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Stroke is a leading cause of death in the United States. Although the number of deaths from stroke has declined in recent years, it continues to be a major public health problem in the United States, with an estimated $34.3 billion in direct cost and indirect cost of stroke in the year 2008. Carotid artery stenosis represents an important risk factor for ischemic stroke, which accounts for nearly 90 percent of all strokes among U.S. men and women. Carotid artery stenosis is increasingly prevalent from the fifth decade of life onward. Patients with vascular disease and multiple risk factors (e.g., diabetes, hypertension, hyperlipidemia, and smoking) have a higher probability of having asymptomatic carotid stenosis. Since carotid artery atherosclerosis can largely proceed silently and unpredictably, the first manifestation can be a debilitating or fatal stroke. Asymptomatic carotid artery stenosis affects approximately 7 percent of women and over 12 percent of men, older than 70 years of age. Clinically important stenosis, at which the risk of stroke is increased, is defined as stenosis of over 50 or 60 percent. Natural history studies have reported that patients with asymptomatic carotid stenosis are at an increased risk of ipsilateral carotid territory ischemic stroke ranging from 5 to 17 percent. The goal of management of asymptomatic carotid stenosis is to decrease the risk of stroke and stroke-related deaths. However, screening asymptomatic patients for carotid stenosis is not part of common clinical practice as noted in a review by the U.S. Preventive Services Task Force from 1996, which concluded that evidence was insufficient to recommend either for or against screening. As the general U.S. population ages, and with the availability of noninvasive imaging studies, asymptomatic carotid artery stenosis may be more frequently detected in the course of patient management. Auscultation of the carotid arteries to listen for bruits is by convention an initial means of clinical assessment of high-risk patients, but the presence of bruits is not necessarily indicative of significant stenosis. Since carotid auscultation has limited sensitivity in detecting significant carotid stenosis, additional imaging modalities including digital subtraction angiography (DSA), Doppler ultrasound (DUS), computed tomography angiography (CTA), and magnetic resonance angiography (MRA) are being increasingly utilized. The most commonly used measurement method of carotid stenosis used in clinical trials or most common angiographic method was introduced in the North American Symptomatic Carotid Endarterectomy Trial (NASCET). In the NASCET method, the stenosis is measured as the ratio of the linear luminal diameter of the narrowest portion of the artery's diseased segment divided by the diameter of the healthy distal carotid artery (above the post-stenotic dilation). An alternative method was used in the European Carotid Surgery Trial (ECST), which utilized the estimated carotid bulb at the site of maximal stenosis as the denominator. The ECST method tends to yield higher degrees of stenosis, but measurements made by each method can be converted to those of the other using a simple arithmetic equation. According to the 2003 Society of Radiologists in Ultrasound consensus criteria, a carotid stenosis is not quantified as an exact percentage of luminal stenosis but can be classified by range of stenoses that represent clinically relevant categories (normal, < 50 percent, 50-69 percent, ≥ 70 percent but less than near occlusion, near occlusion, or total occlusion). Therapeutic options in asymptomatic carotid stenosis include medical therapy alone, carotid endarterectomy (CEA) and medical therapy, or carotid angioplasty and stenting (CAS) and medical therapy. However, the optimal therapeutic management strategy for patients with asymptomatic carotid stenosis is unclear. The Centers for Medicare and Medicaid Services (CMS) is interested in a systematic review of the literature on these three treatment strategies in patients with asymptomatic carotid stenosis. The Coverage and Analysis Group at the CMS requested the present report from the Technology Assessment Program (TAP) at the Agency for Healthcare Research and Quality (AHRQ). AHRQ assigned this report to the Tufts Evidence-based Practice Center (Tufts EPC) (Contract number, HSSA 290 2007 10055 I).

Carotid Stenosis --- Vascular Surgical Procedures --- Stents --- Stroke --- Treatment Outcome --- surgery. --- prevention & control.

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The Coverage and Analysis Group at the Centers for Medicare & Medicaid Services (CMS) requested from The Technology Assessment Program (TAP) at the Agency for Healthcare Research and Quality (AHRQ) a horizon scan to summarize the available scientific evidence on the quality of laboratory-developed ("home brew" or "in-house") molecular tests, which are currently not actively regulated by the U.S. Food and Drug Administration (FDA). CMS has concerns about the quality of laboratory-developed tests and the validation currently being performed on these tests. AHRQ assigned this report to the following Evidence-based Practice Center (EPC): ECRI EPC (Contract Number: 290 2007 10063 I). To help CMS to address its concerns, this horizon scan is intended to: 1. identify types of laboratory-developed molecular tests (LDMTs) currently available for conditions relevant to the Medicare over-65-year-old population; 2. identify the methodologies and the processes that have been developed for the assessment of analytical and clinical performance of molecular tests; 3. summarize the role of Federal agencies in regulating LDMTs; and 4. identify the quality standards that have been developed for molecular tests by regulatory bodies, the industry, and the medical community.

Molecular Diagnostic Techniques --- Laboratory Proficiency Testing --- Government Regulation --- standards. --- United States

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OBJECTIVES: To synthesize evidence from randomized controlled trials (RCTs) on the effectiveness of lifestyle interventions to control progression of type 2 diabetes, progression to diabetes from metabolic syndrome, or recurrence of breast cancer and prostate cancer. Lifestyle interventions were defined as any intervention that included exercise, diet, and at least one other component (e.g., counseling, stress management, smoking cessation). DATA SOURCES: A systematic and comprehensive literature search was conducted to identify RCTs from 1980 to the present. REVIEW METHODS: Study selection, quality assessment, and data extraction were completed by several investigators in duplicate and independently. Random effects models were used for meta-analyses. RESULTS: From 1,288 citations, we included 20 unique RCTs (plus 80 associated publications): diabetes = 10 studies, metabolic syndrome = 7, breast and prostate cancer = 3. All studies had a "high" or "unclear" risk of bias. Type 2 diabetes: One RCT reported that, at 13 years postintervention, the lifestyle intervention group had fewer nonfatal strokes, reduced incidence of retinopathy, reduced progression of autonomic neuropathy, and reduced incidence of nephropathy. In this trial the lifestyle intervention included pharmacotherapy. A number of studies reported positive effects for lifestyle interventions on changes in body composition, metabolic variables, physical activity, and dietary intake; however, the results were not always statistically significant and were not always sustained following the end of the active intervention. Metabolic syndrome: Four studies reported that lifestyle interventions decreased the risk of developing type 2 diabetes. Most studies also reported positive effects for changes in body composition, metabolic variables, physical activity, and dietary intake. The results were not always statistically significant and were not always sustained following the end of the active intervention. Breast and prostate cancer: One RCT on prostate cancer reported that the lifestyle intervention decreased PSA levels. Two studies reported positive effects for changes in body composition, metabolic variables, physical activity, and dietary intake; however, the results generally were not statistically significant. CONCLUSIONS: Comprehensive lifestyle interventions that include exercise, dietary changes, and at least one other component are effective in decreasing the incidence of type 2 diabetes mellitus in high risk patients and the benefit extends beyond the active intervention phase. In patients who have already been diagnosed with type 2 diabetes, there is some evidence to suggest long-term benefit on microvascular and macrovascular outcomes, although the evidence is from one trial of high risk diabetic patients and included pharmacotherapy. The evidence for lifestyle interventions to prevent cancer recurrence is insufficient to draw conclusions. Comprehensive lifestyle interventionsappear to have a positive impact on behavioral outcomes including exercise and dietary intake, as well as a number of metabolic variables, at least in the short-term in all populations addressed in this report.

Health Behavior --- Life Style --- Diabetes Mellitus, Type 2 --- Metabolic Syndrome --- Breast Neoplasms --- Prostatic Neoplasms --- Randomized Controlled Trials as Topic --- prevention & control. --- prevention & control. --- prevention & control. --- prevention & control.