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Reporting Rates (reporting + rate)
Selected AbstractsComparison of military and civilian reporting rates for smallpox vaccine adverse events,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2007A. W. McMahon MD Abstract Introduction US smallpox vaccination (SMA) started most recently in December 2002. Military and civilian personnel report adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS), a surveillance system that relies on spontaneous reports. Although reported rates of probable myo/pericarditis after SMA in the literature are similar between military personnel and civilian healthcare workers, some civilian AE reporting rates after SMA appeared higher than those in the military. Objective Determine if SMA-associated reporting rates are different in civilians than in the military, considering age, sex, seriousness, and expectedness of the AE, as well as self-reporting. Methods Numerators were SMA reports in VAERS from 12/12/02 to 3/1/04. Limitations of VAERS include underreporting and lack of diagnostic confirmation. Denominators were number of military and civilian vaccinees. Results Reporting rates stratified by age and sex of serious and non-serious AEs were significantly higher in civilian than military personnel ages <55 years (rate ratios 4,27). These rate ratios decreased with increasing age. Conclusions Reporting rates in VAERS differed significantly and substantially in civilians compared to military personnel <55 years of age. Differences in stimulated passive surveillance systems, and AE reporting practices, including the ,threshold' for reporting most likely explain these findings. These results suggest that in the case of smallpox vaccine AEs, there may be systematic differences in reporting completeness between the civilian and military sectors, and that passive surveillance data should be interpreted with caution. Copyright © 2006 John Wiley & Sons, Ltd. [source] Rhabdomyolysis with HMG-CoA reductase inhibitors and gemfibrozil combination therapy,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2004Jennie T. Chang PharmD Abstract Context Elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C) levels are established risk factors for cardiovascular disease (CVD). HMG-CoA reductase inhibitors (statins) are effective cholesterol-lowering drugs that are commonly prescribed to treat this condition. These drugs are often combined with another class of drugs, fibric acid derivatives, to lower both cholesterol and triglyceride levels. Rhabdomyolysis is a known, rare serious side effect of statin monotherapy and of statin-fibrate combination therapy. Objective To examine Food and Drug Administration's (FDA's) postmarketing database for cases of rhabdomyolysis in relation to monotherapy and combination use and calculate reporting rates for this event. Design Domestic cases of statin- and statin/gemfibrozil-associated rhabdomyolysis were culled from FDA's database and reviewed. Rhabdomyolysis was defined by CPK,,,10,000 IU/L, myopathic signs and symptoms and clinical diagnosis of rhabdomyolysis. Reporting rates, consisting of number of reported cases/number of prescriptions for each drug, were then calculated to determine whether the reporting of rhabdomyolysis cases was commensurate with extent of use of each statin in the population. Setting Cases were obtained from the FDA adverse event reporting system (AERS) database. Patients NA. Main Outcome Measures Number of rhabdomyolysis cases were evaluated, along with outcomes, such as renal failure, dialysis and death. Results Of 866 total reported cases, 482 (56%) were associated with monotherapy and 384 (44%) related to combination therapy. More than 80% of reported cases for each drug resulted in hospitalization for renal failure and dialysis. 80 patients expired from events related directly to rhabdomyolysis. Reporting rates for all statins, except for cerivastatin, were similar and much lower than 1 per 100,000 prescriptions. The cerivastatin-reporting rate was much higher at 4.24/100,000 prescriptions. Conclusions Rhabdomyolysis is a rare, serious side effect of statin monotherapy and of statin-fibrate combination therapy. Clinicians need to remain cognizant of this potential adverse event and discuss signs and symptoms of muscle toxicity with patients in order improve the benefits-to-risks of treating dyslipidemia with statins. Copyright © 2004 John Wiley & Sons, Ltd. [source] Tumor necrosis factor , blockers and malignancy in children: Forty-eight cases reported to the food and drug administration,ARTHRITIS & RHEUMATISM, Issue 8 2010Peter Diak Objective Malignancies reported in children using tumor necrosis factor , (TNF,) blockers have raised concerns of a potential increased risk. This study was undertaken to investigate postmarketing reports of malignancy in children treated with TNF blockers. Methods The FDA's Adverse Event Reporting System was searched to identify malignancies associated with the use of infliximab, etanercept, and adalimumab in children in whom therapy was initiated between the ages of 0 and 18 years. The reporting rates for infliximab and etanercept were compared with the background rate of malignancy in the general pediatric population. Results Forty-eight reports of malignancy in children were identified: 31 following infliximab use, 15 following etanercept use, and 2 following adalimumab use. Half of the malignancies reported were lymphomas and included both Hodgkin's and non-Hodgkin's lymphoma. The remaining reported cases involved a variety of different malignancies including leukemia, melanoma, and solid organ cancers. The majority of the reported cases (88%) involved the concomitant use of other immunosuppressants. Reporting rates for malignancy showed that infliximab had a consistently higher reporting rate when compared with background rates in the general pediatric population for lymphomas and all malignancies. The reporting rates for etanercept were elevated above background for lymphomas and were on par with background for all malignancies. Conclusion There is evidence that treatment with TNF blockers in children may increase the risk of malignancy. However, the cases were confounded by the potential risk of malignancy associated with underlying illnesses and the use of concomitant immunosuppressants; therefore, a clear causal relationship could not be established. [source] Reporting of adverse drug reactions: predictors of under-reporting in Malaysia,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007Zoriah Aziz PhD Abstract Background Malaysia like many other countries worldwide uses spontaneous reporting systems as a mean of collecting data on suspected adverse drug reaction (ADR). However, compared to other countries, which use the system, the reporting rate in Malaysia is very low. Why some physicians do not report ADRs is not well understood. Objective To identify factors, which would predict physicians' failure to send ADR reports. Design and Setting Face-to-face interview using a structured questionnaire involving physicians working at the University of Malaya Medical Centre, Malaysia. Results About a third of the physicians in the Centre participated. Sixty-five of the 415 approached refused to participate. A high proportion of the respondents (81.4%) indicated that they had suspected an ADR but did not report it, while about 40% of the respondents were not aware of the existence of the national reporting system in Malaysia. Logistic regression modelling identified the variable ,ADR considered to be too trivial or too well known to report' as the strongest predictor of not reporting, followed by physicians' category and uncertainty that the reaction had been definitely caused by a drug. Conclusion Important predictor variables, which limit physicians from reporting ADR in Malaysia, were related to uncertainty of types of reaction to report, lack of awareness about the existence, function and purpose of national ADR reporting. The findings could be useful for planning strategies to improve the reporting rate. Copyright © 2006 John Wiley & Sons, Ltd. [source] Using simple species lists to monitor trends in animal populations: new methods and a comparison with independent dataANIMAL CONSERVATION, Issue 3 2007R. L. Roberts Abstract There is an urgent need to develop simple and inexpensive methods for monitoring wildlife populations in resource-poor countries. List-based methods have been advocated as simple yet potentially useful biodiversity monitoring tools, and systems have recently been launched in a number of countries to collect species lists. We attempt to advance the use of systematic list-based monitoring by (1) suggesting improvements to the way in which list reporting rates are calculated; (2) assessing the extent to which degrading effort-corrected measures of abundance into simple species lists results in loss of information on population trends; (3) comparing long-term trends in list reporting rates with population trends from a wholly independent monitoring scheme. Daily species lists of birds were derived from regular trapping at a nature reserve in southern England. Most species showed a strong correlation across years between the proportion of lists on which they occurred, adjusted for list length (adjusted list reporting rate; ALRR), and an effort-corrected measure of abundance (captures per unit effort; CPUE). ALRR revealed almost as much about annual variation in abundance as CPUE for all but the most frequently captured species. Long-term (>20 years) trends in ALRRs at the nature reserve were positively correlated with UK national population trends recorded over the same period by an independent, labour-intensive monitoring scheme that counted birds at a large number of widely spread sites. Our results support previous claims that simple species lists could generate data useful for monitoring long-term population trends, particularly where such lists are collected systematically. However, further research on the efficiency of list reporting rates relative to more sophisticated methods is necessary, before list-based methods can be advocated for dedicated monitoring schemes in resource-poor regions. [source] Case ascertainment and estimated incidence of drug-induced long-QT syndrome: study in Southwest FranceBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 3 2008Mariam Molokhia WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT , Drug-induced long-QT syndrome (LQTS) is a potentially fatal condition that has led to a number of postmarketing withdrawals in recent years. , However, many cases may not survive long enough to reach hospital, and only a small proportion are reported to pharmacovigilance agencies. , The extent to which genetic determinants of susceptibility to LQTS are specific to particular drugs, or common to several classes of drug, remains to be determined. WHAT THIS STUDY ADDS , We estimated population prevalence of drug-induced LQTS in the Midi-Pyrenees region, southwest France, using five different institutions and assessed feasibility of tracing potential cases (in addition to pharmacovigilance data), using hospital data and rigorous case definition. , These methods can be adapted to a wider region, used to augment pharmacovigilance reporting, and offer researchers the opportunity to study genetic susceptibility to drug-induced LQTS. AIMS The aim of this study was to investigate the incidence and reporting rate of drug-induced long-QT syndrome (LQTS) in France [defined by evidence of torsades de pointes (TdP), QT prolongation and exposure to a relevant drug] and to assess feasibility of case collection for drug-induced LQTS. METHODS A retrospective population-based study was carried out in Southwest France in five institutions: three main hospitals, one private clinic and one cardiac emergency unit, searched from 1 January 1999 to 1 January 2005 (population coverage of 614 000). The study population consisted of 861 cases with International Classification of Diseases-10 diagnostic codes for ventricular tachycardia (I147.2), ventricular fibrillation (I149.0) and sudden cardiac death (I146.1) from hospital discharge summaries, supplemented by cases reported to national or regional pharmacovigilance systems, and voluntary reporting by physicians, validated according to internationally defined criteria for drug-induced LQTS. RESULTS Of 861 patients coded with arrhythmias or sudden cardiac death, there were 40 confirmed surviving acquired cases of drug-induced LQTS. We estimated that the incidence of those who survive to reach hospital drug-induced LQTS is approximately 10.9 per million annually in France (95% confidence interval 7.8, 14.8). CONCLUSIONS Many cases of drug-induced LQTS may not survive before they reach hospital, as the reporting rate for drug-induced LQTS identified through the cardiology records and also reported to pharmacovigilance systems for the Midi-Pyrenees area is 3/40 (7.5%). Using the methods outlined it is possible to assemble cases to study genetic susceptibility to drug-induced LQTS and adapt these methods more widely. [source] Comparison of military and civilian reporting rates for smallpox vaccine adverse events,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2007A. W. McMahon MD Abstract Introduction US smallpox vaccination (SMA) started most recently in December 2002. Military and civilian personnel report adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS), a surveillance system that relies on spontaneous reports. Although reported rates of probable myo/pericarditis after SMA in the literature are similar between military personnel and civilian healthcare workers, some civilian AE reporting rates after SMA appeared higher than those in the military. Objective Determine if SMA-associated reporting rates are different in civilians than in the military, considering age, sex, seriousness, and expectedness of the AE, as well as self-reporting. Methods Numerators were SMA reports in VAERS from 12/12/02 to 3/1/04. Limitations of VAERS include underreporting and lack of diagnostic confirmation. Denominators were number of military and civilian vaccinees. Results Reporting rates stratified by age and sex of serious and non-serious AEs were significantly higher in civilian than military personnel ages <55 years (rate ratios 4,27). These rate ratios decreased with increasing age. Conclusions Reporting rates in VAERS differed significantly and substantially in civilians compared to military personnel <55 years of age. Differences in stimulated passive surveillance systems, and AE reporting practices, including the ,threshold' for reporting most likely explain these findings. These results suggest that in the case of smallpox vaccine AEs, there may be systematic differences in reporting completeness between the civilian and military sectors, and that passive surveillance data should be interpreted with caution. Copyright © 2006 John Wiley & Sons, Ltd. [source] Rhabdomyolysis with HMG-CoA reductase inhibitors and gemfibrozil combination therapy,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2004Jennie T. Chang PharmD Abstract Context Elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C) levels are established risk factors for cardiovascular disease (CVD). HMG-CoA reductase inhibitors (statins) are effective cholesterol-lowering drugs that are commonly prescribed to treat this condition. These drugs are often combined with another class of drugs, fibric acid derivatives, to lower both cholesterol and triglyceride levels. Rhabdomyolysis is a known, rare serious side effect of statin monotherapy and of statin-fibrate combination therapy. Objective To examine Food and Drug Administration's (FDA's) postmarketing database for cases of rhabdomyolysis in relation to monotherapy and combination use and calculate reporting rates for this event. Design Domestic cases of statin- and statin/gemfibrozil-associated rhabdomyolysis were culled from FDA's database and reviewed. Rhabdomyolysis was defined by CPK,,,10,000 IU/L, myopathic signs and symptoms and clinical diagnosis of rhabdomyolysis. Reporting rates, consisting of number of reported cases/number of prescriptions for each drug, were then calculated to determine whether the reporting of rhabdomyolysis cases was commensurate with extent of use of each statin in the population. Setting Cases were obtained from the FDA adverse event reporting system (AERS) database. Patients NA. Main Outcome Measures Number of rhabdomyolysis cases were evaluated, along with outcomes, such as renal failure, dialysis and death. Results Of 866 total reported cases, 482 (56%) were associated with monotherapy and 384 (44%) related to combination therapy. More than 80% of reported cases for each drug resulted in hospitalization for renal failure and dialysis. 80 patients expired from events related directly to rhabdomyolysis. Reporting rates for all statins, except for cerivastatin, were similar and much lower than 1 per 100,000 prescriptions. The cerivastatin-reporting rate was much higher at 4.24/100,000 prescriptions. Conclusions Rhabdomyolysis is a rare, serious side effect of statin monotherapy and of statin-fibrate combination therapy. Clinicians need to remain cognizant of this potential adverse event and discuss signs and symptoms of muscle toxicity with patients in order improve the benefits-to-risks of treating dyslipidemia with statins. Copyright © 2004 John Wiley & Sons, Ltd. [source] Researcher judgment and study design: Challenges of using administrative dataAMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 1 2010Leslie I. Boden PhD Abstract Background Questions have been raised about methods of studies finding substantial undercounting of workplace injuries and illnesses by the Bureau of Labor Statistics (BLS) and workers' compensation agencies. A more recent study of Minnesota concluded that the BLS survey captures 84,90% of workers' compensation cases. Methods We examined the sensitivity of findings in two studies to alternate sample definitions and study assumptions. Results Applying alternate sample construction rules to the earlier study increased estimated BLS reporting rates from 68% to 77%, assuming source independence. Applying alternate assumptions to the more recent Minnesota study reduced its high estimate of BLS reporting from 90% to 53,64%. Conclusions Studies linking administrative data from different sources require substantial judgment in constructing research datasets and choosing analytic methods. Moreover, different sample construction rules lead to different results. This suggests that sensitivity analysis should be carried out when alternatives cannot be ruled out. In this case, sensitivity analysis supports the hypothesis of substantial underreporting. Am. J. Ind. Med. 53:37,41, 2010. © 2009 Wiley-Liss, Inc. [source] Using simple species lists to monitor trends in animal populations: new methods and a comparison with independent dataANIMAL CONSERVATION, Issue 3 2007R. L. Roberts Abstract There is an urgent need to develop simple and inexpensive methods for monitoring wildlife populations in resource-poor countries. List-based methods have been advocated as simple yet potentially useful biodiversity monitoring tools, and systems have recently been launched in a number of countries to collect species lists. We attempt to advance the use of systematic list-based monitoring by (1) suggesting improvements to the way in which list reporting rates are calculated; (2) assessing the extent to which degrading effort-corrected measures of abundance into simple species lists results in loss of information on population trends; (3) comparing long-term trends in list reporting rates with population trends from a wholly independent monitoring scheme. Daily species lists of birds were derived from regular trapping at a nature reserve in southern England. Most species showed a strong correlation across years between the proportion of lists on which they occurred, adjusted for list length (adjusted list reporting rate; ALRR), and an effort-corrected measure of abundance (captures per unit effort; CPUE). ALRR revealed almost as much about annual variation in abundance as CPUE for all but the most frequently captured species. Long-term (>20 years) trends in ALRRs at the nature reserve were positively correlated with UK national population trends recorded over the same period by an independent, labour-intensive monitoring scheme that counted birds at a large number of widely spread sites. Our results support previous claims that simple species lists could generate data useful for monitoring long-term population trends, particularly where such lists are collected systematically. However, further research on the efficiency of list reporting rates relative to more sophisticated methods is necessary, before list-based methods can be advocated for dedicated monitoring schemes in resource-poor regions. [source] | ||||||||||