NHS EVIDENCE

Antiplatelet dosage for PCI
Overview: Percutaneous coronary intervention (PCI) is an important advance in the treatment of patients with acute coronary syndromes, with or without ST segment elevation. Despite the capacity of PCI to reduce major cardiovascular events, the risk of thrombotic complications remains an important concern. Hence, attention is being focused on the development of fast-acting anti-platelet regimens that achieve high levels of platelet inhibition.

Current advice: Aspirin, in combination with clopidogrel – a thienopyridine adenosine diphosphate receptor antagonist – prevents major thrombotic events in patients undergoing PCI and has been the standard of care for more than a decade.NICE guidance on the early management of unstable angina and non ST segment elevation myocardial infarction recommends offering a single loading dose of 300 mg aspirin and continuing aspirin indefinitely.For patients with no contraindications, who may undergo PCI within 24 hours of admission to hospital, NICE recommends offering a 300 mg loading dose of clopidogrel. The guidance states that there is emerging evidence about the use of a 600 mg loading dose of clopidogrel for patients undergoing PCI within 24 hours of admission. However, NICE was not able to formally review all the evidence and was therefore unable to recommend this at the time of guidance publication (March 2010).
New evidence: The CURRENT-OASIS 7 trial (The Lancet Volume 376, Issue 9748) assessed whether doubling of the loading and maintenance dose of clopidogrel for 7 days was better than the standard dose and if high dose aspirin was better than low dose aspirin in patients undergoing PCI.A 7 day double dose clopidogrel regimen (600 mg on day 1, 150 mg on days 2 to 7, then 75 mg daily) was associated with a reduction in cardiovascular events and stent thrombosis compared to the standard dose (300 mg on day 1 then 75 mg daily). The analysis suggests a clear benefit in the 17,236 patients who underwent a PCI procedure.
Using the CURRENT/OASIS 7 trial definition, major bleeding was more common with double than standard dose clopidogrel. Before PCI, rates of ischaemic events or major bleeding did not differ between the groups.The researchers conclude that a double-dose clopidogrel regimen (600 mg loading dose) can be considered for all patients with acute coronary syndromes treated with an early invasive strategy and intended early PCI.Efficacy and safety did not differ between high dose (300 to 325 mg daily) and low dose (75 to 100mg daily) aspirin. However, since the dose comparison was for only 30 days, use of low-dose aspirin is still thought to be reasonable for long-term therapy.

Commentary:"CURRENT-OASIS 7 is the latest in a long list of trials that tests the impact of dual anti-platelet therapy on efficacy, and since most trials look at the effect of increased therapy to prevent stent thrombosis (or its surrogate acute myocardial infarction/death), also importantly bleeding. A number of studies and retrospective analyses of large trials have shown the benefit of 600 mg over 300 mg.
"I see two problems with this study. First, two things were changed at once (so we don't really know which change, aspirin or clopidogrel, was beneficial in this study) and secondly, increasing the loading dose of clopidogrel to 150 mg with maintenance of 150 mg, if this is thought to be of value (and the trial suggests it might be), was associated with extra bleeding risk.
"So how should we use this study as applied to UK practice? In patients presenting with acute coronary syndrome who are at a low risk of bleeding (i.e. normal renal function, body weight of more than 60kg and no evidence of GI tract disease), it might be reasonable to give 600 mg clopidogrel loading but then to increase the maintenance clopidogrel dose to 150 mg for one week (only) and to maintain the patient on 75 mg aspirin and 75 mg clopidogrel." - Tony Gershlick, Professor of Interventional Cardiology, University of Leicester.

For more evidence relating to cardiovascular health visit NHS Evidence - Cardiovascular.
NICE guidance on the early management of unstable angina and non ST segment elevation myocardial infarction is due to be updated in March 2013.

Eyes on Evidence helps contextualise significant new evidence, highlighting areas that could signal a change in clinical practice. It does not constitute formal NICE guidance. The commentaries included are the opinions of contributors and do not necessarily reflect the views of NICE.

NICE GUIDELINES

Prevention of cardiovascular disease

http://guidance.nice.org.uk/PH25

NICE GUIDELINES

In the HSJ today

NICE publishes the first set of quality standards
1 July 2010
Trusts should screen all stroke patients for cognitive impairment within six weeks of diagnosis, according to the first set of quality standards to be published by the National Institute for Health and Clinical Excellence.

BLOOD PRESSURE

Rethinking high blood pressure
A recent study (Lancet 2010;375:895–905), suggests that visit-to-visit variation in systolic blood pressure (SBP) and maximum SBP are strong predictors of stroke, independent of mean SBP.Here one of the authors, Professor Peter Rothwell of the Stroke Prevention Research Unit at Oxford's John Radcliffe Hospital discusses some clinical implications of the work.
Hypertension is the most prevalent treatable risk factor for stroke. One in two adults is affected by it, and the risk of being hypertensive during a lifetime is about 90 per cent. Despite this, the underlying mechanisms by which raised blood pressure (BP) can cause cardiovascular disease are poorly understood. Clinical guidelines for the diagnosis and treatment of hypertension focus heavily on average blood pressure.
The dominant hypothesis is that we each have an underlying average 'true' blood pressure, which is difficult to measure precisely, but which accounts for the vast majority of the complications of hypertension, and explains the benefits of BP-lowering drugs. Variability in BP is dismissed as uninformative and 'random', only noteworthy as an obstacle in the measurement of true underlying BP. Under-diagnosis and under-treatment of hypertension is a major, seemingly intractable problem in all healthcare systems. The new research shows that part of the problem is likely to have been under-recognition of the impact of variability in BP on diagnosis in routine clinical practice in primary care. It shows that doctors have to make diagnoses on the basis of BP measurements that often vary substantially from visit to visit.
All current clinical guidelines encourage doctors to ignore variability and occasional high readings and to rely exclusively on the average BP from multiple visits or 24-hour monitoring. The new research shows that increased variability in BP, a high maximum BP and episodic hypertension are associated with high risks of stroke and other vascular events, and emphasise that any reassurance taken from the fact BP is sometimes normal is false.Importantly, the new research shows that excess variability in blood pressure is treatable, and also that it can be made worse by some drugs used to treat hypertension. Some BP-lowering drugs increase variability, some have no effect and some decrease it. The choice of drug or combination should now therefore take into account their likely effect on variability as well as on the average level. Future drug trials should routinely report effects on variability.There should also be a greater emphasis on consistency of control of BP in patients who are already on treatment. The research showed that even patients with well-controlled BP had a five-fold excess risk of vascular events if their BP was highly variable, even when fully compliant with their medication. Recent calls to abandon measurement of BP after treatment are premature. The fact that many people now monitor their own BP at home will be helpful in identifying variability.New antihypertensive drugs should be developed to be BP-stabilising as well as BP-lowering. Drugs that reduced variability without reducing average BP should still prevent stroke, and would be likely to be helpful in patients who cannot tolerate reductions in their average BP.
Safety testing of all new drugs, irrespective of the indication, should include assessment of effects on instability and variability in BP, as well as on average BP.
*NICE recommends that calcium channel blockers or diuretics should be used first-line for most people (patients aged 55 or older or black patients of any age) with uncomplicated hypertension. NICE also currently recommends angiotensin-converting enzyme inhibitors (or angiotensin-II receptor antagonist where not tolerated) for first-line treatment of patients under the age of 55. Beta-blockers, unless otherwise indicated, are an inappropriate first- or second-line antihypertensive choice.For more information seeNHS Evidence - cardiovascular

NHS EVIDENCE CLINICAL PRACTICE

NHS Evidence provides fast, free access to the most up to date, quality information required by health and social care professionals.

Eyes on Evidence, highlights new research with a focus on possible implications for clinical practice.

QOF drives quality of services in primary care
Overview: About 60 per cent of adults have a long-term or chronic health problem such as coronary heart disease, stroke, hypertension, diabetes, mental disorder or asthma. Chronic diseases have a huge impact on individuals' lives and NHS resources.

Current treatment: The UK's government is keen to tackle chronic disease management to reduce unnecessary admissions to hospital for patients and associated NHS costs. The Quality and Outcomes Framework (QOF), a pay-for-performance scheme funded by NICE, was introduced in 2004 to incentivise effective clinical care, practice organisation and providing a positive patient experience in primary care.

New evidence: The analysis (Campbell SM et al. N Engl J Med 2009;361:368–78) investigated the impact of the initiative on the quality of care provided to people with coronary heart disease, diabetes and asthma using medical records and patient questionnaires. Initial improvements were maintained for heart disease and asthma but reached a plateau a year after introduction. Care for diabetes continued to improve but at the same rate before the scheme was introduced. No changes in access to care or interpersonal aspects of care were seen but continuity of care was reduced. In summary, the scheme accelerated improvements in the quality of care in certain areas but this was not sustained when targets were reached. A recent comprehensive review by the Health Foundation shows that although the evidence is not strong, improvement initiatives can sometimes reduce costs to service providers while simultaneously making care better for patients.This research was carried out at the National Primary Care Research and Development Centre at Manchester University, which is contracted by NICE to support the QOF.

Commentary: "The effectiveness of incentive schemes in improving services is an important question for policy makers, and there are few bigger schemes than the UK's QOF. Can a national scheme making up 25 per cent of GPs' income transform care? The scheme was introduced in the absence of experimental controlled studies and therefore the best evidence we can hope for is provided in well-designed time series studies that report on performance before and after the introduction of the QOF.
"The series of studies by Campbell and colleagues that have tracked performance in the care of patients with asthma, diabetes and coronary heart disease in a sample of practices from 1998 is therefore an important and almost unique source of evidence. In earlier studies they have already shown steep increases in activity in practices in association with the introduction of the QOF. This paper takes a longer view, tracking performance from 1998, well before the QOF, to 2007, three years after the introduction of the QOF. This enabled the authors to compare the rate of improvement in performance before the QOF with the rate after the introduction of the QOF. They found that the scheme accelerated improvements in the short term quality for asthma and diabetes, but not coronary heart disease, but once targets were reached improvement slowed. Quality declined between 2005 and 2007 for some aspects of care not linked to the QOF, and continuity of care declined after the introduction of the QOF.
"These findings have three implications. First, major policy changes need careful evaluation; initial pilot studies would be ideal. Second, incentives schemes can impact on performance, but the impact can run out of steam. Third, incentive schemes have unintended consequences. Since the QOF is being retained, its indicators require remodelling in order to increase efficiency and reduce the negative consequences. In large measure, this task will fall to the National Institute for Health and Clinical Excellence, which will be advising on the selection of indicators in the future." - Richard Baker is Professor of Quality in Health Care and Head of Department for Health Sciences at Leicester University.

QOF influences blood pressure recordings

Overview: High blood pressure (hypertension) increases the risk of heart attacks, strokes and other health problems. In the United Kingdom, high blood pressure (hypertension) affects about half of the population over 65, and about 1 in 4 middle-aged adults.

Current treatment: It is universally recognised that controlling hypertension will reap significant public health benefits. Several different bodies including NICE and the British Society of Hypertension have produced guidance on treating people with hypertension through lifestyle modification and drug therapy. If lifestyle modification alone does not lower blood pressure sufficiently, NICE recommends treatment with an ACE inhibitor for those under 55 years of age and a calcium-channel blocker or thiazide-type drug for those over 55 year or black patients of any age (unless contraindicated). Combination therapy is then recommended if blood pressure remains uncontrolled. However, implementing the guidance presents its own challenges. In 2004 the UK Quality and Outcomes Framework (QOF) introduced a remuneration scheme for GPs achieving clinical targets for hypertension set at 150 mmHg systolic or less.

New evidence: This study (Carey IM et al. J Hum Hypertens 2009;23:764–770) investigated whether rewarding GPs for achieving target blood pressure in their practice had an impact on blood pressure recordings. The group analysed more than 3 million blood pressure readings (taken 2000–2005) from over 235 000 patients with ischaemic heart disease, stroke or hypertension. The percentage of people with systolic blood pressure above the target value fell from 36 per cent to 19 per cent during this period. There was a trend towards recording systolic values just below — rather than just above — the cut-off but this did not adversely affect clinical management. In conclusion, blood pressure levels in UK primary care have continued to fall since the QOF was introduced; QOF targets may have contributed to this through increased treatment.

Commentary: "The authors have compared BP recording and BP treatment in 2000-2001 with 2004-2005. They specifically examine for terminal digit preference. Several findings stand out; SBP levels are falling overall, there is some recording bias but not much – the authors predict that the prevalence of SBP above 150mmHg should be 23 per cent and is 19 per cent; and there has been a rise in prevalence of antihypertensive treatment. While there is some terminal digit preference for figures just below 150mmHg, patients with readings of 148-9 mmHg were also more likely to be on antihypertensive medication.
The authors conclude that QOF has contributed to the reduction in BP levels and that this is a positive finding from a public heath perspective. The paper therefore is reassuring and refutes accusations of 'gaming' i.e. recording of BP at just below target level by GPs. The authors are reassured that patients with levels just below the target are more likely to be receiving antihypertensive medication but from a clinical perspective, I hope this does not represent additional prescribing to reach the QOF target but that we can continue to consider the potential additional burdens for patients in terms of medicine - taking and side effects that may be required to reach an arbitrary cut off figure!" – Norma O'Flynn is a GP and Clinical Director of the National Clinical Guideline Centre


Eyes on Evidence helps contextualise significant new evidence, highlighting areas that could signal a change in clinical practice. It does not constitute formal NICE guidance. The commentaries included are the opinions of contributors and do not necessarily reflect the views of NICE.

E-VTE : E-LEARNING RESOURCE

New eLearning resource for VTE
Friday, October 2nd, 2009

The Chief Medical Officer’s Venous Thromboembolism (VTE) Implementation Working Group and eLearning for Healthcare have published a web-based education resource (e-VTE) designed to help raise awareness and improve understanding of VTE.
ActionHealthcare professional, both in primary and secondary care should be aware of the importance of preventing VTE. e-VTE provides pragmatic information on assessing the risk of VTE for an individual and advising appropriate preventative measures. It complements the NPCi educational materials, which provide a detailed summary of the evidence base for the prevention and treatment of VTE.

What is the background to this?
VTE is a significant patient safety issue because it is estimated to cause 25,000 potentially avoidable deaths each year in hospitals in England. The VTE eLearning resource was designed to support the national VTE prevention strategy and aims to improve understanding of VTE within the clinical community in both the hospital setting and in primary care. The interactive learning materials include a pre-learning questionnaire and a post-learning assessment together with four sessions of eLearning. These cover the demographics, epidemiology and risk profile of VTE, and include an overview of methods of thromboprophylaxis (mechanical and pharmacological) and risk assessment and implementation of thromboprophylaxis in hospitals and in primary care.
This resource is likely to be useful in conjunction with the NPC’s suite of educational materials on VTE, available on NPCi. This includes a <60 minute eLearning event, which considers the prevention and treatment of VTE and looks in more detail at the evidence base for pharmacological interventions. A case study, a quiz, and key slides are also available.

NICE is producing a clinical guideline on reducing the risk of VTE, which is due for publication in January 2010.

HEART FAILURE IN PRIMARY CARE

Heart failure is common, deadly and preventable, affecting around 900,000 people in the UK. Heart failure accounts for about 5% of admissions to general medical or elderly care hospital beds, and readmission rates can be as high as 50% in the six months following initial hospital stay. Annual mortality ranges from 10-50% depending on initial severity. We have developed this Evidence Update to provide clinicians and commissioners with the best available evidence to help them provide better patient care.

Overview: Heart failure is abnormal cardiac function which prevents the heart from pumping efficiently. About 900,000 people in the UK have heart failure, costing the NHS more than £600m every year. The incidence of heart failure increases steeply in the elderly and is more common in men than women.There are many treatments available to keep the condition under control and relieve symptoms. Accurate diagnosis is important to determine the underlying cause and initiate treatments to alleviate symptoms, delay progression and improve prognosis.

Current diagnostic strategies: There is no single diagnostic test for heart failure. Diagnosis relies on clinical judgement based on a combination of history, physical examination and appropriate investigations.

NICE recommends healthcare professionals carry out the following investigations:. 12-lead electrocardiogram (ECG) . and/or natriuretic peptides (BNP or NTproBNP) – where available.If one or both are abnormal, transthoracic Doppler 2D echocardiography should be performed because it consolidates the diagnosis and provides information on the underlying functional abnormality of the heart.

Alternative methods of imaging the heart should be considered when a poor image is produced by echocardiography. Such methods may include radionuclide angiography, cardiac magnetic resonance imaging, or transoesophageal Doppler 2D echocardiography.

New evidence: Two recent systematic reviews on the diagnosis of heart failure in primary care have found potential cost savings of sending some patients with symptoms suggestive of heart failure directly for echocardiography.

Madhok et al (BMC Family Practice 2008, 9:56) looked at symptoms, signs and diagnostic tests in the diagnosis of left ventricular dysfunction (which is responsible for about 50 per cent of heart failure). They found that the clinical sign of a displaced apex beat was very useful, if present, at raising suspicion of heart failure (positive likelihood ratio of 16), and confirmed previous findings that ECG and natriuretic peptide measurements have similar potential as 'rule out' tests.

Mant et al (Health Technol Assess. 2009 Jul;13(32):1-207, iii) supplemented a systematic review of symptoms and diagnostic tests with individual patient data analysis. They found natriuretic peptides superior to ECG in diagnosing heart failure. Natriuretic peptides BNP and NT-proBNP were found to be of similar utility. The review also states that simple clinical features (basal crepitations, previous history of myocardial infarction; ankle oedema and gender) could be used as a way of determining which patients should be referred directly for echocardiography without prior testing.

The potential implications of this work are currently being reviewed by NICE; updated guidance will be published later next year.

Commentary: "The evidence from Mant et al's analysis may need to be taken into account by NICE when reviewing the current guideline. The evidence suggests that BNP (or NT-proBNP) should be recommended over ECG and that some patients should be referred straight for echocardiography without undergoing any preliminary investigation. "Mant et al's cost-effectiveness analysis suggests that a clinical decision rule for diagnosis of heart failure in primary care is likely to be considered cost-effective to the NHS in terms of cost per additional case detected. The cost-effectiveness analysis further suggests that, if the likely benefit to the patient in terms of improved life expectancy is taken into account, the optimum strategy would be to refer all patients with symptoms suggestive of heart failure directly for echocardiography."

Professor Tom Quinn is clinical lead for NHS Evidence - cardiovascular, stroke and vascular collections and Professor of Clinical Practice at the Faculty of Health and Medical Sciences, University of Surrey.

NICE GUIDELINES

First NICE quality standards will include stroke
6 August, 2009 | By Helen Crump

The National Institute for Health and Clinical Excellence is to create its first quality standards on stroke, dementia, neonatal care and venous thromboembolism.


The four areas have been referred for development by the national quality board.

Last year’s next stage review expanded NICE’s remit to create more independent standards for the health service.

The statements for each NICE quality standard will be accompanied by a measurable element or indicator to enable assessment of quality and improvement.

NHS medical director Sir Bruce Keogh said: “The quality standards that are being developed by NICE will give patients and NHS and social care staff absolute clarity on what high quality care in these four areas looks like.”

The Care Quality Commission said the standards would apply to private providers as well as NHS organisations. It said it would explore how to build these into its regulatory framework, for both commissioners and providers. This could be done through the registration framework or periodic review.

BRITISH HEART FOUNDATION

http://www.bhf.org.uk/research_health_professionals/health_professionals/factfiles/factfile_index.aspx

FACTFILES INDEX

Arrhythmias
AF and the risk of stroke
Arrhythmias and sudden death - implications for GP's
Atrial fibrillation update
Ventricular arrythmias

Coronary heart disease
Cardiac Rehab
Delays in treatment for acute MI
Returning to work after an MI

General and screening
Abdominal aortic aneurysms
Air travel and venous thromboembolism
Antenatal screening for congenital heart disease
Computer assisted Ecg interpretation
Depression and heart disease
Driving and the heart
Erectile dysfunction
Inherited Cardiovascular Conditions
Role of BNP and Heart failure

Medication
Anti-cancer drugs and the heart
Nsaids and CVD
Use of antiplatelet drugs
Use of Beta blockers in heart failure

Nice Guidelines
Early stroke intervention
JBS risk assessment guidelines
Managing coronary stents
Prevention of Endocarditis

Risk factors for CVD
Blood pressure measurement
Communication risk to patients
Ethnic differences in CHD
Familial Hypercholesterolaemia
Novel risk factors and CHD risk
Obesity 1 of 4 Causes
Obesity 2 of 4 Dietry management
Obesity 3 of 4 PA
Obesity 4 of 4 Surgical interventions
Physical activity to reduce CVD risk
Smoking cessation and NRT in primary care
Triglycerides

CONSULTATION : Prevention of Cardiovascular Disease

Consultation: Prevention of cardiovascular diseaseView full details of consultation
NICE was asked by the Department of Health (DH) to develop guidance on the prevention of cardiovascular disease at the population level.
The consultation will run from 12 May to 10 June 2009.
Publication Date: 12 May 2009
Publication Type: News
Publisher: National Institute for Health and Clinical Excellence (NICE)
Topics
Outcomes
Circulatory diseases
Cardiovascular diseases

NHS EVIDENCE - cardiovascular

Annual Evidence Update on Atrial Fibrillation (NHS Evidence - cardiovascular)
www.library.nhs.uk/cardiovascular
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and if left untreated is a significant risk factor for stroke and other morbidities. NICE published a guideline on management of AF in June 2006. The NHS Evidence - cardiovascular team has systematically identified high quality evidence that has appeared since then, and will present this with summaries written by leading experts in the field.

ROLE OF NICE - an American viewpoint

Towards a Better Value Health System — The Role of NICE in the U.K. Health Care System
By: Rubin Minhas, MB ChB
The snake oil sales man, newly arrived in town and frequently presenting himself as a 'doctor', would begin pitching his concoction with grandiose claims that it was a panacea or perhaps a cure for a disparate and extensive list of ailments. With his claim enthusiastically verified by a surreptitiously placed shill among the assembled audience, he could rely on the invisible catalysts of crowd psychology and peer pressure to gradually take hold. He and his accomplice would then leave town well before any unsuspecting consumers discovered they had been victims of an elaborate and often costly hoax. (1)
The example of the snake oil salesman, taken from popular folklore, illustrates the need for robust methods of assessing the efficacy of health care interventions and trustworthy ways of disseminating this knowledge. Most progress has largely occurred over the last 50 years. The first modern randomised trial (of streptomycin) was performed in the 1950s, and it was not until 1972 when Archie Cochrane's monograph, 'Effectiveness and efficiency: random reflections of health services' (2) began to lay the foundations for the modern evidence-based movement. Cochrane's thesis stated that as resources would always be limited, they should be used to provide equitably those forms of health care which had been shown in properly designed evaluations to be effective. In particular, he stressed the use of the randomised controlled trial (RCTs) as he felt these were likely to provide much more reliable information than other sources of evidence.
Almost simultaneously, John Wennberg's work in the U.S. led to methods for determining population-based rates for the utilization and distribution of health-care services. This demonstrated large variations in health care across different geographical areas. David Eddy's doctoral thesis also imparted vital early momentum to the nascent discipline for which he introduced the term 'evidence based' in 1990 (3), which was then extended to 'evidence-based medicine' by Gordon Guyatt and colleagues in 1992. (4) Eddy's analysis challenged the value of routine chest xrrays and annual Pap smears for women at low risk of cervical cancer and overturned the prevailing medical dogma. The implication was clear — medicine was (and still is) susceptible to what John Eisenberg termed 'eminence based medicine'. Since then, international variations in health care processes and outcomes have been documented with the realization that increased health care spending is not uniformly associated with improvements in patients' health status. Variation is a constant.
Identifying 'what works' and disseminating this information to health care professionals has been made increasingly difficult by the explosion in scientific knowledge and an epidemiological transition that has increased demands on clinicians while increasing the complexity of health care. Novel drugs are now released at the rate of almost one per every one and a half weeks (5), over 30,000 biomedical journals are published annually, and more than 17,000 new medical books published each year. (6) Systematic reviews of the literature have demonstrated that many studies are grossly inadequate and thus potentially misleading, and that over 95% of articles in medical journals do not meet the minimal standards of critical appraisal. (7)
Clinical guidelines have become increasing popular as a tool for synthesizing the biomedical literature. They have also attracted the attention of policy makers in light of their potential to reduce the delivery of inappropriate care and support the timely introduction of new knowledge into clinical practice. Proponents of clinical guidelines have claimed that use of the available scientific evidence can be increased by putting in place the infrastructure required to assure the systematic implementation of practice guidelines. (8)
However, the quality of clinical guidelines is also susceptible to variation. Biases or conflicts of interests may affect the interpretation of evidence, and the views of guideline authors may not be representative of multidisciplinary professionals. Their recommendations may also be harmful if they are incorrect or do not consider the impact on the resources available for other services. Guidelines have also been described as ideal vehicles for the rapid market dissemination of the pharmaceutical industry's products, particularly if they avoid mention of cost altogether. (9) For these reasons, there have been attempts to introduce quality criteria for the process of developing clinical guidelines.
During the 1990s, there was widespread public discontent in England with variations in care that have come to be termed 'postcode' variations, analogous to 'zip code variations' in the U.S. This resulted in patients in adjoining geographical areas, whose care came under the responsibility of different funding bodies in the single payer system, having different and sometimes contradictory coverage policies. (10) In the case of life extending treatments, this soon became publically and politically unacceptable.
This issue eventually led to a decision to establish a centralized, government-funded body called the 'National Institute for Health and Clinical Excellence' (NICE) whose role it would be to provide national guidance on which 'health technologies' should be available, for whom, and in which circumstances. In addition to appraising evidence of clinical effectiveness, NICE was remitted to also consider cost effectiveness. This was based on the premise that without explicit consideration of cost, recommendations could have no implications for policy. This process is worth reviewing in more detail.
The essence of the NICE approach to resource allocation is a utilitarian perspective that seeks to maximize efficiency ('the greatest good for the greatest number') of the pharmaceutical budget by estimating the value for money obtained from particular treatments. An independent advisory committee of health service professionals and lay people is requested to review clinical evidence that is submitted by an academic centre, which also undertakes a health economic assessment in addition to that submitted by the manufacturer of the technology under evaluation. Stakeholder engagement has played a significant role in the process, and testimony is also provided by clinical specialists and lay people who are selected from professional and voluntary sector bodies.
Both scientific value judgments ('what is good about the evidence') and social value judgments ('what is good for society') are involved in weighing evidence. As NICE's appraisal committee has no legitimacy in making social value judgments, a 'citizens council' of 30 lay people, demographically representative of the population has been established. This council has been consulted on the bioethical principles underpinning the challenge of ensuring distributive justice (or 'fairness' in allocating resources). How generalisable the views of these are to the greater population of the U.K. (around 60 million people) is a moot point.
NICE's advisory committees may produce binding recommendations that deal with a drug or several drugs within a therapeutic class (termed health technology guidance) or nonbinding recommendations that span a complete pathway of care (termed 'guidelines'). At this time, 117 NICE guideline summaries are currently posted to the National Guideline Clearinghouse. The guidance and guidelines are produced according to the prerequisites of deliberative democracy, i.e., publicity, revision, relevance, and in the case of binding guidance, the opportunity for stakeholders to lodge an appeal.
Recommendations by NICE that a particular drug should not receive funding within the single payer health care system of England and Wales can have important ramifications. These are particularly acute for individuals with life threatening illnesses and when a treatment which extends life is being considered. Unsurprisingly, NICE receives considerable public and media scrutiny. Its guidance may be subject to an appeal by drug manufacturers, and approximately half of these are upheld and returned to the (original) appraisal committee for reconsideration. In some notable cases, the judgment of the appeals panel, which is overseen by NICE's chairman, has subsequently been tested by judicial review within the courts, with mixed results so far that have largely been in favor of NICE.
The NICE guidelines are less controversial although this is not always the case. The main area where value has been added is for topics where there is no pre-existing guidance. Where there is already strong professional consensus, existing specialist guidelines hold sway for clinicians. Establishing credibility with professional groups is a slow process that improves gradually as participation increases.
What evidence exists, then, for the effectiveness of NICE? NICE is successful in producing guidance, and the majority of the recognition that it receives is based on its responsibility for process. In outcome terms, there is largely an absence of evidence. What evidence there is suggests a modest effect in specific therapy areas. Therefore, it may be best to conceive of NICE as having slowed the rate of health care expenditure on drugs (around 10% of health spending in the U.K. and U.S.), rather than as a tool for reducing it below baseline levels. This is partly because guidance primarily designed for synthesizing knowledge is not necessarily effective as a practical implementation tool, and guidance implementation is, itself, subject to variation. The increased use of guideline derived indicators may help lay the foundations for further translating the value of guidelines into practice and monitoring progress.
A criticism of NICE sometimes lies in that the length of time needed to produce guidelines (up to 2 years) and undertake technology appraisals is too long. This may result in the withholding of funding until NICE has produced guidance, or the diffusion of a particular innovation may already be substantially underway by the time guidance arrives. NICE is attempting to streamline its processes to remedy this and is considering evaluating products at the time of launch.
There is likely to be increased attention on learning from the experience of organizations like NICE following the $1.1 billion recently allocated to studying clinical effectiveness in the United States. Several caveats should be borne in mind. The utilitarian perspective is intrinsically population based, and so clinical excellence for the individual and cost effective, 'clinical excellence' for the population are not always the same. Also, as Alexis de Tocqueville noted over 170 years ago, cultural preferences in the United States place particular emphasis on the autonomy of the individual, the individual's freedom to choose, and a limited role for government. (11) Culturally sensitive approaches will need to be considered.
Notwithstanding these differences, the NICE paradigm offers a valuable insight into the application and challenges facing the application of evidence-based medicine and health economics in pursuit of the current holy grail of resources strapped health systems: better value.
Author
Rubin Minhas, MB ChBSanta Monica, Calif.
Disclaimer
The views and opinions expressed are those of the author and do not necessarily state or reflect those of the National Guideline Clearinghouse™ (NGC), the Agency for Healthcare Research and Quality (AHRQ), or its contractor ECRI Institute.
Potential Conflicts of Interest
Dr. Minhas states that he has chaired guidelines for the National Institute for Health and Clinical Excellence (NICE) (UK) and is an independent member of one of its advisory committees. He is a Harkness Fellow in Healthcare Policy and Practice, supported by the Commonwealth Fund.
References

Snake oil salesmen were onto something. Scientific American. Nov 1. 2007.
Cochrane AL. Effectiveness and Efficiency: Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust, 1972.
Eddy DM. "Practice policies: where do they come from?" JAMA 1990;263 (9): 1265, 1269, 1272.
Guyatt G, Cairns J, Churchill D, et al. ['Evidence-Based Medicine Working Group'] "Evidence-based medicine. A new approach to teaching the practice of medicine." JAMA 1992;268:2420-5.
The Pharmaceutical Price Regulation Scheme: an OFT market study. 2007. http://www.oft.gov.uk/shared_oft/reports/comp_policy/oft885.pdf.
Lowe HJ, Barnett O. Understanding and using the medical subject headings (MeSH) vocabulary to perform literature searches. JAMA 1994;271:1103-1108.
Haynes RB. Where's the meat in clinical journals? ACP J Club 1993;119:A23-A24.
Jencks SF, Huff ED, Cuerdon T. Change in the quality of care delivered to Medicare beneficiaries, 1998-1999 to 2000-2001. JAMA 2003;289:305-312.
Haycox A, Bagust A, Walley T. Clinical guidelines-the hidden costs. BMJ 1999;318: 391-3.
'NHS body to end postcode prescribing.' BBC News http://news.bbc.co.uk/2/hi/health/271522.stm.
A. de Tocqueville, Democracy in America (New York: Alfred A. Knopf, 1948).

NHS EVIDENCE - NEW!

Provided by NICE, NHS Evidence is a new service which will develop, enhance and expand the services that were previously provided by the National Library for Health (NLH). The NLH and its Specialist Libraries became part of NHS Evidence on 1 April 2009. Release 1 of the NHS Evidence portal and search engine went live on 30 April 2009, at http://www.evidence.nhs.uk/.

"Specialist collections" is the new name for the Specialist Libraries. Each collection has been renamed under NHS Evidence as "NHS Evidence - specialty", so, for example, the Stroke Specialist Library has become NHS Evidence - stroke, and the Skin Disorders Specialist Library has become NHS Evidence - skin disorders. But apart from the new name and branding on the websites, if you are a previous user of the Specialist Libraries, you shouldn't notice any other differences - even the URLs are staying the same for now. Within each collection, you will still find the same high quality resources, chosen for each specialty to ensure easy access to the best available evidence.

For more information about NHS Evidence, please follow this link: www.evidence.nhs.uk/AboutUs.aspx.

Background to the NHS Evidence Specialist Collections and Annual Evidence Updates
The specialist collections have been developed to identify and meet the information needs of particular communities of practice. They are web-based collections containing clinical and non-clinical information on the major health priority areas. Each specialist collection identifies and provides access to quality assessed information of relevance to the community that it serves. An aspect of this involves the production of Annual Evidence Updates, which aim to highlight the best current evidence for selected healthcare topics. Annual Evidence Updates consist of the good quality evidence from a search of research evidence on a particular topic over a 12 month period, plus user-friendly summaries written by relevant experts, and links to guidelines, secondary research and primary research, if applicable. All information included in Annual Evidence Updates has been subject to rigorous selection criteria.

The calendar of currently confirmed Annual Evidence Updates until September 2009 is available at www.library.nhs.uk/forlibrarians/sl.

Chest pain - Annual Evidence Update

Annual Evidence Update on Chest Pain (Cardiovascular Diseases Specialist Library)
http://www.library.nhs.uk/cardiovascular/
The Chest Pain annual evidence update (AEU) 2009 updates the previous AEU published in February 2007.

Chest pain is a common reason for patients seeking healthcare, often as an emergency. But not all chest pain is cardiac in origin, and (for example) the proportion of patients calling for an ambulance with chest pain who have proven heart attack is low – less than 10% in some studies. We have identified key systematic reviews and related documents to support clinicians and commissioners in identifying the best available, current evidence on this topic. NICE are due to publish guidance on chest pain in December 2009.

The Update includes commentaries from an Expert Group, chaired by our Clinical Lead, Professor Tom Quinn, from the Faculty of Health and Medical Sciences, University of Surrey.