Lessons Learned from the European Cardiovascular Magnetic Resonance (EuroCMR) Registry Pilot Phase

The data from 11,040 patients of the European Cardiovascular Magnetic Resonance (EuroCMR) registry pilot phase offer the first documentation of the clinical use of CMR in a routine setting. The pilot data show that CMR is frequently performed in clinical practice, is a safe procedure with excellent image quality, and has a strong impact on patient management. In the future, the EuroCMR registry will help to set international benchmarks on appropriate indications, quality, and safety of CMR. In addition, outcome and cost effectiveness will be addressed on an international level in order to develop optimized imaging-guided clinical pathways and to avoid unnecessary or even harmful testing

Nutrition, environment and cardiovascular health (NESCAV): protocol of an inter-regional cross-sectional study

BACKGROUND: Despite the remarkable technological progress in health care and treatment, cardiovascular disease remains the leading cause of premature death, prolonged hospitalization and disability in most European countries. In the population of the Greater Region (Grand-Duchy of Luxembourg, Wallonia in Belgium, and Lorraine in France), the prevalence of cardiovascular risk factors and disease is among the highest in Europe, warranting the need for a better understanding of factors contributing to this pattern. In this context, the cross-border "Nutrition, Environment and Cardiovascular Health-NESCAV" project is initiated by an inter-regional multi-disciplinary consortium and supported by the INTERREG IV A program "Greater Region", 2007-2013, to fight synergically and harmoniously against this major public health problem. METHODS/DESIGN: The objectives of the three-year planned project are to assess, in a representative sample of 3000 randomly selected individuals living at the Greater Region, 1) the cardiovascular health and risk profile, 2) the association between the dietary habits and the cardiovascular risk, 3) the association of occupational and environmental pollution markers with the cardiovascular risk, 4) the knowledge, awareness and level of control of cardiovascular risk factors, 5) the potential gaps in the current primary prevention, and finally, to address evidence-based recommendations enabling the development of inter-regional guidance to help policy-makers and health care workers for the prevention of cardiovascular disease. DISCUSSION: The findings will provide tools that may enable the Greater Region's decision-makers and health professionals to implement targeted and cost-effective prevention strategies

Demonstration of the Effect of Generic Anatomical Divisions versus Clinical Protocols on Computed Tomography Dose Estimates and Risk Burden

Objective: Choosing to undertake a CT scan relies on balancing risk versus benefit, however risks associated with CT scanning have generally been limited to broad anatomical locations, which do not provided adequate information to evaluate risk against benefit. Our study aimed to determine differences in radiation dose and risk estimates associated with modern CT scanning examinations when computed for clinical protocols compared with those using anatomical area. Methods: Technical data were extracted from a tertiary hospital Picture Archiving Communication System for random samples of 20–40 CT examinations per adult clinical CT protocol. Organ and whole body radiation dose were calculated using ImPACT Monte Carlo simulation software and cancer incidence and mortality estimated using BEIR VII age and gender specific lifetime attributable risk weights. Results: Thirty four unique CT protocols were identified by our study. When grouped according to anatomic area the radiation dose varied substantially, particularly for abdominal protocols. The total estimated number of incident cancers and cancer related deaths using the mean dose of anatomical area were 86 and 69 respectively. Using more specific protocol doses the estimates rose to 214 and 138 incident cancers and cancer related deaths, at least doubling the burden estimated. Conclusions: Modern CT scanning produces a greater diversity of effective doses than much of the literature describes; where a lack of focus on actual scanning protocols has produced estimates that do not reflect the range and complexity of modern CT practice. To allow clinicians, patients and policy makers to make informed risk versus benefit decisions the individual and population level risks associated with modern CT practices are essential

Cohort study of Western Australia computed tomography utilisation patterns and their policy implications

Background: Computed tomography (CT) scanning is a relatively high radiation dose diagnostic imaging modality with increasing concerns about radiation exposure burden at the population level in scientific literature. This study examined the epidemiology of adult CT utilisation in Western Australia (WA) in both the public hospital and private practice settings, and the policy implications. Methods: Retrospective cohort design using aggregate adult CT data from WA public hospitals and Medical Benefits Schedule (MBS) (mid-2006 to mid-2012). CT scanning trends by sex, age, provider setting and anatomical areas were explored using crude CT scanning rates, age-standardised CT scanning rates and Poisson regression modelling. Results: From mid-2006 to mid-2012 the WA adult CT scanning rate was 129 scans per 1,000 person-years (PY). Females were consistently scanned at a higher rate than males. Patients over 65 years presented the highest scanning rates (over 300 scans per 1,000 PY). Private practice accounted for 73% of adult CT scans, comprising the majority in every anatomical area. In the private setting females predominately held higher age-standardised CT scanning rates than males. This trend reversed in the public hospital setting. Patients over 85 years in the public hospital setting were the most likely age group CT scanned in nine of ten anatomical areas. Patients in the private practice setting aged 85+ years were relatively less prominent across every anatomical area, and the least likely age group scanned in facial bones and multiple areas CT scans.Conclusion: In comparison to the public hospital setting, the MBS subsidised private sector tended to service females and relatively younger patients with a more diverse range of anatomical areas, constituting the majority of CT scans performed in WA. Patient risk and subsequent burden is greater for females, lower ages and some anatomical areas. In the context of a national health system, Australia has various avenues to monitor radiation exposure levels, improve physician training and modify funding mechanisms to ensure individual and population medical radiation exposure is as low as reasonably achievable

Radiological informed consent in cardiovascular imaging: towards the medico-legal perfect storm?

Use of radiation for medical examinations and tests is the largest manmade source of radiation exposure. No one can doubt the immense clinical and scientific benefits of imaging to the modern practice of medicine. Every radiological and nuclear medicine examination confers a definite (albeit low) long-term risk of cancer, but patients undergoing such examinations often receive no or inaccurate information about radiological dose exposure and corresponding risk directly related to the radiological dose received. Too detailed information on radiological dose and risk may result in undue anxiety, but information "economical with the truth" may violate basic patients' rights well embedded in ethics (Oviedo convention 1997) and law (97/43 Euratom Directive 1997). Informed consent is a procedure needed to establish a respectful and ethical relation between doctors and patients. Nevertheless, in an "ideal" consent process, the principle of patient autonomy in current radiological practice might be reinforced by making it mandatory to obtain explicit and transparent informed consent form for radiological examination with high exposure (≥ 500 chest x-rays). The form may spell-out the type of examination, the exposure in effective dose (mSv), derived from reference values in guidelines or – better – from actual values from their department. The dose equivalent might be also expressed in number of chest radiographs and the risk of cancer as number of extra cases in the exposed population, derived from most recent and authorative guidelines (e.g., BEIR VII Committee, release 2006). Common sense, deontological code, patients'rights, medical imaging guidelines, Euratom law, all coherently and concordantly encourage and recommend a justified, optimized, responsible and informed use of testing with ionizing radiation. Although the idea of informed consent for radiation dose does not seem to be on the immediate radar screen at least in the US, the current practice clashes against these guidelines and laws

Individual Assessment of Arteriosclerosis by Empiric Clinical Profiling

BACKGROUND: Arteriosclerosis is a common cause of chronic morbidity and mortality. Myocardial infarction, stroke or other cardiovascular events identify vulnerable patients who suffer from symptomatic arteriosclerosis. Biomarkers to identify vulnerable patients before cardiovascular events occur are warranted to improve care for affected individuals. We tested how accurately basic clinical data can describe and assess the activity of arteriosclerosis in the individual patient. METHODOLOGY/PRINCIPAL FINDINGS: 269 in-patients who were treated for various conditions at the department of general medicine of an academic tertiary care center were included in a cross-sectional study. Personal history and clinical examination were obtained. When paraclinical tests were performed, the results were added to the dataset. The numerical variables in the clinical examination were statistically compared between patients with proven symptomatic arteriosclerosis (n = 100) and patients who had never experienced cardiovascular events in the past (n = 110). 25 variables were different between these two patient groups and contributed to the disease activity score. The percentile distribution of these variables defined the empiric clinical profile. Anthropometric data, signs of arterial, cardiac and renal disease, systemic inflammation and health economics formed the major categories of the empiric clinical profile that described an individual patient's disease activity. The area under the curve of the receiver operating curve for symptomatic arteriosclerosis was 0.891 (95% CI 0.799-0.983) for the novel disease activity score compared to 0.684 (95% CI 0.600-0.769) for the 10-year risk calculated according to the Framingham score. In patients suffering from symptomatic arteriosclerosis, the disease activity score deteriorated more rapidly after two years of follow-up (from 1.25 to 1.48, P = 0.005) compared to age- and sex-matched individuals free of cardiovascular events (from 1.09 to 1.19, P = 0.125). CONCLUSIONS/SIGNIFICANCE: Empiric clinical profiling and the disease activity score that are based on accessible, available and affordable clinical data are valid markers for symptomatic arteriosclerosis

Economic analysis including long-term risks and costs of alternative diagnostic strategies to evaluate patients with chest pain

Background: Diagnosis costs for cardiovascular disease waste a large amount of healthcare resources. The aim of the study is to evaluate the clinical and economic outcomes of alternative diagnostic strategies in low risk chest pain patients. Methods: We evaluated direct and indirect downstream costs of 6 strategies: coronary angiography (CA) after positive troponin I or T (cTn-I or cTnT) (strategy 1); after positive exercise electrocardiography (ex-ECG) (strategy 2); after positive exercise echocardiography (ex-Echo) (strategy 3); after positive pharmacologic stress echocardiography (PhSE) (strategy 4); after positive myocardial exercise stress single-photon emission computed tomography with technetium Tc 99m sestamibi (ex-SPECT-Tc) (strategy 5) and direct CA (strategy 6). Results: The predictive accuracy in correctly identifying the patients was 83,1% for cTn-I, 87% for cTn-T, 85,1% for ex-ECG, 93,4% for ex-Echo, 98,5% for PhSE, 89,4% for ex-SPECT-Tc and 18,7% for CA. The cost per patient correctly identified results $2.051 for cTn-I,$2.086 for cTn-T, $1.890 for ex-ECG,$803 for ex-Echo, $533 for PhSE,$1.521 for ex-SPECT-Tc ($1.634 including cost of extra risk of cancer) and$29.673 for CA ($29.999 including cost of extra risk of cancer). The average relative cost-effectiveness of cardiac imaging compared with the PhSE equal to 1 (as a cost comparator), the relative cost of ex-Echo is 1.5×, of a ex-SPECT-Tc is 3.1×, of a ex-ECG is 3.5×, of cTnI is ×3.8, of cTnT is ×3.9 and of a CA is 56.3×. Conclusion: Stress echocardiography based strategies are cost-effective versus alternative imaging strategies and the risk and cost of radiation exposure is void

Methods for the guideline-based development of quality indicators--a systematic review

<p>Abstract</p> <p>Background</p> <p>Quality indicators (QIs) are used in many healthcare settings to measure, compare, and improve quality of care. For the efficient development of high-quality QIs, rigorous, approved, and evidence-based development methods are needed. Clinical practice guidelines are a suitable source to derive QIs from, but no gold standard for guideline-based QI development exists. This review aims to identify, describe, and compare methodological approaches to guideline-based QI development.</p> <p>Methods</p> <p>We systematically searched medical literature databases (Medline, EMBASE, and CINAHL) and grey literature. Two researchers selected publications reporting methodological approaches to guideline-based QI development. In order to describe and compare methodological approaches used in these publications, we extracted detailed information on common steps of guideline-based QI development (topic selection, guideline selection, extraction of recommendations, QI selection, practice test, and implementation) to predesigned extraction tables.</p> <p>Results</p> <p>From 8,697 hits in the database search and several grey literature documents, we selected 48 relevant references. The studies were of heterogeneous type and quality. We found no randomized controlled trial or other studies comparing the ability of different methodological approaches to guideline-based development to generate high-quality QIs. The relevant publications featured a wide variety of methodological approaches to guideline-based QI development, especially regarding guideline selection and extraction of recommendations. Only a few studies reported patient involvement.</p> <p>Conclusions</p> <p>Further research is needed to determine which elements of the methodological approaches identified, described, and compared in this review are best suited to constitute a gold standard for guideline-based QI development. For this research, we provide a comprehensive groundwork.</p