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Rapid Responses: Rapid Responses published:
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Infective endocarditis and IV drug users
- Dr Arun Viswanath, Dr Shailesh Mukunda (5 April 2008)
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NICE guidance on prophylaxis of endocarditis need further debate
- David C Shanson (10 April 2008)
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NICE guidance on prophylaxis against infective endocarditis: Some potential problems.
- John O'Sullivan, Graham Walton (12 April 2008)
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NICE Guidelines on antibiotic prophylaxis against infective endocarditis: A call for national monitoring of outcome
- Neil Herring, David C. Sprigings (20 April 2008)
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Prophylaxis against Infective Endocarditis:NICE Guidelines
- David R Ramsdale, Dr Nicholas Palmer, Mr John Chalmers, Mr Brian Fabri (24 April 2008)
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NICE Guideline on Prophylaxis against Infective Endocarditis: guideline developer's response
- David Wray, Nicholas Brooks, John Gibbs, Danny Keenan, Jonathan Sandoe, Tim Stokes (13 June 2008)
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NICE confusion between cost-effectiveness and research
- Raj Mohindra (1 July 2008)
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Dr Arun Viswanath, Speciality Registrar Sheffield Care Trust, Dr Shailesh Mukunda
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Bacterial endocarditis as contrasted with other endocarditis is usually curable with appropriate use of antimicrobial. The challenge of devising and applying effective therapy is multiplied in addicts (IDUs). Given it is a significant risk group it has to be addressed in particular along with the NICE guidance.(1,5,3, 4).Endocarditis was more common in SAB among drug abusers a Finland study.(8) Previous studies have demonstrated higher rates of IE among HIV-infected IDUs than among HIV- negative IDUs (6,7) .Staphylococcal endocarditis in injection drug users is now the dominant form of the disease. Right sided endocarditis accounts for 10% of all IE in population based surveys in the US. The clinical manifestations of endocarditis associated with injection drug use differ from those in person who do not use drugs. Endocarditis in drug users more often affects the right side of the heart and presents with fever and pulmonary emboli rather than left-sided emboli. Blood cultures and echocardiography is the mainstay of diagnosis; these tests are particularly helpful in identification of endocarditis associated with injection drug use because of the high frequency of right-sided valvular involvement and the low incidence of culture-negative endocarditis in this population. A systematic review found no clear benefit of one antimicrobial over another.(2) For those IDUs who are not yet able to abstain from injecting drug use, harm reduction approaches are used to educate IDUs about methods of safer injection, including the use of clean needles, sterile injection techniques, and safe disposal of needles. Such outreach approaches may be effective in promoting behaviour change in preventing other infections. References: 1.) Prophylaxis against infective endocarditis.NICE( www.nice.org.uk) 2.) Antimicrobials for right-sided endocarditis in intravenous drug users: a systematic review. Derek Yung1, Dan Kottachchi1, Binod Neupane2, Shariq Haider1 and Mark Loeb,* 3).Weinstein, WL, Brusch, JL. Infective endocarditis, Oxford University Press, New York 1996. 4).Berlin, JA, Abrutyn, E, Strom, BL, et al. Incidence of infective endocarditis in the Delaware Valley, 1988-1990. Am J Cardiol 1995; 76:933. 5). Griffin MR, Wilson WR, Edwards WD, et al. Infective endocarditis. Olmsted County, Minnesota, 1950 through 1981. JAMA. 1985;254:1199-1202 6).Wilson LE, Thomas DL, Astemborski J, et al. Prospective study of infective endocarditis among injection drug users. J Infect Dis. 2002;185:1761-1766 7).Incidence of, Risk Factors for, Clinical Presentation, and 1-Year Outcomes of Infective Endocarditis in an Urban HIV Cohort -Kelly A. Gebo, MD, MPH; Matthew D. Burkey, MPH; Gregory M. Lucas, MD, PhD; Richard D. Moore, MD, MHS; Lucy E. Wilson, MD, ScM 8). Eeva Ruotsalainen, 1 Kari Sammalkorpi, Janne Laine, Kaisa Huotari, Seppo Sarna, Ville Valtonen, and Asko Järvinen BMC Infect Dis. 2006; 6: 137. Published online 2006 September 11. doi: 10.1186/1471-2334-6-137. Competing interests: None declared |
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David C Shanson, Honorary Consultant Microbiologist Great Ormond Street Hospital For Children,London WC1N3JH
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With regard to the NICE guidance(1) ,the American Heart Association reviewed similar literature and instead of recommending no prophylaxis for dental procedures they advised antibiotic prophylaxis for some dental procedures in patients with high risk cardiac conditions(2). NICE states that there is no clinical trial evidence for the efficacy of amoxicillin prophylaxis for preventing endocarditis.This is not surprising due to the rarity of the disease and the fact that there is less than a 1 in 500 chance of endocarditis occuring after a single dental extraction.However,stringent experimental animal models,where more than 90% of controls developed streptococcal endocarditis,have shown a single dose of amoxicillin to be highly effective for preventing endocarditis. The interpretation of the epidemiological and bacteraemia data is controversial.In particular the Netherlands case control studies did not include patients with prosthetic heart valves ,and total bacteraemia rates are often discussed rather than bacteraemia due to the dentally relevant viridans streptococci.These issues, are discussed in detail elsewhere(2). The main argument of NICE against prophylaxis is the risk that fatal amoxicillin anaphylaxis may cause more deaths than the number of deaths preventable by giving prophylaxis.However,this risk of fatal anaphylaxis is exaggerated as no fatal case has ever been reported in association with the amoxicillin prophylaxis of endocarditis either in America(2) or the UK(3). In conclusion,the latest American Heart Association guidelines appear more logical than those of NICE. REFERENCES 1)Richey R,Wray D,Stokes,T Prophylaxis against infective endocarditis:summary of NICE guidance.BMJ 2008;336:770-771 2)Shanson D,New British and American guidelines for the antibiotic prophylaxis of infective endocarditis:do the changes make sense?A critical review Current Opinion in Infectious Diseases 2008;21:191-199 3)Lee P,Shanson D,Results of a UK survey of fatal anaphylaxis after oral amoxicillin J Antimicrob Chemother 2007;60:1172-1173 Competing interests: None declared |
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John O'Sullivan, Consultant Paediatric Cardiologist Newcastle Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, Graham Walton
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Date: 10/04/2008 Dear Sir / Madam, The recently published NICE guidelines, which effectively abandon the practice of prophylactic antibiotics for dental procedures, will be welcomed by many as it simplifies dental management of many patients. This document shifts the emphasis from the potentially inappropriate prophylactic use of antibiotics to the need for maintenance of general oral health by provision of regular dental care. There remains, however, understandable concern about endocarditis in patients with congenital heart disease as oral streptococci are implicated in 50% of cases (Kaye D 1986)1 In a recent audit of adults with congenital heart disease in the Cardiology unit at Freeman Hospital, we found that at the time of a routine clinic visit 58% (of 398 patients) were not dentally fit, as assessed by a dental practitioner. The problems noted included caries (decay), calculus (tartar) build up and gingivitis (visible inflammatory gum disease). This is most likely an underestimate of treatment need as this dental screening did not include radiographic examinations. Chronic symptomless dental abscesses, more advanced periodontal disease, and potentially significant sources of oral sepsis, may therefore have been present in a proportion of these cases. Patients over the age of 18 have to pay for routine dental examinations and the recent changes in the NHS contract (April 2006) for dentists is likely to result in a further decrease in the number of dentists providing NHS treatment and therefore of patients being able to access routine care. (Already, from March 2006 to September 2007, 500,000 fewer NHS patients have been seen. (The Information Centre)2 The recently published NICE guidelines rightly emphasise the importance of regular dental care, but the increasing population of adults with congenital heart disease, and changes in access to routine dental care arising from the contract changes, will undoubtedly result in an increase in the already unacceptable level of dental problems as evidenced by the current prevalence of dental caries in this high risk population (O’Sullivan and Walton unpublished data)3. It would have been more logical to bring in these NICE recommendations with a realistic plan on how we can improve the general dental health of the adults with congenital heart disease rather that an aspiration that the basic dental health will improve despite an environment that may make obtaining regular NHS dental care more difficult for this relatively high risk group of patients. Yours sincerely Dr John O`Sullivan Consultant Paediatric Cardiologist & Dr Graham Walton Associate Specialist Restorative Dentistry Refs 1. Kaye D. Prophylaxis for infective endocarditis: an update. Ann Intern Med 1986; 104:419-423 2. The Information Centre (NHS) www.ic.nhs.uk/webfiles 3. O’Sullivan J, Walton G. An audit of the dental health of Adult survivors of Congenital Cardiac Conditions 2005-2007. Unpublished data Competing interests: None declared |
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Neil Herring, Clinical Lecturer in Cardiovascular Medicine Northampton General Hospital, NN1 5BD, David C. Sprigings
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The National Institute of Clinical Evidence (NICE) in the UK has recently published guidelines on the use of antibiotic prophylaxis for the prevention of infective endocarditis (IE) in patients predisposed to the condition because of structural heart disease(1). The guidelines no longer recommend their use during dental and other invasive procedures of the respiratory tract, genitourinary and upper and lower gastrointestinal tract, a significant change from current practice. The guidelines apply to all high risk patients, even those with prosthetic valve replacements, congenital heart disease and previously treated IE. In particular the guidelines point out the lack of high quality evidence linking such procedures to IE and their prevention by antibiotics. Other recently published guidelines, for example by the American Heart Association(2), have also highlighted the absence of an adequate evidence base but have stopped short of recommending such a change to current practice. This undoubtedly raises questions and anxiety amongst patients used to taking antibiotic prophylaxis and those involved in the treatment of IE. The report highlights reactions to antibiotics (including anaphylaxis) as an argument against their use on a population scale. However the Cardiologist in outpatients’ clinic is able to ask the individual patient about previous antibiotic use and reactions, making the argument less relevant in practice. Unlike most areas where NICE issues guidance, there are no randomised control trials on antibiotic prophylaxis for IE and those studies that exist are small, observational and case-controlled. Although there is inconclusive evidence in favour of antibiotic prophylaxis in this area, the statistical power of such studies is poor and false negative results are a possibility. One could view the change in guidelines as an excellent opportunity to see if the incidence of IE does indeed change with their introduction. However, IE is not a notifiable disease in the UK and we are unaware of any current system in place that could accurately detect a rise in incidence on a national level corrected to the use of antibiotic prophylaxis in individual cases. IE is a serious, life threatening condition often requiring many weeks of intravenous antibiotics, the possibility of open-heart surgery and prolonged inpatient stays with an overall mortality rate estimated at around 20%(1). Regardless of opinion on the sparse and inconclusive evidence for, as well as against the use of antibiotic prophylaxis, we would call for a system that can robustly assess the outcome of such a substantial change in practice to be in place alongside their implementation given the potential for lives to be lost. Dr Neil Herring
Dr David C. Sprigings
Conflicts of interest: none declared References: 1. http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11938 2. Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, Bolger A, Cabell CH, Takahashi M, Baltimore RS, Newburger JW, Strom BL, Tani LY, Gerber M, Bonow RO, Pallasch T, Shulman ST, Rowley AH, Burns JC, Ferrieri P, Gardner T, Goff D, Durack DT. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007, 116(15):1736-54. Competing interests: None declared |
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David R Ramsdale, Consultant Cardiologist The Cardiotrhoracic Centre, Liverpool, Dr Nicholas Palmer, Mr John Chalmers, Mr Brian Fabri
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PROPHYLAXIS AGAINST INFECTIVE ENDOCARDITIS:NICE GUIDELINES 22nd April 2008 Dear Editor, It is our opinion that patients will be harmed if these guidelines are taken up by dental, medical and surgical colleagues on recommendations from NICE.1 The advice is contrary to the views of the majority of practising cardiologists and cardiac surgeons in the UK who are responsible for managing those unfortunate enough to develop infective endocarditis (IE) as a result of a failure to offer preventative measures to patients who are particularly susceptible. In our survey of 520 cardiologists and cardiac surgeons in the UK carried out 12 months ago, 94.2% felt that patients “at risk” of IE should receive antibiotic prophylaxis (ABP) prior to dental procedures in an attempt to try and prevent IE.2 In November 2007, we detailed our criticisms to NICE in response to the publication of the unwieldy and voluminous draft document that was virtually unreadable, unclear and disorganised. A summary of our opinion was published on the British Cardiac Society website.3 In this draft document, numerous summaries of data from the literature were presented which associate IE with various dental, surgical and interventional procedures but conclusions were then illogically drawn by the authors that patients “at risk” did not need to receive ABP. The conclusions were not supported by evidence from the literature but were simply the opinion of those responsible for this misleading publication. The authors tried to justify their conclusions by quoting estimates of risk for patients with particular cardiac defects, and estimates of risks for certain procedures. We regard this as a meaningless exercise and such guestimates cannot be accepted as the science on which to base advice which is illogical. Pathology has taught us that IE cannot occur without bacteraemia and a susceptible endocardial lesion or intravascular foreign body in-situ. The consequences of this are ignored by the authors because randomised clinical trials do not exist to support the case for antibiotic prophylaxis (ABP). We agree that the conditions that need to exist for an endocardial vegetation to develop in a patient include a susceptible cardiac lesion with endocardium that is in such a state to enable bacteria to adhere to it, bacteraemia itself sufficient to allow seeding of the endocardium and the ability of the bacteria to resist the body’s immune defense mechanisms to eradicate the infection. This understanding explains why not every patient “at risk” who undergoes a bacteraemia-producing procedure goes on to develop IE and why those who do, present at various intervals from the interventional procedure. To recommend not trying to eradicate or minimise predictable bacteraemia associated with these procedures in patients “at-risk”, especially when thousands of case reports have been published in the literature linking them with IE is in our view illogical and perverse. The authors have chosen to ignore such reports and their significance. In the UK, 83.3% of cardiac specialists believe that case reports of bacteraemia associated with invasive procedures constitute “evidence” to support the need to try and prevent IE associated with those procedures in cardiac patients at risk. Moreover, 74.6% felt that case reports of IE associated with invasive/interventional procedures constituted “evidence” sufficient enough to warrant ABP for those patients at risk who were undergoing those procedures.2 The value and importance of case reports in helping us to understand disease mechanisms, pathogenesis and treatment strategies should not be underestimated and thankfully most editors of peer-review journals still take this view. There is also evidence in the literature that bacteraemia may persist for > 1 hour after procedures.4 Although we accept that ABP will not be successful all the time there is also evidence that bacteraemia can be abolished or minimised by ABP5 - but this too has been conveniently ignored. We all have to accept that although day-to-day tasks such as eating and tooth brushing are associated with bacteraemia, it is impractical to use ABP for these events even though occasionally these episodes may indeed be responsible for IE in patients at risk. We must therefore strongly support the need for good dental hygiene and regular dental care for such patients in order to try and minimise their risk of IE. Surprisingly, there is no mention in the draft document of the devastating consequences of IE – the serious systemic upset, the devastating vasculitic and embolic extracardiac complications and the destructive cardiac effects that result in the need for urgent or emergency cardiac surgery in patients who are very sick. The prolonged in- hospital stay – much of which will be in intensive care, the prolonged need for high-dose, expensive parenteral antibiotics, serial haematological, biochemical, microbiological and cardiac investigations and the input required from other specialists to deal with the complications of IE are also ignored. The long-lasting devastating effects of the embolic complications particularly those associated with the CNS such as embolic/haemorrhagic stroke and cerebral abscess including hemiplegia, paraplegia, aphasia and visual loss are disastrous in patients of any age but particularly in the younger patient who has a career and family responsibilities which may be wiped out in an instance. The ideas that the risk of antibiotic-associated adverse events exceeds the benefit that ABP has to offer “at risk” patients who undergo a dental, gastrointestinal or genitourinary tract procedure and that ABP is likely to be responsible for the development of antibiotic resistance among micro -organisms are neither borne out in clinical practice nor supported by any evidence in the literature. These are not good enough reasons to abandon ABP for these susceptible individuals. The opening sentence of the NICE draft document “This guideline offers best practice advice on antimicrobial prophylaxis against infective endocarditis before an interventional procedure …..” cannot be further from the truth. Moreover, the “Quick reference guide” is illogical, will be ignored by those physicians, dentists and surgeons responsible for managing patients “at risk” of IE and will remain an embarrassment to the authors. References 1. Prophylaxis against Infective Endocarditis: Antimicrobial prophylaxis against infective endocarditis in adults and children undergoing interventional procedures. Quick reference guide. National Institute for Health and Clinical Excellence (NICE) clinical guideline 64. www.nice.org.uk 2. Ramsdale DR. Against the motion: “Prophylactic antibiotic therapy to prevent endocarditis after dental procedures is unnecessary and inappropriate”. BCS Annual Scientific Conference, Glasgow. June 6th 2007. 3. Ramsdale DR. Response to draft document by NICE on “Antibiotic Prophylaxis against Infective Endocarditis in adults and children”, 27th November 2007. www.bcs.com/pages/news 4. Tomas I, Alvarez M, Limeres J, Potel C, Medina J, Diz P. Prevalence, duration and aetiology of bacteraemia following dental extractions. Oral Dis 2007;13:56-62. 5. Lockhart PB, Brennan MT, Kent ML, Norton HJ, Weinrib DA. Impact of amoxicillin prophylaxis on the incidence, nature and duration of bacteraemia in children after intubation and dental procedures. Circulation 2004;109:2878-84. Yours sincerely, Dr David R Ramsdale FRCP MD and Dr Nicholas D Palmer MRCP MD Consultant Cardiologists, Mr John A C Chalmers FRCS and Mr Brian Fabri FRCS Consultant Cardiac Surgeons From: The Cardiothoracic Centre, Thomas Drive, Liverpool, UK. L14 3PE. Competing interests: None declared |
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David Wray, Professor of Oral Medicine University of Glasgow, Nicholas Brooks, John Gibbs, Danny Keenan, Jonathan Sandoe, Tim Stokes
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The NICE guideline on prophylaxis against infective endocarditis (IE) (www.nice.org.uk/CG064) recommends an important change in clinical practice and it is therefore not surprising that there should be concerns expressed about the basis for not recommending the use of antibiotics as prophylaxis against infective endocarditis before dental and other interventional procedures. Shanson notes that, in contrast to the NICE guidelines, the American Heart Association (AHA) guideline advises antibiotic prophylaxis for some dental procedures in patients with high risk cardiac conditions and concludes that these guidelines appear more logical than those of NICE. It should be noted that there is an absence of evidence to support antibiotic prophylaxis for such a 'high risk' subgroup. Critically, the absolute risk of developing IE as a consequence of an interventional procedure is small even in those with an increased relative risk of developing the disease. Shanson has also argued that NICE has placed unjustified emphasis on the competing risk of fatal anaphylaxis following amoxicillin administration. The baseline analysis of the de novo cost-effectiveness model assumes no negative consequences of antibiotics (fatal or otherwise), which is arguably optimistic. It is also important to recognise that the economic analysis did not take into account any anaphylactic episodes that would result in hospitalisation but not death: these are rare, but not as rare as fatal anaphylaxis. The resulting incremental cost effectiveness ratio (ICER) for the cheapest option (oral amoxicillin) was estimated to be around £88,000 per QALY. Informing that estimate were assumptions about the risk of developing IE following a dental procedure that were in line with GDG opinion following consideration of the available evidence. Other assumptions were made that would favour antibiotic prophylaxis. This ICER is of course well outside normally accepted thresholds, notwithstanding the limitations of the analysis. The ICERs produced by the de novo analysis were also consistent with earlier non-UK analyses that also took a similar view of the risk of developing IE following an interventional procedure. Ramsdale and colleagues offer strong criticism of the guideline recommendations and claim they are contrary to the views of the majority of practising cardiologists and cardiac surgeons in the UK. These opinions were submitted to NICE during stakeholder consultation on the draft guideline, were answered in full by the guideline developers and our response can be reviewed on the NICE website (see: http://www.nice.org.uk/guidance/index.jsp?action=download&o=40215). It should also be noted that the British Cardiovascular Society has endorsed the published guideline (see: http://www.bcs.com/pages/news_full.asp?NewsID=18569894). The decisions NICE makes on behalf of the NHS are amongst the most difficult in public life. These decisions take account of the best available evidence of clinical and cost effectiveness. In the context of prophylaxis against infective endocarditis, therefore, the adoption of extremely high cost-effectiveness thresholds as implied by the arguments of Ramsdale and colleagues are clearly unjustified. It is important to reiterate that the NICE guideline is not alone on the international stage in terms of recommending a much more limited role for antibiotic prophylaxis against infective endocarditis prior to interventional procedures.1 As Harrison, Hoen and Prendergast note in a recent Lancet editorial on this topic “practices for prophylaxis of IE seem set to change. New guidelines aim to provide simple, unambiguous protocols for everyone involved in the care of those few patients at risk of the disease”.2 It is our belief that this NICE clinical guideline has achieved this important task. David Wray, Chair, NICE Prophylaxis against Infective Endocarditis Guideline Development Group (GDG) and Professor of Oral Medicine; d.wray@dental.gla.ac.uk Nicholas Brooks, GDG member and Consultant Cardiologist John Gibbs, GDG member and Consultant Cardiologist Danny Keenan, GDG member and Consultant Cardiothoracic Surgeon Jonathan Sandoe, GDG member and Consultant Microbiologist Tim Stokes, Short Clinical Guidelines Technical Team and Associate Director, Centre for Clinical Practice, NICE 1. Wilson W, Taubert K, Gewitz M et al. (2007) Prevention of Infective Endocarditis. Guidelines from the American Heart Association. A Guideline From the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation 2007;116:1736-54. 2. Harrison JL, Hoen B, Prendergast BD. Antibiotic prophylaxis for infective endocarditis. Lancet 2008;371:1317-1319. Competing interests: None declared |
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Raj Mohindra, Consultant Cardiologist Newcastle upon Tyne
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The basis of the recent NICE guidance in relation to antibiotic prophylaxis is the view that giving prophylactic antibiotics to a large number of people to prevent a relatively few cases of infective endocarditis is not justified. Particularly given the lack of evidence supporting the proposition that giving antibiotic prophylaxis reduces the incidence of infective endocarditis. The situation is in fact one of equipoise in relation to this proposition. (1) The effect of the NICE guidance is to precipitated an implicit population wide clinical trial comparing the incidence of infective endocarditis in historical controls who received antibiotic prophylaxis for dental treatment with a prospective cohort that will not. The difficulty with this is that the decision has been based on cost- effectiveness in the absence of any meaningful evidence base rather than a desire to explore the scientific uncertainty. The solution I would offer is this: A clinical trial is ethically defensible given the equipoise. However, given NICE has precipitated this trial it is morally incumbent upon NICE to recognise this effect of its decision and to ensure that the data collection is undertaken in as complete a way as is possible. Further NICE should explicitly undertake to reverse its guidance if this data suggests that there is a significant increase in the incidence of infective endocarditis in the prospective cohort. The general principle is that decisions about cost-effectiveness cannot be meaningful in the absence of a sound evidence base. The power of NICE should be constrained by this principle. (1) Prendergast BD, Harrison JL, Naber CK. Commentary on endocarditis prophylaxis: a quaint custom or medical necessity? Heart. 2008 Jul;94(7):931-4. Competing interests: None declared |
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