. But, what happened? Medical textbooks are generally organized by similar chapters: definition, epidemiology, etiology, pathogenesis, pathology, clinical features, diagnosis, prognosis and treatment. Despite continuously updating, the total number of pages of textbooks has not substantially increased in 40 years (perhaps this is due to an agreement between editors and publishers). However, some chapters have enlarged more than others. This is especially apparent in books related to evidence- based medicine (the so call Academic medicine, which “recognises that an evidence based approach is important in discussing the problems of medicine”). (4) In the areas of etiology and pathogenesis, there are descriptions of newly discovered agents and chemical mediators, genetic and immunological advances, and risk factors. Chapters that address diagnostic methods have also increased in length. This is due to the “Imagenologic boom”, and advances in nuclear medicine, microbiology, pathology, monoclonal tests, and modern clinical techniques. Therapeutics is another area of rapid growth. Drug guidelines are constantly being updated and new biotechnological products introduced. There have also been tremendous advances in surgery. After all of this updating, what has been compressed? What has been overlooked? What has been written too concisely? It seems that contents related to actual clinical practice, especially Semiology, has been affected. Many of the not-so-young clinicians are dreaming for the “old” medical textbooks. Diseases were better described. What can be done? Although there have been many important advances in medicine, the basics of clinics has remained the same. It is extremely important for medical students and junior doctors to have detailed clinical descriptions –including new or atypical clinical manifestations of old diseases and emerging or reemerging ones- as it was for clinicians 50 years ago. It is quite interesting for a group of collegues here, the reading of Rothwell editorial and the points expressed on it. (3) He comments about several conditions in the field of Neurology in which basic clinical research could provide important answers in terms of diagnosis, prognosis, treatment, approach, etc., for patients benefit, including that basic clinical reasearch has been neglected. Is this situation only confined to the scope of Clinical Neurology or limited to some institutions of the United Kingdom? We believe that the answer is most probably: No, taking into consideration our experience as practicing clinicians working at a Provincial Hospital in Cuba, involved not only with patients, but also with teaching and investigations. Not seldom the concern about the future of basic clinical investigation has been analised. The topic also has been presented in national medical journals as a matter of concern and multiple reasons are considered to explain the problem. Some of the elements more frequently considered are: a) Clinical basic research operates without “strong data” and some collegues regard it as “second class investigation”. b) The concept of health (and research) is mainly focused towards biological parameters and medical care oriented to the replacement of functions or organs that are damaged; “non biological” problems are not very important. (5) c) We are not exception to the strong influence of the moderm medical technologies; this might generates among some collegues the pattern of dealing more with biologcal tests and results rather than with paients complaints or clinical signs. (5) d) The changing patterns of morbidity and clinical presentation of many diseases might misguide to assume that clinical findings (and of course research) are not very reliable. During many years we have followed different causes of action in order to minimize the potential damage. Among them are: Several kinds of staff meetings, such as: demonstrative rounds, illustrative case presentations, collective diagnostic discussions, clinic-pathologic conferences and clinic-imagenologic meetings. What is it that doctors offer that other professionals cannot? "Diagnosis, diagnosis, diagnosis…" A nurse might one day transplant a heart, a technician anaesthetise a patient, and a pharmacist control a patient's complex drug regimen. But doctors are needed for diagnosis. (6) Diagnosis is hard to study. Evidence based medicine has concentrated on treatments and stayed away from diagnostic methods. This is partly because it's much less clear how to analyse systematically studies of diagnostic methods. (5) It is important to define what is essential in clinical medicine and clinical research should include observational research for improving the accuracy of early recognition and management of many disorders which are in the focus of practicing clinicians. The authors believe that it is the holistic approach of caring patients. It is important to combine science and clinics in daily diagnostic, prognostic and therapeutic practice. Technology is important, however it should be used as to complement clinical science and patient care. Sincerely, Professor Alfredo D. Espinosa-Brito, MD, PhD; Associate Professor Orestes M. Álvarez-Fernández, MD; and Associate Professor Angel J. Romero-Cabrera, MD Department of Internal Medicine Teaching Hospital "Dr. Gustavo Aldereguia Lima", Ave 5 de Septiembre and Calle 51A, Cienfuegos, 55100, CUBA E-mail: espinosa@perla.inf.cu Competing interests: None declared References 1. Smith R. Doctors are not scientists BMJ 2004;328;328.7454 2. Espinosa-Brito AD, Bermúdez-López JM. The clinical method is the scientific method applied to the care of a patient. BMJ Rapid Responses (27 June 2004). Available in www.bmj.com. 3. Rothwell PM. Medical academia is failing patients and clinicians. Editorial. BMJ 2006;332:863-864. 4. International Working Party to Promote and Revitalise Academic Medicine. Academic medicine: the evidence base. BMJ 2004;329:789-792. 5. Alonso Chill O. El clínico y la tecnología instrumental en la actuación científica y humana. Bol Ateneo Juan César García 1996;4:87-92. 6. Editor's choice. Diagnosis, diagnosis, diagnosis. BMJ 2002;324 (2 March) Competing interests: None declared |
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Gareth L Ackland, Lecturer, Critical Care Medicine University College Hospital, Professor MG Mythen
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The lack of infrastructure in basic observational research necessary for effective clinical practice is a multi-speciality problem. Despite the recent (political) desire to reduce length of hospital stay, astonishingly little is known about why and for how long surgical patients reside in hospital post-operatively. In the absence of such data, advancing anaesthetic and surgical practice with the aim of substantially reducing morbidity for the patient AND costly health expenditure for the funding agencies will remain impossible. This lack of investment into perioperative medicine research and practice will continue to impair any attempts to utilize precious hospital-based resources efficiently, with major knock-on effects for all hospital-based specialties. Competing interests: None declared |
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anthony a schiff, retd bracknell rg12 9lq
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Rothwell lists 7 possible causes (see box) for the "hardly credible" situation that "basic observational research....which could and should have been done decades ago, is only now being published". He doesn't include the fundamental cause, perhaps because it is too sensitive to mention, namely, the mindset of most hospital consultants who of course were in the best position to organise such research. The kind of person who took up medicine was generally unscientific in outlook, and wanted medicine to remain more of an art than a science. My experience from medical student circa 1960 onwards through junior hospital posts was that consultants were usually uninterested in, or hostile to research, held strong opinions on most clinical questions based on their "clinical experience", and regarded any questioning of these as impertinent and undermining their authority with nursing staff and patients, as well as disrupting clinical routine. But science is inimical to authority, hence the different status of the modern hospital consultant.
Competing interests: None declared |
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