202 resultados para Adverse Event Reporting


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Background: The self-reported use of natural health products (NHPs) (herbal products and vitamin and mineral supplements) has increased over the past decade in Canada. Because the elderly population might have comorbidities and concurrently administered medications, there is a need to explore the perceptions and behaviors associated with NHPs in this age group. Objective: The goal of this study was to assess the use of NHPs in a cohort of older Canadian residents and the characteristics, perceptions, and behaviors associated with NHP use. Methods: Survey participants aged =60 years were randomly selected from telephone listings in the area of greater Hamilton, Ontario, Canada. Data were collected using a standardized computer-assisted telephone interview system. Self-reported data covering 7 domains were collected: (1) demographics; (2) self-reported 12-month NHP use; (3) reasons for NHP use; (4) self-reported 12-month prescription medication use; (5) expenditures on NHPs; (6) patient-reported adverse events and drug-NHP interactions; and (7) perceptions of physicians' attitudes regarding NHPs. Descriptive statistics were used to compare the characteristics of NHP users with those of nonusers and to assess the characteristics of NHP users across these 7 domains. Multivariate regression analysis was conducted to determine the demographic variables that might be associated with NHP user status. Results: Of 2528 persons identified as age =60 years, 1206 (48%) completed the telephone interview. Six hundred sixteen of these respondents (51%) reported the use of =1 NHP during the previous 12 months. On the initial univariate analysis, younger age and higher income were significantly associated with reporting NHP use (mean age, users vs nonusers, 71.1 vs 72.7 years, respectively; 95% CI, 1.02-1.06; P <0.001; income more than Can $26,000 was 28% and 22% in users and nonusers, respectively; P = 0.028). One hundred seventy of 616 users (28%) used an NHP to treat the same condition for which they were concurrently receiving a prescription medication, and 43 (25%) had not informed their physicians about their NHP use. Patients' characteristics such as sex, education, smoking status, and self-reported health status did not differ significantly between users and nonusers. In individuals who regularly spent money to purchase NHPs (n = 394), the mean cost was $20.38/mo. NHP expenditure was not significantly associated with age, sex, or income. Conclusion: Based on these findings, a substantial proportion of those Ontarians aged =60 years reported NHP use, and there is a need for greater communication with physicians to avoid potential drug-NHP interactions. © 2009 Excerpta Medica Inc. All rights reserved.

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RC beams shear strengthened with externally bonded fiber-reinforced polymer (FRP) U strips or side strips usually fail owing to debonding of the bonded FRP shear reinforcement. Because such debonding usually occurs in a brittle manner at relatively small shear crack widths, some of the internal steel stirrups intersected by the critical shear crack may not have reached yielding at beam shear failure. Consequently, the yield stress of internal steel stirrups in such a strengthened RC beam cannot be fully utilized. This adverse shear interaction between the internal steel shear reinforcement and the external FRP shear reinforcement may significantly reduce the benefit of the shear strengthening FRP but has not been considered explicitly by any of the shear strength models in the existing design guidelines. This paper presents a new shear strength model considering this adverse shear interaction through the introduction of a shear interaction factor. A comprehensive evaluation of the proposed model, as well as three other shear strength models, is conducted using a large test database. It is shown that the proposed shear strength model performs the best among the models compared, and the performance of the other shear strength models can be significantly improved by including the proposed shear interaction factor. Finally, a design recommendation is presented.

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OBJECTIVE: The goal was to describe the temporal pattern of neonatal plasma glucose levels and associations with maternal glucose levels, cord serum C-peptide levels, and neonatal size and adiposity. METHODS: A total of 17 094 mothers and infants were included in the Hyperglycemia and Adverse Pregnancy Outcome Study (15 centers in 9 countries). Mothers underwent a 75-g, 2-hour, oral glucose tolerance test (OGTT) at 24 to 32 weeks of gestation. Cord blood and neonatal blood samples were collected. Biochemical neonatal hypoglycemia was defined as glucose levels of 90th percentile. CONCLUSIONS: Mean neonatal plasma glucose concentrations varied little in the first 5 hours after birth, which suggests normal postnatal adjustment. Biochemical and clinical hypoglycemia were weakly related to maternal OGTT glucose measurements but were strongly associated with elevated cord serum C-peptide levels. Larger and/or fatter infants were more likely to develop hypoglycemia and hyperinsulinemia. These relationships suggest physiologic relationships between maternal glycemia and fetal insulin production. Copyright © 2010 by the American Academy of Pediatrics.

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OBJECTIVE-To examine associations of neonatal adiposity with maternal glucose levels and cord serum C-peptide in a multicenter multinational study, the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, thereby assessing the Pederson hypothesis linking maternal glycemia and fetal hyperinsulinemia to neonatal adiposity. RESEARCH DESIGN AND METHODS-Eligible pregnant women underwent a standard 75-g oral glucose tolerance test between 24 and 32 weeks gestation (as close to 28 weeks as possible). Neonatal anthropometrics and cord serum C-peptide were measured. Associations of maternal glucose and cord serum C-peptide with neonatal adiposity (sum of skin folds >90th percentile or percent body fat >90th percentile) were assessed using multiple logistic regression analyses, with adjustment for potential confounders, including maternal age, parity, BMI, mean arterial pressure, height, gestational age at delivery, and the baby's sex. RESULTS-Among 23,316 HAPO Study participants with glucose levels blinded to caregivers, cord serum C-peptide results were available for 19,885 babies and skin fold measurements for 19,389. For measures of neonatal adiposity, there were strong statistically significant gradients across increasing levels of maternal glucose and cord serum C-peptide, which persisted after adjustment for potential confounders. In fully adjusted continuous variable models, odds ratios ranged from 1.35 to 1.44 for the two measures of adiposity for fasting, 1-h, and 2-h plasma glucose higher by 1 SD. CONCLUSIONS-These findings confirm the link between maternal glucose and neonatal adiposity and suggest that the relationship is mediated by fetal insulin production and that the Pedersen hypothesis describes a basic biological relationship influencing fetal growth. © 2009 by the American Diabetes Association.

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Background. From the mid-1980s to mid-1990s, the WHO MONICA Project monitored coronary events and classic risk factors for coronary heart disease (CHD) in 38 populations from 21 countries. We assessed the extent to which changes in these risk factors explain the variation in the trends in coronary-event rates, across the populations. Methods. In men and women aged 35-64 years, non-fatal myocardial infarction and coronary deaths were registered continuously to assess trends in rates of coronary events. We carried out population surveys to estimate trends in risk factors. Trends in event rates were regressed on trends in risk score and in individual risk factors. Findings. Smoking rates decreased in most male populations but trends were mixed in women; mean blood pressures and cholesterol concentrations decreased, body-mass index increased, and overall risk scores and coronary-event rates decreased. The model of trends in 10-year coronary-event rates against risk scores and single risk factors showed a poor fit, but this was improved with a 4-year time lag for coronary events. The explanatory power of the analyses was limited by imprecision of the estimates and homogeneity of trends in the study populations. Interpretation. Changes in the classic risk factors seem to partly explain the variation in population trends in CHD. Residual variance is attributable to difficulties in measurement and analysis, including time lag, and to factors that were not included, such as medical interventions. The results support prevention policies based on the classic risk factors but suggest potential for prevention beyond these.

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PURPOSE: Scanning laser polarimetry (SLP) has been proposed as a useful diagnostic test for glaucoma. This study was conducted to evaluate the quality of reporting of published studies using the SLP for diagnosing glaucoma. METHODS: A validated Medline and hand search of English-language articles reporting on measures of diagnostic accuracy of the SLP for glaucoma was performed. Two reviewers independently selected and appraised the manuscripts. The Standards for Reporting of Diagnostic Accuracy (STARD) checklist was used to evaluate the quality of each publication. RESULTS: A total of 47 papers were identified of which the first 10 (from 1997 to 2000) and the last 10 articles (from 2004 to 2005) were appraised. Interobserver rating agreement of STARD items was high (85.5% agreement, ?=0.796). The number of STARD items properly reported ranged from 3/25 to 19/25. Only a quarter of studies (5/20) explicitly reported more than half of the STARD items. Important aspects of the methodology were often missing such as participant sampling (reported in 40% of manuscripts), masking of the readers of the index test and reference standard (reported in 20% of manuscripts), and estimation of uncertainty (eg, 95% confidence intervals, reported in 25% of manuscripts). There was a slight increase in the number of STARD items reported with time. CONCLUSIONS: The quality of reporting of diagnostic accuracy tests for glaucoma with SLP is suboptimal. The STARD initiative may be a useful tool for appraising the strengths and weaknesses of diagnostic accuracy studies. © 2007 Lippincott Williams & Wilkins, Inc.

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PURPOSE. Scanning laser tomography with the Heidelberg retina tomograph (HRT; Heidelberg Engineering, Heidelberg, Germany) has been proposed as a useful diagnostic test for glaucoma. This study was conducted to evaluate the quality of reporting of published studies using the HRT for diagnosing glaucoma. METHODS. A validated Medline and hand search of English-language articles reporting on measures of diagnostic accuracy of the HRT for glaucoma was performed. Two reviewers selected and appraised the papers independently. The Standards for Reporting of Diagnostic Accuracy (STARD) checklist was used to evaluate the quality of each publication. RESULTS. A total of 29 articles were included. Interobserver rating agreement was observed in 83% of items (? = 0.76). The number of STARD items properly reported ranged from 5 to 18. Less than a third of studies (7/29) explicitly reported more than half of the STARD items. Descriptions of key aspects of the methodology were frequently missing. For example, the design of the study (prospective or retrospective) was reported in 6 of 29 studies, and details of participant sampling (e.g., consecutive or random selection) were described in 5 of 29 publications. The commonest description of diagnostic accuracy was sensitivity and specificity (25/29) followed by area under the ROC curve (13/29), with 9 of 29 publications reporting both. CONCLUSIONS. The quality of reporting of diagnostic accuracy tests for glaucoma with HRT is suboptimal. The STARD initiative may be a useful tool for appraising the strengths and weaknesses of diagnostic accuracy studies. Copyright © Association for Research in Vision and Ophthalmology.

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Aim: To evaluate the quality of reporting of all diagnostic studies published in five major ophthalmic journals in the year 2002 using the Standards for Reporting of Diagnostic Accuracy (STARD) initiative parameters. Methods: Manual searching was used to identify diagnostic studies published in 2002 in five leading ophthalmic journals, the American Journal of Ophthalmology (AJO), Archives of Ophthalmology (Archives), British Journal of Ophthalmology (BJO), Investigative Ophthalmology and Visual Science (IOVS), and Ophthalmology. The STARD checklist of 25 items and flow chart was used to evaluate the quality of each publication. Results: A total of 16 publications were included (AJO = 5, Archives = 1, BJO = 2, IOVS = 2, and Ophthalmology = 6). More than half of the studies (n = 9) were related to glaucoma diagnosis. Other specialties included retina (n = 4) cornea (n = 2), and neuro-ophthalmology (n = 1). The most common description of diagnostic accuracy was sensitivity and specificity values, published in 13 articles. The number of fully reported items in evaluated studies ranged from eight to 19. Seven studies reported more than 50% of the STARD items. Conclusions: The current standards of reporting of diagnostic accuracy tests are highly variable. The STARD initiative may be a useful tool for appraising the strengths and weaknesses of diagnostic accuracy studies.

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Objective: To evaluate the quality of reporting of diagnostic accuracy studies using optical coherence tomography (OCT) in glaucoma. Design: Descriptive series of published studies. Participants: Published studies reporting a measure of the diagnostic accuracy of OCT for glaucoma. Methods: Review of English language papers reporting measures of diagnostic accuracy of OCT for glaucoma. Papers were identified from a Medline literature search performed in June 2006. Articles were appraised using the 25 items provided by the Standards for Reporting of Diagnostic Accuracy (STARD) initiative. Each item was recorded as full, partially, or not reported. Main Outcome Measures: Degree of compliance with the STARD guidelines. Results: Thirty papers were appraised. Eight papers (26.7%) fully reported more than half of the STARD items. The lowest number of fully reported items in a study was 5 and the highest was 17. Descriptions of key aspects of methodology frequently were missing. For example, details of participant sampling (e.g., consecutive or random selection) were described in only 8 (26.7%) of 30 publications. Measures of statistical uncertainty were reported in 18 (60%) of 30 publications. No single STARD item was fully reported by all the papers. Conclusions: The standard of reporting of diagnostic accuracy studies in glaucoma using OCT was suboptimal. It is hoped that adoption of the STARD guidelines will lead to an improvement in reporting of diagnostic accuracy studies, enabling clearer evidence to be produced for the usefulness of OCT for the diagnosis of glaucoma. © 2007 American Academy of Ophthalmology.

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Background: The main objective of this study was to assess psychiatric morbidity among adolescentsfollowing the Omagh car bombing in Northern Ireland in 1998.

Methods: Data was collected within schools from adolescents aged between 14 and 18 years via a selfcompletionbooklet comprised of established predictors of PTSD; type of exposure, initialemotional response, long-term adverse physical problems, predictors derived from Ehlers andClark’s (2000) cognitive model, a PTSD symptoms measure (PDS) and the General HealthQuestionnaire (GHQ).

Results:Those with more direct physical exposure were significantly more likely to meet caseness onthe GHQ and the PDS. The combined pre and peri trauma risk factors highlighted in previousmeta-analyses accounted for 20% of the variance in PDS scores but the amount of varianceaccounted for increased to 56% when the variables highlighted in Ehlers and Clark’scognitive model for PTSD were added.

Conclusions: High rates of chronic PTSD were observed in adolescents exposed to the bombing. Whilstincreased exposure was associated with increased psychiatric morbidity, the best predictors ofPTSD were specific aspects of the trauma (‘seeing someone you think is dying’), what youare thinking during the event (‘think you are going to die’) and the cognitive mechanismsemployed after the trauma. As these variables are in principle amenable to treatment theresults have implications for teams planning treatment interventions after future traumas.