Prioritizing health outcomes in a limited world: writing lipid guidelines.

PURPOSE OF REVIEW: Guidelines are increasing in importance as healthcare becomes standardized. This article examines the processes by which the new US American College of Cardiology-American Heart Association and UK National Institute of Health and Care Excellence lipid guidelines came to their conclusions and how the nature of the evidence base and health economics contributed to the recommendations made. RECENT FINDINGS: The writing of guidelines is becoming a systematic formal process with increasing emphasis on maintaining integrity, minimizing conflicts of interest and using consistent systematic methods to define the evidence base, grade its quality and then make recommendations. These processes are illustrated by showing why new cardiovascular disease risk assessment tools were required, what recommendations could be made about diet and lifestyle, why a fixed-dose drug treatment protocol as opposed to a target-based approach was recommended for the management of patients in secondary prevention, diabetes and primary prevention and how these would impact clinical practice. SUMMARY: Modern systematic evidence assessment and economic appraisal convincingly favour the use of lipid-lowering drugs especially statins at higher doses than currently prescribed in secondary prevention and at lower risk thresholds in primary care than previously imagined. As long-term adherence to treatment is required patient choice is key to realizing the benefits of these interventions.

Healthcare system performance improvement: a comparison of key policies in seven high-income countries.

PURPOSE: Evidence suggests that healthcare system performance may be improved with policy emphasis on primary care, quality improvement, and information technology. The authors therefore sought to investigate the extent to which policy makers in seven countries are emphasizing these areas. DESIGN/METHODOLOGY/APPROACH: Policies in these three areas in seven high-income countries were compared. A comparative descriptive approach was taken in which each of the country-specialist authors supplied information on key policies and developments pertaining to primary care, quality improvement and information technology, supplemented with routine data. FINDINGS: Each of the seven countries faces similar challenges with healthcare system performance, yet differs in emphasis on the three key policy areas; efforts in each are, at best, patchy. The authors conclude that there is substantial scope for policy makers to further emphasize primary care, quality improvement and information technology if aiming for high-performing healthcare systems. ORIGINALITY/VALUE: This is the first study to investigate policy-makers' commitment to key areas known to improve health system performance. The comparative method illustrates the different emphases that countries have placed on primary care, quality improvement and information technology development.

Explanatory models are needed to integrate RCT and observational data with the patient's unique biology.

In this review, we make the case for evidence-based medicine (EBM) to include models of disease underscored by evidence in order to integrate evidence, as it is currently defined, with the patient's unique biology. This would allow clinicians to use a pathophysiologic rationale, but underscoring the pathophysiological model with evidence would create an objective evidence base for extrapolating randomized controlled trial evidence. EBM encourages practitioners not to be passive receivers of information, but to question the information. By the same token, practitioners should not be passive executors of the process by which information is generated, appraised and applied, but should question the process. We use the historical examples of the evolution of EBM to show that its subordination of a pathophysiological perspective was unintentional, and of essential hypertension to illustrate the importance of disease models and the fact that evidence supporting them comes from many sources. We follow this with an illustration of the benefits a pathophysiological perspective can bring and a suggested model of how inclusion of pathophysiological models in the EBM approach would work. From a practical perspective, information cannot be integrated with the patient's unique biology without knowledge of that biology; this is why EBM is currently so silent on how to carry out its fourth stage. It is also clear that, regardless of whether a philosophical or practical definition of evidence is used, pathophysiology is evidence and should be regarded as such.

Identification and management of familial hypercholesterolaemia: what does it mean to primary care?

Familial hypercholesterolaemia is one of the most common dominantly inherited disorders to be identified in primary care, leading to raised serum cholesterol evident from the first year of life. Around 1 in 500 people are affected by this condition, but less than 15% of these are currently attending lipid clinics, suggesting that the vast majority are unrecognised in general practice. The recently released National Institute for Health and Clinical Excellence evidence-based guideline on the identification and management of familial hypercholesterolaemia provides an opportunity to bridge this gap. Primary care has a role in systematic and opportunistic case finding, such as recognising the relevance of a family history of premature coronary heart disease and/or grossly elevated cholesterol. Although affected individuals need specialist care, GPs can reinforce the information provided by specialists and support cascade screening to other affected members of the extended family.

Predicting cardiovascular risk in England and Wales: prospective derivation and validation of QRISK2.

OBJECTIVE: To develop and validate version two of the QRISK cardiovascular disease risk algorithm (QRISK2) to provide accurate estimates of cardiovascular risk in patients from different ethnic groups in England and Wales and to compare its performance with the modified version of Framingham score recommended by the National Institute for Health and Clinical Excellence (NICE). DESIGN: Prospective open cohort study with routinely collected data from general practice, 1 January 1993 to 31 March 2008. SETTING: 531 practices in England and Wales contributing to the national QRESEARCH database. PARTICIPANTS: 2.3 million patients aged 35-74 (over 16 million person years) with 140,000 cardiovascular events. Overall population (derivation and validation cohorts) comprised 2.22 million people who were white or whose ethnic group was not recorded, 22,013 south Asian, 11,595 black African, 10,402 black Caribbean, and 19,792 from Chinese or other Asian or other ethnic groups. MAIN OUTCOME MEASURES: First (incident) diagnosis of cardiovascular disease (coronary heart disease, stroke, and transient ischaemic attack) recorded in general practice records or linked Office for National Statistics death certificates. Risk factors included self assigned ethnicity, age, sex, smoking status, systolic blood pressure, ratio of total serum cholesterol:high density lipoprotein cholesterol, body mass index, family history of coronary heart disease in first degree relative under 60 years, Townsend deprivation score, treated hypertension, type 2 diabetes, renal disease, atrial fibrillation, and rheumatoid arthritis. RESULTS: The validation statistics indicated that QRISK2 had improved discrimination and calibration compared with the modified Framingham score. The QRISK2 algorithm explained 43% of the variation in women and 38% in men compared with 39% and 35%, respectively, by the modified Framingham score. Of the 112,156 patients classified as high risk (that is, >or=20% risk over 10 years) by the modified Framingham score, 46,094 (41.1%) would be reclassified at low risk with QRISK2. The 10 year observed risk among these reclassified patients was 16.6% (95% confidence interval 16.1% to 17.0%)-that is, below the 20% treatment threshold. Of the 78 024 patients classified at high risk on QRISK2, 11,962 (15.3%) would be reclassified at low risk by the modified Framingham score. The 10 year observed risk among these patients was 23.3% (22.2% to 24.4%)-that is, above the 20% threshold. In the validation cohort, the annual incidence rate of cardiovascular events among those with a QRISK2 score of >or=20% was 30.6 per 1000 person years (29.8 to 31.5) for women and 32.5 per 1000 person years (31.9 to 33.1) for men. The corresponding figures for the modified Framingham equation were 25.7 per 1000 person years (25.0 to 26.3) for women and 26.4 (26.0 to 26.8) for men). At the 20% threshold, the population identified by QRISK2 was at higher risk of a CV event than the population identified by the Framingham score. CONCLUSIONS: Incorporating ethnicity, deprivation, and other clinical conditions into the QRISK2 algorithm for risk of cardiovascular disease improves the accuracy of identification of those at high risk in a nationally representative population. At the 20% threshold, QRISK2 is likely to be a more efficient and equitable tool for treatment decisions for the primary prevention of cardiovascular disease. As the validation was performed in a similar population to the population from which the algorithm was derived, it potentially has a "home advantage." Further validation in other populations is therefore advised.

Best practice in primary care pathology: review 7.

This seventh best-practice review examines four series of common primary care questions in laboratory medicine: (1) blood count abnormalities 2; (2) cardiac troponins; (3) high-density lipoprotein cholesterol; and (4) viral diseases 2. The review is presented in a question-answer format, with authorship attributed for each question series. The recommendations are a précis of guidance found using a standardised literature search of national and international guidance notes, consensus statements, health policy documents and evidence-based medicine reviews, supplemented by Medline Embase searches to identify relevant primary research documents. The recommendations are not standards, but form a guide to be set in the clinical context. Most are consensus based rather than evidence based. They will be updated periodically to take account of new information.