WorldWideScience

Sample records for event reporting system

  1. Adverse Event Reporting System (AERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all...

  2. CDC Wonder Vaccine Adverse Event Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination,...

  3. FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files

    Data.gov (United States)

    U.S. Department of Health & Human Services — The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database...

  4. CDC WONDER: Vaccine Adverse Event Reporting System (VAERS)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Vaccine Adverse Event Reporting System (VAERS) online database on CDC WONDER provides counts and percentages of adverse event case reports after vaccination, by...

  5. Military healthcare providers reporting of adverse events following immunizations to the vaccine adverse event reporting system.

    Science.gov (United States)

    Li, Rongxia; McNeil, Michael M; Pickering, Susanne; Pemberton, Michael R; Duran, Laurie L; Collins, Limone C; Nelson, Michael R; Engler, Renata J M

    2014-04-01

    We studied military health care provider (HCP) practices regarding reporting of adverse events following immunization (AEFI). A convenience sample of HCP was surveyed to assess familiarity with Vaccine Adverse Event Reporting System (VAERS), AEFI they were likely to report, methods used and preferred for reporting, and perceived barriers to reporting. We analyzed factors associated with HCP reporting AEFI to VAERS. A total of 547 surveys were distributed with 487 completed and returned for an 89% response rate. The percentage of HCP aware of VAERS (54%) varied by occupation. 47% of respondents identified knowledge of at least one AEFI with only 34% of these indicating that they had ever reported to VAERS. More serious events were more likely to be reported. Factors associated with HCP reporting AEFIs in bivariate analysis included HCP familiarity with filing a paper VAERS report, HCP familiarity with filing an electronic VAERS report, HCP familiarity with VAERS, and time spent on immunization tasks. In a multivariable analysis, only HCP familiarity with filing a paper VAERS report was statistically significant (Odds ratio = 115.3; p reports may improve vaccine safety reporting practices. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

  6. [Validation of an adverse event reporting system in primary care].

    Science.gov (United States)

    de Lourdes Rojas-Armadillo, María; Jiménez-Báez, María Valeria; Chávez-Hernández, María Margarita; González-Fondón, Araceli

    2016-01-01

    Patient safety is a priority issue in health systems, due to the damage costs, institutional weakening, lack of credibility, and frustration on those who committed an error that resulted in an adverse event. There is no standardized instrument for recording, reporting, and analyzing sentinel or adverse events (AE) in primary care. Our aim was to design and validate a surveillance system for recording sentinel events, adverse events and near miss incidents in primary care. We made a review of systems for recording and reporting adverse events in primary care. Then, we proposed an instrument to record these events, and register faults in the structure and process, in primary health care units in the Instituto Mexicano del Seguro Social. We showed VENCER-MF format to 35 subjects. Out of them, 100% identified a failure in care process, 90% recorded a sentinel event, 85% identified the cause of this event, 75% of them suggested some measures for avoiding the recurrence of adverse events. We used a Cronbach's alpha of 0.6, p=0.03. The instrument VENCER-MF has a good consistency for the identification of adverse events.

  7. 10 CFR 50.73 - Licensee event report system.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Licensee event report system. 50.73 Section 50.73 Energy... shared dependency among trains or channels that is a natural or expected consequence of the approved... component, if known. (F) The Energy Industry Identification System component function identifier and system...

  8. Triptans and serious adverse vascular events: data mining of the FDA Adverse Event Reporting System database.

    Science.gov (United States)

    Roberto, Giuseppe; Piccinni, Carlo; D'Alessandro, Roberto; Poluzzi, Elisabetta

    2014-01-01

    The aim of this article is to investigate the vascular safety profile of triptans through an analysis of the United States Food and Drug Administration Adverse Event Reporting System (FDA_AERS) database with a special focus on serious and unexpected adverse events. A CASE/NON-CASE analysis was performed on the reports entered in the FDA_AERS from 2004 to 2010: CASES were reports with at least one event included in the MedDRA system organ classes 'Cardiac disorder' or 'Vascular disorders', whereas NON-CASES were all the remaining reports. Co-reported cardiovascular drugs were used as a proxy of cardiovascular risk and the adjusted reporting odds ratio (adj.ROR) with 95% confidence intervals (95% CI) was calculated. Disproportionality signals were defined as adj.ROR value >1. Adverse events were considered unexpected if not mentioned on the relevant label. Among 2,131,688 reports, 7808 concerned triptans. CASES were 2593 among triptans and 665,940 for all other drugs. Unexpected disproportionality signals were found in the following high-level terms of the MedDRA hierarchy: 'Cerebrovascular and spinal necrosis and vascular insufficiency' (103 triptan cases), 'Aneurysms and dissections non-site specific' (15), 'Pregnancy-associated hypertension' (10), 'Reproductive system necrosis and vascular insufficiency' (3). Our analysis revealed three main groups of unexpected associations between triptans and serious vascular events: ischaemic cerebrovascular events, aneurysms and artery dissections, and pregnancy-related vascular events. A case-by-case assessment is needed to confirm or disprove their plausibility and large-scale analytical studies should be planned for risk rate estimation. In the meantime, clinicians should pay special attention to migraine diagnosis and vascular risk assessment before prescribing a triptan, also promptly reporting any unexpected event to pharmacovigilance systems.

  9. Classification system for reporting events involving human malfunctions

    DEFF Research Database (Denmark)

    Rasmussen, Jens; Pedersen, O.M.; Mancini, G.

    1981-01-01

    The report describes a set of categories for reporting indus-trial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify "human error......" rates. The classification system has a multifacetted non-hierarchical struc-ture and its compatibility with Isprals ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors oriented...

  10. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

    Science.gov (United States)

    Shimabukuro, Tom T; Nguyen, Michael; Martin, David; DeStefano, Frank

    2015-08-26

    The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. Published by Elsevier Ltd.

  11. Adverse drug event reporting systems: a systematic review.

    Science.gov (United States)

    Bailey, Chantelle; Peddie, David; Wickham, Maeve E; Badke, Katherin; Small, Serena S; Doyle-Waters, Mary M; Balka, Ellen; Hohl, Corinne M

    2016-07-01

    Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance. © 2016 The British Pharmacological Society.

  12. Announcement: Implementation of the Vaccine Adverse Event Reporting System 2.0 Reporting Form.

    Science.gov (United States)

    2017-07-14

    The Vaccine Adverse Event Reporting System (VAERS), co-managed by CDC and the Food and Drug Administration (FDA), is the national postmarketing safety monitoring system that accepts reports about adverse events that occur after administration of U.S.-licensed vaccines (1,2). On June 30, 2017, CDC and FDA implemented a revised reporting form and a new process for submitting reports to VAERS. Persons reporting adverse events are now able to use the VAERS 2.0 online reporting tool to submit reports directly online; alternatively, they may download and complete the writable and savable VAERS 2.0 form and submit it using an electronic document upload feature.

  13. Novel adverse events of vortioxetine: A disproportionality analysis in USFDA adverse event reporting system database.

    Science.gov (United States)

    Subeesh, Viswam; Singh, Hemendra; Maheswari, Eswaran; Beulah, Elsa

    2017-12-01

    Signal detection is one of the most advanced and emerging field in pharmacovigilance. It is a modern method of detecting new reaction (which can be desired or undesired) of a drug. It facilitates early adverse drug reaction detection which enables health professionals to identify adverse events that may not have been identified in pre-marketing clinical trials. Vortioxetine, the first mixed serotonergic antidepressant was initially approved by the US Food and Drug Administration (USFDA) on September 30, 2013 for the treatment of adults with Major Depressive Disorder (MDD). This study was to identify the signal strength for vortioxetine associated ADRs using data mining technique in USFDA Adverse Event Reporting System (AERS) database. Most commonly used three data mining algorithms, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC) were selected for the study and they were applied retrospectively in USFDA AERS database from 2015Q1 to 2016Q3. A value of ROR-1.96SE >1, PRR≥2, IC- 2SD>0 were considered as the positive signal. A study population of 61,22,000 were reported all over the world. Among which 3481 reactions were associated with vortioxetine which comprised of 632 unique events encompassed with 27 clinically relevant reactions. ROR, PRR and IC showed positive signal for weight loss, agitation, anger, ketoacidosis, insomnia and abnormal dreams. The present study suggests that vortioxetine may result in these adverse events. Further pharmacoepidemiologic studies are necessary to confirm this conclusion and to improve the precision of the prevalence and/or the risk factors of this ADRs. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Developmental Regression and Autism Reported to the Vaccine Adverse Event Reporting System

    Science.gov (United States)

    Woo, Emily Jane; Ball, Robert; Landa, Rebecca; Zimmerman, Andrew W.; Braun, M. Miles

    2007-01-01

    We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the…

  15. Adverse events after Fluzone ® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013.

    Science.gov (United States)

    Moro, Pedro L; Harrington, Theresa; Shimabukuro, Tom; Cano, Maria; Museru, Oidda I; Menschik, David; Broder, Karen

    2013-10-09

    In May 2011, the first trivalent inactivated influenza vaccine exclusively for intradermal administration (TIV-ID) was licensed in the US for adults aged 18-64 years. To characterize adverse events (AEs) after TIV-ID reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. We searched VAERS for US reports after TIV-ID among persons vaccinated from July 1, 2011-February 28, 2013. Medical records were requested for reports coded as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis. Clinicians reviewed available information and assigned a primary clinical category to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following TIV-ID. Causality was not assessed. VAERS received 466 reports after TIV-ID; 9 (1.9%) were serious, including one reported fatality in an 88-year-old vaccinee. Median age was 43 years (range 4-88 years). The most common AE categories were: 218 (46.8%) injection site reactions; 89 (19.1%) other non-infectious (comprised mainly of constitutional signs and symptoms); and 74 (15.9%) allergy. Eight reports (1.7%) of anaphylaxis were verified by the Brighton criteria or a documented physician diagnosis. Disproportional reporting was identified for three AEs: 'injection site nodule', 'injection site pruritus', and 'drug administered to patient of inappropriate age'. The findings for the first two AEs were expected. Twenty-four reports of vaccinees reported, and 14 of 24 were coded with the AE 'drug administered to patient of inappropriate age'. Review of VAERS reports did not identify any new or unexpected safety concerns after TIV-ID. Injection site reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Use of TIV-ID in younger and older individuals outside the approved age range highlights the need for education of healthcare providers

  16. Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000-2013.

    Science.gov (United States)

    Hibbs, Beth F; Moro, Pedro L; Lewis, Paige; Miller, Elaine R; Shimabukuro, Tom T

    2015-06-22

    Vaccination errors are preventable events. Errors can have impacts including inadequate immunological protection, possible injury, cost, inconvenience, and reduced confidence in the healthcare delivery system. To describe vaccination error reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and identify opportunities for prevention. We conducted descriptive analyses using data from VAERS, the U.S. spontaneous surveillance system for adverse events following immunization. The VAERS database was searched from 2000 through 2013 for U.S. reports describing vaccination errors and reports were categorized into 11 error groups. We analyzed numbers and types of vaccination error reports, vaccines involved, reporting trends over time, and descriptions of errors for selected reports. We identified 20,585 vaccination error reports documenting 21,843 errors. Annual reports increased from 10 in 2000 to 4324 in 2013. The most common error group was "Inappropriate Schedule" (5947; 27%); human papillomavirus (quadrivalent) (1516) and rotavirus (880) vaccines were most frequently involved. "Storage and Dispensing" errors (4983; 23%) included mostly expired vaccine administered (2746) and incorrect storage of vaccine (2202). "Wrong Vaccine Administered" errors (3372; 15%) included mix-ups between vaccines with similar antigens such as varicella/herpes zoster (shingles), DTaP/Tdap, and pneumococcal conjugate/polysaccharide. For error reports with an adverse health event (5204; 25% of total), 92% were classified as non-serious. We also identified 936 vaccination error clusters (i.e., same error, multiple patients, in a common setting) involving over 6141 patients. The most common error in clusters was incorrect storage of vaccine (582 clusters and more than 1715 patients). Vaccination error reports to VAERS have increased substantially. Contributing factors might include changes in reporting practices, increasing complexity of the immunization schedule

  17. Reported Adverse Events with Painkillers: Data Mining of the US Food and Drug Administration Adverse Events Reporting System.

    Science.gov (United States)

    Min, Jae; Osborne, Vicki; Kowalski, Allison; Prosperi, Mattia

    2017-11-02

    One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to painkillers. We used 2015 and 2016 AE reports from the US FDA's Adverse Events Reporting System (FAERS) to conduct exploratory analysis on the demographics of those who reported painkiller-related AEs, examine the AEs most commonly associated with different types of painkillers, and identify potential safety signals. Summary descriptive statistics and proportional reporting ratios (PRRs) were performed. Out of over 2 million reports submitted to FAERS in 2015 and 2016, a total of 64,354 AE reports were associated with painkillers. Reports of opioid-associated AEs were more likely to be from males or younger patients (mean age 47.6 years). The highest numbers of AEs were reported for NSAID and opioid use, and the most commonly found AEs were related to drug ineffectiveness, administration issues, abuse, and overdose. Death was reported in 20.0% of the reports, and serious adverse reactions, including death, were reported in 67.0%; both adverse outcomes were highest among patients using opioids or combinations of painkillers and were associated with PRRs of 2.12 and 1.87, respectively. This study examined the AEs most commonly associated with varying classes of painkillers by mining the FAERS database. Our results and methods are relevant for future secondary analyses of big data and for understanding adverse outcomes related to painkillers.

  18. Cardiovascular thromboembolic events associated with febuxostat: investigation of cases from the FDA adverse event reporting system database.

    Science.gov (United States)

    Gandhi, Pranav K; Gentry, William M; Bottorff, Michael B

    2013-06-01

    Uloric (Febuxostat) has been linked with cardiovascular thromboembolic events in gout patients. However, no post-marketing data analysis has investigated these drug-associated adverse event reports. The study objective was to identify febuxostat-associated cardiovascular thromboembolic event reports in the US using the Food and Drug Administration adverse event reporting system (AERS) database. Reports listing uloric and febuxostat as the suspect drug and cardiovascular thromboembolic events (combined in a single term based on adverse event reports of myocardial infarction, stroke, among others) as the adverse event were extracted from the drug's approval date through the fourth quarter of 2011. Bayesian statistics within the neural network architecture was implemented to identify potential signals of febuxostat-associated cardiovascular thromboembolic events. A potential signal for the drug-adverse event combination reports is generated when the lower limit of the 95% two-sided confidence interval of the information component (IC), denoted by IC025 is greater than zero. Twenty-one combination reports of febuxostat-associated cardiovascular thromboembolic events were identified in gout patients in the US. The mean age of combination cases was 64 years. Potential signals (IC025 = 4.09) was generated for combination reports of febuxostat-associated cardiovascular thromboembolic events. AERS indicated potential signals of febuxostat-associated cardiovascular thromboembolic events. AERS is not capable of establishing the causal link and detecting the true frequency of an adverse event associated with a drug. The positive IC value found in this study merits continued surveillance and assessment of cardiovascular thromboembolic events associated with Febuxostat. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database

    OpenAIRE

    Park, Kyounghoon; Soukavong, Mick; Kim, Jungmee; Kwon, Kyoung-Eun; Jin, Xue-Mei; Lee, Joongyub; Yang, Bo Ram; Park, Byung-Joo

    2017-01-01

    Purpose To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). Materials and Methods We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We d...

  20. Postmarketing safety surveillance of trivalent recombinant influenza vaccine: Reports to the Vaccine Adverse Event Reporting System.

    Science.gov (United States)

    Woo, Emily Jane; Moro, Pedro L; Cano, Maria; Jankosky, Christopher

    2017-10-09

    On January 16, 2013, the Food and Drug Administration approved recombinant hemagglutinin influenza vaccine (RIV3) (Spodoptera frugiperda cell line; Flublok), which is the first completely egg-free flu vaccine licensed in the United States. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized reports to the Vaccine Adverse Event Reporting System (VAERS) following RIV3. Through June 30, 2016, VAERS received 88 reports. Allergic reactions, including anaphylaxis, were the most common type of adverse event. Based on medical review, 10 cases met the Brighton Collaboration case definition of anaphylaxis, 21 reports described allergic reactions other than anaphylaxis, and 11 reports described signs and symptoms that suggested hypersensitivity. Other adverse events included injection site reactions, fatigue, myalgia, headache, and fever. The occurrence of anaphylaxis and other allergic reactions in some individuals may reflect an underlying predisposition to atopy that may manifest itself after an exposure to any drug or vaccine, and it does not necessarily suggest a causal relationship with the unique constituents that are specific to the vaccine product administered. Further research may elucidate the mechanism of allergic reactions following influenza vaccination: it is possible that egg proteins and influenza hemagglutinin play little or no role. Vaccination remains the single best defense against influenza and its complications. The information summarized here may enable policy makers, health officials, clinicians, and patients to make a more informed decision regarding vaccination strategies. Published by Elsevier Ltd.

  1. Cognitive testing to evaluate revisions to the Vaccine Adverse Event Reporting System (VAERS) reporting form.

    Science.gov (United States)

    Suragh, Tiffany A; Miller, Elaine R; Hibbs, Beth F; Winiecki, Scott K; Zinderman, Craig; Shimabukuro, Tom T

    2017-04-25

    The Vaccine Adverse Event Reporting System (VAERS) is the spontaneous (passive) reporting system CDC and FDA use to monitor vaccine safety. We used cognitive testing to evaluate proposed revisions to the current VAERS form. We conducted in-person cognitive interviews with 22 volunteers to evaluate proposed revisions in a prototype VAERS 2.0 form (new VAERS form). We analyzed data using thematic analysis. Repeating themes included preferences for: brevity, simplicity and clarity; features to minimize time requirements and facilitate ease of completion; logical ordering of questions by topic and importance; and visual cues like color-coded highlighting. Interviews identified instances of discordance between the intended meaning questions (from the perspective of CDC and FDA) and interpretation by volunteers. Cognitive testing yielded useful information to guide further revisions of the VAERS form. Cognitive testing can be an effective tool for public health programs interested in developing surveys and reporting forms. Published by Elsevier Ltd.

  2. Automatically Recognizing Medication and Adverse Event Information From Food and Drug Administration's Adverse Event Reporting System Narratives.

    Science.gov (United States)

    Polepalli Ramesh, Balaji; Belknap, Steven M; Li, Zuofeng; Frid, Nadya; West, Dennis P; Yu, Hong

    2014-06-27

    The Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) is a repository of spontaneously-reported adverse drug events (ADEs) for FDA-approved prescription drugs. FAERS reports include both structured reports and unstructured narratives. The narratives often include essential information for evaluation of the severity, causality, and description of ADEs that are not present in the structured data. The timely identification of unknown toxicities of prescription drugs is an important, unsolved problem. The objective of this study was to develop an annotated corpus of FAERS narratives and biomedical named entity tagger to automatically identify ADE related information in the FAERS narratives. We developed an annotation guideline and annotate medication information and adverse event related entities on 122 FAERS narratives comprising approximately 23,000 word tokens. A named entity tagger using supervised machine learning approaches was built for detecting medication information and adverse event entities using various categories of features. The annotated corpus had an agreement of over .9 Cohen's kappa for medication and adverse event entities. The best performing tagger achieves an overall performance of 0.73 F1 score for detection of medication, adverse event and other named entities. In this study, we developed an annotated corpus of FAERS narratives and machine learning based models for automatically extracting medication and adverse event information from the FAERS narratives. Our study is an important step towards enriching the FAERS data for postmarketing pharmacovigilance.

  3. FDA Adverse Event Reporting System: Recruiting Doctors to Make Surveillance a Little Less Passive.

    Science.gov (United States)

    Mann, Justin M

    2015-01-01

    Within the last few decades, a shift has taken place in FDA's approach to drug development, with greater emphasis put on postmarketing data collection and less on the traditional premarketing scheme. The FDA Adverse Event Reporting System (FAERS) is the primary system for collecting Adverse Events, but has been criticized for years for the low reporting rate into the system and the poor quality of the information submitted. This paper argues that physicians need to be required to submit adverse event reports to FAERS, because such a requirement (1) would produce a greater number of the high quality reports necessary to better determine causality; (2) is merely an extension of physicians' ethical obligations; and (3) aligns with the approach in the Vaccine Adverse Event Reporting System (VAERS). Furthermore, advances in electronic health records can aid in reporting efficiency.

  4. Special Data Collection System (SDCS) event report, Unimak Island region, 16 May 1975

    Energy Technology Data Exchange (ETDEWEB)

    Hill, K.J.; Dawkins, M.S.; Baumstark, R.R.; Gillespie, M.D.

    1976-01-22

    Seismic data are reported from the Special Data Collection System (SDCS) and other sources for the Unimak Island Region event on 16 May 1975. Published epicenter information from seismic observations is given.

  5. Reporting Vaccine Complications: What Do Obstetricians and Gynecologists Know About the Vaccine Adverse Event Reporting System?

    Directory of Open Access Journals (Sweden)

    L. O. Eckert

    2013-01-01

    Full Text Available Background. Obstetrician-gynecologists are increasingly called upon to be vaccinators as an essential part of a woman’s primary and preventive health care. Despite the established safety of vaccines, vaccine adverse events may occur. A national Vaccine Adverse Event Reporting System (VAERS is a well-established mechanism to track adverse events. However, we hypothesized that many obstetrician-gynecologists are naive to the role and use of VAERS. Methods. We devised a ten-question survey to a sample of ACOG fellows to assess their knowledge and understanding of VAERS. We performed descriptive and frequency analysis for each of the questions and used one-way analysis of variance for continuous and chi-squared for categorical variables. Results. Of the 1000 fellows who received the survey, 377 responded. Only one respondent answered all nine knowledge questions correctly, and 9.2% of physicians had used VAERS. Older physicians were less familiar with VAERS in general and with the specific objectives of VAERS in particular (χ2=10.7,P=.005. Conclusions. Obstetrician-gynecologist familiarity with VAERS is lacking. Only when the obstetrician-gynecologist is completely knowledgeable regarding standard vaccine practices, including the availability and use of programs such as VAERS, will providers be functioning as competent and complete vaccinators.

  6. Pediatric medication error reports in Korea adverse event reporting system database, 1989-2012: comparing with adult reports.

    Science.gov (United States)

    Woo, Yeonju; Kim, Hyung Eun; Chung, Sooyoun; Park, Byung Joo

    2015-04-01

    Children have dynamic process of maturation and substantial changes in growth and development which eventually make the drug safety profiles different from adults. Medication errors (MEs) in pediatrics are reported to occur three times more likely than adults. The aims of this study were to identify the characteristics of pediatric MEs in Korea at national level and help raise awareness of risks from the MEs in pediatrics. We conducted a descriptive analysis with the pediatric ME reports in Korea Adverse Event Reporting System (KAERS) database from 1989 to 2012 and 208 ME reports in pediatrics were found. Based on KAERS database, the proportion of reported pediatric ME in adverse drug event (ADE) reports was 2.73 times (95% CI, 2.35-3.17) higher than that of adult ME. In 208 ME reports, we found a total of 236 ME-related terms within 19 types of MEs. The most common type of MEs was "accidental overdose" (n=58, 24.6%), followed by "drug maladministration" (n=50, 21.2%) and "medication error" (n=41, 17.4%). After the narratives of ME reports were reviewed, we noticed that most of them did no harm to patients, but some cases were needed for medical treatment. Our data suggest that MEs in pediatrics are not negligible in Korea. We expect that this study would increase the awareness of the problem in pediatric MEs and induce the need for further development of an effective national ME preventing system in Korea.

  7. Data mining of the public version of the FDA Adverse Event Reporting System.

    Science.gov (United States)

    Sakaeda, Toshiyuki; Tamon, Akiko; Kadoyama, Kaori; Okuno, Yasushi

    2013-01-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.

  8. Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

    2017-12-01

    The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

  9. Design of a User-Centered Voluntary Reporting System for Patient Safety Events.

    Science.gov (United States)

    Kang, Hong; Gong, Yang

    2017-01-01

    As the third leading cause of death in the U.S., patient safety events (PSE) are difficult to control due to multiple inputs from healthcare providers, systems, or even patients. Inspired by the success of reporting systems in other fields, PSE reporting systems could be a good resource to share and to learn from previous cases. However, the success of such systems in healthcare is yet to be seen due to the low report quality and the lack of interoperability and communication. A knowledge-based and user-centered PSE reporting system is needed to organize the scattered knowledge and improve user-friendliness. We described the development of a knowledge base for patient falls, the most frequent PSE. Based on the knowledge base, user-centered design features were incorporated into the system to improve the reporting accuracy, completeness, and timeliness. This prototype holds promise in improving PSE reporting quality and facilitating human-computer communication.

  10. Development of an automated assessment tool for MedWatch reports in the FDA adverse event reporting system.

    Science.gov (United States)

    Han, Lichy; Ball, Robert; Pamer, Carol A; Altman, Russ B; Proestel, Scott

    2017-09-01

    As the US Food and Drug Administration (FDA) receives over a million adverse event reports associated with medication use every year, a system is needed to aid FDA safety evaluators in identifying reports most likely to demonstrate causal relationships to the suspect medications. We combined text mining with machine learning to construct and evaluate such a system to identify medication-related adverse event reports. FDA safety evaluators assessed 326 reports for medication-related causality. We engineered features from these reports and constructed random forest, L1 regularized logistic regression, and support vector machine models. We evaluated model accuracy and further assessed utility by generating report rankings that represented a prioritized report review process. Our random forest model showed the best performance in report ranking and accuracy, with an area under the receiver operating characteristic curve of 0.66. The generated report ordering assigns reports with a higher probability of medication-related causality a higher rank and is significantly correlated to a perfect report ordering, with a Kendall's tau of 0.24 ( P  = .002). Our models produced prioritized report orderings that enable FDA safety evaluators to focus on reports that are more likely to contain valuable medication-related adverse event information. Applying our models to all FDA adverse event reports has the potential to streamline the manual review process and greatly reduce reviewer workload.

  11. Adverse events following quadrivalent meningococcal CRM-conjugate vaccine (Menveo®) reported to the Vaccine Adverse Event Reporting system (VAERS), 2010-2015.

    Science.gov (United States)

    Myers, Tanya R; McNeil, Michael M; Ng, Carmen S; Li, Rongxia; Lewis, Paige W; Cano, Maria V

    2017-03-27

    Limited data are available describing the post-licensure safety of meningococcal vaccines, including Menveo®. We reviewed reports of adverse events (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in all age groups. VAERS is a national spontaneous vaccine safety surveillance system co-administered by the Centers for Disease Control and Prevention and the US Food and Drug Administration. We searched the VAERS database for US reports of adverse events in persons who received Menveo from 1 January 2010 through 31 December 2015. We clinically reviewed reports and available medical records for serious AEs, selected pre-specified outcomes, and vaccination during pregnancy. We used empirical Bayesian data mining to identify AEs that were disproportionately reported after receipt of Menveo. During the study period, VAERS received 2614 US reports after receipt of Menveo. Of these, 67 were classified as serious, including 1 report of death. Adolescents (aged 11-18years) accounted for 74% of reports. Most of the reported AEs were non-serious and described AEs consistent with data from pre-licensure studies. Anaphylaxis and syncope were the two most common events in the serious reports. We did not identify any new safety concerns after review of AEs that exceeded the data mining threshold, although we did observe disproportionate reporting for terms that were not associated with an adverse event (e.g., "incorrect drug dosage form administered", "wrong technique in drug usage process"). Although reports were limited, we did not find any evidence for concern regarding the use of Menveo during pregnancy. In our review of VAERS reports, findings of AEs were consistent with the data from pre-licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Antipsychotics and torsadogenic risk : Signals emerging from the US FDA adverse event reporting system database

    NARCIS (Netherlands)

    E. Poluzzi (Elisabetta); E. Raschi (Emanuel); A. Koci (Ariola); U. Moretti (Ugo); E. Spina (Edoardo); E.R. Behr (Elijah ); M.C.J.M. Sturkenboom (Miriam); F. de Ponti (Fabrizio)

    2013-01-01

    textabstractBackground: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US FDA Adverse Event Reporting System

  13. Empirical estimation of under-reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Alatawi, Yasser M; Hansen, Richard A

    2017-07-01

    To examine how closely reporting rates in the FDA Adverse Event Reporting System (FAERS) reflect expected rates of known adverse drug events (ADEs). We selected three groups of drugs to reflect hypothesized variation in sensitivity to reporting, including statins, biologics, and narrow therapeutics index drugs (NTI). The numbers of ADEs in FAERS were divided by utilization estimates from ambulatory health care data (NAMCS/NHAMCS) to calculate a reported proportion. One sample z-test for proportions compared the proportion of ADEs reported to an expected ADE proportion derived from drug labels, reference databases, and peer-reviewed papers. The majority of drug-ADE pairs showed significant under-reporting. For example, roughly 0.01% to 44% of statin events were reported (z-test p 100%) and NTI (20% to >100%) drugs had relatively higher reporting rates. Roughly 20% to 33% of the minimum number of expected serious events were reported with biologics and NTI drugs. This study supports previous evidence of under-reporting of ADEs in spontaneous reporting data. But, under-reporting varies considerably by the type of drug and the type of ADEs, and this variability in under-reporting should be considered when interpreting safety signals.

  14. Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

    2017-09-01

    Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pevents with lamotrigine, 13,950 events with carbamazepine, and 5077 events with oxcarbazepine were reported, with generics accounting for 27%, 41%, and 32% of reports, respectively. Although RORs for the majority of known AEs were different between brand and generics for all three drugs of interest (Breslow-Day Preports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted Preporting rates were observed for the AG and generic comparisons for most outcomes and drugs, suggesting that brands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Enhancing Patient Safety Event Reporting. A Systematic Review of System Design Features.

    Science.gov (United States)

    Gong, Yang; Kang, Hong; Wu, Xinshuo; Hua, Lei

    2017-08-30

    Electronic patient safety event reporting (e-reporting) is an effective mechanism to learn from errors and enhance patient safety. Unfortunately, the value of e-reporting system (a software or web server based platform) in patient safety research is greatly overshadowed by low quality reporting. This paper aims at revealing the current status of system features, detecting potential gaps in system design, and accordingly proposing suggestions for future design and implementation of the system. Three literature databases were searched for publications that contain informative descriptions of e-reporting systems. In addition, both online publicly accessible reporting forms and systems were investigated. 48 systems were identified and reviewed. 11 system design features and their frequencies of occurrence (Top 5: widgets (41), anonymity or confidentiality (29), hierarchy (20), validator (17), review notification (15)) were identified and summarized into a system hierarchical model. The model indicated the current e-reporting systems are at an immature stage in their development, and discussed their future development direction toward efficient and effective systems to improve patient safety.

  16. Signal Detection of Adverse Drug Reaction of Amoxicillin Using the Korea Adverse Event Reporting System Database.

    Science.gov (United States)

    Soukavong, Mick; Kim, Jungmee; Park, Kyounghoon; Yang, Bo Ram; Lee, Joongyub; Jin, Xue Mei; Park, Byung Joo

    2016-09-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability.

  17. Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system.

    Science.gov (United States)

    Fukuda, Akiho; Tahara, Kohei; Hane, Yuuki; Matsui, Toshinobu; Sasaoka, Sayaka; Hatahira, Haruna; Motooka, Yumi; Hasegawa, Shiori; Naganuma, Misa; Abe, Junko; Nakao, Satoshi; Takeuchi, Hirofumi; Nakamura, Mitsuhiro

    2017-01-01

    Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS). This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ) database. We also calculated the reporting odds ratios (RORs) of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX). The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI) from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89-13.68), 6.43 (5.81-7.13), and 14.73 (11.42-18.99), respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI) for palmar-plantar erythrodysesthesia (PPE) associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74-9.07), 64.77 (56.84-73.80), and 28.76 (15.77-52.45), respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated

  18. Association rule mining in the US Vaccine Adverse Event Reporting System (VAERS).

    Science.gov (United States)

    Wei, Lai; Scott, John

    2015-09-01

    Spontaneous adverse event reporting systems are critical tools for monitoring the safety of licensed medical products. Commonly used signal detection algorithms identify disproportionate product-adverse event pairs and may not be sensitive to more complex potential signals. We sought to develop a computationally tractable multivariate data-mining approach to identify product-multiple adverse event associations. We describe an application of stepwise association rule mining (Step-ARM) to detect potential vaccine-symptom group associations in the US Vaccine Adverse Event Reporting System. Step-ARM identifies strong associations between one vaccine and one or more adverse events. To reduce the number of redundant association rules found by Step-ARM, we also propose a clustering method for the post-processing of association rules. In sample applications to a trivalent intradermal inactivated influenza virus vaccine and to measles, mumps, rubella, and varicella (MMRV) vaccine and in simulation studies, we find that Step-ARM can detect a variety of medically coherent potential vaccine-symptom group signals efficiently. In the MMRV example, Step-ARM appears to outperform univariate methods in detecting a known safety signal. Our approach is sensitive to potentially complex signals, which may be particularly important when monitoring novel medical countermeasure products such as pandemic influenza vaccines. The post-processing clustering algorithm improves the applicability of the approach as a screening method to identify patterns that may merit further investigation. Copyright © 2015 John Wiley & Sons, Ltd.

  19. Signal Detection of Imipenem Compared to Other Drugs from Korea Adverse Event Reporting System Database.

    Science.gov (United States)

    Park, Kyounghoon; Soukavong, Mick; Kim, Jungmee; Kwon, Kyoung Eun; Jin, Xue Mei; Lee, Joongyub; Yang, Bo Ram; Park, Byung Joo

    2017-05-01

    To detect signals of adverse drug events after imipenem treatment using the Korea Institute of Drug Safety & Risk Management-Korea adverse event reporting system database (KIDS-KD). We performed data mining using KIDS-KD, which was constructed using spontaneously reported adverse event (AE) reports between December 1988 and June 2014. We detected signals calculated the proportional reporting ratio, reporting odds ratio, and information component of imipenem. We defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries. There were 807582 spontaneous AEs reports in the KIDS-KD. Among those, the number of antibiotics related AEs was 192510; 3382 reports were associated with imipenem. The most common imipenem-associated AE was the drug eruption; 353 times. We calculated the signal by comparing with all other antibiotics and drugs; 58 and 53 signals satisfied the three methods. We compared the drug labelling information of nine countries, including the USA, the UK, Japan, Italy, Switzerland, Germany, France, Canada, and South Korea, and discovered that the following signals were currently not included in drug labels: hypokalemia, cardiac arrest, cardiac failure, Parkinson's syndrome, myocardial infarction, and prostate enlargement. Hypokalemia was an additional signal compared with all other antibiotics, and the other signals were not different compared with all other antibiotics and all other drugs. We detected new signals that were not listed on the drug labels of nine countries. However, further pharmacoepidemiologic research is needed to evaluate the causality of these signals.

  20. Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women.

    Science.gov (United States)

    Moro, Pedro L; Museru, Oidda I; Niu, Manette; Lewis, Paige; Broder, Karen

    2014-06-01

    To characterize adverse events (AEs) after hepatitis A vaccines (Hep A) and hepatitis A and hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. We searched VAERS for AEs reports in pregnant women who received Hep A or Hep AB from Jan. 1, 1996-April 5, 2013. Clinicians reviewed all reports and available medical records. VAERS received 139 reports of AEs in pregnant women; 7 (5.0%) were serious; no maternal or infant deaths were identified. Sixty-five (46.8%) did not describe any AEs. For those women whose gestational age was available, most were vaccinated during the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The most common pregnancy-specific outcomes following Hep A or Hep AB vaccinations were spontaneous abortion in 15 (10.8%) reports, elective termination in 10 (7.2%), and preterm delivery in 7 (5.0%) reports. The most common nonpregnancy specific outcome was urinary tract infection and nausea/vomiting with 3 (2.2%) reports each. One case of amelia of the lower extremities was reported in an infant following maternal Hep A immunization. This review of VAERS reports did not identify any concerning pattern of AEs in pregnant women or their infants following maternal Hep A or Hep AB immunizations during pregnancy. Published by Mosby, Inc.

  1. Vaccine adverse event text mining system for extracting features from vaccine safety reports.

    Science.gov (United States)

    Botsis, Taxiarchis; Buttolph, Thomas; Nguyen, Michael D; Winiecki, Scott; Woo, Emily Jane; Ball, Robert

    2012-01-01

    To develop and evaluate a text mining system for extracting key clinical features from vaccine adverse event reporting system (VAERS) narratives to aid in the automated review of adverse event reports. Based upon clinical significance to VAERS reviewing physicians, we defined the primary (diagnosis and cause of death) and secondary features (eg, symptoms) for extraction. We built a novel vaccine adverse event text mining (VaeTM) system based on a semantic text mining strategy. The performance of VaeTM was evaluated using a total of 300 VAERS reports in three sequential evaluations of 100 reports each. Moreover, we evaluated the VaeTM contribution to case classification; an information retrieval-based approach was used for the identification of anaphylaxis cases in a set of reports and was compared with two other methods: a dedicated text classifier and an online tool. The performance metrics of VaeTM were text mining metrics: recall, precision and F-measure. We also conducted a qualitative difference analysis and calculated sensitivity and specificity for classification of anaphylaxis cases based on the above three approaches. VaeTM performed best in extracting diagnosis, second level diagnosis, drug, vaccine, and lot number features (lenient F-measure in the third evaluation: 0.897, 0.817, 0.858, 0.874, and 0.914, respectively). In terms of case classification, high sensitivity was achieved (83.1%); this was equal and better compared to the text classifier (83.1%) and the online tool (40.7%), respectively. Our VaeTM implementation of a semantic text mining strategy shows promise in providing accurate and efficient extraction of key features from VAERS narratives.

  2. Adverse event reporting patterns of newly approved drugs in the USA in 2006: an analysis of FDA Adverse Event Reporting System data.

    Science.gov (United States)

    Chhabra, Pankdeep; Chen, Xing; Weiss, Sheila R

    2013-11-01

    The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communication of safety information and new policies regarding the reporting of AEs by healthcare professionals and consumers, prompting reassessment of the existence of the Weber effect in the current AE reporting scenario. To determine the AE reporting patterns for new molecular entity (NME) drugs and biologics approved in 2006 and to examine these patterns for the existence of the Weber effect. Publicly available FDA Adverse Event Reporting System data were used to assess the AE reporting patterns for a 5-year period from the drug’s approval date. The total number of annual reports from all sources, based on the report date, was plotted against time (in years). In the period from 2006 to 2011, a total of 91,187 AE reports were submitted for 19 NMEs approved in 2006. The highest number of AE reports were submitted for varenicline tartrate (N = 47,158) and the lowest number for anidulafungin (N = 161). Anidulafungin was reported to have the highest proportion of death reports (36 %) and varenicline tartrate the lowest proportion (1.7 %). The classic Weber pattern was not observed for any of the 19 NMEs approved in 2006. While there was no one predominant pattern of AE report volume, we grouped the drugs into four general categories; the majority of drugs had either a continued increase in reports (Category A 31.6 %) or an N-pattern with reporting reaching an initial peak in year 2 or 3, declining and then beginning to climb again (Category B 42.1 %). There have been numerous changes in AE reporting, particularly a huge increase in overall annual report volume, since the Weber effect was first reported. Our results suggest that a Weber-type reporting pattern should not be assumed

  3. Identifying natural health product and dietary supplement information within adverse event reporting systems.

    Science.gov (United States)

    Sharma, Vivekanand; Sarkar, Indra Neil

    2018-01-01

    Data on safety and efficacy issues associated with natural health products and dietary supplements (NHP&S) remains largely cloistered within domain specific databases or embedded within general biomedical data sources. A major challenge in leveraging analytic approaches on such data is due to the inefficient ability to retrieve relevant data, which includes a general lack of interoperability among related sources. This study developed a thesaurus of NHP&S ingredient terms that can be used by existing biomedical natural language processing (NLP) tools for extracting information of interest. This process was evaluated relative to intervention name strings sampled from the United States Food and Drug Administration Adverse Event Reporting System (FAERS). A use case was used to demonstrate the potential to utilize FAERS for monitoring NHP&S adverse events. The results from this study provide insights on approaches for identifying additional knowledge from extant repositories of knowledge, and potentially as information that can be included into larger curation efforts.

  4. Can the vaccine adverse event reporting system be used to increase vaccine acceptance and trust?

    Science.gov (United States)

    Scherer, Laura D; Shaffer, Victoria A; Patel, Niraj; Zikmund-Fisher, Brian J

    2016-05-05

    Vaccine refusal has an impact on public health, and the human pappillomavirus (HPV) vaccine is particularly underutilized. Research suggests that it may be difficult to change vaccine-related attitudes, and there is currently no good evidence to recommend any particular intervention strategy. One reason for vaccine hesitancy is lack of trust that vaccine harms are adequately documented and reported, yet few communication strategies have explicitly attempted to improve this trust. This study tested the possibility that data from the vaccine adverse event reporting system (VAERS) can be used to increase trust that vaccine harms are adequately researched and that potential harms are disclosed to the public, and thereby improve perceptions of vaccines. In the study, participants were randomly assigned to one of three communication interventions. All participants read the Centers for Disease Control (CDC) vaccine information statement (VIS) for the HPV vaccine. Two other groups were exposed to additional information about VAERS, either summary data or full detailed reports of serious adverse events from 2013. Results showed that the CDC's VIS alone significantly increased perceptions of vaccine benefits and decreased perceived risks. Participants who were also educated about VAERS and given summary data about the serious adverse events displayed more trust in the CDC and greater HPV vaccine acceptance relative to the VIS alone. However, exposure to the detailed VAERS reports significantly reduced trust in the CDC and vaccine acceptance. Hence, general information about the VAERS data slightly increased trust in the CDC and improved vaccine acceptance, but the specific VAERS reports negatively influenced both trust and acceptance. Implications for communicating about vaccines are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. Field test results of a new ambulatory care Medication Error and Adverse Drug Event Reporting System--MEADERS.

    Science.gov (United States)

    Hickner, John; Zafar, Atif; Kuo, Grace M; Fagnan, Lyle J; Forjuoh, Samuel N; Knox, Lyndee M; Lynch, John T; Stevens, Brian Kelly; Pace, Wilson D; Hamlin, Benjamin N; Scherer, Hilary; Hudson, Brenda L; Oppenheimer, Caitlin Carroll; Tierney, William M

    2010-01-01

    In this study, we developed and field tested the Medication Error and Adverse Drug Event Reporting System (MEADERS)-an easy-to-use, Web-based reporting system designed for busy office practices. We conducted a 10-week field test of MEADERS in which 220 physicians and office staff from 24 practices reported medication errors and adverse drug events they observed during usual clinical care. The main outcomes were (1) use and acceptability of MEADERS measured with a postreporting survey and interviews with office managers and lead physicians, and (2) distributions of characteristics of the medication event reports. A total of 507 anonymous event reports were submitted. The mean reporting time was 4.3 minutes. Of these reports, 357 (70%) included medication errors only, 138 (27%) involved adverse drug events only, and 12 (2.4%) included both. Medication errors were roughly equally divided among ordering medications, implementing prescription orders, errors by patients receiving the medications, and documentation errors. The most frequent contributors to the medication errors and adverse drug events were communication problems (41%) and knowledge deficits (22%). Eight (1.6%) of the reported events led to hospitalization. Reporting raised staff and physician awareness of the kinds of errors that occur in office medication management; however, 36% agreed or strongly agreed that the event reporting "has increased the fear of repercussion in the practice." Time pressure was the main barrier to reporting. It is feasible for primary care clinicians and office staff to report medication errors and adverse drug events to a Web-based reporting system. Time pressures and a punitive culture are barriers to event reporting that must be overcome. Further testing of MEADERS as a quality improvement tool is warranted.

  6. Motor palsies of cranial nerves (excluding VII) after vaccination: reports to the US Vaccine Adverse Event Reporting System.

    Science.gov (United States)

    Woo, Emily Jane; Winiecki, Scott K; Ou, Alan C

    2014-01-01

    We reviewed cranial nerve palsies, other than VII, that have been reported to the US Vaccine Adverse Event Reporting System (VAERS). We examined patterns for differences in vaccine types, seriousness, age, and clinical characteristics. We identified 68 reports of cranial nerve palsies, most commonly involving the oculomotor (III), trochlear (IV), and abducens (VI) nerves. Isolated cranial nerve palsies, as well as palsies occurring as part of a broader clinical entity, were reported. Forty reports (59%) were classified as serious, suggesting that a cranial nerve palsy may sometimes be the harbinger of a broader and more ominous clinical entity, such as a stroke or encephalomyelitis. There was no conspicuous clustering of live vs. inactivated vaccines. The patient age range spanned the spectrum from infants to the elderly. Independent data may help to clarify whether, when, and to what extent the rates of cranial nerve palsies following particular vaccines may exceed background levels.

  7. Acute disseminated encephalomyelitis onset: evaluation based on vaccine adverse events reporting systems.

    Directory of Open Access Journals (Sweden)

    Paolo Pellegrino

    Full Text Available OBJECTIVE: To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM by considering data from different pharmacovigilance surveillance systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS database and the EudraVigilance post-authorisation module (EVPM were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. RESULTS: We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. CONCLUSIONS: This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely not [corrected] due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction.

  8. Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS).

    Science.gov (United States)

    Hoffman, Keith B; Demakas, Andrea R; Dimbil, Mo; Tatonetti, Nicholas P; Erdman, Colin B

    2014-11-01

    The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs. Currently, almost one million case reports are submitted to FAERS each year, making it a vast repository of drug safety information. Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the FDA. To determine the extent of "stimulated reporting" in the modern-day FAERS database. One hundred drugs approved by the FDA between 2001 and 2010 were included in this analysis. FDA alerts were obtained by a comprehensive search of the FDA's MedWatch and main websites. Publicly available FAERS data were used to assess the "primary suspect" AE reporting pattern for up to four quarters before, and after, the issuance of an FDA alert. A few drugs did demonstrate "stimulated reporting" trends. A majority of the drugs, however, showed little evidence for significant reporting changes associated with the issuance of alerts. When we compared the percentage changes in reporting after an FDA alert with those after a sham "control alert", the overall reporting trends appeared to be quite similar. Of 100 drugs analyzed for short-term reporting trends, 21 real alerts and 25 sham alerts demonstrated an increase (greater than or equal to 1 %) in reporting. The long-term analysis of 91 drugs showed that 24 real alerts and 28 sham alerts demonstrated a greater than or equal to 1 % increase. Our results suggest that most of modern day FAERS reporting is not significantly affected by the issuance of FDA alerts.

  9. Chemical Leukoderma Associated with Methylphenidate Transdermal System: Data From the US Food and Drug Administration Adverse Event Reporting System.

    Science.gov (United States)

    Cheng, Carmen; La Grenade, Lois; Diak, Ida-Lina; Brinker, Allen; Levin, Robert L

    2017-01-01

    To identify and characterize cases of chemical leukoderma, an underrecognized adverse event, associated with the methylphenidate transdermal system (MTS) reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS). We searched the Food and Drug Administration Adverse Event Reporting System for reports of chemical leukoderma associated with MTS, received by the Food and Drug Administration from April 6, 2006 to December 23, 2014. We identified 51 cases of chemical leukoderma reported with the use of MTS. The median age was 11 years; 43 cases reported leukoderma at or near the application site only, and 7 reported leukoderma at other parts of the body in addition to the application site; 1 case did not provide enough information to confirm the affected site. The time to onset ranged from 2 months to 4 years after the initiation of MTS. MTS was discontinued in 31 cases. Thirteen patients were prescribed treatment for repigmentation. Three cases reported continued spread of leukoderma after MTS was discontinued. Nineteen cases were diagnosed as vitiligo, including 5 cases reporting histologic features consistent with vitiligo. Leukoderma was persistent in all cases. The median follow-up interval after the discontinuation of MTS in 23 cases was 14 months. As outlined in recent changes to the prescribing information for MTS, health care professionals need to be aware of the potential risk of chemical leukoderma caused by MTS, especially given that chemical leukoderma is often misdiagnosed as idiopathic vitiligo. MTS should be discontinued at the earliest sign of pigment loss and other treatment options considered. Published by Elsevier Inc.

  10. Event Index - a LHCb Event Search System

    CERN Document Server

    INSPIRE-00392208; Kazeev, Nikita; Redkin, Artem

    2015-12-23

    LHC experiments generate up to $10^{12}$ events per year. This paper describes Event Index - an event search system. Event Index's primary function is quickly selecting subsets of events from a combination of conditions, such as the estimated decay channel or stripping lines output. Event Index is essentially Apache Lucene optimized for read-only indexes distributed over independent shards on independent nodes.

  11. Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System.

    Science.gov (United States)

    Arana, Jorge; Mba-Jonas, Adamma; Jankosky, Christopher; Lewis, Paige; Moro, Pedro L; Shimabukuro, Tom T; Cano, Maria

    2017-11-01

    Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS). We searched the VAERS database for reports of POTS following any type of HPV vaccination (bivalent, quadrivalent, or nonavalent) from June 2006 to August 2015. We reviewed reports and applied established POTS diagnostic criteria. We calculated unadjusted POTS case reporting rates based on HPV vaccine doses distributed and conducted empirical Bayesian data mining to screen for disproportional reporting of POTS following HPV vaccination. Among 40,735 VAERS reports following HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of these, 27 (93.1%) were in females and mean age was 14 years (range 12-32). Median time from vaccination to start of symptoms was 43 days (range 0-407); most (18, 75.0%) had onset between 0 and 90 days. Symptoms frequently reported concomitantly included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3%) were most common. Approximately one POTS case is reported for every 6.5 million HPV vaccine doses distributed in the United States. No empirical Bayesian data mining safety signals for POTS and HPV vaccination were detected. POTS is rarely reported following HPV vaccination. Our review did not detect any unusual or unexpected reporting patterns that would suggest a safety problem. Published by Elsevier Inc.

  12. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.

    Science.gov (United States)

    Zhou, Weigong; Pool, Vitali; Iskander, John K; English-Bullard, Roseanne; Ball, Robert; Wise, Robert P; Haber, Penina; Pless, Robert P; Mootrey, Gina; Ellenberg, Susan S; Braun, M Miles; Chen, Robert T

    2003-01-24

    Vaccines are usually administered to healthy persons who have substantial expectations for the safety of the vaccines. Adverse events after vaccinations occur but are generally rare. Some adverse events are unlikely to be detected in prelicensure clinical trials because of their low frequency, the limited numbers of enrolled subjects, and other study limitations. Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events. This report summarizes the adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from January 1, 1991, through December 31, 2001. VAERS was established in 1990 under the joint administration of CDC and the Food and Drug Administration (FDA) to accept reports of suspected adverse events after administration of any vaccine licensed in the United States. VAERS is a passive surveillance system: reports of events are voluntarily submitted by those who experience them, their caregivers, or others. Passive surveillance systems (e.g., VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups. Because of these limitations, determining causal associations between vaccines and adverse events from VAERS reports is usually not possible. Vaccine safety concerns identified through adverse event monitoring nearly always require confirmation using an epidemiologic or other (e.g., laboratory) study. Reports may be submitted by anyone suspecting that an adverse event might have been caused by vaccination and are usually submitted by mail or fax. A web-based electronic reporting system has recently become available. Information from the reports is entered into the VAERS database, and new reports are analyzed weekly. VAERS data stripped of personal identifiers can be reviewed by the

  13. A Review of Dietary Supplement Adverse Event Report Data From the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2004-2013.

    Science.gov (United States)

    Timbo, Babgaleh B; Chirtel, Stuart J; Ihrie, John; Oladipo, Taiye; Velez-Suarez, Loy; Brewer, Vickery; Mozersky, Robert

    2017-11-01

    The Food and Drug Administration (FDA)'s Center for Food Safety and Applied Nutrition (CFSAN) oversees the safety of the nation's foods, dietary supplements, and cosmetic products. To present a descriptive analysis of the 2004-2013 dietary supplement adverse event report (AER) data from CAERS and evaluate the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act as pertaining to dietary supplements adverse events reporting. We queried CAERS for data from the 2004-2013 AERs specifying at least 1 suspected dietary supplement product. We extracted the product name(s), the symptom(s) reported, age, sex, and serious adverse event outcomes. We examined time trends for mandatory and voluntary reporting and performed analysis using SAS v9.4 and R v3.3.0 software. Of the total AERs (n = 15 430) received from January 1, 2004, through December 31, 2013, indicating at least 1 suspected dietary supplement product, 66.9% were mandatory, 32.2% were voluntary, and 0.9% were both mandatory and voluntary. Reported serious outcomes included death, life-threatening conditions, hospitalizations, congenital anomalies/birth defects and events requiring interventions to prevent permanent impairments (5.1%). The dietary supplement adverse event reporting rate in the United States was estimated at ~2% based on CAERS data. This study characterizes CAERS dietary supplement adverse event data for the 2004-2013 eriod and estimates a reporting rate of 2% for dietary supplement adverse events based on CAERS data. The findings show that the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act had a substantial impact on the reporting of adverse events.

  14. A signal detection method for temporal variation of adverse effect with vaccine adverse event reporting system data.

    Science.gov (United States)

    Cai, Yi; Du, Jingcheng; Huang, Jing; Ellenberg, Susan S; Hennessy, Sean; Tao, Cui; Chen, Yong

    2017-07-05

    To identify safety signals by manual review of individual report in large surveillance databases is time consuming; such an approach is very unlikely to reveal complex relationships between medications and adverse events. Since the late 1990s, efforts have been made to develop data mining tools to systematically and automatically search for safety signals in surveillance databases. Influenza vaccines present special challenges to safety surveillance because the vaccine changes every year in response to the influenza strains predicted to be prevalent that year. Therefore, it may be expected that reporting rates of adverse events following flu vaccines (number of reports for a specific vaccine-event combination/number of reports for all vaccine-event combinations) may vary substantially across reporting years. Current surveillance methods seldom consider these variations in signal detection, and reports from different years are typically collapsed together to conduct safety analyses. However, merging reports from different years ignores the potential heterogeneity of reporting rates across years and may miss important safety signals. Reports of adverse events between years 1990 to 2013 were extracted from the Vaccine Adverse Event Reporting System (VAERS) database and formatted into a three-dimensional data array with types of vaccine, groups of adverse events and reporting time as the three dimensions. We propose a random effects model to test the heterogeneity of reporting rates for a given vaccine-event combination across reporting years. The proposed method provides a rigorous statistical procedure to detect differences of reporting rates among years. We also introduce a new visualization tool to summarize the result of the proposed method when applied to multiple vaccine-adverse event combinations. We applied the proposed method to detect safety signals of FLU3, an influenza vaccine containing three flu strains, in the VAERS database. We showed that it had high

  15. Online reporting system for transfusion-related adverse events to enhance recipient haemovigilance in Japan: a pilot study.

    Science.gov (United States)

    Odaka, Chikako; Kato, Hidefumi; Otsubo, Hiroko; Takamoto, Shigeru; Okada, Yoshiaki; Taneichi, Maiko; Okuma, Kazu; Sagawa, Kimitaka; Hoshi, Yasutaka; Tasaki, Tetsunori; Fujii, Yasuhiko; Yonemura, Yuji; Iwao, Noriaki; Tanaka, Asashi; Okazaki, Hitoshi; Momose, Shun-Ya; Kitazawa, Junichi; Mori, Hiroshi; Matsushita, Akio; Nomura, Hisako; Yasoshima, Hitoshi; Ohkusa, Yasushi; Yamaguchi, Kazunari; Hamaguchi, Isao

    2013-02-01

    A surveillance system for transfusion-related adverse reactions and infectious diseases in Japan was started at a national level in 1993, but current reporting of events in recipients is performed on a voluntary basis. A reporting system which can collect information on all transfusion-related events in recipients is required in Japan. We have developed an online reporting system for transfusion-related events and performed a pilot study in 12 hospitals from 2007 to 2010. The overall incidence of adverse events per transfusion bag was 1.47%. Platelet concentrates gave rise to statistically more adverse events (4.16%) than red blood cells (0.66%) and fresh-frozen plasma (0.93%). In addition, we found that the incidence of adverse events varied between hospitals according to their size and patient characteristics. This online reporting system is useful for collection and analysis of actual adverse events in recipients of blood transfusions and may contribute to enhancement of the existing surveillance system for recipients in Japan. Copyright © 2012. Published by Elsevier Ltd.

  16. Antipsychotics, glycemic disorders, and life-threatening diabetic events: a Bayesian data-mining analysis of the FDA adverse event reporting system (1968-2004).

    Science.gov (United States)

    DuMouchel, William; Fram, David; Yang, Xionghu; Mahmoud, Ramy A; Grogg, Amy L; Engelhart, Luella; Ramaswamy, Krishnan

    2008-01-01

    This analysis compared diabetes-related adverse events associated with use of different antipsychotic agents. A disproportionality analysis of the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) was performed. Data from the FDA postmarketing AERS database (1968 through first quarter 2004) were evaluated. Drugs studied included aripiprazole, clozapine, haloperidol, olanzapine, quetiapine, risperidone, and ziprasidone. Fourteen Medical Dictionary for Regulatory Activities (MedDRA) Primary Terms (MPTs) were chosen to identify diabetes-related adverse events; 3 groupings into higher-level descriptive categories were also studied. Three methods of measuring drug-event associations were used: proportional reporting ratio, the empirical Bayes data-mining algorithm known as the Multi-Item Gamma Poisson Shrinker, and logistic regression (LR) analysis. Quantitative measures of association strength, with corresponding confidence intervals, between drugs and specified adverse events were computed and graphed. Some of the LR analyses were repeated separately for reports from patients under and over 45 years of age. Differences in association strength were declared statistically significant if the corresponding 90% confidence intervals did not overlap. Association with various glycemic events differed for different drugs. On average, the rankings of association strength agreed with the following ordering: low association, ziprasidone, aripiprazole, haloperidol, and risperidone; medium association, quetiapine; and strong association, clozapine and olanzapine. The median rank correlation between the above ordering and the 17 sets of LR coefficients (1 set for each glycemic event) was 93%. Many of the disproportionality measures were significantly different across drugs, and ratios of disproportionality factors of 5 or more were frequently observed. There are consistent and substantial differences between atypical antipsychotic drugs in the

  17. Lessons Learned from the Evolution of Mandatory Adverse Event Reporting Systems

    National Research Council Canada - National Science Library

    Flink, Ellen; Chevalier, C. L; Ruperto, Angelo; Dameron, Peg; Heigel, Frederick J; Leslie, Ruth; Mannion, Janet; Panzer, Robert J

    2005-01-01

    .... The current system, the New York Patient Occurrence Reporting and Tracking System (NYPORTS), was implemented in 1998 pursuant to New York State Public Health Law Section 2805-1, Incident Reporting...

  18. The reliability of manual reporting of clinical events in an anesthesia information management system (AIMS).

    Science.gov (United States)

    Simpao, Allan F; Pruitt, Eric Y; Cook-Sather, Scott D; Gurnaney, Harshad G; Rehman, Mohamed A

    2012-12-01

    Manual incident reports significantly under-report adverse clinical events when compared with automated recordings of intraoperative data. Our goal was to determine the reliability of AIMS and CQI reports of adverse clinical events that had been witnessed and recorded by research assistants. The AIMS and CQI records of 995 patients aged 2-12 years were analyzed to determine if anesthesia providers had properly documented the emesis events that were observed and recorded by research assistants who were present in the operating room at the time of induction. Research assistants recorded eight cases of emesis during induction that were confirmed with the attending anesthesiologist at the time of induction. AIMS yielded a sensitivity of 38 % (95 % confidence interval [CI] 8.5-75.5 %), while the sensitivity of CQI reporting was 13 % (95 % CI 0.3-52.7 %). The low sensitivities of the AIMS and CQI reports suggest that user-reported AIMS and CQI data do not reliably include significant clinical events.

  19. An Event Logging, Analysis, and Reporting System (ELARS) as a Knowledge Management Technology

    Science.gov (United States)

    2009-04-01

    Systems (SBIRS) program represents a "system of systems," combining the power of geosynchronous orbit (GEO), highly elliptical orbit (HEO), and low...identification and time- stamp information. The monitoring and logging ELARS components can be combined into a powerful to the system; therefore, it...repository. All event-related storage a~d retrieval operations are performed through this component, which represents a central poin ! of access control and

  20. Dipeptidyl peptidase-4 inhibitors and heart failure: Analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System.

    Science.gov (United States)

    Raschi, E; Poluzzi, E; Koci, A; Antonazzo, I C; Marchesini, G; De Ponti, F

    2016-05-01

    We tested the possible association between dipeptidyl peptidase-4 inhibitors (DPP-4-I) use and heart failure (HF) occurrence by assessing the publicly available US-FDA Adverse Event Reporting System (FAERS). FAERS data reporting HF and DPP-4-Is use in the period from the fourth quarter of 2006 through 2013 were extracted, using the Standardized MedDRA Query "Cardiac failure". Disproportionality (case/non-case method) was implemented by calculating Reporting Odds Ratios (RORs) with 95% Confidence Interval (CI): (1) exploratory analysis on the entire FAERS (using rosiglitazone as positive control); (2) consolidated analyses by therapeutic area (within antidiabetics), correcting for event- and drug-related competition bias and adjusting for co-reported drugs as confounders. HF during DPP4-I use was recorded in 390 reports (4.4% of total reports). In exploratory analysis, statistically significant ROR emerged for DPP-4-I as a class (ROR = 1.17; 95% CI = 1.05-1.29), saxagliptin (1.68; 1.29-2.17), vildagliptin (2.39; 1.38-4.14), and rosiglitazone (13.98; 13.30-14.70). In consolidated analyses, the ROR for saxagliptin (2.60; 1.92-3.50) and vildagliptin (4.07; 2.28-7.27) increased, and became also significant for sitagliptin (1.61; 1.40-1.86). Concomitant drugs were reported in more than 50% of cases; the adjusted RORs of saxagliptin (2.30; 1.70-3.10), vildagliptin (3.15; 1.76-5.63), and sitagliptin (1.48; 1.28-1.71) were nonetheless significant. FAERS data are consistent with clinical studies on a possible association between saxagliptin and HF. The disproportionate reporting of HF with sitagliptin, conflicting with a recent phase IV trial, suggests that cardiovascular safety requires close post-marketing vigilance by clinicians of individual DPP-4-I in the community until the issue of class effect is solved. Copyright © 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the

  1. Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system.

    Directory of Open Access Journals (Sweden)

    Toshiyuki Sakaeda

    Full Text Available OBJECTIVE: Adverse event reports (AERs submitted to the US Food and Drug Administration (FDA were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA reductase inhibitors (statins and to attempt to determine the rank-order of the association. METHODS: After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. RESULTS: Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. CONCLUSIONS: Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.

  2. Tumor necrosis factor α antagonist-associated psoriasis in inflammatory diseases: an analysis of the FDA adverse event reporting system.

    Science.gov (United States)

    Kip, Kevin E; Swoger, Jason M; Grandinetti, Lisa M; Barrie, Arthur M; Greer, Julia B; Regueiro, Miguel D

    2013-05-01

    Crohn's disease (CD) is a chronic inflammatory, relapsing, and progressive condition that leads to bowel damage and subsequent stricturing or penetrating complications. Tumor necrosis factor (TNF) α antagonists (e.g., infliximab) can achieve sustained remission in CD. However, a paradox exists as to whether use of these medications, which effectively treat psoriasis, also confer risk of developing psoriasiform lesions. Data from the Food and Drug Administration Adverse Event Reporting System (2004-2011) were analyzed. Adverse event reports for the TNF-α antagonists infliximab, adalimumab, and certolizumab were reviewed. Primary "control" drugs examined included the non-CD drugs propranolol and lithium because of their recognized association with risk of psoriasis and the nonbiological CD drug mesalamine. Proportional reporting ratios for psoriasis adverse events were calculated for TNF-α antagonists versus control drugs. From more than 13 million reports in Adverse Event Reporting System, the biological group included 5432 reports with psoriasis listed (infliximab = 1789; adalimumab = 3475; and certolizumab = 168) compared with just 88 psoriasis reports for the control group (propranolol = 24; mesalamine = 24; and lithium = 40). Compared with control drugs, the psoriasis proportional reporting ratios for TNF-α antagonists were as follows: infliximab (6.61), adalimumab (12.13), and certolizumab (5.43) (P reporting ratio for all TNF-α antagonists versus control drugs was 9.24 (P reports were compared between TNF-α antagonists and other drugs used to treat CD, including azathioprine, 6-mercaptopurine, methotrexate, corticosteroids, ciprofloxacin, and the antimalarial drug, hydroxychloroquine. Data from the Food and Drug Administration Adverse Event Reporting System suggest that TNF-α antagonists used in the treatment of CD confer an increased risk of psoriasiform adverse events.

  3. Using Probabilistic Record Linkage of Structured and Unstructured Data to Identify Duplicate Cases in Spontaneous Adverse Event Reporting Systems.

    Science.gov (United States)

    Kreimeyer, Kory; Menschik, David; Winiecki, Scott; Paul, Wendy; Barash, Faith; Woo, Emily Jane; Alimchandani, Meghna; Arya, Deepa; Zinderman, Craig; Forshee, Richard; Botsis, Taxiarchis

    2017-07-01

    Duplicate case reports in spontaneous adverse event reporting systems pose a challenge for medical reviewers to efficiently perform individual and aggregate safety analyses. Duplicate cases can bias data mining by generating spurious signals of disproportional reporting of product-adverse event pairs. We have developed a probabilistic record linkage algorithm for identifying duplicate cases in the US Vaccine Adverse Event Reporting System (VAERS) and the US Food and Drug Administration Adverse Event Reporting System (FAERS). In addition to using structured field data, the algorithm incorporates the non-structured narrative text of adverse event reports by examining clinical and temporal information extracted by the Event-based Text-mining of Health Electronic Records system, a natural language processing tool. The final component of the algorithm is a novel duplicate confidence value that is calculated by a rule-based empirical approach that looks for similarities in a number of criteria between two case reports. For VAERS, the algorithm identified 77% of known duplicate pairs with a precision (or positive predictive value) of 95%. For FAERS, it identified 13% of known duplicate pairs with a precision of 100%. The textual information did not improve the algorithm's automated classification for VAERS or FAERS. The empirical duplicate confidence value increased performance on both VAERS and FAERS, mainly by reducing the occurrence of false-positives. The algorithm was shown to be effective at identifying pre-linked duplicate VAERS reports. The narrative text was not shown to be a key component in the automated detection evaluation; however, it is essential for supporting the semi-automated approach that is likely to be deployed at the Food and Drug Administration, where medical reviewers will perform some manual review of the most highly ranked reports identified by the algorithm.

  4. Detecting Signals of Disproportionate Reporting from Singapore's Spontaneous Adverse Event Reporting System: An Application of the Sequential Probability Ratio Test.

    Science.gov (United States)

    Chan, Cheng Leng; Rudrappa, Sowmya; Ang, Pei San; Li, Shu Chuen; Evans, Stephen J W

    2017-08-01

    The ability to detect safety concerns from spontaneous adverse drug reaction reports in a timely and efficient manner remains important in public health. This paper explores the behaviour of the Sequential Probability Ratio Test (SPRT) and ability to detect signals of disproportionate reporting (SDRs) in the Singapore context. We used SPRT with a combination of two hypothesised relative risks (hRRs) of 2 and 4.1 to detect signals of both common and rare adverse events in our small database. We compared SPRT with other methods in terms of number of signals detected and whether labelled adverse drug reactions were detected or the reaction terms were considered serious. The other methods used were reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Gamma Poisson Shrinker (GPS). The SPRT produced 2187 signals in common with all methods, 268 unique signals, and 70 signals in common with at least one other method, and did not produce signals in 178 cases where two other methods detected them, and there were 403 signals unique to one of the other methods. In terms of sensitivity, ROR performed better than other methods, but the SPRT method found more new signals. The performances of the methods were similar for negative predictive value and specificity. Using a combination of hRRs for SPRT could be a useful screening tool for regulatory agencies, and more detailed investigation of the medical utility of the system is merited.

  5. Event Index - an LHCb Event Search System

    CERN Document Server

    Ustyuzhanin, Andrey

    2015-01-01

    During LHC Run 1, the LHCb experiment recorded around 1011 collision events. This paper describes Event Index | an event search system. Its primary function is to quickly select subsets of events from a combination of conditions, such as the estimated decay channel or number of hits in a subdetector. Event Index is essentially Apache Lucene [1] optimized for read-only indexes distributed over independent shards on independent nodes.

  6. Implementation and evaluation of a prototype consumer reporting system for patient safety events.

    Science.gov (United States)

    Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C; Quigley, Denise D; Hunter, Lauren E; Ridgely, M Susan; Schneider, Eric C

    2017-08-01

    No methodologically robust system exists for capturing consumer-generated patient safety reports. To address this challenge, we developed and pilot-tested a prototype consumer reporting system for patient safety, the Health Care Safety Hotline. Mixed methods evaluation. The Hotline was implemented in two US healthcare systems from 1 February 2014 through 30 June 2015. Patients, family members and caregivers associated with two US healthcare systems. A consumer-oriented incident reporting system for telephone or web-based administration was developed to elicit medical mistakes and care-related injuries. Key informant interviews, measurement of website traffic and analysis of completed reports. Key informants indicated that Hotline participation was motivated by senior leaders' support and alignment with existing quality and safety initiatives. During the measurement period from 1 October 2014 through 30 June 2015, the home page had 1530 visitors with a unique IP address. During its 17 months of operation, the Hotline received 37 completed reports including 20 mistakes without harm and 15 mistakes with injury. The largest category of mistake concerned problems with diagnosis or advice from a health practitioner. Hotline reports prompted quality reviews, an education intervention, and patient follow-ups. While generating fewer reports than its capacity to manage, the Health Care Safety Hotline demonstrated the feasibility of consumer-oriented patient safety reporting. Further research is needed to understand how to increase consumers' use of these systems.

  7. Tocilizumab-induced pancreatitis: case report and review of data from the FDA Adverse Event Reporting System.

    Science.gov (United States)

    Flaig, T; Douros, A; Bronder, E; Klimpel, A; Kreutz, R; Garbe, E

    2016-12-01

    Tocilizumab (TCZ) is a humanized monoclonal antibody acting against the IL-6 receptor. It is a drug used in the treatment of rheumatoid arthritis and can be either given intravenously every 4 weeks or subcutaneously once a week. Known adverse events (AE) associated with TCZ include: infections of the upper respiratory tract, arterial hypertension, hypercholesterolaemia and hypertriglyceridaemia. Here, we present the first well-documented case of TCZ-induced acute pancreatitis (AP) and a systematic review of the literature including data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Patient data collection was performed within the Berlin Case-Control Surveillance Study. A literature search for TCZ-induced AP was conducted. Analysis of the FAERS database concerning TCZ-associated pancreatic AE from the period of 2009 until the first quarter of 2013 was conducted. A 40-year-old man presented with a 2-day history of progressive upper abdominal pain with elevated serum lipase and triglyceride levels. Biliary pancreatitis was ruled out by abdominal sonography and CT scan. Cessation of intravenously administered TCZ resulted in improvement of the patient's condition and a decline in elevated laboratory values, suggesting a probable relationship between TCZ intake and AP. Analysis of the FAERS database retrieved 52 cases of TCZ-associated AP that accounted for 70% of all pancreatic AE in association with TCZ use. Further literature search detected three additional cases in which TCZ use was associated with AP. Physicians should be aware of the probable association between TCZ use and AP. Targeted post-authorization studies are needed to confirm and quantify the risk of TCZ-induced AP. © 2016 John Wiley & Sons Ltd.

  8. Analysis of the Interaction between Clopidogrel, Aspirin, and Proton Pump Inhibitors Using the FDA Adverse Event Reporting System Database.

    Science.gov (United States)

    Suzuki, Yukiya; Suzuki, Honami; Umetsu, Ryogo; Uranishi, Hiroaki; Abe, Junko; Nishibata, Yuri; Sekiya, Yasuaki; Miyamura, Nobuteru; Hara, Hideaki; Tsuchiya, Teruo; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Clopidogrel is an antiplatelet agent widely used in combination with aspirin to limit the occurrence of cardiovascular (embolic/thrombotic) events. Consensus guidelines recommend proton pump inhibitors (PPIs) as a gastrointestinal (GI) prophylactic measure for all patients receiving dual antiplatelet therapy with clopidogrel and aspirin. The objective of this study was to analyze the effect of the simultaneous use of clopidogrel, aspirin, and PPIs on hemorrhagic and embolic/thrombotic events using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Reports of hemorrhagic and embolic/thrombotic events between 2004 and 2013 were analyzed with a reporting odds ratio (ROR) algorithm and logistic regression methods. The Medical Dictionary for Regulatory Activities Preferred Terms was used to identify such events. Regarding hemorrhagic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 4.40 (95% confidence interval [CI], 4.02-4.81) and 3.40 (95% CI, 2.84-4.06), respectively. For embolic/thrombotic events, the adjusted RORs of the concomitant use of aspirin and clopidogrel and those of PPIs prescribed with aspirin and clopidogrel were 2.37 (95% CI, 2.16-2.59) and 2.38 (95% CI, 2.00-2.84), respectively. Among patients included in the FAERS database, the concurrent use of aspirin and clopidogrel with PPIs reduced the adjusted ROR of GI hemorrhagic events. PPIs had little influence on the adjusted ROR of embolic/thrombotic events. These results support the use of PPIs as a preventive measure against GI hemorrhagic events for patients receiving clopidogrel and aspirin.

  9. Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS

    Directory of Open Access Journals (Sweden)

    Sakaeda Toshiyuki

    2011-10-01

    Full Text Available Abstract Background Previously, adverse event reports (AERs submitted to the US Food and Drug Administration (FDA database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. Methods After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. Conclusions The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.

  10. Design of a system for detecting and reporting security incidents and adverse events in thyroid and parathyroid surgery

    Directory of Open Access Journals (Sweden)

    José Luis PARDAL-REFOYO

    2016-03-01

    Full Text Available Introduction: Patient safety is defined as the reduction of risk of unnecessary harm associated with healthcare. Up to 9.3% of patients admitted into a hospital present some adverse event related to the assistance. This can cause damage to the patient, more instrumentation, increased morbidity, increased hospital stay and increased cost. To identify, record and analyze adverse events is necessary to have an incident reporting system. Objective: Developing a local system for reporting security incidents and adverse events in surgery of the thyroid gland. Method: A working group was formed with representatives from all units related to the process of thyroidectomy, checkpoints were established, checklists for each control point were designed, a strategic analysis of the group's activity was performed, a literature review was done in order to identify the major incident reporting systems, the items that the incident report form must have were identified and the form was designed. Results: The incident report form collects data on the patient, the communicator and the incident (type, cause, consequence, severity, frequency, risk matrix. It has a first paragraph with narrative sections and a second with drop-down lists. The form is accessible only to the working group for voluntary use. Conclusions: The purpose of the reporting system is learning and prevention.

  11. Omeprazole- and esomeprazole-associated hypomagnesaemia: data mining of the public version of the FDA Adverse Event Reporting System.

    Science.gov (United States)

    Tamura, Takao; Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

    2012-01-01

    Case reports showing that proton-pump inhibitors (PPIs), omeprazole and esomeprazole, can cause hypomagnesaemia have been accumulating since 2006. In this study, the reports submitted to the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) were evaluated to assess omeprazole and esomeprazole in terms of susceptibility to hypomagnesaemia. After a revision of arbitrary drug names and the deletion of duplicated submissions, the reports involving omeprazole and esomeprazole were analyzed. Standardized official pharmacovigilance tools were used for the quantitative detection of a signal, i.e., an association between a drug and an adverse drug event, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. A total of 22,017,956 co-occurrences were found in 1,644,220 reports from 2004 to 2009, where a co-occurrence was a pair of a drug and an adverse drug event. In total, 818 and 743 adverse drug events were listed as omeprazole- and esomeprazole-associated, with hypomagnesaemia ranking 85th and 135th, respectively. Although both PPIs were associated with hypomagnesaemia, the statistical metrics suggested that the association was more noteworthy for omeprazole. The data obtained in this study do not provide sufficient evidence to recommend systematic monitoring of magnesium levels in plasma, but chronic exposure to a PPI can lead to severe hypomagnesaemia.

  12. Omeprazole- and Esomeprazole-associated Hypomagnesaemia: Data Mining of the Public Version of the FDA Adverse Event Reporting System

    Science.gov (United States)

    Tamura, Takao; Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

    2012-01-01

    Objective: Case reports showing that proton-pump inhibitors (PPIs), omeprazole and esomeprazole, can cause hypomagnesaemia have been accumulating since 2006. In this study, the reports submitted to the Adverse Event Reporting System (AERS) of the US Food and Drug Administration (FDA) were evaluated to assess omeprazole and esomeprazole in terms of susceptibility to hypomagnesaemia. Methods: After a revision of arbitrary drug names and the deletion of duplicated submissions, the reports involving omeprazole and esomeprazole were analyzed. Standardized official pharmacovigilance tools were used for the quantitative detection of a signal, i.e., an association between a drug and an adverse drug event, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Results: A total of 22,017,956 co-occurrences were found in 1,644,220 reports from 2004 to 2009, where a co-occurrence was a pair of a drug and an adverse drug event. In total, 818 and 743 adverse drug events were listed as omeprazole- and esomeprazole-associated, with hypomagnesaemia ranking 85th and 135th, respectively. Although both PPIs were associated with hypomagnesaemia, the statistical metrics suggested that the association was more noteworthy for omeprazole. Conclusion: The data obtained in this study do not provide sufficient evidence to recommend systematic monitoring of magnesium levels in plasma, but chronic exposure to a PPI can lead to severe hypomagnesaemia. PMID:22745572

  13. Evaluation of Dabigatran- and Warfarin-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database Stratified by Age.

    Science.gov (United States)

    Abe, Junko; Umetsu, Ryogo; Kato, Yamato; Ueda, Natsumi; Nakayama, Yoko; Suzuki, Yukiya; Suzuki, Toshiyuki; Nagasawa, Hideko; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Dabigatran and warfarin are oral anticoagulant drugs widely used for the prevention of stroke in patients with atrial fibrillation. The objective of this study was to evaluate the interaction between aging and dabigatran- and warfarin-induced gastrointestinal (GI) and nervous system hemorrhage using data available in the FDA Adverse Event Reporting System (FAERS) database. We analyzed reports of hemorrhagic events in the GI and nervous system recorded in the FAERS database between 2004 and 2014 using an adjusted reporting odds ratio (ROR). We demonstrated that dabigatran-associated GI hemorrhage was significantly increased in patients over the age of 80 years. The RORs of dabigatran increased with increasing age, although aging had little effect on warfarin-associated GI hemorrhage. The ROR for anticoagulant-associated nervous system hemorrhage was not significantly affected by aging, as compared to GI hemorrhage. Our results indicate that the excretion of dabigatran may be affected by aging, as compared to warfarin, likely due to renal function decline. Our results emphasize the need for physicians to closely monitor GI bleeding in aging patients, because it is closely related to renal function deterioration.

  14. Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990-2016.

    Science.gov (United States)

    Moro, Pedro L; Zheteyeva, Yenlik; Barash, Faith; Lewis, Paige; Cano, Maria

    2018-01-02

    The safety of hepatitis B vaccination during pregnancy has not been well studied. We characterized adverse events (AEs) after hepatitis B vaccination of pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. We searched VAERS for AEs reports involving pregnant women who received hepatitis B vaccine from January 1, 1990-June 30, 2016. All reports and available medical records were reviewed by physicians. Observed AEs were compared to expected AEs and known rates of pregnancy outcomes to assess for any unexpected safety concern. We found 192 reports involving pregnant women following hepatitis B vaccination of which 110 (57.3%) described AEs; 12 (6.3%) were classified as serious; one newborn death was identified in a severely premature delivery, and there were no maternal deaths. Eighty-two (42.7%) reports did not describe any AEs. Among pregnancies for which gestational age was reported, most women were vaccinated during the first trimester, 86/115 (74.7%). Among reports describing an AE, the most common pregnancy-specific outcomes included spontaneous abortion in 23 reports, preterm delivery in 7 reports, and elective termination in 5 reports. The most common non-pregnancy specific outcomes were general disorders and administration site conditions, such as injection site and systemic reactions, in 21 reports. Among 22 reports describing an AE among infants born to women vaccinated during pregnancy, 5 described major birth defects each affecting different organ systems. Our analysis of VAERS reports involving hepatitis B vaccination during pregnancy did not identify any new or unexpected safety concerns. Published by Elsevier Ltd.

  15. Cardiotoxicity in targeted therapy for breast cancer: A study of the FDA adverse event reporting system (FAERS).

    Science.gov (United States)

    Wittayanukorn, Saranrat; Qian, Jingjing; Johnson, Brandon S; Hansen, Richard A

    2017-03-01

    Purpose Cancer chemotherapy-induced cardiotoxicity is concerning. Certain anthracyclines and targeted therapies are known to have potential for cardiotoxicity, but existing trial evidence is inadequate to understand real-world patterns of cardiotoxicity with newer targeted therapies and their common combinations with older agents. This study evaluated chemotherapy-related cardiotoxicity reports for targeted therapies and their combinations in breast cancer patients. Methods The US Food and Drug Administration Adverse Event Reporting System (FAERS) database from January 2004 through September 2012 was used to summarize characteristics of reported cardiotoxicity events and their health outcomes. Disproportionality analyses with reporting odds ratios (ROR) and 95% confidence intervals (95% CI) were conducted to detect event signals using a case/non-case method for each targeted therapy and combination. Results A total of 59,739 cases of cardiotoxicity reports were identified; 937 cases identified targeted therapy as the suspect drug. Trastuzumab had the highest number of reports followed by bevacizumab and lapatinib. Proportions of reports of death and disability outcomes for each targeted therapy were approximately 20-25% of the total reports of serious events. Trastuzumab had the highest ROR as a single agent (ROR = 5.74; 95% CI = 5.29-6.23) or combination use of cyclophosphamide (ROR = 16.83; 95% CI = 13.32-21.26) or doxorubicin (ROR = 17.84; 95% CI = 13.77-23.11). Relatively low cardiotoxicity reporting rates were found with lapatinib, regardless of use with combination therapy. Conclusions Analysis of FAERS data identified signals for adverse cardiotoxicity events with targeted therapies and their combinations. Practitioners should consider factors that may increase the likelihood of cardiotoxicity when assessing treatment. Findings support continued surveillance, risk factor identification, and comparative studies.

  16. Extreme Energy Events Monitoring report

    CERN Document Server

    Baimukhamedova, Nigina

    2015-01-01

    Following paper reflects the progress I made on Summer Student Program within Extreme Energy Events Monitor project I was working on. During 8 week period I managed to build a simple detector system that is capable of triggering events similar to explosions (sudden change in sound levels) and measuring approximate location of the event. Source codes are available upon request and settings described further.

  17. Physicians' knowledge and attitude towards adverse event reporting system and result to intervention--randomized nested trial among Bulgarian physicians.

    Science.gov (United States)

    Stoynova, Veselina; Getov, Ilko N; Naseva, Emilia K; Lebanova, Hristina V; Grigorov, Evgeni E

    2013-08-01

    To identify the factors that influence physicians' under-reporting in Bulgaria and their attitude towards adverse event reporting system and to estimate the role of self-education by providing educational materials. A randomized nested trial among physicians-general practitioners and specialists in Bulgaria was conducted by a validated questionnaire in order to evaluate their knowledge and attitude towards adverse event reporting system. One month after the intervention the participants were re-visited and were asked to answer the same questions again in order to estimate the change in their knowledge and attitude towards pharmacovigilance system and to obtain their evaluation for the materials provided. The response rate was 91. Fifty seven (46.3%) physicians were not familiar with the pharmacovigilance system. The most common reason for non-reporting adverse drug reactions (ADRs) was uncertainty concerning the relationship between the suspected drug and ADRs, the ADRs were already known and the fact that the physician was not aware where they should report. Although 103 (83.7%) respondents in the entry survey and by 102 (82.9%) of those participating in the exit survey consider ADRs reporting as their obligation (p more than 0.05), only 50 (40.7%) and 31 (25.2%), respectively answered that they had ever reported ADRs; 109 (88.6%) of the surveyed physicians assessed the provided educational materials as useful for them. The physicians in Bulgaria have poor knowledge for the pharmacovigilance system; however self-education leads to a better knowledge and positive attitude towards ADRs reporting system. National drug regulatory authority should play a more active role in improving physicians' adherence to the ADRs reporting systems and the developed educational pack can be used in nationwide campaign.

  18. Assessing dutasteride-associated sexual dysfunction using the U.S. Food and Drug Administration Adverse Event Reporting System.

    Science.gov (United States)

    Gupta, A K; Carviel, J; Gupta, M A; Shear, N H

    2017-12-01

    Incidences of sexual dysfunction due to the use of 5 α-reductase inhibitors have been suggested. Despite low sexual dysfunction reported in clinical trials, an analysis of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database revealed a significant disproportionality in the reporting of sexual dysfunction with the use of finasteride. Therefore, it is likely that a similar relationship with dutasteride may exist. To determine whether dutasteride use leads to a higher risk of sexual dysfunction compared to a baseline risk for all other drugs using the FAERS database. A case by non-case disproportionality approach was used whereby a reporting odds ratio (ROR) with 95% confidence interval (CI) was calculated. Cases of dutasteride-associated sexual dysfunction were compared to a reference risk of sexual dysfunction for all other drugs in the database. A significant disproportionality in reporting of sexual dysfunction with the use of dutasteride was observed. The disproportionality was present for all age ranges except for 31-45 years where there were few overall reports of adverse events. Adverse events can be underreported, and selection bias is inherent in the FAERS. Dutasteride use is associated with an increase in reports of sexual dysfunction. © 2017 European Academy of Dermatology and Venereology.

  19. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases.

    Science.gov (United States)

    Vermeer, Niels S; Straus, Sabine M J M; Mantel-Teeuwisse, Aukje K; Domergue, Francois; Egberts, Toine C G; Leufkens, Hubert G M; De Bruin, Marie L

    2013-08-01

    Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from small differences in the manufacturing process. Detailed exposure information should be readily available in systems for postmarketing safety surveillance of biopharmaceuticals, including spontaneous reporting systems (SRSs), in which reports of ADRs are collected. The aim of this study was to explore the current status of traceability of biopharmaceuticals in the US and the EU up to patient level in SRSs. A cross-sectional study was conducted over the period 2004-2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU. The availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs. For biopharmaceuticals for which a biosimilar has been approved for marketing in the EU, the identifiability of the product (i.e. the possibility of distinguishing the biosimilar from the reference biopharmaceutical) was determined. A total of 2,028,600 unique ADR reports were identified in the FAERS, reporting a total of 591,380 biopharmaceuticals (of which 487,065 were suspected). In EV there were 2,108,742 unique ADR reports, reporting a total of 439,971 biopharmaceuticals (356,293 suspected). Overall, for 24.0 % of the suspected biopharmaceuticals in the FAERS and 7.4 % of the suspected small molecule drugs (p biopharmaceuticals batch numbers were available, compared with only 3.6 % of the small molecule drugs (p biopharmaceuticals (9,759 suspected) for which a biosimilar has been approved in the EU were identified in EV. For 90.4 % of these biopharmaceuticals and 96.2 % of the suspected biopharmaceuticals the product was clearly identifiable. This study underlines the need for improving traceability of biopharmaceuticals, in particular with respect to individual batches, allowing better identification and monitoring of postmarketing safety issues

  20. Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Zhang, Xiaoyan; Hamadeh, Issam S; Song, Shuang; Katz, Joseph; Moreb, Jan S; Langaee, Taimour Y; Lesko, Lawrence J; Gong, Yan

    2016-02-01

    Osteonecrosis of the jaw (ONJ) is a serious adverse drug event that was initially reported with intravenous bisphosphonates (BPs) and more recently with other classes of drugs such as receptor activator of NF-κB ligand (RANKL) inhibitor, antiangiogenic agents, and mammalian target of rapamycin (m-TOR) inhibitors. The purpose of this study is to analyze the ONJ cases and the associated drugs in the US Food and Drug Administration's adverse event reporting system (FAERS). The FAERS database was queried for the adverse drug events reported from the first quarter of 2010 to the first quarter of 2014. The reporting odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each queried drug. A total of 17,119 unique ONJ cases were identified. In the overall analysis, the drugs with the highest reporting ORs were BPs: pamidronate (OR = 498.9), zoledronate (OR = 171.7), and alendronate (OR = 63.6), whereas denosumab had lower ORs than all the BPs except for etidronate. The antiangiogenic and m-TOR inhibitors had the lowest ORs. In cancer patients who were treated for prevention of skeletal-related events (SREs), the reporting ORs for zoledronate and denosumab were 125.2 and 4.9, respectively. In patients with osteoporosis, the ORs were 1.1 (1.0-1.18) for zoledronate and 0.63 (0.56-0.70) for denosumab, respectively. Our analysis of the FAERS database showed that the intravenous BPs were associated with the highest risk for ONJ, RANKL inhibitor was associated with risk comparable to BPs used for osteoporosis such as etidronate, and the antiangiogenic agents and m-TOR inhibitors were associated with the lowest risk for ONJ. The high risk for ONJ with zoledronate and denosumab was mainly observed in those who were treated for prevention of SREs, whereas there was limited evidence for such risk in those who were treated for osteoporosis. © 2015 American Society for Bone and Mineral Research.

  1. Developing and Testing the Health Care Safety Hotline: A Prototype Consumer Reporting System for Patient Safety Events.

    Science.gov (United States)

    Schneider, Eric C; Ridgely, M Susan; Quigley, Denise D; Hunter, Lauren E; Leuschner, Kristin J; Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C

    2017-06-01

    This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.

  2. Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax(®)) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015.

    Science.gov (United States)

    Moro, Pedro L; Winiecki, Scott; Lewis, Paige; Shimabukuro, Tom T; Cano, Maria

    2015-11-27

    In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax(®), ccIIV3), was approved in the US for adults aged ≥ 18 years. To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. We searched VAERS for US reports after ccIIV3 among persons vaccinated from July 1, 2013-March 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category using MedDRA system organ classes (SOC) to each report. Empirical Bayesian data mining was used to identify disproportional AE reporting following ccIIV3. VAERS received 629 reports following ccIIV3 of which 313 were for administration of vaccine to persons reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for 'drug administered to patient of inappropriate age.' Review of VAERS reports did not identify any concerning pattern of AEs after ccIIV3. Injection site and systemic reactions were the most commonly reported AEs, similar to the pre-licensure clinical trials. Reports following ccIIV3 in persons <18 years highlight the need for education of healthcare providers regarding approved ccIIV3 use. Published by Elsevier Ltd.

  3. How safe are recently FDA-approved antimicrobials? A review of the FDA adverse event reporting system database.

    Science.gov (United States)

    Khadem, Tina M; van Manen, Robbert P; Brown, Jack

    2014-12-01

    To review quantitatively and qualitatively the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database to provide clinicians with a general understanding of the comparative occurrence of clinically meaningful adverse events associated with 15 antimicrobial new molecular entities approved by the FDA since 2006: anidulafungin, darunavir, maraviroc, raltegravir, doripenem, telavancin, ceftaroline, boceprevir, telaprevir, fidaxomicin, bedaquiline, dolutegravir, simeprevir, sofosbuvir, and dalbavancin. Retrospective analysis. FDA AERS database. Empirica Signal software was used to query the AERS database from November 1968 to December 2012. Using disproportionality analyses, we calculated a relative reporting ratio (RRR) estimate for reports of antimicrobial adverse events. The RRR estimate compares the occurrence of a specific adverse event with an index drug of interest to the occurrence of the same adverse event with similar agents or with all other FDA-approved prescription drugs. Common industry practice considers an RRR meaningful if the 5th percentile of the distribution is at least 2 (RRR05 of 2.0 or higher). Antimicrobials were compared with agents within their respective antimicrobial therapeutic class as well as with all agents in the AERS database. Seventeen adverse signals with an RRR05 of 2.0 or higher were identified from the database for six agents. Ten of the 17 signals were not included in the most up-to-date manufacturers' package inserts for four of the six agents: doripenem-associated hepatic dysfunction (RRR05 3.7) and hyperchloremia (RRR05 2.6); boceprevir-associated weight loss (RRR05 2.2); darunavir-associated premature labor (RRR05 3.1), sudden infant death syndrome (RRR05 2.9), ventricular hypertrophy (RRR05 2.7), acute coronary syndrome (RRR05 2.4), and congenital anomaly in offspring (RRR05 2.4); and raltegravir-associated congenital heart valve disorders (RRR05 2.5) and SIDS (RRR05 2.3). Clinically meaningful

  4. [Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases].

    Science.gov (United States)

    Sasaoka, Sayaka; Matsui, Toshinobu; Abe, Junko; Umetsu, Ryogo; Kato, Yamato; Ueda, Natsumi; Hane, Yuuki; Motooka, Yumi; Hatahira, Haruna; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2016-01-01

    The Japanese Ministry of Health, Labor, and Welfare lists hand-foot syndrome as a serious adverse drug event. Therefore, we evaluated its association with anticancer drug therapy using case reports in the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In addition, we calculated the reporting odds ratio (ROR) of anticancer drugs potentially associated with hand-foot syndrome, and applied the Weibull shape parameter to time-to-event data from JADER. We found that JADER contained 338224 reports from April 2004 to November 2014, while FAERS contained 5821354 reports from January 2004 to June 2014. In JADER, the RORs [95% confidence interval (CI)] of hand-foot syndrome for capecitabine, tegafur-gimeracil-oteracil, fluorouracil, sorafenib, and regorafenib were 63.60 (95%CI, 56.19-71.99), 1.30 (95%CI, 0.89-1.89), 0.48 (95%CI, 0.30-0.77), 26.10 (95%CI, 22.86-29.80), and 133.27 (95%CI, 112.85-157.39), respectively. Adverse event symptoms of hand-foot syndrome were observed with most anticancer drugs, which carry warnings of the propensity to cause these effects in their drug information literature. The time-to-event analysis using the Weibull shape parameter revealed differences in the time-dependency of the adverse events of each drug. Therefore, anticancer drugs should be used carefully in clinical practice, and patients may require careful monitoring for symptoms of hand-foot syndrome.

  5. Ischemic Colitis as a Complication of Medication Use: An Analysis of the Federal Adverse Event Reporting System.

    Science.gov (United States)

    Bielefeldt, Klaus

    2016-09-01

    More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetron's approval as treatment of irritable bowel syndrome (IBS). The aim of this study was to identify medical therapies associated with development of IC. The Federal Adverse Event Reporting System was queried for the time between January 2004 and September 2015. We identified reports listing IC as treatment complication and extracted suspected causative and concomitantly administered drugs, indications for their use and outcomes. After eliminating duplicates, we found 2811 cases of IC (68.4 % women; 59.4 ± 0.4 years). Patients with IBS accounted for 3.9 % of the cases, mostly attributed to tegaserod or alosetron. Chemotherapeutic and immunosuppressive drugs, sex hormones, and anticoagulants were the most commonly suspected causes. Bisphosphonates, nonsteroidal anti-inflammatory drugs, antipsychotics, triptans, interferon therapy, and laxative use prior to colonoscopy were among the more commonly listed treatments. In 8 %, the adverse event contributed to the patient's death with male sex and older age predicting fatal outcomes. Beyond confirming known risks of IC, the results identified several potential culprits of ischemic colitis. This information may not only explain the development of this serious adverse event, but could also guide treatment decisions, cautioning healthcare providers when considering these agents in persons with known risk factors or other drugs that may increase their risk of IC.

  6. Quadrivalent human papillomavirus vaccine and autoimmune adverse events: a case-control assessment of the vaccine adverse event reporting system (VAERS) database.

    Science.gov (United States)

    Geier, David A; Geier, Mark R

    2017-02-01

    Gardasil is a quadrivalent human papillomavirus (HPV4) vaccine that was approved for use by the US Food and Drug Administration in June 2006. HPV4 vaccine is routinely recommended for administration to women in the USA who are 11-12 years old by the Advisory Committee on Immunization Practices. Previous studies suggest HPV4 vaccine administration was associated with autoimmune diseases. As a consequence, an epidemiological assessment of the vaccine adverse event reporting system database was undertaken for adverse event reports associated with vaccines administered from 2006 to 2014 to 6-39 year-old recipients with a listed US residence and a specified female gender. Cases with the serious autoimmune adverse event (SAAE) outcomes of gastroenteritis (odds ratio (OR) 4.627, 95 % confidence interval (CI) 1.892-12.389), rheumatoid arthritis (OR 5.629, 95 % CI 2.809-12.039), thrombocytopenia (OR 2.178, 95 % CI 1.222-3.885), systemic lupus erythematosus (OR 7.626, 95 % CI 3.385-19.366), vasculitis (OR 3.420, 95 % CI 1.211-10.408), alopecia (OR 8.894, 95 % CI 6.255-12.914), CNS demyelinating conditions (OR 1.585, 95 % CI 1.129-2.213), ovarian damage (OR 14.961, 95 % CI 6.728-39.199), or irritable bowel syndrome (OR 10.021, 95 % CI 3.725-33.749) were significantly more likely than controls to have received HPV4 vaccine (median onset of initial symptoms ranged from 3 to 37 days post-HPV4 vaccination). Cases with the outcome of Guillain-Barre syndrome (OR 0.839, 95 % CI 0.601-1.145) were no more likely than controls to have received HPV4 vaccine. In addition, cases with the known HPV4-related outcome of syncope were significantly more likely than controls to have received HPV4 vaccine (OR 5.342, 95 % CI 4.942-5.777). Cases with the general health outcomes of infection (OR 0.765, 95 % CI 0.428-1.312), conjunctivitis (OR 1.010, 95 % CI 0.480-2.016), diarrhea (OR 0.927, 95 % CI 0.809-1.059), or pneumonia (OR 0.785, 95 % CI 0.481-1.246) were no more likely

  7. Attitudes and Usage of the Food and Drug Administration Adverse Event Reporting System Among Gastroenterology Nurse Practitioners and Physician Assistants.

    Science.gov (United States)

    Salk, Allison; Ehrenpreis, Eli D

    2016-01-01

    The Food and Drug Administration Adverse Event Reporting System (FAERS) is used for postmarketing pharmacovigilance. Our study sought to assess attitudes and usage of the FAERS among gastroenterology nurse practitioners (NPs) and physician assistants (PAs). A survey was administered at the August 2012 Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course, held in Chicago, IL. Of the 128 respondents, 123 (96%) reported a specialty in gastroenterology or hepatology and were included in analysis. Eighty-nine participants were NPs and 32 PAs, whereas 2 did not report their profession. Although 119 (98%) agreed or strongly agreed with the statement that accurately reporting adverse drug reactions is an important process to optimize patient safety, the majority of participants (54% NPs and 81% PAs) were unfamiliar with the FAERS. In addition, only 20% of NPs and 9% of PAs reported learning about the FAERS in NP or PA schooling. Our study shows enthusiasm among gastroenterology NPs and PAs for the reporting of adverse drug reactions, coupled with a lack of familiarity with the FAERS. This presents an opportunity for enhanced education about reporting of adverse drug reactions for gastroenterology NPs and PAs.

  8. Event-based Formalization of Safety-critical Operating System Standards: An Experience Report on ARINC 653 using Event-B

    OpenAIRE

    Zhao, Yongwang; Yang,Zhibin; Sanan, David; Liu, Yang

    2015-01-01

    Standards play the key role in safety-critical systems. Errors in standards could mislead system developer's understanding and introduce bugs into system implementations. In this paper, we present an Event-B formalization and verification for the ARINC 653 standard, which provides a standardized interface between safety-critical real-time operating systems and application software, as well as a set of functionalities aimed to improve the safety and certification process of such safety-critica...

  9. Joint Single Integrated Air Picture (SIAP) System Engineering Organization (JSSEO) Standard Event Test Readiness Report Template

    Science.gov (United States)

    2004-12-01

    Analysis r-f)~"~<=)zt - t01H~ ~ USAF Deputy Director. JSSEO Jeffery W. Wilson, USN Dir ctor. JSSEO Brig Gen ( ) Daniel R, Dink ’ USAF Director, JSSEO...Integration Center (JNIC» The JTAMD Application Area Manager provides technical environment support services, maintains visibility over a family of systems...Executive Steering Group E-2C Systems Test and Evaluation Laboratory Federation Object Model Family of Systems Page A-I 7.2.7.2_TRR(04-016L

  10. Alleged isotretinoin-associated inflammatory bowel disease: disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System.

    Science.gov (United States)

    Stobaugh, Derrick J; Deepak, Parakkal; Ehrenpreis, Eli D

    2013-09-01

    Some studies have purported to link isotretinoin prescribed for acne with the development of inflammatory bowel disease (IBD). We sought to identify existence of disproportionate attorney-initiated reporting of isotretinoin-associated IBD in the Food and Drug Administration Adverse Event Reporting System (FAERS). A total of 3,338,835 cases (2003-2011) were downloaded from the FAERS. These were queried for IBD cases reported with isotretinoin for a usage indication of acne while recording reporter category. Trends were analyzed over time for reports by attorneys for all medications compared with reports of IBD with isotretinoin. Signal inflation factor was calculated to determine the distortion of pharmacovigilance signals for IBD with isotretinoin. There were 2214 cases of IBD resulting from isotretinoin. Attorneys reported 1944 (87.8%) cases whereas physicians reported 132 (6.0%) and consumers reported 112 (5.1%) cases (P value reports for all drug reactions during the same time period were reported by attorneys (P value reports was 5.82, signifying a clear distortion. The accuracy of reports was not ascertained. Attorney-initiated reports inflate the pharmacovigilance signal of isotretinoin-associated IBD in the FAERS. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  11. Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system.

    Science.gov (United States)

    Raschi, Emanuel; Poluzzi, Elisabetta; Koci, Ariola; Salvo, Francesco; Pariente, Antoine; Biselli, Maurizio; Moretti, Ugo; Moore, Nicholas; De Ponti, Fabrizio

    2015-08-01

    We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US-FDA adverse event reporting system (FAERS). We extracted reports of drug-induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event- and drug-related competition bias, and case-by-case evaluation for concomitant medications. DILI reports represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: n = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (<1 week) was detected in 46% of patients (47% and 44%, respectively). The disproportionality signal for rivaroxaban calls for further comparative population-based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug- and patient-related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of NOACs when they diagnose a liver injury. © 2015 The British Pharmacological Society.

  12. Consumer reporting of adverse events following immunization.

    Science.gov (United States)

    Clothier, Hazel J; Selvaraj, Gowri; Easton, Mee Lee; Lewis, Georgina; Crawford, Nigel W; Buttery, Jim P

    2014-01-01

    Surveillance of adverse events following immunisation (AEFI) is an essential component of vaccine safety monitoring. The most commonly utilized passive surveillance systems rely predominantly on reporting by health care providers (HCP). We reviewed adverse event reports received in Victoria, Australia since surveillance commencement in July 2007, to June 2013 (6 years) to ascertain the contribution of consumer (vaccinee or their parent/guardian) reporting to vaccine safety monitoring and to inform future surveillance system development directions. Categorical data included were: reporter type; serious and non-serious AEFI category; and, vaccinee age group. Chi-square test and 2-sample test of proportions were used to compare categories; trend changes were assessed using linear regression. Consumer reporting increased over the 6 years, reaching 21% of reports received in 2013 (Pattendance (Psystems to implement efficient consumer AEFI reporting, but may be justified for their potential impact on signal detection sensitivity.

  13. Proton Pump Inhibitors and the Risk for Fracture at Specific Sites: Data Mining of the FDA Adverse Event Reporting System.

    Science.gov (United States)

    Wang, Liwei; Li, Mei; Cao, Yuying; Han, Zhengqi; Wang, Xueju; Atkinson, Elizabeth J; Liu, Hongfang; Amin, Shreyasee

    2017-07-17

    Proton pump inhibitors (PPIs) are widely used to treat gastric acid-related disorders. Concerns have been raised about potential fracture risk, especially at the hip, spine and wrist. However, fracture risk at other bone sites has not been as well studied. We investigated the association between PPIs and specific fracture sites using an aggregated knowledge-enhanced database, the Food and Drug Administration Adverse Event Reporting System Data Mining Set (AERS-DM). Proportional reporting ratio (PRR) was used to detect statistically significant associations (signals) between PPIs and fractures. We analyzed both high level terms (HLT) and preferred terms (PT) for fracture sites, defined by MedDRA (Medical Dictionary for Regulatory Activities). Of PPI users reporting fractures, the mean age was 65.3 years and the female to male ratio was 3.4:1. Results revealed signals at multiple HLT and PT fracture sites, consistent for both sexes. These included fracture sites with predominant trabecular bone, not previously reported as being associated with PPIs, such as 'rib fractures', where signals were detected for overall PPIs as well as for each of 5 generic ingredients (insufficient data for dexlansoprazole). Based on data mining from AERS-DM, PPI use appears to be associated with an increased risk for fractures at multiple sites.

  14. Seismic event classification system

    Science.gov (United States)

    Dowla, Farid U.; Jarpe, Stephen P.; Maurer, William

    1994-01-01

    In the computer interpretation of seismic data, the critical first step is to identify the general class of an unknown event. For example, the classification might be: teleseismic, regional, local, vehicular, or noise. Self-organizing neural networks (SONNs) can be used for classifying such events. Both Kohonen and Adaptive Resonance Theory (ART) SONNs are useful for this purpose. Given the detection of a seismic event and the corresponding signal, computation is made of: the time-frequency distribution, its binary representation, and finally a shift-invariant representation, which is the magnitude of the two-dimensional Fourier transform (2-D FFT) of the binary time-frequency distribution. This pre-processed input is fed into the SONNs. These neural networks are able to group events that look similar. The ART SONN has an advantage in classifying the event because the types of cluster groups do not need to be pre-defined. The results from the SONNs together with an expert seismologist's classification are then used to derive event classification probabilities.

  15. Safety of vaccines that have been kept outside of recommended temperatures: Reports to the Vaccine Adverse Event Reporting System (VAERS), 2008-2012.

    Science.gov (United States)

    Hibbs, Beth F; Miller, Elaine; Shi, Jing; Smith, Kamesha; Lewis, Paige; Shimabukuro, Tom T

    2018-01-25

    Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE) following administration of vaccines kept outside of recommended temperatures. To describe reports to the Vaccine Adverse Event Reporting System (VAERS) involving vaccines inappropriately stored outside of recommended temperatures and/or exposed to temperatures outside of manufacturer specifications for inappropriate amounts of time. We searched the VAERS database (analytic period 2008-2012) for reports describing vaccines kept outside of recommended temperatures. We analyzed reports by vaccine type, length outside of recommended temperature and type of temperature excursion, AE following receipt of potentially compromised vaccine, and reasons for cold chain breakdown. We identified 476 reports of vaccines kept outside of recommended temperatures; 77% described cluster incidents involving multiple patients. The most commonly reported vaccines were quadrivalent human papillomavirus (n = 146, 30%), 23-valent pneumococcal polysaccharide (n = 51, 11%), and measles, mumps, and rubella (n = 45, 9%). Length of time vaccines were kept outside of recommended temperatures ranged from 15 mins to 6 months (median 51 h). Most (n = 458, 96%) reports involved patients who were administered potentially compromised vaccines; AE were reported in 32 (7%), with local reactions (n = 21) most frequent. Two reports described multiple patients contracting diseases they were vaccinated against, indicating possible influenza vaccine failure. Lack of vigilance, inadequate training, and equipment failure were reasons cited for cold chain management breakdowns. Our review does not indicate any substantial direct health risk from administration of vaccines kept outside of recommended temperatures. However, there are potential costs and risks, including vaccine wastage, possible decreased

  16. Exploration of the association rules mining technique for the signal detection of adverse drug events in spontaneous reporting systems.

    Science.gov (United States)

    Wang, Chao; Guo, Xiao-Jing; Xu, Jin-Fang; Wu, Cheng; Sun, Ya-Lin; Ye, Xiao-Fei; Qian, Wei; Ma, Xiu-Qiang; Du, Wen-Min; He, Jia

    2012-01-01

    The detection of signals of adverse drug events (ADEs) has increased because of the use of data mining algorithms in spontaneous reporting systems (SRSs). However, different data mining algorithms have different traits and conditions for application. The objective of our study was to explore the application of association rule (AR) mining in ADE signal detection and to compare its performance with that of other algorithms. Monte Carlo simulation was applied to generate drug-ADE reports randomly according to the characteristics of SRS datasets. Thousand simulated datasets were mined by AR and other algorithms. On average, 108,337 reports were generated by the Monte Carlo simulation. Based on the predefined criterion that 10% of the drug-ADE combinations were true signals, with RR equaling to 10, 4.9, 1.5, and 1.2, AR detected, on average, 284 suspected associations with a minimum support of 3 and a minimum lift of 1.2. The area under the receiver operating characteristic (ROC) curve of the AR was 0.788, which was equivalent to that shown for other algorithms. Additionally, AR was applied to reports submitted to the Shanghai SRS in 2009. Five hundred seventy combinations were detected using AR from 24,297 SRS reports, and they were compared with recognized ADEs identified by clinical experts and various other sources. AR appears to be an effective method for ADE signal detection, both in simulated and real SRS datasets. The limitations of this method exposed in our study, i.e., a non-uniform thresholds setting and redundant rules, require further research.

  17. Adverse Event Reporting: Harnessing Residents to Improve Patient Safety.

    Science.gov (United States)

    Tevis, Sarah E; Schmocker, Ryan K; Wetterneck, Tosha B

    2017-10-13

    Reporting of adverse and near miss events are essential to identify system level targets to improve patient safety. Resident physicians historically report few events despite their role as front-line patient care providers. We sought to evaluate barriers to adverse event reporting in an effort to improve reporting. Our main outcomes were as follows: resident attitudes about event reporting and the frequency of event reporting before and after interventions to address reporting barriers. We surveyed first year residents regarding barriers to adverse event reporting and used this input to construct a fishbone diagram listing barriers to reporting. Barriers were addressed, and resident event reporting was compared before and after efforts were made to reduce obstacles to reporting. First year residents (97%) recognized the importance of submitting event reports; however, the majority (85%) had not submitted an event report in the first 6 months of residency. Only 7% of residents specified that they had not witnessed an adverse event in 6 months, whereas one third had witnessed 10 or more events. The main barriers were as follows: lack of knowledge about how to submit events (38%) and lack of time to submit reports (35%). After improving resident education around event reporting and simplifying the reporting process, resident event reporting increased 230% (68 to 154 annual reports, P = 0.025). We were able to significantly increase resident event reporting by educating residents about adverse events and near misses and addressing the primary barriers to event reporting. Moving forward, we will continue annual resident education about patient safety, focus on improving feedback to residents who submit reports, and empower senior residents to act as role models to junior residents in patient safety initiatives.

  18. Preparation for global introduction of inactivated poliovirus vaccine: safety evidence from the US Vaccine Adverse Event Reporting System, 2000-12.

    Science.gov (United States)

    Iqbal, Shahed; Shi, Jing; Seib, Katherine; Lewis, Paige; Moro, Pedro L; Woo, Emily J; Shimabukuro, Tom; Orenstein, Walter A

    2015-10-01

    Safety data from countries with experience in the use of inactivated poliovirus vaccine (IPV) are important for the global polio eradication strategy to introduce IPV into the immunisation schedules of all countries. In the USA, IPV has been included in the routine immunisation schedule since 1997. We aimed to analyse adverse events after IPV administration reported to the US Vaccine Adverse Event Reporting System (VAERS). We analysed all VAERS data associated with IPV submitted between Jan 1, 2000, and Dec 31, 2012, either as individual or as combination vaccines, for all age and sex groups. We analysed the number and event type (non-serious, non-fatal serious, and death reports) of individual reports, and explored the most commonly coded event terms to describe the adverse event. We classified death reports according to previously published body-system categories (respiratory, cardiovascular, neurological, gastrointestinal, other infectious, and other non-infectious) and reviewed death reports to identify the cause of death. We classified sudden infant death syndrome as a separate cause of death considering previous concerns about sudden infant syndrome after vaccines. We used empirical Bayesian data mining methods to identify disproportionate reporting of adverse events for IPV compared with other vaccines. Additional VAERS data from 1991 to 2000 were analysed to compare the safety profiles of IPV and oral poliovirus vaccine (OPV). Of the 41,792 adverse event reports submitted, 39,568 (95%) were for children younger than 7 years. 38,381 of the reports for children in this age group (97%) were for simultaneous vaccination with IPV and other vaccines (most commonly pneumococcal and acellular pertussis vaccines), whereas standalone IPV vaccines accounted for 0·5% of all reports. 34,880 reports were for non-serious events (88%), 3905 reports were for non-fatal serious events (10%), and 783 reports were death reports (2%). Injection-site erythema was the most

  19. Event Reports for Operating Reactors

    Data.gov (United States)

    Nuclear Regulatory Commission — Raw data of all the events for the last month. Raw data is presented in pipe delimited format. This data set is updated monthly on the first business day of the month.

  20. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015.

    Science.gov (United States)

    Moro, Pedro L; Woo, Emily Jane; Paul, Wendy; Lewis, Paige; Petersen, Brett W; Cano, Maria

    2016-07-01

    In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.

  1. DESIGNING AN EVENT EXTRACTION SYSTEM

    Directory of Open Access Journals (Sweden)

    Botond BENEDEK

    2017-06-01

    Full Text Available In the Internet world, the amount of information available reaches very high quotas. In order to find specific information, some tools were created that automatically scroll through the existing web pages and update their databases with the latest information on the Internet. In order to systematize the search and achieve a result in a concrete form, another step is needed for processing the information returned by the search engine and generating the response in a more organized form. Centralizing events of a certain type is useful first of all for creating a news service. Through this system we are pursuing a knowledge - events from the Internet documents - extraction system. The system will recognize events of a certain type (weather, sports, politics, text data mining, etc. depending on how it will be trained (the concept it has in the dictionary. These events can be provided to the user, or it can also extract the context in which the event occurred, to indicate the initial form in which the event was embedded.

  2. Incidence of patient safety events and process-related human failures during intra-hospital transportation of patients: retrospective exploration from the institutional incident reporting system.

    Science.gov (United States)

    Yang, Shu-Hui; Jerng, Jih-Shuin; Chen, Li-Chin; Li, Yu-Tsu; Huang, Hsiao-Fang; Wu, Chao-Ling; Chan, Jing-Yuan; Huang, Szu-Fen; Liang, Huey-Wen; Sun, Jui-Sheng

    2017-11-03

    Intra-hospital transportation (IHT) might compromise patient safety because of different care settings and higher demand on the human operation. Reports regarding the incidence of IHT-related patient safety events and human failures remain limited. To perform a retrospective analysis of IHT-related events, human failures and unsafe acts. A hospital-wide process for the IHT and database from the incident reporting system in a medical centre in Taiwan. All eligible IHT-related patient safety events between January 2010 to December 2015 were included. Incidence rate of IHT-related patient safety events, human failure modes, and types of unsafe acts. There were 206 patient safety events in 2 009 013 IHT sessions (102.5 per 1 000 000 sessions). Most events (n=148, 71.8%) did not involve patient harm, and process events (n=146, 70.9%) were most common. Events at the location of arrival (n=101, 49.0%) were most frequent; this location accounted for 61.0% and 44.2% of events with patient harm and those without harm, respectively (pprocess step was the preparation of the transportation team (n=91, 48.9%). Contributing unsafe acts included perceptual errors (n=14, 7.5%), decision errors (n=56, 30.1%), skill-based errors (n=48, 25.8%), and non-compliance (n=68, 36.6%). Multivariate analysis showed that human failure found in the arrival and hand-off sub-process (OR 4.84, pprocess at the location of arrival and prevent errors other than omissions. Long-term monitoring of IHT-related events is also warranted. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Filing Sources after Oral P2Y12 Platelet Inhibitors to the Food and Drug Administration Adverse Event Reporting System (FAERS).

    Science.gov (United States)

    Serebruany, Victor L; Cherepanov, Vasily; Kim, Moo Hyun; Litvinov, Oleg; Cabrera-Fuentes, Hector A; Marciniak, Thomas A

    The US Food and Drug Administration Adverse Event Reporting System (FAERS) is a global passive surveillance database that relies on voluntary reporting by health care professionals and consumers as well as required mandatory reporting by pharmaceutical manufacturers. However, the initial filers and comparative patterns for oral P2Y12 platelet inhibitor reporting are unknown. We assessed who generated original FAERS reports for clopidogrel, prasugrel, and ticagrelor in 2015. From the FAERS database we extracted and examined adverse event cases coreported with oral P2Y12 platelet inhibitors. All adverse event filing originating sources were dichotomized into consumers, lawyers, pharmacists, physicians, other health care professionals, and unknown. Overall, 2015 annual adverse events were more commonly coreported with clopidogrel (n = 13,234) with known source filers (n = 12,818, or 96.9%) than with prasugrel (2,896; 98.9% out of 2,927 cases) or ticagrelor (2,163, or 82.3%, out of 2,627 cases, respectively). Overall, most adverse events were filed by consumers (8,336, or 44.4%), followed by physicians (5,290, or 28.2%), other health care professionals (2,997, or 16.0%), pharmacists (1,125, or 6.0%), and finally by lawyers (129, or 0.7%). The origin of 811 (4.7%) initial reports remains unknown. The adverse event filing sources differ among drugs. While adverse events coreported with clopidogrel and prasugrel were commonly originated by patients (40.4 and 84.3%, respectively), most frequently ticagrelor reports (42.5%) were filed by physicians. The reporting quality and initial sources differ among oral P2Y12 platelet inhibitors in FAERS. The ticagrelor surveillance in 2015 was inadequate when compared to clopidogrel and prasugrel. Patients filed most adverse events for clopidogrel and prasugrel, while physicians originated most ticagrelor complaints. These differences justify stricter compliance control for ticagrelor manufacturers and may be attributed to the

  4. Adverse event reporting tool for sedation

    African Journals Online (AJOL)

    sedation practitioners, do these definitions provide us with any value? The International Sedation Task Force (ISTF) is ... the definition of adverse events during sedation. Members of the ISTF believe that adverse events are ... event reporting tool, available through Internet access. This tool represents five steps, which will be ...

  5. Development and validation of an automated ventilator-associated event electronic surveillance system: A report of a successful implementation.

    Science.gov (United States)

    Hebert, Courtney; Flaherty, Jennifer; Smyer, Justin; Ding, Jing; Mangino, Julie E

    2017-11-10

    Surveillance is an important tool for infection control; however, this task can often be time-consuming and take away from infection prevention activities. With the increasing availability of comprehensive electronic health records, there is an opportunity to automate these surveillance activities. The objective of this article is to describe the implementation of an electronic algorithm for ventilator-associated events (VAEs) at a large academic medical center METHODS: This article reports on a 6-month manual validation of a dashboard for VAEs. We developed a computerized algorithm for automatically detecting VAEs and compared the output of this algorithm to the traditional, manual method of VAE surveillance. Manual surveillance by the infection preventionists identified 13 possible and 11 probable ventilator-associated pneumonias (VAPs), and the VAE dashboard identified 16 possible and 13 probable VAPs. The dashboard had 100% sensitivity and 100% accuracy when compared with manual surveillance for possible and probable VAP. We report on the successfully implemented VAE dashboard. Workflow of the infection preventionists was simplified after implementation of the dashboard with subjective time-savings reported. Implementing a computerized dashboard for VAE surveillance at a medical center with a comprehensive electronic health record is feasible; however, this required significant initial and ongoing work on the part of data analysts and infection preventionists. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  6. The Knowledge, Attitude and Practice of Physicians and Nurses toward Adverse Event Reporting System in Primary Health Care Setting

    Directory of Open Access Journals (Sweden)

    Mohammad Alboliteeh

    2017-01-01

    Full Text Available Introduction: To determine the influence of physicians and nurses’ Knowledge, Attitude and Practice (KAP on Occurrence, Variance and Accident or OVA Reporting System usage in order to improve and to contribute to patient safety.  Materials and Methods: The study utilized a quantitative research methodology specifically descriptive design. The samples of this study were primary health care physicians and nurses working at NGHA, Saudi Arabia. A hard copy of the survey was distributed to two Primary Care Centers which are Yarmook and Khashim ala’an.  Results:Most of the physicians and nurses had a good knowledge of OVA utilization (89.5%, although nurses were more likely than physicians to have good knowledge (94% vs. 53.6% and to have a better practice level of the OVA system (82.1% vs. 52.4%. In another point, physicians were more likely to have negative attitude toward the OVA system than nurses (71.4% vs.42.9%. A significant difference emerged between physicians’ and nurses’ KAP toward the OVA reporting system and nationality, language, and working site as revealed by the results. Conclusion:This was the first survey to assess nurses’ and physicians’ KAP toward the use of the OVA reporting system among primary health care level in Saudi Arabia. Apparently, 6% of the participants were not aware of the existing OVA reporting system. The findings of the survey demonstrated that nurses had better knowledge and practice and a less negative attitude to the system.

  7. Pharmacy student perceptions of adverse event reporting.

    Science.gov (United States)

    Kalari, Sirisha; Dormarunno, Matthew; Zvenigorodsky, Oleg; Mohan, Aparna

    2011-09-10

    To assess US pharmacy students' knowledge and perceptions of adverse event reporting. To gauge pharmacy students' impressions of adverse event reporting, a 10-question survey instrument was administered that addressed student perceptions of the reporting procedures of the Food and Drug Administration (FDA) and pharmaceutical manufacturers, as well as student understanding of the Health Insurance Portability and Accountability Act (HIPAA) and its relationship to adverse event reporting. Two hundred twenty-eight pharmacy students responded to the survey. The majority of respondents believed that the FDA is more likely than a pharmaceutical company to take action regarding an adverse event. There were misconceptions relating to the way adverse event reports are handled and the influence of HIPAA regulations on reporting. Communication between the FDA and pharmaceutical manufacturers regarding adverse event reports is not well understood by pharmacy students. Education about adverse event reporting should evolve so that by the time pharmacy students become practitioners, they are well acquainted with the relevance and importance of adverse event reporting.

  8. Serious adverse events and reactions in organ transplantation; a web-net tool-based nationwide system for reporting and monitoring.

    Science.gov (United States)

    Czerwiński, Jarosław; Kaliciński, Piotr; Danielewicz, Roman

    2015-04-30

    Organ transplantation is vulnerable to serious adverse reactions and events, which require a system for their monitoring and management, as required of EU Member States by Directive 2010/53/EU. A management system was implemented in Poland using modern network technologies through the following steps: 1) the development of a catalogue of events and reactions, 2) the preparation and implementation of the network module, 3) the operational procedures, 4) the evaluation system. The catalogue consists of reactions and events in recipients and living donors related to organ procurement. A referral system was introduced as a module of a web tool www.rejestry.net (400 participated institutions). Notification includes information regarding the location, type, description, analysis, and measures taken to resolve and prevent problems. During the period 2012-2013, 17 serious adverse events and 112 reactions were documented among 3223 transplanted organs (events in 0.5% and reactions in 3.4% of the cases). The major cases included: transplantation from a donor with neoplasia, early recipient death, early graft loss, and transmission of severe infection. Evaluation revealed underestimated number of notifications of "death of recipient within 30 post-transplant days", which reported 74 of the 92 reactions (80%) occurring in reality. The system is a platform for self-assessment and the dissemination of information regarding the potential dangers, including alarms in cases in which an event/reaction in one center is accessible to others. However, the system is not punitive, because the fear of disclosing failures in the transplant centers plays an important role in the monitoring process.

  9. The impact of a standardized incident reporting system in the perioperative setting: a single center experience on 2,563 'near-misses' and adverse events.

    Science.gov (United States)

    Heideveld-Chevalking, Anita J; Calsbeek, Hiske; Damen, Johan; Gooszen, Hein; Wolff, André P

    2014-01-01

    The reduction of perioperative harm is a major priority of in-hospital health care and the reporting of incidents and their causes is an important source of information to improve perioperative patient safety. We explored the number, nature and causes of voluntarily reported perioperative incidents in order to highlight the areas where further efforts are required to improve patient safety. Data from the Hospital Incident Management System (HIMS), entered in the period from July 2009 to July 2012, were analyzed in a Dutch university hospital. Employees in the perioperatve field filled out a semi-structured digital form of the reporting system. The risk classification of the reported adverse events and 'near misses' was based on the estimated patient consequences and the risk of recurrence, according to national guidelines. Predefined reported incident causes were categorized as human, organizational, technical and patient related. In total, 2,563 incidents (1,300 adverse events and 1,263 'near-miss' events) were reported during 67,360 operations. Reporters were anesthesia, operating room and recovery nurses (37%), ward nurses (31%), physicians (17%), administrative personnel (5%), others (6%) and unmentioned (3%). A total of 414 (16%) adverse events had patient consequences (which affected 0,6% of all surgery patients), estimated as catastrophic in 2, very serious in 34, serious in 105, and marginally serious in 273 cases. Shortcomings in communication was the most frequent reported type of incidents. Non-compliance with Standard Operating Procedures (SOPs: instructions, regulations, protocols and guidelines) was reported with 877 (34%) of incident reports. In total, 1,194 (27%) voluntarily reported causes were SOP-related, mainly human-based (79%) and partially organization-based (21%). SOP-related incidents were not associated with more patient consequences than other voluntarily reported incidents. Furthermore 'mistake or forgotten' (15%) and 'communication

  10. Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.

    Science.gov (United States)

    Miller, Elaine R; Moro, Pedro L; Cano, Maria; Lewis, Paige; Bryant-Genevier, Marthe; Shimabukuro, Tom T

    2016-05-27

    23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. Published by Elsevier Ltd.

  11. Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015.

    Science.gov (United States)

    Haber, Penina; Moro, Pedro L; Ng, Carmen; Lewis, Paige W; Hibbs, Beth; Schillie, Sarah F; Nelson, Noele P; Li, Rongxia; Stewart, Brock; Cano, Maria V

    2018-01-25

    Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. We searched VAERS for reports of AEs following single antigen HepB vaccine and HepB-containing vaccines (either given alone or with other vaccines), from January 2005 - December 2015. We conducted descriptive analyses and performed empirical Bayesian data mining to assess disproportionate reporting. We reviewed serious reports including reports of special interest. VAERS received 20,231 reports following HepB or HepB-containing vaccines: 10,291 (51%) in persons 18 years; for 1485 (7.3%) age was missing. Dizziness and nausea (8.4% each) were the most frequently reported AEs following a single antigen HepB vaccine: fever (23%) and injection site erythema (11%) were most frequent following Hep-containing vaccines. Of the 4444 (22%) reports after single antigen HepB vaccine, 303 (6.8%) were serious, including 45 deaths. Most commonly reported cause of death was Sudden Infant Death Syndrome (197). Most common non-death serious reports following single antigen HepB vaccines among infants aged 18 years. Most common vaccination error following single antigen HepB was incorrect product storage. Review current U.S.-licensed HepB vaccines administered alone or in combination with other vaccines did not reveal new or unexpected safety concerns. Vaccination errors were identified which indicate the need for training and education of providers on HepB vaccine indications and recommendations. Published by Elsevier Ltd.

  12. Features, Events, and Processes: System Level

    Energy Technology Data Exchange (ETDEWEB)

    D. McGregor

    2004-04-19

    The primary purpose of this analysis is to evaluate System Level features, events, and processes (FEPs). The System Level FEPs typically are overarching in nature, rather than being focused on a particular process or subsystem. As a result, they are best dealt with at the system level rather than addressed within supporting process-level or subsystem level analyses and models reports. The System Level FEPs also tend to be directly addressed by regulations, guidance documents, or assumptions listed in the regulations; or are addressed in background information used in development of the regulations. This evaluation determines which of the System Level FEPs are excluded from modeling used to support the total system performance assessment for license application (TSPA-LA). The evaluation is based on the information presented in analysis reports, model reports, direct input, or corroborative documents that are cited in the individual FEP discussions in Section 6.2 of this analysis report.

  13. Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System database of the Food and Drug Administration.

    Science.gov (United States)

    Bigi, Caterina; Tuccori, Marco; Bocci, Guido

    2017-02-17

    To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis. The drugs suspected as primary cause of the ADRs in pediatric subjects and their principal anatomic group according to the Anatomical Therapeutic Chemical classification system were considered. To classify the ADRs, the Medical Dictionary for Regularity Activities terminology was adopted. Between 2008 and 2012, FDA collected 113,077 ADRs in pediatric patients. Of the total pediatric ADR reports, those performed by medical doctors were 32%, followed by consumers (26%) and healthcare professionals (25%). Most of the ADR reports were related to the adolescent group (39%). Healthcare professionals resulted the category with the highest rate of ADR reports in neonates and infants. Drugs acting on nervous system and antineoplastic/immunomodulating agents were the most involved the pediatric ADR reports. Pyrexia, convulsion, vomiting and accidental overdose were the reactions more reported both from healthcare professionals and medical doctors. The present study describes the pediatric ADR reports of the FDA database through healthcare professional's perspective, describing the various aspects of pediatric pharmacovigilance.

  14. Association between Concomitant Use of Acyclovir or Valacyclovir with NSAIDs and an Increased Risk of Acute Kidney Injury: Data Mining of FDA Adverse Event Reporting System.

    Science.gov (United States)

    Yue, Zhihua; Shi, Jinhai; Li, Haona; Li, Huiyi

    2018-02-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) are likely to be used concomitantly with acyclovir or valacyclovir in clinical practice, but the study on the safety of such combinations was seldom reported. The objective of the study was to investigate reports of acute kidney injury (AKI) events associated with the concomitant use of oral acyclovir or valacyclovir with an NSAID by using the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database between January 2004 and June 2012. The frequency of AKI events in patients while simultaneously taking either acyclovir or valacyclovir and an NSAID was compared using the Chi-square test. The effect of concomitant use of acyclovir or valacyclovir and individual NSAIDs on AKI was analyzed by the reporting odds ratio (ROR). The results showed that AKI was reported as the adverse event in 8.6% of the 10923 patients taking valacyclovir compared with 8.7% of the 2556 patients taking acyclovir (p=NS). However, AKI was significantly more frequently reported in patients simultaneously taking valacyclovir and an NSAID (19.4%) than in patients simultaneously taking acyclovir and an NSAID (10.5%) (p<0.01). The results also suggested that increased risk of AKI was likely associated with the concomitant use of valacyclovir and some NSAIDs such as loxoprofen, diclofenac, etodolac, ketorolac, piroxicam or lornoxicam. The case series from the AERS indicated that compared with acyclovir, valacyclovir is more likely to be affected by NSAIDs, and the concomitant use of valacyclovir with some NSAIDs might be associated with increased risk of AKI. The drug interactions with this specific combination of medications are worth exploring further.

  15. Evaluation of epidemic intelligence systems integrated in the early alerting and reporting project for the detection of A/H5N1 influenza events.

    Science.gov (United States)

    Barboza, Philippe; Vaillant, Laetitia; Mawudeku, Abla; Nelson, Noele P; Hartley, David M; Madoff, Lawrence C; Linge, Jens P; Collier, Nigel; Brownstein, John S; Yangarber, Roman; Astagneau, Pascal

    2013-01-01

    The objective of Web-based expert epidemic intelligence systems is to detect health threats. The Global Health Security Initiative (GHSI) Early Alerting and Reporting (EAR) project was launched to assess the feasibility and opportunity for pooling epidemic intelligence data from seven expert systems. EAR participants completed a qualitative survey to document epidemic intelligence strategies and to assess perceptions regarding the systems performance. Timeliness and sensitivity were rated highly illustrating the value of the systems for epidemic intelligence. Weaknesses identified included representativeness, completeness and flexibility. These findings were corroborated by the quantitative analysis performed on signals potentially related to influenza A/H5N1 events occurring in March 2010. For the six systems for which this information was available, the detection rate ranged from 31% to 38%, and increased to 72% when considering the virtual combined system. The effective positive predictive values ranged from 3% to 24% and F1-scores ranged from 6% to 27%. System sensitivity ranged from 38% to 72%. An average difference of 23% was observed between the sensitivities calculated for human cases and epizootics, underlining the difficulties in developing an efficient algorithm for a single pathology. However, the sensitivity increased to 93% when the virtual combined system was considered, clearly illustrating complementarities between individual systems. The average delay between the detection of A/H5N1 events by the systems and their official reporting by WHO or OIE was 10.2 days (95% CI: 6.7-13.8). This work illustrates the diversity in implemented epidemic intelligence activities, differences in system's designs, and the potential added values and opportunities for synergy between systems, between users and between systems and users.

  16. Evaluation of epidemic intelligence systems integrated in the early alerting and reporting project for the detection of A/H5N1 influenza events.

    Directory of Open Access Journals (Sweden)

    Philippe Barboza

    Full Text Available The objective of Web-based expert epidemic intelligence systems is to detect health threats. The Global Health Security Initiative (GHSI Early Alerting and Reporting (EAR project was launched to assess the feasibility and opportunity for pooling epidemic intelligence data from seven expert systems. EAR participants completed a qualitative survey to document epidemic intelligence strategies and to assess perceptions regarding the systems performance. Timeliness and sensitivity were rated highly illustrating the value of the systems for epidemic intelligence. Weaknesses identified included representativeness, completeness and flexibility. These findings were corroborated by the quantitative analysis performed on signals potentially related to influenza A/H5N1 events occurring in March 2010. For the six systems for which this information was available, the detection rate ranged from 31% to 38%, and increased to 72% when considering the virtual combined system. The effective positive predictive values ranged from 3% to 24% and F1-scores ranged from 6% to 27%. System sensitivity ranged from 38% to 72%. An average difference of 23% was observed between the sensitivities calculated for human cases and epizootics, underlining the difficulties in developing an efficient algorithm for a single pathology. However, the sensitivity increased to 93% when the virtual combined system was considered, clearly illustrating complementarities between individual systems. The average delay between the detection of A/H5N1 events by the systems and their official reporting by WHO or OIE was 10.2 days (95% CI: 6.7-13.8. This work illustrates the diversity in implemented epidemic intelligence activities, differences in system's designs, and the potential added values and opportunities for synergy between systems, between users and between systems and users.

  17. Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database.

    Science.gov (United States)

    Kim, Seonji; Park, Kyounghoon; Kim, Mi-Sook; Yang, Bo Ram; Choi, Hyun Jin; Park, Byung-Joo

    2017-10-01

    Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database. We defined signals in this study by the reporting odds ratios (ROR), proportional reporting ratios (PRR), and information components (IC) indices. The KAERS database included 860,224 AE reports, among which 866 reports contained fluoxetine. We compared the labels of fluoxetine among the United States, UK, Germany, France, China, and Korea. Some of the signals, including emotional lability, myositis, spinal stenosis, paradoxical drug reaction, drug dependence, extrapyramidal disorder, adrenal insufficiency, and intracranial hemorrhage, were not labeled in the six countries. In conclusion, we identified new signals that were not known at the time of market approval. However, certain factors should be required for signal evaluation, such as clinical significance, preventability, and causality of the detected signals. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Acute incident rapid response at a mass-gathering event through comprehensive planning systems: a case report from the 2013 Shamrock Shuffle.

    Science.gov (United States)

    Başdere, Mehmet; Ross, Colleen; Chan, Jennifer L; Mehrotra, Sanjay; Smilowitz, Karen; Chiampas, George

    2014-06-01

    Planning and execution of mass-gathering events involves various challenges. In this case report, the Chicago Model (CM), which was designed to organize and operate such events and to maintain the health and wellbeing of both runners and the public in a more effective way, is described. The Chicago Model also was designed to prepare for unexpected incidents, including disasters, during the marathon event. The model has been used successfully in the planning and execution stages of the Bank of America Shamrock Shuffle and the Bank of America Chicago Marathon since 2008. The key components of the CM are organizational structure, information systems, and communication. This case report describes how the organizers at the 2013 Shamrock Shuffle used the key components of the CM approach in order to respond to an acute incident caused by a man who was threatening to jump off the State Street Bridge. The course route was changed to accommodate this unexpected event, while maintaining access to key health care facilities. The lessons learned from the incident are presented and further improvements to the existing model are proposed.

  19. Systemic glucocorticoid therapy: risk factors for reported adverse events and beliefs about the drug. A cross-sectional online survey of 820 patients.

    Science.gov (United States)

    Morin, Clément; Fardet, Laurence

    2015-12-01

    Despite systemic glucocorticoids are widely used, risk factors for most of their adverse events and patients' beliefs about the drug are poorly known. An online survey was conducted between February and July 2013 through the website www.cortisone-info.fr . Demographic (e.g., age, gender) and therapeutic (e.g., type of prescribed glucocorticoid, duration of prescription) data were collected. Patients were further asked to answer questions about glucocorticoid-induced adverse events and their beliefs about efficacy and safety of the drug. Risk factors for adverse events and efficacy/safety beliefs were assessed using multivariate logistic regression models. Eight hundred twenty questionnaires were analyzed (women 74.3 %; median age 49 [34-62] years, median equivalent prednisone dosage 20 [10-48] mg/day). The most frequently reported adverse events were insomnia (n = 477, 58.2 %), mood disturbances (n = 411, 50.1 %), hyperphagia (n = 402, 49.0 %), and lipodystrophy (n = 387, 47.2 %). The risk of some adverse events (e.g., weight gain, easy bruising) increased with the duration of exposure while other adverse events (e.g., insomnia, mood disorders, epigastric pain) were present since the first days of exposure. The risk of hirsutism, altered wound healing, mood disturbances, weight gain, lipodystrophy, hyperphagia, and epigastric pain decreased with age. Cutaneous disorders, morphological changes, and epigastric pain were more frequently reported by women. Interestingly, patients prescribed prednisolone reported less adverse events than those prescribed prednisone. No adverse event, demographical or prescribing characteristics were associated with beliefs about efficacy while factors associated with safety concerns were age (OR: 1.2 [1.1-1.3] per 10-year increase), osteoporosis (OR: 3.3 [1.4-7.9]), easy bruising (OR: 1.6 [1.1-2.3]), insomnia (OR: 1.7 [1.2-2.4]), and weight gain (OR: 1.6 [1.1-2.2]). These results may help clinicians to adapt information

  20. The Weber effect and the United States Food and Drug Administration's Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010.

    Science.gov (United States)

    Hoffman, Keith B; Dimbil, Mo; Erdman, Colin B; Tatonetti, Nicholas P; Overstreet, Brian M

    2014-04-01

    The United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs. The database is widely used to support post-marketing safety surveillance programs. Sometimes cited as a limitation to the usefulness of FAERS, however, is the 'Weber effect,' which is often summarized by stating that AE reporting peaks at the end of the second year after a regulatory authority approves a drug. Weber described this effect in 1984 based upon a single class of medications prescribed in the United Kingdom. Since that time, the FDA has made a concerted effort to improve both reporting and the database itself. Both volume and quality of AE reporting has dramatically improved since Weber's report, with an estimated 800,000 yearly reports now being logged into FAERS. The aim of this study was to determine if current FAERS reporting follows the trend described by Weber. Sixty-two drugs approved by the FDA between 2006 and 2010 were included in this analysis. Publicly available FAERS data were used to assess the 'primary suspect' AE reporting pattern for up to a 4-year period following each drug's approval date. A total of 334,984 AE reports were logged into FAERS for the 62 drugs analyzed here. While a few of the drugs demonstrated what could be considered 'Weber effect' curves, a majority of the drugs showed little evidence for the effect. In fact, the general AE reporting pattern observed in this study appears to consist simply of increasing case counts over the first three quarters after approval followed by relatively constant counts thereafter. Our results suggest that most of the modern adverse event reporting into FAERS does not follow the pattern described by Weber. Factors that may have contributed to this finding include large increases in the volume of AE reports since the Weber effect was described, as well as a concerted effort by the FDA to increase awareness regarding the utility of

  1. Impact of a reengineered electronic error-reporting system on medication event reporting and care process improvements at an urban medical center.

    Science.gov (United States)

    McKaig, Donald; Collins, Christine; Elsaid, Khaled A

    2014-09-01

    A study was conducted to evaluate the impact of a reengineered approach to electronic error reporting at a 719-bed multidisciplinary urban medical center. The main outcome of interest was the monthly reported medication errors during the preimplementation (20 months) and postimplementation (26 months) phases. An interrupted time series analysis was used to describe baseline errors, immediate change following implementation of the current electronic error-reporting system (e-ERS), and trend of error reporting during postimplementation. Errors were categorized according to severity using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Medication Error Index classifications. Reported errors were further analyzed by reporter and error site. During preimplementation, the monthly reported errors mean was 40.0 (95% confidence interval [CI]: 36.3-43.7). Immediately following e-ERS implementation, monthly reported errors significantly increased by 19.4 errors (95% CI: 8.4-30.5). The change in slope of reported errors trend was estimated at 0.76 (95% CI: 0.07-1.22). Near misses and no-patient-harm errors accounted for 90% of all errors, while errors that caused increased patient monitoring or temporary harm accounted for 9% and 1%, respectively. Nurses were the most frequent reporters, while physicians were more likely to report high-severity errors. Medical care units accounted for approximately half of all reported errors. Following the intervention, there was a significant increase in reporting of prevented errors and errors that reached the patient with no resultant harm. This improvement in reporting was sustained for 26 months and has contributed to designing and implementing quality improvement initiatives to enhance the safety of the medication use process.

  2. The Contribution of the Vaccine Adverse Event Text Mining System to the Classification of Possible Guillain-Barré Syndrome Reports

    Science.gov (United States)

    Botsis, T.; Woo, E. J.; Ball, R.

    2013-01-01

    Background We previously demonstrated that a general purpose text mining system, the Vaccine adverse event Text Mining (VaeTM) system, could be used to automatically classify reports of an-aphylaxis for post-marketing safety surveillance of vaccines. Objective To evaluate the ability of VaeTM to classify reports to the Vaccine Adverse Event Reporting System (VAERS) of possible Guillain-Barré Syndrome (GBS). Methods We used VaeTM to extract the key diagnostic features from the text of reports in VAERS. Then, we applied the Brighton Collaboration (BC) case definition for GBS, and an information retrieval strategy (i.e. the vector space model) to quantify the specific information that is included in the key features extracted by VaeTM and compared it with the encoded information that is already stored in VAERS as Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs). We also evaluated the contribution of the primary (diagnosis and cause of death) and secondary (second level diagnosis and symptoms) diagnostic VaeTM-based features to the total VaeTM-based information. Results MedDRA captured more information and better supported the classification of reports for GBS than VaeTM (AUC: 0.904 vs. 0.777); the lower performance of VaeTM is likely due to the lack of extraction by VaeTM of specific laboratory results that are included in the BC criteria for GBS. On the other hand, the VaeTM-based classification exhibited greater specificity than the MedDRA-based approach (94.96% vs. 87.65%). Most of the VaeTM-based information was contained in the secondary diagnostic features. Conclusion For GBS, clinical signs and symptoms alone are not sufficient to match MedDRA coding for purposes of case classification, but are preferred if specificity is the priority. PMID:23650490

  3. A Novel Patient Safety Event Reporting Tool in Otolaryngology.

    Science.gov (United States)

    Vila, Peter M; Lewis, Sean; Cunningham, Gene; Brereton, Jean; Espinel, Alexandra G; Roberson, David W; Shah, Rahul K

    2017-07-01

    Objective To report the results of a preliminary analysis of a quality improvement initiative aimed to identify potential latent systems defects. Methods A pilot study of an anonymous, voluntary, event reporting system made available to all members of the American Academy of Otolaryngology-Head and Neck Surgery was performed. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) index was used to classify error types. Descriptive statistics were used to summarize submissions to the database. Results In the 53 cases reported to the database over 22 months, the majority involved errors that had resulted in harm (n = 34, 64%), followed by errors that occurred and did not result in harm (n = 7, 13%). Errors occurred predominantly in the hospital (n = 23, 44%) and operating room (n = 19, 35%). Most entries were classified as either technical (n = 21, 39%) or related to postoperative care (n = 15, 30%). Discussion This preliminary descriptive analysis of a novel otolaryngology patient safety event reporting tool shows that this platform brings unique value to the identification of errors and adverse events in our specialty. Most reported events were classified as errors resulting in harm. The most common type of reported event was a technical error, most often resulting in a nerve injury. Implications for Practice This reporting tool will likely allow for identification and prioritization of improvement opportunities. This example may serve as a guide for other societies to create similar platforms as we strive for a standardized process for event reporting.

  4. ENGINEERED BARRIER SYSTEM FEATURES, EVENTS AND PROCESSES

    Energy Technology Data Exchange (ETDEWEB)

    Jaros, W.

    2005-08-30

    The purpose of this report is to evaluate and document the inclusion or exclusion of engineered barrier system (EBS) features, events, and processes (FEPs) with respect to models and analyses used to support the total system performance assessment for the license application (TSPA-LA). A screening decision, either Included or Excluded, is given for each FEP along with the technical basis for exclusion screening decisions. This information is required by the U.S. Nuclear Regulatory Commission (NRC) at 10 CFR 63.114 (d, e, and f) [DIRS 173273]. The FEPs addressed in this report deal with those features, events, and processes relevant to the EBS focusing mainly on those components and conditions exterior to the waste package and within the rock mass surrounding emplacement drifts. The components of the EBS are the drip shield, waste package, waste form, cladding, emplacement pallet, emplacement drift excavated opening (also referred to as drift opening in this report), and invert. FEPs specific to the waste package, cladding, and drip shield are addressed in separate FEP reports: for example, ''Screening of Features, Events, and Processes in Drip Shield and Waste Package Degradation'' (BSC 2005 [DIRS 174995]), ''Clad Degradation--FEPs Screening Arguments (BSC 2004 [DIRS 170019]), and Waste-Form Features, Events, and Processes'' (BSC 2004 [DIRS 170020]). For included FEPs, this report summarizes the implementation of the FEP in the TSPA-LA (i.e., how the FEP is included). For excluded FEPs, this analysis provides the technical basis for exclusion from TSPA-LA (i.e., why the FEP is excluded). This report also documents changes to the EBS FEPs list that have occurred since the previous versions of this report. These changes have resulted due to a reevaluation of the FEPs for TSPA-LA as identified in Section 1.2 of this report and described in more detail in Section 6.1.1. This revision addresses updates in Yucca Mountain Project

  5. Licensee Event Report (LER) compilation for month of March 1988

    Energy Technology Data Exchange (ETDEWEB)

    None

    1988-04-01

    This monthly report contains Licensee Event Report (LER) operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during the one-month period identified on the cover of the document. The LERS, from which this information is derived, are submitted to the Nuclear Regulatory Commission (NRC) by nuclear power plant licensees in accordance with federal regulations. Procedures for LER reporting for revisions to those events occurring prior to 1984 are described in NRC Regulatory Guide 1.16 and NUREG-1061, Instructions for preparation of data entry sheets for licensee event reports. For those events occurring on and after January 1, 1984, LERs are being submitted in accordance with the revised rule contained in Title 10 Part 50.73 of the Code of Federal Regulations (10 CFR 50.73 - Licensee Event Report System) which was published in the Federal Register (Vol. 48, No. 144) on July 26, 1983. NUREG-1022, Licensee Event Report System - Description of systems and guidelines for reporting, provides supporting guidance and information on the revised LER rule.

  6. Self-reported versus 'true' adherence in heart failure patients: a study using the Medication Event Monitoring System

    National Research Council Canada - National Science Library

    Nieuwenhuis, M. M. W; Jaarsma, T; van Veldhuisen, D. J; van der Wal, M. H. L

    2012-01-01

    .... Although self-reported and objectively measured medication adherence in HF patients have been compared in previous studies, none of these studies have used an evidence-based cutpoint to differentiate...

  7. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    Science.gov (United States)

    Ali, Ayad K; Hartzema, Abraham G

    2012-01-01

    Background Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US. Methods and materials Reports of arterial thrombotic events submitted to the US Food and Drug Administration’s Adverse Event Reporting System (AERS) between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction). Results In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports), corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4). Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39–316) and 1.09 (0.95–1.24), respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA. Conclusion Omalizumab is associated with higher than expected reporting of arterial thrombotic events in asthmatic patients. This hypothesis needs further testing in robust

  8. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting.

    Science.gov (United States)

    Ali, Ayad K; Hartzema, Abraham G

    2012-01-01

    Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US. Reports of arterial thrombotic events submitted to the US Food and Drug Administration's Adverse Event Reporting System (AERS) between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction). In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports), corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4). Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39-316) and 1.09 (0.95-1.24), respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA. Omalizumab is associated with higher than expected reporting of arterial thrombotic events in asthmatic patients. This hypothesis needs further testing in robust epidemiological studies.

  9. Designing an Adverse Drug Event Reporting System to Prevent Unintentional Reexposures to Harmful Drugs: Study Protocol for a Multiple Methods Design.

    Science.gov (United States)

    Peddie, David; Small, Serena S; Badke, Katherin; Wickham, Maeve E; Bailey, Chantelle; Chruscicki, Adam; Ackerley, Christine; Balka, Ellen; Hohl, Corinne M

    2016-08-18

    Adverse drug events (ADEs) are unintended and harmful events related to medication use. Up to 30% of serious ADEs recur within six months because culprit drugs are unintentionally represcribed and redispensed. Improving the electronic communication of ADE information between care providers, and across care settings, has the potential to reduce recurrent ADEs. We aim to describe the methods used to design Action ADE, a novel electronic ADE reporting system that can be leveraged to prevent unintentional reexposures to harmful drugs in British Columbia, Canada. To develop the new system, our team will use action research and participatory design, approaches that employ social scientific research methods and practitioner participation to generate insights into work settings and problem resolution. We will develop a systematic search strategy to review existing ADE reporting systems identified in academic and grey literature, and analyze the content of these systems to identify core data fields used to communicate ADE information. We will observe care providers in the emergency departments and on the wards of two urban tertiary hospitals and one urban community hospital, in one rural ambulatory care center, and in three community pharmacies in British Columbia, Canada. We will also conduct participatory workshops with providers to understand their needs and priorities related to communicating ADEs and preventing erroneous represcribing or redispensing of culprit medications. These methods will inform the iterative development of a preliminary paper-based reporting form, which we will then pilot test with providers in a real-world setting. This is an ongoing project with results being published as analyses are completed. The systematic review has been completed; field observations, focus groups, and pilot testing of a preliminary paper-based design are ongoing. Results will inform the development of software that will enable clinically useful user-friendly documentation

  10. Statistical alliance for vital events: Strengthening reporting ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Statistical alliance for vital events: Strengthening reporting & program uses of facility-based child & maternal mortality. Most deaths in sub-Saharan Africa occur without medical attention, and as a result, the causes of death (COD) remain unknown. This lack of information greatly limits evidence-based planning and slows ...

  11. Self-reported versus 'true' adherence in heart failure patients : a study using the Medication Event Monitoring System

    NARCIS (Netherlands)

    Nieuwenhuis, M. M. W.; Jaarsma, T.; van Veldhuisen, D. J.; van der Wal, M. H. L.

    Adherence to (non)pharmacological treatment is important in heart failure (HF) patients, since it leads to better clinical outcome. Although self-reported and objectively measured medication adherence in HF patients have been compared in previous studies, none of these studies have used an

  12. Identification of a Syndrome Class of Neuropsychiatric Adverse Reactions to Mefloquine from Latent Class Modeling of FDA Adverse Event Reporting System Data.

    Science.gov (United States)

    Nevin, Remington L; Leoutsakos, Jeannie-Marie

    2017-03-01

    Although mefloquine use is known to be associated with a risk of severe neuropsychiatric adverse reactions that are often preceded by prodromal symptoms, specific combinations of neurologic or psychiatric reactions associated with mefloquine use are not well described in the literature. This study sought to identify a distinct neuropsychiatric syndrome class associated with mefloquine use in reports of adverse events. Latent class modeling of US Food and Drug Administration Adverse Event Reporting System (FAERS) data was performed using indicators defined by the Medical Dictionary for Regulatory Activities neurologic and psychiatric high-level group terms, in a study dataset of FAERS reports (n = 5332) of reactions to common antimalarial drugs. A distinct neuropsychiatric syndrome class was identified that was strongly and significantly associated with reports of mefloquine use (odds ratio = 3.92, 95% confidence interval 2.91-5.28), defined by a very high probability of symptoms of deliria (82.7%) including confusion and disorientation, and a moderate probability of other severe psychiatric and neurologic symptoms including dementia and amnesia (18.6%) and seizures (18.1%). The syndrome class was also associated with symptoms that are considered prodromal including anxiety, depression, sleep disturbance, and abnormal dreams, and neurological symptoms such as dizziness, vertigo, and paresthesias. This study confirms in FAERS reports the existence of a severe mefloquine neuropsychiatric syndrome class associated with common symptoms that may be considered prodromal. Clinical identification of the characteristic symptoms of this syndrome class may aid in improving case finding in pharmacovigilance studies of more serious adverse reactions to the drug.

  13. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting

    Directory of Open Access Journals (Sweden)

    Ali AK

    2012-05-01

    Full Text Available Ayad K Ali, Abraham G HartzemaDepartment of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USABackground: Omalizumab is a monoclonal antibody, indicated for the treatment of severe allergic asthma. In Europe, there have been concerns about the cardiovascular safety of omalizumab. The objective of this study was to analyze the association between omalizumab and arterial thrombotic events in a spontaneous adverse drug reaction reporting database in the US.Methods and materials: Reports of arterial thrombotic events submitted to the US Food and Drug Administration's Adverse Event Reporting System (AERS between 2004 and 2011 were retrieved and analyzed by the reporting odds ratio data mining algorithm. The reporting odds ratio of arterial thrombotic events for omalizumab was compared with specific asthma medications and all drugs in the AERS. Values ≥2 were considered significant safety signals. The Medical Dictionary for Regulatory Activities Preferred Terms were used to identify arterial thrombotic events (eg, stroke, myocardial infarction.Results: In total, 293,783 reports of arterial thrombotic events were retrieved (about 2% of all adverse drug reaction reports, corresponding to 2274 asthma drug-arterial thrombotic events pairs (omalizumab, 222; inhaled corticosteroids [ICS], 131; long-acting beta-agonists [LABA], 102; single-device combination ICS-LABA, 506; inhaled short-acting beta-agonists [SABA], 475; oral SABA, 6; inhaled antimuscarinics [AMC], 477; single-device combination AMC-SABA, 127; xanthines, 50; leukotriene modifiers, 174; and mast cell stabilizers, 4. Reporting odds ratio and 95% confidence interval values for omalizumab compared with other asthma drugs and all drugs in AERS were 2.75 (2.39–316 and 1.09 (0.95–1.24, respectively. Omalizumab ranked second after ICS in the risk of arterial thrombotic events, followed by AMC, AMC-SABA, and ICS-LABA.Conclusion: Omalizumab is

  14. Elucidating Reasons for Resident Underutilization of Electronic Adverse Event Reporting.

    Science.gov (United States)

    Hatoun, Jonathan; Suen, Winnie; Liu, Constance; Shea, Sandy; Patts, Gregory; Weinberg, Janice; Eng, Jessica

    2016-07-01

    Reasons for resident underutilization of adverse event (AE) reporting systems are unclear, particularly given frequent resident exposure to AEs and near misses (NMs). Residents at an academic medical center were surveyed about AEs/NMs, barriers to reporting, patient safety climate, and educational interventions. A total of 350 of 527 eligible residents (66%) completed the survey; 77% of respondents reported involvement in an AE/NM, though only 43% had used the reporting system. Top barriers to reporting were not knowing what or how to report. Surgeons reported more than other residents (surgery, 61%; medical, 38%; hospital-based, 15%; P reporting (surgery, 49%; medical, 28%; hospital-based. 18%; P reporting. Efforts to increase resident reporting should address common barriers to reporting as well as department-specific differences in resident knowledge, perceptions of system effectiveness, and educational preferences. © The Author(s) 2015.

  15. Features, Events, and Processes: system Level

    Energy Technology Data Exchange (ETDEWEB)

    D. McGregor

    2004-10-15

    The purpose of this analysis report is to evaluate and document the inclusion or exclusion of the system-level features, events, and processes (FEPs) with respect to modeling used to support the total system performance assessment for the license application (TSPA-LA). A screening decision, either Included or Excluded, is given for each FEP along with the technical basis for screening decisions. This information is required by the U.S. Nuclear Regulatory Commission (NRC) at 10 CFR 63.113 (d, e, and f) (DIRS 156605). The system-level FEPs addressed in this report typically are overarching in nature, rather than being focused on a particular process or subsystem. As a result, they are best dealt with at the system level rather than addressed within supporting process-level or subsystem-level analyses and models reports. The system-level FEPs also tend to be directly addressed by regulations, guidance documents, or assumptions listed in the regulations; or are addressed in background information used in development of the regulations. For included FEPs, this analysis summarizes the implementation of the FEP in the TSPA-LA (i.e., how the FEP is included). For excluded FEPs, this analysis provides the technical basis for exclusion from the TSPA-LA (i.e., why the FEP is excluded). The initial version of this report (Revision 00) was developed to support the total system performance assessment for site recommendation (TSPA-SR). This revision addresses the license application (LA) FEP List (DIRS 170760).

  16. Seasonal and Geographic Variation in Adverse Event Reporting.

    Science.gov (United States)

    Marrero, Osvaldo; Hung, Eric Y; Hauben, Manfred

    2016-09-01

    Many illnesses demonstrate seasonal and geographic variations. Pharmacovigilance is unique among public health surveillance systems in terms of the clinical diversity of the events under surveillance. Since many pharmacovigilance signal detection methodologies are geared towards looking for increased frequency of spontaneous adverse drug event (ADE) reporting over variable time frames, seasonality of ADEs may have implications for signal detection. The aim of this study was to investigate whether a set of illnesses that might be expected to display seasonality in general, did so when spontaneously reported as ADEs. We performed our analysis with the publically available US FDA Adverse Event Reporting System (FAERS) data. We selected a convenience sample of events possibly triggered by seasonal factors (hypothermia, Raynaud's phenomenon, photosensitivity reaction, heat exhaustion, heat stroke, and sunburn) and events for which previous literature experience suggests seasonality (anencephaly and interstitial lung disease). Our statistical procedures can be explained in terms of a simple physicogeometric setting: the unit circle divided into 6 (semiannual sinusoidal) or 12 (annual sinusoidal) arcs. When reporting frequencies (weights) are more or less evenly distributed across months, the center of mass of the circle would not be significantly displaced from the origin (0, 0). Distinct seasonal patterns will significantly displace the center of mass of the circle. Various patterns of seasonality were identified for some, but not all, events and region-event pairs. USA displayed the most instances of seasonality. Scandinavia did not display seasonality for any events. Seasonality was usually annual sinusoidal. Possible explanations for failure to observe seasonality are briefly considered. Understanding seasonality of spontaneous ADE reporting may have public health policy and research implications and may mitigate false-positive and missed true

  17. Adverse event reporting for botulinum toxin type A.

    Science.gov (United States)

    Batra, R Sonia; Dover, Jeffrey S; Arndt, Kenneth A

    2005-12-01

    A recent article published in the Journal of the American Academy of Dermatology reviewed adverse events regarding botulinum toxin type A (BTX-A) reported to the Food and Drug Administration between 1989 and 2003. Although postmarketing surveillance is a vital mechanism to ensure drug safety, the events reported in this paper must be considered in context to be appropriately interpreted. The majority of data was related to therapeutic rather than cosmetic use. The proportion of serious adverse events was 33-fold higher for therapeutic use and no deaths were reported after cosmetic use. The data were derived from a spontaneous reporting system and do not include assessments of causality between the BTX-A and purported adverse events. The report notes that over a third of these events were related to off-label use of BTX-A, a common practice in dermatology, yet no significant differences were reported in rates of adverse events between on-label and off-label use. The report reflects a favorable safety profile for cosmetic use of BTX-A, and if misinterpreted, could lead to unreasonable conclusions regarding a product considered to be highly safe and effective.

  18. Sky Event Reporting Metadata (VOEvent) Version 2.0

    Science.gov (United States)

    Seaman, Rob; Williams, Roy; Allan, Alasdair; Barthelmy, Scott; Bloom, Joshua S.; Brewer, John M.; Denny, Robert B.; Fitzpatrick, Mike; Graham, Matthew; Gray, Norman; hide

    2011-01-01

    VOEvent [20] defines the content and meaning of a standard information packet for representing, transmitting, publishing and archiving information about a transient celestial event, with the implication that timely follow-up is of interest. The objective is to motivate the observation of targets-of-opportunity, to drive robotic telescopes, to trigger archive searches, and to alert the community. VOEvent is focused on the reporting of photon events, but events mediated by disparate phenomena such as neutrinos, gravitational waves, and solar or atmospheric particle bursts may also be reported. Structured data is used, rather than natural language, so that automated systems can effectively interpret VOEvent packets. Each packet may contain zero or more of the "who, what, where, when & how" of a detected event, but in addition, may contain a hypothesis (a "why") regarding the nature of the underlying physical cause of the event.

  19. Use of case reports and the Adverse Event Reporting System in systematic reviews: overcoming barriers to assess the link between Crohn’s disease medications and hepatosplenic T-cell lymphoma

    Science.gov (United States)

    2013-01-01

    Background To identify demographic and clinical characteristics associated with cases of hepatosplenic T-cell lymphoma (HSTCL) in patients with Crohn’s disease, and to assess strength of evidence for a causal relationship between medications and HSTCL in Crohn’s disease. Methods We identified cases of HSTCL in Crohn’s disease in studies included in a comparative effectiveness review of Crohn’s disease medications, through a separate search of PubMed and Embase for published case reports, and from the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS). We used three causality assessment tools to evaluate the relationship between medication exposure and HSTCL. Results We found 37 unique cases of HSTCL in patients with Crohn’s disease. Six cases were unique to the published literature and nine were unique to AERS. Cases were typically young (reported medications were anti-metabolites (97%) and anti-tumor necrosis factor alpha (anti-TNFa) medications (76%). Dose and duration of therapy were not consistently reported. Use of aminosalicylates and corticosteroids were rarely reported, despite the high prevalence of these medications in routine treatment. Using the causality assessment tools, it could only be determined that anti-metabolite and anti-TNFa therapies were possible causes of HSTCL in Crohn’s disease based on the data contained in the case reports. Conclusion Systematic reviews that incorporate case reports of rare lethal events should search both published literature and AERS, but consideration should be given to the limitations of case reports. In this study, establishing a causative effect other than ‘possible’ between anti-metabolite or anti-TNFa therapies and HSTCL was not feasible because case reports lacked data required by the causality assessments, and because of the limited applicability of causality assessment tools for rare irreversible events. We recommend minimum reporting requirements for case reports to

  20. An Event Reporting and Early-Warning Safety System Based on the Internet of Things for Underground Coal Mines: A Case Study

    Directory of Open Access Journals (Sweden)

    Byung Wan Jo

    2017-09-01

    Full Text Available Fatal accidents associated with underground coal mines require the implementation of high-level gas monitoring and miner’s localization approaches to promote underground safety and health. This study introduces a real-time monitoring, event-reporting and early-warning platform, based on cluster analysis for outlier detection, spatiotemporal statistical analysis, and an RSS range-based weighted centroid localization algorithm for improving safety management and preventing accidents in underground coal mines. The proposed platform seamlessly integrates monitoring, analyzing, and localization approaches using the Internet of Things (IoT, cloud computing, a real-time operational database, application gateways, and application program interfaces. The prototype has been validated and verified at the operating underground Hassan Kishore coal mine. Sensors for air quality parameters including temperature, humidity, CH4, CO2, and CO demonstrated an excellent performance, with regression constants always greater than 0.97 for each parameter when compared to their commercial equivalent. This framework enables real-time monitoring, identification of abnormal events (>90%, and verification of a miner’s localization (with <1.8 m of error in the harsh environment of underground mines. The main contribution of this study is the development of an open source, customizable, and cost-effective platform for effectively promoting underground coal mine safety. This system is helpful for solving the problems of accessibility, serviceability, interoperability, and flexibility associated with safety in coal mines.

  1. Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA's adverse event reporting system.

    Science.gov (United States)

    Raisch, Dennis W; Rafi, John A; Chen, Cheng; Bennett, Charles L

    2016-08-01

    To identify and summarize FDA's Adverse Event Reporting System (FAERS) cases of progressive multifocal leukoencephalopathy (PML) associated with biological and targeted cancer therapies (BTCT) that were approved between 2009 and 2015. FAERS was searched using each BTCT name as primary or secondary suspect drug and the adverse reaction of PML. Among BTCTs with >2 case reports of PML, proportional reporting ratios (PRR) and 95% confidence intervals (CI) were calculated. Among 49 new BTCTs, 82 cases of PML were found for 16 drugs. Significant PRR signals were found among 7 (14.6%) BTCTs including: brentuximab (24.5, CI:14.8-40.6), ofatumumab (16.3, CI:9.6-27.4), alemtuzumab (9.9, CI:6.0-16.4), obinutuzumab (7.4, CI:2.4-22.8), ibrutinib (5.6 CI:3.0-10.5), belimumab (4.5 CI:2.3-9.0), and idelalisib (4.1, CI:1.3-12.6). Among the 82 cases with significant signals, confirmation of the diagnosis of PML using objective criteria was found in 56% of the cases. A limitation of FAERS data is that missing data are common. When using BTCTs, clinicians and patients consider the risk of PML versus the therapeutic benefit, particularly when used in combination with other drugs which may cause PML, such as rituximab. It is important to recognize that PML may occur in some conditions, such as chronic lymphocytic leukemia, regardless of drug therapy.

  2. 10 CFR Appendix G to Part 73 - Reportable Safeguards Events

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Reportable Safeguards Events G Appendix G to Part 73.... G Appendix G to Part 73—Reportable Safeguards Events Pursuant to the provisions of 10 CFR 73.71 (b... shall report or record, as appropriate, the following safeguards events. I. Events to be reported within...

  3. 10 CFR Appendix A to Part 70 - Reportable Safety Events

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Reportable Safety Events A Appendix A to Part 70 Energy... Appendix A to Part 70—Reportable Safety Events Licensees must comply with reporting requirements in this... report: (a) One hour reports. Events to be reported to the NRC Operations Center within 1 hour of...

  4. Systematic Analysis of Adverse Event Reports for Sex Differences in Adverse Drug Events

    Science.gov (United States)

    Yu, Yue; Chen, Jun; Li, Dingcheng; Wang, Liwei; Wang, Wei; Liu, Hongfang

    2016-01-01

    Increasing evidence has shown that sex differences exist in Adverse Drug Events (ADEs). Identifying those sex differences in ADEs could reduce the experience of ADEs for patients and could be conducive to the development of personalized medicine. In this study, we analyzed a normalized US Food and Drug Administration Adverse Event Reporting System (FAERS). Chi-squared test was conducted to discover which treatment regimens or drugs had sex differences in adverse events. Moreover, reporting odds ratio (ROR) and P value were calculated to quantify the signals of sex differences for specific drug-event combinations. Logistic regression was applied to remove the confounding effect from the baseline sex difference of the events. We detected among 668 drugs of the most frequent 20 treatment regimens in the United States, 307 drugs have sex differences in ADEs. In addition, we identified 736 unique drug-event combinations with significant sex differences. After removing the confounding effect from the baseline sex difference of the events, there are 266 combinations remained. Drug labels or previous studies verified some of them while others warrant further investigation. PMID:27102014

  5. Surface Management System Departure Event Data Analysis

    Science.gov (United States)

    Monroe, Gilena A.

    2010-01-01

    This paper presents a data analysis of the Surface Management System (SMS) performance of departure events, including push-back and runway departure events.The paper focuses on the detection performance, or the ability to detect departure events, as well as the prediction performance of SMS. The results detail a modest overall detection performance of push-back events and a significantly high overall detection performance of runway departure events. The overall detection performance of SMS for push-back events is approximately 55%.The overall detection performance of SMS for runway departure events nears 100%. This paper also presents the overall SMS prediction performance for runway departure events as well as the timeliness of the Aircraft Situation Display for Industry data source for SMS predictions.

  6. Factors influencing adverse events reporting within the health care system: the case of artemisinin-based combination treatments in northern Ghana.

    Science.gov (United States)

    Chatio, Samuel; Aborigo, Raymond; Adongo, Philip Baba; Anyorigiya, Thomas; Dalinjong, Philip Ayizem; Akweongo, Patricia; Oduro, Abraham

    2016-02-27

    The use of artemisinin-based combination therapy (ACT) as first-line treatment for uncomplicated malaria was a policy recommended by World Health Organization. In 2004, Ghana changed her first-line anti-malarial drug policy to use ACT. This study examined factors affecting adverse events reporting in northern Ghana after the introduction of ACT. This was a qualitative study based on sixty in-depth interviews with health workers, chemical shop owners and patients with malaria who were given ACT at the health facilities. Purposive sampling method was used to select study participants. The interviews were transcribed, coded into themes using Nvivo 9 software. The thematic analysis framework was used to analyse the data. Study respondents reported body weakness and dizziness as the most frequent side effects they had experienced from the used of ACT. Other side effects they reported were swollen testes, abdominal pain and shivering. These side effects were mostly associated with the use of artesunate-amodiaquine compared to other artemisinin-based combinations. Patients were not provided information about the side effects of the drugs and so did not report when they experienced them. Also long queues at health facilities and unfriendly health worker attitude were the main factors affecting adverse events reporting. Other factors such as wrong use of ACT at home, farming and commercial activities also affected effective adverse events reporting in the study area. Patients' lack of knowledge and health sector drawbacks affected side effect reporting on ACT. Intensive health education on likely side effects of ACT should be provided to patients by health workers. Also, improving health worker attitude toward clients will encourage patients to visit the health facilities when they react negatively to ACT and, subsequently, will improve on adverse events reporting.

  7. Serious adverse events with infliximab: analysis of spontaneously reported adverse events.

    Science.gov (United States)

    Hansen, Richard A; Gartlehner, Gerald; Powell, Gregory E; Sandler, Robert S

    2007-06-01

    Serious adverse events such as bowel obstruction, heart failure, infection, lymphoma, and neuropathy have been reported with infliximab. The aims of this study were to explore adverse event signals with infliximab by using a long period of post-marketing experience, stratifying by indication. The relative reporting of infliximab adverse events to the U.S. Food and Drug Administration (FDA) was assessed with the public release version of the adverse event reporting system (AERS) database from 1968 to third quarter 2005. On the basis of a systematic review of adverse events, Medical Dictionary for Regulatory Activities (MedDRA) terms were mapped to predefined categories of adverse events, including death, heart failure, hepatitis, infection, infusion reaction, lymphoma, myelosuppression, neuropathy, and obstruction. Disproportionality analysis was used to calculate the empiric Bayes geometric mean (EBGM) and corresponding 90% confidence intervals (EB05, EB95) for adverse event categories. Infliximab was identified as the suspect medication in 18,220 reports in the FDA AERS database. We identified a signal for lymphoma (EB05 = 6.9), neuropathy (EB05 = 3.8), infection (EB05 = 2.9), and bowel obstruction (EB05 = 2.8). The signal for granulomatous infections was stronger than the signal for non-granulomatous infections (EB05 = 12.6 and 2.4, respectively). The signals for bowel obstruction and infusion reaction were specific to patients with IBD; this suggests potential confounding by indication, especially for bowel obstruction. In light of this additional evidence of risk of lymphoma, neuropathy, and granulomatous infections, clinicians should stress this risk in the shared decision-making process.

  8. Reports about Occurrence of Events with Effect on Aviation Safety

    Directory of Open Access Journals (Sweden)

    Vladimír Plos

    2014-07-01

    Full Text Available This article deals with a system, that is established to report the events with effect on safety. This system is based on requirements published in Annex 13 to the Chicago Convention and legislative foundations laid down in Regulation L13, Regulation of the European Parliament and of the Council (EU No 376/2014, Decree No. 359/2006 Sb. and Act No. 49/1997 Sb. Standards and legislative rules precisely define the types of events that are subject of reporting and also define the structure and content of the reporting message. This content is consists mainly of the identification data about the airplane and crew, information about the route and a short description of the damage to the airplane. In the following, we discuss the possible use of such a system of mandatory reporting for the needs of safety indicators. Then there are proposals of changes in the content of the reporting message for the need of safety indicators. The present knowledge indicates that the use of all opportunities provided by the law for the reporting of events can lead to a creating of sufficient basis for safety indicators.

  9. Time-to-Onset Analysis of Drug-Induced Long QT Syndrome Based on a Spontaneous Reporting System for Adverse Drug Events.

    Directory of Open Access Journals (Sweden)

    Sayaka Sasaoka

    Full Text Available Long QT syndrome (LQTS is a disorder of the heart's electrical activity that infrequently causes severe ventricular arrhythmias such as a type of ventricular tachycardia called torsade de pointes (TdP and ventricular fibrillation, which can be fatal. There have been no previous reports on the time-to-onset for LQTS based on data from spontaneous reporting systems. The aim of this study was to assess the time-to-onset of LQTS according to drug treatment. We analyzed the association between 113 drugs in 37 therapeutic categories and LQTS including TdP using data obtained from the Japanese Adverse Drug Event Report database. For signal detection, we used the reporting odds ratio (ROR. Furthermore, we analyzed the time-to-onset data and assessed the hazard type using the Weibull shape parameter. The RORs (95% confidence interval for bepridil, amiodarone, pilsicainide, nilotinib, disopyramide, arsenic trioxide, clarithromycin, cibenzoline, donepezil, famotidine, sulpiride, and nifekalant were 174.4 (148.6-204.6, 17.3 (14.7-20.4, 52.0 (43.4-62.4, 13.9 (11.5-16.7, 69.3 (55.3-86.8, 54.2 (43.2-68.0, 4.7 (3.8-5.8, 19.9 (15.9-25.0, 8.1 (6.5-10.1, 3.2 (2.5-4.1, 7.1 (5.5-9.2, and 254.8 (168.5-385.4, respectively. The medians and quartiles of time-to-onset for aprindine (oral and bepridil were 20.0 (11.0-35.8 and 18.0 (6.0-43.0 days, respectively. The lower 95% confidence interval of the shape parameter β of bepridil was over 1 and the hazard was considered to increase over time.Our study indicated that the pattern of LQTS onset might differ among drugs. Based on these results, careful long-term observation is recommended, especially for specific drugs such as bepridil and aprindine. This information may be useful for the prevention of sudden death following LQTS and for efficient therapeutic planning.

  10. Extreme Events in Deterministic Dynamical Systems

    Science.gov (United States)

    Nicolis, C.; Balakrishnan, V.; Nicolis, G.

    2006-11-01

    The principal signatures of a deterministic dynamics in the statistical properties of extreme events are identified. Explicit expressions are derived for generic classes of dynamical systems giving rise to quasiperiodic, strongly chaotic, and intermittent chaotic behaviors.

  11. Adverse events following pandemic influenza A (H1N1) 2009 monovalent and seasonal influenza vaccinations during the 2009-2010 season in the active component U.S. military and civilians aged 17-44years reported to the Vaccine Adverse Event Reporting System.

    Science.gov (United States)

    Bardenheier, Barbara H; Duderstadt, Susan K; Engler, Renata J M; McNeil, Michael M

    2016-08-17

    No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season among U.S. military personnel has been published. We compared military vs. civilian adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines. Military vaccination coverage was provided by the Department of Defense's Defense Medical Surveillance System. Civilian vaccination coverage was estimated using data from the National 2009 H1N1 Flu Survey and the Behavioral Risk Factor Surveillance System survey. Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the military than in the civilian population. The reporting rate of serious AE reports following MIV in service personnel (1.19 per 100,000) was about half that reported by the civilian population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among service personnel (1.32 per 100,000) was more than twice that of the civilian population. Although fewer military AEs following MIV were reported overall, the rate of Guillain-Barré Syndrome (GBS) (4.01 per million) was four times greater than that in the civilian population. (1.04 per million). Despite higher vaccination coverage in service personnel, the rate of serious AEs following MIV was about half that in civilians. The rate of GBS reported following MIV was higher in the military. Published by Elsevier Ltd.

  12. Adverse event reporting in Czech long-term care facilities.

    Science.gov (United States)

    Hěib, Zdenřk; Vychytil, Pavel; Marx, David

    2013-04-01

    To describe adverse event reporting processes in long-term care facilities in the Czech Republic. Prospective cohort study involving a written questionnaire followed by in-person structured interviews with selected respondents. Long-term care facilities located in the Czech Republic. Staff of 111 long-term care facilities (87% of long-term care facilities in the Czech Republic). None. Sixty-three percent of long-term health-care facilities in the Czech Republic have adverse event-reporting processes already established, but these were frequently very immature programs sometimes consisting only of paper recording of incidents. Compared to questionnaire responses, in-person interview responses only partially tended to confirm the results of the written survey. Twenty-one facilities (33%) had at most 1 unconfirmed response, 31 facilities (49%) had 2 or 3 unconfirmed responses and the remaining 11 facilities (17%) had 4 or more unconfirmed responses. In-person interviews suggest that use of a written questionnaire to assess the adverse event-reporting process may have limited validity. Staff of the facilities we studied expressed an understanding of the importance of adverse event reporting and prevention, but interviews also suggested a lack of knowledge necessary for establishing a good institutional reporting system in long-term care.

  13. ENGINEERED BARRIER SYSTEM FEATURES, EVENTS, AND PROCESSES

    Energy Technology Data Exchange (ETDEWEB)

    na

    2005-05-30

    This analysis report is one of the technical reports containing documentation of the Environmental Radiation Model for Yucca Mountain, Nevada (ERMYN), a biosphere model supporting the total system performance assessment (TSPA) for the license application (LA) for the Yucca Mountain repository. This analysis report describes the development of biosphere dose conversion factors (BDCFs) for the volcanic ash exposure scenario, and the development of dose factors for calculating inhalation dose during volcanic eruption. A graphical representation of the documentation hierarchy for the ERMYN is presented in Figure 1 - 1. This figure shows the interrelationships among the products (i.e., analysis and model reports) developed for biosphere modeling and provides an understanding of how this analysis report contributes to biosphere modeling. This report is one of two reports that develop biosphere BDCFs, which are input parameters for the TSPA model. The ''Biosphere Model Report'' (BSC 2004 [DIRS 169460]) describes in detail the ERMYN conceptual model and mathematical model. The input parameter reports, shown to the right of the Biosphere Model Report in Figure 1-1, contain detailed descriptions of the model input parameters, their development and the relationship between the parameters and specific features, events and processes (FEPs). This report describes biosphere model calculations and their output, the BDCFs, for the volcanic ash exposure scenario. This analysis receives direct input from the outputs of the ''Biosphere Model Report'' (BSC 2004 [DIRS 169460]) and from the five analyses that develop parameter values for the biosphere model (BSC 2005 [DIRS 172827]; BSC 2004 [DIRS 169672]; BSC 2004 [DIRS 169673]; BSC 2004 [DIRS 169458]; and BSC 2004 [DIRS 169459]). The results of this report are further analyzed in the ''Biosphere Dose Conversion Factor Importance and Sensitivity Analysis'' (Figure 1 - 1). The

  14. Discrete event systems diagnosis and diagnosability

    CERN Document Server

    Sayed-Mouchaweh, Moamar

    2014-01-01

    Discrete Event Systems: Diagnosis and Diagnosability addresses the problem of fault diagnosis of Discrete Event Systems (DES). This book provides the basic techniques and approaches necessary for the design of an efficient fault diagnosis system for a wide range of modern engineering applications. The different techniques and approaches are classified according to several criteria such as: modeling tools (Automata, Petri nets) that is used to construct the model; the information (qualitative based on events occurrences and/or states outputs, quantitative based on signal processing and data analysis) that is needed to analyze and achieve the diagnosis; the decision structure (centralized, decentralized) that is required to achieve the diagnosis. The goal of this classification is to select the efficient method to achieve the fault diagnosis according to the application constraints. This book focuses on the centralized and decentralized event based diagnosis approaches using formal language and automata as mode...

  15. Advancing pharmacovigilance through academic–legal collaboration: the case of gadolinium-based contrast agents and nephrogenic systemic fibrosis—a research on adverse drug events and reports (RADAR) report

    Science.gov (United States)

    Edwards, B J; Laumann, A E; Nardone, B; Miller, F H; Restaino, J; Raisch, D W; McKoy, J M; Hammel, J A; Bhatt, K; Bauer, K; Samaras, A T; Fisher, M J; Bull, C; Saddleton, E; Belknap, S M; Thomsen, H S; Kanal, E; Cowper, S E; Abu Alfa, A K

    2014-01-01

    Objective: To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts. Methods: The Research on Adverse Drug events And Reports methodology was used for assessment—the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration. Results: The FAERS encompassed the largest number (n = 1395) of NSF reports. The ICNSFR contained the most complete (n = 335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA. Conclusion: Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA. Advances in knowledge: This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research. PMID:25230161

  16. The CMS event builder and storage system

    CERN Document Server

    Bauer, Gerry; Behrens, Ulf; Biery, Kurt; Brett, Angela; Branson, James; Cano, Eric; Cheung, Harry; Ciganek, Marek; Cittolin, Sergio; Coarasa, Jose Antonio; Deldicque, Christian; Dusinberre, Elizabeth; Erhan, Samim; Fortes Rodrigues, Fabiana; Gigi, Dominique; Glege, Frank; Gomez-Reino, Robert; Gutleber, Johannes; Hatton, Derek; Klute, Markus; Laurens, Jean-François; Loizides, Constantin; Lopez Perez, Juan Antonio; Meijers, Frans; Meschi, Emilio; Meyer, Andreas; Mommsen, Remigius K; Moser, Roland; O'Dell, Vivian; Oh, Alexander; Orsini, Luciano; Patras, Vaios; Paus, Christoph; Petrucci, Andrea; Pieri, Marco; Racz, Attila; Sakulin, Hannes; Sani, Matteo; Schieferdecker, Philipp; Schwick, Christoph; Serrano Margaleff, Josep Francesc; Shpakov, Dennis; Simon, Sean; Sumorok, Konstanty; Zanetti, Marco

    2010-01-01

    The CMS event builder assembles events accepted by the first level trigger and makes them available to the high-level trigger. The event builder needs to handle a maximum input rate of 100\\,kHz and an aggregated throughput of 100\\,GB/s originating from approximately 500 sources. This paper presents the chosen hardware and software architecture. The system consists of 2 stages: an initial pre-assembly reducing the number of fragments by one order of magnitude and a final assembly by several independent readout builder (RU-builder) slices. The RU-builder is based on 3 separate services: the buffering of event fragments during the assembly, the event assembly, and the data flow manager. A further component is responsible for handling events accepted by the high-level trigger: the storage manager (SM) temporarily stores the events on disk at a peak rate of 2\\,GB/s until they are permanently archived offline. In addition, events and data-quality histograms are served by the SM to online monitoring clients. We disc...

  17. Adverse event reports following yellow fever vaccination, 2007-13.

    Science.gov (United States)

    Lindsey, Nicole P; Rabe, Ingrid B; Miller, Elaine R; Fischer, Marc; Staples, J Erin

    2016-05-01

    Yellow fever (YF) vaccines have been available since the 1930s and are generally considered safe and effective. However, rare reports of serious adverse events (SAE) following vaccination have prompted the Advisory Committee for Immunization Practices to periodically expand the list of conditions considered contraindications and precautions to vaccination. We describe adverse events following YF vaccination reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2007 through 2013 and calculate age- and sex-specific reporting rates of all SAE, anaphylaxis, YF vaccine-associated neurologic disease (YEL-AND) and YF vaccine-associated viscerotropic disease (YEL-AVD). There were 938 adverse events following YF vaccination reported to VAERS from 2007 through 2013. Of these, 84 (9%) were classified as SAEs for a rate of 3.8 per 100 000 doses distributed. Reporting rates of SAEs increased with increasing age with a rate of 6.5 per 100 000 in persons aged 60-69 years and 10.3 for ≥70 years. The reporting rate for anaphylaxis was 1.3 per 100 000 doses distributed and was highest in persons ≤18 years (2.7 per 100 000). Reporting rates of YEL-AND and YEL-AVD were 0.8 and 0.3 per 100 000 doses distributed, respectively; both rates increased with increasing age. These findings reinforce the generally acceptable safety profile of YF vaccine, but highlight the importance of continued physician and traveller education regarding the risks and benefits of YF vaccination, particularly for older travellers. Published by Oxford University Press on behalf of the International Society of Travel Medicine, 2016. This work is written by US Government employees and is in the public domain in the United States.

  18. Modeling and simulation of discrete event systems

    CERN Document Server

    Choi, Byoung Kyu

    2013-01-01

    Computer modeling and simulation (M&S) allows engineers to study and analyze complex systems. Discrete-event system (DES)-M&S is used in modern management, industrial engineering, computer science, and the military. As computer speeds and memory capacity increase, so DES-M&S tools become more powerful and more widely used in solving real-life problems. Based on over 20 years of evolution within a classroom environment, as well as on decades-long experience in developing simulation-based solutions for high-tech industries, Modeling and Simulation of Discrete-Event Systems is the only book on

  19. Aggregation in hierarchical discrete-event systems

    NARCIS (Netherlands)

    Al-Falou, AA; Van Schuppen, JH

    2003-01-01

    We propose an algorithm for the hierarchical decomposition of a large automaton-based discrete-event system. We also provide an estimation of the numerical cost in terms of the size of the system. Our hierarchical decomposition is illustrated with simple examples from dynamical ST-control and

  20. Distributed discrete event simulation. Final report

    Energy Technology Data Exchange (ETDEWEB)

    De Vries, R.C. [Univ. of New Mexico, Albuquerque, NM (United States). EECE Dept.

    1988-02-01

    The presentation given here is restricted to discrete event simulation. The complexity of and time required for many present and potential discrete simulations exceeds the reasonable capacity of most present serial computers. The desire, then, is to implement the simulations on a parallel machine. However, certain problems arise in an effort to program the simulation on a parallel machine. In one category of methods deadlock care arise and some method is required to either detect deadlock and recover from it or to avoid deadlock through information passing. In the second category of methods, potentially incorrect simulations are allowed to proceed. If the situation is later determined to be incorrect, recovery from the error must be initiated. In either case, computation and information passing are required which would not be required in a serial implementation. The net effect is that the parallel simulation may not be much better than a serial simulation. In an effort to determine alternate approaches, important papers in the area were reviewed. As a part of that review process, each of the papers was summarized. The summary of each paper is presented in this report in the hopes that those doing future work in the area will be able to gain insight that might not otherwise be available, and to aid in deciding which papers would be most beneficial to pursue in more detail. The papers are broken down into categories and then by author. Conclusions reached after examining the papers and other material, such as direct talks with an author, are presented in the last section. Also presented there are some ideas that surfaced late in the research effort. These promise to be of some benefit in limiting information which must be passed between processes and in better understanding the structure of a distributed simulation. Pursuit of these ideas seems appropriate.

  1. Cultural Issues in Adverse Event Reporting - An ethnographic study.

    Science.gov (United States)

    Harter, Christopher D; Nøhr, Christian

    2015-01-01

    Adverse event reporting is a frequently used mechanism to establish a learning cycle to avoid future errors. However a precondition is that the potential - as well as the occurred adverse events is reported. This study explores two comparable internal medicine departments to find possible explanations on a differing frequency of adverse event reporting. Ethnographic methods - observation and interviews - are applied to collect data. The analysis reveals specific, but common ways of doing task prioritization and rating of adverse event severity. The interpesonal relationships, however, show significant differences in the two departments and can be the most plausible explanation of the difference in adverse event reporting.

  2. Use of a handheld computer application for voluntary medication event reporting by inpatient nurses and physicians.

    Science.gov (United States)

    Dollarhide, Adrian W; Rutledge, Thomas; Weinger, Matthew B; Dresselhaus, Timothy R

    2008-04-01

    To determine the feasibility of capturing self-reported medication events using a handheld computer-based Medication Event Reporting Tool (MERT). Handheld computers operating the MERT software application were deployed among volunteer physician (n = 185) and nurse (n = 119) participants on the medical wards of four university-affiliated teaching hospitals. Participants were encouraged to complete confidential reports on the handheld computers for medication events observed during the study period. Demographic variables including age, gender, education level, and clinical experience were recorded for all participants. Each MERT report included details on the provider, location, timing and type of medication event recorded. Over the course of 2,311 days of clinician participation, 76 events were reported; the median time for report completion was 231 seconds. The average event reporting rate for all participants was 0.033 reports per clinician shift. Nurses had a significantly higher reporting rate compared to physicians (0.045 vs 0.026 reports/shift, p = .02). Subgroup analysis revealed that attending physicians reported events more frequently than resident physicians (0.042 vs 0.021 reports/shift, p = .03), and at a rate similar to that of nurses (p = .80). Only 5% of MERT medication events were reported to require increased monitoring or treatment. A handheld-based event reporting tool is a feasible method to record medication events in inpatient hospital care units. Handheld reporting tools may hold promise to augment existing hospital reporting systems.

  3. Integrated system checkout report

    Energy Technology Data Exchange (ETDEWEB)

    1991-08-14

    The planning and preparation phase of the Integrated Systems Checkout Program (ISCP) was conducted from October 1989 to July 1991. A copy of the ISCP, DOE-WIPP 90--002, is included in this report as an appendix. The final phase of the Checkout was conducted from July 10, 1991, to July 23, 1991. This phase exercised all the procedures and equipment required to receive, emplace, and retrieve contact handled transuranium (CH TRU) waste filled dry bins. In addition, abnormal events were introduced to simulate various equipment failures, loose surface radioactive contamination events, and personnel injury. This report provides a detailed summary of each days activities during this period. Qualification of personnel to safely conduct the tasks identified in the procedures and the abnormal events were verified by observers familiar with the Bin-Scale CH TRU Waste Test requirements. These observers were members of the staffs of Westinghouse WID Engineering, QA, Training, Health Physics, Safety, and SNL. Observers representing a number of DOE departments, the state of new Mexico, and the Defense Nuclear Facilities Safety Board observed those Checkout activities conducted during the period from July 17, 1991, to July 23, 1991. Observer comments described in this report are those obtained from the staff member observers. 1 figs., 1 tab.

  4. 10 CFR 73.71 - Reporting of safeguards events.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Reporting of safeguards events. 73.71 Section 73.71 Energy... § 73.71 Reporting of safeguards events. (a)(1) Each licensee subject to the provisions of §§ 73.25, 73... revised information. Each licensee shall maintain a copy of the written report of an event submitted under...

  5. MedWatch, the FDA Safety Information and Adverse Event Reporting Program

    Science.gov (United States)

    ... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it More sharing ... Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations ...

  6. The waveform correlation event detection system global prototype software design

    Energy Technology Data Exchange (ETDEWEB)

    Beiriger, J.I.; Moore, S.G.; Trujillo, J.R.; Young, C.J.

    1997-12-01

    The WCEDS prototype software system was developed to investigate the usefulness of waveform correlation methods for CTBT monitoring. The WCEDS prototype performs global seismic event detection and has been used in numerous experiments. This report documents the software system design, presenting an overview of the system operation, describing the system functions, tracing the information flow through the system, discussing the software structures, and describing the subsystem services and interactions. The effectiveness of the software design in meeting project objectives is considered, as well as opportunities for code refuse and lessons learned from the development process. The report concludes with recommendations for modifications and additions envisioned for regional waveform-correlation-based detector.

  7. Post-licensure surveillance of quadrivalent live attenuated influenza vaccine United States, Vaccine Adverse Event Reporting System (VAERS), July 2013-June 2014.

    Science.gov (United States)

    Haber, Penina; Moro, Pedro L; Cano, Maria; Lewis, Paige; Stewart, Brock; Shimabukuro, Tom T

    2015-04-15

    Quadrivalent live attenuated influenza vaccine (LAIV4) was approved in 2012 for healthy persons aged 2-49 years. Beginning with the 2013-2014 influenza season, LAIV4 replaced trivalent live attenuated influenza vaccine (LAIV3). We analyzed LAIV4 reports to VAERS, a national spontaneous reporting system. LAIV4 reports in 2013-2014 were compared to LAIV3 reports from the previous three influenza seasons. Medical records were reviewed for non-manufacturer serious reports (i.e., death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability) and reports of selected conditions of interest. We conducted Empirical Bayesian data mining to identify disproportional reporting for LAIV4. In 2013-2014, 12.7 million doses of LAIV4 were distributed and VAERS received 779 reports in individuals aged 2-49 years; 95% were non-serious. Expired drug administered (42%), fever (13%) and cough (8%) were most commonly reported in children aged 2-17 years when LAIV4 was administered alone, while headache (18%), expired drug administered (15%) and exposure during pregnancy (12%) were most common in adults aged 18-49 years. We identified one death report in a child who died from complications of cerebellar vascular tumors. Among non-death serious reports, neurologic conditions were common in children and adults. In children, seizures (3) and Guillain-Barré syndrome (2) were the most common serious neurologic outcomes. We identified three serious reports of asthma/wheezing following LAIV4 in children. Data mining detected disproportional reporting for vaccine administration errors and for influenza illness in children. Our analysis of VAERS reports for LAIV4 did not identify any concerning patterns. The data mining finding for reports of influenza illness is consistent with low LAIV4 vaccine effectiveness observed for influenza A disease in children in 2013-2014. Reports of LAIV4 administration to persons in whom the vaccine is not recommended (e

  8. Serious adverse events reported for antiobesity medicines

    DEFF Research Database (Denmark)

    Aagaard, L; Hallgreen, C E; Hansen, E H

    2016-01-01

    . The majority of AE cases were reported for female adults. The majority of serious AEs was reported for orlistat (37%) and rimonabant (22%). The largest share of serious AEs was of the type 'cardiac disorders' (19%) and 'psychiatric disorders' (18%). Consumer AEs reporting differed from other sources...

  9. Adverse event reporting in cancer clinical trial publications.

    Science.gov (United States)

    Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

    2014-01-10

    Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

  10. Standardizing Medication Error Event Reporting in the U.S. Department of Defense

    National Research Council Canada - National Science Library

    Nosek, Ronald A., Jr; McMeekin, Judy; Rake, Geoffrey W

    2005-01-01

    ...) began an aggressive examination of medical errors and the strategies for minimizing them. A primary goal was the creation of a standardized medication event reporting system, including a central registry for the compilation of reported data...

  11. Adverse clinical events reported during Invisalign treatment: Analysis of the MAUDE database.

    Science.gov (United States)

    Allareddy, Veerasathpurush; Nalliah, Romesh; Lee, Min Kyeong; Rampa, Sankeerth; Allareddy, Veerajalandhar

    2017-11-01

    The objectives of this study were to examine adverse clinical events after the use of the Invisalign system and to provide an overview of the actions taken by the manufacturer to address these events. A retrospective analysis of the Manufacturer and User Facility Device Experience database of the United States Food and Drug Administration was used. All medical device reports reported to the United States Food and Drug Administration pertaining to products of Align Technology from November 1, 2006, to November 30, 2016, were analyzed. Qualitative content analysis was conducted of event descriptions and manufacturer narrative reports. A total of 173 medical device reports were reported in the Manufacturer and User Facility Device Experience database: 169 (97.7%) were designated as adverse event reports, and 45 (26%) were deemed by the treating doctor to be serious or life threatening. The most medical device reports that reported a serious or life-threatening event were in 2014 (50%). The most frequently reported adverse event was difficulty breathing (56 events) followed by sore throat (35 events), swollen throat (34 events), swollen tongue (31 events), hives and itchiness (31 events), anaphylaxis (30 events), swollen lips (27 events), and feeling of throat closing/tight airway/airway obstruction/laryngospasm (24 events). Serious or life-threatening events could be associated with use of Invisalign systems. Health care providers should be aware of these events and know how to handle them if they arise in their practices. Copyright © 2017 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  12. Report of the Event Tag Review and Recommendation Group

    Energy Technology Data Exchange (ETDEWEB)

    ATLAS Group; Assamagan, K.A.; Barberis, D.; Bentvelsen, S.; Brooijmans, G.; Cranmer, K.; Cranshaw, J.; Dell' Acqua, A.; Farbin, A.; Froidevaux, D.; Gianotti, F.; Hinchliffe, I.; LeCompte, T.; Maeno, T.; Malon, D.; Paige, F.; Polesello, G.; Quarrie, D.; Rousseau, D.; Schaffer, R.D.; Smizanska, M.; Unal, G.; Voss, K.; Wielers, M.

    2006-04-12

    In order to facilitate access to the large volumes of data (multiple petabytes per year) which will be produced during data taking and Monte Carlo production at ATLAS, work has proceeded on building a system of event-level metadata to allow selections of a subset of events to use as input to an analysis. This was included in the ATLAS Computing Model and was first studied and implemented by the Physics Analysis Tools group based on the decisions of the ESD/AOD Task Force. They used tools developed and supported by the CERN IT group and the ATLAS Database group. During 2005 this structure was put through various tests and evaluations. Also, work by physicists on reconstruction and analysis led to an improved understanding of the requirements on the TAG. This report addresses the effect of these new inputs on the previous work with regard to content and the infrastructure needed to support it.

  13. Time-to-Onset Analysis of Drug-Induced Long QT Syndrome Based on a Spontaneous Reporting System for Adverse Drug Events

    OpenAIRE

    Sasaoka, Sayaka; Matsui, Toshinobu; Hane, Yuuki; Abe, Junko; Ueda, Natsumi; Motooka, Yumi; Hatahira, Haruna; Fukuda, Akiho; Naganuma, Misa; HASEGAWA, Shiori; KINOSADA, Yasutomi; Nakamura, Mitsuhiro

    2016-01-01

    Long QT syndrome (LQTS) is a disorder of the heart?s electrical activity that infrequently causes severe ventricular arrhythmias such as a type of ventricular tachycardia called torsade de pointes (TdP) and ventricular fibrillation, which can be fatal. There have been no previous reports on the time-to-onset for LQTS based on data from spontaneous reporting systems. The aim of this study was to assess the time-to-onset of LQTS according to drug treatment. We analyzed the association between 1...

  14. Case report of a near medical event in stereotactic radiotherapy due to improper units of measure from a treatment planning system.

    Science.gov (United States)

    Gladstone, D J; Li, S; Jarvis, L A; Hartford, A C

    2011-07-01

    The authors hereby notify the Radiation Oncology community of a potentially lethal error due to improper implementation of linear units of measure in a treatment planning system. The authors report an incident in which a patient was nearly mistreated during a stereotactic radiotherapy procedure due to inappropriate reporting of stereotactic coordinates by the radiation therapy treatment planning system in units of centimeter rather than in millimeter. The authors suggest a method to detect such errors during treatment planning so they are caught and corrected prior to the patient positioning for treatment on the treatment machine. Using pretreatment imaging, the authors found that stereotactic coordinates are reported with improper linear units by a treatment planning system. The authors have implemented a redundant, independent method of stereotactic coordinate calculation. Implementation of a double check of stereotactic coordinates via redundant, independent calculation is simple and accurate. Use of this technique will avoid any future error in stereotactic treatment coordinates due to improper linear units, transcription, or other similar errors. The authors recommend an independent double check of stereotactic treatment coordinates during the treatment planning process in order to avoid potential mistreatment of patients.

  15. Prospective study of neuropsychiatric events in systemic lupus erythematosus.

    Science.gov (United States)

    Hanly, John G; Su, Li; Farewell, Vern; McCurdy, Grace; Fougere, Lisa; Thompson, Kara

    2009-07-01

    To prospectively examine neuropsychiatric (NP) events and their association with health related quality of life (HRQOL) over time in patients with systemic lupus erythematosus (SLE). In an observational cohort study from a single academic center, NP events and their attribution were identified at enrollment and at annual assessments for up to 7 years. NP events were characterized using the American College of Rheumatology case definitions; other variables were global SLE disease activity and cumulative organ damage. The outcomes of NP events were recorded and self-report HRQOL was measured with the mental (MCS) and physical (PCS) component summary scores of the Medical Outcomes Study Short Form-36. There were 209 patients, 88% female and 92% Caucasian, with a mean (standard deviation) age of 43.7 (13.8) years. Followup was available in 175/209 (84%) patients. There were 299 NP events in 132/209 (63%) patients over a mean followup of 3.6 (2.5) years. Thirty-one percent of NP events in 54 patients were attributed to SLE. Multivariate analysis indicated lower MCS scores in patients with NP events compared to those without events (p attribution. The group means for PCS scores were significantly lower in patients with NP events (p attribution. There was no association between HRQOL and cumulative organ damage, nor between NP events and the progression of organ damage. The association of lower HRQOL with NP events over time, which is independent of progression in cumulative organ damage, emphasizes the persistent negative effect of NP events in the lives of patients with SLE.

  16. Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015.

    Science.gov (United States)

    Haber, Penina; Arana, Jorge; Pilishvili, Tamara; Lewis, Paige; Moro, Pedro L; Cano, Maria

    2016-12-07

    The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65years. We assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting. VAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19-64years and 86% were in persons aged ⩾65years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19-64years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged ⩾65years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19-64years old; injection site reactions, general malaise and Guillain-Barré syndrome among those ⩾65years (Table 2). Data mining did not detect disproportional reporting for any unexpected AE. The results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs. Published by Elsevier Ltd.

  17. Event streaming in the online system

    CERN Document Server

    Klous, S; The ATLAS collaboration

    2010-01-01

    The Large Hadron Collider (LHC), currently in operation at CERN in Geneva, is a circular 27-kilometer-circumference machine, accelerating bunches of protons in opposite directions. The bunches will cross at four different interaction points with a bunch-crossing frequency of 40MHz. ATLAS, the largest LHC experiment, registers the signals induced by particles traversing the detector components on each bunch crossing. When this happens a total of around 1.5MB of data are collected. This results in a data rate of around 60 TB/s flowing out of the detector. Note that the available event storage space is limited to about 6 PB per year. With an operational period of about 20 million seconds per year, this requires a data reduction factor of 200:000 in the trigger and data acquisition (TDAQ) system. Events included in the recording rate budget are already subdivided and organized by ATLAS during data acquisition. So, the TDAQ system does not only take care of data reduction, but also organizes the collected events. ...

  18. Public Health System Response to Extreme Weather Events.

    Science.gov (United States)

    Hunter, Mark D; Hunter, Jennifer C; Yang, Jane E; Crawley, Adam W; Aragón, Tomás J

    2016-01-01

    Extreme weather events, unpredictable and often far-reaching, constitute a persistent challenge for public health preparedness. The goal of this research is to inform public health systems improvement through examination of extreme weather events, comparing across cases to identify recurring patterns in event and response characteristics. Structured telephone-based interviews were conducted with representatives from health departments to assess characteristics of recent extreme weather events and agencies' responses. Response activities were assessed using the Centers for Disease Control and Prevention Public Health Emergency Preparedness Capabilities framework. Challenges that are typical of this response environment are reported. Forty-five local health departments in 20 US states. Respondents described public health system responses to 45 events involving tornadoes, flooding, wildfires, winter weather, hurricanes, and other storms. Events of similar scale were infrequent for a majority (62%) of the communities involved; disruption to critical infrastructure was universal. Public Health Emergency Preparedness Capabilities considered most essential involved environmental health investigations, mass care and sheltering, surveillance and epidemiology, information sharing, and public information and warning. Unanticipated response activities or operational constraints were common. We characterize extreme weather events as a "quadruple threat" because (1) direct threats to population health are accompanied by damage to public health protective and community infrastructure, (2) event characteristics often impose novel and pervasive burdens on communities, (3) responses rely on critical infrastructures whose failure both creates new burdens and diminishes response capacity, and (4) their infrequency and scale further compromise response capacity. Given the challenges associated with extreme weather events, we suggest opportunities for organizational learning and

  19. General practitioners′ attitudes toward reporting and learning from adverse events: results from a survey

    DEFF Research Database (Denmark)

    Mikkelsen, Thorbjørn H.; Sokolowski, Ineta; Olesen, Frede

    2006-01-01

    OBJECTIVE: To investigate GPs' attitudes to and willingness to report and learn from adverse events and to study how a reporting system should function. DESIGN: Survey. SETTING: General practice in Denmark. MAIN OUTCOME MEASURES: GPs' attitudes to exchange of experience with colleagues and others......, and circumstances under which such exchange is accepted. SUBJECTS: A structured questionnaire sent to 1198 GPs of whom 61% responded. RESULTS. GPs had a positive attitude towards discussing adverse events in the clinic with colleagues and staff and in their continuing medical education groups. The GPs had...... a positive attitude to reporting adverse events to a database if the system granted legal and administrative immunity to reporters. The majority preferred a reporting system located at a research institute. CONCLUSION: GPs have a very positive attitude towards discussing and reporting adverse events...

  20. Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs.

    Science.gov (United States)

    Bohn, J; Kortepeter, C; Muñoz, M; Simms, K; Montenegro, S; Dal Pan, G

    2015-05-01

    Spontaneous adverse event reports constitute an important source of information on previously unknown adverse reactions to marketed medicines. However, the dynamics of such reporting following generic introduction are poorly understood. Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of product-identifying information contained therein. The majority of reports were sent by innovator drug manufacturers while few were sent by generic manufacturers, even when generics accounted for >90% of dispensed prescriptions. We manually reviewed narratives from 2,500 reports and found that the suspect product type (brand or generic) could not be determined in 84% of reports, while generic products (16%) were identified more often than brand-name products (reporting practices. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  1. Incidence and pattern of 12 years of reported transfusion adverse events in Zimbabwe: a retrospective analysis

    Science.gov (United States)

    Mafirakureva, Nyashadzaishe; Khoza, Star; Mvere, David A.; Chitiyo, McLeod E.; Postma, Maarten J.; van Hulst, Marinus

    2014-01-01

    Background Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe. Materials and methods A retrospective review of the transfusion-event records of the National Blood Service Zimbabwe was conducted covering the period from 1 January 1999 to 31 December 2011. All transfusion-related event reports received during the period were analysed. Results A total of 308 transfusion adverse events (0.046%) were reported for 670,625 blood components distributed. The majority (61.6%) of the patients who experienced an adverse event were female. The median age was 36 years (range, 1–89 years). The majority (68.8%) of the adverse events were acute transfusion reactions consisting of febrile non-haemolytic transfusion reactions (58.5%), minor allergies (31.6%), haemolytic reactions (5.2%), severe allergic reactions (2.4%), anaphylaxis (1.4%) and hypotension (0.9%). Two-thirds (66.6%) of the adverse events occurred following administration of whole blood, although only 10.6% of the blood was distributed as whole blood. Packed cells, which accounted for 75% of blood components distributed, were associated with 20.1% of the events. Discussion The incidence of suspected transfusion adverse events was generally lower than the incidences reported globally in countries with well-established haemovigilance systems. The administration of whole blood was disproportionately associated with transfusion adverse events. The pattern of the transfusion adverse events reported here highlights the probable differences in practice between different settings. Under-reporting of transfusion events is rife in passive reporting systems. PMID:24887217

  2. Peer influence on event reports among adolescents and young adults.

    Science.gov (United States)

    McGuire, Katherine; London, Kamala; Wright, Daniel B

    2011-08-01

    When two or more people witness an event together, the event report from one person can influence others' reports. In the current study we examined the role of age and motivational factors on peer influence regarding event reports in adolescents and young adults. Participants (N=249) watched a short video of a robbery then answered questions with no co-witness information or with information believed to be from a co-witness. Public and private response conditions were included to explore motivations for peer influence. Co-witness information influenced participants' responses, although the effect was equally strong in the private and the public co-witness conditions. Peer influence on event reports was steady across a large age range (11- to 25-year-olds).

  3. Standardizing Falls Reporting: Using Data From Adverse Event Reporting to Drive Quality Improvement.

    Science.gov (United States)

    Gardner, Lea Anne; Bray, Phyllis J; Finley, Edward; Sterner, Carly; Ignudo, Thomas L; Stauffer, Cherie L; Kincaid, Shawn A; Marella, William M

    2015-09-01

    To enhance the value of the Pennsylvania Patient Safety Reporting System (PA-PSRS) falls reports by developing a falls reporting program that standardizes falls reporting and provides timely benchmarked falls rates and process measurement reports hospitals can use to identify areas of improvement in their falls program. The new PA-PSRS falls reporting program requires adherence to standardized definitions of falls to generate standardized, customizable analytic reports. An advisory committee and statewide survey guided the development of the program, data definitions, system features and functionality, and methods for stratifying reporting criteria. Three real-time falls outcomes and 2 falls process reports with multiple configurable options were created. A falls dashboard was developed based on gaps in falls risk assessment processes identified in PA-PSRS falls event reports. Six months after launching the program, 41.3% of Pennsylvania hospitals enrolled. The Authority's annual survey indicated 82.9% of participating hospitals found that the new falls analytic reports were somewhat useful to very useful. Preliminary impact on the falls with harm rate has been limited, a less than 1% reduction, but the ability to identify specific organizational and patient risk factors in a timely manner provides hospitals with opportunities to target falls prevention resources more effectively. The PA-PSRS falls reporting program's standardized definition of falls offers new analytic reports that include falls rates with benchmarking data and a falls dashboard. The benchmarking data allow hospitals to compare themselves to peer hospitals statewide. The newly expanded PA-PSRS falls reporting program has turned an adverse event-reporting program into a quality improvement tool.

  4. Proarrhythmic potential of dronedarone: emerging evidence from spontaneous adverse event reporting.

    Science.gov (United States)

    Kao, David P; Hiatt, William R; Krantz, Mori J

    2012-08-01

    To characterize the frequency and type of cardiac events, including torsade de pointes, associated with dronedarone and its structural analog, amiodarone, outside of the clinical trial setting. Retrospective analysis. Spontaneous reports in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database generated between July 1, 2009, and June 30, 2011. All reports of adverse events during the study period were reviewed to identify cardiac events associated with any approved drug in the United States. The type and number of cardiac events associated with dronedarone and amiodarone were determined. Active ingredients were identified using the Drugs@FDA database, and the Medical Dictionary for Regulatory Activities (MedDRA) was used to aggregate related adverse events. To avoid redundant reporting, all statistics were generated in reference to unique case identifiers. Dronedarone was associated with more adverse cardiovascular event reports than amiodarone (810 vs 493 reports) during the study period. Dronedarone was also associated with the most reports of torsade de pointes of any approved drug in the United States (37 reports), followed by amiodarone (29 reports). Reports of ventricular arrhythmias and cardiac arrest (138 vs 113 reports) as well as heart failure (179 vs 126 reports) were more common with dronedarone than amiodarone. Dronedarone was associated with reports of ventricular arrhythmia, cardiac arrest, and torsade de pointes in clinical practice. Whether this observation accounts for the increased risk of fatal arrhythmia observed in a recent prospective trial requires further investigation. © 2012 Pharmacotherapy Publications, Inc. All rights reserved.

  5. Final Project Report, DynAX Innovations in Programming Models, Compilers and Runtime Systems for Dynamic Adaptive Event Driven Execution Models

    Energy Technology Data Exchange (ETDEWEB)

    Gao, Guang [ET International, Inc., Newark, DE (United States); Meister, Benoit [Reservoir Labs, Inc. New York, NY (United States); Padua, David [Univ. of Illinois, Urbana-Champaign, IL (United States); Marquez, Andres [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-12-31

    This report contains a summary of the work done for the Dynax Project from 9/1/2012 to 8/31/2015. Much of the information presented is discussed in further detail in other STI annual and quarterly reports. Additionally, a NCE report was submitted covering work done from the period of 9/1/2015 to 12/31/2015.

  6. Can we rely on patients' reports of adverse events?

    NARCIS (Netherlands)

    Zhu, J.; Stuver, S.O.; Epstein, A.M.; Schneider, E.C.; Weissman, J.S.; Weingart, S.N.

    2011-01-01

    BACKGROUND: Evidence suggests that patients can report a variety of adverse events (AEs) not captured by traditional methods such as a chart review. Little is known, however, about whether patient reports are useful for measuring patient safety. OBJECTIVES: To examine the degree to which physician

  7. International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability.

    Science.gov (United States)

    2016-06-23

    The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.

  8. Barriers to adverse event and error reporting in anesthesia.

    Science.gov (United States)

    Heard, Gaylene C; Sanderson, Penelope M; Thomas, Rowan D

    2012-03-01

    Although anesthesiologists are leaders in patient safety, there has been little research on factors affecting their reporting of adverse events and errors. First, we explored the attitudinal/emotional factors influencing reporting of an unspecified adverse event caused by error. Second, we used a between-groups study design to ask whether there are different perceived barriers to reporting a case of anaphylaxis caused by an error compared with anaphylaxis not caused by error. Finally, we examined strategies that anesthesiologists believe would facilitate reporting. Where possible, we contrasted our results with published findings from other physician groups. An anonymous, self-administered, mailed survey was conducted of 629 consultant anesthesiologists and 263 anesthesiology residents on the mailing list of the Australian and New Zealand College of Anaesthetists in Victoria, Australia. Participants were randomized into "Error" versus "No Error" groups for the specified anaphylaxis adverse event section of the survey. Data were analyzed using nonparametric descriptive and inferential tests. There were 433 usable returned surveys, a usable response rate of 49%. First, there was only 1 of 13 statements on attitudinal/emotional factors that influenced reporting of an unspecified adverse event caused by error with which more anesthesiologists agreed/strongly agreed than disagreed/strongly disagreed: "Doctors who make errors are blamed by their colleagues." Second, when an error rather than no error had caused anaphylaxis, participants were more likely to agree/strongly agree that 6 statements about litigation, getting into trouble, disciplinary action, being blamed, unsupportive colleagues, and not wanting the case discussed in meetings, were perceived as reporting barriers. Finally, the most favored assistive strategies for reporting were generalized deidentified feedback about adverse event and error reports, role models such as senior colleagues who openly encourage

  9. Self-reported non-severe hypoglycaemic events in Europe

    DEFF Research Database (Denmark)

    Östenson, C G; Geelhoed-Duijvestijn, P; Lahtela, J

    2014-01-01

    AIMS: Hypoglycaemia presents a barrier to optimum diabetes management but data are limited on the frequency of hypoglycaemia incidents outside of clinical trials. The present study investigated the rates of self-reported non-severe hypoglycaemic events, hypoglycaemia awareness and physician......, nurses, telephone recruitment and family referrals. Respondents completed four online questionnaires. The first questionnaire collected background information on demographics and hypoglycaemia-related behaviour, whilst all four questionnaires collected data on non-severe hypoglycaemic events...

  10. Age-related trends in injection site reaction incidence induced by the tumor necrosis factor-α (TNF-α) inhibitors etanercept and adalimumab: the Food and Drug Administration adverse event reporting system, 2004-2015.

    Science.gov (United States)

    Matsui, Toshinobu; Umetsu, Ryogo; Kato, Yamato; Hane, Yuuki; Sasaoka, Sayaka; Motooka, Yumi; Hatahira, Haruna; Abe, Junko; Fukuda, Akiho; Naganuma, Misa; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2017-01-01

    Tumor necrosis factor-α (TNF-α) inhibitors are increasingly being used as treatment for rheumatoid arthritis (RA). However, the administration of these drugs carries the risk of inducing injection site reaction (ISR). ISR gives rise to patient stress, nervousness, and a decrease in quality of life (QoL). In order to alleviate pain and other symptoms, early countermeasures must be taken against this adverse event. In order to improve understanding of the risk factors contributing to the induction of ISR, we evaluated the association between TNF-α inhibitors and ISR by applying a logistic regression model to age-stratified data obtained from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The FAERS database contains 7,561,254 reports from January 2004 to December 2015. Adjusted reporting odds ratios (RORs) (95% Confidence Intervals) were obtained for interaction terms for age-stratified groups treated with etanercept (ETN) and adalimumab (ADA). The adjusted RORs for ETN* ≥ 70 and ADA* ≥ 70 groups were the lowest among the age-stratified groups undergoing the respective monotherapies. Furthermore, we found that crude RORs for ETN + methotrexate (MTX) combination therapy and ADA + MTX combination therapy were lower than those for the respective monotherapies. This study was the first to evaluate the relationship between aging and ISR using the FAERS database.

  11. FEATURES, EVENTS, AND PROCESSES: SYSTEM-LEVEL AND CRITICALITY

    Energy Technology Data Exchange (ETDEWEB)

    D.L. McGregor

    2000-12-20

    The primary purpose of this Analysis/Model Report (AMR) is to identify and document the screening analyses for the features, events, and processes (FEPs) that do not easily fit into the existing Process Model Report (PMR) structure. These FEPs include the 3 1 FEPs designated as System-Level Primary FEPs and the 22 FEPs designated as Criticality Primary FEPs. A list of these FEPs is provided in Section 1.1. This AMR (AN-WIS-MD-000019) documents the Screening Decision and Regulatory Basis, Screening Argument, and Total System Performance Assessment (TSPA) Disposition for each of the subject Primary FEPs. This AMR provides screening information and decisions for the TSPA-SR report and provides the same information for incorporation into a project-specific FEPs database. This AMR may also assist reviewers during the licensing-review process.

  12. Analysis of loss of offsite power events reported in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Volkanovski, Andrija, E-mail: Andrija.VOLKANOVSKI@ec.europa.eu [European Commission, Joint Research Centre, Institute for Energy and Transport, P.O. Box 2, NL-1755 ZG Petten (Netherlands); Ballesteros Avila, Antonio; Peinador Veira, Miguel [European Commission, Joint Research Centre, Institute for Energy and Transport, P.O. Box 2, NL-1755 ZG Petten (Netherlands); Kančev, Duško [Kernkraftwerk Goesgen-Daeniken AG, CH-4658 Daeniken (Switzerland); Maqua, Michael [Gesellschaft für Anlagen-und-Reaktorsicherheit (GRS) gGmbH, Schwertnergasse 1, 50667 Köln (Germany); Stephan, Jean-Luc [Institut de Radioprotection et de Sûreté Nucléaire (IRSN), BP 17 – 92262 Fontenay-aux-Roses Cedex (France)

    2016-10-15

    Highlights: • Loss of offsite power events were identified in four databases. • Engineering analysis of relevant events was done. • The dominant root cause for LOOP are human failures. • Improved maintenance procedures can decrease the number of LOOP events. - Abstract: This paper presents the results of analysis of the loss of offsite power events (LOOP) in four databases of operational events. The screened databases include: the Gesellschaft für Anlagen und Reaktorsicherheit mbH (GRS) and Institut de Radioprotection et de Sûreté Nucléaire (IRSN) databases, the IAEA International Reporting System for Operating Experience (IRS) and the U.S. Licensee Event Reports (LER). In total 228 relevant loss of offsite power events were identified in the IRSN database, 190 in the GRS database, 120 in U.S. LER and 52 in IRS database. Identified events were classified in predefined categories. Obtained results show that the largest percentage of LOOP events is registered during On power operational mode and lasted for two minutes or more. The plant centered events is the main contributor to LOOP events identified in IRSN, GRS and IAEA IRS database. The switchyard centered events are the main contributor in events registered in the NRC LER database. The main type of failed equipment is switchyard failures in IRSN and IAEA IRS, main or secondary lines in NRC LER and busbar failures in GRS database. The dominant root cause for the LOOP events are human failures during test, inspection and maintenance followed by human failures due to the insufficient or wrong procedures. The largest number of LOOP events resulted in reactor trip followed by EDG start. The actions that can result in reduction of the number of LOOP events and minimize consequences on plant safety are identified and presented.

  13. National Outbreak Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — The National Outbreak Reporting System (NORS) is a web-based platform designed to support reporting to CDC by local, state, and territorial health departments in the...

  14. Adverse event reporting tool for sedation | Roelofse | Southern ...

    African Journals Online (AJOL)

    Southern African Journal of Anaesthesia and Analgesia. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue · Archives · Journal Home > Vol 18, No 1 (2012) >. Log in or Register to get access to full text downloads. Username, Password, Remember me, or Register. Adverse event reporting tool for ...

  15. Assessing the Effectiveness of the Early Aberration Reporting System (EARS) for Early Event Detection of the H1N1 ("Swine Flu") Virus

    Science.gov (United States)

    2010-09-01

    symptoms file: • “NOSE BLEEDS” maps to COLD because of keyword “NOSE” • “ VAGINAL DISCHARGE ” maps to COLD because of keyword “DISCH” • “4 YEAR...quarantines for infected individuals and/or regions. Modern biosurveillance systems are intended to drastically shorten the time it takes to analyze and... INFECT PAP CHDP COUGH,DXd W/ ASTHMA WI C/O HA//MM CHDP PAP per Kennedy DEPO BOOK PER MD ROB 4WK FU OB ..OVBK COLD ABD PAIN CONJESTION WALK IN BURN

  16. Prevalence and preventability of sentinel events in Saudi Arabia: analysis of reports from 2012 to 2015.

    Science.gov (United States)

    Al Wahabi, Salem; Farahat, Fayssal; Bahloul, Ahmed Y

    2017-08-27

    This study aimed to assess the pattern of sentinel events reported to Ministry of Health of Saudi Arabia from January 2012 to June 2015. Sentinel event reports were examined for patient characteristics, type of event, outcome, cause and preventability. There were 433 sentinel events: 58.2% were deaths, 14.8% were unexpected loss of a limb or a function, 7.4% major medication errors and 7.4% retained instruments or sponges. Among the reported events, 44% were associated with surgical interventions and most were classified as preventable (91.6%). Age 19-64 years was significantly associated with death as an outcome (P = 0.02). Non-preventable sentinel events were significantly more likely among women than men (P = 0.01). Unavailability of policy and procedures and/ or failure to implement them (55%), and lack of proper communication (35%) and training (33%) were the main causes for the adverse events. Efforts should focus on enhancing the National Sentinel Events Reporting System, adopting criteria for effective reporting and ensuring availability and implementation of policies and procedures.

  17. Integrated Reporting Information System -

    Data.gov (United States)

    Department of Transportation — The Integrated Reporting Information System (IRIS) is a flexible and scalable web-based system that supports post operational analysis and evaluation of the National...

  18. A Key Event Path Analysis Approach for Integrated Systems

    Directory of Open Access Journals (Sweden)

    Jingjing Liao

    2012-01-01

    Full Text Available By studying the key event paths of probabilistic event structure graphs (PESGs, a key event path analysis approach for integrated system models is proposed. According to translation rules concluded from integrated system architecture descriptions, the corresponding PESGs are constructed from the colored Petri Net (CPN models. Then the definitions of cycle event paths, sequence event paths, and key event paths are given. Whereafter based on the statistic results after the simulation of CPN models, key event paths are found out by the sensitive analysis approach. This approach focuses on the logic structures of CPN models, which is reliable and could be the basis of structured analysis for discrete event systems. An example of radar model is given to characterize the application of this approach, and the results are worthy of trust.

  19. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Science.gov (United States)

    2011-01-07

    ... announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting... discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs... entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an...

  20. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Science.gov (United States)

    2012-02-24

    ... announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting for... intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical... guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary...

  1. A comparison of active adverse event surveillance systems worldwide.

    Science.gov (United States)

    Huang, Yu-Lin; Moon, Jinhee; Segal, Jodi B

    2014-08-01

    Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems' structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based-the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian-the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European-the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK-the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances.

  2. The logic of surveillance guidelines: an analysis of vaccine adverse event reports from an ontological perspective.

    Directory of Open Access Journals (Sweden)

    Mélanie Courtot

    Full Text Available BACKGROUND: When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processing can make this process more efficient. METHODS AND FINDINGS: Using the Brighton anaphylaxis case definition, we show that existing clinical guidelines used as standards in pharmacovigilance can be logically encoded using a formal representation such as the Adverse Event Reporting Ontology we developed. We validated the classification of vaccine adverse event reports using the ontology against existing rule-based systems and a manually curated subset of the Vaccine Adverse Event Reporting System. However, we encountered a number of critical issues in the formulation and application of the clinical guidelines. We report these issues and the steps being taken to address them in current surveillance systems, and in the terminological standards in use. CONCLUSIONS: By standardizing and improving the reporting process, we were able to automate diagnosis confirmation. By allowing medical experts to prioritize reports such a system can accelerate the identification of adverse reactions to vaccines and the response of regulatory agencies. This approach of combining ontology and semantic technologies can be used to improve other areas of vaccine adverse event reports analysis and should inform both the design of clinical guidelines and how they are used in the future. AVAILABILITY: Sufficient material to reproduce our results is available, including documentation, ontology, code and datasets, at http://purl.obolibrary.org/obo/aero.

  3. Measurement System & Calibration report

    DEFF Research Database (Denmark)

    Gómez Arranz, Paula; Villanueva, Héctor

    This Measurement System & Calibration report is describing DTU’s measurement system installed at a specific wind turbine. A part of the sensors has been installed by others, the rest of the sensors have been installed by DTU. The results of the measurements, described in this report, are only val...

  4. Incidence and pattern of 12 years of reported transfusion adverse events in Zimbabwe: A retrospective analysis

    NARCIS (Netherlands)

    Mafirakureva, Nyashadzaishe; Khoza, Star; Mvere, David A.; Chitiyo, McLeod E.; Postma, Maarten J.; Van Hulst, Marinus

    2014-01-01

    Background. Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe. Materials and

  5. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of...... reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad....

  6. Barriers and Facilitators of Adverse Event Reporting by Adolescent Patients and Their Families.

    Science.gov (United States)

    Sawhney, Payal Naresh; Davis, Linda Sue; Daraiseh, Nancy M; Belle, Lisa; Walsh, Kathleen E

    2017-03-07

    The objectives were (1) to describe barriers and facilitators of adverse event reporting by adolescent patients and parents in a pediatric hospital and (2) to identify characteristics the participants wished to have in a formal reporting system of adverse events. We used a qualitative design in which 6 focus groups, 3 with parents and 3 with adolescents, were conducted. The transcripts of audio recordings, notes of team debriefings, and written field notes of group behaviors were analyzed using NVivo software for qualitative data analysis. Participants reported that the quality of the experience with the health care system, type of communication with health care providers, and degree of personal self-confidence in communication within the health care system were 3 interacting factors influencing willingness to report adverse events. Preferred reporting mechanisms were different for different participants and included face-to-face meetings with hospital representatives, Web sites, smart phone capability, phone calls from a human, and paper mail. Reporting systems should be easy to use, ensure confidentiality, and provide user feedback. Experience, communication, and confidence are 3 factors that can engage an adolescent patient and parents in their health care. Confident adolescent patients and parents in turn have a possibility of reporting an adverse safety event given an opportunity.

  7. The practice of reporting adverse events in a teaching hospital

    OpenAIRE

    Siman, Andréia Guerra; Cunha, Simone Graziele Silva; Brito, Maria José Menezes

    2017-01-01

    Abstract OBJECTIVE Understanding the practice of reporting adverse events by health professionals. METHOD A qualitative case study carried out in a teaching hospital with participants of the Patient Safety Center and the nursing team. The collection took place from May to December 2015, and was conducted through interviews, observation and documentary research to treat the data using Content Analysis. RESULTS 31 professionals participated in the study. Three categories were elaborated: The...

  8. Stochastic Event Counter for Discrete-Event Systems Under Unreliable Observations

    Energy Technology Data Exchange (ETDEWEB)

    Tae-Sic Yoo; Humberto E. Garcia

    2008-06-01

    This paper addresses the issues of counting the occurrence of special events in the framework of partiallyobserved discrete-event dynamical systems (DEDS). First, we develop a noble recursive procedure that updates active counter information state sequentially with available observations. In general, the cardinality of active counter information state is unbounded, which makes the exact recursion infeasible computationally. To overcome this difficulty, we develop an approximated recursive procedure that regulates and bounds the size of active counter information state. Using the approximated active counting information state, we give an approximated minimum mean square error (MMSE) counter. The developed algorithms are then applied to count special routing events in a material flow system.

  9. A general framework for statistical inference on discrete event systems.

    NARCIS (Netherlands)

    R.P. Nicolai (Robin); A.J. Koning (Alex)

    2006-01-01

    textabstractWe present a framework for statistical analysis of discrete event systems which combines tools such as simulation of marked point processes, likelihood methods, kernel density estimation and stochastic approximation to enable statistical analysis of the discrete event system, even if

  10. Siren system installed to alert campus community to emergency events

    OpenAIRE

    Miller, Allan

    2006-01-01

    Virginia Tech is installing a system of warning sirens to alert the campus community to emergency events. The first test of the siren system is scheduled to occur on Wednesday, April 19, at 12:10 p.m.

  11. News and Events - Nanodelivery Systems and Devices Branch

    Science.gov (United States)

    The latest news from the Nanodelivery Systems and Devices Branch and the Alliance, as well as upcoming and past events attended by the Nanodelivery Systems and Devices Branchstaff, and relevant upcoming scientific meetings.

  12. Under-reporting of Adverse Events in the Biomedical Literature

    Directory of Open Access Journals (Sweden)

    Ronald N. Kostoff

    2016-11-01

    Full Text Available Purpose: To address the under-reporting of research results, with emphasis on the underreporting/distorted reporting of adverse events in the biomedical research literature. Design/methodology/approach: A four-step approach is used:(1 To identify the characteristics of literature that make it adequate to support policy; (2 to show how each of these characteristics becomes degraded to make inadequate literature; (3 to identify incentives to prevent inadequate literature; and (4 to show policy implications of inadequate literature. Findings: This review has provided reasons for, and examples of, adverse health effects of myriad substances (1 being under-reported in the premiere biomedical literature, or (2 entering this literature in distorted form. Since there is no way to gauge the extent of this under/distorted-reporting, the quality and credibility of the ‘premiere’ biomedical literature is unknown. Therefore, any types of meta-analyses or scientometric analyses of this literature will have unknown quality and credibility. The most sophisticated scientometric analysis cannot compensate for a highly flawed database. Research limitations: The main limitation is in identifying examples of under-reporting. There are many incentives for under-reporting and few dis-incentives. Practical implications: Almost all research publications, addressing causes of disease, treatments for disease, diagnoses for disease, scientometrics of disease and health issues, and other aspects of healthcare, build upon previous healthcare-related research published. Many researchers will not have laboratories or other capabilities to replicate or validate the published research, and depend almost completely on the integrity of this literature. If the literature is distorted, then future research can be misguided, and health policy recommendations can be ineffective or worse. Originality/value: This review has examined a much wider range of technical and nontechnical

  13. A Risk Assessment System with Automatic Extraction of Event Types

    Science.gov (United States)

    Capet, Philippe; Delavallade, Thomas; Nakamura, Takuya; Sandor, Agnes; Tarsitano, Cedric; Voyatzi, Stavroula

    In this article we describe the joint effort of experts in linguistics, information extraction and risk assessment to integrate EventSpotter, an automatic event extraction engine, into ADAC, an automated early warning system. By detecting as early as possible weak signals of emerging risks ADAC provides a dynamic synthetic picture of situations involving risk. The ADAC system calculates risk on the basis of fuzzy logic rules operated on a template graph whose leaves are event types. EventSpotter is based on a general purpose natural language dependency parser, XIP, enhanced with domain-specific lexical resources (Lexicon-Grammar). Its role is to automatically feed the leaves with input data.

  14. Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting.

    Science.gov (United States)

    Baker, Meghan A; Kaelber, David C; Bar-Shain, David S; Moro, Pedro L; Zambarano, Bob; Mazza, Megan; Garcia, Crystal; Henry, Adam; Platt, Richard; Klompas, Michael

    2015-09-15

    Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values, and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the MetroHealth System, an integrated healthcare system in Ohio. We queried the VAERS database to determine MetroHealth's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society

  15. New thoughts on the "forgotten" aspect of antimicrobial stewardship: adverse event reporting.

    Science.gov (United States)

    Hoffmann, Charles; Khadem, Tina; Schweighardt, Anne; Brown, Jack

    2015-01-01

    Antimicrobial stewardship is an activity that optimizes patient care through selection of the most appropriate antimicrobial therapy. Antimicrobial stewardship programs strive to enhance patient care and reduce preventable consequences of antimicrobial use. They are also vital in monitoring for the development of adverse events occurring as a result of antimicrobial therapy, although literature reviews of this activity are scarce. Although randomized controlled trials are considered the gold standard to study the efficacy of a medication, these trials are not designed to test safety end points and often are only able to identify the most commonly occurring and acute adverse events. In addition, prior to a drug going to market, it is difficult to detect rare adverse events because the associated costs are economically untenable given the limited pipeline of novel agents. These limitations in some ways may be resolved with the use of postmarketing surveillance and spontaneous reporting systems such as the United States Food and Drug Administration Adverse Event Reporting System. The focus of this commentary is to highlight the importance of adverse event reporting by antimicrobial stewardship programs to spontaneous reporting systems as a means to improve patient care. © 2015 Pharmacotherapy Publications, Inc.

  16. Incremental System Modelling in Event-B

    DEFF Research Database (Denmark)

    Hallerstede, Stefan

    2009-01-01

    A reasonable approach to formal modelling is to start with a specification that captures the requirements of a system and then use formal refinement to implement it. The problem with this approach is that for complex systems the specification itself is complex. It becomes a challenge to say whether...... the specification is the right one for the given requirements. Sometimes requirements also concern features of a system closely related to its implementation. This would make an abstract specification necessarily incomplete. We believe that it is better not to follow the rigid approach to modelling described above...... demonstrate how this can be applied to cope with the complexity of specifications. On the one hand we benefit from the reduced number of detail to consider at different times. On the other hand we are encouraged to reason about the formal model since the beginning and to rethink it occasionally to capture...

  17. Mixed Methods Analysis of Medical Error Event Reports: A Report from the ASIPS Collaborative

    National Research Council Canada - National Science Library

    Harris, Daniel M; Westfall, John M; Fernald, Douglas H; Duclos, Christine W; West, David R; Niebauer, Linda; Marr, Linda; Quintela, Javan; Main, Deborah S

    2005-01-01

    .... This paper presents a mixed methods approach to analyzing narrative error event reports. Mixed methods studies integrate one or more qualitative and quantitative techniques for data collection and analysis...

  18. Field Test Results of a New Ambulatory Care Medication Error and Adverse Drug Event Reporting System—MEADERS

    Science.gov (United States)

    Hickner, John; Zafar, Atif; Kuo, Grace M.; Fagnan, Lyle J.; Forjuoh, Samuel N.; Knox, Lyndee M.; Lynch, John T.; Stevens, Brian Kelly; Pace, Wilson D.; Hamlin, Benjamin N.; Scherer, Hilary; Hudson, Brenda L.; Oppenheimer, Caitlin Carroll; Tierney, William M.

    2010-01-01

    PURPOSE In this study, we developed and field tested the Medication Error and Adverse Drug Event Reporting System (MEADERS)—an easy-to-use, Web-based reporting system designed for busy office practices. METHODS We conducted a 10-week field test of MEADERS in which 220 physicians and office staff from 24 practices reported medication errors and adverse drug events they observed during usual clinical care. The main outcomes were (1) use and acceptability of MEADERS measured with a postreporting survey and interviews with office managers and lead physicians, and (2) distributions of characteristics of the medication event reports. RESULTS A total of 507 anonymous event reports were submitted. The mean reporting time was 4.3 minutes. Of these reports, 357 (70%) included medication errors only, 138 (27%) involved adverse drug events only, and 12 (2.4%) included both. Medication errors were roughly equally divided among ordering medications, implementing prescription orders, errors by patients receiving the medications, and documentation errors. The most frequent contributors to the medication errors and adverse drug events were communication problems (41%) and knowledge deficits (22%). Eight (1.6%) of the reported events led to hospitalization. Reporting raised staff and physician awareness of the kinds of errors that occur in office medication management; however, 36% agreed or strongly agreed that the event reporting “has increased the fear of repercussion in the practice.” Time pressure was the main barrier to reporting. CONCLUSIONS It is feasible for primary care clinicians and office staff to report medication errors and adverse drug events to a Web-based reporting system. Time pressures and a punitive culture are barriers to event reporting that must be overcome. Further testing of MEADERS as a quality improvement tool is warranted. PMID:21060122

  19. Sources Of Incidental Events In Collective Water Supply System

    Directory of Open Access Journals (Sweden)

    Szpak Dawid

    2015-11-01

    Full Text Available The publication presents the main types of incidental events in collective water supply system. The special attention was addressed to the incidental events associated with a decrease in water quality, posing a threat to the health and life of inhabitants. The security method against incidental contamination in the water source was described.

  20. Licensee Event Report (LER) compilation for month of February 1984. Vol. 3, No. 2

    Energy Technology Data Exchange (ETDEWEB)

    1984-03-01

    This monthly report contains LER operational information that was processed into the LER data file of the Nuclear Safety Information Center (NSIC) during this period. The LER summaries are arranged alphabetically by facility name and then chronologically by event date for each facility. Component, system, keyword, and component vendor indexes follow the summaries.

  1. System on chip module configured for event-driven architecture

    Science.gov (United States)

    Robbins, Kevin; Brady, Charles E.; Ashlock, Tad A.

    2017-10-17

    A system on chip (SoC) module is described herein, wherein the SoC modules comprise a processor subsystem and a hardware logic subsystem. The processor subsystem and hardware logic subsystem are in communication with one another, and transmit event messages between one another. The processor subsystem executes software actors, while the hardware logic subsystem includes hardware actors, the software actors and hardware actors conform to an event-driven architecture, such that the software actors receive and generate event messages and the hardware actors receive and generate event messages.

  2. Proarrhythmic Potential of Dronedarone: Emerging Evidence from Spontaneous Adverse Event Reporting

    Science.gov (United States)

    Kao, David P.; Hiatt, William R.; Krantz, Mori J.

    2012-01-01

    Context Dronedarone has not been previously associated with a major risk for ventricular arrhythmia, but increased fatal arrhythmias among patients with permanent atrial fibrillation in a recent randomized trial. The mechanism of this adverse safety signal leading to trial discontinuation is unknown. Study Objective To characterize cardiac events, including torsade de pointes, associated with dronedarone and its structural analogue, amiodarone, outside of the clinical trial setting. Design Publicly available extracts from the US Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) system were screened for events occurring from 7/1/2009, the time of dronedarone approval, through 6/30/2011. Data extraction Cardiac events were defined as serious if they involved death, disability, hospitalization, required intervention, or were life-threatening. Active ingredients were identified using the Drugs@FDA Database, and the Medical Dictionary for Regulatory Activities (MedDRA) was used to aggregate related adverse events. To avoid redundant counting, all statistics were generated in reference to unique case identifiers. Results Dronedarone was associated with more adverse cardiovascular event reports than amiodarone (810 vs. 493)during the evaluation period. Dronedarone was the leading reported culprit for torsade de pointes in the US (37 cases) followed by amiodarone (29 cases). Dronedarone was also associated with more cases of ventricular arrhythmias and cardiac arrest than amiodarone (138 vs. 113) as well a heart failure events (179 vs. 126). Limitations AERS data is subject to reporting biases and cannot generate actual incidence rates. Conclusion Dronedarone is associated with reports of ventricular arrhythmia and torsade de pointes in clinical practice. Whether this observation accounts for the increased risk of fatal arrhythmia observed in a recent prospective trial requires further investigation. PMID:22744806

  3. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

    Science.gov (United States)

    2011-01-01

    Background Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review. Methods We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1) informal and 2) formal complaints by patients/relatives, 3) medico-legal claims by patients/relatives and 4) incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports. Results In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6%) adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals reported relatively more

  4. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2011-02-01

    Full Text Available Abstract Background Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in which patient safety issues are already reported, such as incidents reported by healthcare professionals and complaints and medico-legal claims filled by patients or their relatives. The aim of the study is to examine to what extent the hospital reporting systems cover the adverse events identified by patient record review. Methods We conducted a retrospective study using a database from a record review study of 5375 patient records in 14 hospitals in the Netherlands. Trained nurses and physicians using a method based on the protocol of The Harvard Medical Practice Study previously reviewed the records. Four reporting systems were linked with the database of reviewed records: 1 informal and 2 formal complaints by patients/relatives, 3 medico-legal claims by patients/relatives and 4 incident reports by healthcare professionals. For each adverse event identified in patient records the equivalent was sought in these reporting systems by comparing dates and descriptions of the events. The study focussed on the number of adverse event matches, overlap of adverse events detected by different sources, preventability and severity of consequences of reported and non-reported events and sensitivity and specificity of reports. Results In the sample of 5375 patient records, 498 adverse events were identified. Only 18 of the 498 (3.6% adverse events identified by record review were found in one or more of the four reporting systems. There was some overlap: one adverse event had an equivalent in both a complaint and incident report and in three cases a patient/relative used two or three systems to complain about an adverse event. Healthcare professionals

  5. A review of the Office of Inspector General's reports on adverse event identification and reporting.

    Science.gov (United States)

    Howe, Christopher L

    2011-01-01

    The Office of Inspector General published a series of four reports from 2008 to 2010 after investigating the frequency and financial impact of "never events" on Medicare recipients. This series investigated healthcare's ability to identify the occurrence of these events and yielded a detailed analysis of data that must, or at least should, be reviewed to fully understand the clinical risks affecting organizations. These reports also shed light on the reality that there remains gross underreporting of adverse events in healthcare and begs several questions about healthcare's current efforts to fully identify and understand risk. This article summarizes the reports and considers their risk management implications, particularly regarding adverse events. © 2011 American Society for Healthcare Risk Management of the American Hospital Association.

  6. Technology-Induced Errors and Adverse Event Reporting in an Organizational Learning Perspective.

    Science.gov (United States)

    Vinther, Line Dausel; Jensen, Christian Møller; Hjelmager, Ditte Meulengracht; Lyhne, Nicoline; Nøhr, Christian

    2017-01-01

    This paper addresses the possibilities of evaluating technology-induced errors, through the utilization of experiences of the Danish adverse event reporting system. The learning loop in the adverse event reporting system is identified and analyzed, to examine which elements can be utilized to evaluate technologies. The empirical data was collected through interviews and a workshop with members of the nursing staff at a nursing home in Aalborg, Denmark. It was found that, the establishment of sustainable feedback learning loops depends on shared visions in the organization and how creating shared visions requires involvement and participation. Secondly, care workers must possess fundamental knowledge about the technologies available to them. Thirdly comprehensive classification of adverse events should be established to allow for a systematic and goal directed feed-back process.

  7. Operation event logging system of the Swiss Light Source

    Science.gov (United States)

    Lüdeke, Andreas

    2009-02-01

    Modern 3rd generation synchrotron light sources aim for 100% availability. No single beam interruption is acceptable and every beam disturbance should be investigated: what caused the interruption? Can it be avoided in the future? If it cannot be avoided, how can the recovery be accelerated? An automated event recording system has been implemented at the Swiss Light Source (SLS) in order to simplify beam distortion investigations with respect to a well-defined metrics. The system identifies beam disturbances and records automatically the type and duration of the event. Relevant information of the event, like control system archive data or shift summaries, is linked to the event and presented in Web pages. Tools for the automated evaluation of alarm logs are provided that generate summaries of a beam distortion. On the basis of this information each event will be assigned to a failure cause. The means to filter the events are provided. We will describe the concept and the implementation of the system at the SLS and our experiences with it. Finally, the SLS operation event logging system will be compared with failure analysis at other light sources.

  8. Traceability of biopharmaceuticals in spontaneous reporting systems

    DEFF Research Database (Denmark)

    Vermeer, Niels S; Straus, Sabine M J M; Mantel-Teeuwisse, Aukje K

    2013-01-01

    the period 2004-2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU. MAIN OUTCOME MEASURES: The availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs...

  9. Discrete event systems in dioid algebra and conventional algebra

    CERN Document Server

    Declerck, Philippe

    2013-01-01

    This book concerns the use of dioid algebra as (max, +) algebra to treat the synchronization of tasks expressed by the maximum of the ends of the tasks conditioning the beginning of another task - a criterion of linear programming. A classical example is the departure time of a train which should wait for the arrival of other trains in order to allow for the changeover of passengers.The content focuses on the modeling of a class of dynamic systems usually called "discrete event systems" where the timing of the events is crucial. Events are viewed as sudden changes in a process which i

  10. Adverse Events of Acupuncture: A Systematic Review of Case Reports

    Science.gov (United States)

    Xu, Shifen; Wang, Lizhen; Cooper, Emily; Zhang, Ming; Manheimer, Eric; Berman, Brian; Shen, Xueyong; Lao, Lixing

    2013-01-01

    Acupuncture, moxibustion, and cupping, important in traditional Eastern medicine, are increasingly used in the West. Their widening acceptance demands continual safety assessment. This review, a sequel to one our team published 10 years ago, is an evaluation of the frequency and severity of adverse events (AEs) reported for acupuncture, moxibustion, and cupping between 2000 and 2011. Relevant English-language reports in six databases were identified and assessed by two reviewers. During this 12-year period, 117 reports of 308 AEs from 25 countries and regions were associated with acupuncture (294 cases), moxibustion (4 cases), or cupping (10 cases). Country of occurrence, patient's sex and age, and outcome were extracted. Infections, mycobacterial, staphylococcal, and others, were the main complication of acupuncture. In the previous review, we found the main source of infection to be hepatitis, caused by reusable needles. In this review, we found the majority of infections to be bacterial, caused by skin contact at acupoint sites; we found no cases of hepatitis. Although the route of infection had changed, infections were still the major complication of acupuncture. Clearly, guidelines such as Clean Needle Technique must be followed in order to minimize acupuncture AEs. PMID:23573135

  11. Role of systems pharmacology in understanding drug adverse events

    Science.gov (United States)

    Berger, Seth I.; Iyengar, Ravi

    2011-01-01

    Systems pharmacology involves the application of systems biology approaches, combining large-scale experimental studies with computational analyses, to the study of drugs, drug targets, and drug effects. Many of these initial studies have focused on identifying new drug targets, new uses of known drugs, and systems-level properties of existing drugs. This review focuses on systems pharmacology studies that aim to better understand drug side effects and adverse events. By studying the drugs in the context of cellular networks, these studies provide insights into adverse events caused by off-targets of drugs as well as adverse events-mediated complex network responses. This allows rapid identification of biomarkers for side effect susceptibility. In this way, systems pharmacology will lead to not only newer and more effective therapies, but safer medications with fewer side effects. PMID:20803507

  12. OSCAR experiment high-density network data report: Event 1 - April 8-9, 1981

    Energy Technology Data Exchange (ETDEWEB)

    Dana, M.T.; Easter, R.C.; Thorp, J.M.

    1984-12-01

    The OSCAR (Oxidation and Scavenging Characteristics of April Rains) experiment, conducted during April 1981, was a cooperative field investigation of wet removal in cyclonic storm systems. The high-densiy component of OSCAR was located in northeast Indiana and included sequential precipitation chemistry measurements on a 100 by 100 km network, as well as airborne air chemistry and cloud chemistry measurements, surface air chemistry measurements, and supporting meteorological measurements. Four separate storm events were studied during the experiment. This report summarizes data taken by Pacific Northwest Laboratory (PNL) during the first storm event, April 8-9. The report contains the high-density network precipitation chemistry data, air chemistry data from the PNL aircraft, and meteorological data for the event, including standard National Weather Service products and radar data from the network. 4 references, 72 figures, 5 tables.

  13. OSCAR experiment high-density network data report: Event 3 - April 16-17, 1981

    Energy Technology Data Exchange (ETDEWEB)

    Dana, M.T.; Easter, R.C.; Thorp, J.M.

    1984-12-01

    The OSCAR (Oxidation and Scavenging Characteristics of April Rains) experiment, conducted during April 1981, was a cooperative field investigation of wet removal in cyclonic storm systems. The high-density component of OSCAR was located in northeast Indiana and included sequential precipitation chemistry measurements on a 100 by 100 km network, as well as airborne air chemistry and cloud chemistry measurements, surface air chemistry measurements, and supporting meteorological measurements. Four separate storm events were studied during the experiment. This report summarizes data taken by Pacific Northwest Laboratory (PNL) during the third storm event, April 16-17. The report contains the high-density network precipitation chemistry data, air chemistry and cloud chemistry data from the PNL aircraft, and meteorological data for the event, including standard National Weather Service products and radar and rawindsonde data from the network. 4 references, 76 figures, 6 tables.

  14. Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database.

    Science.gov (United States)

    Al-Safi, Zain A; Shavell, Valerie I; Hobson, Deslyn T G; Berman, Jay M; Diamond, Michael P

    2013-01-01

    The Manufacturer and User Facility Device Experience database may be useful for clinicians using a Food and Drug Administration-approved medical device to identify the occurrence of adverse events and complications. We sought to analyze and investigate reports associated with the Essure hysteroscopic sterilization system (Conceptus Inc., Mountain View, CA) using this database. Retrospective review of the Manufacturer and User Facility Device Experience database for events related to Essure hysteroscopic sterilization from November 2002 to February 2012 (Canadian Task Force Classification III). Online retrospective review. Online reports of patients who underwent Essure tubal sterilization. Essure tubal sterilization. Four hundred fifty-seven adverse events were reported in the study period. Pain was the most frequently reported event (217 events [47.5%]) followed by delivery catheter malfunction (121 events [26.4%]). Poststerilization pregnancy was reported in 61 events (13.3%), of which 29 were ectopic pregnancies. Other reported events included perforation (90 events [19.7%]), abnormal bleeding (44 events [9.6%]), and microinsert malposition (33 events [7.2%]). The evaluation and management of these events resulted in an additional surgical procedure in 270 cases (59.1%), of which 44 were hysterectomies. Sixty-one unintended poststerilization pregnancies were reported in the study period, of which 29 (47.5%) were ectopic gestations. Thus, ectopic pregnancy must be considered if a woman becomes pregnant after Essure hysteroscopic sterilization. Additionally, 44 women underwent hysterectomy after an adverse event reported to be associated with the use of the device. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  15. A reliable sewage quality abnormal event monitoring system.

    Science.gov (United States)

    Li, Tianling; Winnel, Melissa; Lin, Hao; Panther, Jared; Liu, Chang; O'Halloran, Roger; Wang, Kewen; An, Taicheng; Wong, Po Keung; Zhang, Shanqing; Zhao, Huijun

    2017-09-15

    With closing water loop through purified recycled water, wastewater becomes a part of source water, requiring reliable wastewater quality monitoring system (WQMS) to manage wastewater source and mitigate potential health risks. However, the development of reliable WQMS is fatally constrained by severe contamination and biofouling of sensors due to the hostile analytical environment of wastewaters, especially raw sewages, that challenges the limit of existing sensing technologies. In this work, we report a technological solution to enable the development of WQMS for real-time abnormal event detection with high reliability and practicality. A vectored high flow hydrodynamic self-cleaning approach and a dual-sensor self-diagnostic concept are adopted for WQMS to effectively encounter vital sensor failing issues caused by contamination and biofouling and ensure the integrity of sensing data. The performance of the WQMS has been evaluated over a 3-year trial period at different sewage catchment sites across three Australian states. It has demonstrated that the developed WQMS is capable of continuously operating in raw sewage for a prolonged period up to 24 months without maintenance and failure, signifying the high reliability and practicality. The demonstrated WQMS capability to reliably acquire real-time wastewater quality information leaps forward the development of effective wastewater source management system. The reported self-cleaning and self-diagnostic concepts should be applicable to other online water quality monitoring systems, opening a new way to encounter the common reliability and stability issues caused by sensor contamination and biofouling. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. WHO efforts to promote reporting of adverse events and global learning

    Directory of Open Access Journals (Sweden)

    Itziar Larizgoitia

    2013-12-01

    Full Text Available Despite the importance of reporting systems to learn about the casual chain and consequences of patient safety incidents, this is an area that requires of further conceptual and technical developments to conduce reporting to effective learning. The World Health Organization, through its Patient Safety Programme, adopted as a priority the objective to facilitate and stimulate global learning through enhanced reporting of patient safety incidents. Landmark developments were the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, and the Conceptual Framework for the International Classification for Patient Safety, as well as the Global Community of Practice for Reporting and Learning Systems. WHO is currently working with a range of scientists, medical informatics specialists and healthcare officials from various countries around the world, to arrive at a Minimal Information Model that could serve as a basis to structure the core of reporting systems in a comparable manner across the world. Undoubtedly, there is much need for additional scientific developments in this challenging and innovative area. For effective reporting systems and enhanced global learning, other key contextual factors are essential for reporting to serve to the needs of clinicians, patients and the healthcare system at large. Moreover, the new data challenges and needs of organizations must be assessed as the era of big data comes to heath care. These considerations delineate a broad agenda for action, which offer an ambitious challenge for WHO and their partners interested in strengthening learning for improving through reporting and communicating about patient safety incidents.

  17. Discrete event simulation versus conventional system reliability analysis approaches

    DEFF Research Database (Denmark)

    Kozine, Igor

    2010-01-01

    Discrete Event Simulation (DES) environments are rapidly developing and appear to be promising tools for building reliability and risk analysis models of safety-critical systems and human operators. If properly developed, they are an alternative to the conventional human reliability analysis models...... and systems analysis methods such as fault and event trees and Bayesian networks. As one part, the paper describes briefly the author’s experience in applying DES models to the analysis of safety-critical systems in different domains. The other part of the paper is devoted to comparing conventional approaches...

  18. Security information and event management systems: benefits and inefficiencies

    OpenAIRE

    Κάτσαρης, Δημήτριος Σ.

    2014-01-01

    In this Master’s thesis, the new trend in computer and information security industry called Security Information and Event Management systems will be covered. The evolution, advantages and weaknesses of these systems will be described, as well as a home-based implementation with open source tools will be proposed and implemented.

  19. REPORTS OF ADVERSE EVENTS TO BLOOD TRANSFUSION IN SLOVENIA IN 2002

    Directory of Open Access Journals (Sweden)

    Marjeta Potočnik

    2004-12-01

    Full Text Available Background. The risk of severe adverse events to blood transfusion is very low. More frequent are adverse events to transfusion, which are not severe, but must also be treated. Introduction of the haemovigilance system is a way of detecting and analysing them in order to correct their cause and to prevent their recurrence.Methods. In 2002 we collected data on transfusion adverse events registered by the Blood Transfusion Centre of Slovenia and blood transfusion departments in Slovene general hospitals.Results. 86 adverse events to transfusion were reported in 2002. The most frequent were non-haemolytic fever (42 cases and allergic reactions (27 cases. 5 cases of haemolysis and 1 of pulmonary oedema were also reported. 11 cases were not categorised.Conclusions. We suppose that the collected data is not complete. However, it does give us insight into the clinical part of the transfusion chain. The most frequently registered adverse events in Slovenia are the same as in other countries. The presented data is the beginning of a systematic registration, using standard forms and reporting. Analysis and a followup activities are the basis for improvement of the blood transfusion safety and quality of treatment.

  20. Digital disease detection: A systematic review of event-based internet biosurveillance systems.

    Science.gov (United States)

    O'Shea, Jesse

    2017-05-01

    Internet access and usage has changed how people seek and report health information. Meanwhile,infectious diseases continue to threaten humanity. The analysis of Big Data, or vast digital data, presents an opportunity to improve disease surveillance and epidemic intelligence. Epidemic intelligence contains two components: indicator based and event-based. A relatively new surveillance type has emerged called event-based Internet biosurveillance systems. These systems use information on events impacting health from Internet sources, such as social media or news aggregates. These systems circumvent the limitations of traditional reporting systems by being inexpensive, transparent, and flexible. Yet, innovations and the functionality of these systems can change rapidly. To update the current state of knowledge on event-based Internet biosurveillance systems by identifying all systems, including current functionality, with hopes to aid decision makers with whether to incorporate new methods into comprehensive programmes of surveillance. A systematic review was performed through PubMed, Scopus, and Google Scholar databases, while also including grey literature and other publication types. 50 event-based Internet systems were identified, including an extraction of 15 attributes for each system, described in 99 articles. Each system uses different innovative technology and data sources to gather data, process, and disseminate data to detect infectious disease outbreaks. The review emphasises the importance of using both formal and informal sources for timely and accurate infectious disease outbreak surveillance, cataloguing all event-based Internet biosurveillance systems. By doing so, future researchers will be able to use this review as a library for referencing systems, with hopes of learning, building, and expanding Internet-based surveillance systems. Event-based Internet biosurveillance should act as an extension of traditional systems, to be utilised as an

  1. On the Design of Adaptive Supervisors for Discrete Event Systems

    Directory of Open Access Journals (Sweden)

    Vigyan Chandra

    2006-04-01

    Full Text Available The supervised control of complex event-driven Discrete Event Systems (DESs such as those present in manufacturing systems, or the communication processes involved therein, continue to pose a challenge to system designers. To a certain extent this complexity can be reduced by applying existing modular control approaches to large-scale DES design. These solutions divide the system into different sections in such a way that its overall behavior is given by a suitable arrangement of the different sections. However, if the system is reconfigured frequently, the overall plant models and control specifications computed earlier would no longer be valid. Thus a new controlled system will have to be computed. We propose a new methodology, for ensuring that the new controlled plant will meet any valid control specifications taken from the existing modules. Being built on the framework of Supervisory control theory, this method is guaranteed to work even as the system is being dynamically reconfigured.

  2. Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

    Science.gov (United States)

    Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

    2017-11-01

    Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P reporting patterns were observed more between brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

  3. 76 FR 57045 - Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

    Science.gov (United States)

    2011-09-15

    ... HUMAN SERVICES Announcement of Requirements and Registration for ``Reporting Device Adverse Events... monitoring product safety and effectiveness. The ``Reporting Device Adverse Events Challenge'' asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to...

  4. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Science.gov (United States)

    2010-04-01

    ... Requirements for Individual Adverse Event Reports § 803.20 How do I complete and submit an individual adverse... individual reports of adverse events. If you are a health professional or consumer, you may use the FDA Form...) If you are a user facility, importer, or manufacturer, you do not have to report an adverse event if...

  5. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...... of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. METHODS: All ADR reports handled by the ADEM in 2014 were recorded anonymously...... reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. FUNDING: none. TRIAL REGISTRATION: not relevant. ....

  6. DoD-Wide Medical Surveillance for Potential Long-Term Adverse Events Associated With Smallpox Vaccination, Hospitalizations, and Self-Reported Outcomes

    National Research Council Canada - National Science Library

    Wells, Timothy S

    2005-01-01

    ...-wide smallpox vaccination program. It is designed to complement the collaborative monitoring effort for short-term adverse events associated with the administration of vaccines known as the Vaccine Adverse Events Reporting System (VAERS...

  7. From Harmful Treatment to Secondary Gain: Adverse Event Reporting in Dyspepsia and Gastroparesis.

    Science.gov (United States)

    Bielefeldt, Klaus

    2017-11-01

    Medical management of gastroparesis and functional dyspepsia remains difficult with several recent trials showing limited or no benefit. If treatment comes with only marginal improvements, concerns about adverse events become more relevant. We therefore examined the type and outcomes of side effects submitted to a public repository. We searched the Federal Adverse Event Reporting System for reports associated with the treatment of dyspepsia or gastroparesis. Demographic data, medications used and implicated, side effects, and outcomes were abstracted for the years 2004-2015. Acid-suppressive agents and prokinetics were the most commonly listed medications with a stronger emphasis on prokinetics in gastroparesis. Submissions related to metoclopramide by far exceeded reports about other agents and mostly described tardive dyskinesia or other neurological concerns. They peaked around 2012, driven by submissions through legal workers. Most reports about metoclopramide described short-term use to prevent or treat nausea and vomiting. Concerns about acid-suppressive medications increased over time and spanned a wide spectrum of potential problems, including osteoporosis, worsening renal function, or cardiac events. Despite biasing factors, such as pending legal action, the voluntary repository of adverse events provides insight into current medical practice and its associated risk. Knowing about common and uncommon, but potentially serious risks may enable patients and providers to decide on effective and safe management strategies.

  8. Wheelchair type biomedical system with event-recorder function.

    Science.gov (United States)

    Han, Dong-Kyoon; Kim, Jong-Myoung; Cha, Eun-Jong; Lee, Tae-Soo

    2008-01-01

    The present study is about a biometric system for a wheelchair, which can measure both bio-signal (ECG-Electrocardiogram, BCG-Ballistocardiogram) and kinetic signal (acceleration) simultaneously and send the data to a remote medical server. The equipment was developed with the object of building a system that measures the bio-signal and kinetic signal of a subject who is moving or at rest on a wheelchair and transmits the measured signals to a remote server through a CDMA (Code Division Multiple Access) network. The equipment is composed of body area network and remote medical server. The body area network was designed to obtain bio-signal and kinetic signal simultaneously and, on the occurrence of an event, to transmit data to a remote medical server through a CDMA network. The remote medical server was designed to display event data transmitted from the body area network in real time. The performance of the developed system was evaluated through two experiments. First, we measured battery life on the occurrence of events, and second, we tested whether biometric data are transmitted accurately to the remote server on the occurrence of an event. In the first experiment using the developed equipment, events were triggered 16 times and the battery worked stably for around 29 hours. In the second experiment, when an event took place, the corresponding data were transmitted accurately to the remote medical server through a CDMA network. This system is expected to be usable for the healthcare of those moving on a wheelchair and applicable to a mobile healthcare system.

  9. System events: readily accessible features for surgical phase detection.

    Science.gov (United States)

    Malpani, Anand; Lea, Colin; Chen, Chi Chiung Grace; Hager, Gregory D

    2016-06-01

    Surgical phase recognition using sensor data is challenging due to high variation in patient anatomy and surgeon-specific operating styles. Segmenting surgical procedures into constituent phases is of significant utility for resident training, education, self-review, and context-aware operating room technologies. Phase annotation is a highly labor-intensive task and would benefit greatly from automated solutions. We propose a novel approach using system events-for example, activation of cautery tools-that are easily captured in most surgical procedures. Our method involves extracting event-based features over 90-s intervals and assigning a phase label to each interval. We explore three classification techniques: support vector machines, random forests, and temporal convolution neural networks. Each of these models independently predicts a label for each time interval. We also examine segmental inference using an approach based on the semi-Markov conditional random field, which jointly performs phase segmentation and classification. Our method is evaluated on a data set of 24 robot-assisted hysterectomy procedures. Our framework is able to detect surgical phases with an accuracy of 74 % using event-based features over a set of five different phases-ligation, dissection, colpotomy, cuff closure, and background. Precision and recall values for the cuff closure (Precision: 83 %, Recall: 98 %) and dissection (Precision: 75 %, Recall: 88 %) classes were higher than other classes. The normalized Levenshtein distance between predicted and ground truth phase sequence was 25 %. Our findings demonstrate that system events features are useful for automatically detecting surgical phase. Events contain phase information that cannot be obtained from motion data and that would require advanced computer vision algorithms to extract from a video. Many of these events are not specific to robotic surgery and can easily be recorded in non-robotic surgical modalities. In future

  10. Modeling and Analysis of Real-Time Database Systems in the Framework of Discrete Event Systems

    National Research Council Canada - National Science Library

    Ghosh, Anunoy

    1994-01-01

    .... Such database systems are called Real-Time Database Systems (RTDBS). The problem of concurrency control and scheduling of transactions in real time database systems is studied in the framework of discrete event dynamical systems (DEDS...

  11. Elaborative Talk during and after an Event: Conversational Style Influences Children's Memory Reports

    Science.gov (United States)

    Hedrick, Amy M.; Haden, Catherine A.; Ornstein, Peter A.

    2009-01-01

    An experimental design was utilized to examine the effects of elaborative talk during and/or after an event on children's event memory reports. Sixty preschoolers were assigned randomly to one of four conditions that varied according to a researcher's use of high- or low- elaborative during- and/or post-event talk about a camping event. In a…

  12. Mixed Methods Analysis of Medical Error Event Reports: A Report from the ASIPS Collaborative

    National Research Council Canada - National Science Library

    Harris, Daniel M; Westfall, John M; Fernald, Douglas H; Duclos, Christine W; West, David R; Niebauer, Linda; Marr, Linda; Quintela, Javan; Main, Deborah S

    2005-01-01

    The Applied Strategies for Improving Patient Safety (ASIPS) collaborative developed an ambulatory primary care patient safety reporting system through an Agency for Healthcare Research and Quality (AHRQ...

  13. Events

    Directory of Open Access Journals (Sweden)

    Igor V. Karyakin

    2016-02-01

    Full Text Available The 9th ARRCN Symposium 2015 was held during 21st–25th October 2015 at the Novotel Hotel, Chumphon, Thailand, one of the most favored travel destinations in Asia. The 10th ARRCN Symposium 2017 will be held during October 2017 in the Davao, Philippines. International Symposium on the Montagu's Harrier (Circus pygargus «The Montagu's Harrier in Europe. Status. Threats. Protection», organized by the environmental organization «Landesbund für Vogelschutz in Bayern e.V.» (LBV was held on November 20-22, 2015 in Germany. The location of this event was the city of Wurzburg in Bavaria.

  14. Fuels Reporting System Data

    Data.gov (United States)

    U.S. Environmental Protection Agency — This asset includes compliance data (registrations and reports), including reports related to reformulated gasoline and conventional gasoline (anti-dumping),...

  15. An ATLAS event with a high mass dijet system

    CERN Multimedia

    ATLAS, Experiment

    2014-01-01

    Event with a high mass dijet system: the invariant mass of the two highest-pT jets is 2.55 TeV. The highest pT jet has a pT of 420 GeV, and an eta of -1.51, the second leading jet has pT of 320 GeV and an eta of 2.32. Jet momenta are calibrated according to the "EM+JES" scheme. No other jets are found with pT above 20 GeV. Event collected on 4 July 2010.

  16. Report of a serious reportable communicable disease at a major sporting event.

    Science.gov (United States)

    Cummiskey, J; Borrione, P; Bachil, N; Ergen, E; Pigozzi, F

    2008-06-01

    A European Youth Olympic Sports Festival (EYOF), in Jaca, Northern Aragon, Spain, involving 1500 athletes, from 43 countries was held in January for 7 days. The event was marred by a case of type B Neisseria meningitidis. The usual care of the patient was performed in a local hospital. He eventually made a full recovery. The case was reported to the Local Health Authority and the National Public Health authority of the patient's country. Their advice was to treat the core case, give prophylactic therapy to the inner circle (28 athletes and officials) and surveillance of the other close contacts (84 total) with temperature and symptom review daily. They advised against further information being given to the rest of the athletes and officials, in case it might give rise to a panic situation. The dilemma of the responsible physicians was that 1500 athletes were traveling back to 43 countries within the incubation period of the bacterial meningitis. It was decided that informing each country was appropriate. This was done at the event by informing the Chef of the Missions and writing to the Secretary Generals of each National Olympic Committee attending. This was the first serious contagious disease at a major sporting event. The way in which the wider dispersing attendees were informed at the event should form the basis of management at sporting events in the likelihood of a serious communicable disease.

  17. A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals.

    Science.gov (United States)

    Stergiopoulos, Stella; Brown, Carrie A; Felix, Thomas; Grampp, Gustavo; Getz, Kenneth A

    2016-11-01

    The under-reporting of adverse drug events (ADEs) is an international health concern. A number of studies have assessed the root causes but, to our knowledge, little information exists relating under-reporting to practices and systems used for the recording and tracking of drug-related adverse event observations in ambulatory settings, institutional settings, and retail pharmacies. Our objective was to explore the process for reporting ADEs in US hospitals, ambulatory settings, and retail pharmacies; to explore gaps and inconsistencies in the reporting process; and to identify the causes of under-reporting ADEs in these settings. The Tufts Center for the Study of Drug Development (Tufts CSDD) interviewed 11 thought leaders and conducted a survey between May and August 2014 among US-based healthcare providers (HCPs) in diverse settings to assess their experiences with, and processes for, reporting ADEs. A total of 123 individuals completed the survey (42 % were pharmacists; 27 % were nurses; 15 % were physicians; and 16 % were classified as 'other'). HCPs indicated that the main reasons for under-reporting were difficulty in determining the cause of the ADE, given that most patients receive multiple therapies simultaneously (66 % of respondents); that HCPs lack sufficient time to report ADEs (63 % of respondents); poor integration of ADE-reporting systems (53 % of respondents); and uncertainty about reporting procedures (52 % of respondents). The results of this pilot study identify that key factors contributing to the under-reporting of ADEs relate to a lack of standardized process, a lack of training and education, and a lack of integrated health information technologies.

  18. Healthcare providers’ knowledge, experience and challenges of reporting adverse events following immunisation: a qualitative study

    Science.gov (United States)

    2013-01-01

    Background Healthcare provider spontaneous reporting of suspected adverse events following immunisation (AEFI) is central to monitoring post-licensure vaccine safety, but little is known about how healthcare professionals recognise and report to surveillance systems. The aim of this study was explore the knowledge, experience and attitudes of medical and nursing professionals towards detecting and reporting AEFI. Methods We conducted a qualitative study, using semi-structured, face to face interviews with 13 Paediatric Emergency Department consultants from a tertiary paediatric hospital, 10 General Practitioners, 2 local council immunisation and 4 General Practice nurses, recruited using purposive sampling in Adelaide, South Australia, between December 2010 and September 2011. We identified emergent themes related to previous experience of an AEFI in practice, awareness and experience of AEFI reporting, factors that would facilitate or impede reporting and previous training in vaccine safety. Thematic analysis was used to analyse the data. Results AEFI reporting was infrequent across all groups, despite most participants having reviewed an AEFI. We found confusion about how to report an AEFI and variability, according to the provider group, as to the type of events that would constitute a reportable AEFI. Participants’ interpretation of a “serious” or “unexpected” AEFI varied across the three groups. Common barriers to reporting included time constraints and unsatisfactory reporting processes. Nurses were more likely to have received formal training in vaccine safety and reporting than medical practitioners. Conclusions This study provides an overview of experience and beliefs of three healthcare professional groups in relation to identifying and reporting AEFI. The qualitative assessment reveals differences in experience and awareness of AEFI reporting across the three professional groups. Most participants appreciated the importance of their role in

  19. Multi Agent System Based Wide Area Protection against Cascading Events

    DEFF Research Database (Denmark)

    Liu, Zhou; Chen, Zhe; Liu, Leo

    2012-01-01

    In this paper, a multi-agent system based wide area protection scheme is proposed in order to prevent long term voltage instability induced cascading events. The distributed relays and controllers work as a device agent which not only executes the normal function automatically but also can...... be modified to fulfill the extra function according to external requirements. The control center is designed as a highest level agent in MAS to coordinate all the lower agents to prevent the system wide voltage disturbance. A hybrid simulation platform with MATLAB and RTDS is set up to demonstrate...... the effectiveness of proposed protection strategy. The simulation results indicate that the proposed multi agent control system can effectively coordinate the distributed relays and controllers to prevent the long term voltage instability induced cascading events....

  20. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

    Science.gov (United States)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne; Darsø, Perle; Christophersen, Anette Kvindebjerg; Borck, Bille; Christensen, Catrine; Hansen, Melissa Voigt; Halladin, Natalie Monica Løvland; Christensen, Mikkel Bring; Harboe, Kirstine Moll; Lund, Marie; Jimenez-Solem, Espen

    2017-01-01

    Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. none. not relevant. .

  1. The reasons for Chinese nursing staff to report adverse events: a questionnaire survey.

    Science.gov (United States)

    Hong, Su; Li, QiuJie

    2017-04-01

    To investigate the impact of nurses' perception of patient safety culture and adverse event reporting, and demographic factors on adverse event reporting in Chinese hospitals. Accurate and timely adverse event reporting is integral in promoting patient safety and professional learning around the incident. In a cross-sectional survey, a sample of 919 nurses completed a structured questionnaire composed of two validated instruments measuring nurses' perception of patient safety culture and adverse event reporting. Associations between the variables were examined using multiple linear regression analysis. The positive response rates of five dimensions of the Patient Safety Culture Assessment Scale varied from 47.55% to 80.62%. The accuracy rate of Adverse Event Reporting Perception Scale was 63.16%. Five hundred and thirty-one (58.03%) nurses did not report adverse event in past 12 months. Six variables were found to be associated with nurses' adverse event reporting: total work experience (P = 0.003), overall patient safety culture score (P safety climate (P safety culture and nurses' perception of adverse event reporting were related to an increase in voluntary adverse event reporting. The knowledge of adverse event reporting should be integrated into the patient safety curriculum. Interventions that target a specific domain are necessary to improve the safety culture. © 2017 John Wiley & Sons Ltd.

  2. Designing adverse event forms for real-world reporting: participatory research in Uganda.

    Directory of Open Access Journals (Sweden)

    Emma C Davies

    Full Text Available The wide-scale roll-out of artemisinin combination therapies (ACTs for the treatment of malaria should be accompanied by continued surveillance of their safety. Post-marketing pharmacovigilance (PV relies on adverse event (AE reporting by clinicians, but as a large proportion of treatments are provided by non-clinicians in low-resource settings, the effectiveness of such PV systems is limited. To facilitate reporting, AE forms should be easily completed; however, most are challenging for lower-level health workers and non-clinicians to complete. Through participatory research, we sought to develop user-friendly AE report forms to capture information on events associated with ACTs.Following situation analysis, we undertook workshops with community medicine distributors and health workers in Jinja, Uganda, to develop a reporting form based on experiences and needs of users, and communication and visual perception principles. Participants gave feedback for revisions of subsequent versions. We then conducted 8 pretesting sessions with 77 potential end users to test and refine passive and active versions of the form.The development process resulted in a form that included a pictorial storyboard to communicate the rationale for the information needed and facilitate rapport between the reporter and the respondent, and a diary format to record the drug administration and event details in chronological relation to each other. Successive rounds of pretesting used qualitative and quantitative feedback to refine the form, with the final round showing over 80% of the form completed correctly by potential end users.We developed novel AE report forms that can be used by non-clinicians to capture pharmacovigilance data for anti-malarial drugs. The participatory approach was effective for developing forms that are intuitive for reporters, and motivating for respondents. The forms, or their key components, could be adapted for use in other low-literacy settings

  3. Physician Quality Reporting System

    Data.gov (United States)

    U.S. Department of Health & Human Services — PQRS is a reporting program that uses a combination of incentive payments and negative payment adjustments to promote reporting of quality information by eligible...

  4. Address-event-based platform for bioinspired spiking systems

    Science.gov (United States)

    Jiménez-Fernández, A.; Luján, C. D.; Linares-Barranco, A.; Gómez-Rodríguez, F.; Rivas, M.; Jiménez, G.; Civit, A.

    2007-05-01

    Address Event Representation (AER) is an emergent neuromorphic interchip communication protocol that allows a real-time virtual massive connectivity between huge number neurons, located on different chips. By exploiting high speed digital communication circuits (with nano-seconds timings), synaptic neural connections can be time multiplexed, while neural activity signals (with mili-seconds timings) are sampled at low frequencies. Also, neurons generate "events" according to their activity levels. More active neurons generate more events per unit time, and access the interchip communication channel more frequently, while neurons with low activity consume less communication bandwidth. When building multi-chip muti-layered AER systems, it is absolutely necessary to have a computer interface that allows (a) reading AER interchip traffic into the computer and visualizing it on the screen, and (b) converting conventional frame-based video stream in the computer into AER and injecting it at some point of the AER structure. This is necessary for test and debugging of complex AER systems. In the other hand, the use of a commercial personal computer implies to depend on software tools and operating systems that can make the system slower and un-robust. This paper addresses the problem of communicating several AER based chips to compose a powerful processing system. The problem was discussed in the Neuromorphic Engineering Workshop of 2006. The platform is based basically on an embedded computer, a powerful FPGA and serial links, to make the system faster and be stand alone (independent from a PC). A new platform is presented that allow to connect up to eight AER based chips to a Spartan 3 4000 FPGA. The FPGA is responsible of the network communication based in Address-Event and, at the same time, to map and transform the address space of the traffic to implement a pre-processing. A MMU microprocessor (Intel XScale 400MHz Gumstix Connex computer) is also connected to the FPGA

  5. Development of INSTEC(INformation System of Trip Event Cases)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jeong Woon; Shim, Bong Sik; Park, Keun Oak; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    1996-09-01

    In this research, we established an incident analysis procedure based on the concept of interaction between plant components and developed INSTEC(INformation System of Trip Event Cases) which can manage data obtained as the result of incident analysis. The analysis procedure is consisted of the following steps; reconfiguration of incident context, identification of the paths and contents of the interaction between plant components, identification of unit event obstructing normal plant operation, identification of possible erroneous actions, decision of error modes, identification of likely causes, summarization of analysis results. INSTEC was developed to effectively present the result of incident analysis. This system offers the analyzed information such as analysis results of human error cases, operating issues and problems, recommendations to prevent a similar incident, etc. 24 tabs., 18 figs., 10 refs. (Author).

  6. Medication incidents reported to an online incident reporting system.

    LENUS (Irish Health Repository)

    Alrwisan, Adel

    2011-01-15

    AIMS: Approximately 20% of deaths from adverse events are related to medication incidents, costing the NHS an additional £500 million annually. Less than 5% of adverse events are reported. This study aims to assess the reporting rate of medication incidents in NHS facilities in the north east of Scotland, and to describe the types and outcomes of reported incidents among different services. Furthermore, we wished to quantify the proportion of reported incidents according to the reporters\\' profession. METHODS: A retrospective description was made of medication incidents reported to an online reporting system (DATIX) over a 46-month-period (July 2005 to April 2009). Reports originated from acute and community hospitals, mental health, and primary care facilities. RESULTS: Over the study period there were 2,666 incidents reported with a mean monthly reporting rate of 78.2\\/month (SD±16.9). 6.1% of all incidents resulted in harm, with insulin being the most commonly implicated medication. Nearly three-quarters (74.2%, n=1,978) of total incidents originated from acute hospitals. Administration incidents were implicated in the majority of the reported medication incidents (59%), followed by prescribing (10.8%) and dispensing (9.9%), while the nondescript "other medication incidents" accounted for 20.3% of total incidents. The majority of reports were made by nursing and midwifery staff (80%), with medical and dental professionals reporting the lowest number of incidents (n=56, 2%). CONCLUSIONS: The majority of medication incidents in this study were reported by nursing and midwifery staff, and were due to administration incidents. There is a clear need to elucidate the reasons for the limited contribution of the medical and dental professionals to reporting medication incidents.

  7. JOURNAL CLUB: Evaluation of Near-Miss Wrong-Patient Events in Radiology Reports.

    Science.gov (United States)

    Sadigh, Gelareh; Loehfelm, Thomas; Applegate, Kimberly E; Tridandapani, Srini

    2015-08-01

    The purpose of this study was to estimate the prevalence of reported near-miss wrong-patient events in radiology at two large academic hospitals and its relation to imaging modality, clinical setting, and time of occurrence. An institutional imaging report database was searched for reports between January 1, 2009, and May 30, 2013, that contained the phrases "incorrect patient" or "wrong patient." These imaging reports were categorized into either mislabeled or misidentified patient or wrong dictation or report events. The mislabeling-misidentification events involved patients whose images were incorrectly placed in another patient's folder. In wrong dictation or report events, a patient's images were placed in the correct imaging folder, but another patient's images were used in error for dictation of the report. The time to detect each of these events was also evaluated. Overall, 67 eligible reports were identified among 1,717,713 examinations performed during the study period. The estimated event rate was 4 per 100,000 examinations (mislabeling-misidentification, 52%; wrong dictation, 48%). The monthly mean of mislabeling-misidentification events was 0.7 (SD, 0.9) and of wrong dictation events was 0.6 (SD, 0.7). The median time for mislabeling-misidentification reports to be identified was 22 hours and for wrong dictation reports was 0 hours. Portable chest radiography was the modality involved in 69% (24/35) of reported mislabeling-misidentification and 44% (14/32) of wrong dictation events (p = 0.08); 43% (15/35) of mislabeling-misidentification and 28% (9/32) of wrong dictation events occurred during off hours; 63% (22/35) of mislabeling-misidentification and 56% (18/32) of wrong dictation events occurred in the inpatient setting. Despite use of the dual-identifier technique mandated by The Joint Commission, the number of near-miss mislabeled patient events for imaging tests and the delay in awareness of these events were substantial, especially for

  8. Dietary Supplements: Knowledge and Adverse Event Reporting Among American Medical Society for Sports Medicine Physicians.

    Science.gov (United States)

    Pascale, Blaise; Steele, Clay; Attipoe, Selasi; OʼConnor, Francis G; Deuster, Patricia A

    2016-03-01

    Certain dietary supplements (DSs) used by military populations pose a threat to overall readiness. This study assessed members of the American Medical Society for Sports Medicine (AMSSM) regarding their knowledge of DS use among their patients and reporting of suspected adverse events. A thirteen-question retrospective, cross-sectional, Web-based survey sought data on practices regarding DSs and adverse event reporting. Anonymous Web-based survey. Military and civilian sports medicine physicians. The primary finding of the study was how frequently practitioners report adverse events associated with DS use. A total of 311 physicians responded to the survey. Only 51% of respondents had a reliable source for information on DS safety and 58% routinely discussed DS use with their patients. Although a majority (71%) of respondents had encountered adverse events associated with DS use, few of those (10%) confirmed reporting such events. Reasons that physicians did not report adverse events were lack of knowledge regarding where to report (68%), how to report (61%), and availability of time (9%). Our results indicate that some AMSSM physicians are familiar with DSs and have encountered adverse events associated with their use. However, reporting of these adverse events to the appropriate agency is minimal at best. The significant gaps in physician knowledge regarding how and where to report such events indicate a need to educate physicians on this subject. The findings of this survey indicate the need for provider education on reporting adverse events associated with DS use. Although reporting of adverse events is essential for removing harmful DSs from the market, a majority of physicians have limited knowledge on this issue. Moreover, the survey provides insight into the barriers to physician reporting of adverse events.

  9. Simulation of random events for adaptive control systems calibration

    Directory of Open Access Journals (Sweden)

    Drăgoi Mircea Viorel

    2017-01-01

    Full Text Available The paper deals with a mathematical model that simulates the random occurrence of events during cutting processes by milling. The evolution of certain parameters that typify the cutting processes depends on predictable and non-predictable variables. In this context, either the material hardness that varies in different sides of billet, or cutting depth, can act as non-predictable variables. In order to design a response in terms of cutting parameters to non-predictable variations of inputs, a simulation of such phenomena is very useful. A mathematical model that generates random events, both in terms of non-uniform frequency and intensity is here described. A virtual instrument built in LabVIEW generates (pseudo random events based on a combination of random numbers, as the evolution of the simulated process to be much like a real one. Furthermore the user of virtual instrument can generate himself events at certain moments and of certain intensity. This can be a useful tool to study the algorithms of designing the response which should re-balance the process within adaptive control systems.

  10. Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review.

    Science.gov (United States)

    Clarkson, Carl E; O'mahony, Deborah; Jones, Diana E

    2015-05-01

    Acupuncture within pregnancy has frequently been investigated, often finding this to be more effective than standard care. However, the adverse event severity, types and occurrence are unclear. To investigate the quality of reporting adverse events and to attempt to identify occurrence, type and severity of adverse events in acupuncture and non-acupuncture groups. MEDLINE, CINAHL, Allied and Complementary Medicine Database, and Physiotherapy Evidence Database (PEDro) were searched for relevant studies between 2000 and 2014. Seventeen studies using penetrating acupuncture and making comment on adverse events experienced were included. Quality appraisal of the selected publications was performed using either the PEDro scale or the Downs and Black checklist. Quality of reporting was evaluated against STRICTA and CONSORT guidelines, with data on adverse events extracted in accordance with CONSORT and Good Clinical Practice adverse event guidelines. Overall quality of reporting of adverse events was poor, with information describing the adverse events often lacking in detail. A number of trends were noted: adverse events occurring within a treatment session was 3-17% in the acupuncture groups and 4-25% in the non-acupuncture groups. The percentage of women affected by an adverse event was between 14 and 17% in the acupuncture groups and between 15 and 19% in non-acupuncture groups. Adverse event reporting within acupuncture trials is generally poor. The trends noted were that adverse events do occur, but would appear to be largely minor and comparable to non-acupuncture-related interventions. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  11. The metoclopramide black box warning for tardive dyskinesia: effect on clinical practice, adverse event reporting, and prescription drug lawsuits.

    Science.gov (United States)

    Ehrenpreis, Eli D; Deepak, Parakkal; Sifuentes, Humberto; Devi, Radha; Du, Hongyan; Leikin, Jerrold B

    2013-06-01

    We examined the effects of the black box warning about the risk of tardive dyskinesia (TD) with chronic use of metoclopramide on management of gastroparesis within a single clinical practice, and on reporting of adverse events. Medical records of gastroparesis patients were evaluated for physician management choices. The FDA Adverse Event Reporting System (FAERS) was analyzed for event reports, and for lawyer-initiated reports, with metoclopramide from 2004 to 2010. Google Scholar was searched for court opinions against metoclopramide manufacturers. Before the black box warning, 69.8% of patients received metoclopramide for gastroparesis, compared with 23.7% after the warning. Gastroenterologists prescribed domperidone more often after than before the warning. Metoclopramide prescriptions decreased after 2008. Adverse event reporting increased after the warning. Only 3.6% of all FAERS reports but 70% of TD reports were filed by lawyers, suggesting a distortion in signal. Forty-seven legal opinions were identified, 33 from 2009-2010. The black box warning for metoclopramide has decreased its usage and increased its rate of adverse event reporting. Lawyer-initiated reports of TD hinder pharmacovigilance.

  12. Dansgaard–Oeschger events: bifurcation points in the climate system

    Directory of Open Access Journals (Sweden)

    A. A. Cimatoribus

    2013-02-01

    Full Text Available Dansgaard–Oeschger events are a prominent mode of variability in the records of the last glacial cycle. Various prototype models have been proposed to explain these rapid climate fluctuations, and no agreement has emerged on which may be the more correct for describing the palaeoclimatic signal. In this work, we assess the bimodality of the system, reconstructing the topology of the multi-dimensional attractor over which the climate system evolves. We use high-resolution ice core isotope data to investigate the statistical properties of the climate fluctuations in the period before the onset of the abrupt change. We show that Dansgaard–Oeschger events have weak early warning signals if the ensemble of events is considered. We find that the statistics are consistent with the switches between two different climate equilibrium states in response to a changing external forcing (e.g. solar, ice sheets, either forcing directly the transition or pacing it through stochastic resonance. These findings are most consistent with a model that associates Dansgaard–Oeschger with changing boundary conditions, and with the presence of a bifurcation point.

  13. A Specification Patterns System for Discrete Event Systems Analysis

    Directory of Open Access Journals (Sweden)

    Jose Creissac Campos

    2013-08-01

    Full Text Available As formal verification tools gain popularity, the problem arises of making them more accessible to engineers. A correct understanding of the logics used to express the properties of a system's behaviour is needed in order to guarantee that properties correctly encode the intent of the verification process. Writing appropriate properties, in a logic suitable for verification, is a skilful process. Errors in this step of the process can create serious problems since a false sense of safety is gained from the analysis. However, when compared to the effort put into developing and applying modelling languages, little attention has been devoted to the process of writing properties that accurately capture verification requirements. In this paper we illustrate how a collection of property patterns can help in simplifying the process of generating logical formulae from informally expressed requirements.

  14. Elaborative Talk During and After an Event: Conversational Style Influences Children’s Memory Reports

    OpenAIRE

    Hedrick, Amy M.; Haden, Catherine A.; Ornstein, Peter A.

    2009-01-01

    An experimental design was utilized to examine the effects of elaborative talk during and/or after an event on children’s event memory reports. Sixty preschoolers were assigned randomly to one of four conditions that varied according to a researcher’s use of high or low elaborative during- and/or post-event talk about a camping event. In a memory conversation 1 day after the event, children who were engaged in high elaborative during-event talk and those whose memory conversation featured hig...

  15. Adverse Event Reporting and Quality Improvement in the Intensive Care Unit.

    Science.gov (United States)

    Heavner, Jason J; Siner, Jonathan M

    2015-09-01

    Patients in the intensive care unit are at high risk for experiencing adverse events and errors. The high-acuity health care needs of these vulnerable patients expose them to numerous medications, procedures, and health care providers. The occurrence of adverse events is associated with detriments to patient outcomes including increased mortality. Adverse event reporting is the most commonly used event-detection tool, but it should also be complimented with other tools such as trigger tools, chart review, and direct observation. Although adverse event reporting is essential for continuous improvement processes and is associated with improvements in safety culture, it remains significantly underutilized. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse......,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though...... this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat...

  17. Events

    Directory of Open Access Journals (Sweden)

    Igor V. Karyakin

    2015-12-01

    Full Text Available On the April 8-10 of 2014 an International Conference “Birds of Prey in the North Caucasus and Adjacent Regions: distribution, ecology, population dynamics, protection” was held in Sochi National Park, Sochi, Russia. The Saker Falcon Falco cherrug Global Action Plan (SakerGAP has been presented at the 11th Meeting of the Parties of the Bonn Convention (CMS, which took place in Quito (Ecuador on 4-9 November 2014. On the December 17 of 2014 a meeting between inspectors of Nature Reserve “Khakasskiy”, police of Khakasia Republic and experts of Siberian Environmental Center was held in the Nature Reserve “Khakasskiy”. On the December 20 of 2014 an annual meeting of members of Siberian Environmental Center (SEC was held in Akademgorodok, Novosibirsk, Russia. Project leaders presented reports on the main activities and achievements gained in 2014. The Long-eared Owl (Asio otus became the Bird of the Year announced by the public organization "APB-BirdLife Belarus". The 9th ARRCN Symposium 2015 will be held during 21st–25th October 2015 at the Novotel Hotel, Chumphon, Thailand, one of the most favored travel destinations in Asia.

  18. 17th East European Conference on Advances in Databases and Information Systems and Associated Satellite Events

    CERN Document Server

    Cerquitelli, Tania; Chiusano, Silvia; Guerrini, Giovanna; Kämpf, Mirko; Kemper, Alfons; Novikov, Boris; Palpanas, Themis; Pokorný, Jaroslav; Vakali, Athena

    2014-01-01

    This book reports on state-of-art research and applications in the field of databases and information systems. It includes both fourteen selected short contributions, presented at the East-European Conference on Advances in Databases and Information Systems (ADBIS 2013, September 1-4, Genova, Italy), and twenty-six papers from ADBIS 2013 satellite events. The short contributions from the main conference are collected in the first part of the book, which covers a wide range of topics, like data management, similarity searches, spatio-temporal and social network data, data mining, data warehousing, and data management on novel architectures, such as graphics processing units, parallel database management systems, cloud and MapReduce environments. In contrast, the contributions from the satellite events are organized in five different parts, according to their respective ADBIS satellite event: BiDaTA 2013 - Special Session on Big Data: New Trends and Applications); GID 2013 – The Second International Workshop ...

  19. Rare events and phase transitions in reaction-diffusion systems

    Science.gov (United States)

    Elgart, Vlad

    The last decade witnessed a rapid growth of interest in reaction-diffusion models. Such models are employed for the description of phenomena ranging from the kinetics of chemical reactions to the evolution of biological populations. Reaction-diffusion (RD) systems provide a way to translate local assumptions about movement, mortality and reproduction of individuals into global conclusions about the persistence or extinction of populations. Recently, RD models in low dimensions have been investigated extensively with an emphasis on fluctuation-dominated effects, specifically, the breakdown of the standard chemical rate equations which correspond to the "mean-field" approximation of reaction kinetics. Recent interest has been largely focused on the description of dynamical phase transitions in reaction-diffusion systems. An important example is the absorbing phase transitions. Upon such a transition the system goes from an active ("living") state to an absorbing ("dead") state with no escape from it. We explore a broad class of single species models, trying to quantitatively estimate various aspects of reaction kinetics. Among the questions we have been studying are estimates of rare events probabilities and classification of absorbing phase transitions. We develop a rigorous, simple, and efficient method to calculate the rare event statistics in reaction-diffusion systems. To this end, we develop a Hamiltonian formulation of reaction-diffusion dynamics. Although the system is specified by a set of rules, rather than a Hamiltonian, one may nevertheless show that there is a certain canonical Hamiltonian associated with the systems dynamics. As for absorbing phase transitions, we suggest a simple scheme, making it possible to have, at least, an educated guess regarding the universality class of a reaction-diffusion model at hand. The scheme is based on the topology of phase portraits of the system's Hamiltonian.

  20. Adverse events associated with yoga: a systematic review of published case reports and case series.

    Science.gov (United States)

    Cramer, Holger; Krucoff, Carol; Dobos, Gustav

    2013-01-01

    While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopenia. Pranayama, hatha yoga, and Bikram yoga were the most common yoga practices; headstand, shoulder stand, lotus position, and forceful breathing were the most common yoga postures and breathing techniques cited. Twenty-seven adverse events (35.5%) affected the musculoskeletal system; 14 (18.4%) the nervous system; and 9 (11.8%) the eyes. Fifteen cases (19.7%) reached full recovery; 9 cases (11.3%) partial recovery; 1 case (1.3%) no recovery; and 1 case (1.3%) died. As any other physical or mental practice, yoga should be practiced carefully under the guidance of a qualified instructor. Beginners should avoid extreme practices such as headstand, lotus position and forceful breathing. Individuals with medical preconditions should work with their physician and yoga teacher to appropriately adapt postures; patients with glaucoma should avoid inversions and patients with compromised bone should avoid forceful yoga practices.

  1. Adverse events associated with yoga: a systematic review of published case reports and case series.

    Directory of Open Access Journals (Sweden)

    Holger Cramer

    Full Text Available While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopenia. Pranayama, hatha yoga, and Bikram yoga were the most common yoga practices; headstand, shoulder stand, lotus position, and forceful breathing were the most common yoga postures and breathing techniques cited. Twenty-seven adverse events (35.5% affected the musculoskeletal system; 14 (18.4% the nervous system; and 9 (11.8% the eyes. Fifteen cases (19.7% reached full recovery; 9 cases (11.3% partial recovery; 1 case (1.3% no recovery; and 1 case (1.3% died. As any other physical or mental practice, yoga should be practiced carefully under the guidance of a qualified instructor. Beginners should avoid extreme practices such as headstand, lotus position and forceful breathing. Individuals with medical preconditions should work with their physician and yoga teacher to appropriately adapt postures; patients with glaucoma should avoid inversions and patients with compromised bone should avoid forceful yoga practices.

  2. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    Directory of Open Access Journals (Sweden)

    Aditi Anand Apte

    2016-01-01

    Full Text Available Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders.

  3. Deficiency Report Management System

    Science.gov (United States)

    1989-09-28

    The Customer Feedback Office of the Product Assurance Directorate, MICOM has the mission to manage and analyze data in the Deficiency Reporting...capability within the Customer Feedback Office (CFO) of the MICOM Product Assurance Directorate for government comment. The objective of this program is

  4. Reporting of unintended events in an intensive care unit: comparison between staff and observer

    Directory of Open Access Journals (Sweden)

    Verri Marco

    2005-05-01

    Full Text Available Abstract Background In order to identify relevant targets for change, it is essential to know the reliability of incident staff reporting. The aim of this study is to compare the incidence and type of unintended events (UE reported by facilitated Intensive Care Unit (ICU staff with those recorded concurrently by an observer. Methods The study is a prospective data collection performed in two 4-bed multidisciplinary ICUs of a teaching hospital. The format of the UE reporting system was voluntary, facilitated and not necessarily anonymous, and used a structured form with a predetermined list of items. UEs were reported by ICU staff over a period of 4 weeks. The reporting incidence during the first fourteen days was compared with that during the second fourteen. During morning shifts in the second fourteen days, one observer in each ICU recorded any UE seen. The staff was not aware of the observers' study. The incidence of UEs reported by staff was compared with that recorded by the observers. Results The staff reported 36 UEs in the first fourteen days and 31 in the second.. The incidence of UE detection during morning shifts was significantly higher than during afternoon or night shifts (p Conclusion UE incidence is strongly underreported by staff in comparison with observers. Also the types of UEs reported are different. Invaluable information about incidents in ICU can be obtained in a few days by observer monitoring.

  5. Nonstochastic Analysis of Manufacturing Systems Using Timed-Event Graphs

    DEFF Research Database (Denmark)

    Hulgaard, Henrik; Amon, Tod

    1996-01-01

    Using automated methods to analyze the temporal behavior ofmanufacturing systems has proven to be essential and quite beneficial.Popular methodologies include Queueing networks, Markov chains,simulation techniques, and discrete event systems (such as Petrinets). These methodologies are primarily......, which we argue can be useful for verifying{\\em correct} operation. We model manufacturing systems using timedevent graphs which are similar to decision free Petri nets augmentedwith timing information, and present an example that demonstratesthe efficacy of non-stochastic analysis....... stochastic. Performanceevaluation mandates results which are probabilistic in nature (such asthe average rate of part deliveries) and relies on probabilisticinputs (such as the probability of breakdown, or the distributionsassociated with a manufacturing process). This paper examinesnon-stochastic analysis...

  6. Contractor Performance Assessment Reporting System

    Data.gov (United States)

    US Agency for International Development — CPARS is a web-based system used to input data on contractor performance. Reports from the system are used as an aid in awarding contracts to contractors that...

  7. WHO Efforts to Promote Reporting of Adverse Events and Global Learning

    Science.gov (United States)

    Larizgoitia, Itziar; Bouesseau, Marie-Charlotte; Kelley, Edward

    2013-01-01

    Despite the importance of reporting systems to learn about the casual chain and consequences of patient safety incidents, this is an area that requires of further conceptual and technical developments to conduce reporting to effective learning. The World Health Organization, through its Patient Safety Programme, adopted as a priority the objective to facilitate and stimulate global learning through enhanced reporting of patient safety incidents. Landmark developments were the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, and the Conceptual Framework for the International Classification for Patient Safety, as well as the Global Community of Practice for Reporting and Learning Systems. WHO is currently working with a range of scientists, medical informatics specialists and healthcare officials from various countries around the world, to arrive at a Minimal Information Model that could serve as a basis to structure the core of reporting systems in a comparable manner across the world. Undoubtedly, there is much need for additional scientific developments in this challenging and innovative area. For effective reporting systems and enhanced global learning, other key contextual factors are essential for reporting to serve to the needs of clinicians, patients and the healthcare system at large. Moreover, the new data challenges and needs of organizations must be assessed as the era of big data comes to heath care. These considerations delineate a broad agenda for action, which offer an ambitious challenge for WHO and their partners interested in strengthening learning for improving through reporting and communicating about patient safety incidents. Significance for public health Understanding the causes and consequences of incidents is cornerstone for patient safety improvement. Likewise, setting up systems to facilitate such understanding and communicate the learning across all healthcare actors is crucial. Over the past decade, the World Health

  8. Venous and Arterial Thrombotic Events in Systemic Lupus Erythematosus.

    Science.gov (United States)

    Hinojosa-Azaola, Andrea; Romero-Diaz, Juanita; Vargas-Ruiz, Angel Gabriel; Nuñez-Alvarez, Carlos A; Cicero-Casarrubias, Alba; Ocampo-Torres, Mario C; Sanchez-Guerrero, Jorge

    2016-03-01

    The incidence of thrombosis in patients with systemic lupus erythematosus (SLE) is 25 to 50-fold higher than in the general population; we aimed to define the characteristics of venous thrombotic events (VTE) and arterial thrombotic events (ATE) to identify the patients at highest risk. The study included 219 patients with recent-onset SLE. At baseline, standardized medical history and laboratory tests were done. Followup visits occurred quarterly, and information about damage accrual, comorbidities, and cardiovascular risk factors was updated annually. Main outcome was development of TE after SLE diagnosis. Thirty-five patients (16%) developed TE (27 VTE, 8 ATE) during 5.21 years of followup; incidence rate 31/1000 patient-years. Most events (57%) developed within the first year of diagnosis, and 69% were not associated with lupus anticoagulant (LAC), determined with 1 method. VTE developed earlier than ATE (2.0 vs 57.5 mos, p = 0.02). In the multivariate analysis, variables preceding VTE included cutaneous vasculitis, nephrotic syndrome, dose of prednisone, and LAC in combination with anti-RNP/Sm antibodies (p LAC in combination with anti-RNP/Sm antibodies was associated with VTE and improved the accuracy for predicting it. Our study suggests that in SLE, VTE and ATE have different risk factors. Understanding these differences is helpful for identifying patients at highest risk. The use of LAC plus anti-RNP/Sm for predicting VTE deserves further study.

  9. Risk evaluation system for operational events and inspection findings

    Energy Technology Data Exchange (ETDEWEB)

    Lopez G, A.; Godinez S, V.; Lopez M, R., E-mail: alopezg@cnsns.gob.m [Comision Nacional de Seguridad Nuclear y Salvaguardias, Dr. Barragan No. 779, Col. Narvarte, 03020 Mexico D. F. (Mexico)

    2010-10-15

    The Mexican Nuclear Regulatory Commission has developed an adaptation of the US NRC Significance Determination Process (SDP) to evaluate the risk significance of operational events and inspection findings in Laguna Verde nuclear power plant. The Mexican Nuclear Regulatory Commission developed a plant specific flow chart for preliminary screening instead of the open questionnaire used by the US NRC-SDP, with the aim to improve the accuracy of the screening process. Also, the work sheets and support information tables required by the SDP were built up in an Excel application which allows to perform the risk evaluation in an automatic way, focusing the regulator staff efforts in the risk significance analysis instead of the risk calculation tasks. In order to construct this tool a simplified PRA model was developed and validated with the individual plant examination model. This paper shows the Mexican Nuclear Regulatory Commission process and some risk events evaluations performed using the Risk Evaluation System for Operational Events and Inspection Findings (SERHE, by its acronyms in Spanish). (Author)

  10. 77 FR 21776 - Announcement of Requirements and Registration for “Reporting Patient Safety Events Challenge”

    Science.gov (United States)

    2012-04-11

    ... HUMAN SERVICES Announcement of Requirements and Registration for ``Reporting Patient Safety Events...: Notice. SUMMARY: Patient Safety Organizations (PSOs) listed by the Agency for Healthcare Research and... to do root cause analyses and follow-up. The ``Reporting Patient Safety Events Challenge'' asks multi...

  11. Guidelines for submitting adverse event reports for publication

    NARCIS (Netherlands)

    Kelly, William; Arellano, Felix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina; Freedman, Stephen; Goldsmith, David; Huang, Kui; Jones, Judith; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William; van Puijenbroek, Eugène; Williams, Frank; Wise, Robert

    2009-01-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these

  12. The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review.

    Science.gov (United States)

    Gorrell, Lindsay M; Engel, Roger M; Brown, Benjamin; Lystad, Reidar P

    2016-09-01

    Spinal manipulative therapy (SMT) is commonly used to treat spinal disorders. Although clinical practice guidelines recommend the use of SMT in the treatment of neck and back disorders, concerns exist about the nature and incidence of adverse events associated with the intervention. Comprehensive reporting of adverse events in clinical trials could allow for accurate incidence estimates through meta-analysis. However, it is not clear if randomized clinical trials (RCTs) that involve SMT are currently reporting adverse events adequately. This study aimed to describe the extent of adverse events reporting in published RCTs involving SMT, and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement. This is a systematic literature review. The Physiotherapy Evidence Database (PEDro) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analyzed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analyzed using tests for equality of proportions with continuity correction. There was no funding obtained for this study. The authors declare no conflict of interest. Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events

  13. Neuropsychiatric events in systemic lupus erythematosus: attribution and clinical significance.

    Science.gov (United States)

    Hanly, John G; McCurdy, Grace; Fougere, Lisa; Douglas, Jo-Anne; Thompson, Kara

    2004-11-01

    To describe the range and attribution of neuropsychiatric (NP) disease in an unselected cohort of patients with systemic lupus erythematosus (SLE) and to examine the association with cumulative organ damage, medication use, and quality of life. One hundred eleven patients with SLE in a single referral center were studied. NP syndromes were defined using the American College of Rheumatology (ACR) nomenclature and case definitions. Overall disease activity was measured by the SLE Disease Activity Index (SLEDAI); cumulative organ damage was determined by the ACR/SLICC damage index; and quality of life by the SF-36. Patients' mean age was 44.7 years, 87% were female, and 92% were Caucasian. The mean (+/- SE) disease duration was 10.1 +/- 0.7 years. A total of 74 NP events were identified in 41 of 111 (37%) patients. Thirteen of the 19 ACR NP syndromes were identified and 2 or more NP manifestations occurred in 56% of patients. Central nervous system manifestations accounted for 92% of the events compared to involvement of the peripheral nervous system in 8%. Thirty-five (47%) of these events were attributed entirely to SLE, 30 (41%) were attributed exclusively to non-SLE factors, and in the remaining 9 events (12%) both SLE and non-SLE factors were felt to be contributory. Cumulative organ damage was higher in patients with NP disease, although this was not statistically significant and they were more likely to have received prednisone or immunosuppressive drugs (p attribution of NP disease. In contrast, the occurrence of renal disease in the same cohort of patients was not associated with lower SF-36 scores or fatigue. In patients with SLE, NP disease has diverse manifestations and can be attributed to lupus in roughly half of the cases. The occurrence of NP disease is associated with more frequent use of corticosteroids and immunosuppressive drugs. In contrast to other serious manifestations of SLE, such as renal disease, NP disease is associated with a significant

  14. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

    2017-12-01

    Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

  15. VA Suicide Prevention Applications Network: A National Health Care System-Based Suicide Event Tracking System.

    Science.gov (United States)

    Hoffmire, Claire; Stephens, Brady; Morley, Sybil; Thompson, Caitlin; Kemp, Janet; Bossarte, Robert M

    2016-11-01

    The US Department of Veterans Affairs' Suicide Prevention Applications Network (SPAN) is a national system for suicide event tracking and case management. The objective of this study was to assess data on suicide attempts among people using Veterans Health Administration (VHA) services. We assessed the degree of data overlap on suicide attempters reported in SPAN and the VHA's medical records from October 1, 2010, to September 30, 2014-overall, by year, and by region. Data on suicide attempters in the VHA's medical records consisted of diagnoses documented with E95 codes from the International Classification of Diseases, Ninth Revision. Of 50 518 VHA patients who attempted suicide during the 4-year study period, data on fewer than half (41%) were reported in both SPAN and the medical records; nearly 65% of patients whose suicide attempt was recorded in SPAN had no data on attempted suicide in the VHA's medical records. Evaluation of administrative data suggests that use of SPAN substantially increases the collection of data on suicide attempters as compared with the use of medical records alone, but neither SPAN nor the VHA's medical records identify all suicide attempters. Further research is needed to better understand the strengths and limitations of both systems and how to best combine information across systems.

  16. SENTINEL EVENTS

    Directory of Open Access Journals (Sweden)

    Andrej Robida

    2004-09-01

    Full Text Available Background. The Objective of the article is a two year statistics on sentinel events in hospitals. Results of a survey on sentinel events and the attitude of hospital leaders and staff are also included. Some recommendations regarding patient safety and the handling of sentinel events are given.Methods. In March 2002 the Ministry of Health introduce a voluntary reporting system on sentinel events in Slovenian hospitals. Sentinel events were analyzed according to the place the event, its content, and root causes. To show results of the first year, a conference for hospital directors and medical directors was organized. A survey was conducted among the participants with the purpose of gathering information about their view on sentinel events. One hundred questionnaires were distributed.Results. Sentinel events. There were 14 reports of sentinel events in the first year and 7 in the second. In 4 cases reports were received only after written reminders were sent to the responsible persons, in one case no reports were obtained. There were 14 deaths, 5 of these were in-hospital suicides, 6 were due to an adverse event, 3 were unexplained. Events not leading to death were a suicide attempt, a wrong side surgery, a paraplegia after spinal anaesthesia, a fall with a femoral neck fracture, a damage of the spleen in the event of pleural space drainage, inadvertent embolization with absolute alcohol into a femoral artery and a physical attack on a physician by a patient. Analysis of root causes of sentinel events showed that in most cases processes were inadequate.Survey. One quarter of those surveyed did not know about the sentinel events reporting system. 16% were having actual problems when reporting events and 47% beleived that there was an attempt to blame individuals. Obstacles in reporting events openly were fear of consequences, moral shame, fear of public disclosure of names of participants in the event and exposure in mass media. The majority of

  17. [Alcohol use and self-reported violent events in Chile].

    Science.gov (United States)

    Castillo-Carniglia, Álvaro; Pizarro, Esteban; Luengo, Daniela; Soto-Brandt, Gonzalo

    2014-01-01

    The objective is to examine the association between binge drinking and frequency of alcohol consumption during the last month with self-reported episodes of violence committed by people under the influence of alcohol or other drugs. We carried out a cross-sectional study that uses data from the National Survey on Drug Use on the General Population of Chile of 2010. A sample of 16,000 subjects, from 12 to 64 years of age (mean 35.8 years), representing a population of 9,536,602 individuals (49.5% men and 50.5% women) was used. The dependent variables were: being a victim of assault, aggression or sexual violence. The independent variables were: binge drinking (six or more drinks on one occasion at least once in the month) and the monthly frequency of alcohol consumption. The adjusted prevalence ratio (PR) for men reporting binge drinking (vs. negative reporting) was of 1.85 (95% CI: 1.28 to 2.66) for assault, 2.0 for aggression (1.40 to 2.66), and 1.35 for sexual violence (0.43 to 4.23). Among women, the PR was 2.08 (0.97 to 4.50), 1.61 (0.78 to 3.35) and 1.37 times (0.48 to 3.91), respectively. Regarding the frequency of alcohol use, for each day a month of alcohol consumption the PR increases significantly for aggression among men and for the three victimization variables among women. Men and women who reported frequent alcohol consumption and/or binge drinking had significantly a higher prevalence of episodes of aggression, assault or sexual violence; compared to those who did not report these consumption patterns.

  18. Bridging data models and terminologies to support adverse drug event reporting using EHR data.

    Science.gov (United States)

    Declerck, G; Hussain, S; Daniel, C; Yuksel, M; Laleci, G B; Twagirumukiza, M; Jaulent, M-C

    2015-01-01

    This article is part of the Focus Theme of METHODs of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". SALUS project aims at building an interoperability platform and a dedicated toolkit to enable secondary use of electronic health records (EHR) data for post marketing drug surveillance. An important component of this toolkit is a drug-related adverse events (AE) reporting system designed to facilitate and accelerate the reporting process using automatic prepopulation mechanisms. To demonstrate SALUS approach for establishing syntactic and semantic interoperability for AE reporting. Standard (e.g. HL7 CDA-CCD) and proprietary EHR data models are mapped to the E2B(R2) data model via SALUS Common Information Model. Terminology mapping and terminology reasoning services are designed to ensure the automatic conversion of source EHR terminologies (e.g. ICD-9-CM, ICD-10, LOINC or SNOMED-CT) to the target terminology MedDRA which is expected in AE reporting forms. A validated set of terminology mappings is used to ensure the reliability of the reasoning mechanisms. The percentage of data elements of a standard E2B report that can be completed automatically has been estimated for two pilot sites. In the best scenario (i.e. the available fields in the EHR have actually been filled), only 36% (pilot site 1) and 38% (pilot site 2) of E2B data elements remain to be filled manually. In addition, most of these data elements shall not be filled in each report. SALUS platform's interoperability solutions enable partial automation of the AE reporting process, which could contribute to improve current spontaneous reporting practices and reduce under-reporting, which is currently one major obstacle in the process of acquisition of pharmacovigilance data.

  19. LCLS XTOD Attenuator System System Concept Report

    Energy Technology Data Exchange (ETDEWEB)

    Kishiyama, K; Roeben, M; Trent, J; Ryutov, D; Shen, S

    2006-04-12

    The attenuator system for the Linac Coherent Light Source (LCLS) X-ray Transport, Optics and Diagnostics (XTOD) system has been configured and analyzed by the Lawrence Livermore National Laboratory's New Technologies Engineering Division (NTED) as requested by the SLAC/LCLS program. The system layout, performance analyses and selection of the vacuum components are presented in this System Conceptual Review (SCR) report. Also included are the plans for prototype, procurement, mechanical integration, and the cost estimates.

  20. Online surveillance of media health event reporting in Nepal: digital disease detection from a One Health perspective.

    Science.gov (United States)

    Schwind, Jessica S; Norman, Stephanie A; Karmacharya, Dibesh; Wolking, David J; Dixit, Sameer M; Rajbhandari, Rajesh M; Mekaru, Sumiko R; Brownstein, John S

    2017-09-21

    Traditional media and the internet are crucial sources of health information. Media can significantly shape public opinion, knowledge and understanding of emerging and endemic health threats. As digital communication rapidly progresses, local access and dissemination of health information contribute significantly to global disease detection and reporting. Health event reports in Nepal (October 2013-December 2014) were used to characterize Nepal's media environment from a One Health perspective using HealthMap - a global online disease surveillance and mapping tool. Event variables (location, media source type, disease or risk factor of interest, and affected species) were extracted from HealthMap. A total of 179 health reports were captured from various sources including newspapers, inter-government agency bulletins, individual reports, and trade websites, yielding 108 (60%) unique articles. Human health events were reported most often (n = 85; 79%), followed by animal health events (n = 23; 21%), with no reports focused solely on environmental health. By expanding event coverage across all of the health sectors, media in developing countries could play a crucial role in national risk communication efforts and could enhance early warning systems for disasters and disease outbreaks.

  1. Water Fluoridation Reporting System (Public Water Systems)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Water Fluoridation Reporting System (WFRS) has been developed to provide tools to assist states in managing fluoridation programs. WFRS is designed to track all...

  2. Differences in Adverse Event Reporting Rates of Therapeutic Failure Between Two Once-daily Extended-release Methylphenidate Medications in Canada: Analysis of Spontaneous Adverse Event Reporting Databases.

    Science.gov (United States)

    Park-Wyllie, Laura; van Stralen, Judy; Castillon, Genaro; Sherman, Stephen E; Almagor, Doron

    2017-10-01

    Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, methylphenidate ER-C), which was approved for marketing in Canada based on bioequivalence to OROS methylphenidate. This study was initiated following reports that some US-marketed generic methylphenidate ER products had substantially higher reporting rates of therapeutic failure than did the referenced brands. Through methodology similar to that used by the US Food and Drug Administration to investigate the issue with the US-marketed generic, reporting rates were calculated from cases of therapeutic failure identified in the Canadian Vigilance Adverse Reaction Online database for a 1-year period beginning 8 months after each product launch. Corresponding population exposure was estimated from the number of tablets dispensed. An in-depth analysis of narratives of individual case safety reports (ICSRs) with the use of the generic product was conducted in duplicate by 2 physicians to assess causality and to characterize the potential safety risk and clinical pattern of therapeutic failure. Similar secondary analyses were conducted on the US-marketed products. Reporting rates of therapeutic failure with the use of methylphenidate ER-C (generic) and OROS methylphenidate (brand name) were 411.5 and 37.5 cases per 100,000 patient-years, respectively (reporting rate ratio, 10.99; 95% CI, 5.93-22.21). In-depth analysis of narratives of 230 ICSRs of therapeutic failure with the Canadian-marketed generic determined that all ICSRs were either probably (60 [26%]) or possibly (170 [74%]) causally related to methylphenidate ER-C. Clinical symptoms suggestive of overdose were present in 31 reports of loss of efficacy (13.5%) and occurred primarily in the morning, and

  3. NASA Aviation Safety Reporting System (ASRS)

    Science.gov (United States)

    Connell, Linda J.

    2017-01-01

    The NASA Aviation Safety Reporting System (ASRS) collects, analyzes, and distributes de-identified safety information provided through confidentially submitted reports from frontline aviation personnel. Since its inception in 1976, the ASRS has collected over 1.4 million reports and has never breached the identity of the people sharing their information about events or safety issues. From this volume of data, the ASRS has released over 6,000 aviation safety alerts concerning potential hazards and safety concerns. The ASRS processes these reports, evaluates the information, and provides selected de-identified report information through the online ASRS Database at http:asrs.arc.nasa.gov. The NASA ASRS is also a founding member of the International Confidential Aviation Safety Systems (ICASS) group which is a collection of other national aviation reporting systems throughout the world. The ASRS model has also been replicated for application to improving safety in railroad, medical, fire fighting, and other domains. This presentation will discuss confidential, voluntary, and non-punitive reporting systems and their advantages in providing information for safety improvements.

  4. Adolescent inpatient girls’ report of dependent life events predicts prospective suicide risk

    Science.gov (United States)

    Stone, Lindsey Beth; Liu, Richard; Yen, Shirley

    2014-01-01

    Adolescents with a history of suicidal behavior are especially vulnerable for future suicide attempts, particularly following discharge from an inpatient psychiatric admission. This study is the first to test whether adolescents’ tendency to generate stress, or report more dependent events to which they contributed, was predictive of prospective suicide events. Ninety adolescent psychiatric inpatients who were admitted for recent suicide risk, completed diagnostic interviews, assessments of history of suicidal behavior, and a self-report questionnaire of major life events at baseline. Participants were followed over the subsequent 6 months after discharge to assess stability vs. onset of suicide events. Cox proportional hazard regressions were used to predict adolescents’ time to suicide events. Results supported hypothesis, such that only recent greater dependent events, not independent or overall events, predicted risk for prospective suicide events. This effect was specific to adolescent girls. Importantly, dependent events maintained statistical significance as a predictor of future suicide events after co-varying for the effects of several established risk factors and psychopathology. Results suggest that the tendency to generate dependent events may contribute unique additional prediction for adolescent girls’ prospective suicide risk, and highlight the need for future work in this area. PMID:24893759

  5. Adolescent inpatient girls׳ report of dependent life events predicts prospective suicide risk.

    Science.gov (United States)

    Stone, Lindsey B; Liu, Richard T; Yen, Shirley

    2014-09-30

    Adolescents with a history of suicidal behavior are especially vulnerable for future suicide attempts, particularly following discharge from an inpatient psychiatric admission. This study is the first to test whether adolescents׳ tendency to generate stress, or report more dependent events to which they contributed, was predictive of prospective suicide events. Ninety adolescent psychiatric inpatients who were admitted for recent suicide risk, completed diagnostic interviews, assessments of history of suicidal behavior, and a self-report questionnaire of major life events at baseline. Participants were followed over the subsequent 6 months after discharge to assess stability vs. onset of suicide events. Cox proportional hazard regressions were used to predict adolescents׳ time to suicide events. Results supported hypothesis, such that only recent greater dependent events, not independent or overall events, predicted risk for prospective suicide events. This effect was specific to adolescent girls. Importantly, dependent events maintained statistical significance as a predictor of future suicide events after co-varying for the effects of several established risk factors and psychopathology. Results suggest that the tendency to generate dependent events may contribute unique additional prediction for adolescent girls׳ prospective suicide risk, and highlight the need for future work in this area. Published by Elsevier Ireland Ltd.

  6. Increased use in propofol and reported patterns of adverse events among anesthetics in Korea.

    Science.gov (United States)

    Park, Hyo-Ju; Shin, Ju-Young; Kim, Mi-Hee; Park, Byung-Joo

    2015-04-01

    Propofol is an addictive drug, and the problem of its abuse and dependence has occurred. To compare the safety profiles of propofol and other similar anesthetics such as diazepam, lorazepam, and midazolam, we evaluated their uses and related adverse drug reactions (ADRs) using Korean Adverse Event Reporting System (KAERS) data. The domestic consumption data and the ADR reports of four anesthetics from 2008 to 2012 were retrieved. ADR proportions were calculated using defined daily dose/1000 inhabitants/day (DID) for the denominator. The patient's characteristics were compared among the four drugs statistically, and the types of ADRs were analyzed. The consumption and ADR reports increased during the study period, particularly in the cases of propofol and midazolam. Lorazepam showed the highest overall and serious ADR proportions (220.81 reports/DID, 58.47 reports/DID, respectively); however, with respect to death proportion, propofol was the first (19.21 reports/DID). Also, ADRs related to drug addiction were mainly observed in the propofol group. Four anesthetics were different with regard to the consumption and proportion or the type of ADRs. The use of propofol increased more than 2 times, and propofol showed the highest ADR proportions in death and drug addiction cases among the four anesthetics. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Defining and representing events in a satellite scheduling system - The IEPS (Interactive Experimenter Planning System) approach

    Science.gov (United States)

    Mclean, David R.; Littlefield, Ronald G.; Macoughtry, William O.

    1987-01-01

    A methodology is described for defining and representing satellite events from the IEPS perspective. The task of doing this is divided into four categories and includes defining and representing resource windows, event parameters, event scheduling strategies, and event constraints. The description of each of these categories includes examples from the IEPS ERBS-TDRSS Contact Planning System. This is a system which is being used by the Earth Radiation Budget Satellite (ERBS) schedulers to request TDRSS contact times from the NCC. The system is written in the C programming language and uses a custom built inference engine (TIE1) to do constraint checking and a custom built strategies interpreter to derive the plan. The planning system runs on the IBM-PC/AT or on any similar hardware which has a C development environment and 640K of memory.

  8. Adverse Events Following Immunisation under the National Vaccination Programme of the Netherlands Number X - Reports in 2003

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Maas NAT van der; Wesselo C; Dzaferagic A; Phaff TAJ; CIE

    2005-01-01

    Adverse events following immunisation (AEFI) in the National Vaccination Programme of the Netherlands (RVP) have been monitored through an enhanced passive surveillance system by RIVM since 1962. Until 2003 evaluation is done in close collaboration with the Health Council from 1984 onwards. Reports

  9. Adverse Events Following Immunisation under the National Vaccination Programme of The Netherlands Number IX - Reports in 2002

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Maas NAT van der; Wesselo C; Dzaferagic A; Phaff TAJ; LTR

    2004-01-01

    Adverse events following immunisation (AEFI) in the National Vaccination Programme of the Netherlands (RVP) have been monitored through an enhanced passive surveillance system by RIVM since 1962. From 1984 onwards evaluation was done in close collaboration with the Health Council. Reports are

  10. Adverse Events Following Immunisation under the National Vaccination Programme of The Netherlands Number VIII - Reports in 2001

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Wesselo C; Dzaferagic A; Phaff TAJ; LTR

    2004-01-01

    Adverse events following immunisation (AEFIs) in the National Vaccination Programme of the Netherlands (RVP) have been monitored through an enhanced passive surveillance system by RIVM since 1962. From 1984 onwards evaluation was done in close collaboration with the Dutch Health Council. Reports

  11. Difficulties reporting system in intensive care

    Directory of Open Access Journals (Sweden)

    Claudio Bianchin

    2008-02-01

    Full Text Available In 2005, Belluno Health Authority’s Resuscitation Unit took part in a regional project coordinated by Veneto Regional Health and Social Services to test an incident re p o rting system. The main aims were to experiment an electronic incident rep o rting sheet and the relative computerised procedure for data e n t ry and analysis with the aim of developing an incident rep o rting system. The Australian Incident Monitoring System (AIMS was designed to obtain information about the event, the context and concomitant causes. We observed 58 anonymous incident reports over a six-month period. The main incidents include issues relating to the management of medication, the a i rways, catheters and equipment. Most incidents had modest consequences or led to temporary disability and they often caused longer hospitalisation or further treatment and investigations. Communication problems, inadequate superv i s i o n , poor teamwork and difficulties in applying procedures and protocols were the contributory factors most frequently identified as the concomitant causes of the incidents. The report sheet and experience as a whole were evaluated favourably by the operators involved. This reporting system does not provide the real frequency of the adverse events, but it does provide useful information for improving patient safety.

  12. Study of model of anesthesia related adverse event by incident report at King Chulalongkorn Memorial Hospital.

    Science.gov (United States)

    Narasethkamol, Arunchai; Charuluxananan, Somrat; Kyokong, Oranuch; Premsamran, Porntep; Kundej, Sarawut

    2011-01-01

    As a site of the Thai Anesthesia Incidents Monitoring Study (Thai AIMS), the authors continued data collection of incident reports to find out the frequency, clinical course, contributing factors, factors minimizing adverse events, and investigation of model appropriate for possible corrective strategies in a Thai university hospital. A standardized anesthesia incident report form that included close-end and open-end questions was provided to the attending anesthesia personnel of King Chulalongkorn Memorial Hospital between January I and December 31, 2007. They filled it on a voluntary and anonymous basis. Each incident report was reviewed by three reviewers. Any disagreement was discussed to achieve a consensus. One hundred sixty three incident reports were filled reporting 191 incidents. There were fewer male (44%) than female (56%) patients and they had an ASA physical status classification 1 (41%), 2 (43%), 3 (10%), 4 (4%) and 5 (2%). Surgical specialties that posed high risk of incidents were general, orthopedic, gynecological, otorhino-laryngological and urological surgery. Locations of incident were operating room (85%), ward (8%) and recovery room (2%). The common adverse incidents were oxygen desaturation (23%), arrhythmia needing treatment (14%), equipment malfunction (13%), drug error (9%), difficult intubation (6%), esophageal intubation (5%), cardiac arrest (5%), reintubation (4%), and endobronchial intubation (4%). Adverse events were detected by monitoring only (27%), by monitoring before clinical diagnosis (26%), by clinical diagnosis before monitoring (21%), and by clinical diagnosis only (26%). Incidents were considered to be from anesthesia related factor (73%), system factor (16%) and preventable (47%). Common factors related to incident were inexperience, lack of vigilance, haste, inappropriate decision, not comply with guidelines, and lack of equipment maintenance. Suggested corrective strategies were quality assurance activity, additional

  13. Modeling energy market dynamics using discrete event system simulation

    Energy Technology Data Exchange (ETDEWEB)

    Gutierrez-Alcaraz, G. [Department of Electrical and Electronics Engineering, Instituto Tecnologico de Morelia, Av. Tecnologico 1500, Col. Lomas de Santiaguito 58120, Morelia Michoacan (Mexico); Sheble, G.B. [Department of Electrical and Computer Engineering, Portland State University, Portland, OR 97207-0751 (United States)

    2009-10-15

    This paper proposes the use of Discrete Event System Simulation to study the interactions among fuel and electricity markets and consumers, and the decision-making processes of fuel companies (FUELCOs), generation companies (GENCOs), and consumers in a simple artificial energy market. In reality, since markets can reach a stable equilibrium or fail, it is important to observe how they behave in a dynamic framework. We consider a Nash-Cournot model in which marketers are depicted as Nash-Cournot players that determine supply to meet end-use consumption. Detailed engineering considerations such as transportation network flows are omitted, because the focus is upon the selection and use of appropriate market models to provide answers to policy questions. (author)

  14. Summary and bibliography of safety-related events at boiling-water nuclear power plants as reported in 1980

    Energy Technology Data Exchange (ETDEWEB)

    McCormack, K.E.; Gallaher, R.B.

    1982-03-01

    This document presents a bibliography that contains 100-word abstracts of event reports submitted to the US Nuclear Regulatory Commission concerning operational events that occurred at boiling-water-reactor nuclear power plants in 1980. The 1547 abstracts included on microfiche in this bibliography describe incidents, failures, and design or construction deficiencies that were experienced at the facilities. These abstracts are arranged alphabetically by reactor name and then chronologically for each reactor. Full-size keyword and permuted-title indexes to facilitate location of individual abstracts are provided following the text. Tables that summarize the information contained in the bibliography are also provided. The information in the tables includes a listing of the equipment items involved in the reported events and the associated number of reports for each item. Similar information is given for the various kinds of instrumentation and systems, causes of failures, deficiencies noted, and the time of occurrence (i.e., during refueling, operation, testing, or construction).

  15. Outcomes of neuropsychiatric events in systemic lupus erythematosus based on clinical phenotypes; prospective data from the Leiden NP SLE cohort.

    Science.gov (United States)

    Magro-Checa, C; Beaart-van de Voorde, L J J; Middelkoop, H A M; Dane, M L; van der Wee, N J; van Buchem, M A; Huizinga, T W J; Steup-Beekman, G M

    2017-04-01

    Objective The objective of this study was to assess whether clinical and patient's reported outcomes are associated with a different pathophysiological origin of neuropsychiatric events presenting in systemic lupus erythematosus. Methods A total of 232 neuropsychiatric events presenting in 131 systemic lupus erythematosus patients were included. Neuropsychiatric systemic lupus erythematosus diagnosis was established per event by multidisciplinary evaluation. All neuropsychiatric events were divided according to a suspected underlying pathophysiological process into one of the following: non-neuropsychiatric systemic lupus erythematosus related, inflammatory and ischaemic neuropsychiatric systemic lupus erythematosus. The clinical outcome of all neuropsychiatric events was determined by a physician-completed four-point Likert scale. Health-related quality of life was measured with the subscales of the patient-generated Short Form 36 (SF-36) health survey questionnaire. The change between scores at paired visits of all domain scores, mental component summary (SF-36 MCS) and physical component summary (SF-36 PCS) scores were retrospectively calculated and used as patient-reported outcome. The association among these outcomes and the different origin of neuropsychiatric events was obtained using multiple logistic regression analysis. Results The clinical status of 26.8% non-neuropsychiatric systemic lupus erythematosus events, 15.8% ischaemic neuropsychiatric systemic lupus erythematosus and 51.6% inflammatory neuropsychiatric systemic lupus erythematosus improved after re-assessment. Almost all SF-36 domains had a positive change at re-assessment in all groups independently of the origin of neuropsychiatric events. Neuropsychiatric systemic lupus erythematosus ( B = 0.502; p lupus erythematosus ( B = 0.827; p lupus erythematosus ( B = 5.783; p lupus erythematosus ( B = 11.133; p lupus erythematosus events have better clinical outcome and

  16. Undetected latent failures of safety-related systems. Preliminary survey of events in nuclear power plants 1980-1997

    Energy Technology Data Exchange (ETDEWEB)

    Lydell, B. [RSA Technologies, Vista, CA (United States)

    1998-03-01

    This report summarizes results and insights from a preliminary survey of events involving undetected, latent failures of safety-related systems. The survey was limited to events where mispositioned equipment (e.g., valves, switches) remained undetected, thus rendering standby equipment or systems unavailable for short or long time periods. Typically, these events were symptoms of underlying latent errors (e.g., design errors, procedure errors, unanalyzed safety conditions) and programmatic errors. The preliminary survey identified well over 300 events. Of these, 95 events are documented in this report. Events involving mispositioned equipment are commonplace. Most events are discovered soon after occurrence, however. But as evidenced by the survey results, some events remained undetected beyond several shift changes. The recommendations developed by the survey emphasize the importance of applying modern root cause analysis techniques to the event analysis to ensure that the causes and implications of occurred events are fully understood. 7 refs, 4 tabs, 3 figs. Also available at the SKI Home page: //www.ski.se.

  17. Fault diagnosis for discrete event systems: Modelling and verification

    Energy Technology Data Exchange (ETDEWEB)

    Simeu-Abazi, Zineb, E-mail: Zineb.simeu-Abazi@g-scop.inpg.f [Laboratoire G-SCOP (Grenoble - Sciences pour la Conception, l' Optimisation et la Production), Grenoble INP, UJF, CNRS UMR5272, 46 avenue Felix Viallet, 38031 Grenoble Cedex 1 (France); Di Mascolo, Maria, E-mail: Maria.Di-Mascolo@g-scop.inpg.f [Laboratoire G-SCOP (Grenoble - Sciences pour la Conception, l' Optimisation et la Production), Grenoble INP, UJF, CNRS UMR5272, 46 avenue Felix Viallet, 38031 Grenoble Cedex 1 (France); Knotek, Michal, E-mail: michal.knotek@gmail.co [Honewell HTSL, Brnoe Aerospace (France)

    2010-04-15

    This paper proposes an effective way for diagnosis of discrete-event systems using a timed-automaton. It is based on the model-checking technique, thanks to time analysis of the timed model. The paper proposes a method to construct all the timed models and details the different steps used to obtain the diagnosis path. A dynamic model with temporal transitions is proposed in order to model the system. By 'dynamical model', we mean an extension of timed automata for which the faulty states are identified. The model of the studied system contains the faultless functioning states and all the faulty states. Our method is based on the backward exploitation of the dynamic model, where all possible reverse paths are searched. The reverse path is the connection of the faulty state to the initial state. The diagnosis method is based on the coherence between the faulty occurrence time and the reverse path length. A real-world batch process is used to demonstrate the modelling steps and the proposed backward time analysis method to reach the diagnosis results.

  18. Multi-threaded, discrete event simulation of distributed computing systems

    Science.gov (United States)

    Legrand, Iosif; MONARC Collaboration

    2001-10-01

    The LHC experiments have envisaged computing systems of unprecedented complexity, for which is necessary to provide a realistic description and modeling of data access patterns, and of many jobs running concurrently on large scale distributed systems and exchanging very large amounts of data. A process oriented approach for discrete event simulation is well suited to describe various activities running concurrently, as well the stochastic arrival patterns specific for such type of simulation. Threaded objects or "Active Objects" can provide a natural way to map the specific behaviour of distributed data processing into the simulation program. The simulation tool developed within MONARC is based on Java (TM) technology which provides adequate tools for developing a flexible and distributed process oriented simulation. Proper graphics tools, and ways to analyze data interactively, are essential in any simulation project. The design elements, status and features of the MONARC simulation tool are presented. The program allows realistic modeling of complex data access patterns by multiple concurrent users in large scale computing systems in a wide range of possible architectures, from centralized to highly distributed. Comparison between queuing theory and realistic client-server measurements is also presented.

  19. Strengthening Community Networks for Vital Event Reporting: Community-Based Reporting of Vital Events in Rural Mali.

    Directory of Open Access Journals (Sweden)

    Melinda K Munos

    Full Text Available Like many developing countries, Mali has few sources of mortality data. High quality mortality estimates are available from household surveys, such as the demographic and health surveys (DHS, approximately every five years, making it difficult to track progress in reducing mortality. The Rapid Mortality Monitoring (RMM project in Mali aimed to address this issue by testing a community-based approach to measuring under-five mortality on a yearly basis.Seventy-eight community-based workers (relais were identified in 20 villages comprising approximately 5,300 households. The relais reported pregnancies, births, and under-five deaths from July, 2012 to November, 2013. Data were double-entered, reconciled, cleaned, and analyzed monthly. In November-December 2013, we administered a full pregnancy history (FPH to women of reproductive age in a census of the households in the project villages. We assessed the completeness of the counts of births and deaths, and the validity of under-five, infant, and neonatal mortality rates from the community-based method against the retrospective FPH for two rolling twelve-month periods. Monthly reporting by relais was high, with reports on pregnancies, births, and deaths consistently provided from all 78 relais catchment areas. Relais reported 1,660 live births and 276 under-five deaths from July, 2012 to November, 2013. The under-five mortality rate calculated from the relais data was similar to that estimated using the validation survey, where the overall ratios of the community-based to FPH-based mortality rates for the reporting periods were 100.4 (95% CI: 80.4, 120.5 and 100.8 (95% CI: 79.5, 122.0.On a small scale, the community-based method in Mali produced estimates of annualized under-five mortality rates that were consistent with those obtained from a FPH. The community-based method should be considered for scale-up in Mali, with appropriate measures to ensure community engagement, data quality, and cross

  20. Vessel Electronic Reporting System (VERS)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The VERS system is composed of a database and other related applications which facilitate the reporting of electronically collected research data via Fisheries...

  1. Key Events and Lessons for Managers in a Diverse Workforce: A Report on Research and Findings.

    Science.gov (United States)

    Douglas, Christina A.

    The research documented in this report builds on earlier work in the 1980s in the area of on-the-job experiences in developing effective leaders. The current study was designed to answer the following: (1) What are the significant events from which African American managers learn and develop? (2) Are the key events and lessons learned different…

  2. Mother-Child Joint Conversational Exchanges during Events: Linkages to Children's Memory Reports over Time

    Science.gov (United States)

    Hedrick, Amy M.; San Souci, Priscilla; Haden, Catherine A.; Ornstein, Peter A.

    2009-01-01

    This longitudinal study explores linkages between patterns of mother-child conversation as events unfold and children's subsequent event memory reports. Eighty-nine mother-child dyads took part in novel "adventures" in their homes when the children were 36 and 42 months old. In contrast to "low joint talk" dyads, the conversations of "high joint…

  3. Adverse event reporting and patient safety at a University Hospital: Mapping, correlating and associating events for a data-based patient risk management.

    Science.gov (United States)

    Buja, Alessandra; Saieva, Anna Maria; Vinelli, Angela; Cacco, Rosaria Manola; Ottolitri, Ketty; De Battisti, Elisa; Dario, Claudio; Baldo, Vincenzo

    2016-09-17

    Reporting adverse events (AE) with a bearing on patient safety is fundamentally important to the identification and mitigation of potential clinical risks. The aim of this study was to analyze the AE reporting systems adopted at a university hospital for the purpose of enhancing the learning potential afforded by these systems. Retrospective cohort study Data were collected from different information flows (reports of incidents and falls, patients' claims and complaints, and cases of hospital-acquired infection [HAI]) at an university hospital. A composite risk indicator was developed to combine the data from the different flows. Spearman's nonparametric test was applied to investigate the correlation between the AE rates and a Poisson regression analysis to verify the association among characteristics of the wards and AE rates. Sixty-four wards at a University Hospital. There was a marked variability among wards AE rates. Correlations emerged between patients' claims with complaints and the number of incidents reported. Falls were positively associated with average length of hospital stay, number of beds, patients' mean age, and type of ward, and they were negatively associated with the average Cost Weight of the Diagnosis-related group (DRG) of patients on a given ward. Claims and complaints were associated directly with the average DRG weight of a ward's patient admissions. This study attempted to learn something useful from an analysis of the mandatory (but often little used) data flows generated on adverse events occurring at an university hospital with a view to managing the associated clinical risk to patients.

  4. The nature and causes of unintended events reported at ten emergency departments

    Directory of Open Access Journals (Sweden)

    van der Wal Gerrit

    2009-09-01

    Full Text Available Abstract Background Several studies on patient safety have shown that a substantial number of patients suffer from unintended harm caused by healthcare management in hospitals. Emergency departments (EDs are challenging hospital settings with regard to patient safety. There is an increased sense of urgency to take effective countermeasures in order to improve patient safety. This can only be achieved if interventions tackle the dominant underlying causes. The objectives of our study are to examine the nature and causes of unintended events in EDs and the relationship between type of event and causal factor structure. Methods Study at EDs of 10 hospitals in the Netherlands. The study period per ED was 8 to 14 weeks, in which staff were asked to report unintended events. Unintended events were broadly defined as all events, no matter how seemingly trivial or commonplace, that were unintended and could have harmed or did harm a patient. Reports were analysed with a Root Cause Analysis tool (PRISMA by an experienced researcher. Results 522 unintended events were reported. Of the events 25% was related to cooperation with other departments and 20% to problems with materials/equipment. More than half of the events had consequences for the patient, most often resulting in inconvenience or suboptimal care. Most root causes were human (60%, followed by organisational (25% and technical causes (11%. Nearly half of the root causes was external, i.e. attributable to other departments in or outside the hospital. Conclusion Event reporting gives insight into diverse unintended events. The information on unintended events may help target research and interventions to increase patient safety. It seems worthwhile to direct interventions on the collaboration between the ED and other hospital departments.

  5. To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?

    NARCIS (Netherlands)

    Christiaans-Dingelhoff, I.; Smits, M.; Zwaan, L.; Lubberding, S.; Wal, G. van der; Wagner, C.

    2011-01-01

    BACKGROUND: Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients. However, the method has some practical and financial disadvantages. Some of these disadvantages might be overcome by using existing reporting systems in

  6. Facilitated Nurse Medication-Related Event Reporting to Improve Medication Management Quality and Safety in Intensive Care Units.

    Science.gov (United States)

    Xu, Jie; Reale, Carrie; Slagle, Jason M; Anders, Shilo; Shotwell, Matthew S; Dresselhaus, Timothy; Weinger, Matthew B

    Medication safety presents an ongoing challenge for nurses working in complex, fast-paced, intensive care unit (ICU) environments. Studying ICU nurse's medication management-especially medication-related events (MREs)-provides an approach to analyze and improve medication safety and quality. The goal of this study was to explore the utility of facilitated MRE reporting in identifying system deficiencies and the relationship between MREs and nurses' work in the ICUs. We conducted 124 structured 4-hour observations of nurses in three different ICUs. Each observation included measurement of nurse's moment-to-moment activity and self-reports of workload and negative mood. The observer then obtained MRE reports from the nurse using a structured tool. The MREs were analyzed by three experts. MREs were reported in 35% of observations. The 60 total MREs included four medication errors and seven adverse drug events. Of the 49 remaining MREs, 65% were associated with negative patient impact. Task/process deficiencies were the most common contributory factor for MREs. MRE occurrence was correlated with increased total task volume. MREs also correlated with increased workload, especially during night shifts. Most of these MREs would not be captured by traditional event reporting systems. Facilitated MRE reporting provides a robust information source about potential breakdowns in medication management safety and opportunities for system improvement.

  7. Measurement System and Calibration report

    DEFF Research Database (Denmark)

    Gómez Arranz, Paula; Villanueva, Héctor

    This Measurement System & Calibration report is describing DTU’s measurement system installed at a specific wind turbine. A major part of the sensors has been installed by others (see [1]) the rest of the sensors have been installed by DTU. The results of the measurements, described in this repor...

  8. Statins and interstitial lung disease: a systematic review of the literature and of food and drug administration adverse event reports.

    Science.gov (United States)

    Fernández, Antonio B; Karas, Richard H; Alsheikh-Ali, Alawi A; Thompson, Paul D

    2008-10-01

    To systematically review all published case reports and the US Food and Drug Administration adverse event reporting (FDA-AER) database to examine the relationship between statins and interstitial lung disease (ILD). PubMed (1987 to September 2007) and the FDA-AER database (as of June 2007) were searched for reports of ILD in which a statin was listed as a causative suspect. Two authors (one author for Pub Med cases and one for FDA-AER cases) independently abstracted patient data. Given the paucity of information, all case reports and case series in English and French were included. All adverse event reports from the FDA-AER database in which a statin was listed as causative suspect were included. The literature search using PubMed yielded eight articles describing a total of 14 case reports of ILD in association with statin use. The FDA-AER system database contained 162 cases of reported statin-induced ILD as of June 2007. For every 10,000 reports of a statin-associated adverse event, approximately 1 to 40 reports were for ILD. Statin-induced ILD is a possible newly recognized side effect of statin therapy. The mechanism of lung injury is not defined. The current review provides novel information from the FDA-AER that supports a possible, although unusual, pulmonary class effect of statins.

  9. Vaccine Adverse Events Reported during the First Ten Years (1998–2008 after Introduction in the State of Rondonia, Brazil

    Directory of Open Access Journals (Sweden)

    Mônica P. L. Cunha

    2013-01-01

    Full Text Available Despite good safety records, vaccines given to young children can cause adverse events. We investigated the reported adverse events following immunization (AEFI of vaccines given to children of less than seven years of age during the first ten years (1998 to 2008 in the state of Rondonia, Brazil. We worked with the events related to BCG (Bacillus Calmett-Guérin, HB (hepatitis B, DTwP/Hib (diphtheria-tetanus-pertussis+Hemophillus influenza b, DTP (diphtheria-tetanus-pertussis, MMR (mumps, measles, rubella, and YF (yellow fever vaccines because they were part of the recommended scheme. The number of doses of vaccines given was 3,231,567 with an average of AEFI of 57.2/year during the studied period. DTwP/Hib was responsible for 298 (57.8%, DTP 114 (22.9%, HB 31 (6%, MMR 28 (5.4%, BCG 24 (4.7%, and YF 20 (3.9% of the reported AEFI. The combination of the AEFI for DTwP/Hib vaccines showed the highest number of systemic (61.4% and local events (33.8%. Young children (≤1-year old were more susceptible to AEFI occurring in the 6 hours (54.2% following vaccine uptake. This study suggests significant differences in reactogenicity of vaccines and that despite limitations of the AEFI Brazilian registry system we cannot ignore underreporting and should use the system to expand our understanding of adverse events and effects.

  10. Development of an integrated electronic platform for patient self-report and management of adverse events during cancer treatment.

    Science.gov (United States)

    Holch, P; Warrington, L; Bamforth, L C A; Keding, A; Ziegler, L E; Absolom, K; Hector, C; Harley, C; Johnson, O; Hall, G; Morris, C; Velikova, G

    2017-09-01

    Significant adverse events (AE) during cancer therapy disrupt treatment and escalate to emergency admissions. Approaches to improve the timeliness and accuracy of AE reporting may improve safety and reduce health service costs. Reporting AE via patient reported outcomes (PROs), can improve clinician-patient communication and making data available to clinicians in 'real-time' using electronic PROs (ePROs) could potentially transform clinical practice by providing easily accessible records to guide treatment decisions. This manuscript describes the development of eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is a National Institute for Health Research-funded programme, a system for patients to self-report and manage AE online during and after cancer treatment. A multidisciplinary team of IT experts, staff and patients developed using agile principles a secure web application interface (QStore) between an existing online questionnaire builder (QTool) displaying real-time ePRO data to clinicians in the electronic patient record at Leeds Teaching Hospitals NHS Trust. Hierarchical algorithms were developed corresponding to Common Terminology Criteria for Adverse Events grading using the QTool question dependency function. Patient advocates (N = 9), patients (N = 13), and staff (N = 19) usability tested the system reporting combinations of AE. The eRAPID system allows patients to report AE from home on PC, tablet or any web enabled device securely during treatment. The system generates immediate self-management advice for low or moderate AE and for severe AE advice to contact the hospital immediately. Clinicians can view patient AE data in the electronic patient record and receive email notifications when patients report severe AE. Evaluation of the system in a randomised controlled trial in breast, gynaecological and colorectal cancer patients undergoing systemic therapy is currently underway. To adapt eRAPID for

  11. Evaluating adverse drug event reporting in administrative data from emergency departments: a validation study

    Science.gov (United States)

    2013-01-01

    Background Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data. Methods We linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data. Results Among 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0–11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%). Conclusions Adverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care. PMID:24219303

  12. Use of HIT for adverse event reporting in nursing homes: barriers and facilitators.

    Science.gov (United States)

    Wagner, Laura M; Castle, Nicholas G; Handler, Steven M

    2013-01-01

    Approximately 8 million adverse events occur annually in nursing homes (NHs). The focus of this research is to determine barriers and health information technology (HIT)-related facilitators to adverse event reporting among U.S. NHs. Surveys were returned by 399 nursing home administrators using a mailed survey approach. Respondents were asked to report on their adverse event reporting processes focusing on barriers and role of HIT facilitators. About 15% of NHs had computerized entry by the nurse on the unit and almost 18% used no computer technology to track, monitor, or maintain adverse event data. One-third of nursing directors conducted data analysis "by-hand." NHs without HIT were more likely to not be accredited (p = 0.04) and not part of a chain/corporation (p = 0.03). Two of the top three barriers focused on fears of reporting as a barrier. This study found numerous barriers and few HIT-related facilitators to assist with adverse event reporting. Improvements in facilitating adverse event reporting through the use of HIT approaches may be warranted. Copyright © 2013 Mosby, Inc. All rights reserved.

  13. Nurse willingness to report for work in the event of an earthquake in Israel.

    Science.gov (United States)

    Ben Natan, Merav; Nigel, Simon; Yevdayev, Innush; Qadan, Mohamad; Dudkiewicz, Mickey

    2014-10-01

    To examine variables affecting nurse willingness to report for work in the event of an earthquake in Israel and whether this can be predicted through the Theory of Self-Efficacy. The nursing profession has a major role in preparing for earthquakes. Nurse willingness to report to work in the event of an earthquake has never before been examined. Self-administered questionnaires were distributed among a convenience sample of 400 nurses and nursing students in Israel during January-April 2012. High willingness to report to work in the event of an earthquake was declared by 57% of respondents. High perceived self-efficacy, level of knowledge and experience predict willingness to report to work in the event of an earthquake. Multidisciplinary collaboration and support was also cited as a meaningful factor. Perceived self-efficacy, level of knowledge, experience and the support of a multidisciplinary staff affect nurse willingness to report to work in the event of an earthquake. Nurse managers can identify factors that increase nurse willingness to report to work in the event of an earthquake and consequently develop strategies for more efficient management of their nursing workforce. © 2013 John Wiley & Sons Ltd.

  14. 2014 Runtime Systems Summit. Runtime Systems Report

    Energy Technology Data Exchange (ETDEWEB)

    Sarkar, Vivek [US Dept. of Energy, Washington, DC (United States); Budimlic, Zoran [US Dept. of Energy, Washington, DC (United States); Kulkani, Milind [US Dept. of Energy, Washington, DC (United States)

    2016-09-19

    This report summarizes runtime system challenges for exascale computing, that follow from the fundamental challenges for exascale systems that have been well studied in past reports, e.g., [6, 33, 34, 32, 24]. Some of the key exascale challenges that pertain to runtime systems include parallelism, energy efficiency, memory hierarchies, data movement, heterogeneous processors and memories, resilience, performance variability, dynamic resource allocation, performance portability, and interoperability with legacy code. In addition to summarizing these challenges, the report also outlines different approaches to addressing these significant challenges that have been pursued by research projects in the DOE-sponsored X-Stack and OS/R programs. Since there is often confusion as to what exactly the term “runtime system” refers to in the software stack, we include a section on taxonomy to clarify the terminology used by participants in these research projects. In addition, we include a section on deployment opportunities for vendors and government labs to build on the research results from these projects. Finally, this report is also intended to provide a framework for discussing future research and development investments for exascale runtime systems, and for clarifying the role of runtime systems in exascale software.

  15. Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports

    Directory of Open Access Journals (Sweden)

    Judith U. Cope

    2015-01-01

    Full Text Available Background. Ewing sarcoma family of tumors (ESFT are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.

  16. Locked Discrete Event Systems: How to Model and How to Unlock

    NARCIS (Netherlands)

    Smedinga, Rein

    1993-01-01

    To model qualitative aspects of discrete event systems, i.e., the order of the events is of sole importance, we use a triple consisting of the set of all possible events (the alphabet), the set of all behavior (possible strings of events), and the set of all tasks (completed behavior). We use this

  17. Extreme events in the forced Liénard system

    Science.gov (United States)

    Kingston, S. Leo; Thamilmaran, K.; Pal, Pinaki; Feudel, Ulrike; Dana, Syamal K.

    2017-11-01

    We observe extremely large amplitude intermittent spikings in a dynamical variable of a periodically forced Liénard-type oscillator and characterize them as extreme events, which are rare, but recurrent and larger in amplitude than a threshold. The extreme events occur via two processes, an interior crisis and intermittency. The probability of occurrence of the events shows a long-tail distribution in both the cases. We provide evidence of the extreme events in an experiment using an electronic analog circuit of the Liénard oscillator that shows good agreement with our numerical results.

  18. An automated standardized system for managing adverse events in clinical research networks.

    Science.gov (United States)

    Richesson, Rachel L; Malloy, Jamie F; Paulus, Kathleen; Cuthbertson, David; Krischer, Jeffrey P

    2008-01-01

    Multi-site clinical protocols and clinical research networks require tools to manage and monitor adverse events (AEs). To be successful, these tools must be designed to comply with applicable regulatory requirements, reflect current data standards, international directives and advances in pharmacovigilance, and be convenient and adaptable to multiple needs. We describe an Adverse Event Data Management System (AEDAMS) that is used across multiple study designs in the various clinical research networks and multi-site studies for which we provide data and technological support. Investigators enter AE data using a standardized and structured web-based data collection form. The automated AEDAMS forwards the AE information to individuals in designated roles (investigators, sponsors, Data Safety and Monitoring Boards) and manages subsequent communications in real time, as the entire reporting, review and notification is done by automatically generated emails. The system was designed to adhere to timelines and data requirements in compliance with Good Clinical Practice (International Conference on Harmonisation E6) reporting standards and US federal regulations, and can be configured to support AE management for many types of study designs and adhere to various domestic or international reporting requirements. This tool allows AEs to be collected in a standard way by multiple distributed users, facilitates accurate and timely AE reporting and reviews, and allows the centralized management of AEs. Our design justification and experience with the system are described.

  19. Neurologic adverse events associated with smallpox vaccination in the United States – response and comment on reporting of headaches as adverse events after smallpox vaccination among military and civilian personnel

    Directory of Open Access Journals (Sweden)

    Schumm Walter R

    2006-11-01

    Full Text Available Abstract Background Accurate reporting of adverse events occurring after vaccination is an important component of determining risk-benefit ratios for vaccinations. Controversy has developed over alleged underreporting of adverse events within U.S. military samples. This report examines the accuracy of adverse event rates recently published for headaches, and examines the issue of underreporting of headaches as a function of civilian or military sources and as a function of passive versus active surveillance. Methods A report by Sejvar et al was examined closely for accuracy with respect to the reporting of neurologic adverse events associated with smallpox vaccination in the United States. Rates for headaches were reported by several scholarly sources, in addition to Sejvar et al, permitting a comparison of reporting rates as a function of source and type of surveillance. Results Several major errors or omissions were identified in Sejvar et al. The count of civilian subjects vaccinated and the totals of both civilians and military personnel vaccinated were reported incorrectly by Sejvar et al. Counts of headaches reported in VAERS were lower (n = 95 for Sejvar et al than for Casey et al (n = 111 even though the former allegedly used 665,000 subjects while the latter used fewer than 40,000 subjects, with both using approximately the same civilian sources. Consequently, rates of nearly 20 neurologic adverse events reported by Sejvar et al were also incorrectly calculated. Underreporting of headaches after smallpox vaccination appears to increase for military samples and for passive adverse event reporting systems. Conclusion Until revised or corrected, the rates of neurologic adverse events after smallpox vaccinated reported by Sejvar et al must be deemed invalid. The concept of determining overall rates of adverse events by combining small civilian samples with large military samples appears to be invalid. Reports of headaches as adverse events

  20. Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review

    Science.gov (United States)

    Golder, Su; Wright, Kath

    2016-01-01

    Background We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events. Methods and Findings Studies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95

  1. Reporting adverse events in randomized controlled trials in periodontology: a systematic review.

    Science.gov (United States)

    Faggion, Clovis M; Tu, Yu-Kang; Giannakopoulos, Nikolaos N

    2013-09-01

    Reporting of adverse events is of paramount importance in randomized controlled trials (RCTs) to guide the implementation of new therapeutic approaches in clinical practice. The aim of this study was to assess the quality of adverse events reporting in RCTs published in the periodontal literature. Two authors (CMF and NNG) searched the PubMed and LILACS electronic databases independently and in duplicate to identify RCTs published in periodontology from 2002 to 2003 and from 2011 to 2012. Reporting quality in RCTs was assessed with reference to the 2004 CONSORT Extension for Harms checklist. Differences in adverse events reporting between industry- and non-industry-funded RCTs were also determined. Cohen's kappa statistic was used to determine the extent of inter-reviewer agreement. Fischer's exact test was used to assess differences in reporting between the two samples. The analysis included 246 publications. One hundred twenty-four of 990 (13%) items and 223 of 1460 (15%) items were adequately reported in publications from 2002 to 2003 and from 2011 to 2012 respectively. Three checklist topics were significantly better reported in the 2011-2012 sample; two recommendations were better reported in non-industry-funded trials in publications from both periods. Improvement and standardization of adverse events reporting in periodontology are needed. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Shuttle Propulsion System Major Events and the Final 22 Flights

    Science.gov (United States)

    Owen, James W.

    2011-01-01

    Numerous lessons have been documented from the Space Shuttle Propulsion elements. Major events include loss of the Solid Rocket Boosters (SRB's) on STS-4 and shutdown of a Space Shuttle Main Engine (SSME) during ascent on STS-51F. On STS-112 only half the pyrotechnics fired during release of the vehicle from the launch pad, a testament for redundancy. STS-91 exhibited freezing of a main combustion chamber pressure measurement and on STS-93 nozzle tube ruptures necessitated a low liquid level oxygen cut off of the main engines. A number of on pad aborts were experienced during the early program resulting in delays. And the two accidents, STS-51L and STS-107, had unique heritage in history from early program decisions and vehicle configuration. Following STS-51L significant resources were invested in developing fundamental physical understanding of solid rocket motor environments and material system behavior. And following STS-107, the risk of ascent debris was better characterized and controlled. Situational awareness during all mission phases improved, and the management team instituted effective risk assessment practices. The last 22 flights of the Space Shuttle, following the Columbia accident, were characterized by remarkable improvement in safety and reliability. Numerous problems were solved in addition to reduction of the ascent debris hazard. The Shuttle system, though not as operable as envisioned in the 1970's, successfully assembled the International Space Station (ISS). By the end of the program, the remarkable Space Shuttle Propulsion system achieved very high performance, was largely reusable, exhibited high reliability, and was a heavy lift earth to orbit propulsion system. During the program a number of project management and engineering processes were implemented and improved. Technical performance, schedule accountability, cost control, and risk management were effectively managed and implemented. Award fee contracting was implemented to provide

  3. e-Prescription: An e-Health System for Preventing Adverse Drug Events in Community Healthcare

    Directory of Open Access Journals (Sweden)

    Irma M. Puspitasari

    2012-03-01

    Full Text Available The paper describes development activities of an e-health system for community health center (Puskesmas with integrated adverse drug events e-prescription module, consist of system design and development, human resource development, e-health system realization, laboratory and implementation test of e-health system. Some e-readiness evaluations were conducted, through a number of field visits and questionnaires. The results had been used in the e-health system design and development, installation of the internet access infrastructure, and implementation of the education and hands-on training for the medical and administrative staff of the healthcare units. After completing the e-health system design and development as well as system realization and laboratory tests stages, a series of field implementation and experiments have been successfully conducted at Puskesmas Babakansari in Bandung. A number of users feed back have been obtained and used for further improvements on both of the software and hardware modules. The e-health system with integrated e-prescription module has successfully developed and shown its expected functions in: patient registration, medical record, paperless prescription, producing the required reports and preventing possible adverse drug events.

  4. Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication.

    Science.gov (United States)

    Birk, Karin; Pađen, Ljubiša; Markič, Mirko

    2016-08-01

    The provision of safe healthcare is considered a priority in European Union (EU) member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.

  5. Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication

    Directory of Open Access Journals (Sweden)

    Birk Karin

    2016-01-01

    Full Text Available Background/Aim. The provision of safe healthcare is considered a priority in European Union (EU member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. Methods. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Results. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. Conclusion. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.

  6. The validity of a patient-reported adverse drug event questionnaire using different recall periods

    NARCIS (Netherlands)

    de Vries, Sieta T; Haaijer-Ruskamp, Flora M; de Zeeuw, Dick; Denig, Petra

    2014-01-01

    PURPOSE: To assess the validity of a patient-reported adverse drug events (ADEs) questionnaire with a 3-month or 4-week recall period. METHODS: Patients receiving at least one oral glucose-lowering drug were asked to report potential ADEs they experienced related to any drug in a daily diary for a

  7. Neuropsychiatric Adverse Events of Varenicline A Systematic Review of Published Reports

    NARCIS (Netherlands)

    Ahmed, Amir I. A.; Ali, Abdullah N. A.; Kramers, Cees; Harmark, Linda V. D.; Burger, David M.; Verhoeven, Willem M. A.

    Introduction: Over the past years, the impact of varenicline in patients with mental illness has been debated as serious neuropsychiatric adverse events (AEs) have been reported with varenicline use. Aim: To identify and summarize published case reports of neuropsychiatric AEs ascribed to

  8. 21 CFR 803.19 - Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

    Science.gov (United States)

    2010-04-01

    ... forms of adverse event reporting requirements? 803.19 Section 803.19 Food and Drugs FOOD AND DRUG... General Provisions § 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements? (a) We exempt the following persons from the adverse event reporting requirements in...

  9. Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets

    Science.gov (United States)

    Maciejewski, Mateusz; Lounkine, Eugen; Whitebread, Steven; Farmer, Pierre; DuMouchel, William; Shoichet, Brian K; Urban, Laszlo

    2017-01-01

    The Food and Drug Administration Adverse Event Reporting System (FAERS) remains the primary source for post-marketing pharmacovigilance. The system is largely un-curated, unstandardized, and lacks a method for linking drugs to the chemical structures of their active ingredients, increasing noise and artefactual trends. To address these problems, we mapped drugs to their ingredients and used natural language processing to classify and correlate drug events. Our analysis exposed key idiosyncrasies in FAERS, for example reports of thalidomide causing a deadly ADR when used against myeloma, a likely result of the disease itself; multiplications of the same report, unjustifiably increasing its importance; correlation of reported ADRs with public events, regulatory announcements, and with publications. Comparing the pharmacological, pharmacokinetic, and clinical ADR profiles of methylphenidate, aripiprazole, and risperidone, and of kinase drugs targeting the VEGF receptor, demonstrates how underlying molecular mechanisms can emerge from ADR co-analysis. The precautions and methods we describe may enable investigators to avoid confounding chemistry-based associations and reporting biases in FAERS, and illustrate how comparative analysis of ADRs can reveal underlying mechanisms. DOI: http://dx.doi.org/10.7554/eLife.25818.001 PMID:28786378

  10. Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets.

    Science.gov (United States)

    Maciejewski, Mateusz; Lounkine, Eugen; Whitebread, Steven; Farmer, Pierre; DuMouchel, William; Shoichet, Brian K; Urban, Laszlo

    2017-08-08

    The Food and Drug Administration Adverse Event Reporting System (FAERS) remains the primary source for post-marketing pharmacovigilance. The system is largely un-curated, unstandardized, and lacks a method for linking drugs to the chemical structures of their active ingredients, increasing noise and artefactual trends. To address these problems, we mapped drugs to their ingredients and used natural language processing to classify and correlate drug events. Our analysis exposed key idiosyncrasies in FAERS, for example reports of thalidomide causing a deadly ADR when used against myeloma, a likely result of the disease itself; multiplications of the same report, unjustifiably increasing its importance; correlation of reported ADRs with public events, regulatory announcements, and with publications. Comparing the pharmacological, pharmacokinetic, and clinical ADR profiles of methylphenidate, aripiprazole, and risperidone, and of kinase drugs targeting the VEGF receptor, demonstrates how underlying molecular mechanisms can emerge from ADR co-analysis. The precautions and methods we describe may enable investigators to avoid confounding chemistry-based associations and reporting biases in FAERS, and illustrate how comparative analysis of ADRs can reveal underlying mechanisms.

  11. The effects of power, leadership and psychological safety on resident event reporting.

    Science.gov (United States)

    Appelbaum, Nital P; Dow, Alan; Mazmanian, Paul E; Jundt, Dustin K; Appelbaum, Eric N

    2016-03-01

    Although the reporting of adverse events is a necessary first step in identifying and addressing lapses in patient safety, such events are under-reported, especially by frontline providers such as resident physicians. This study describes and tests relationships between power distance and leader inclusiveness on psychological safety and the willingness of residents to report adverse events. A total of 106 resident physicians from the departments of neurosurgery, orthopaedic surgery, emergency medicine, otolaryngology, neurology, obstetrics and gynaecology, paediatrics and general surgery in a mid-Atlantic teaching hospital were asked to complete a survey on psychological safety, perceived power distance, leader inclusiveness and intention to report adverse events. Perceived power distance (β = -0.26, standard error [SE] 0.06, 95% confidence interval [CI] -0.37 to 0.15; p culture external to the individual, it should be viewed as an organisational as much as a personal function. Supervisors and other leaders in health care should ensure that policies, procedures and leadership practices build psychological safety and minimise power distance between low- and high-status members in order to support greater reporting of adverse events. © 2016 John Wiley & Sons Ltd.

  12. Security Event Counts Estimate in Automated Systems for Network Attacks Detection

    Directory of Open Access Journals (Sweden)

    D. O. Kovalev

    2011-03-01

    Full Text Available Information security monitoring systems specifics in large automated systems are being analyzed. Security events distribution for different time intervals was determined and further used to estimate the security events counts. Proposed events counts estimate method is based on a dynamically updated table of moments. This method allows to determine the acceptable number of security events at different time intervals as well as exceeding situations which are being the signal for abnormal network activity.

  13. Control of discrete event systems---research at the interface of control theory and computer science

    OpenAIRE

    Overkamp, A.A.F.; Schuppen, Jan

    1994-01-01

    textabstractThis expository paper is directed to a general audience of engineers, mathematicians, and computer scientists. A discrete event system is a mathematical model (in the form of an automaton, Petri nets, or process algebra) of, for example, a computer controlled engineering system such as a communication network. Control theory for discrete event systems aims at synthesis procedures for a supervisor that forces a discrete event system such that it satisfies prespecified control objec...

  14. The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital.

    Science.gov (United States)

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2014-01-01

    With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. The 74.1% of the nurses definition of "severe adverse effect" of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance.

  15. Adverse Events Associated with Yoga: A Systematic Review of Published Case Reports and Case Series

    OpenAIRE

    Holger Cramer; Carol Krucoff; Gustav Dobos

    2013-01-01

    While yoga is gaining increased popularity in North America and Europe, its safety has been questioned in the lay press. The aim of this systematic review was to assess published case reports and case series on adverse events associated with yoga. Medline/Pubmed, Scopus, CAMBase, IndMed and the Cases Database were screened through February 2013; and 35 case reports and 2 case series reporting a total of 76 cases were included. Ten cases had medical preconditions, mainly glaucoma and osteopeni...

  16. A systems-based assessment of the PrePex device adverse events active surveillance system in Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Paul C Adamson

    Full Text Available Voluntary Medical Male Circumcision (VMMC is an effective method for HIV prevention and the World Health Organization (WHO has recommended its expansion in 14 African countries with a high prevalence of HIV and low prevalence of male circumcision. The WHO has recently pre-qualified the PrePex device, a non-surgical male circumcision device, which reduces procedure time, can increase acceptability of VMMC, and can expand the set of potential provider cadres. The PrePex device was introduced in Zimbabwe as a way to scale-up VMMC services in the country. With the rapid scale-up of the PrePex device, as well as other similar devices, a strong surveillance system to detect adverse events (AE is needed to monitor the safety profile of these devices. We performed a systems-based evaluation of the PrePex device AE active surveillance system in Zimbabwe.The evaluation was based on the Centers for Disease Control and Prevention's Updated Guidelines for Evaluating Public Health Surveillance Systems. We adapted these guidelines to fit our local context. The evaluation incorporated the review of the standard operating procedures and surveillance system documents. Additionally, structured, in-person interviews were performed with key stakeholders who were users of the surveillance system at various levels. These key stakeholders were from the Ministry of Health, implementing partners, and health facilities in Harare.Clients were requested to return to the facility for follow-up on days 7, 14 and 49 after placement of the device. In the event of a severe AE, a standard report was generated by the health facility and relayed to the Ministry of Health Child and Care and donor agencies through predefined channels within 24 hours of diagnosis. Clinic staff reported difficulties with the amount of documentation required to follow up with clients and to report AEs. The surveillance system's acceptability among users interviewed was high, and users were motivated to

  17. Reliability of piping system components. Volume 4: The pipe failure event database

    Energy Technology Data Exchange (ETDEWEB)

    Nyman, R.; Erixon, S. [Swedish Nuclear Power Inspectorate, Stockholm (Sweden); Tomic, B. [ENCONET Consulting GmbH, Vienna (Austria); Lydell, B. [RSA Technologies, Visat, CA (United States)

    1996-07-01

    Available public and proprietary databases on piping system failures were searched for relevant information. Using a relational database to identify groupings of piping failure modes and failure mechanisms, together with insights from published PSAs, the project team determined why, how and where piping systems fail. This report represents a compendium of technical issues important to the analysis of pipe failure events, and statistical estimation of failure rates. Inadequacies of traditional PSA methodology are addressed, with directions for PSA methodology enhancements. A `data driven and systems oriented` analysis approach is proposed to enable assignment of unique identities to risk-significant piping system component failure. Sufficient operating experience does exist to generate quality data on piping failures. Passive component failures should be addressed by today`s PSAs to allow for aging analysis and effective, on-line risk management. 42 refs, 25 figs.

  18. Faraday rotation system. Topical report

    Energy Technology Data Exchange (ETDEWEB)

    Bauman, L.E.; Wang, W.

    1994-07-01

    The Faraday Rotation System (FRS) is one of the advanced laser-based diagnostics developed at DIAL to provide support for the demonstration of prototype-scale coal-fired combustion magnetohydrodynamic (MHD) electrical power generation. Intended for application in the MHD channel, the system directly measures electron density through a measurement of the induced rotation in the polarization of a far infrared laser beam after passing through the MHD flow along the magnetic field lines. A measurement of the induced polarization ellipticity provides a measure of the electron collision frequency which together with the electron density gives the electron conductivity, a crucial parameter for MHD channel performance. The theory of the measurements, a description of the system, its capabilities, laboratory demonstration measurements on seeded flames with comparison to emission absorption measurements, and the current status of the system are presented in this final report.

  19. Building a knowledge base of severe adverse drug events based on AERS reporting data using semantic web technologies.

    Science.gov (United States)

    Jiang, Guoqian; Wang, Liwei; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2013-01-01

    A semantically coded knowledge base of adverse drug events (ADEs) with severity information is critical for clinical decision support systems and translational research applications. However it remains challenging to measure and identify the severity information of ADEs. The objective of the study is to develop and evaluate a semantic web based approach for building a knowledge base of severe ADEs based on the FDA Adverse Event Reporting System (AERS) reporting data. We utilized a normalized AERS reporting dataset and extracted putative drug-ADE pairs and their associated outcome codes in the domain of cardiac disorders. We validated the drug-ADE associations using ADE datasets from SIDe Effect Resource (SIDER) and the UMLS. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the ADEs into the CTCAE in the Web Ontology Language (OWL). We identified and validated 2,444 unique Drug-ADE pairs in the domain of cardiac disorders, of which 760 pairs are in Grade 5, 775 pairs in Grade 4 and 2,196 pairs in Grade 3.

  20. Evaluation of Seismic Event Location Methods on the Regional Event Location System (RELS).

    Science.gov (United States)

    1981-11-26

    Dato Entered) $11 TYCLASI ICATION OF THIS PAOE(Wh DAia Em)o, ’"All the methods evaluated in this report appear to give smaller absolute epicenter and...computer in tabular form. One can obtain halfway travel times of any model simply by adding these corrections to the halfway travel time of the Herrin

  1. Analysis of Spontaneous Postmarket Case Reports Submitted to the FDA Regarding Thromboembolic Adverse Events and JAK Inhibitors.

    Science.gov (United States)

    Verden, Abril; Dimbil, Mo; Kyle, Robert; Overstreet, Brian; Hoffman, Keith B

    2017-12-02

    The Janus kinase (JAK) inhibitor baricitinib is approved in Europe and Japan for the treatment of rheumatoid arthritis. In April 2017, the US FDA expressed concern about thromboembolic events (deep venous thrombosis [DVT] and pulmonary embolism [PE]) observed in placebo-controlled clinical trials of baricitinib. The European and Japanese labels for baricitinib were recently updated to include a precaution related to potential thromboembolic events in patients at risk. Given that the FDA-approved drugs tofacitinib and ruxolitinib are in the same class, we conducted a safety review of the FDA's Adverse Event Reporting System (FAERS) to assess postmarketing reporting rates for related thromboembolic risks. Adverse event (AE) data for tofacitinib, tofacitinib extended-release (XR), and ruxolitinib were obtained from the FAERS. Reporting odds ratios (RORs) and the R package 'PhViD' to estimate the empirical Bayesian geometric mean (EBGM) were used to detect AEs with higher-than-expected reporting rates within the FAERS. We did not find evidence in the FAERS for elevated reporting rates for DVT and PE across the three JAK inhibitors we analyzed. However, multiple drug-AE combinations relating to thromboembolic events had both RORs and EBGM values above 1, indicating a trend toward higher-than-expected reporting rates. For pulmonary thrombosis, the ROR values for ruxolitinib, tofacitinib, and tofacitinib XR were 1.46 (95% confidence interval [CI] 0.76-2.80), 2.46 (1.55-3.91), and 2.48 (0.80-7.71), respectively, while the EBGM values were 1.25 (0.70), 2.46 (1.64), and 1.56 (0.57), respectively. Ruxolitinib had ROR values of 4.08 (2.25-7.38) and 1.22 (0.97-1.53) for portal vein thrombosis and thrombosis, respectively. The EBGM values for the same drug-AE combinations were 3.04 (1.79) and 1.16 (0.96). Our safety review of postmarketing FAERS reports associated with three FDA-approved JAK inhibitors did not find elevated reporting rates for DVT and PE specifically. However

  2. The Emergency Medicine Events Register: An analysis of the first 150 incidents entered into a novel, online incident reporting registry.

    Science.gov (United States)

    Hansen, Kim; Schultz, Timothy; Crock, Carmel; Deakin, Anita; Runciman, William; Gosbell, Andrew

    2016-10-01

    Incident reporting systems are critical to understanding adverse events, in order to create preventative and corrective strategies. There are very few systems dedicated to Emergency Medicine with published results. All EDs in Australia and New Zealand were contacted to encourage the use of an Emergency Medicine - specific online reporting system called the Emergency Medicine Events Register (EMER). We conducted an analysis of the first 150 incidents entered into EMER. EMER captures Emergency-medicine-specific details including triage score, clinical presentation, outcome, contributing factors, mitigating factors, other specialities involved and patient journey stage. These details were analysed by an expert panel. Over the first 26 months, 150 incidents were reported into EMER. The most common categories reported, in order, were diagnostic error, procedural complication and investigation errors. Most incidents contained more than one category of error. The most common stage of the patient's journey in which an incident was detected was after discharge from the ED. A focus on correct diagnosis, procedure performance and investigation interpretation may reduce errors in the ED. The ability to learn from incidents and make system changes to enhance patient safety in healthcare organisations is an inherent part of providing a proactive, quality culture. © 2016 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  3. Implications of electronic health record downtime: an analysis of patient safety event reports.

    Science.gov (United States)

    Larsen, Ethan; Fong, Allan; Wernz, Christian; Ratwani, Raj M

    2018-02-01

    We sought to understand the types of clinical processes, such as image and medication ordering, that are disrupted during electronic health record (EHR) downtime periods by analyzing the narratives of patient safety event report data. From a database of 80 381 event reports, 76 reports were identified as explicitly describing a safety event associated with an EHR downtime period. These reports were analyzed and categorized based on a developed code book to identify the clinical processes that were impacted by downtime. We also examined whether downtime procedures were in place and followed. The reports were coded into categories related to their reported clinical process: Laboratory, Medication, Imaging, Registration, Patient Handoff, Documentation, History Viewing, Delay of Procedure, and General. A majority of reports (48.7%, n = 37) were associated with lab orders and results, followed by medication ordering and administration (14.5%, n = 11). Incidents commonly involved patient identification and communication of clinical information. A majority of reports (46%, n = 35) indicated that downtime procedures either were not followed or were not in place. Only 27.6% of incidents (n = 21) indicated that downtime procedures were successfully executed. Patient safety report data offer a lens into EHR downtime-related safety hazards. Important areas of risk during EHR downtime periods were patient identification and communication of clinical information; these should be a focus of downtime procedure planning to reduce safety hazards. EHR downtime events pose patient safety hazards, and we highlight critical areas for downtime procedure improvement.

  4. ATLAS EventIndex monitoring system using the Kibana analytics and visualization platform

    CERN Document Server

    AUTHOR|(INSPIRE)INSPIRE-00064378; Cardenas Zarate, Simon Ernesto; Favareto, Andrea; Fernandez Casani, Alvaro; Gallas, Elizabeth; Garcia Montoro, Carlos; Gonzalez de la Hoz, Santiago; Hrivnac, Julius; Malon, David; Prokoshin, Fedor; Salt, Jose; Sanchez, Javier; Toebbicke, Rainer; Yuan, Ruijun

    2016-01-01

    The ATLAS EventIndex is a data catalogue system that stores event-related metadata for all (real and simulated) ATLAS events, on all processing stages. As it consists of different components that depend on other applications (such as distributed storage, and different sources of information) we need to monitor the conditions of many heterogeneous subsystems, to make sure everything is working correctly. This paper describes how we gather information about the EventIndex components and related subsystems: the Producer-Consumer architecture for data collection, health parameters from the servers that run EventIndex components, EventIndex web interface status, and the Hadoop infrastructure that stores EventIndex data. This information is collected, processed, and then displayed using CERN service monitoring software based on the Kibana analytic and visualization package, provided by CERN IT Department. EventIndex monitoring is used both by the EventIndex team and ATLAS Distributed Computing shifts crew

  5. Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine.

    Science.gov (United States)

    Carlesso, Lisa C; Macdermid, Joy C; Santaguida, Lina P

    2010-08-01

    Orthopaedic physical therapy is considered safe, based on a lack of reported harms. Most of the research until now has focused on benefits. Consideration of benefits and harm involves informed consent, clinical decision making, and cost-benefit analyses. Benefits and harms are treatment and dosage specific. There is currently an insufficient number of dosage trials in orthopaedic physical therapy to identify optimal dosage for common interventions, including exercise and manual therapy. Published cases of severe adverse events following chiropractic manipulation illustrate the need for physical therapy to have high-quality data documenting the safety of orthopaedic physical therapy, including cervical manipulation. A recent systematic review identified poor reporting standards of harms within clinical research in this area. Lack of standardization of terminology has contributed to this problem. Pharmacovigilence provides a framework for terms that orthopaedic physical therapy can adapt and thereafter adopt into clinical practice and research. Adverse events are unexpected events that occur following an intervention without evidence of causality. Where temporality of an event is highly suggestive of causality, the term "adverse reaction" may be more appropriate. Future studies in orthopaedic physical therapy should adopt the CONSORT statement extension on the reporting of harms, published in 2004, to ensure better reporting. Consistent reporting of harms in both research and clinical practice requires professional consensus on terminology pertaining to harms, as well as defining what constitutes an adverse event or an adverse reaction. Widespread consultation and consensus should support optimal definitions and processes and facilitate their implementation into practice. This paper is focused on theoretical considerations and evidence in terms of harm reporting within physical therapy using cervical manual therapy as an example.

  6. 78 FR 41125 - Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event Reporting

    Science.gov (United States)

    2013-07-09

    ... COMMISSION Interim Enforcement Policy for Permanent Implant Brachytherapy Medical Event Reporting AGENCY...'s permanent implant brachytherapy program. This interim policy affects NRC licensees that are authorized to perform permanent implant brachytherapy. DATES: This policy revision is effective July 9, 2013...

  7. Environmental Events and Life Satisfaction Reports of Adolescents: A Test of Cognitive Mediation.

    Science.gov (United States)

    Ash, Chris; Huebner, E. Scott

    2001-01-01

    Explores demographic, environmental, and personality correlates of adolescents' positive life satisfaction reports. Findings indicate that demographic variables did not relate to life satisfaction, and that acute events and chronic life experiences were related significantly to life satisfaction. Findings demonstrate the importance of integrative…

  8. The Role of a Research Administration Program in Adverse Event Reporting

    Science.gov (United States)

    Fedor, Carol; Cola, Philip; Polites, Stephanie

    2007-01-01

    The reporting, analysis, and management of adverse events (AEs) provide an ongoing assessment of risk in the context of a clinical trial and enhance the protection of human research participants and the informed consent process. Effective and efficient review of AEs has been a long-standing challenge for Institutional Review Boards (IRBs) and…

  9. Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

    NARCIS (Netherlands)

    de Vries, Sieta T.; Mol, Peter G. M.; de Zeeuw, Dick; Haaijer-Ruskamp, Flora M.; Denig, Petra

    2013-01-01

    Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to

  10. Adverse Events in the Netherlands Vaccination Programme : Reports in 2010 and Review 1994-2010

    NARCIS (Netherlands)

    Vermeer-de Bondt PE; Moorer-Lanser N; PHaff TAJ; Oostvogels B; Wesselo C; van der Maas NAT; LCI; cib

    2012-01-01

    In 2010, 800,000 children received one or more vaccines on 1.3 million dates, with more than 7 million vaccine components. There is always some chance of adverse reactions but these are usually not severe, though sometimes frightening. This year, RIVM received 1380 reports of adverse events

  11. Bad news: The influence of news coverage and Google searches on Gardasil adverse event reporting.

    Science.gov (United States)

    Faasse, Kate; Porsius, Jarry T; Faasse, Jonathan; Martin, Leslie R

    2017-12-14

    Human papilloma virus vaccines are a safe and effective tool for reducing HPV infections that can cause cervical cancer. However, uptake of these vaccines has been suboptimal, with many people holding negative beliefs and misconceptions. Such beliefs have been linked with the experience of unpleasant side effects following medical treatment, and media coverage may heighten such concerns. The present study sought to assess the influence of news coverage (number of news articles per month) on adverse event reporting in response to Gardasil vaccination in New Zealand over a 7.5-year period, and whether the influence of news coverage was mediated by internet search activity (Google search volumes). Multiple linear regression analyses and simple mediation analyses were used, controlling for year and number of vaccinations delivered. News coverage in the previous month, and Google search volumes in the same month, were significant predictors of adverse event reporting, after accounting for vaccination rates and year. Concurrent Google search volumes partially mediated the effect of prior news coverage. The results suggest that some of the adverse events reported were not related to the vaccination itself, but to news coverage and internet search volumes, which may have contributed to public concerns about potentially unpleasant or harmful outcomes. These findings have implications for the importance of psychological and social factors in adverse event reporting, and the role of the news media in disseminating health information. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...

  13. Self-Reported Life Events, Social Support and Psychological Problems in Adults with Intellectual Disabilities

    Science.gov (United States)

    Hulbert-Williams, Lee; Hastings, Richard P.; Crowe, Rachel; Pemberton, Jemma

    2011-01-01

    Background: Several studies have reported relationships between life events and psychological problems in people with intellectual disabilities. In contrast to the general literature, data have consistently been collected via proxy informants and putative moderator variables such as social support have not been examined. Materials and Methods:…

  14. Analytical models for parallel-processing systems. Technical report

    Energy Technology Data Exchange (ETDEWEB)

    Ammar, H.; Huang, Y.F.; Liu, R.

    1986-05-01

    This report proposes to use generalized stochastic Petri nets (GSPN) in reliability, maintainability, and availability studies. The novelty of this modeling approach results from the following distinctive reasons: (1) the GSPN offers a precise description of system activities and conditions while involving less complexity, comparing to other modeling techniques; specifically, it is an inherently effective bookkeeping for conditions and activities; (2) it provides a clairvoyant insight of the key parameters that effect RMA analysis; causes and results of events can be easily tracked by executing the GSPN; and (3) it takes the advantage of the existence of concurrency and timing of events, thus describes accurately the sequence of events.

  15. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...... of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. METHODS: All ADR reports handled by the ADEM in 2014 were recorded anonymously...... and analysed descriptively. RESULTS: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11...

  16. Adverse events associated with incretin-based drugs in Japanese spontaneous reports: a mixed effects logistic regression model

    Directory of Open Access Journals (Sweden)

    Daichi Narushima

    2016-03-01

    Full Text Available Background: Spontaneous Reporting Systems (SRSs are passive systems composed of reports of suspected Adverse Drug Events (ADEs, and are used for Pharmacovigilance (PhV, namely, drug safety surveillance. Exploration of analytical methodologies to enhance SRS-based discovery will contribute to more effective PhV. In this study, we proposed a statistical modeling approach for SRS data to address heterogeneity by a reporting time point. Furthermore, we applied this approach to analyze ADEs of incretin-based drugs such as DPP-4 inhibitors and GLP-1 receptor agonists, which are widely used to treat type 2 diabetes. Methods: SRS data were obtained from the Japanese Adverse Drug Event Report (JADER database. Reported adverse events were classified according to the MedDRA High Level Terms (HLTs. A mixed effects logistic regression model was used to analyze the occurrence of each HLT. The model treated DPP-4 inhibitors, GLP-1 receptor agonists, hypoglycemic drugs, concomitant suspected drugs, age, and sex as fixed effects, while the quarterly period of reporting was treated as a random effect. Before application of the model, Fisher’s exact tests were performed for all drug-HLT combinations. Mixed effects logistic regressions were performed for the HLTs that were found to be associated with incretin-based drugs. Statistical significance was determined by a two-sided p-value <0.01 or a 99% two-sided confidence interval. Finally, the models with and without the random effect were compared based on Akaike’s Information Criteria (AIC, in which a model with a smaller AIC was considered satisfactory. Results: The analysis included 187,181 cases reported from January 2010 to March 2015. It showed that 33 HLTs, including pancreatic, gastrointestinal, and cholecystic events, were significantly associated with DPP-4 inhibitors or GLP-1 receptor agonists. In the AIC comparison, half of the HLTs reported with incretin-based drugs favored the random effect

  17. Second-Order Multiagent Systems with Event-Driven Consensus Control

    Directory of Open Access Journals (Sweden)

    Jiangping Hu

    2013-01-01

    Full Text Available Event-driven control scheduling strategies for multiagent systems play a key role in future use of embedded microprocessors of limited resources that gather information and actuate the agent control updates. In this paper, a distributed event-driven consensus problem is considered for a multi-agent system with second-order dynamics. Firstly, two kinds of event-driven control laws are, respectively, designed for both leaderless and leader-follower systems. Then, the input-to-state stability of the closed-loop multi-agent system with the proposed event-driven consensus control is analyzed and the bound of the inter-event times is ensured. Finally, some numerical examples are presented to validate the proposed event-driven consensus control.

  18. A volcano-seismic event spotting system for the use in rapid response systems

    Science.gov (United States)

    Hammer, Conny; Ohrnberger, Matthias

    2010-05-01

    The classification of seismic signals of volcanic origin is an important task in monitoring active volcanoes. The number and size of certain types of seismic events usually increase before periods of volcanic crisis and can be used to quantify the volcanic activity. Due to the advantage of providing consistent, objective and time-invariant results automatic classification systems are preferred. Most automatic classification systems are trained in a supervised fashion from a sufficiently large pre-classified data set. The setup of an automatic classification system thus requires the pre-existence of these training data. For a rapid volcano-response team, however, the situation is often different. In the worst case, no prior observations exist (e.g. re-awakening of a dormant volcano). More frequently, archive data exist for a particular observatory network, but no record of seismicity for a high volcanic activity level exists and new seismicity patterns occur. Usually, the networks are additionally sparse and new equipment will be installed for better surveillance during the actual crisis. For the new recording sites again no prior example data is available. Finally, due to the imminent crisis there might be no time for the time-consuming and tedious process of preparing a training data set. For all these reasons a classification system which allows a "learning-while-recording" approach would be very advantageous for use in rapid response systems. Within this study, we show a novel seismic event spotting approach in order to reduce the dependency on the existence of previously acquired data bases and classification schemes. One main goal is therefore to provide the observatory staff with a robust event classification system based on a minimum number of reference waveforms and thus allowing for a fast build-up of a volcanic signal classification scheme as early as interesting events have been identified. For implementation issues we make use of the Hidden Markov

  19. 'Case reporting of rare adverse events in otolaryngology': can we defend the case report?

    LENUS (Irish Health Repository)

    Dias, Andrew

    2012-01-31

    The study of errors in medicine has proliferated since the publication of The Institute of Medicine Report \\'TO ERR IS HUMAN\\' in 2000. Case nuances and process of care issues are valuable areas to explore if the goal is to provide the health care worker with the knowledge to avoid future errors. Meta-analysis and randomized controlled trials provide a large data base of evidence towards improvement and opportunities, but it is suggested that case reports can still provide valuable clinical information. The aim is to use the published literature to produce a series of rare harm case reports in E.N.T. The methods include systematic literature review. Journals searched in PUBMED were 60. Rare harm case obtained from the search were 5,322. Rare harm case reports not reported in any other form of evidence-based medicine were 40. Yes, the case report can be defended as it is an important pillar of evidence-based medicine.

  20. Analysis of earth-moving systems using discrete-event

    Directory of Open Access Journals (Sweden)

    K.M. Shawki

    2015-09-01

    Full Text Available Discrete-event simulation has been widely used technique in analyzing construction operations for the past three decades due to its great effect on optimizing cost and productivity. In this paper we will present Arena as a tool for simulating earthwork operations, the advantage of Arena is its easiness and flexibility in simulating most kinds of models in different areas of construction. A case study will be presented, a model will be built and results obtained to reveal the mentioned objectives.

  1. An assessment of an educational intervention on resident physician attitudes, knowledge, and skills related to adverse event reporting.

    Science.gov (United States)

    Jericho, Barbara G; Tassone, Rosalie F; Centomani, Nikki M; Clary, Jennifer; Turner, Crescent; Sikora, Michael; Mayer, David; McDonald, Timothy

    2010-06-01

    Reporting and learning from events linked to patient harm and unsafe conditions is critical to improving patient safety. Programs that engage resident physicians in adverse event reporting can enhance patient safety and simultaneously address all 6 Accreditation Council for Graduate Medical Education competencies. Yet fewer than 60% of physicians know how to report adverse events and near misses, and fewer than 40% know what to report. Our study evaluated the effect of an educational intervention on anesthesiology residents' attitudes, knowledge, and skills related to adverse event reporting and the associated follow-up. In a prospective study, anesthesiology residents participated in a training program focused on the importance of reporting methods and on reporting adverse events for patient safety. Quarterly adverse event reports were analyzed retrospectively for 2 years before the intervention and prospectively for 7 quarters after the intervention. Residents also completed a survey, before and 1 year after the intervention, that evaluated their attitudes, experience, and knowledge regarding adverse event reporting. After the intervention, the number of adverse event reports increased from 0 per quarter to almost 30 per quarter. We identified several categories of harm events, near misses, and unsafe conditions, including reports of disruptive providers. Of the harm events associated with invasive procedures, more than half were associated with lack of attending physician supervision. We also observed significant progress in the residents' ability to appropriately file a report, improved attitudes regarding the value of reporting and available emotional support, and a reduction in the perceived impediments to reporting. An educational intervention increased the number of adverse event reports submitted by anesthesiology residents, improved their attitudes about the importance of reporting, and produced a source for learning opportunities and process

  2. Debugging and Event Tracing for Multi-Agent Systems Project

    Data.gov (United States)

    National Aeronautics and Space Administration — Large-scale agent systems have become a key part of in modeling and simulation tools such as NASA's Airspace Concept Evaluation System (ACES), an agent-based...

  3. Debugging and Event Tracing for Multi-Agent Systems Project

    Data.gov (United States)

    National Aeronautics and Space Administration — Large-scale agent systems have become key tools in modeling and simulation tools such as NASA's Airspace Concept Evaluation System (ACES), an agent-based simulation...

  4. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Science.gov (United States)

    2010-04-01

    ... reporting codes for adverse events that I use with medical device reports? (a) The MEDWATCH Medical Device Reporting Code Instruction Manual contains adverse event codes for use with FDA Form 3500A. You may obtain... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Where can I find the reporting codes for adverse...

  5. Detection of events of public health importance under the international health regulations: a toolkit to improve reporting of unusual events by frontline healthcare workers.

    Science.gov (United States)

    MacDonald, Emily; Aavitsland, Preben; Bitar, Dounia; Borgen, Katrine

    2011-09-21

    The International Health Regulations (IHR (2005)) require countries to notify WHO of any event which may constitute a public health emergency of international concern. This notification relies on reports of events occurring at the local level reaching the national public health authorities. By June 2012 WHO member states are expected to have implemented the capacity to "detect events involving disease or death above expected levels for the particular time and place" on the local level and report essential information to the appropriate level of public health authority. Our objective was to develop tools to assist European countries improve the reporting of unusual events of public health significance from frontline healthcare workers to public health authorities. We investigated obstacles and incentives to event reporting through a systematic literature review and expert consultations with national public health officials from various European countries. Multi-day expert meetings and qualitative interviews were used to gather experiences and examples of public health event reporting. Feedback on specific components of the toolkit was collected from healthcare workers and public health officials throughout the design process. Evidence from 79 scientific publications, two multi-day expert meetings and seven qualitative interviews stressed the need to clarify concepts and expectations around event reporting in European countries between the frontline and public health authorities. An analytical framework based on three priority areas for improved event reporting (professional engagement, communication and infrastructure) was developed and guided the development of the various tools. We developed a toolkit adaptable to country-specific needs that includes a guidance document for IHR National Focal Points and nine tool templates targeted at clinicians and laboratory staff: five awareness campaign tools, three education and training tools, and an implementation plan. The

  6. Objectively Measured, but Not Self-Reported, Medication Adherence Independently Predicts Event-Free Survival in Patients With Heart Failure

    Science.gov (United States)

    WU, JIA-RONG; MOSER, DEBRA K.; CHUNG, MISOOK L.; LENNIE, TERRY A.

    2009-01-01

    Objective Medication nonadherence is presumed to be related to poor clinical outcomes, yet this relationship rarely has been tested using objective adherence measures in patients with heart failure. Which objective indicators of medication adherence predict clinical outcomes are unknown. The study objective was to determine which indicators of medication adherence are predictors of event-free survival. Methods Patients (N = 134) with heart failure (69% were male, aged 61 ± 11 years, 61% with New York Heart Association class III/IV heart disease) were enrolled in this 6-month longitudinal study. Adherence was measured using two measures: 1) an objective measure, the Medication Event Monitoring System (MEMS); and 2) self-reported adherence (Medical Outcomes Studies Specific Adherence Scale). Three indicators of adherence were assessed by MEMS: 1) dose-count, percentage of prescribed doses taken; 2) dose-days, percentage of days correct number of doses taken; and 3) dose-time, percentage of doses taken on schedule. Events (emergency department visits, rehospitalization, and mortality) were obtained by patient/family interview and hospital databases. Results In Cox regression, two of the three MEMS indicators, dose-count and dose-day, predicted event-free survival before and after controlling for age, gender, ejection fraction, New York Heart Association class, angiotensin-converting enzyme inhibitor use, and beta-blocker use (P = .004, P = .008, and P = .224, respectively). Self-report adherence did not predict outcomes (P = .402). Conclusion Dose-count and dose-day predicted event-free survival. Neither dose-time nor self-reported adherence predicted outcomes. Health care providers should assess specific behaviors related to medication taking rather than a global patient self-assessment of patient adherence. PMID:18381183

  7. Sequential Window Diagnoser for Discrete-Event Systems Under Unreliable Observations

    Energy Technology Data Exchange (ETDEWEB)

    Wen-Chiao Lin; Humberto E. Garcia; David Thorsley; Tae-Sic Yoo

    2009-09-01

    This paper addresses the issue of counting the occurrence of special events in the framework of partiallyobserved discrete-event dynamical systems (DEDS). Developed diagnosers referred to as sequential window diagnosers (SWDs) utilize the stochastic diagnoser probability transition matrices developed in [9] along with a resetting mechanism that allows on-line monitoring of special event occurrences. To illustrate their performance, the SWDs are applied to detect and count the occurrence of special events in a particular DEDS. Results show that SWDs are able to accurately track the number of times special events occur.

  8. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.

    Science.gov (United States)

    Bruland, Philipp; McGilchrist, Mark; Zapletal, Eric; Acosta, Dionisio; Proeve, Johann; Askin, Scott; Ganslandt, Thomas; Doods, Justin; Dugas, Martin

    2016-11-22

    Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

  9. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

    Directory of Open Access Journals (Sweden)

    Philipp Bruland

    2016-11-01

    Full Text Available Abstract Background Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Methods Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. Results The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Conclusions Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

  10. Serious reportable events within the inpatient mental health care: Impact on physicians and nurses.

    Science.gov (United States)

    Martens, J; Van Gerven, E; Lannoy, K; Panella, M; Euwema, M; Sermeus, W; De Hert, M; Vanhaecht, K

    2016-07-01

    To investigate the prevalence of physicians and nurses involved in an adverse event within mental health. A quantitative, cross-sectional study was performed. Six Flemish psychiatric hospitals (Belgium) participated in this exploratory cross-sectional study. All psychiatrists and nurses working in these hospitals were invited to complete an online questionnaire in March 2013. 28 psychiatrists and 252 nurses completed the survey. 205 (73%) of the 280 respondents were personally involved at least once in an adverse event within their entire career. Respondents reported that the adverse event with the greatest impact was related to suicide in almost 64% of the cases. About one in eight respondents considered quitting their job because of it. Almost 18% declared that due to the impact of the event, they believed that the quality of the administered care was affected for longer than one month. Respondents stated that they received much support of colleagues (95%), the chief nurse (86%) and the partner (71%). Colleagues seemed to be most supportive in the recovery process. Physicians and nurses working in inpatient mental health care may be at high risk to being confronted with an adverse event at some point in their career. The influence on health professionals involved in an adverse event on their work is particularly important in the first 4-24h. Professionals at those moments had higher likelihood to be involved in another adverse event. Institutions should seriously consider giving support almost at that time. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Inter-rater reliability of professional-caregiver-reported life events in adults with intellectual disabilities.

    Science.gov (United States)

    Hove, O; Assmus, J; Braatveit, K; Havik, O E

    2017-07-01

    The inter-rater reliability (IRR) of the measure of life events in adults with intellectual disabilities was investigated. Two staff members for each of 79 adults with intellectual disabilities (ID) living in group homes used a checklist to report the adults' exposure to and intensity of life events over the previous 12 months. The IRR was estimated with intraclass correlation analysis (ICC). The factors of the level of ID, number of years the rater knew the rated person and quality of community care were investigated for possible associations with level of reliability. The ICC values for the occurrence of life events were .44-.80 depending on the category of life events. In general, intensity measures showed lower ICC values. When the rater had known the person rated for 2 or more years or the quality of community care was high, the ICC values increased, whereas lower levels of ID were associated with lower ICC values. Inter-rater reliability in general was found to be acceptable. Further development and research are needed to improve the reliability of life event measures for more severe ID. © 2017 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

  12. Enhancing the Effectiveness of Significant Event Analysis: Exploring Personal Impact and Applying Systems Thinking in Primary Care.

    Science.gov (United States)

    Bowie, Paul; McNaughton, Elaine; Bruce, David; Holly, Deirdre; Forrest, Eleanor; Macleod, Marion; Kennedy, Susan; Power, Ailsa; Toppin, Denis; Black, Irene; Pooley, Janet; Taylor, Audrey; Swanson, Vivien; Kelly, Moya; Ferguson, Julie; Stirling, Suzanne; Wakeling, Judy; Inglis, Angela; McKay, John; Sargeant, Joan

    2016-01-01

    Significant event analysis (SEA) is well established in many primary care settings but can be poorly implemented. Reasons include the emotional impact on clinicians and limited knowledge of systems thinking in establishing why events happen and formulating improvements. To enhance SEA effectiveness, we developed and tested "guiding tools" based on human factors principles. Mixed-methods development of guiding tools (Personal Booklet-to help with emotional demands and apply a human factors analysis at the individual level; Desk Pad-to guide a team-based systems analysis; and a written Report Format) by a multiprofessional "expert" group and testing with Scottish primary care practitioners who submitted completed enhanced SEA reports. Evaluation data were collected through questionnaire, telephone interviews, and thematic analysis of SEA reports. Overall, 149/240 care practitioners tested the guiding tools and submitted completed SEA reports (62.1%). Reported understanding of how to undertake SEA improved postintervention (P systems issues (85/123, 69.1%), while most found the Report Format clear (94/123, 76.4%) and would recommend it (88/123, 71.5%). Most SEA reports adopted a systems approach to analyses (125/149, 83.9%), care improvement (74/149, 49.7), or planned actions (42/149, 28.2%). Applying human factors principles to SEA potentially enables care teams to gain a systems-based understanding of why things go wrong, which may help with related emotional demands and with more effective learning and improvement.

  13. A systematic review of adverse event reporting in companion animal clinical trials evaluating cancer treatment.

    Science.gov (United States)

    Giuffrida, Michelle A

    2016-11-01

    OBJECTIVE To evaluate methods used to ascertain, define, and report adverse events (AEs) in companion animal clinical trials involving cancer treatment. DESIGN Systematic review. SAMPLE English-language articles describing prospective clinical trials involving dogs and cats with naturally occurring cancer published in peer-reviewed journals between 2008 and 2014. PROCEDURES Reports were identified via MEDLINE and CAB database searches combined with a hand-searching strategy. General article characteristics were abstracted and summarized. Data for AE reporting were collected with a 14-item checklist adapted from the 2004 CONSORT extension for reporting harms. Study characteristics associated with the AE reporting checklist score were identified by means of linear regression analysis. RESULTS 168 articles with data for 6,132 animals were included. Standardized terminology was significantly more likely to be used to describe AEs for trials that included chemotherapy (92/115 [80.0%]) than for trials that did not (16/53 [30.2%]). Median AE reporting checklist score was 5 out of 14 (range, 0 to 12). Poorly reported items included methods and time frame of AE ascertainment, AE data analysis, and reasons for treatment discontinuation and death. Trials with industry funding, a single-arm design, and treatment with chemotherapy were associated with a significantly higher quality of AE reporting. CONCLUSIONS AND CLINICAL RELEVANCE Reporting of adverse events in veterinary clinical trials evaluating cancer treatment was selective and heterogeneous. Harms associated with cancer treatments could be underestimated because of suboptimal collection and reporting of AE data. Findings supported the adoption of a higher standard for AE surveillance and reporting in veterinary patients.

  14. Demand response pilot event conducted August 2,2011 : summary report.

    Energy Technology Data Exchange (ETDEWEB)

    Lincoln, Donald; Evans, Christoper

    2012-01-01

    Energy management in a commercial facility can be segregated into two areas: energy efficiency and demand response (DR). Energy efficiency focuses on steady-state load minimization. Demand response reduces load for event driven periods during the peak load. Demand-response-driven changes in electricity use are designed to be short-term in nature, centered on critical hours during the day when demand is high or when the electricity supplier's reserve margins are low. Due to the recent Federal Energy Regulatory Commission (FERC) Order 745, Demand Response Compensation in Organized Wholesale Energy Markets the potential annual compensation to Sandia National Laboratories (SNL) from performing DR ranges from $300K to $2,400K. While the current energy supply contract does not offer any compensation for participating in DR, there is benefit in understanding the issues and potential value in performing a DR event. This Report will be helpful in upcoming energy supply contract negotiations to quantify the energy savings and power reduction potential from DR at SNL. On August 25, 2011 the Facilities Management and Operations Center (FMOC) performed the first DR pilot event at SNL/NM. This report describes the details and results of this DR event.

  15. Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis.

    Science.gov (United States)

    Belknap, Steven M; Aslam, Imran; Kiguradze, Tina; Temps, William H; Yarnold, Paul R; Cashy, John; Brannigan, Robert E; Micali, Giuseppe; Nardone, Beatrice; West, Dennis P

    2015-06-01

    Two meta-analyses conclude that finasteride treatment of androgenic alopecia (AGA) is safe but do not assess quality of safety reporting. To assess safety reporting for clinical trial reports of finasteride for AGA. MEDLINE, ClinicalTrials.gov, and a clinical data repository for an academic medical center. Published clinical trial reports for finasteride treatment of AGA. For each trial, we assessed quality of adverse event reporting, extracted the number and type of adverse events in treatment and placebo groups, and assessed duration of safety evaluation and adequacy of blinding. Two observers independently extracted the data; differences were resolved by consensus. We assessed generalizability in a large cohort of men prescribed finasteride, 1.25 mg/d or less, by assessing for eligibility in the finasteride-AGA pivotal trials. Quality was assessed as adequate, partially adequate, inadequate, or no events reported. We used funnel plots of the hazard ratio to assess bias. Of 34 clinical trials, none had adequate safety reporting, 19 were partially adequate, 12 were inadequate, and 3 reported no adverse events. Funnel plots were asymmetric with a bias toward lower odds ratio for sexual adverse effects, suggesting systematic underdetection. No reports assessed adequacy of blinding, 18 (53%) disclosed conflicts of interest, and 19 (56%) received funding from the manufacturer. Duration of drug safety evaluation was 1 year or less for 26 of 34 trials (76%). Of 5704 men in the clinical data repository who were treated for AGA with finasteride, 1.25 mg/d or less, for AGA, only 31% met inclusion criteria for the pivotal trials referenced in the manufacturer's full prescribing information and 33% took finasteride for more than 1 year. Available toxicity information from clinical trials of finasteride in men with AGA is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of AGA, most would

  16. Quality of the record of drug-related problems in a database for voluntary adverse event reporting

    Directory of Open Access Journals (Sweden)

    Maria Teresa Aznar-Saliente

    2017-07-01

    Full Text Available Objective: To determine the number and type of errors found in the record of drug-related problems in the SINEA database, an electronic system for voluntary reporting of adverse events in healthcare, in order to quantify the differences between the raw and refined databases, suggest improvements, and determine the need for refining said databases. Methods: A Pharmacist reviewed the database and refined the adverse events reported from January to August, 2014, considering the “describe_what_happened” field as the gold standard. There was a comparison of the rates of medication errors, both potential and real, adverse reactions, impact on the patient, impact on healthcare, and medications more frequently involved in the raw and refined databases. Agreement was calculated through Cohen’s Kappa Coefficient. Results: 364 adverse events were reported: 66.7% were medication errors, 2.7% adverse reactions to the medication (2 were wrongly classified as both, showing a total percentage >100% and 31% were other events. After refinement, the percentages were 69.5%, 5.8% and 24.7%, respectively (κ=0.85; CI95% [0.80-0.90]. Before refinement, 73.6% of medication errors were considered potential vs. 82.3% after refinement (κ=0.65; CI95% [0.54- 0.76]. The medication most frequently involved was trastuzumab (20.9%. The “molecule” field was blank in 133 entries. A mean of 1.8±1.9 errors per entry were detected. Conclusions: Although agreement is good, the refinement process cannot be avoided, as it provides valuable information to improve pharmacotherapy. Data quality could be improved by reducing the number of type-in text fields, using drop-down lists, and by increasing the training of the reporters.

  17. A Numerical Approach for Hybrid Simulation of Power System Dynamics Considering Extreme Icing Events

    DEFF Research Database (Denmark)

    Chen, Lizheng; Zhang, Hengxu; Wu, Qiuwei

    2017-01-01

    The global climate change leads to more extreme meteorological conditions such as icing weather, which have caused great losses to power systems. Comprehensive simulation tools are required to enhance the capability of power system risk assessment under extreme weather conditions. A hybrid...... numerical simulation scheme integrating icing weather events with power system dynamics is proposed to extend power system numerical simulation. A technique is developed to efficiently simulate the interaction of slow dynamics of weather events and fast dynamics of power systems. An extended package for PSS....../E enabling hybrid simulation of icing event and power system disturbance is developed, based on which a hybrid simulation platform is established. Numerical studies show that the functionality of power system simulation is greatly extended by taking into account the icing weather events....

  18. Building a time-saving and adaptable tool to report adverse drug events.

    Science.gov (United States)

    Parès, Yves; Declerck, Gunnar; Hussain, Sajjad; Ng, Romain; Jaulent, Marie-Christine

    2013-01-01

    The difficult task of detecting adverse drug events (ADEs) and the tedious process of building manual reports of ADE occurrences out of patient profiles result in a majority of adverse reactions not being reported to health regulatory authorities. The SALUS individual case safety report (ICSR) reporting tool, a component currently developed within the SALUS project, aims to support semi-automatic reporting of ADEs to regulatory authorities. In this paper, we present an initial design and current state of of our ICSR reporting tool that features: (i) automatic pre-population of reporting forms through extraction of the patient data contained in an Electronic Health Record (EHR); (ii) generation and electronic submission of the completed ICSRs by the physician to regulatory authorities; and (iii) integration of the reporting process into the physician's work-flow to limit the disturbance. The objective is to increase the rates of ADE reporting and the quality of the reported data. The SALUS interoperability platform supports patient data extraction independently of the EHR data model in use and allows generation of reports using the format expected by regulatory authorities.

  19. Self-reported potentially traumatic life events and symptoms of post-traumatic stress and dissociation.

    Science.gov (United States)

    Nilsson, Doris; Gustafsson, Per E; Svedin, Carl Göran

    2010-01-01

    To investigate single potentially traumatic events and cumulative effects of these events based on the reported symptoms of post-traumatic stress and dissociation. An additional goal was to evaluate the psychometric properties of Life Incidence of Traumatic Events-Student scale (LITE-S). 400 adolescents from the normative population answered the questionnaire Life Incidence of Traumatic Experiences (LITE-S) together with Trauma Symptom Checklist for Children (TSCC), Dissociation-Questionnaire-Sweden (Dis-Q-Sweden) and Adolescent-Dissociative Experience Scale (A-DES). The single self-reported traumas, and the cumulative self-reported traumas and their effects on post-traumatic stress disorder and dissociative symptoms scales were examined. The psychometric properties of LITE-S were first investigated through calculating, test-retest reliability by Pearson correlation for the total scale and by Cohen's kappa item per item. Self-reported symptoms were related to both the cumulative traumas and exposure to some single traumas, such as seeing somebody get hurt, having parents destroy things or hurting each other, being whipped or hit, or even being made to carry out some kind of sexual act. Interpersonal events were consistently more strongly related to symptoms across the TSCC clinical scales. Finally, test-retest reliability as found to be for the total scale r=0.76 and kappa item per item ranging between k=0.33 and 0.86. The cumulative effects of potentially traumatic events on adolescents are significant, and interpersonal traumas results in more self-reported symptoms of post-traumatic stress and dissociation than non-interpersonal. LITE has satisfactory psychometric properties concerning reliability. The results underline the importance in clinical practice of taking into consideration how many potentially traumatic events an adolescent has experienced before, seeking help on specific occasion. This knowledge can help the clinician to understand better the breadth

  20. Analyzing System on A Chip Single Event Upset Responses using Single Event Upset Data, Classical Reliability Models, and Space Environment Data

    Science.gov (United States)

    Berg, Melanie; LaBel, Kenneth; Campola, Michael; Xapsos, Michael

    2017-01-01

    We are investigating the application of classical reliability performance metrics combined with standard single event upset (SEU) analysis data. We expect to relate SEU behavior to system performance requirements. Our proposed methodology will provide better prediction of SEU responses in harsh radiation environments with confidence metrics. single event upset (SEU), single event effect (SEE), field programmable gate array devises (FPGAs)

  1. Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

    Science.gov (United States)

    Hunsinger, Matthew; Smith, Shannon M; Rothstein, Daniel; McKeown, Andrew; Parkhurst, Melissa; Hertz, Sharon; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Turk, Dennis C; Dworkin, Robert H

    2014-11-01

    Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs. Copyright © 2014 International Association for the Study of Pain. All rights reserved.

  2. Development of an adverse events reporting form for Korean folk medicine.

    Science.gov (United States)

    Park, Jeong Hwan; Choi, Sun-Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min-Kyeoung; Lee, Sanghun

    2017-05-01

    We developed an adverse events (AEs) reporting form for Korean folk medicine. The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

  3. Development of an adverse events reporting form for Korean folk medicine

    Science.gov (United States)

    Park, Jeong Hwan; Choi, Sun‐Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min‐Kyeoung

    2016-01-01

    Abstract Purpose We developed an adverse events (AEs) reporting form for Korean folk medicine. Methods The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. Results We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. Conclusions This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. PMID:27501410

  4. An Event-based Approach to Hybrid Systems Diagnosability

    Data.gov (United States)

    National Aeronautics and Space Administration — Diagnosability is an important issue in the design of diagnostic systems, because it helps identify whether sufficient information is available to distinguish all...

  5. Importance sampling of rare events in chaotic systems

    Science.gov (United States)

    Leitão, Jorge C.; Parente Lopes, João M. Viana; Altmann, Eduardo G.

    2017-10-01

    Finding and sampling rare trajectories in dynamical systems is a difficult computational task underlying numerous problems and applications. In this paper we show how to construct Metropolis-Hastings Monte-Carlo methods that can efficiently sample rare trajectories in the (extremely rough) phase space of chaotic systems. As examples of our general framework we compute the distribution of finite-time Lyapunov exponents (in different chaotic maps) and the distribution of escape times (in transient-chaos problems). Our methods sample exponentially rare states in polynomial number of samples (in both low- and high-dimensional systems). An open-source software that implements our algorithms and reproduces our results can be found in reference [J. Leitao, A library to sample chaotic systems, 2017, https://github.com/jorgecarleitao/chaospp].

  6. Algorithm for Screening Phasor Measurement Unit Data for Power System Events and Categories and Common Characteristics for Events Seen in Phasor Measurement Unit Relative Phase-Angle Differences and Frequency Signals

    Energy Technology Data Exchange (ETDEWEB)

    Allen, A.; Santoso, S.; Muljadi, E.

    2013-08-01

    A network of multiple phasor measurement units (PMU) was created, set up, and maintained at the University of Texas at Austin to obtain actual power system measurements for power system analysis. Power system analysis in this report covers a variety of time ranges, such as short- term analysis for power system disturbances and their effects on power system behavior and long- term power system behavior using modal analysis. The first objective of this report is to screen the PMU data for events. The second objective of the report is to identify and describe common characteristics extracted from power system events as measured by PMUs. The numerical characteristics for each category and how these characteristics are used to create selection rules for the algorithm are also described. Trends in PMU data related to different levels and fluctuations in wind power output are also examined.

  7. Quality of reporting in systematic reviews of adverse events: systematic review

    Science.gov (United States)

    Zorzela, Liliane; Golder, Su; Liu, Yali; Pilkington, Karen; Hartling, Lisa; Joffe, Ari; Loke, Yoon

    2014-01-01

    Objectives To examine the quality of reporting of harms in systematic reviews, and to determine the need for a reporting guideline specific for reviews of harms. Design Systematic review. Data sources Cochrane Database of Systematic Reviews (CDSR) and Database of Abstracts of Reviews of Effects (DARE). Review methods Databases were searched for systematic reviews having an adverse event as the main outcome, published from January 2008 to April 2011. Adverse events included an adverse reaction, harms, or complications associated with any healthcare intervention. Articles with a primary aim to investigate the complete safety profile of an intervention were also included. We developed a list of 37 items to measure the quality of reporting on harms in each review; data were collected as dichotomous outcomes (“yes” or “no” for each item). Results Of 4644 reviews identified, 309 were systematic reviews or meta-analyses primarily assessing harms (13 from CDSR; 296 from DARE). Despite a short time interval, the comparison between the years of 2008 and 2010-11 showed no difference on the quality of reporting over time (P=0.079). Titles in fewer than half the reviews (proportion of reviews 0.46 (95% confidence interval 0.40 to 0.52)) did not mention any harm related terms. Almost one third of DARE reviews (0.26 (0.22 to 0.31)) did not clearly define the adverse events reviewed, nor did they specify the study designs selected for inclusion in their methods section. Almost half of reviews (n=170) did not consider patient risk factors or length of follow-up when reviewing harms of an intervention. Of 67 reviews of complications related to surgery or other procedures, only four (0.05 (0.01 to 0.14)) reported professional qualifications of the individuals involved. The overall, unweighted, proportion of reviews with good reporting was 0.56 (0.55 to 0.57); corresponding proportions were 0.55 (0.53 to 0.57) in 2008, 0.55 (0.54 to 0.57) in 2009, and 0.57 (0.55 to 0.58) in

  8. Event-Driven Contrastive Divergence for Spiking Neuromorphic Systems

    Directory of Open Access Journals (Sweden)

    Emre eNeftci

    2014-01-01

    Full Text Available Restricted Boltzmann Machines (RBMs and Deep Belief Networks have been demonstrated to perform efficiently in variety of applications, such as dimensionality reduction, feature learning, and classification. Their implementation on neuromorphic hardware platforms emulating large-scale networks of spiking neurons can have significant advantages from the perspectives of scalability, power dissipation and real-time interfacing with the environment. However the traditional RBM architecture and the commonly used training algorithm known as Contrastive Divergence (CD are based on discrete updates and exact arithmetics which do not directly map onto a dynamical neural substrate. Here, we present an event-driven variation of CD to train a RBM constructed with Integrate & Fire (I&F neurons, that is constrained by the limitations of existing and near future neuromorphic hardware platforms. Our strategy is based on neural sampling, which allows us to synthesize a spiking neural network that samples from a target Boltzmann distribution. The reverberating activity of the network replaces the discrete steps of the CD algorithm, while Spike Time Dependent Plasticity (STDP carries out the weight updates in an online, asynchronous fashion.We demonstrate our approach by training an RBM composed of leaky I&F neurons with STDP synapses to learn a generative model of the MNIST hand-written digit dataset, and by testing it in recognition, generation and cue integration tasks. Our results contribute to a machine learning-driven approach for synthesizing networks of spiking neurons capable of carrying out practical, high-level functionality.

  9. An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. FUNDING: none. TRIAL REGISTRATION: not relevant. ....

  10. Hierarchical Address Event Routing for Reconfigurable Large-Scale Neuromorphic Systems.

    Science.gov (United States)

    Park, Jongkil; Yu, Theodore; Joshi, Siddharth; Maier, Christoph; Cauwenberghs, Gert

    2017-10-01

    We present a hierarchical address-event routing (HiAER) architecture for scalable communication of neural and synaptic spike events between neuromorphic processors, implemented with five Xilinx Spartan-6 field-programmable gate arrays and four custom analog neuromophic integrated circuits serving 262k neurons and 262M synapses. The architecture extends the single-bus address-event representation protocol to a hierarchy of multiple nested buses, routing events across increasing scales of spatial distance. The HiAER protocol provides individually programmable axonal delay in addition to strength for each synapse, lending itself toward biologically plausible neural network architectures, and scales across a range of hierarchies suitable for multichip and multiboard systems in reconfigurable large-scale neuromorphic systems. We show approximately linear scaling of net global synaptic event throughput with number of routing nodes in the network, at 3.6×107 synaptic events per second per 16k-neuron node in the hierarchy.

  11. The Development and the Evaluation of a System for Extracting Events from Web Pages

    Directory of Open Access Journals (Sweden)

    Mihai-Constantin AVORNICULUI

    2010-01-01

    Full Text Available The centralization of a particular event is primarily useful for running news services. These services should provide updated information, if possible even in real time, on a specific type of event. These events and their extraction involved the automatic analysis of linguistic structure documents to determine the possible sequences in which these events occur in documents. This analysis will provide structured and semi-structured documents in which the unit events can be extracted automatically. In order to measure the quality of a system, a methodology will be introduced, which describes the stages and how the decomposition of a system for extracting events in components, quality attributes and properties will be defined for these components, and finally will be introduced metrics for evaluation.

  12. Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review.

    Science.gov (United States)

    Williams, Mark R; McKeown, Andrew; Pressman, Zachary; Hunsinger, Matthew; Lee, Kendrick; Coplan, Paul; Gilron, Ian; Katz, Nathaniel P; McDermott, Michael P; Raja, Srinivasa N; Rappaport, Bob A; Rowbotham, Michael C; Turk, Dennis C; Dworkin, Robert H; Smith, Shannon M

    2016-11-01

    Thorough assessment and reporting of adverse events (AEs) facilitates a detailed understanding of a treatment's risk-benefit profile. Although the Consolidated Standards of Reporting Trials (CONSORT) 2004 statement provides recommendations regarding AE reporting, adherence to these standards is often inadequate. We investigated AE reporting in clinical trials of intravenous and invasive pain treatments published in 6 major anesthesiology and pain journals between 2000 to 2003 and 2006 to 2012. We examined whether AE reporting improved after publication of the 2004 CONSORT recommendations and also comprehensively reviewed AE assessment using the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting recommendations. No improvement was found overall in CONSORT harms reporting scores from pre- to postpublication of the CONSORT recommendations, with only 5 of 10 fulfilled on average. AE reporting assessed using the ACTTION coding manual was generally inadequate, and 8% of articles failed to report any AE information at all. Anesthesiology and pain journals were similar in AE reporting quality, although industry-sponsored trials reported more AE information than nonindustry sponsored trials. Improvement is needed in AE reporting in analgesic clinical trials. The CONSORT checklist and ACTTION AE recommendations can assist investigators and editors in improving clinical trial transparency and quality. This systematic review of AE reporting in intravenous and invasive pain treatment trials shows that little improvement has been made since the 2004 CONSORT harms reporting guidelines. Better assessment and reporting of treatment AEs is necessary to understand the full clinical effect of intravenous and invasive treatments. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  13. Torsadogenic risk of antipsychotics: combining adverse event reports with drug utilization data across Europe.

    Directory of Open Access Journals (Sweden)

    Emanuel Raschi

    Full Text Available BACKGROUND: Antipsychotics (APs have been associated with risk of torsade de Pointes (TdP. This has important public health implications. Therefore, (a we exploited the public FDA Adverse Event Reporting System (FAERS to characterize their torsadogenic profile; (b we collected drug utilization data from 12 European Countries to assess the population exposure over the 2005-2010 period. METHODS: FAERS data (2004-2010 were analyzed based on the following criteria: (1 ≥ 4 cases of TdP/QT abnormalities; (2 Significant Reporting Odds Ratio, ROR [Lower Limit of the 95% confidence interval>1], for TdP/QT abnormalities, adjusted and stratified (Arizona CERT drugs as effect modifiers; (3 ≥ 4 cases of ventricular arrhythmia/sudden cardiac death (VA/SCD; (4 Significant ROR for VA/SCD; (5 Significant ROR, combined by aggregating TdP/QT abnormalities with VA and SCD. Torsadogenic signals were characterized in terms of signal strength: from Group A (very strong torsadogenic signal: all criteria fulfilled to group E (unclear/uncertain signal: only 2/5 criteria. Consumption data were retrieved from 12 European Countries and expressed as defined daily doses per 1,000 inhabitants per day (DID. RESULTS: Thirty-five antipsychotics met at least one criterium: 9 agents were classified in Group A (amisulpride, chlorpromazine, clozapine, cyamemazine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone. In 2010, the overall exposure to antipsychotics varied from 5.94 DID (Estonia to 13.99 (France, 2009. Considerable increment of Group A agents was found in several Countries (+3.47 in France: the exposure to olanzapine increased across all Countries (+1.84 in France and peaked 2.96 in Norway; cyamemazine was typically used only in France (2.81 in 2009. Among Group B drugs, levomepromazine peaked 3.78 (Serbia; fluphenazine 1.61 (Slovenia. CONCLUSIONS: This parallel approach through spontaneous reporting and drug utilization analyses highlighted drug- and

  14. Event maps in a stick-slip system

    DEFF Research Database (Denmark)

    Galvanetto, Ugo; Knudsen, Carsten

    1997-01-01

    This paper describes a one-dimensional map generated by a two degree-of-freedom mechanical system that undergoes self-sustained oscillations induced by dry friction. The iterated map allows a much simpler representation and a better understanding of some dynamic features of the system. Some...... applications of the map are illustrated and its behaviour is simulated by means of an analytically defined one-dimensional map. A method of reconstructing one-dimensional maps from experimental data from the system is introduced. The method uses cubic splines to approximate the iterated mappings. From...... a sequence of such time series the parameter dependent bifurcation behaviour is analysed by interpolating between the defined mappings. Similarities and differences between the bifurcation behaviour of the exact iterated mapping and the reconstructed mapping are discussed....

  15. Knowledge, practice and approaches of health professionals to adverse events following immunization and their reporting in Albania

    Directory of Open Access Journals (Sweden)

    Irsida Mehmeti

    2017-06-01

    Full Text Available In Albania, the reporting of an adverse events following immunization (AEFI is done not only by immunization providers but also from clinicians providing clinical treatment of AEFI in health posts, health centers and private or public hospitals. The AEFI reporting system in Albania has started in 2001 with the establishment of National Regulatory Authority of Vaccines in the Institute of Public Health. The most important problems of passive surveillance systems include underreporting, deficiency and inaccuracy of information. A structured questionnaire containing 68 questions constructed from immunization experts constituted the study tool. The questionnaire addressed health professionals working at child consultant’s facilities and primary health centers in the district of Tirana. There were a total of 102 health professional interviewed. The majority of the respondents working at health centers in the district of Tirana in general, had poor knowledge levels on AEFI surveillance. The lowest score were received in knowledge about the role of different stakeholders involved in AEFI surveillance. The number of years practicing the profession did not influence in the total score of “practice and attitude toward reporting and managing an AEFI”. Although the majority of health care professionals have encountered an AEFI during their practice (72/102, 70,5%, only half of them have never reported an AEFI (37/102, 36,2%. Barriers to reporting included lack of interest, unclear definition of AEFI and lack of awareness of what to report. Nevertheless, the main reason for not reporting was because a respondent thought he or she had not observed an AEFI in the last years (44,1%. Majority of the respondents did not have any training about AEFI (68,6%, 70/102. From this study it is concluded that it is necessary to develop training and educational programs in order to increase awareness of all health professionals involved in child health toward

  16. A novel security information and event management system for enhancing cyber security in a hydroelectric dam.

    OpenAIRE

    Matteucci, Ilaria; Di Sarno, Cesario; Garofalo, Alessia; Vallini, Marco

    2016-01-01

    Security information and event management (SIEM) systems are increasingly used to cope with the security challenges involved in critical infrastructure protection. However, these systems have several limitations. This paper describes an enhanced security information and event management system that (i) resolves conflicts between security policies; (ii) discovers unauthorized network data paths and appropriately reconfigures network devices; and (iii) provides an intrusion- and fault-tolerant ...

  17. [Foodborne illness report systems in China].

    Science.gov (United States)

    Zhu, Jianghui; Li, Fengqin; Li, Ning; Yan, Weixing; Xu, Haibin; Ma, Ning; Song, Xiaoyu; Liang, Jiang; Wang, Xiaodan; Gao, Peng

    2013-09-01

    To introduce the current foodborne illness report system in China. Foodborne illness (food poisoning included) report system and food related unusual cases reported system were characterized by their report definitions, scopes and report procedures as well as their differences. From October, 2010 to June, 2012, there are 2961 centers of disease control and prevention and heath executive organizations at the different local levels registered in the foodborne illness (food poisoning included) report system and 1525 incidents were reported. There were 553 hospitals registered in the food related unusual cases reported system while only 38 cases reported. The foodborne illness report system has been set up in China and further efforts in capacities building are needed.

  18. Importance sampling of rare events in chaotic systems

    DEFF Research Database (Denmark)

    Leitão, Jorge C.; Parente Lopes, João M.Viana; Altmann, Eduardo G.

    2017-01-01

    Finding and sampling rare trajectories in dynamical systems is a difficult computational task underlying numerous problems and applications. In this paper we show how to construct Metropolis-Hastings Monte-Carlo methods that can efficiently sample rare trajectories in the (extremely rough) phase ...

  19. Electronic circuit detects left ventricular ejection events in cardiovascular system

    Science.gov (United States)

    Gebben, V. D.; Webb, J. A., Jr.

    1972-01-01

    Electronic circuit processes arterial blood pressure waveform to produce discrete signals that coincide with beginning and end of left ventricular ejection. Output signals provide timing signals for computers that monitor cardiovascular systems. Circuit operates reliably for heart rates between 50 and 200 beats per minute.

  20. Event Highlight: Nigeria Evidence-based Health System Initiative

    International Development Research Centre (IDRC) Digital Library (Canada)

    2012-06-01

    Jun 1, 2012 ... Since limited resources are available for life-saving health services in Nigeria, those who plan health programs need to know which interventions are most effective and how to prioritise them. An important objective of the Nigeria Evidence-based Health. System Initiative (NEHSI) is to build the capacity of.

  1. On Event/Time Triggered and Distributed Analysis of a WSN System for Event Detection, Using Fuzzy Logic

    Directory of Open Access Journals (Sweden)

    Sofia Maria Dima

    2016-01-01

    Full Text Available Event detection in realistic WSN environments is a critical research domain, while the environmental monitoring comprises one of its most pronounced applications. Although efforts related to the environmental applications have been presented in the current literature, there is a significant lack of investigation on the performance of such systems, when applied in wireless environments. Aiming at addressing this shortage, in this paper an advanced multimodal approach is followed based on fuzzy logic. The proposed fuzzy inference system (FIS is implemented on TelosB motes and evaluates the probability of fire detection while aiming towards power conservation. Additionally to a straightforward centralized approach, a distributed implementation of the above FIS is also proposed, aiming towards network congestion reduction while optimally distributing the energy consumption among network nodes so as to maximize network lifetime. Moreover this work proposes an event based execution of the aforementioned FIS aiming to further reduce the computational as well as the communication cost, compared to a periodical time triggered FIS execution. As a final contribution, performance metrics acquired from all the proposed FIS implementation techniques are thoroughly compared and analyzed with respect to critical network conditions aiming to offer realistic evaluation and thus objective conclusions’ extraction.

  2. Patient safety culture and nurse-reported adverse events in outpatient hemodialysis units.

    Science.gov (United States)

    Thomas-Hawkins, Charlotte; Flynn, Linda

    2015-01-01

    Patient safety culture is an important quality indicator in health care facilities and has been associated with key patient outcomes in hospitals. The purpose of this analysis was to examine relationships between patient safety culture and nurse-reported adverse patient events in outpatient hemodialysis facilities. A cross-sectional correlational, mailed survey design was used. The analytic sample consisted of 422 registered nurses who worked in outpatient dialysis facilities in the United States. The Handoff and Transitions and the Overall Patient Safety Grade scales of the Agency for Healthcare Research and Quality's (AHRQ) Hospital Patient on Safety Survey were modified and used to measure patient safety culture in outpatient dialysis facilities. Nurse-reported adverse patient events was measured as a series of questions designed to capture the frequency with which nurses report that 13 adverse events occur in the outpatient dialysis facility setting. Handoff and transitions safety during patient shift change in dialysis centers was perceived negatively by a majority of nurses. On the other hand, a majority of nurses rated the overall patient safety culture in their dialysis facility as good to excellent. All relationships between patient safety culture items and adverse patient events were in the expected direction. Negative ratings of handoffs and transitions safety were independently associated with increased odds of frequent occurrences of vascular access thrombosis and patient complaints. Negative ratings of overall patient safety culture in dialysis units were independently associated with increased odds of frequent occurrences of medication errors by nurses, patient hospitalization, vascular access infection, and patient complaints. Findings from this analysis indicate that a positive patient safety culture is an important antecedent for optimal patient outcomes in ambulatory care settings.

  3. Adaptive neuro-fuzzy inference systems for semi-automatic discrimination between seismic events: a study in Tehran region

    Science.gov (United States)

    Vasheghani Farahani, Jamileh; Zare, Mehdi; Lucas, Caro

    2012-04-01

    Thisarticle presents an adaptive neuro-fuzzy inference system (ANFIS) for classification of low magnitude seismic events reported in Iran by the network of Tehran Disaster Mitigation and Management Organization (TDMMO). ANFIS classifiers were used to detect seismic events using six inputs that defined the seismic events. Neuro-fuzzy coding was applied using the six extracted features as ANFIS inputs. Two types of events were defined: weak earthquakes and mining blasts. The data comprised 748 events (6289 signals) ranging from magnitude 1.1 to 4.6 recorded at 13 seismic stations between 2004 and 2009. We surveyed that there are almost 223 earthquakes with M ≤ 2.2 included in this database. Data sets from the south, east, and southeast of the city of Tehran were used to evaluate the best short period seismic discriminants, and features as inputs such as origin time of event, distance (source to station), latitude of epicenter, longitude of epicenter, magnitude, and spectral analysis (fc of the Pg wave) were used, increasing the rate of correct classification and decreasing the confusion rate between weak earthquakes and quarry blasts. The performance of the ANFIS model was evaluated for training and classification accuracy. The results confirmed that the proposed ANFIS model has good potential for determining seismic events.

  4. Urbanization, Extreme Events, and Health: The Case for Systems Approaches in Mitigation, Management, and Response.

    Science.gov (United States)

    Siri, José Gabriel; Newell, Barry; Proust, Katrina; Capon, Anthony

    2016-03-01

    Extreme events, both natural and anthropogenic, increasingly affect cities in terms of economic losses and impacts on health and well-being. Most people now live in cities, and Asian cities, in particular, are experiencing growth on unprecedented scales. Meanwhile, the economic and health consequences of climate-related events are worsening, a trend projected to continue. Urbanization, climate change and other geophysical and social forces interact with urban systems in ways that give rise to complex and in many cases synergistic relationships. Such effects may be mediated by location, scale, density, or connectivity, and also involve feedbacks and cascading outcomes. In this context, traditional, siloed, reductionist approaches to understanding and dealing with extreme events are unlikely to be adequate. Systems approaches to mitigation, management and response for extreme events offer a more effective way forward. Well-managed urban systems can decrease risk and increase resilience in the face of such events. © 2015 APJPH.

  5. Fine grained event processing on HPCs with the ATLAS Yoda system

    CERN Document Server

    Calafiura, Paolo; The ATLAS collaboration; Guan, Wen; Maeno, Tadashi; Nilsson, Paul; Oleynik, Danila; Panitkin, Sergey; Tsulaia, Vakhtang; van Gemmeren, Peter; Wenaus, Torre

    2015-01-01

    High performance computing facilities present unique challenges and opportunities for HENP event processing. The massive scale of many HPC systems means that fractionally small utilizations can yield large returns in processing throughput. Parallel applications which can dynamically and efficiently fill any scheduling opportunities the resource presents benefit both the facility (maximal utilization) and the (compute-limited) science. The ATLAS Yoda system provides this capability to HENP-like event processing applications by implementing event-level processing in an MPI-based master-client model that integrates seamlessly with the more broadly scoped ATLAS Event Service. Fine grained, event level work assignments are intelligently dispatched to parallel workers to sustain full utilization on all cores, with outputs streamed off to destination object stores in near real time with similarly fine granularity, such that processing can proceed until termination with full utilization. The system offers the efficie...

  6. National Fire Incident Reporting System (NFIRS)

    Data.gov (United States)

    Department of Homeland Security — The National Fire Incident Reporting System (NFIRS) is a reporting standard that fire departments use to uniformly report on the full range of their activities, from...

  7. Impacts of European drought events: insights from an international database of text-based reports

    Science.gov (United States)

    Stahl, Kerstin; Kohn, Irene; Blauhut, Veit; Urquijo, Julia; De Stefano, Lucia; Acácio, Vanda; Dias, Susana; Stagge, James H.; Tallaksen, Lena M.; Kampragou, Eleni; Van Loon, Anne F.; Barker, Lucy J.; Melsen, Lieke A.; Bifulco, Carlo; Musolino, Dario; de Carli, Alessandro; Massarutto, Antonio; Assimacopoulos, Dionysis; Van Lanen, Henny A. J.

    2016-03-01

    Drought is a natural hazard that can cause a wide range of impacts affecting the environment, society, and the economy. Providing an impact assessment and reducing vulnerability to these impacts for regions beyond the local scale, spanning political and sectoral boundaries, requires systematic and detailed data regarding impacts. This study presents an assessment of the diversity of drought impacts across Europe based on the European Drought Impact report Inventory (EDII), a unique research database that has collected close to 5000 impact reports from 33 European countries. The reported drought impacts were classified into major impact categories, each of which had a number of subtypes. The distribution of these categories and types was then analyzed over time, by country, across Europe and for particular drought events. The results show that impacts on agriculture and public water supply dominate the collection of drought impact reports for most countries and for all major drought events since the 1970s, while the number and relative fractions of reported impacts in other sectors can vary regionally and from event to event. The analysis also shows that reported impacts have increased over time as more media and website information has become available and environmental awareness has increased. Even though the distribution of impact categories is relatively consistent across Europe, the details of the reports show some differences. They confirm severe impacts in southern regions (particularly on agriculture and public water supply) and sector-specific impacts in central and northern regions (e.g., on forestry or energy production). The protocol developed thus enabled a new and more comprehensive view on drought impacts across Europe. Related studies have already developed statistical techniques to evaluate the link between drought indices and the categorized impacts using EDII data. The EDII is a living database and is a promising source for further research on

  8. Reported weather events in medieval Hungary: the 11th-15th centuries

    Science.gov (United States)

    Kiss, Andrea

    2017-04-01

    In the presentation an overview of weather events, documented in contemporary written sources - available both in private and institutional evidence -, is provided: geographically the study covers the Hungarian kingdom (occasionally also with sources from the medieval Croatian kingdoms) that included most parts of the Carpathian Basin. Even if the temporal coverage extends the high and late medieval period between 1000 to 1500, most of the data comes from the late medieval times, with special emphasis on the 15th century. Most of the information is available regarding cold spells (e.g. early and late frosts), but especially cold winter periods. Nevertheless, contemporary documentary evidence - mainly legal documentation (charters), official and private correspondence, partly narratives and town accounts - also consists of evidence concerning other, weather-related extreme events such as (thunder)storms, floods and droughts. Apart from the discussion of the availability and type of these events, based on the relative frequency of occurrence we can define periods when a higher frequency and magnitude of weather-related events were reported that is mainly not dependent on changing source densities. These detectable periods (e.g. the early and mid-14th, early and late 15th centuries) are also a further, separate topic of discussion in the presentation.

  9. Tag and Neighbor based Recommender systems for Medical events

    DEFF Research Database (Denmark)

    Bayyapu, Karunakar Reddy; Dolog, Peter

    2010-01-01

    This paper presents an extension of a multifactor recommendation approach based on user tagging with term neighbours. Neighbours of words in tag vectors and documents provide for hitting larger set of documents and not only those matching with direct tag vectors or content of the documents. Tag...... in the situations where the quality of tags is lower. We discuss the approach on the examples from the existing Medworm system to indicate the usefulness of the approach....

  10. Parametric Parallel Simulation of Discrete Event Systems on SIMD Supercomputers

    Science.gov (United States)

    1994-05-01

    systems which can be modeled using these techniques usually have some sort of buffer capacity at each of their nodes. Extending the SIMD parallel... buffer capacity at each node. The flow conservation equations now have a additional factor that accounts for thinning that occurs as a result of a full... buffer capacity . If Kj is the buffer capacity of node j, then 1- n (Kj) is the long run probability of node j being able to accept arrivals from any

  11. How to Take HRMS Process Management to the Next Level with Workflow Business Event System

    Science.gov (United States)

    Rajeshuni, Sarala; Yagubian, Aram; Kunamaneni, Krishna

    2006-01-01

    Oracle Workflow with the Business Event System offers a complete process management solution for enterprises to manage business processes cost-effectively. Using Workflow event messaging, event subscriptions, AQ Servlet and advanced queuing technologies, this presentation will demonstrate the step-by-step design and implementation of system solutions in order to integrate two dissimilar systems and establish communication remotely. As a case study, the presentation walks you through the process of propagating organization name changes in other applications that originated from the HRMS module without changing applications code. The solution can be applied to your particular business cases for streamlining or modifying business processes across Oracle and non-Oracle applications.

  12. Real-Time Microbiology Laboratory Surveillance System to Detect Abnormal Events and Emerging Infections, Marseille, France.

    Science.gov (United States)

    Abat, Cédric; Chaudet, Hervé; Colson, Philippe; Rolain, Jean-Marc; Raoult, Didier

    2015-08-01

    Infectious diseases are a major threat to humanity, and accurate surveillance is essential. We describe how to implement a laboratory data-based surveillance system in a clinical microbiology laboratory. Two historical Microsoft Excel databases were implemented. The data were then sorted and used to execute the following 2 surveillance systems in Excel: the Bacterial real-time Laboratory-based Surveillance System (BALYSES) for monitoring the number of patients infected with bacterial species isolated at least once in our laboratory during the study periodl and the Marseille Antibiotic Resistance Surveillance System (MARSS), which surveys the primary β-lactam resistance phenotypes for 15 selected bacterial species. The first historical database contained 174,853 identifications of bacteria, and the second contained 12,062 results of antibiotic susceptibility testing. From May 21, 2013, through June 4, 2014, BALYSES and MARSS enabled the detection of 52 abnormal events for 24 bacterial species, leading to 19 official reports. This system is currently being refined and improved.

  13. Examination of pharmacists' intention to report serious adverse drug events (ADEs) to the FDA using the theory of planned behavior.

    Science.gov (United States)

    Gavaza, Paul; Brown, Carolyn M; Lawson, Kenneth A; Rascati, Karen L; Wilson, James P; Steinhardt, Mary

    2011-12-01

    Adverse drug event (ADE) reporting by pharmacists is an indispensable part of the drug safety system. U.S. pharmacists may submit reports of serious ADEs that they encounter to the Food and Drug Administration (FDA) through MedWatch. However, underreporting of serious ADEs is a common problem. Little is known about pharmacists' decision making with respect to ADE reporting. This study explored the utility of the theory of planned behavior (TPB) model in predicting Texas pharmacists' intention to report serious ADEs to the FDA. Data were collected from practicing Texas pharmacists using a mail questionnaire. A total of 1500 surveys were mailed, and 377 usable responses were obtained for a response rate of 26.4%. A majority (70.2%) of the 377 respondents were white/Caucasian, and 52.9% were male. Overall, pharmacists intended to report serious ADEs (mean=15.87±4.22; possible range: 3-21), had a positive attitude toward reporting (mean=4.62±4.92; possible range: -15 to +15), perceived that important others wanted them to report (subjective norm [SN] score=5.65±2.99; possible range: -9 to +9), and believed that they had control over their reporting behavior (perceived behavioral control [PBC] score=3.54±2.69; possible/actual range: -6 to +6). Attitude (β=0.221, P.05) did not. Attitude, SN, and PBC together accounted for 34.0% of the variance in intention to report serious ADEs (Preporting behavior (P=.021) and perceived moral obligation (Preport serious ADEs to the FDA. Strategies to increase pharmacists' intentions to report serious ADEs should focus on helping them see the value of reporting and altering their perception of social pressure toward reporting. The TPB may have utility in predicting ADE-reporting behavior. Copyright © 2011 Elsevier Inc. All rights reserved.

  14. Improving the Teaching of Discrete-Event Control Systems Using a LEGO Manufacturing Prototype

    Science.gov (United States)

    Sanchez, A.; Bucio, J.

    2012-01-01

    This paper discusses the usefulness of employing LEGO as a teaching-learning aid in a post-graduate-level first course on the control of discrete-event systems (DESs). The final assignment of the course is presented, which asks students to design and implement a modular hierarchical discrete-event supervisor for the coordination layer of a…

  15. Airport Economics: Management Control Financial Reporting Systems

    Science.gov (United States)

    Buchbinder, A.

    1972-01-01

    The development of management control financial reporting systems for airport operation is discussed. The operation of the system to provide the reports required for determining the specific revenue producing facilities of airports is described. The organization of the cost reporting centers to show the types of information provided by the system is analyzed.

  16. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Science.gov (United States)

    2010-05-25

    ... of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food... Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this draft guidance is to assist sponsors or non-applicants with filling out form FDA 1932, ``Veterinary Adverse Drug...

  17. System-Events Toolbox--Activating Urban Places for Social Cohesion through Designing a System of Events That Relies on Local Resources

    Science.gov (United States)

    Fassi, Davide; Motter, Roberta

    2014-01-01

    This paper is a reflection on the use of public spaces in towns and the development of a system-events toolbox to activate them towards social cohesion. It is the result of a 1 year action research developed together with POLIMI DESIS Lab of the Department of Design to develop design solutions to open up the public spaces of the campus to the…

  18. Event-Based Specification and Verification of Distributed Systems.

    Science.gov (United States)

    1982-01-01

    B); RTI5(A, B); RT21(A, B); End behavior End system. A distributed design [HOA78] to generate prime * numbers using the " sieve of Eratosthenes ...D. Theorem 3.7. The distributed " sieve of Eratosthenes " is a correct prime number generator. Proof By the sequence of theorems 3.7.1. to 3.7.6...made many valuable suggestions for improving the final document’s readability. With pleasure I acknowledge the advice and encourage- 2. ment I

  19. Using event-B for critical device software systems

    CERN Document Server

    Singh, Neeraj Kumar

    2013-01-01

    Defining a new development life-cycle methodology, together with a set of associated techniques and tools to develop highly critical systems using formal techniques, this book adopts a rigorous safety assessment approach explored via several layers (from requirements analysis to automatic source code generation). This is assessed and evaluated via a standard case study: the cardiac pacemaker. Additionally a formalisation of an Electrocardiogram (ECG) is used to identify anomalies in order to improve existing medical protocols. This allows the key issue - that formal methods are not currently i

  20. Adverse Events Associated with Immune Checkpoint Blockade in Patients with Cancer: A Systematic Review of Case Reports.

    Directory of Open Access Journals (Sweden)

    Noha Abdel-Wahab

    Full Text Available Three checkpoint inhibitor drugs have been approved by the US Food and Drug Administration for use in specific types of cancers. While the results are promising, severe immunotherapy-related adverse events (irAEs have been reported.To conduct a systematic review of case reports describing the occurrence of irAEs in patients with cancer following checkpoint blockade therapy, primarily to identify potentially unrecognized or unusual clinical findings and toxicity.We searched Medline, EMBASE, Web of Science, PubMed ePubs, and Cochrane CENTRAL with no restriction through August 2015.Studies reporting cases of cancer develop irAEs following treatment with anti CTLA-4 (ipilimumab or anti PD-1 (nivolumab or pembrolizumab antibodies were included.We extracted data on patient characteristics, irAEs characteristics, how irAEs were managed, and their outcomes.191 publications met inclusion criteria, reporting on 251 cases. Most patients had metastatic melanoma (95.6%, and the majority were treated with ipilimumab (93.2%. Autoimmune colitis, hepatitis, endocrinopathies, and cutaneous irAEs were the most frequently reported irAEs in ipilimumab treated patients. A broad spectrum of toxicities were reported for almost every body system. Moreover, well-defined diseases such as sarcoidosis, polyarthritis, polymyalgia rheumatica/arteritis, lupus, celiac disease, dermatomyositis, and Vogt-Koyanagi-like syndrome were reported. The most frequent irAEs reported with anti-PD1 agents were dermatitis for pembrolizumab, and thyroid disease and pneumonitis for nivolumab. Complete resolution of adverse events occurred in most cases. However, persistent irAEs and death were reported, mainly in patients treated with ipilimumab.Our study is limited by information available in the original reports.Evidence from case reports shows that cancer patients develop irAEs following checkpoint blockade therapy, and can occasionally develop clearly defined autoimmune systemic diseases

  1. Adverse events in cancer patients with sickle cell trait or disease: case reports.

    Science.gov (United States)

    Swede, Helen; Andemariam, Biree; Gregorio, David I; Jones, Beth A; Braithwaite, Dejana; Rohan, Thomas E; Stevens, Richard G

    2015-03-01

    Given the relatively high prevalence of sickle cell trait and disease among African Americans and established racial disparities in cancer outcomes, we reviewed the literature regarding adverse events in cancer patients with these hematologic genotypes. Erythrocyte sickling can result from extreme hypoxia and other physiologic stressors, as might occur during cancer therapy. Further, tumoral hypoxia, a poor prognostic and predictive factor, could lead to a cycle of local sickling and increased hypoxia. A search of PubMed produced 150 publications, most of which were excluded because of incidental relevance. Eleven case reports of patients diagnosed from 1993 to 2013 were reviewed. Two reports of patients with sickle cell trait describe an abundance of sickled erythrocytes within tumors, and a third report describes sickling-related events requiring multiday hospitalization. Eight reports of patients with sickle cell disease delineated multiorgan failure, vaso-occlusive crises, and rapid renal deterioration. Hypothesized triggers are delayed clearance of anticancer agents attributable to baseline kidney damage, activation of vasoadherent neutrophils from treatment to counter chemotherapy-induced neutropenia, hypoxia from general anesthesia, and intratumoral hypoxia. Clinical implications include pretreatment genotyping for prophylaxis, dose adjustment, and enhanced patient monitoring. With the current lack of high-quality evidence, however, the scope of poor outcomes remains unknown.

  2. Modeling Temporal Bias of Uplift Events in Recommender Systems

    KAUST Repository

    Altaf, Basmah

    2013-05-08

    Today, commercial industry spends huge amount of resources in advertisement campaigns, new marketing strategies, and promotional deals to introduce their product to public and attract a large number of customers. These massive investments by a company are worthwhile because marketing tactics greatly influence the consumer behavior. Alternatively, these advertising campaigns have a discernible impact on recommendation systems which tend to promote popular items by ranking them at the top, resulting in biased and unfair decision making and loss of customers’ trust. The biasing impact of popularity of items on recommendations, however, is not fixed, and varies with time. Therefore, it is important to build a bias-aware recommendation system that can rank or predict items based on their true merit at given time frame. This thesis proposes a framework that can model the temporal bias of individual items defined by their characteristic contents, and provides a simple process for bias correction. Bias correction is done either by cleaning the bias from historical training data that is used for building predictive model, or by ignoring the estimated bias from the predictions of a standard predictor. Evaluated on two real world datasets, NetFlix and MovieLens, our framework is shown to be able to estimate and remove the bias as a result of adopted marketing techniques from the predicted popularity of items at a given time.

  3. Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review.

    Science.gov (United States)

    Chowers, Michal Y; Gottesman, Bat Sheva; Leibovici, Leonard; Pielmeier, Ulrike; Andreassen, Steen; Paul, Mical

    2009-08-01

    Our objectives were to systematically assess the quality of reporting of adverse events (AEs) in publications of randomized trials of highly active antiretroviral therapy (HAART), and to examine whether reporting quality affects the effect estimates reported for AEs. We searched the PubMed, Cochrane library and EMBASE electronic databases up to December 2008. We included all published randomized controlled trials assessing HAART for treatment-naive adult HIV-infected individuals, with 48 weeks' follow-up. The quality of AE reporting was extracted according to CONSORT guidelines. We pooled the relative risks for AEs and compared results by sponsorship and different reporting methods. Forty-nine trials, including 19 882 patients, published between 2000 and 2008, met the inclusion criteria. Only one of the trials reported on AE collection methods. Twenty-six trials reported only AEs attributed to drugs, 17 of which did not refer to the attribution methods. AE reporting was nearly always selective and selection criteria were highly variable, based on severity grading or occurrence threshold. Presentation of AEs above an occurrence threshold was more common in studies sponsored by industry (30/31) than in studies sponsored by non-profit organizations (3/18). Moreover, we showed that differences in the methods of reporting AEs may affect the results reported for AEs. No significant improvement in AE reporting was seen over this period. We found substantial variability in AE reporting. Variability was influenced by sponsor identity and affected outcomes. These facts obstruct our ability to choose HAART based on currently published data.

  4. The nature and causes of unintended events reported at 10 internal medicine departments.

    Science.gov (United States)

    Lubberding, Sanne; Zwaan, Laura; Timmermans, Daniëlle R M; Wagner, Cordula

    2011-12-01

    This study aimed to examine the nature and causes of unintended events (UEs) at internal medicine departments (IMD). An observational study was conducted at 10 IMDs in 8 Dutch hospitals. The study period per participating department was 5 to 14 weeks. During this period, staff were asked to report all UEs concerning patient safety. To identify underlying root causes, experienced researchers analyzed the reports using a standardized root cause analysis method called PRISMA medical. Hospital staff reported 625 UEs. Medication-related UEs were the most reported events (42%). Of all reported UEs, 12% involved the collaboration between the IMD and other departments within the hospital.On the basis of the 625 UEs, 920 root causes were identified. The mean (SD) number of root causes per incident was 1.47 (0.68). Human root causes were related to 83.2% of the UEs, organizational root causes were related to 15.7%, technical root causes were related to 7%, and other root causes were related to 8.6% of the UEs.More than half of the reported UEs reached the patient (62%), with suboptimal care as the most frequently occurring consequence (44.7%). Physical injury occurred in 10.3% of the UEs. Hospital staff reporting UEs seems to be a good method for gaining insight into the types of UEs that occur at hospital departments. Although many UEs had human causes, identifying technical and organizational causes is important for the development of successful improvement strategies considering their contribution to human error. Important targets for these strategies are the medication process and collaboration within the hospital.

  5. Adverse events recording in electronic health record systems in primary care.

    Science.gov (United States)

    de Hoon, Sabine E M; Hek, Karin; van Dijk, Liset; Verheij, Robert A

    2017-12-06

    Adequate record keeping of medication adverse events in electronic health records systems is important for patient safety. Events that remain unrecorded cannot be communicated from one health professional to another. In the absence of a gold standard, we investigate the variation between Dutch general practices in the extent to which they record medication adverse events. Data were derived from electronic health records (EHR) of Dutch general practices participating in NIVEL Primary Care Database (NIVEL-PCD) in 2014, including 308 general practices with a total practice population of 1,256,049 listed patients. Medication adverse events were defined as recorded ICPC-code A85 (adverse effect medical agent). Between practice variation was studied using multilevel logistic regression analysis corrected for age, gender, number of different medicines prescriptions and number of chronic diseases. In 2014 there were 8330 patients with at least one medication adverse event recorded. This corresponds to 6.9 medication adverse events per 1000 patients and is higher for women, elderly, patients with polypharmacy and for patients with comorbidity. Corrected for these patient characteristics the median odds ratio (MOR = 1.92) suggests an almost twofold difference between general practices in recorded medication adverse events. Our results suggest that improvement in terms of uniformity in recording medication adverse events is possible, preventing potential damage for patients. We suggest that creating a learning health system by individual practice feedback on the number of recordings of adverse events would help practitioners to improve their recording habits.

  6. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary......, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. CONCLUSION: Data on adverse events in tables......OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...

  7. Comparison of manual and automated documentation of adverse events with an Anesthesia Information Management System (AIMS).

    Science.gov (United States)

    Benson, M; Junger, A; Michel, A; Sciuk, G; Quinzio, L; Marquardt, K; Hempelmann, G

    2000-01-01

    In this study, an Anesthesia Information Management System (AIMS) is used for the comparison of manually recorded adverse events with automatically detected events from anesthesiological procedures. In 1998, data from all anesthesia procedures, including the data set for quality assurance defined by the German Society of Anesthesiology and Intensive Care Medicine (DGAI), were recorded online with the documentation software NarkoData 4 (IMESO GmbH, Hüttenberg, Germany) followed by storage into a relational database (Oracle Corporation). The occurrence of manually recorded adverse events, as defined by the DGAI, is compared with automatically detected events. Automated detection was done with SQL-statements. The following adverse events were selected: hypotension, hypertension, bradycardia, tachycardia and hypovolemia. Data obtained from 16,019 electronic anesthesia records show that in 911 patients (5.7%), one of the selected adverse events was documented manually whereas in 2,996 patients (18.7%) a adverse event was detected automatically. The incidence of automatically detected events is obviously higher compared to manually recorded events. With the help of an AIMS, automatic detection proved significant deficiencies in the manual documentation of adverse events.

  8. Dietary supplement adverse events: report of a one-year poison center surveillance project.

    Science.gov (United States)

    Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

    2008-06-01

    The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

  9. Tank waste remediation system mission analysis report

    Energy Technology Data Exchange (ETDEWEB)

    Acree, C.D.

    1998-01-06

    The Tank Waste Remediation System Mission Analysis Report identifies the initial states of the system and the desired final states of the system. The Mission Analysis Report identifies target measures of success appropriate to program-level accomplishments. It also identifies program-level requirements and major system boundaries and interfaces.

  10. Predictive factors for reporting adverse events following spinal manipulation in randomized clinical trials - secondary analysis of a systematic review.

    Science.gov (United States)

    Gorrell, Lindsay M; Brown, Benjamin; Lystad, Reidar P; Engel, Roger M

    2017-08-01

    While spinal manipulative therapy (SMT) is recommended for the treatment of spinal disorders, concerns exist about adverse events associated with the intervention. Adequate reporting of adverse events in clinical trials would allow for more accurate estimations of incidence statistics through meta-analysis. However, it is not currently known if there are factors influencing adverse events reporting following SMT in randomized clinical trials (RCTs). Thus our objective was to investigate predictive factors for the reporting of adverse events in published RCTs involving SMT. The Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included: sample size; publication date relative to the 2010 CONSORT statement; risk of bias; the region treated; and number of intervention sessions. 7398 records were identified, of which 368 articles were eligible for inclusion. A total of 140 (38.0%) articles reported on adverse events. Articles were more likely to report on adverse events if they possessed larger sample sizes, were published after the 2010 CONSORT statement, had a low risk of bias and involved multiple intervention sessions. The region treated was not a significant predictor for reporting on adverse events. Predictors for reporting on adverse events included larger sample size, publication after the 2010 CONSORT statement, low risk of bias and trials involving multiple intervention sessions. We recommend that researchers focus on developing robust methodologies and participant follow-up regimens for RCTs involving SMT. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Optical timing receiver for the NASA Spaceborne Ranging System. Part II: high precision event-timing digitizer

    Energy Technology Data Exchange (ETDEWEB)

    Leskovar, Branko; Turko, Bojan

    1978-08-01

    Position-resolution capabilities of the NASA Spaceborne Laser Ranging System are essentially determined by the timeresolution capabilities of its optical timing receiver. The optical timing receiver consists of a fast photoelectric device; (e.g., photomultiplier or an avalanche photodiode detector), a timing discriminator, a high-precision event-timing digitizer, and a signal-processing system. The time-resolution capabilities of the receiver are determined by the photoelectron time spread of the photoelectric device, the time walk and resolution characteristics of the timing discriminator, and the resolution of the event-timing digitizer. It is thus necessary to evaluate available fast photoelectronic devices with respect to the time-resolution capabilities, and to develop a very low time walk timing discriminator and a high-resolution event-timing digitizer to be used in the high-resolution spaceborne laser ranging system receiver. This part of the report describes the development of a high precision event-timing digitizer. The event-timing digitizer is basically a combination of a very accurate high resolution real time digital clock and an interval timer. The timing digitizer is a high resolution multiple stop clock, counting the time up to 131 days in 19.5 ps increments.

  12. Financial system loss as an example of high consequence, high frequency events

    Energy Technology Data Exchange (ETDEWEB)

    McGovern, D.E.

    1996-07-01

    Much work has been devoted to high consequence events with low frequency of occurrence. Characteristic of these events are bridge failure (such as that of the Tacoma Narrows), building failure (such as the collapse of a walkway at a Kansas City hotel), or compromise of a major chemical containment system (such as at Bhopal, India). Such events, although rare, have an extreme personal, societal, and financial impact. An interesting variation is demonstrated by financial losses due to fraud and abuse in the money management system. The impact can be huge, entailing very high aggregate costs, but these are a result of the contribution of many small attacks and not the result of a single (or few) massive events. Public awareness is raised through publicized events such as the junk bond fraud perpetrated by Milikin or gross mismanagement in the failure of the Barings Bank through unsupervised trading activities by Leeson in Singapore. These event,s although seemingly large (financial losses may be on the order of several billion dollars), are but small contributors to the estimated $114 billion loss to all types of financial fraud in 1993. This paper explores the magnitude of financial system losses and identifies new areas for analysis of high consequence events including the potential effect of malevolent intent.

  13. Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices.

    Science.gov (United States)

    Gagliardi, Anna R; Ducey, Ariel; Lehoux, Pascale; Turgeon, Thomas; Ross, Sue; Trbovich, Patricia; Easty, Anthony; Bell, Chaim; Urbach, David

    2017-08-02

    Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting. Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions. Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes. There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems. © Article author(s) (or their employer(s) unless otherwise stated in

  14. Qualitative Event-based Diagnosis with Possible Conflicts Applied to Spacecraft Power Distribution Systems

    Data.gov (United States)

    National Aeronautics and Space Administration — Model-based diagnosis enables efficient and safe operation of engineered systems. In this paper, we describe two algorithms based on a qualitative event-based fault...

  15. Seabed resident event driven profiling system (SREP). Concept, design and tests

    Digital Repository Service at National Institute of Oceanography (India)

    Mascarenhas, A.A.M.Q.; Afzulpurkar, S.; Maurya, P.K.; Fernandes, L.; Madhan, R.; Desa, E.S.; Dabolkar, N.A.; Navelkar, G.S.; Naik, L.; Shetye, V.G.; Shetty, N.B.; Prabhudesai, S.P.; Nagvekar, S.; Vimalakumari, D.

    The seabed resident event driven profiling system (SREP) described here offers a novel, optimized approach to profiling in coastal waters from seabed to sea surface during the rough seas encountered in the southwest monsoon season (June...

  16. Event reporting guidelines 10 CFR 50.72 and 50.73. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Allison, D.P.; Harper, M.R.; Jones, W.R.; MacKinnon, J.B.; Sandin, S.S.

    1998-01-01

    Revision 1 to NUREG-1022 clarifies the immediate notification requirements of Title 10 of the Code of Federal Regulations, Part 50, Section 50.72 (10 CFR 50.72), and the 30-day written licensee event report (LER) requirements of 10 CFR 50.73 for nuclear power plants. This revision was initiated to improve the reporting guidelines related to 10 CFR 50.72 and 50.73 and to consolidate these guidelines into a single reference document. A first draft of this document was noticed for public comment in the Federal Register on october 7, 1991 (56 FR 50598). A second draft was noticed for comment in the Federal Register on February 7, 1994 (59 FR 5614). This document updates and supersedes NUREG-1022 and its Supplements 1 and 2 (published in September 1983, February 1984, and September 1985, respectively). It does not change the reporting requirements of 10 CFR 50.72 and 50.73.

  17. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. SETTING: 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency...... identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical cod