Home About us Contact | |||
European Guidelines (european + guideline)
Selected AbstractsEuropean guidelines for quality assurance in cervical cancer screening: recommendations for cytology laboratories,CYTOPATHOLOGY, Issue 2 2007H. G. Wiener The quality of a cervical cytology laboratory depends on adequate handling and staining of the samples, screening and interpretation of the slides and reporting of the results. These guidelines give an overview of procedures recommended in Europe to manage the balance between best patient care possible, laboratory quality assurance and cost effectiveness and will be published as a chapter 4 in the European Guidelines for Quality Assurance in Cervical Cancer Screening. The laboratory guidelines include protocols for personnel and organisation, material requirements, handling and analysing cervical samples, recording of results, quality management and communication. The section on quality management is comprehensive and includes protocols for all aspects of internal and external quality assurance. The guidelines are extensively referenced and as far as possible the recommendations are evidence-based. [source] Environmental risk assessment of human pharmaceuticals in the European Union: A case study with the ,-blocker atenololINTEGRATED ENVIRONMENTAL ASSESSMENT AND MANAGEMENT, Issue S1 2010Anette Küster Abstract ,-Adrenergic receptor blockers (,-blockers) are applied to treat high blood pressure, ischemic heart disease, and heart rhythm disturbances. Due to their widespread use and limited human metabolism, ,-blockers are widely detected in sewage effluents and surface waters. ,-Adrenergic receptors have been characterized in fish and other aquatic animals, so it can be expected that physiological processes regulated by these receptors in wild animals may be affected by the presence of ,-blockers. Because ecotoxicological data on ,-blockers are scarce, it was decided to choose the ,-blocker atenolol as a case study pharmaceutical within the project ERAPharm. A starting point for the assessment of potential environmental risks was the European guideline on the environmental risk assessment of medicinal products for human use. In Phase I of the risk assessment, the initial predicted environmental concentration (PEC) of atenolol in surface water (500,ng L,1) exceeded the action limit of 10,ng L,1. Thus, a Phase II risk assessment was conducted showing acceptable risks for surface water, for groundwater, and for aquatic microorganisms. Furthermore, atenolol showed a low potential for bioaccumulation as indicated by its low lipophilicity (log KOW,=,0.16), a low potential for exposure of the terrestrial compartment via sludge (log KOC,=,2.17), and a low affinity for sorption to the sediment. Thus, the risk assessment according to Phase II-Tier A did not reveal any unacceptable risk for atenolol. Beyond the requirements of the guideline, additional data on effects and fate were generated within ERAPharm. A 2-generation reproduction test with the waterflea Daphnia magna resulted in the most sensitive no-observed-effect concentration (NOEC) of 1.8,mg L,1. However, even with this NOEC, a risk quotient of 0.003 was calculated, which is still well below the risk threshold limit of 1. Additional studies confirm the outcome of the environmental risk assessment according to EMEA/CHMP (2006). However, atenolol should not be considered as representative for other ,-blockers, such as metoprolol, oxprenolol, and propranolol, some of which show significantly different physicochemical characteristics and varying toxicological profiles in mammalian studies. Integr Environ Assess Manag 2010;6:514,523. © 2009 SETAC [source] European guidelines on cervical screeningCYTOPATHOLOGY, Issue 4 2007J. H. F. Smith No abstract is available for this article. [source] European guidelines for quality assurance in cervical cancer screening: recommendations for cytology laboratories,CYTOPATHOLOGY, Issue 2 2007H. G. Wiener The quality of a cervical cytology laboratory depends on adequate handling and staining of the samples, screening and interpretation of the slides and reporting of the results. These guidelines give an overview of procedures recommended in Europe to manage the balance between best patient care possible, laboratory quality assurance and cost effectiveness and will be published as a chapter 4 in the European Guidelines for Quality Assurance in Cervical Cancer Screening. The laboratory guidelines include protocols for personnel and organisation, material requirements, handling and analysing cervical samples, recording of results, quality management and communication. The section on quality management is comprehensive and includes protocols for all aspects of internal and external quality assurance. The guidelines are extensively referenced and as far as possible the recommendations are evidence-based. [source] Beneficial lactobacilli in food and feed: long-term use, biodiversity and proposals for specific and realistic safety assessmentsFEMS MICROBIOLOGY REVIEWS, Issue 4 2006Marion Bernardeau Abstract Lactobacilli have played a crucial role in the production of fermented products for millennia. Their probiotic effects have recently been studied and used in new products. Isolated cases of lactobacillemia have been reported in at-risk populations, but lactobacilli present an essentially negligible biological risk. We analyzed the current European guidelines for safety assessment in food/feed and conclude that they are not relevant for the Lactobacillus genus. We propose new specific guidelines, beginning by granting a ,long-standing presumption of safety' status to Lactobacillus genus based on its long history of safe use. Then, based on the available body of knowledge and intended use, only such tests as are useful will be necessary before attributing ,qualified presumption of safety' status. [source] Combined therapy in the treatment of hypertensionFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 1 2010Carlos Escobar Abstract The majority of patients with hypertension need at least two antihypertensive agents to achieve blood pressure (BP) objectives. As current European guidelines for the treatment of arterial hypertension recommend, combined therapy is required when monotherapy fails and as a first-line treatment in certain situations, such as subjects at high or very high cardiovascular risk, markedly elevated BP values, or when lower targets are required (<130/80 mmHg). The advantages of combined therapy are well known and include an earlier and higher antihypertensive efficacy because of complementary mechanisms of action, and a lower incidence of side effects due to the possible compensatory responses and, in many cases, the lower doses used. In the present study, available evidence about the efficacy and tolerability of combined therapy for the treatment of hypertension is updated. [source] European guidelines on resistance testing: why are they needed?HIV MEDICINE, Issue 3 2000V. Miller No abstract is available for this article. [source] Risk-Based Classification of Hypertension and the Role of Combination TherapyJOURNAL OF CLINICAL HYPERTENSION, Issue 2008Matthew R. Weir MD The recognition of a continuous relationship between elevated blood pressure (BP) and cardiovascular risk has influenced national and international guidelines for the classification, prevention, and management of hypertension. The most recent report (2003) of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure uses BP thresholds to define categories of normal, prehypertension, and hypertension. A new definition proposed by the Hypertension Writing Group in 2005 offers an approach to diagnosis and management based on global or total risk. Thus, even in the absence of sustained elevations in BP, patients may have a moderate to high risk of vascular events due to the presence of additional cardiovascular risk factors, disease markers, and target organ damage. The 2007 European guidelines continue to classify hypertension based on cutoffs while also placing emphasis on multivariate formulations for cardiovascular risk assessment and goals of therapy. All 3 sets of guidelines acknowledge the necessity of using ,2 antihypertensive agents to attain BP goals in many patients. [source] Evidence-based treatment and quality of life in heart failureJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 3 2006Daniela Dobre MD MPH Abstract Objectives, To explore whether prescription of evidence-based drug therapy is associated with better quality of life (QoL) in patients with heart failure (HF). Methods, Patients (n = 62) were recruited in the outpatient clinic of Groningen University Hospital. Inclusion criteria were previous diagnosis of HF, age 40,80 years; ejection fraction of less than 45%, free from other serious disease (such as cancer) and psychiatric problems in the last year. QoL was assessed with the RAND 36-item health survey questionnaire, on five scales: physical functioning, mental health, social functioning, vitality and general health perception. Medication prescribed for 1 to 6 months before the QoL assessment was classified as either evidence-based treatment or under-treatment, according to the 2001 European guidelines on optimal HF treatment. The study had a cross-sectional design. Results, QoL did not differ significantly between evidence-based and under-treated patients, unadjusted or after adjustment for significant patient imbalances. Conclusions, Conventional step-up medication approach in HF may have a positive impact on survival or morbidity, but it seems not beneficial in relation to QoL. Other interventions should be designed to improve QoL of patients with HF. [source] Slug control in Australian canola: monitoring, molluscicidal baits and economic thresholdsPEST MANAGEMENT SCIENCE (FORMERLY: PESTICIDE SCIENCE), Issue 9 2007Michael A Nash Abstract Exotic slugs have become serious pests of canola, at establishment, in Southern Australian high-rainfall cropping zones. Slugs were monitored using relatively inexpensive 300 mm × 300 mm terracotta tiles acting as refuges. An investigation was made of the effects of the time of application of chelated iron baits on the slug species Deroceras reticulatum Müller and Lehmannia nyctelia Bourguignat. Baits reduced the number of surface-active slug species. A single application at sowing provided greater efficacy than one application before sowing, and efficacy was comparable with that of two applications. Canola seedling densities showed a negative response to D. reticulatum numbers; the presence of even one individual per refuge trap reduced seedling numbers below optimum densities. Thistles and other vegetation were associated with increased numbers of slugs. European guidelines for slug monitoring and damage appear to be at least partly applicable to Australian conditions. Copyright © 2007 Society of Chemical Industry [source] Proton Pump Inhibitors and Helicobacter pylori Gastritis: Friends or Foes?BASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 3 2006Ernst J. Kuipers In H. pylori -positive patients, profound acid suppressive therapy induces a corpus-predominant pangastritis, which is associated with accelerated corpus gland loss and development of atrophic gastritis. Both corpus-predominant and atrophic gastritis have been associated with an increased risk of development of gastric cancer. H. pylori eradication leads to resolution of gastritis and may induce partial regression of pre-existent gland loss. H. pylori eradication does not aggravate GERD nor does it impair the efficacy of proton pump inhibitor maintenance therapy for this condition. This is the background of the advise within the European guidelines for the management of H. pylori infection to offer an H. pylori test and treat policy to patients who require proton pump inhibitor maintenance therapy for GERD. As such a policy fully reverses H. pylori pangastritis even in patients who have been treated for years with proton pump inhibitors, there is no need to eradicate H. pylori before the start of proton pump inhibitors. In fact, the somewhat slower initial response of H. pylori -negative GERD patients to proton pump inhibitor therapy and the fact that many GERD patients will only require short-term therapy suggests to first start the proton pump inhibitor, and only test and treat when maintenance therapy needs to be prescribed. Such considerations prevent the persistent presence of active corpus-predominant gastritis in proton pump inhibitor-treated reflux patients without impairing the clinical efficacy of treatment [source] |