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Official Guidelines (official + guideline)
Selected AbstractsComparison of analytical approaches for liquid chromatography/mass spectrometry determination of the alcohol biomarker ethyl glucuronide in urineRAPID COMMUNICATIONS IN MASS SPECTROMETRY, Issue 12 2010Anders Helander Official guidelines originating from a European Union directive regulate requirements for analytical methods used to identify chemical compounds in biological matrices. This study compared different liquid chromatography/electropray ionization mass spectrometry (LC/ESI-MS) and tandem mass spectrometry (LC/ESI-MS/MS) procedures for accurate determination of the conjugated ethanol metabolite and alcohol biomarker ethyl glucuronide (EtG) in urine, and the value of combined EtG and ethyl sulfate (EtS) measurement. Analysis was carried out on 482 urines following solid-phase extraction (SPE) sample cleanup or using direct injection of a diluted sample. SPE combined with LC/MS/MS was demonstrated to be the most selective and sensitive method and was chosen as reference method. The EtG results by different methods showed good correlation (r,=,0.96,0.98). When comparing five reporting limits for EtG in the range 0.10,1.00,mg/L, the overall agreement with the reference method (frequency of true positives plus true negatives) was 82,97% for direct-injection LC/MS/MS, 90,97% for SPE-LC/MS, 86,98% for direct-injection LC/MS, and 86,98% for direct-injection LC/MS analysis of EtG and EtS. Most deviations were attributable to uncertainty in quantitation, when the value was close to a cutoff but the respective results were slightly above and below, or vice versa, the critical limit. However, for direct-injection LC/MS/MS, despite earning 4 identification points, equally many negative results were due to a product ion ratio outside the ±20% deviation accepted by the guidelines. These results indicate that the likelihood of different analytical methods to provide reliable analytical results depends on the reporting limit applied. Copyright © 2010 John Wiley & Sons, Ltd. [source] Importance of arterial stiffness as cardiovascular risk factor for future development of new type of drugsFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 3 2008Pierre Boutouyrie Abstract Cardiovascular risk prediction relies on classical risk factors such as age, gender, lipids, hypertension, smoking and diabetes. Although the value of such scales of risk is high for populations, its value for individual is reduced and too much influenced by non-modifiable risk factors (age and gender). Biomarkers of risk have been deceiving and genome wide scan approach is too recent. Target organ damage may help in selecting patients at high risk and in determining intervention. Aortic pulse wave velocity, an index of aortic stiffness, has been widely validated as providing additional risk predictions beyond and above classical risk factors, and has now entered into official guidelines. Many interventions (dietary, behaviour, drug treatment) were shown to influence arterial stiffness positively, but little evidence of a direct effect of intervention on arterial stiffness independent of blood pressure is available. New pharmacological targets and new drugs need to be identified. To become a surrogate endpoint for drug development, there is a need to demonstrate that regression arterial stiffness is associated with improved outcome. In parallel to this demonstration, points to be improved are the homogenization and spreading of the technique of measurement, the establishment of a reference value database. [source] The role of women's self-injury support-groups: a grounded theoryJOURNAL OF COMMUNITY & APPLIED SOCIAL PSYCHOLOGY, Issue 1 2007Jennifer Corcoran Abstract Research evidence suggests that services are struggling to adequately address the increasing incidence of self-injury and the needs of women who self-injure, while national self-injury support-groups across the UK appear to be growing in number. Despite their reported value, evidence regarding the role of self-injury support-groups in women's management of their self-injury is lacking although government policy and official guidelines are advocating the incorporation of support-groups into self-injury services. Seven semi-structured interviews were conducted and analysed using Grounded Theory to investigate the role of three UK self-injury support-groups in women's management of self-injury and associated difficulties. Empowerment-as-process emerged as the core theme of self-injury support-groups, mediated through experiences of belonging, sharing, autonomy, positive feeling and change. Findings are discussed in relation to relevant theory and research, followed by critical evaluation and implications of the study. Copyright © 2006 John Wiley & Sons, Ltd. [source] The European standard for sun-protective clothing: EN 13758JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 2 2006T Gambichler Abstract Clothing is considered one of the most important tools for sun protection. Contrary to popular opinion, however, some summer fabrics provide insufficient ultraviolet (UV) protection. The European Committee for Standardization (CEN), has developed a new standard on requirements for test methods and labelling of sun-protective garments. This document has now been completed and is published. Within CEN, a working group, CEN/TC 248 WG14 ,UV protective clothing', was set up with the mission to produce standards on the UV-protective properties of textile materials. This working group started its activities in 1998 and included 30 experts (dermatologists, physicists, textile technologists, fabric manufacturers and retailers of apparel textiles) from 11 European member states. Within this working group, all medical, ethical, technical and economical aspects of standardization of UV-protective clothing were discussed on the basis of the expertise of each member and in consideration of the relevant literature in this field. Decisions were made in consensus. The first part of the standard (EN 13758-1) deals with all details of test methods (e.g. spectrophotometric measurements) for textile materials and part 2 (EN 13758-2) covers classification and marking of apparel textiles. UV-protective cloths for which compliance with this standard is claimed must fulfill all stringent instructions of testing, classification and marking, including a UV protection factor (UPF) larger than 40 (UPF 40+), average UVA transmission lower than 5%, and design requirements as specified in part 2 of the standard. A pictogram, which is marked with the number of the standard EN 13758-2 and the UPF of 40+, shall be attached to the garment if it is in compliance with the standard. The dermatology community should take cognizance of this new standard document. Garment manufacturers and retailers may now follow these official guidelines for testing and labelling of UV-protective summer clothes, and the sun-aware consumer can easily recognize garments that definitely provide sufficient UV protection. [source] Screening for hepatitis B, C and non-alcoholic fatty liver disease: a survey of community-based physiciansALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009J. B. KALLMAN Summary Background, Screening guidelines for hepatitis B (HBV) and hepatitis C viruses (HCV) as well as a position statement for non-alcoholic fatty liver disease (NAFLD) have been put forth by different sources, but awareness of these guidelines and their impact on the physician practices have not been assessed. Aim, To assess the attitudes of primary care physicians (PCPs), gastroenterologists (GEs) and hepatologists (HEPs) regarding screening for HBV, HCV and NAFLD. Design, A survey questionnaire was sent to community-based PCPs and GEs to assess issues related to HBV, HCV and NAFLD. The same questionnaire was sent to hepatologists (HEPs). The questionnaire contained 10 items related to demographic and practice patterns of these physicians, 35 items related to HBV, 35 items related to HCV and 29 items related to NAFLD. Results, A total of 214 physicians (103 PCPs, 59 GEs and 52 HEPs) completed the survey. A majority of PCPs, GEs and HEPs agreed on most screening issues for these causes of liver disease. Nevertheless, within group comparison of physicians (guideline aware versus guideline unaware) showed significant differences in accurate response between those who were aware of guidelines and those who were not aware. Conclusions, A large percentage of PCPs and GEs were unaware of official guidelines for viral hepatitis B and hepatitis C. Those aware of guidelines were more likely to screen appropriately and avoid unnecessary testing. More needs to be done to assess awareness and the impact implementation of guidelines in hepatology. [source] Drug use investigation (DUI) and prescription-event monitoring in Japan (J-PEM),PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2001Katsutoshi Tanaka BSc Abstract Objective To present ethical issues and relevant problems in observational studies of drug safety in Japan. Methods The Pharmaceutical Affairs Law, associated ordinances, and notifications relevant to Drug Use Investigations (DUIs), and published documents for two pilot studies of prescription-event monitoring in Japan (J-PEM) were examined, particularly with regard to the protection of privacy. Information relevant to the proposed legislation intended to protect personal information and proposed guidelines on ethical issues in epidemiological studies were also collected. Results and Conclusion The formal studies inaugurated as the ,side-effect investigations' in the late 1960s and replaced by those of the DUI in 1980 have been conducted by drug manufacturers, in accordance with the Pharmaceutical Affairs Law. The first pilot study of J-PEM was started in 1997 and the second one is currently operated under a Health Sciences Research grant, supported by the Ministry of Health and Welfare. Those observational studies have been conducted while maintaining the confidentiality of personal data, but without requiring either approval by institutional ethics boards or informed consent from patients. However, according to the Pharmaceutical Affairs Law, those involved in postmarketing surveillance studies must protect the privacy of study subjects and those who break this rule may be subject to penalties. Ethical issues associated with pharmacoepidemiological studies will be clearly determined in Japan before the end of 2001 when the law designed to protect personal information will be introduced and official guidelines on ethical issues in epidemiological studies will have come into effect. Copyright © 2001 John Wiley & Sons, Ltd. [source] Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: A multicenter active-surveillance reportARTHRITIS & RHEUMATISM, Issue 8 2003Juan J. Gómez-Reino Objective The long-term safety of therapeutic agents that neutralize tumor necrosis factor (TNF) is uncertain. Recent evidence based on spontaneous reporting shows an association with active tuberculosis (TB). We undertook this study to determine and describe the long-term safety of 2 of these agents, infliximab and etanercept, in rheumatic diseases based on a national active-surveillance system following the commercialization of the drugs. Methods We analyzed the safety data actively collected in the BIOBADASER (Base de Datos de Productos Biológicos de la Sociedad Española de Reumatología) database, which was launched in February 2000 by the Spanish Society of Rheumatology. For the estimation of TB risk, the annual incidence rate in patients treated with these agents was compared with the background rate and with the rate in a cohort of patients with rheumatoid arthritis (RA) assembled before the era of anti-TNF treatment. Results Seventy-one participating centers sent data on 1,578 treatments with infliximab (86%) or etanercept (14%) in 1,540 patients. Drug survival rates (reported as the cumulative percentage of patients still receiving medication) for infliximab and etanercept pooled together were 85% and 81% at 1 year and 2 years, respectively. Instances of discontinuation were essentially due to adverse events. Seventeen cases of TB were found in patients treated with infliximab. The estimated incidence of TB associated with infliximab in RA patients was 1,893 per 100,000 in the year 2000 and 1,113 per 100,000 in the year 2001. These findings represent a significant increased risk compared with background rates. In the first 5 months of 2002, after official guidelines were established for TB prevention in patients treated with biologics, only 1 new TB case was registered (in January). Conclusion Therapy with infliximab is associated with an increased risk of active TB. Proper measures are needed to prevent and manage this adverse event. [source] | ||||||||||