Confidential reporting of patient safety events in primary care: results from a multilevel classification of cognitive and system factors

PubMed Central

Kostopoulou, Olga; Delaney, Brendan

2007-01-01

Objective To classify events of actual or potential harm to primary care patients using a multilevel taxonomy of cognitive and system factors. Methods Observational study of patient safety events obtained via a confidential but not anonymous reporting system. Reports were followed up with interviews where necessary. Events were analysed for their causes and contributing factors using causal trees and were classified using the taxonomy. Five general medical practices in the West Midlands were selected to represent a range of sizes and types of patient population. All practice staff were invited to report patient safety events. Main outcome measures were frequencies of clinical types of events reported, cognitive types of error, types of detection and contributing factors; and relationship between types of error, practice size, patient consequences and detection. Results 78 reports were relevant to patient safety and analysable. They included 21 (27%) adverse events and 50 (64%) near misses. 16.7% (13/71) had serious patient consequences, including one death. 75.7% (59/78) had the potential for serious patient harm. Most reports referred to administrative errors (25.6%, 20/78). 60% (47/78) of the reports contained sufficient information to characterise cognition: “situation assessment and response selection” was involved in 45% (21/47) of these reports and was often linked to serious potential consequences. The most frequent contributing factor was work organisation, identified in 71 events. This included excessive task demands (47%, 37/71) and fragmentation (28%, 22/71). Conclusions Even though most reported events were near misses, events with serious patient consequences were also reported. Failures in situation assessment and response selection, a cognitive activity that occurs in both clinical and administrative tasks, was related to serious potential harm. PMID:17403753

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

ERIC Educational Resources Information Center

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…

Patient safety event reporting in critical care: a study of three intensive care units.

PubMed

Harris, Carolyn B; Krauss, Melissa J; Coopersmith, Craig M; Avidan, Michael; Nast, Patricia A; Kollef, Marin H; Dunagan, W Claiborne; Fraser, Victoria J

2007-04-01

To increase patient safety event reporting in three intensive care units (ICUs) using a new voluntary card-based event reporting system and to compare and evaluate observed differences in reporting among healthcare workers across ICUs. Prospective, single-center, interventional study. A medical ICU (19 beds), surgical ICU (24 beds), and cardiothoracic ICU (17 beds) at a 1,371-bed urban teaching hospital. Adult patients admitted to these three study ICUs. Use of a new, internally designed, card-based reporting program to solicit voluntary anonymous reporting of medical errors and patient safety concerns. During a 14-month period, 714 patient safety events were reported using a new card-based reporting system, reflecting a significant increase in reporting compared with pre-intervention Web-based reporting (20.4 reported events/1,000 patient days pre-intervention to 41.7 reported events/1,000 patient days postintervention; rate ratio, 2.05; 95% confidence interval, 1.79-2.34). Nurses submitted the majority of reports (nurses, 67.1%; physicians, 23.1%; other reporters, 9.5%); however, physicians experienced the greatest increase in reporting among their group (physicians, 43-fold; nurses, 1.7-fold; other reporters, 4.3-fold) relative to pre-intervention rates. There were significant differences in the reporting of harm by job description: 31.1% of reports from nurses, 36.2% from other staff, and 17.0% from physicians described events that did not reach/affect the patient (p = .001); and 33.9% of reports from physicians, 27.2% from nurses, and 13.0% from other staff described events that caused harm (p = .005). Overall reported patient safety events per 1,000 patient days differed by ICU (medical ICU = 55.5, cardiothoracic ICU = 25.3, surgical ICU = 40.2; p < .001). This card-based reporting system increased reporting significantly compared with pre-intervention Web-based reporting and revealed significant differences in reporting by healthcare worker and ICU. These differences may reveal important preferences and priorities for reporting medical errors and patient safety events.

Preventable mix-ups of tuberculin and vaccines: reports to the US Vaccine and Drug Safety Reporting Systems.

PubMed

Chang, Soju; Pool, Vitali; O'Connell, Kathryn; Polder, Jacquelyn A; Iskander, John; Sweeney, Colleen; Ball, Robert; Braun, M Miles

2008-01-01

Errors involving the mix-up of tuberculin purified protein derivative (PPD) and vaccines leading to adverse reactions and unnecessary medical management have been reported previously. To determine the frequency of PPD-vaccine mix-ups reported to the US Vaccine Adverse Event Reporting System (VAERS) and the Adverse Event Reporting System (AERS), characterize adverse events and clusters involving mix-ups and describe reported contributory factors. We reviewed AERS reports from 1969 to 2005 and VAERS reports from 1990 to 2005. We defined a mix-up error event as an incident in which a single patient or a cluster of patients inadvertently received vaccine instead of a PPD product or received a PPD product instead of vaccine. We defined a cluster as inadvertent administration of PPD or vaccine products to more than one patient in the same facility within 1 month. Of 115 mix-up events identified, 101 involved inadvertent administration of vaccines instead of PPD. Product confusion involved PPD and multiple vaccines. The annual number of reported mix-ups increased from an average of one event per year in the early 1990s to an average of ten events per year in the early part of this decade. More than 240 adults and children were affected and the majority reported local injection site reactions. Four individuals were hospitalized (all recovered) after receiving the wrong products. Several patients were inappropriately started on tuberculosis prophylaxis as a result of a vaccine local reaction being interpreted as a positive tuberculin skin test. Reported potential contributory factors involved both system factors (e.g. similar packaging) and human errors (e.g. failure to read label before product administration). To prevent PPD-vaccine mix-ups, proper storage, handling and administration of vaccine and PPD products is necessary.

A new safety event reporting system improves physician reporting in the surgical intensive care unit.

PubMed

Schuerer, Douglas J E; Nast, Patricia A; Harris, Carolyn B; Krauss, Melissa J; Jones, Rebecca M; Boyle, Walter A; Buchman, Timothy G; Coopersmith, Craig M; Dunagan, W Claiborne; Fraser, Victoria J

2006-06-01

Medical errors are common, and physicians have notably been poor medical error reporters. In the SICU, reporting was generally poor and reporting by physicians was virtually nonexistent. This study was designed to observe changes in error reporting in an SICU when a new card-based system (SAFE) was introduced. Before implementation of the SAFE reporting system, education was given to all SICU healthcare providers. The SAFE system was introduced into the SICU for a 9-month period from March 2003 through November 2003, to replace an underused online system. Data were collected from the SAFE card reports and the online reporting systems during introduction, removal, and reimplementation of these cards. Reporting rates were calculated as number of reported events per 1,000 patient days. Reporting rates increased from 19 to 51 reports per 1,000 patient days after the SAFE cards were introduced into the ICU (p

An Evaluation of Departmental Radiation Oncology Incident Reports: Anticipating a National Reporting System

DOE Office of Scientific and Technical Information (OSTI.GOV)

Terezakis, Stephanie A., E-mail: stereza1@jhmi.edu; Harris, Kendra M.; Ford, Eric

Purpose: Systems to ensure patient safety are of critical importance. The electronic incident reporting systems (IRS) of 2 large academic radiation oncology departments were evaluated for events that may be suitable for submission to a national reporting system (NRS). Methods and Materials: All events recorded in the combined IRS were evaluated from 2007 through 2010. Incidents were graded for potential severity using the validated French Nuclear Safety Authority (ASN) 5-point scale. These incidents were categorized into 7 groups: (1) human error, (2) software error, (3) hardware error, (4) error in communication between 2 humans, (5) error at the human-software interface,more » (6) error at the software-hardware interface, and (7) error at the human-hardware interface. Results: Between the 2 systems, 4407 incidents were reported. Of these events, 1507 (34%) were considered to have the potential for clinical consequences. Of these 1507 events, 149 (10%) were rated as having a potential severity of ≥2. Of these 149 events, the committee determined that 79 (53%) of these events would be submittable to a NRS of which the majority was related to human error or to the human-software interface. Conclusions: A significant number of incidents were identified in this analysis. The majority of events in this study were related to human error and to the human-software interface, further supporting the need for a NRS to facilitate field-wide learning and system improvement.« less

Patients' identification and reporting of unsafe events at six hospitals in Japan.

PubMed

Hasegawa, Tomonori; Fujita, Shigeru; Seto, Kanako; Kitazawa, Takefumi; Matsumoto, Kunichika

2011-11-01

Hospitals and other health care organizations have increasingly recognized the need to engage patients as participants in patient safety. A study was conducted to compare patients' and health care staff's identification and reporting of such events. A questionnaire was administered at six hospitals in Japan to outpatients and inpatients from November 2004 through February 2007. Patients were asked to respond to questions about experiences of possibly unsafe events. Patients experiencing such events were then asked about the events and whether they had reported their experience to health care staff. A specialist panel classified reported events as "uneasy-dissatisfying" or "unsafe." The response rates of outpatients and inpatients were 85.4% (1,506/1,764) and 54.3% (1,738/3,198), respectively. Among the respondents (> or = 20 years of age), 125 (8.7%) of the outpatients and 185 (10.9%) of the inpatients experienced uneasy-dissatisfying or unsafe events; 35 (2.4%) of the outpatients and 67 (4.0%) of the inpatients experienced unsafe events, the percent increasing with hospital stay. Only 38 (30.4%) of the outpatients and 62 (33.5%) of the inpatients reported the unsafe events to health care staff Only 17.1% of unsafe events reported by inpatients were identified by the in-house reporting systems of adverse events and near misses. For the uneasy-dissatisfying or unsafe events that patients did not think necessary to report, the patients often felt they were self-evident or easily identifiable by health care staff, had difficulty evaluating the event, did not expect their report to bring any improvement, or even felt that reporting it would create some disadvantage in their medical treatment. Patient reporting programs and in-house reporting systems, among other detection methods, should be regarded as complementary sources of information.

Identifying and Synchronizing Health Information Technology (HIT) Events from FDA Medical Device Reports.

PubMed

Kang, Hong; Wang, Frank; Zhou, Sicheng; Miao, Qi; Gong, Yang

2017-01-01

Health information technology (HIT) events, a subtype of patient safety events, pose a major threat and barrier toward a safer healthcare system. It is crucial to gain a better understanding of the nature of the errors and adverse events caused by current HIT systems. The scarcity of HIT event-exclusive databases and event reporting systems indicates the challenge of identifying the HIT events from existing resources. FDA Manufacturer and User Facility Device Experience (MAUDE) database is a potential resource for HIT events. However, the low proportion and the rapid evolvement of HIT-related events present challenges for distinguishing them from other equipment failures and hazards. We proposed a strategy to identify and synchronize HIT events from MAUDE by using a filter based on structured features and classifiers based on unstructured features. The strategy will help us develop and grow an HIT event-exclusive database, keeping pace with updates to MAUDE toward shared learning.

Data Mining of the Public Version of the FDA Adverse Event Reporting System

PubMed Central

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. PMID:23794943

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

PubMed Central

Schumm, Walter R

2006-01-01

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 after smallpox vaccination appear to be have occurred much less frequently using passive surveillance systems and by members of the U.S. military compared to civilians, especially those employed in healthcare occupations. Such concerns impact risk-benefit ratios associated with vaccines and weigh against making vaccinations mandatory, without informed consent, even among military members. Because of the issues raised here, adverse event rates derived solely or primarily from U.S. Department of Defense reporting systems, especially passive surveillance systems, should not be used, given better alternatives, for making public health policy decisions. PMID:17096855

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants.

PubMed

Cornell, Erika; Kwa, Michael; Paller, Amy S; Xu, Shuai

2018-03-01

Despite their ubiquitous use and several recent health controversies involving cosmetics and personal care products for children, the Food and Drug Administration has little oversight of these products and relies on consumer-submitted adverse event reports. We assessed the recently released Center for Food Safety and Applied Nutrition's Adverse Event Reporting System database for adverse event reports submitted to the Food and Drug Administration for baby personal care products and to determine whether useful insights can be derived. We extracted the Center for Food Safety and Applied Nutrition's Adverse Event Reporting System data file from 2004 to 2016 and examined the subset classified according to the Food and Drug Administration-designated product class as a baby product. Events were manually categorized into product type and symptom type to assess for trends. Only 166 total adverse events were reported to the Food and Drug Administration for baby products from 2004 to 2016. The majority of reports indicated rash or other skin reaction; 46% of reported events led to a health care visit. Pediatric dermatologists should consider submitting cosmetics and personal care product adverse event reports and encouraging consumers to do so likewise in situations in which a product adversely affects a child's health. © 2018 Wiley Periodicals, Inc.

On Building an Ontological Knowledge Base for Managing Patient Safety Events.

PubMed

Liang, Chen; Gong, Yang

2015-01-01

Over the past decade, improving healthcare quality and safety through patient safety event reporting systems has drawn much attention. Unfortunately, such systems are suffering from low data quality, inefficient data entry and ineffective information retrieval. For improving the systems, we develop a semantic web ontology based on the WHO International Classification for Patient Safety (ICPS) and AHRQ Common Formats for patient safety event reporting. The ontology holds potential in enhancing knowledge management and information retrieval, as well as providing flexible data entry and case analysis for both reporters and reviewers of patient safety events. In this paper, we detailed our efforts in data acquisition, transformation, implementation and initial evaluation of the ontology.

Adverse drug events and the Freedom of Information Act: an apple in Eden.

PubMed

Stang, P E; Fox, J L

1992-02-01

To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.

Targeting errors in the ICU: use of a national database.

PubMed

Kleinpell, Ruth; Thompson, David; Kelso, Lynn; Pronovost, Peter J

2006-12-01

The authors believe that as we move from viewing adverse event reporting system as punitive, and as the safety culture improves, reporting will likely increase. Voluntary incident reporting systems can be used to improve patient safety in the ICU by identifying broken or inadequate systems that lead to adverse events [26]. Voluntary external reporting systems such as the ICUSRS can be used to target errors and produce evidence-based best practice measures to improve patient safety in the ICU.

Special Data Collection System (SDCS) event report, Kashmir--Tibet border region, 19 May 1975

DOE Office of Scientific and Technical Information (OSTI.GOV)

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

1976-01-23

Seismic data are reported from the Special Data Collection System (SDCS) and other sources for the Kashmir-Tibet Border Region event on 19 May 1975. Published epicenter information from seismic observations is given.

Injury surveillance in multi-sport events: the International Olympic Committee approach.

PubMed

Junge, A; Engebretsen, L; Alonso, J M; Renström, P; Mountjoy, M; Aubry, M; Dvorak, J

2008-06-01

The protection of athletes' health by preventing injuries is an important task for international sports federations. Standardised injury surveillance provides not only important epidemiological information, but also directions for injury prevention, and the opportunity for monitoring long-term changes in the frequency and circumstances of injury. Numerous studies have evaluated sports injuries during the season, but few have focused on injuries during major sport events such as World Championships, World Cups or the Olympic Games. To provide an injury surveillance system for multi-sports tournaments, using the 2008 Olympic Games in Beijing as an example. A group of experienced researchers reviewed existing injury report systems and developed a scientific sound and concise injury surveillance system for large multi-sport events. The injury report system for multi-sport events is based on an established system for team sports tournaments and has proved feasible for individual sports during the International Association of Athletics Federations World Championships in Athletics 2007. The most important principles and advantages of the system are comprehensive definition of injury, injury report by the physician responsible for the athlete, a single-page report of all injuries, and daily report irrespective of whether or not an injury occurred. Implementation of the injury surveillance system, all definitions, the report form, and the analysis of data are described in detail to enable other researchers to implement the injury surveillance system in any sports tournament. The injury surveillance system has been accepted by experienced team physicians and shown to be feasible for single-sport and multi-sport events. It can be modified depending on the specific objectives of a certain sport or research question; however, a standardised use of injury definition, report forms and methodology will ensure the comparability of results.

Comparison of response rates on invitation mode of a web-based survey on influenza vaccine adverse events among healthcare workers: a pilot study.

PubMed

Tai, Xiaochen; Smith, Alanna M; McGeer, Allison J; Dubé, Eve; Holness, Dorothy Linn; Katz, Kevin; McGillis Hall, Linda; McNeil, Shelly A; Powis, Jeff; Coleman, Brenda L

2018-06-20

Web-based surveys have become increasingly popular but response rates are low and may be prone to selection bias. How people are invited to participate may impact response rates and needs further study as previous evidence is contradictory. The purpose of this study was to determine whether response to a web-based survey of healthcare workers would be higher with a posted or an emailed invitation. We also report results of the pilot study, which aims to estimate the percentage of adults vaccinated against influenza who report recurrent systemic adverse events (the same systemic adverse event occurring successively following receipt of influenza vaccines). The pilot study was conducted in November 2016 in Toronto, Canada. Members of a registry of adults (18 years and older and predominantly healthcare workers) who volunteered to receive information regarding future studies about influenza were randomly assigned to receive either an email or postal invitation to complete a web-based survey regarding influenza vaccinations. Non-respondents received one reminder using the same mode of contact as their original invitation. The overall response rate was higher for those sent the invitation by email (34.8%) than by post (25.8%; p < 0.001) and for older versus younger participants (p trend  < 0.001). Of those who responded, 387/401 had been vaccinated against influenza at least once since adulthood. Of those responding to the question, 70/386 (18.1%) reported a systemic adverse event after their most recent influenza vaccine including 22 (5.7%) who reported a recurring systemic event. Systemic adverse events were reported more often by males 18-49 years old than by other groups (p = 0.01). Recurrent systemic adverse events were similar by age and sex with muscle ache being the most commonly reported recurrent reaction. More respondents who reported only a local adverse event (93.1%) planned to be vaccinated again next year than those with a systemic adverse event (69.7%; p = 0.04). In this convenience sample of registry volunteers, response rates were generally low, but were higher for the emailed than posted invitations and for older than younger adults.

Reporting vaccine-associated adverse events.

PubMed Central

Duclos, P.; Hockin, J.; Pless, R.; Lawlor, B.

1997-01-01

OBJECTIVE: To determine family physicians' awareness of the need to monitor and report vaccine-associated adverse events (VAAE) in Canada and to identify mechanisms that could facilitate reporting. DESIGN: Mailed survey. SETTING: Canadian family practices. PARTICIPANTS: Random sample of 747 family physicians. Overall response rate was 32% (226 of 717 eligible physicians). MAIN OUTCOME MEASURES: Access to education on VAAE; knowledge about VAAE monitoring systems, reporting criteria, and reporting forms; method of reporting VAAEs and reasons for not reporting them; and current experience with VAAEs. RESULTS: Of 226 respondents, 55% reported observing VAAEs, and 42% reported the event. Fewer than 50% were aware of a monitoring system for VAAE, and only 39% had had VAAE-related education during medical training. Only 28% knew the reporting criteria. Reporting was significantly associated with knowledge of VAAE monitoring systems and reporting criteria (P < 0.01). CONCLUSION: Physicians need more feedback and education on VAAE reporting and more information about the importance of reporting and about reporting criteria and methods. PMID:9303234

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

PubMed

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 commonly coded term for non-serious events (29%), and pyrexia for non-fatal serious events (38%). Most deaths (96%) were in children aged 12 months or younger; most (52%) had sudden infant death syndrome as the reported cause of death. The safely profiles of combined IPV and whole-cell pertussis vaccines, OPV and whole-cell pertussis vaccines, and OPV and acellular pertussis vaccines were similar. We noted no indication of disproportionate reporting of adverse events after immunisation with IPV-containing vaccines compared with other vaccines between 1990 and 2013. Fairly few adverse events were reported for the more than 250 million IPV doses distributed between 2000 and 2012. Sudden infant death syndrome reports after IPV were consistent with reporting patterns for other vaccines. No new or unexpected vaccine safety problems were identified for fatal, non-fatal serious, and non-serious reports in this assessment of adverse events after IPV. None. Copyright © 2015 Elsevier Ltd. All rights reserved.

Adverse Event Reporting: Harnessing Residents to Improve Patient Safety.

PubMed

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.

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

PubMed

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 level, the sample size was calculated to be 35 providers in each group, which includes an 11% lost to follow-up of chiropractors and 20% of patient visits. This study will be the first direct comparison of adverse event reporting using passive versus active surveillance. It is also the largest prospective evaluation of adverse events reported after chiropractic manual therapy in children, identified as a major gap in the academic literature. ClinicalTrials.gov, ID: NCT02268331 . Registered on 10 October 2014.

Event-based surveillance in Papua New Guinea: strengthening an International Health Regulations (2005) core capacity.

PubMed

Dagina, Rosheila; Murhekar, Manoj; Rosewell, Alexander; Pavlin, Boris I

2013-01-01

Under the International Health Regulations (2005), Member States are required to develop capacity in event-based surveillance (EBS). The Papua New Guinea National Department of Health established an EBS system during the influenza pandemic in August 2009. We review its performance from August 2009 to November 2012, sharing lessons that may be useful to other low-resource public health practitioners working in surveillance. We examined the EBS system's event reporting, event verification and response. Characteristics examined included type of event, source of information, timeliness, nature of response and outcome. Sixty-one records were identified. The median delay between onset of the event and date of reporting was 10 days. The largest proportion of reports (39%) came from Provincial Health Offices, followed by direct reports from clinical staff (25%) and reports in the media (11%). Most (84%) of the events were substantiated to be true public health events, and 56% were investigated by the Provincial Health Office alone. A confirmed or probable etiology could not be determined in 69% of true events. EBS is a simple strategy that forms a cornerstone of public health surveillance and response particularly in low-resource settings such as Papua New Guinea. There is a need to reinforce reporting pathways, improve timeliness of reporting, expand sources of information, improve feedback and improve diagnostic support capacity. For it to be successful, EBS should be closely tied to response.

Defining and classifying medical error: lessons for patient safety reporting systems.

PubMed

Tamuz, M; Thomas, E J; Franchois, K E

2004-02-01

It is important for healthcare providers to report safety related events, but little attention has been paid to how the definition and classification of events affects a hospital's ability to learn from its experience. To examine how the definition and classification of safety related events influences key organizational routines for gathering information, allocating incentives, and analyzing event reporting data. In semi-structured interviews, professional staff and administrators in a tertiary care teaching hospital and its pharmacy were asked to describe the existing programs designed to monitor medication safety, including the reporting systems. With a focus primarily on the pharmacy staff, interviews were audio recorded, transcribed, and analyzed using qualitative research methods. Eighty six interviews were conducted, including 36 in the hospital pharmacy. Examples are presented which show that: (1) the definition of an event could lead to under-reporting; (2) the classification of a medication error into alternative categories can influence the perceived incentives and disincentives for incident reporting; (3) event classification can enhance or impede organizational routines for data analysis and learning; and (4) routines that promote organizational learning within the pharmacy can reduce the flow of medication error data to the hospital. These findings from one hospital raise important practical and research questions about how reporting systems are influenced by the definition and classification of safety related events. By understanding more clearly how hospitals define and classify their experience, we may improve our capacity to learn and ultimately improve patient safety.

Getting the right blood to the right patient: the contribution of near-miss event reporting and barrier analysis.

PubMed

Kaplan, H S

2005-11-01

Safety and reliability in blood transfusion are not static, but are dynamic non-events. Since performance deviations continually occur in complex systems, their detection and correction must be accomplished over and over again. Non-conformance must be detected early enough to allow for recovery or mitigation. Near-miss events afford early detection of possible system weaknesses and provide an early chance at correction. National event reporting systems, both voluntary and involuntary, have begun to include near-miss reporting in their classification schemes, raising awareness for their detection. MERS-TM is a voluntary safety reporting initiative in transfusion. Currently 22 hospitals submit reports anonymously to a central database which supports analysis of a hospital's own data and that of an aggregate database. The system encourages reporting of near-miss events, where the patient is protected from receiving an unsuitable or incorrect blood component due to a planned or unplanned recovery step. MERS-TM data suggest approximately 90% of events are near-misses, with 10% caught after issue but before transfusion. Near-miss reporting may increase total reports ten-fold. The ratio of near-misses to events with harm is 339:1, consistent with other industries' ratio of 300:1, which has been proposed as a measure of reporting in event reporting systems. Use of a risk matrix and an event's relation to protective barriers allow prioritization of these events. Near-misses recovered by planned barriers occur ten times more frequently then unplanned recoveries. A bedside check of the patient's identity with that on the blood component is an essential, final barrier. How the typical two person check is performed, is critical. Even properly done, this check is ineffective against sampling and testing errors. Blood testing at bedside just prior to transfusion minimizes the risk of such upstream events. However, even with simple and well designed devices, training may be a critical issue. Sample errors account for more than half of reported events. The most dangerous miscollection is a blood sample passing acceptance with no previous patient results for comparison. Bar code labels or collection of a second sample may counter this upstream vulnerability. Further upstream barriers have been proposed to counter the precariousness of urgent blood sample collection in a changing unstable situation. One, a linking device, allows safer labeling of tubes away from the bedside, the second, a forcing function, prevents omission of critical patient identification steps. Errors in the blood bank itself account for 15% of errors with a high potential severity. In one such event, a component incorrectly issued, but safely detected prior to transfusion, focused attention on multitasking's contribution to laboratory error. In sum, use of near-miss information, by enhancing barriers supporting error prevention and mitigation, increases our capacity to get the right blood to the right patient.

[EuCliD 5TM Clinic Variance Report: a means to improve the safety of patients and staff].

PubMed

Oggero, Anna Rita; Palmieri, Veronica; Cerreto, Maria; Manna, Luisa; Lettieri, Iolanda; Napoli, Antonio; Ravone, Virginia; Pelliccia, Francesco; Moretti, Manuela; Parisotto, Maria Teresa

2010-01-01

The collection of information about events in the healthcare sector has been documented internationally for more than 25 years. Incident reporting is used for the structured acquisition of information about adverse events to improve patient and healthcare staff safety, prepare corrective action, and prevent event recurrence in the future. The establishment of an incident reporting system requires that the staff involved should be capable of recognizing events which require reporting. The aim of this work was to encourage operators to use the incident reporting system and gradually achieve 100% compliance in the reporting of adverse events and corrective and preventive actions taken. The project was carried out by the staff of one NephroCare dialysis center. The parameters observed were how many times the Variance Report was used, how problems were analyzed, and how many times and by what means the medical and nursing staff took action to correct problems. Ten months from the start of the project 100% reporting was achieved. All selected adverse advents were correctly reported and corrective or preventive action was taken to improve patient care and dialysis center organization. Only effective feedback on the results achieved in terms of safety and tangible improvements by staff will allow the number of reports to be kept high, and maintain participants' compliance with the incident reporting system over the long term.

Decision support environment for medical product safety surveillance.

PubMed

Botsis, Taxiarchis; Jankosky, Christopher; Arya, Deepa; Kreimeyer, Kory; Foster, Matthew; Pandey, Abhishek; Wang, Wei; Zhang, Guangfan; Forshee, Richard; Goud, Ravi; Menschik, David; Walderhaug, Mark; Woo, Emily Jane; Scott, John

2016-12-01

We have developed a Decision Support Environment (DSE) for medical experts at the US Food and Drug Administration (FDA). The DSE contains two integrated systems: The Event-based Text-mining of Health Electronic Records (ETHER) and the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment (PANACEA). These systems assist medical experts in reviewing reports submitted to the Vaccine Adverse Event Reporting System (VAERS) and the FDA Adverse Event Reporting System (FAERS). In this manuscript, we describe the DSE architecture and key functionalities, and examine its potential contributions to the signal management process by focusing on four use cases: the identification of missing cases from a case series, the identification of duplicate case reports, retrieving cases for a case series analysis, and community detection for signal identification and characterization. Published by Elsevier Inc.

Leveraging Event Reporting Through Knowledge Support: A Knowledge-Based Approach to Promoting Patient Fall Prevention.

PubMed

Yao, Bin; Kang, Hong; Miao, Qi; Zhou, Sicheng; Liang, Chen; Gong, Yang

2017-01-01

Patient falls are a common safety event type that impairs the healthcare quality. Strategies including solution tools and reporting systems for preventing patient falls have been developed and implemented in the U.S. However, the current strategies do not include timely knowledge support, which is in great need in bridging the gap between reporting and learning. In this study, we constructed a knowledge base of fall events by combining expert-reviewed fall prevention solutions and then integrating them into a reporting system. The knowledge base enables timely and tailored knowledge support and thus will serve as a prevailing fall prevention tool. This effort holds promise in making knowledge acquisition and management a routine process for enhancing the reporting and understanding of patient safety events.

Patients use an internet technology to report when things go wrong.

PubMed

Wasson, John H; MacKenzie, Todd A; Hall, Michael

2007-06-01

As patients directly experience harm from adverse events, investigators have proposed patient-report to complement professional reporting of adverse events. To investigate how an automated health assessment system can be used to identify adverse events. Internet survey responses from April 2003 to April 2005 involving communities and clinical practices across the USA. 44,860 adults aged 19-69 years. Patient perceptions of adverse events experienced during the previous year. Independent legal review was also used to estimate how many patient-reports were serious enough to be potentially compensable. Although patient reports of possible adverse events was low (1.4%), the percentage of adverse events was eight times higher for patients with the greatest burden of illness than for those with the least (3.4% vs 0.4%). Two expert malpractice attorneys agreed that 9% of the adverse events seemed to be serious. PATIENTS will use internet technology to report their perceptions of health-related adverse events. Some of the patient-reported events reported will be serious.

Safety of herbal products in Thailand: an analysis of reports in the thai health product vigilance center database from 2000 to 2008.

PubMed

Saokaew, Surasak; Suwankesawong, Wimon; Permsuwan, Unchalee; Chaiyakunapruk, Nathorn

2011-04-01

The use of herbal products continues to expand rapidly across the world and concerns regarding the safety of these products have been raised. In Thailand, Thai Vigibase, developed by the Health Product Vigilance Center (HPVC) under the Thai Food and Drug Administration, is the national database that collates reports from health product surveillance systems and programmes. Thai Vigibase can be used to identify signals of adverse events in patients receiving herbal products. The purpose of the study was to describe the characteristics of reported adverse events in patients receiving herbal products in Thailand. Thai Vigibase data from February 2000 to December 2008 involving adverse events reported in association with herbal products were used. This database includes case reports submitted through the spontaneous reporting system and intensive monitoring programmes. Under the spontaneous reporting system, adverse event reports are collected nationwide via a national network of 22 regional centres covering more than 800 public and private hospitals, and health service centres. An intensive monitoring programme was also conducted to monitor the five single herbal products listed in the Thai National List of Essential Medicines (NLEM), while another intensive monitoring programme was developed to monitor the four single herbal products that were under consideration for inclusion in the NLEM. The database contained patient demographics, adverse events associated with herbal products, and details on seriousness, causality and quality of reports. Descriptive statistics were used for data analyses. A total of 593 reports with 1868 adverse events involving 24 different products were made during the study period. The age range of individuals was 1-86 years (mean 47 years). Most case reports were obtained from the intensive monitoring programme. Of the reports, 72% involved females. The herbal products for which adverse events were frequently reported were products containing turmeric (44%), followed by andrographis (10%), veld grape (10%), pennywort (7%), plai (6%), jewel vine (6%), bitter melon (5%) and snake plant (5%). Gastrointestinal problems were the most common adverse effect reported. Serious adverse events included Stevens-Johnson syndrome, anaphylactic shock and exfoliative dermatitis. Adverse event reports on herbals products were diverse, with most of them being reported through intensive monitoring programmes. Thai Vigibase is a potentially effective data source for signal detection of adverse events associated with herbal products.

Special Data Collection System (SDCS) event report, NTS event 'LEYDEN', 26 November 1975. Technical report

DOE Office of Scientific and Technical Information (OSTI.GOV)

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

1976-02-24

Short-period signals associated with the NTS Event 'LEYDEN' on 26 November 1975 were recorded at a RK-ON and LASA. Station descriptions, arrival times, magitude of seismic waves, and seismic signatures are included.

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

PubMed

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.

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).

PubMed

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.

Low Probability Tail Event Analysis and Mitigation in BPA Control Area: Task One Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lu, Shuai; Makarov, Yuri V.

This is a report for task one of the tail event analysis project for BPA. Tail event refers to the situation in a power system when unfavorable forecast errors of load and wind are superposed onto fast load and wind ramps, or non-wind generators falling short of scheduled output, the imbalance between generation and load becomes very significant. This type of events occurs infrequently and appears on the tails of the distribution of system power imbalance; therefore, is referred to as tail events. This report analyzes what happened during the Electric Reliability Council of Texas (ERCOT) reliability event on Februarymore » 26, 2008, which was widely reported because of the involvement of wind generation. The objective is to identify sources of the problem, solutions to it and potential improvements that can be made to the system. Lessons learned from the analysis include the following: (1) Large mismatch between generation and load can be caused by load forecast error, wind forecast error and generation scheduling control error on traditional generators, or a combination of all of the above; (2) The capability of system balancing resources should be evaluated both in capacity (MW) and in ramp rate (MW/min), and be procured accordingly to meet both requirements. The resources need to be able to cover a range corresponding to the variability of load and wind in the system, additional to other uncertainties; (3) Unexpected ramps caused by load and wind can both become the cause leading to serious issues; (4) A look-ahead tool evaluating system balancing requirement during real-time operations and comparing that with available system resources should be very helpful to system operators in predicting the forthcoming of similar events and planning ahead; and (5) Demand response (only load reduction in ERCOT event) can effectively reduce load-generation mismatch and terminate frequency deviation in an emergency situation.« less

Event-based surveillance in north-western Ethiopia: experience and lessons learnt in the field

PubMed Central

Ota, Masaki; Beyene, Belay Bezabih

2015-01-01

This study piloted an event-based surveillance system at the health centre (HC) level in Ethiopia. The system collects rumours in the community and registers them in rumour logbooks to record events of disease outbreaks and public health emergencies. Descriptive analysis was conducted on the events captured at the 59 study HCs in the Amhara Region in north-western Ethiopia between October 2013 and November 2014. A total of 126 rumours were registered at two thirds of the HCs during the study period. The average event reporting time was 3.8 days; response time of the HCs was 0.6 days, resulting in a total response time of 4.4 days. The most commonly reported rumours were measles-related (n = 90, 71%). These rumours followed a similar pattern of measles cases reported in the routine surveillance system. The largest proportion of rumours were reported by community members (n = 38, 36%) followed by health post workers (n = 36, 29%) who were normally informed by the community members about the rumours. This surveillance system was established along with an existing indicator-based surveillance system and was simple to implement. The implementation cost was minimal, requiring only printing and distribution of rumour logbooks to the HCs and brief orientations to focal persons. In countries where routine surveillance is still weak, an event-based surveillance system similar to this should be considered as a supplementary tool for disease monitoring. PMID:26668763

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

PubMed

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. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the United States.

Nurses' systems thinking competency, medical error reporting, and the occurrence of adverse events: a cross-sectional study.

PubMed

Hwang, Jee-In; Park, Hyeoun-Ae

2017-12-01

Healthcare professionals' systems thinking is emphasized for patient safety. To report nurses' systems thinking competency, and its relationship with medical error reporting and the occurrence of adverse events. A cross-sectional survey using a previously validated Systems Thinking Scale (STS), was conducted. Nurses from two teaching hospitals were invited to participate in the survey. There were 407 (60.3%) completed surveys. The mean STS score was 54.5 (SD 7.3) out of 80. Nurses with higher STS scores were more likely to report medical errors (odds ratio (OR) = 1.05; 95% confidence interval (CI) = 1.02-1.08) and were less likely to be involved in the occurrence of adverse events (OR = 0.96; 95% CI = 0.93-0.98). Nurses showed moderate systems thinking competency. Systems thinking was a significant factor associated with patient safety. Impact Statement: The findings of this study highlight the importance of enhancing nurses' systems thinking capacity to promote patient safety.

Idaho National Laboratory Quarterly Event Performance Analysis FY 2013 4th Quarter

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth A.

2013-11-01

This report is published quarterly by the Idaho National Laboratory (INL) Performance Assurance Organization. The Department of Energy Occurrence Reporting and Processing System (ORPS) as prescribed in DOE Order 232.2 “Occurrence Reporting and Processing of Operations Information” requires a quarterly analysis of events, both reportable and not reportable for the previous twelve months. This report is the analysis of occurrence reports and deficiency reports (including not reportable events) identified at the Idaho National Laboratory (INL) during the period of October 2012 through September 2013.

Anomalous event diagnosis for environmental satellite systems

NASA Technical Reports Server (NTRS)

Ramsay, Bruce H.

1993-01-01

The National Oceanic and Atmospheric Administration's (NOAA) National Environmental Satellite, Data, and Information Service (NESDIS) is responsible for the operation of the NOAA geostationary and polar orbiting satellites. NESDIS provides a wide array of operational meteorological and oceanographic products and services and operates various computer and communication systems on a 24-hour, seven days per week schedule. The Anomaly Reporting System contains a database of anomalous events regarding the operations of the Geostationary Operational Environmental Satellite (GOES), communication, or computer systems that have degraded or caused the loss of GOES imagery. Data is currently entered manually via an automated query user interface. There are 21 possible symptoms (e.g., No Data), and 73 possible causes (e.g., Sectorizer - World Weather Building) of an anomalous event. The determination of an event's cause(s) is made by the on-duty computer operator, who enters the event in a paper based daily log, and by the analyst entering the data into the reporting system. The determination of the event's cause(s) impacts both the operational status of these systems, and the performance evaluation of the on-site computer and communication operations contractor.

Patients use an internet technology to report when things go wrong

PubMed Central

Wasson, John H; MacKenzie, Todd A; Hall, Michael

2007-01-01

Background As patients directly experience harm from adverse events, investigators have proposed patient‐report to complement professional reporting of adverse events. Objective To investigate how an automated health assessment system can be used to identify adverse events. Design and setting Internet survey responses from April 2003 to April 2005 involving communities and clinical practices across the USA. Patients 44 860 adults aged 19–69 years. Outcome Patient perceptions of adverse events experienced during the previous year. Independent legal review was also used to estimate how many patient‐reports were serious enough to be potentially compensable. Results Although patient reports of possible adverse events was low (1.4%), the percentage of adverse events was eight times higher for patients with the greatest burden of illness than for those with the least (3.4% vs 0.4%). Two expert malpractice attorneys agreed that 9% of the adverse events seemed to be serious. Conclusions Patients will use internet technology to report their perceptions of health‐related adverse events. Some of the patient‐reported events reported will be serious. PMID:17545349

Adverse events associated with pediatric exposures to dextromethorphan.

PubMed

Paul, Ian M; Reynolds, Kate M; Kauffman, Ralph E; Banner, William; Bond, G Randall; Palmer, Robert B; Burnham, Randy I; Green, Jody L

2017-01-01

Dextromethorphan is the most common over-the-counter (OTC) antitussive medication. We sought to characterize adverse events associated with dextromethorphan in children <12 years old from a surveillance program of OTC cough/cold medication exposures. This is a retrospective case series of oral exposures to dextromethorphan with ≥1 adverse event from multiple U.S. sources (National Poison Data System, FDA Adverse Event Reporting System, manufacturer safety reports, news/media, medical literature) reported between 2008 and 2014. An expert panel determined the relationship between exposure and adverse events, estimated dose ingested, intent of exposure, and identified contributing factors to exposure. 1716 cases contained ≥1 adverse event deemed at least potentially related to dextromethorphan; 1417 were single product exposures. 773/1417 (55%) involved only one single-ingredient dextromethorphan product (dextromethorphan-only). Among dextromethorphan-only cases, 3% followed ingestion of a therapeutic dose; 78% followed an overdose. 69% involved unsupervised self-administration and 60% occurred in children <4 years old. No deaths or pathologic dysrhythmias occurred. Central nervous system [e.g., ataxia (N = 420)] and autonomic symptoms [e.g., tachycardia (N = 224)] were the most common adverse events. Flushing and/or urticarial rash occurred in 18.1% of patients. Dystonia occurred in 5.4%. No fatalities were identified in this multifaceted surveillance program following a dextromethorphan-only ingestion. Adverse events were predominantly associated with overdose, most commonly affecting the central nervous and autonomic systems.

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

PubMed

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.

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

PubMed

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 P<0.01. A total of 27,150 events 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 P<0.001), RORs generally were similar for AG and generic comparisons. Generic lamotrigine and carbamazepine were more commonly involved in reports of suicide or suicidal ideation compared with the respective AGs based on a multiple comparison-adjusted P<0.01. Similar AED reporting 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.

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

PubMed

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 statistical power to detect the variation in reporting rates across years. The identified vaccine-event combinations with significant different reporting rates over years suggested potential safety issues due to changes in vaccines which require further investigation. We developed a statistical model to detect safety signals arising from heterogeneity of reporting rates of a given vaccine-event combinations across reporting years. This method detects variation in reporting rates over years with high power. The temporal trend of reporting rate across years may reveal the impact of vaccine update on occurrence of adverse events and provide evidence for further investigations.

Army Needs to Improve Controls and Audit Trails for the General Fund Enterprise Business System Acquire-to-Retire Business Process

DTIC Science & Technology

2013-09-13

Event 1.4.4,” August 7, 2012 AAA Attestation Report A-2010-0187- FFM , “General Fund Enterprise Business System - Federal Financial Management...Improvement Act Compliance. Examination of Requirements Through Test Event 1.4.0,” September 14, 2010 AAA Audit Report A-2009-0232- FFM , “General Fund...September 30, 2009 AAA Audit Report A-2009-0231- FFM , “General Fund Enterprise Business System - Federal Financial Management Improvement Act

[Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database].

PubMed

Sasaoka, Sayaka; Hatahira, Haruna; Hasegawa, Shiori; Motooka, Yumi; Fukuda, Akiho; Naganuma, Misa; Umetsu, Ryogo; Nakao, Satoshi; Shimauchi, Akari; Ueda, Natsumi; Hirade, Kouseki; Iguchi, Kazuhiro; Nakamura, Mitsuhiro

2018-01-01

 OTC combination cold remedies are widely used in Japan. In the present study, we aimed to evaluate the adverse event profiles of OTC combination cold remedy based on the components using the Japanese Adverse Drug Event Report (JADER) database. The JADER database contained 430587 reports between April 2004 and November 2016. 1084 adverse events associated with the use of OTC combination cold remedy were reported. Reporting odds ratio (ROR) was used to detect safety signals. The ROR values for "skin and subcutaneous tissue disorders", "hepatobiliary disorders", and "immune system disorders" stratified by system organ class of the Medical Dictionary for Regulatory Activities (MedDRA) were 9.82 (8.71-11.06), 2.63 (2.25-3.07), and 3.13 (2.63-3.74), respectively. OTC combination cold remedy containing acetaminophen exhibited a significantly higher reporting ratio for "hepatobiliary disorders" than OTC combination cold remedy without acetaminophen. We demonstrated the potential risk of OTC combination cold remedy in a real-life setting. Our results suggested that the monitoring of individuals using OTC combination cold remedy is important.

Looking Back: Events That Have Shaped Our Current Child Care Delivery System.

ERIC Educational Resources Information Center

Neugebauer, Roger

2000-01-01

Reports findings of an unscientific survey of early childhood professionals asked to reflect upon the history, landmark events, and significant trends in the child care delivery system. Three events viewed as most influential are highlighted: (1) World War II; (2) women's movement; and (3) Head Start. Eleven other events also cited are discussed.…

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

PubMed

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 of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

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

PubMed

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.

12 CFR 621.15 - Reports of accounts and exposures.

Code of Federal Regulations, 2014 CFR

2014-01-01

... officer of the reporting bank or association. In the event the bank or association learns of a material... Credit Administration. (4) Develop, implement, and maintain an effective system of internal controls over... Reporting Entity. In the event the Reporting Entity learns of a material error or misstatement in the...

From infancy to adolescence: the development and future of the national firefighter near-miss reporting system.

PubMed

Taylor, Jennifer A; Lacovara, Alicia V

2015-02-01

The National Fire Fighter Near-Miss Reporting System (NFFNMRS) is a voluntary adverse event reporting system designed as a repository to which firefighters submit information on the hazards seen in their work, detailing the events that led to near-misses and injuries. This descriptive article discusses the development of the system since its inception, the strengths and limitations of the resultant data, and the improvements to be made to ensure the system's usefulness. Especially in their infancy, near-miss systems are very dependent on funding and sensitive to any reductions as they head toward steady-state reporting. This sustainability factor has significant implications for continued reporting to the system and the ultimate utility of the data. Very few such data systems exist for occupational health surveillance. © 2015 SAGE Publications.

Adverse events among Ontario home care clients associated with emergency room visit or hospitalization: a retrospective cohort study

PubMed Central

2013-01-01

Background Home care (HC) is a critical component of the ongoing restructuring of healthcare in Canada. It impacts three dimensions of healthcare delivery: primary healthcare, chronic disease management, and aging at home strategies. The purpose of our study is to investigate a significant safety dimension of HC, the occurrence of adverse events and their related outcomes. The study reports on the incidence of HC adverse events, the magnitude of the events, the types of events that occur, and the consequences experienced by HC clients in the province of Ontario. Methods A retrospective cohort design was used, utilizing comprehensive secondary databases available for Ontario HC clients from the years 2008 and 2009. The data were derived from the Canadian Home Care Reporting System, the Hospital Discharge Abstract Database, the National Ambulatory Care Reporting System, the Ontario Mental Health Reporting System, and the Continuing Care Reporting System. Descriptive analysis was used to identify the type and frequency of the adverse events recorded and the consequences of the events. Logistic regression analysis was used to examine the association between the events and their consequences. Results The study found that the incident rate for adverse events for the HC clients included in the cohort was 13%. The most frequent adverse events identified in the databases were injurious falls, injuries from other than a fall, and medication-related incidents. With respect to outcomes, we determined that an injurious fall was associated with a significant increase in the odds of a client requiring long-term-care facility admission and of client death. We further determined that three types of events, delirium, sepsis, and medication-related incidents were associated directly with an increase in the odds of client death. Conclusions Our study concludes that 13% of clients in homecare experience an adverse event annually. We also determined that an injurious fall was the most frequent of the adverse events and was associated with increased admission to long-term care or death. We recommend the use of tools that are presently available in Canada, such as the Resident Assessment Instrument and its Clinical Assessment Protocols, for assessing and mitigating the risk of an adverse event occurring. PMID:23800280

Implementation of a Data-Based Medical Event Reporting System in the U.S. Department of Defense

DTIC Science & Technology

2005-05-01

where patient safety events warrant further investigation. Introduction Department of Defense Instruction 6025.17 established the Military Health ...Administration (VHA) Patient Safety Reporting Program for error tracking and reporting within all military health care facilities. 5 On August 16, 2001...DoD Instruction number 6025.17 “established a Military Health System Patient Safety Center (MHSPSC), including a MHS Patient Safety Registry (MHSPSR

Sharing adverse drug event data using business intelligence technology.

PubMed

Horvath, Monica M; Cozart, Heidi; Ahmad, Asif; Langman, Matthew K; Ferranti, Jeffrey

2009-03-01

Duke University Health System uses computerized adverse drug event surveillance as an integral part of medication safety at 2 community hospitals and an academic medical center. This information must be swiftly communicated to organizational patient safety stakeholders to find opportunities to improve patient care; however, this process is encumbered by highly manual methods of preparing the data. Following the examples of other industries, we deployed a business intelligence tool to provide dynamic safety reports on adverse drug events. Once data were migrated into the health system data warehouse, we developed census-adjusted reports with user-driven prompts. Drill down functionality enables navigation from aggregate trends to event details by clicking report graphics. Reports can be accessed by patient safety leadership either through an existing safety reporting portal or the health system performance improvement Web site. Elaborate prompt screens allow many varieties of reports to be created quickly by patient safety personnel without consultation with the research analyst. The reduction in research analyst workload because of business intelligence implementation made this individual available to additional patient safety projects thereby leveraging their talents more effectively. Dedicated liaisons are essential to ensure clear communication between clinical and technical staff throughout the development life cycle. Design and development of the business intelligence model for adverse drug event data must reflect the eccentricities of the operational system, especially as new areas of emphasis evolve. Future usability studies examining the data presentation and access model are needed.

Why Clinicians Don't Report Adverse Drug Events: Qualitative Study.

PubMed

Hohl, Corinne M; Small, Serena S; Peddie, David; Badke, Katherin; Bailey, Chantelle; Balka, Ellen

2018-02-27

Adverse drug events are unintended and harmful events related to medications. Adverse drug events are important for patient care, quality improvement, drug safety research, and postmarketing surveillance, but they are vastly underreported. Our objectives were to identify barriers to adverse drug event documentation and factors contributing to underreporting. This qualitative study was conducted in 1 ambulatory center, and the emergency departments and inpatient wards of 3 acute care hospitals in British Columbia between March 2014 and December 2016. We completed workplace observations and focus groups with general practitioners, hospitalists, emergency physicians, and hospital and community pharmacists. We analyzed field notes by coding and iteratively analyzing our data to identify emerging concepts, generate thematic and event summaries, and create workflow diagrams. Clinicians validated emerging concepts by applying them to cases from their clinical practice. We completed 238 hours of observations during which clinicians investigated 65 suspect adverse drug events. The observed events were often complex and diagnosed over time, requiring the input of multiple providers. Providers documented adverse drug events in charts to support continuity of care but never reported them to external agencies. Providers faced time constraints, and reporting would have required duplication of documentation. Existing reporting systems are not suited to capture the complex nature of adverse drug events or adapted to workflow and are simply not used by frontline clinicians. Systems that are integrated into electronic medical records, make use of existing data to avoid duplication of documentation, and generate alerts to improve safety may address the shortcomings of existing systems and generate robust adverse drug event data as a by-product of safer care. ©Corinne M Hohl, Serena S Small, David Peddie, Katherin Badke, Chantelle Bailey, Ellen Balka. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 27.02.2018.

Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative Analysis of FAERS and CAERS Reporting Systems.

PubMed

Raschi, Emanuel; Girardi, Anna; Poluzzi, Elisabetta; Forcesi, Emanuele; Menniti-Ippolito, Francesca; Mazzanti, Gabriela; De Ponti, Fabrizio

2018-03-26

Food supplements containing red yeast rice (RYR) are proposed as an alternative in statin-intolerant patients, although they actually contain natural statin(s) and their safety in clinical practice is still incompletely characterized. We described and compared adverse events (AEs) associated with RYR products submitted to reporting systems maintained by the Food and Drug Administration (FDA), with a focus on liver and muscular events. We extracted RYR-related AEs from the FDA Adverse Event Reporting System (FAERS) [first quarter (Q1)-2004 to Q2-2016], a drug-based archive, and the Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) (Q1-2004 to Q1-2017). Disproportionality via reporting odds ratio (ROR) with 95% confidence interval (CI) calculation and case-by-case inspection were performed, with a focus on muscular and hepatic AEs. One thousand three hundred AEs were extracted from FAERS (RYR mainly reported as a concomitant agent), whereas only 159 AEs were found in CAERS (RYR recorded mainly as a suspect agent). In FAERS, a large number of reports emerged for "general disorders and administration site conditions," whereas CAERS received also a high number of reports for "investigations" and "musculoskeletal and connective tissue disorders". Disproportionality analyses confirmed higher reporting of serious muscular and liver injuries: in FAERS, five cases of hepatic disorders (ROR = 13.71; 95% CI 5.44-34.57); in CAERS, 27 cases of rhabdomyolysis/myopathy (8.44; 5.44-13.10). Notwithstanding recognized limitations, these findings strengthen the importance of exploring multiple databases in safety assessment of RYR products, which should be monitored by clinicians for muscular and hepatic safety, and call for urgent review by policymakers to harmonize their regulatory status.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

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 eventsmore » 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.« less

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

PubMed Central

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

2015-01-01

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. PMID:26209838

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

PubMed

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.

Propagating Molecular Recognition Events through Highly Integrated Sense-Response Chemical Systems

DTIC Science & Technology

2017-08-01

Propagating Molecular Recognition Events through Highly Integrated Sense-Response Chemical Systems The views, opinions and/or findings contained in...University of California - San Diego Title: Propagating Molecular Recognition Events through Highly Integrated Sense-Response Chemical Systems Report Term...including enzymatic reactions , occurring at the aqueous interfaces of thermotropic LCs show promise as the basis of biomolecular triggers of LC

A web-based incident reporting system: a two years' experience in an Italian research and teaching hospital.

PubMed

Bodina, A; Demarchi, A; Castaldi, S

2014-01-01

A web-based incident reporting system (IRS) is a tool allowing healthcare workers to voluntary and anonymously report adverse events/near misses. In 2010, this system was introduced in a research and teaching hospital in metropolitan area in the North part of Italy, in order to detect errors and to learn from failures in care delivery. The aim of this paper is to assess whether and how IRS has proved to be a valuable tool to manage clinical risk and improve healthcare quality. Adverse events are reported anonymously by staff members with the use of an online template form available in the hospital intranet. We retrospectively reviewed the recorded data for each incident/near miss reported between January 2011 and December 2012. The number of reported incidents/near misses was 521 in 2011 and 442 in 2012. In the two years the admissions were 36.974 and 36.107 respectively. We noticed that nursing staff made more use of IRS and that reported errors were basically related to prescription and administration of medications. Much international literature reports that adverse events and near misses are 10% of admissions. Our data are far from that number, thus meaning that a failure in reporting adverse events exists. This consideration, together with the high number of near misses in comparison with occurred errors, leads us to speculate that adverse events with serious consequences for patients are marginally reported. Probably the lack of a strong leadership considering IRS as an instrument for improving quality and operators' reluctance to overcome the culture of blame may negatively affect IRS.

Development of a Classification Scheme for Examining Adverse Events Associated with Medical Devices, Specifically the DaVinci Surgical System as Reported in the FDA MAUDE Database.

PubMed

Gupta, Priyanka; Schomburg, John; Krishna, Suprita; Adejoro, Oluwakayode; Wang, Qi; Marsh, Benjamin; Nguyen, Andrew; Genere, Juan Reyes; Self, Patrick; Lund, Erik; Konety, Badrinath R

2017-01-01

To examine the Manufacturer and User Facility Device Experience Database (MAUDE) database to capture adverse events experienced with the Da Vinci Surgical System. In addition, to design a standardized classification system to categorize the complications and machine failures associated with the device. Overall, 1,057,000 DaVinci procedures were performed in the United States between 2009 and 2012. Currently, no system exists for classifying and comparing device-related errors and complications with which to evaluate adverse events associated with the Da Vinci Surgical System. The MAUDE database was queried for events reports related to the DaVinci Surgical System between the years 2009 and 2012. A classification system was developed and tested among 14 robotic surgeons to associate a level of severity with each event and its relationship to the DaVinci Surgical System. Events were then classified according to this system and examined by using Chi-square analysis. Two thousand eight hundred thirty-seven events were identified, of which 34% were obstetrics and gynecology (Ob/Gyn); 19%, urology; 11%, other; and 36%, not specified. Our classification system had moderate agreement with a Kappa score of 0.52. Using our classification system, we identified 75% of the events as mild, 18% as moderate, 4% as severe, and 3% as life threatening or resulting in death. Seventy-seven percent were classified as definitely related to the device, 15% as possibly related, and 8% as not related. Urology procedures compared with Ob/Gyn were associated with more severe events (38% vs 26%, p < 0.0001). Energy instruments were associated with less severe events compared with the surgical system (8% vs 87%, p < 0.0001). Events that were definitely associated with the device tended to be less severe (81% vs 19%, p < 0.0001). Our classification system is a valid tool with moderate inter-rater agreement that can be used to better understand device-related adverse events. The majority of robotic related events were mild but associated with the device.

MERIS (Medical Error Reporting Information System) as an innovative patient safety intervention: a health policy perspective.

PubMed

Riga, Marina; Vozikis, Athanassios; Pollalis, Yannis; Souliotis, Kyriakos

2015-04-01

The economic crisis in Greece poses the necessity to resolve problems concerning both the spiralling cost and the quality assurance in the health system. The detection and the analysis of patient adverse events and medical errors are considered crucial elements of this course. The implementation of MERIS embodies a mandatory module, which adopts the trigger tool methodology for measuring adverse events and medical errors an intensive care unit [ICU] environment, and a voluntary one with web-based public reporting methodology. A pilot implementation of MERIS running in a public hospital identified 35 adverse events, with approx. 12 additional hospital days and an extra healthcare cost of €12,000 per adverse event or of about €312,000 per annum for ICU costs only. At the same time, the voluntary module unveiled 510 reports on adverse events submitted by citizens or patients. MERIS has been evaluated as a comprehensive and effective system; it succeeded in detecting the main factors that cause adverse events and discloses severe omissions of the Greek health system. MERIS may be incorporated and run efficiently nationally, adapted to the needs and peculiarities of each hospital or clinic. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data

PubMed Central

Alemzadeh, Homa; Raman, Jaishankar; Leveson, Nancy; Kalbarczyk, Zbigniew; Iyer, Ravishankar K.

2016-01-01

Background Use of robotic systems for minimally invasive surgery has rapidly increased during the last decade. Understanding the causes of adverse events and their impact on patients in robot-assisted surgery will help improve systems and operational practices to avoid incidents in the future. Methods By developing an automated natural language processing tool, we performed a comprehensive analysis of the adverse events reported to the publicly available MAUDE database (maintained by the U.S. Food and Drug Administration) from 2000 to 2013. We determined the number of events reported per procedure and per surgical specialty, the most common types of device malfunctions and their impact on patients, and the potential causes for catastrophic events such as patient injuries and deaths. Results During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant (mean = 83.4, 95% confidence interval (CI), 74.2–92.7 per 100,000 procedures) over the years. Surgical specialties for which robots are extensively used, such as gynecology and urology, had lower numbers of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9 per 100,000 procedures, Risk Ratio = 2.2, 95% CI, 1.9–2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of all the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it (2.5%). Conclusions Despite widespread adoption of robotic systems for minimally invasive surgery in the U.S., a non-negligible number of technical difficulties and complications are still being experienced during procedures. Adoption of advanced techniques in design and operation of robotic surgical systems and enhanced mechanisms for adverse event reporting may reduce these preventable incidents in the future. PMID:27097160

Contributory factors in surgical incidents as delineated by a confidential reporting system.

PubMed

Mushtaq, F; O'Driscoll, C; Smith, Fct; Wilkins, D; Kapur, N; Lawton, R

2018-05-01

Background Confidential reporting systems play a key role in capturing information about adverse surgical events. However, the value of these systems is limited if the reports that are generated are not subjected to systematic analysis. The aim of this study was to provide the first systematic analysis of data from a novel surgical confidential reporting system to delineate contributory factors in surgical incidents and document lessons that can be learned. Methods One-hundred and forty-five patient safety incidents submitted to the UK Confidential Reporting System for Surgery over a 10-year period were analysed using an adapted version of the empirically-grounded Yorkshire Contributory Factors Framework. Results The most common factors identified as contributing to reported surgical incidents were cognitive limitations (30.09%), communication failures (16.11%) and a lack of adherence to established policies and procedures (8.81%). The analysis also revealed that adverse events were only rarely related to an isolated, single factor (20.71%) - with the majority of cases involving multiple contributory factors (79.29% of all cases had more than one contributory factor). Examination of active failures - those closest in time and space to the adverse event - pointed to frequent coupling with latent, systems-related contributory factors. Conclusions Specific patterns of errors often underlie surgical adverse events and may therefore be amenable to targeted intervention, including particular forms of training. The findings in this paper confirm the view that surgical errors tend to be multi-factorial in nature, which also necessitates a multi-disciplinary and system-wide approach to bringing about improvements.

Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: investigation from the United States Food and Drug Administration adverse event reporting system database.

PubMed

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

2012-10-01

To investigate reports of thrombotic events associated with the use of C1 esterase inhibitor products in patients with hereditary angioedema in the United States. Retrospective data mining analysis. The United States Food and Drug Administration (FDA) adverse event reporting system (AERS) database. Case reports of C1 esterase inhibitor products, thrombotic events, and C1 esterase inhibitor product-associated thrombotic events (i.e., combination cases) were extracted from the AERS database, using the time frames of each respective product's FDA approval date through the second quarter of 2011. Bayesian statistical methodology within the neural network architecture was implemented to identify potential signals of a drug-associated adverse event. A potential signal is generated when the lower limit of the 95% 2-sided confidence interval of the information component, denoted by IC₀₂₅ , is greater than zero. This suggests that the particular drug-associated adverse event was reported to the database more often than statistically expected from reports available in the database. Ten combination cases of thrombotic events associated with the use of one C1 esterase inhibitor product (Cinryze) were identified in patients with hereditary angioedema. A potential signal demonstrated by an IC₀₂₅ value greater than zero (IC₀₂₅ = 2.91) was generated for these combination cases. The extracted cases from the AERS indicate continuing reports of thrombotic events associated with the use of one C1 esterase inhibitor product among patients with hereditary angioedema. The AERS is incapable of establishing a causal link and detecting the true frequency of an adverse event associated with a drug; however, potential signals of C1 esterase inhibitor product-associated thrombotic events among patients with hereditary angioedema were identified in the extracted combination cases. © 2012 Pharmacotherapy Publications, Inc.

SU-E-T-524: Web-Based Radiation Oncology Incident Reporting and Learning System (ROIRLS)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kapoor, R; Palta, J; Hagan, M

Purpose: Describe a Web-based Radiation Oncology Incident Reporting and Learning system that has the potential to improve quality of care for radiation therapy patients. This system is an important facet of continuing effort by our community to maintain and improve safety of radiotherapy.Material and Methods: The VA National Radiation Oncology Program office has embarked on a program to electronically collect adverse events and near miss data of radiation treatment of over 25,000 veterans treated with radiotherapy annually. Software used for this program is deployed on the VAs intranet as a Website. All data entry forms (adverse event or near missmore » reports, work product reports) utilize standard causal, RT process step taxonomies and data dictionaries defined in AAPM and ASTRO reports on error reporting (AAPM Work Group Report on Prevention of Errors and ASTROs safety is no accident report). All reported incidents are investigated by the radiation oncology domain experts. This system encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions to prevent it from happening again. The operational workflow is similar to that of the Aviation Safety Reporting System. This system is also synergistic with ROSIS and SAFRON. Results: The ROIRLS facilitates the collection of data that help in tracking adverse events and near misses and develop new interventions to prevent such incidents. The ROIRLS electronic infrastructure is fully integrated with each registered facility profile data thus minimizing key strokes and multiple entries by the event reporters. Conclusions: OIRLS is expected to improve the quality and safety of a broad spectrum of radiation therapy patients treated in the VA and fulfills our goal of Effecting Quality While Treating Safely The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations Inc. and is deployed on the VA intranet as a Website. The Radiation Oncology Incident Reporting and Learning System software used for this program has been developed, conceptualized and maintained by TSG Innovations Inc. and is deployed on the VA intranet as a Website.« less

Automatically Recognizing Medication and Adverse Event Information From Food and Drug Administration’s Adverse Event Reporting System Narratives

PubMed Central

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

2014-01-01

Background 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. Objective 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. Methods 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. Results 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. Conclusions 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. PMID:25600332

Cognition- and Dementia-Related Adverse Effects With Sacubitril-Valsartan: Analysis of the FDA Adverse Event Report System Database.

PubMed

Perlman, Amichai; Hirsh Raccah, Bruria; Matok, Ilan; Muszkat, Mordechai

2018-05-07

Because neprilysin is involved in the degradation of amyloid-beta, there is concern that the angiotensin-neprilysin inhibitor sacubitril-valsartan could increase the risk for dementia. We analyzed adverse event cases submitted to the Food and Drug Administration Adverse Event Report System from July 2015 to March 2017. Cognition- and dementia-related adverse event cases were defined with the use of broad and narrow structured medical queries. During the period evaluated, 9,004 adverse event reports (out of a total of 2,249,479) involved the use of sacubitril-valsartan. Based on the broad definition, sacubitril-valsartan was associated with cognition- and dementia-related adverse events in 459 reports (5.1%), but this was lower than the proportion of these reports among other medications (6.6%, reporting odds ratio [ROR] 0.72, 95% confidence interval [CI] 0.65-0.79). Restricting the comparison to cases with age >60 years and with the use of a comparator group with heart failure resulted in no association between sacubitril-valsartan and dementia-related adverse events, with the use of both the broad and the narrow definitions (ROR 0.87, 95% CI 0.76-1.02, and ROR 1.06, 95% CI 0.4-3.16, respectively). Sacubitril-valsartan is not associated with a disproportionately high rate of short-term dementia-related adverse effect reports. Long-term studies assessing cognitive outcomes are required to better establish the medication's cognition effects. Copyright © 2018 Elsevier Inc. All rights reserved.

Analysis of Effects of Sensor Multithreading to Generate Local System Event Timelines

DTIC Science & Technology

2014-03-27

works on logs highlights the importance of logs [17, 18]. The two aforementioned works both reference the same 2009 Data Breach Investigations Report...the data breaches report on, the logs contained evidence of events leading up to 82% of those data breaches . This means that preventing 82% of the data ...report states that of the data breaches reported on, the logs contained evidence of events leading up to 66% of those data breaches . • The 2010 DBIR

[Study on the timeliness of detection and reporting on public health emergency events in China].

PubMed

Li, Ke-Li; Feng, Zi-Jian; Ni, Da-Xin

2009-03-01

To analyze the timeliness of detection and reporting on public health emergency events, and to explore the effective strategies for improving the relative capacity on those issues. We conducted a retrospective survey on 3275 emergency events reported through Public Health Emergency Events Surveillance System from 2005 to the first half of 2006. Developed by county Centers for Disease Control and Prevention, a uniformed self-administrated questionnaire was used to collect data, which would include information on the detection, reporting of the events. For communicable diseases events, the median of time interval between the occurrence of first case and the detection of event was 6 days (P25 = 2, P75 = 13). For food poisoning events and clusters of disease with unknown origin, the medians were 3 hours (P25, P75 = 16) and 1 days (P25 = 0, P75 = 5). 71.54% of the events were reported by the discoverers within 2 hours after the detection. In general, the ranges of time intervals between the occurrence, detection or reporting of the events were different, according to the categories of events. The timeliness of detection and reporting of events could have been improved dramatically if the definition of events, according to their characteristics, had been more reasonable and accessible, as well as the improvement of training program for healthcare staff and teachers.

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

PubMed

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.

A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation.

PubMed

Kaye, Stephen; Baddon, Andrew; Jones, Mark; Armitage, W John; Fehily, Deirdre; Warwick, Ruth M

2010-02-01

Reporting and investigation of serious adverse events and reactions associated with tissue and cell transplantation is a fundamental aspect of ensuring adequate levels of safety and quality and is a requirement of the European Union Directives on tissues and cells. In the UK, a system for the reporting and analysis of events and reactions associated with ocular tissue transplantation is well established. It is operated by a network of individuals and organisations, each with clearly defined roles and responsibilities, following written procedures for reporting and investigation. Analysis of reports indicates that the most important adverse reactions associated with this type of tissue transplantation are endophthalmitis (0.58%) and primary graft failure (0.3%). This system allows the analysis of all types of events and reactions by the professionals involved so that trends can be identified and services improved. Tools to evaluate the severity and imputability of individual events or reactions, such as those developed by the EUSTITE project, can be utilised to facilitate the selection of those cases meeting the criteria for reporting to the Competent Authority. This vigilance model has been shown to be effective and could be applied in other fields of tissue or cell transplantation.

A novel approach to increase residents' involvement in reporting adverse events.

PubMed

Scott, David R; Weimer, Melissa; English, Clea; Shaker, Lynn; Ward, William; Choi, Dongseok; Cedfeldt, Andrea; Girard, Donald

2011-06-01

In the wake of the Patient Safety and Quality Improvement Act of 2005, national attention has increasingly focused on adverse-event reporting as a means of identifying systems changes to improve patient safety. However, physicians and residents have demonstrated meager involvement in this effort. In 2008-2009, the authors measured participation in adverse-event reporting by 680 residents at Oregon Health & Science University before and after implementing a quality improvement initiative, which consisted of a financial incentive and multifaceted educational campaign. The primary measure of success was an increase in the average monthly adverse-event reports submitted by residents to greater than 5% of the institution's overall report submissions. The average number of adverse events reported by residents increased from 1.6% to 9.0% of the institution's overall event reports, representing a 5.6-fold increase during the initiative (P < .001). The relative percentage of resident-submitted reports defined as "near-misses" increased from 6% to 27% during the initiative (P < .001). The novel approach of integrating a retirement benefit and educational campaign to increase residents' involvement in adverse-event reporting was successful. In addition to increasing residents' contributions to adverse-event reporting to levels higher than any documented in the current literature, there was also a remarkable increase in the relative frequency of near-miss reporting by residents.

Leading a highly visible hospital through a serious reportable event.

PubMed

Erickson, Jeanette Ives

2012-03-01

Most preventable adverse events result from systemic causes, not human error. The senior vice president for patient care/chief nurse at a leading hospital recounts the unnecessary death of a patient and the investigation that followed. Citing the critical importance of a "just culture," this case study offers a blueprint for managing a serious reportable event.

Design and implementation of a near-miss reporting system at a large, academic pediatric anesthesia department.

PubMed

Guffey, Patrick; Szolnoki, Judit; Caldwell, James; Polaner, David

2011-07-01

Current incident reporting systems encourage retrospective reporting of morbidity and mortality and have low participation rates. A near miss is an event that did not cause patient harm, but had the potential to. By tracking and analyzing near misses, systems improvements can be targeted appropriately, and future errors may be prevented. An electronic, web based, secure, anonymous reporting system for anesthesiologists was designed and instituted at The Children's Hospital, Denver. This portal was compared to an existing hospital incident reporting system. A total of 150 incidents were reported in the first 3 months of operation, compared to four entered in the same time period 1 year ago. An anesthesia-specific anonymous near-miss reporting system, which eases and facilitates data entry and can prospectively identify processes and practices that place patients at risk, was implemented at a large, academic, freestanding children's hospital. This resulted in a dramatic increase in reported events and provided data to target and drive quality and process improvement. © 2011 Blackwell Publishing Ltd.

Radar network communication through sensing of frequency hopping

DOEpatents

Dowla, Farid; Nekoogar, Faranak

2013-05-28

In one embodiment, a radar communication system includes a plurality of radars having a communication range and being capable of operating at a sensing frequency and a reporting frequency, wherein the reporting frequency is different than the sensing frequency, each radar is adapted for operating at the sensing frequency until an event is detected, each radar in the plurality of radars has an identification/location frequency for reporting information different from the sensing frequency, a first radar of the radars which senses the event sends a reporting frequency corresponding to its identification/location frequency when the event is detected, and all other radars in the plurality of radars switch their reporting frequencies to match the reporting frequency of the first radar upon detecting the reporting frequency switch of a radar within the communication range. In another embodiment, a method is presented for communicating information in a radar system.

A combination HIV reporter virus system for measuring post-entry event efficiency and viral outcome in primary CD4+ T cell subsets.

PubMed

Tilton, Carisa A; Tabler, Caroline O; Lucera, Mark B; Marek, Samantha L; Haqqani, Aiman A; Tilton, John C

2014-01-01

Fusion between the viral membrane of human immunodeficiency virus (HIV) and the host cell marks the end of the HIV entry process and the beginning of a series of post-entry events including uncoating, reverse transcription, integration, and viral gene expression. The efficiency of post-entry events can be modulated by cellular factors including viral restriction factors and can lead to several distinct outcomes: productive, latent, or abortive infection. Understanding host and viral proteins impacting post-entry event efficiency and viral outcome is critical for strategies to reduce HIV infectivity and to optimize transduction of HIV-based gene therapy vectors. Here, we report a combination reporter virus system measuring both membrane fusion and viral promoter-driven gene expression. This system enables precise determination of unstimulated primary CD4+ T cell subsets targeted by HIV, the efficiency of post-entry viral events, and viral outcome and is compatible with high-throughput screening and cell-sorting methods. Copyright © 2013 Elsevier B.V. All rights reserved.

10 CFR 50.73 - Licensee event report system.

Code of Federal Regulations, 2010 CFR

2010-01-01

... plant design; or (2) Normal and expected wear or degradation. (x) Any event that posed an actual threat... discovery of each component or system failure or procedural error. (J) For each human performance related...

Severe Autoimmune Adverse Events Post Herpes Zoster Vaccine: A Case-Control Study of Adverse Events in a National Database.

PubMed

Lai, Yi Chun; Yew, Yik Weng

2015-07-01

Zoster vaccine is recommended to reduce the incidence of herpes zoster and its complication of postherpetic neuralgia in older adults. However, there have been reports of autoimmune side effects post vaccination. We therefore aim to investigate the possible relationship of severe autoimmune adverse events (arthritis, vasculitis, systemic lupus erythematosus, thrombocytopenia, alopecia, Guillain-Barre syndrome, optic neuritis and multiple sclerosis) post zoster vaccination with a matched case-control study of reported events in the Vaccine Adverse Event Reporting System (VAERS). Our study showed no significantly increased risks of severe autoimmune adverse events, except arthritis and alopecia, after vaccination. Compared to the unexposed, patients with zoster vaccination had 2.2 and 2.7 times the odds of developing arthritis and alopecia, respectively (P<0.001 and P=0.015, respectively). However, almost none of these events was life threatening. Zoster vaccine is, therefore, relatively safe and unlikely to exacerbate or induce autoimmune diseases. Given its benefits and safety but low coverage, dermatologists and primary care physicians should encourage zoster vaccine use in elderly patients, including selected patients with autoimmune diseases.

Using HFACS-Healthcare to Identify Systemic Vulnerabilities During Surgery.

PubMed

Cohen, Tara N; Francis, Sarah E; Wiegmann, Douglas A; Shappell, Scott A; Gewertz, Bruce L

2018-03-01

The Human Factors Analysis and Classification System for Healthcare (HFACS-Healthcare) was used to classify surgical near miss events reported via a hospital's event reporting system over the course of 1 year. Two trained analysts identified causal factors within each event narrative and subsequently categorized the events using HFACS-Healthcare. Of 910 original events, 592 could be analyzed further using HFACS-Healthcare, resulting in the identification of 726 causal factors. Most issues (n = 436, 60.00%) involved preconditions for unsafe acts, followed by unsafe acts (n = 257, 35.39%), organizational influences (n = 27, 3.72%), and supervisory factors (n = 6, 0.82%). These findings go beyond the traditional methods of trending incident data that typically focus on documenting the frequency of their occurrence. Analyzing near misses based on their underlying contributing human factors affords a greater opportunity to develop process improvements to reduce reoccurrence and better provide patient safety approaches.

Surveillance of adverse effects during a vaccination campaign against meningitis C.

PubMed

Laribière, Anne; Miremont-Salamé, Ghada; Reyre, Hadrien; Abouelfath, Abdelilah; Liège, Ludovic; Moore, Nicholas; Haramburu, Françoise

2005-12-01

To describe adverse events occurring after mass vaccination with conjugate and nonconjugate vaccines and to assess the incidence of serious adverse effects. A mass immunisation campaign against meningococcal C disease was conducted in two French administrative areas, Landes and Pyrénées atlantiques, for 2 months (from October to December 2002). Adverse events were reported by families and physicians by means of a specific reporting form returned to the pharmacovigilance centre 15 days after vaccination. The target population was 260,630 individuals aged between 2 months and 24 years. About 179,000 children and young adults were vaccinated. A total of 92,711 report forms were received by the pharmacovigilance centre, and 12,695 subjects presented at least one adverse event. The most frequently involved systems/disorders were application site disorders (48.4%), whole-body general disorders (21.8%), central and peripheral nervous system disorders (14.6%), and gastrointestinal system disorders (4.7%). Most of these adverse events were transient and not serious. There were 13 serious adverse events: one each of syncope, fever, headache with fever, neuralgia, serum sickness, arthritis, purpura, facial paralysis, multiple sclerosis, lipoma, and meningism, and two cases of bronchospasm. No significant difference was found in rates of adverse event reports between both vaccines. The estimated incidence of serious adverse effect reports was 7 per 100,000. This campaign was the second immunisation campaign undertaken in France involving both physicians and families as reporters. Although unlabeled adverse effects were identified during this campaign, they were mostly nonserious and have been known to occur with other vaccines.

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

PubMed

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.

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

PubMed

Smith, Shannon M; Jones, Judith K; Katz, Nathaniel P; Roland, Carl L; Setnik, Beatrice; Trudeau, Jeremiah J; Wright, Stephen; Burke, Laurie B; Comer, Sandra D; Dart, Richard C; Dionne, Raymond; Haddox, J David; Jaffe, Jerome H; Kopecky, Ernest A; Martell, Bridget A; Montoya, Ivan D; Stanton, Marsha; Wasan, Ajay D; Turk, Dennis C; Dworkin, Robert H

2017-11-01

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

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

PubMed

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.

Building a knowledge base of severe adverse drug events based on AERS reporting data using semantic web technologies.

PubMed

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.

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

PubMed

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 (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices. © 2015 American Society for Clinical Pharmacology and Therapeutics.

A Physician-based Voluntary Reporting System for Adverse Events and Medical Errors

PubMed Central

Weingart, Saul N; Callanan, Lawrence D; Ship, Amy N; Aronson, Mark D

2001-01-01

OBJECTIVE To create a voluntary reporting method for identifying adverse events (AEs) and potential adverse events (PAEs) among medical inpatients. DESIGN Medical house officers asked their peers about obstacles to care, injuries or extended hospitalizations, and problems with medications that affected their patients. Two independent reviewers coded event narratives for adverse outcomes, responsible parties, preventability, and process problems. We corroborated house officers' reports with hospital incident reports and conducted a retrospective chart review. SETTING The cardiac step-down, oncology, and medical intensive care units of an urban teaching hospital. INTERVENTION Structured confidential interviews by postgraduate year-2 and -3 medical residents of interns during work rounds. MEASUREMENTS AND MAIN RESULTS Respondents reported 88 events over 3 months. AEs occurred among 5 patients (0.5% of admissions) and PAEs among 48 patients (4.9% of admissions). Delayed diagnoses and treatments figured prominently among PAEs (54%). Clinicians were responsible for the greatest number of incidents (55%), followed by workers in the laboratory (11%), radiology (15%), and pharmacy (3%). Respondents identified a variety of problematic processes of care, including problems with diagnosis (16%), therapy (26%), and failure to provide clinical and support services (29%). We corroborated 84% of reported events in the medical record. Participants found voluntary peer reporting of medical errors unobtrusive and agreed that it could be implemented on a regular basis. CONCLUSIONS A physician-based voluntary reporting system for medical errors is feasible and acceptable to front-line clinicians. PMID:11903759

Selected control events and reporting odds ratio in signal detection methodology.

PubMed

Ooba, Nobuhiro; Kubota, Kiyoshi

2010-11-01

To know whether the reporting odds ratio (ROR) using "control events" can detect signals hidden behind striking reports on one or more particular events. We used data of 956 drug use investigations (DUIs) conducted between 1970 and 1998 in Japan and domestic spontaneous reports (SRs) between 1998 and 2008. The event terms in DUIs were converted to the preferred terms in Medical Dictionary for Regulatory Activities (MedDRA). We calculated the incidence proportion for various events and selected 20 "control events" with a relatively constant incidence proportion across DUIs and also reported regularly to the spontaneous reporting system. A "signal" was generated for the drug-event combination when the lower limit of 95% confidence interval of the ROR exceeded 1. We also compared the ROR in SRs with the RR in DUIs. The "control events" accounted for 18.2% of all reports. The ROR using "control events" may detect some hidden signals for a drug with the proportion of "control events" lower than the average. The median of the ratios of the ROR using "control events" to RR was around the unity indicating that "control events" roughly represented the exposure distribution though the range of the ratios was so diverse that the individual ROR might not be regarded as the estimate of RR. The use of the ROR with "control events" may give an adjunctive to the traditional signal detection methods to find a signal hidden behind some major events. Copyright © 2010 John Wiley & Sons, Ltd.

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.

PubMed

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.

Negated bio-events: analysis and identification

PubMed Central

2013-01-01

Background Negation occurs frequently in scientific literature, especially in biomedical literature. It has previously been reported that around 13% of sentences found in biomedical research articles contain negation. Historically, the main motivation for identifying negated events has been to ensure their exclusion from lists of extracted interactions. However, recently, there has been a growing interest in negative results, which has resulted in negation detection being identified as a key challenge in biomedical relation extraction. In this article, we focus on the problem of identifying negated bio-events, given gold standard event annotations. Results We have conducted a detailed analysis of three open access bio-event corpora containing negation information (i.e., GENIA Event, BioInfer and BioNLP’09 ST), and have identified the main types of negated bio-events. We have analysed the key aspects of a machine learning solution to the problem of detecting negated events, including selection of negation cues, feature engineering and the choice of learning algorithm. Combining the best solutions for each aspect of the problem, we propose a novel framework for the identification of negated bio-events. We have evaluated our system on each of the three open access corpora mentioned above. The performance of the system significantly surpasses the best results previously reported on the BioNLP’09 ST corpus, and achieves even better results on the GENIA Event and BioInfer corpora, both of which contain more varied and complex events. Conclusions Recently, in the field of biomedical text mining, the development and enhancement of event-based systems has received significant interest. The ability to identify negated events is a key performance element for these systems. We have conducted the first detailed study on the analysis and identification of negated bio-events. Our proposed framework can be integrated with state-of-the-art event extraction systems. The resulting systems will be able to extract bio-events with attached polarities from textual documents, which can serve as the foundation for more elaborate systems that are able to detect mutually contradicting bio-events. PMID:23323936

A logic programming approach to medical errors in imaging.

PubMed

Rodrigues, Susana; Brandão, Paulo; Nelas, Luís; Neves, José; Alves, Victor

2011-09-01

In 2000, the Institute of Medicine reported disturbing numbers on the scope it covers and the impact of medical error in the process of health delivery. Nevertheless, a solution to this problem may lie on the adoption of adverse event reporting and learning systems that can help to identify hazards and risks. It is crucial to apply models to identify the adverse events root causes, enhance the sharing of knowledge and experience. The efficiency of the efforts to improve patient safety has been frustratingly slow. Some of this insufficiency of progress may be assigned to the lack of systems that take into account the characteristic of the information about the real world. In our daily lives, we formulate most of our decisions normally based on incomplete, uncertain and even forbidden or contradictory information. One's knowledge is less based on exact facts and more on hypothesis, perceptions or indications. From the data collected on our adverse event treatment and learning system on medical imaging, and through the use of Extended Logic Programming to knowledge representation and reasoning, and the exploitation of new methodologies for problem solving, namely those based on the perception of what is an agent and/or multi-agent systems, we intend to generate reports that identify the most relevant causes of error and define improvement strategies, concluding about the impact, place of occurrence, form or type of event recorded in the healthcare institutions. The Eindhoven Classification Model was extended and adapted to the medical imaging field and used to classify adverse events root causes. Extended Logic Programming was used for knowledge representation with defective information, allowing for the modelling of the universe of discourse in terms of data and knowledge default. A systematization of the evolution of the body of knowledge about Quality of Information embedded in the Root Cause Analysis was accomplished. An adverse event reporting and learning system was developed based on the presented approach to medical errors in imaging. This system was deployed in two Portuguese healthcare institutions, with an appealing outcome. The system enabled to verify that the majority of occurrences were concentrated in a few events that could be avoided. The developed system allowed automatic knowledge extraction, enabling report generation with strategies for the improvement of quality-of-care. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

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

PubMed Central

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

2016-01-01

Background In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods 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. Results 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. Conclusions 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. PMID:27410239

Psychiatric disorders, acne and systemic retinoids: comparison of risks.

PubMed

Le Moigne, M; Bulteau, S; Grall-Bronnec, Marie; Gerardin, M; Fournier, Jean-Pascal; Jonville-Bera, A P; Jolliet, Pascale; Dreno, Brigitte; Victorri-Vigneau, C

2017-09-01

The link between isotretinoin, treatment of a severe form of acne, and psychiatric disorders remains controversial, as acne itself could explain the occurrence of psychiatric disorders. This study aims at assessing the disproportionality of psychiatric adverse events reported with isotretinoin in the French National PharmacoVigilance Database, compared with other systemic acne treatments and systemic retinoids. Data were extracted from the French National PharmacoVigilance Database for systemic acne treatments, systemic retinoids and drugs used as comparators. Each report was subjected to double-blind analysis by two psychiatric experts. A disproportionality analysis was performed, calculating the number of psychiatric ADRs divided by the total number of notifications for each drug of interest. Concerning acne systemic treatments: all 71 reports of severe psychiatric disorders involved isotretinoin, the highest proportion of mild/moderate psychiatric adverse events was reported with isotretinoin (14.1%). Among systemic retinoids, the highest proportion of severe and mild/moderate psychiatric events occurred with isotretinoin and alitretinoin. Our study raises the hypothesis that psychiatric disorders associated with isotretinoin are related to a class effect of retinoids, as a signal emerges for alitretinoin. Complementary studies are necessary to estimate the risk and further determine at-risk populations.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe.

PubMed

Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Przybylska, Kamila; Skrobała, Agnieszka; Valero, Marc; Jarvinen, Hannu

2017-04-01

To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. The original data were collected as part of the ACCIRAD project through two online surveys. Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons. Copyright © 2017 Elsevier B.V. All rights reserved.

Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets.

PubMed

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.

Surgical Specimen Management: A Descriptive Study of 648 Adverse Events and Near Misses.

PubMed

Steelman, Victoria M; Williams, Tamara L; Szekendi, Marilyn K; Halverson, Amy L; Dintzis, Suzanne M; Pavkovic, Stephen

2016-12-01

- Surgical specimen adverse events can lead to delays in treatment or diagnosis, misdiagnosis, reoperation, inappropriate treatment, and anxiety or serious patient harm. - To describe the types and frequency of event reports associated with the management of surgical specimens, the contributing factors, and the level of harm associated with these events. - A retrospective review was undertaken of surgical specimen adverse events and near misses voluntarily reported in the University HealthSystem Consortium Safety Intelligence Patient Safety Organization database by more than 50 health care facilities during a 3-year period (2011-2013). Event reports that involved surgical specimen management were reviewed for patients undergoing surgery during which tissue or fluid was sent to the pathology department. - Six hundred forty-eight surgical specimen events were reported in all stages of the specimen management process, with the most common events reported during the prelaboratory phase and, specifically, with specimen labeling, collection/preservation, and transport. The most common contributing factors were failures in handoff communication, staff inattention, knowledge deficit, and environmental issues. Eight percent of the events (52 of 648) resulted in either the need for additional treatment or temporary or permanent harm to the patient. - All phases of specimen handling and processing are vulnerable to errors. These results provide a starting point for health care organizations to conduct proactive risk analyses of specimen handling procedures and to design safer processes. Particular attention should be paid to effective communication and handoffs, consistent processes across care areas, and staff training. In addition, organizations should consider the use of technology-based identification and tracking systems.

The ATLAS EventIndex: architecture, design choices, deployment and first operation experience

NASA Astrophysics Data System (ADS)

Barberis, D.; Cárdenas Zárate, S. E.; Cranshaw, J.; Favareto, A.; Fernández Casaní, Á.; Gallas, E. J.; Glasman, C.; González de la Hoz, S.; Hřivnáč, J.; Malon, D.; Prokoshin, F.; Salt Cairols, J.; Sánchez, J.; Többicke, R.; Yuan, R.

2015-12-01

The EventIndex is the complete catalogue of all ATLAS events, keeping the references to all files that contain a given event in any processing stage. It replaces the TAG database, which had been in use during LHC Run 1. For each event it contains its identifiers, the trigger pattern and the GUIDs of the files containing it. Major use cases are event picking, feeding the Event Service used on some production sites, and technical checks of the completion and consistency of processing campaigns. The system design is highly modular so that its components (data collection system, storage system based on Hadoop, query web service and interfaces to other ATLAS systems) could be developed separately and in parallel during LSI. The EventIndex is in operation for the start of LHC Run 2. This paper describes the high-level system architecture, the technical design choices and the deployment process and issues. The performance of the data collection and storage systems, as well as the query services, are also reported.

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

PubMed

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 additional, supplemental data source to have a more comprehensive estimate of disease burden. Copyright © 2017 Elsevier B.V. All rights reserved.

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

PubMed

Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

2011-01-01

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. 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. 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. 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.

Active surveillance for influenza vaccine adverse events: the integrated vaccine surveillance system.

PubMed

Newes-Adeyi, Gabriella; Greece, Jacey; Bozeman, Sam; Walker, Deborah Klein; Lewis, Faith; Gidudu, Jane

2012-02-01

We conducted a pilot study of the Integrated Vaccine Surveillance System (IVSS), a novel active surveillance system for monitoring influenza vaccine adverse events that could be used in mass vaccination settings. We recruited 605 adult vaccinees from a convenience sample of 12 influenza vaccine clinics conducted by public health departments of two U.S. metropolitan regions. Vaccinees provided daily reports on adverse reactions following immunization (AEFI) using an interactive voice response system (IVR) or the internet for 14 consecutive days following immunization. Followup with nonrespondents was conducted through computer-assisted telephone interviewing (CATI). Data on vaccinee reports were available real-time through a dedicated secure website. 90% (545) of vaccinees made at least one daily report and 49% (299) reported consecutively for the full 14-day period. 58% (315) used internet, 20% (110) IVR, 6% (31) CATI, and 16% (89) used a combination for daily reports. Of the 545 reporters, 339 (62%) reported one or more AEFI, for a total of 594 AEFIs reported. The majority (505 or 85%) of these AEFIs were mild symptoms. It is feasible to develop a system to obtain real-time data on vaccine adverse events. Vaccinees are willing to provide daily reports for a considerable time post vaccination. Offering multiple modes of reporting encourages high response rates. Study findings on AEFIs showed that the IVSS was able to exhibit the emerging safety profile of the 2008 seasonal influenza vaccine. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

PubMed

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 confusion of treating physicians with unexpected fatal, cardiac, and thrombotic adverse events linked to ticagrelor. © 2017 S. Karger AG, Basel.

Idaho National Laboratory Quarterly Performance Analysis - 2nd Quarter FY2014

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lisbeth A. Mitchell

2014-06-01

This report is published quarterly by the Idaho National Laboratory (INL) Performance Assurance Organization. The Department of Energy Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of occurrence reports and other deficiency reports (including not reportable events) identified at INL from January 2014 through March 2014.

[Analysis of Kudiezi injection's security literature].

PubMed

Chang, Yan-Peng; Xie, Yan-Ming

2012-09-01

By retrieving the relevant database, aim was to achieve the security reported of Kudiezi injection (Yueanxin). To analysis the gender, age, underlying disease, medication dosage, solvent, adverse event/adverse reaction time of occurrence, clinical presentation of patients, It was found the adverse event/adverse reaction usually occur in older people, involving the organs and systems include skin and its appendages, digestive system, nervous system, circulatory system, respiratory system, systemic reaction, part of the adverse event/adverse reaction's cause were not according to the instructions. It was found on the adverse event/adverse reaction of the judgment on the lack of objective evidence, to produce certain effect for objective evaluation of security of Kudiezi injection (Yueanxin).

Reporting rates of yellow fever vaccine 17D or 17DD-associated serious adverse events in pharmacovigilance data bases: systematic review.

PubMed

Thomas, Roger E; Lorenzetti, Diane L; Spragins, Wendy; Jackson, Dave; Williamson, Tyler

2011-07-01

To assess the reporting rates of serious adverse events attributable to yellow fever vaccination with 17D and 17DD strains as reported in pharmacovigilance databases, and assess reasons for differences in reporting rates. We searched 9 electronic databases for peer reviewed and grey literature (government reports, conferences), in all languages. Reference lists of key studies were also reviewed to identify additional studies. We identified 2,415 abstracts, of which 472 were selected for full text review. We identified 15 pharmacovigilance databases which reported adverse events attributed to yellow fever vaccination, of which 10 contributed data to this review with about 107,600,000 patients (allowing for overlapping time periods for the studies of the US VAERS database), and the data are very heavily weighted (94%) by the Brazilian database. The estimates of serious adverse events form three groups. The estimates for Australia were low at 0/210,656 for "severe neurological disease" and 1/210,656 for YEL-AVD, and also low for Brazil with 9 hypersensitivity events, 0.23 anaphylactic shock events, 0.84 neurologic syndrome events and 0.19 viscerotropic events cases/million doses. The five analyses of partly overlapping periods for the US VAERS database provide an estimate of 3.6/cases per million YEL-AND in one analysis and 7.8 in another, and 3.1 YEL-AVD in one analysis and 3.9 in another. The estimates for the UK used only the inclusive term of "serious adverse events" not further classified into YEL-And or YEL-AND and reported 34 "serious adverse events." The Swiss database used the term "serious adverse events" and reported 7 such events (including 4 "neurologic reactions") for a reporting rate of 25 "serious adverse events"/million doses. Reporting rates for serious adverse events following yellow fever vaccination are low. Differences in reporting rates may be due to differences in definitions, surveillance system organisation, methods of reporting cases, administration of YFV with other vaccines, incomplete information about denominators, time intervals for reporting events, the degree of passive reporting, access to diagnostic resources, and differences in time periods of reporting.

Low Probability Tail Event Analysis and Mitigation in BPA Control Area: Task 2 Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lu, Shuai; Makarov, Yuri V.; McKinstry, Craig A.

Task report detailing low probability tail event analysis and mitigation in BPA control area. Tail event refers to the situation in a power system when unfavorable forecast errors of load and wind are superposed onto fast load and wind ramps, or non-wind generators falling short of scheduled output, causing the imbalance between generation and load to become very significant.

78 FR 56867 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-16

...: Department of Defense Suicide Event Report, 0720-TBD. Needs and Uses: This data system will provide integrated enterprise and survey data to be used for direct reporting of suicide events and ongoing..., implementation, evaluation, and prevention of suicide behaviors within the Department of Defense. Data is...

Adverse events attributed to traditional Korean medical practices: 1999–2010

PubMed Central

Shin, Hyeun-Kyoo; Jeong, Soo-Jin; Ernst, Edzard

2013-01-01

Abstract Objective To investigate adverse events attributed to traditional medical treatments in the Republic of Korea. Methods Adverse events recorded in the Republic of Korea between 1999 and 2010 – by the Food and Drug Administration, the Consumer Agency or the Association of Traditional Korean Medicine – were reviewed. Records of adverse events attributed to the use of traditional medical practices, including reports of medicinal accidents and consumers’ complaints, were investigated. Findings Overall, 9624 records of adverse events attributed to traditional medical practices – including 522 linked to herbal treatments – were identified. Liver problems were the most frequently reported adverse events. Only eight of the adverse events were recorded by the pharmacovigilance system run by the Food and Drug Administration. Of the 9624 events, 1389 – mostly infections, cases of pneumothorax and burns – were linked to physical therapy (n = 285) or acupuncture/moxibustion (n = 1104). Conclusion In the Republic of Korea, traditional medical practices often appear to have adverse effects, yet almost all of the adverse events attributed to such practices between 1999 and 2010 were missed by the national pharmacovigilance system. The Consumer Agency and the Association of Traditional Korean Medicine should be included in the national pharmacovigilance system. PMID:23940404

Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations

PubMed Central

Smith, Shannon M.; Jones, Judith K.; Katz, Nathaniel P.; Roland, Carl L.; Setnik, Beatrice; Trudeau, Jeremiah J.; Wright, Stephen; Burke, Laurie B.; Comer, Sandra D.; Dart, Richard C.; Dionne, Raymond; Haddox, J. David; Jaffe, Jerome H.; Kopecky, Ernest A.; Martell, Bridget A.; Montoya, Ivan D.; Stanton, Marsha; Wasan, Ajay D.; Turk, Dennis C.; Dworkin, Robert H.

2017-01-01

Accurate assessment of inappropriate medication use events (i.e., misuse, abuse, and related events [MAREs]) occurring in clinical trials is an important component in evaluating a medication’s abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions [27]. Only 2 approaches have been reported that are specifically designed to identify and classify MAREs occurring in clinical trials, rather than to measure an individual’s risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS]. The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively in order to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of both MADDERS and SR-MAD. PMID:28479207

Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases

PubMed Central

Nomura, Kaori; Takahashi, Kunihiko; Hinomura, Yasushi; Kawaguchi, Genta; Matsushita, Yasuyuki; Marui, Hiroko; Anzai, Tatsuhiko; Hashiguchi, Masayuki; Mochizuki, Mayumi

2015-01-01

Background The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can cause variations in AE data. The present study examined similarities and differences between two publicly available databases, ie, the Japanese Adverse Drug Event Report (JADER) database and the US Food and Drug Administration Adverse Event Reporting System (FAERS), and how they affect signal detection. Methods Two AE data sources from 2010 were examined, ie, JADER cases (JP) and Japanese cases extracted from the FAERS (FAERS-JP). Three methods for signals of disproportionate reporting, ie, the reporting odds ratio, Bayesian confidence propagation neural network, and Gamma Poisson Shrinker (GPS), were used on drug-event combinations for three substances frequently recorded in both systems. Results The two databases showed similar elements of AE reports, but no option was provided for a shareable case identifier. The average number of AEs per case was 1.6±1.3 (maximum 37) in the JP and 3.3±3.5 (maximum 62) in the FAERS-JP. Between 5% and 57% of all AEs were signaled by three quantitative methods for etanercept, infliximab, and paroxetine. Signals identified by GPS for the JP and FAERS-JP, as referenced by Japanese labeling, showed higher positive sensitivity than was expected. Conclusion The FAERS-JP was different from the JADER. Signals derived from both datasets identified different results, but shared certain signals. Discrepancies in type of AEs, drugs reported, and average number of AEs per case were potential contributing factors. This study will help those concerned with pharmacovigilance better understand the use and pitfalls of using spontaneous AE data. PMID:26109846

A Multilevel Analysis of U.S. Hospital Patient Safety Culture Relationships With Perceptions of Voluntary Event Reporting.

PubMed

Burlison, Jonathan D; Quillivan, Rebecca R; Kath, Lisa M; Zhou, Yinmei; Courtney, Sam C; Cheng, Cheng; Hoffman, James M

2016-11-03

Patient safety events offer opportunities to improve patient care, but, unfortunately, events often go unreported. Although some barriers to event reporting can be reduced with electronic reporting systems, insight on organizational and cultural factors that influence reporting frequency may help hospitals increase reporting rates and improve patient safety. The purpose of this study was to evaluate the associations between dimensions of patient safety culture and perceived reporting practices of safety events of varying severity. We conducted a cross-sectional survey study using previously collected data from The Agency for Healthcare Research and Quality Hospital Survey of Patient Safety Culture as predictors and outcome variables. The dataset included health-care professionals in U.S. hospitals, and data were analyzed using multilevel modeling techniques. Data from 223,412 individuals, 7816 work areas/units, and 967 hospitals were analyzed. Whether examining near miss, no harm, or potential for harm safety events, the dimension feedback about error accounted for the most unique predictive variance in the outcome frequency of events reported. Other significantly associated variables included organizational learning, nonpunitive response to error, and teamwork within units (all P < 0.001). As the perceived severity of the safety event increased, more culture dimensions became significantly associated with voluntary reporting. To increase the likelihood that a patient safety event will be voluntarily reported, our study suggests placing priority on improving event feedback mechanisms and communication of event-related improvements. Focusing efforts on these aspects may be more efficient than other forms of culture change.

A Multilevel Analysis of U.S. Hospital Patient Safety Culture Relationships with Perceptions of Voluntary Event Reporting

PubMed Central

Burlison, Jonathan D.; Quillivan, Rebecca R.; Kath, Lisa M.; Zhou, Yinmei; Courtney, Sam C.; Cheng, Cheng; Hoffman, James M.

2016-01-01

Objectives Patient safety events offer opportunities to improve patient care, but, unfortunately, events often go unreported. Although some barriers to event reporting can be reduced with electronic reporting systems, insight on organizational and cultural factors that influence reporting frequency may help hospitals increase reporting rates and improve patient safety. The purpose of this study was to evaluate the associations between dimensions of patient safety culture and perceived reporting practices of safety events of varying severity. Methods We conducted a cross-sectional survey study using previously collected data from The Agency for Healthcare Research and Quality Hospital Survey of Patient Safety Culture as predictors and outcome variables. The dataset included healthcare professionals in U.S. hospitals, and data were analyzed by using multilevel modeling techniques. Results Data from 223,412 individuals, 7816 work areas/units and 967 hospitals were analyzed. Whether examining Near-miss, No harm, or Potential for harm safety events, the dimension Feedback about error accounted for the most unique predictive variance in the outcome Frequency of events reported. Other significantly associated variables included Organizational learning, Nonpunitive response to error, and Teamwork within units (all p<.001). As the perceived severity of the safety event increased, more culture dimensions became significantly associated with voluntary reporting. Conclusions To increase the likelihood that a patient safety event will be voluntarily reported, our study suggests placing priority on improving event feedback mechanisms and communication of event-related improvements. Focusing efforts on these aspects may be more efficient than other forms of culture change. PMID:27820722

Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events

PubMed Central

Pietrobon, Ricardo; Lima, Raquel; Shah, Anand; Jacobs, Danny O; Harker, Matthew; McCready, Mariana; Martins, Henrique; Richardson, William

2007-01-01

Background Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. Objective To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. Software architecture DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Results Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. Discussion This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. Conclusion The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License. PMID:17472749

Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events.

PubMed

Pietrobon, Ricardo; Lima, Raquel; Shah, Anand; Jacobs, Danny O; Harker, Matthew; McCready, Mariana; Martins, Henrique; Richardson, William

2007-05-01

Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. SOFTWARE ARCHITECTURE: DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License.

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

PubMed

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.

Disproportionality analysis of buprenorphine transdermal system and cardiac arrhythmia using FDA and WHO postmarketing reporting system data.

PubMed

Sessler, Nelson E; Walker, Ekaterina; Chickballapur, Harsha; Kacholakalayil, James; Coplan, Paul M

2017-01-01

Positive-controlled clinical studies have shown a dose dependent effect of buprenorphine transdermal system on QTc interval prolongation. This study provides assessment of the buprenorphine transdermal system and cardiac arrhythmia using US FDA and WHO postmarketing reporting databases. Disproportionality analysis of spontaneously reported adverse events to assess whether the reporting rate of cardiac arrhythmia events was disproportionately elevated relative to expected rates of reporting in both FDA and WHO databases. Cardiac arrhythmia events were identified using the standardized Medical Dictionary for Regulatory Activities query for torsade de pointes and/or QT prolongation (TdP/QTP). The threshold for a signal of disproportionate adverse event reporting was defined as the lower 90% confidence limit ≥ 2 of the Empiric Bayes geometric mean in FDA database and as the lower 95% confidence limit of the Informational Component >0 in WHO database. There were 124 (<1%) and 77 (2%) cardiac arrhythmia event cases associated with buprenorphine transdermal as compared to 3206 (12%) and 2913 (14%) involving methadone in the FDA and WHO databases, respectively. In the FDA database methadone was associated with a signal of disproportionate reporting for TdP/QTP (EB05 3.26); however, buprenorphine transdermal was not (EB05 0.33). In the WHO database methadone was associated with a signal of disproportionate reporting for TdP/QTP (IC025 2.66); however, buprenorphine transdermal was not (IC025 -0.88). Similar trends were observed in sensitivity analyses by age, gender, and specific terms related to ventricular arrhythmia. The signal identified in the transdermal buprenorphine thorough QTc study, which led to a dose limitation in its US label, does not translate into a signal of increased risk for cardiac arrhythmia in real world use, as assessed by this method of analyzing post-market surveillance data.

Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

DOE Office of Scientific and Technical Information (OSTI.GOV)

Connor, Michael J.; Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California; Marshall, Deborah C.

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact).more » Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer–user training may help mitigate these events.« less

An Overview of Recent Advances in Event-Triggered Consensus of Multiagent Systems.

PubMed

Ding, Lei; Han, Qing-Long; Ge, Xiaohua; Zhang, Xian-Ming

2018-04-01

Event-triggered consensus of multiagent systems (MASs) has attracted tremendous attention from both theoretical and practical perspectives due to the fact that it enables all agents eventually to reach an agreement upon a common quantity of interest while significantly alleviating utilization of communication and computation resources. This paper aims to provide an overview of recent advances in event-triggered consensus of MASs. First, a basic framework of multiagent event-triggered operational mechanisms is established. Second, representative results and methodologies reported in the literature are reviewed and some in-depth analysis is made on several event-triggered schemes, including event-based sampling schemes, model-based event-triggered schemes, sampled-data-based event-triggered schemes, and self-triggered sampling schemes. Third, two examples are outlined to show applicability of event-triggered consensus in power sharing of microgrids and formation control of multirobot systems, respectively. Finally, some challenging issues on event-triggered consensus are proposed for future research.

Reference set for performance testing of pediatric vaccine safety signal detection methods and systems.

PubMed

Brauchli Pernus, Yolanda; Nan, Cassandra; Verstraeten, Thomas; Pedenko, Mariia; Osokogu, Osemeke U; Weibel, Daniel; Sturkenboom, Miriam; Bonhoeffer, Jan

2016-12-12

Safety signal detection in spontaneous reporting system databases and electronic healthcare records is key to detection of previously unknown adverse events following immunization. Various statistical methods for signal detection in these different datasources have been developed, however none are geared to the pediatric population and none specifically to vaccines. A reference set comprising pediatric vaccine-adverse event pairs is required for reliable performance testing of statistical methods within and across data sources. The study was conducted within the context of the Global Research in Paediatrics (GRiP) project, as part of the seventh framework programme (FP7) of the European Commission. Criteria for the selection of vaccines considered in the reference set were routine and global use in the pediatric population. Adverse events were primarily selected based on importance. Outcome based systematic literature searches were performed for all identified vaccine-adverse event pairs and complemented by expert committee reports, evidence based decision support systems (e.g. Micromedex), and summaries of product characteristics. Classification into positive (PC) and negative control (NC) pairs was performed by two independent reviewers according to a pre-defined algorithm and discussed for consensus in case of disagreement. We selected 13 vaccines and 14 adverse events to be included in the reference set. From a total of 182 vaccine-adverse event pairs, we classified 18 as PC, 113 as NC and 51 as unclassifiable. Most classifications (91) were based on literature review, 45 were based on expert committee reports, and for 46 vaccine-adverse event pairs, an underlying pathomechanism was not plausible classifying the association as NC. A reference set of vaccine-adverse event pairs was developed. We propose its use for comparing signal detection methods and systems in the pediatric population. Published by Elsevier Ltd.

Consumer reporting of adverse events following immunization.

PubMed

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 (P<0.001), most commonly for children aged less than 7 years. Consumer reports were 5% more likely to describe serious AEFI than HCP (P=0.018) and 10% more likely to result in specialist clinic attendance (P<0.001). Although online reporting increased to 32% of all report since its introduction in 2010, 85% of consumers continued to report by phone. Consumer reporting of AEFI is a valuable component of vaccine safety surveillance in addition to HCP reporting. Changes are required to AEFI reporting systems to implement efficient consumer AEFI reporting, but may be justified for their potential impact on signal detection sensitivity.

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

PubMed

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.

Operational warning of interplanetary shock arrivals using energetic particle data from ACE: Real-time Upstream Monitoring System

NASA Astrophysics Data System (ADS)

Donegan, M.; Vandegriff, J.; Ho, G. C.; Julia, S. J.

2004-12-01

We report on an operational system which provides advance warning and predictions of arrival times at Earth of interplanetary (IP) shocks that originate at the Sun. The data stream used in our prediction algorithm is real-time and comes from the Electron, Proton, and Alpha Monitor (EPAM) instrument on NASA's Advanced Composition Explorer (ACE) spacecraft. Since locally accelerated energetic storm particle (ESP) events accompany most IP shocks, their arrival can be predicted using ESP event signatures. We have previously reported on the development and implementation of an algorithm which recognizes the upstream particle signature of approaching IP shocks and provides estimated countdown predictions. A web-based system (see (http://sd-www.jhuapl.edu/UPOS/RISP/index.html) combines this prediction capability with real-time ACE/EPAM data provided by the NOAA Space Environment Center. The most recent ACE data is continually processed and predictions of shock arrival time are updated every five minutes when an event is impending. An operational display is provided to indicate advisories and countdowns for the event. Running the algorithm on a test set of historical events, we obtain a median error of about 10 hours for predictions made 24-36 hours before actual shock arrival and about 6 hours when the shock is 6-12 hours away. This system can provide critical information to mission planners, satellite operations controllers, and scientists by providing significant lead-time for approaching events. Recently, we have made improvements to the triggering mechanism as well as re-training the neural network, and here we report prediction results from the latest system.

Space Weather, Geomagnetic Disturbances and Impact on the High-Voltage Transmission Systems

NASA Technical Reports Server (NTRS)

Pullkkinen, A.

2011-01-01

Geomagnetically induced currents (GIC) affecting the performance of high-voltage power transmission systems are one of the most significant hazards space weather poses on the operability of critical US infrastructure. The severity of the threat was emphasized, for example, in two recent reports: the National Research Council (NRC) report "Severe Space Weather Events--Understanding Societal and Economic Impacts: A Workshop Report" and the North American Electric Reliability Corporation (NERC) report "HighImpact, Low-Frequency Event Risk to the North American Bulk Power System." The NRC and NERC reports demonstrated the important national security dimension of space weather and GIC and called for comprehensive actions to forecast and mitigate the hazard. In this paper we will give a brief overview of space weather storms and accompanying geomagnetic storm events that lead to GIC. We will also review the fundamental principles of how GIC can impact the power transmission systems. Space weather has been a subject of great scientific advances that have changed the wonder of the past to a quantitative field of physics with true predictive power of today. NASA's Solar Shield system aimed at forecasting of GIC in the North American high-voltage power transmission system can be considered as one of the ultimate fruits of those advances. We will review the fundamental principles of the Solar Shield system and provide our view of the way forward in the science of GIC.

Idaho National Laboratory Quarterly Performance Analysis for the 2nd Quarter FY 2015

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth A.

2015-04-01

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of events for the 2nd Qtr FY-15.

Confidential close call reporting system (C3RS) lessons learned team baseline phased report

DOT National Transportation Integrated Search

2015-05-08

The Federal Railroad Administration (FRA) has established a program called the Confidential Close Call Reporting System : (C3RS), which allows events to be reported anonymously and dealt with non-punitively and without fear or reprisal through : stru...

Confidential close call reporting system (C3RS) lessons learned team baseline phase report.

DOT National Transportation Integrated Search

2015-05-01

The Federal Railroad Administration (FRA) has established a program called the Confidential Close Call Reporting System : (C3 : RS), which allows events to be reported anonymously and dealt with non-punitively and without fear or reprisal through : s...

Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013-May 31, 2015.

PubMed

Haber, Penina; Moro, Pedro L; Lewis, Paige; Woo, Emily Jane; Jankosky, Christopher; Cano, Maria

2016-05-11

Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013-14 influenza season for individuals aged ≥6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. We searched the Vaccine Adverse Event Reporting System (VAERS) for US reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013-5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining. VAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months-17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children <6 months and 59 in persons of unknown age. Injection site erythema (24%), fever (14%) and injection site swelling (17%) were the most frequent adverse events among persons aged 6 months-17 years, while injection site pain (16%), pain (15%) and pain in extremity (13%) were the most frequent among persons aged 18-64 years given the vaccine alone. Among non-death serious reports, injection site reactions, constitutional symptoms, Guillain-Barré syndrome, seizures, and anaphylaxis were the most frequently reported adverse events. Data mining detected disproportional reporting for incorrect vaccine administration with no associated adverse events. Adverse events following IIV4 reported to VAERS were similar to those following IIV3. In our review of VAERS reports, IIV4 had a similar safety profile to IIV3. Most of the reported AEs were non-serious. Our findings are consistent with data from pre-licensure studies of IIV4. Published by Elsevier Ltd.

Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

PubMed

Du, Dongyi; Goldsmith, John; Aikin, Kathryn J; Encinosa, William E; Nardinelli, Clark

2012-05-01

In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

Practice-based learning and improvement: a two-year experience with the reporting of morbidity and mortality cases by general surgery residents.

PubMed

Falcone, John L; Lee, Kenneth K W; Billiar, Timothy R; Hamad, Giselle G

2012-01-01

The Accreditation Council for Graduate Medical Education (ACGME) core competency of practice-based learning and improvement can be assessed with surgical Morbidity and Mortality Conference (MMC). We aim to describe the MMC reporting patterns of general surgery residents, describe the adverse event rate for patients and compare that with existing published rates, and describe the nature of our institutional adverse events. We hypothesize that reporting patterns and incidence rates will remain constant over time. In this retrospective cohort study, archived MMC case lists were evaluated from January 1, 2009 to December 31, 2010. The reporting patterns of the residents, the adverse event ratios, and the specific categories of adverse events were described over the academic years. χ(2) and Fisher's exact tests were used to compare across academic years, using an α = 0.05. There were 85 surgical MMC case lists evaluated. Services achieved a reporting rate above 80% (p < 0.001). The most consistent reporting was done by postgraduate year (PGY) 5 level chief residents for all services (p > 0.05). Out of 11,368 patients evaluated from complete MMC submissions, 289 patients had an adverse event reported (2.5%). This was lower than published reporting rates for patient adverse event rates (p < 0.001). Adverse event rates were consistent for residents at the postgraduate year 2, 4, and 5 levels for all services (p > 0.05). Over 2 years, 522 adverse events were reported for 461 patients. A majority of adverse events were from death (24.1%), hematologic and/or vascular events (16.7%), and gastrointestinal system events (16.1%). Surgery resident MMC reporting patterns and adverse event rates are generally stable over time. This study shows which adverse event cases are important for chief residents to report. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Toward patient-centered cancer care: patient perceptions of problematic events, impact, and response.

PubMed

Mazor, Kathleen M; Roblin, Douglas W; Greene, Sarah M; Lemay, Celeste A; Firneno, Cassandra L; Calvi, Josephine; Prouty, Carolyn D; Horner, Kathryn; Gallagher, Thomas H

2012-05-20

Cancer treatments are complex, involving multiple clinicians, toxic therapies, and uncertain outcomes. Consequently, patients are vulnerable when breakdowns in care occur. This study explored cancer patients' perceptions of preventable, harmful events; the impact of these events; and interactions with clinicians after such events. In-depth telephone interviews were conducted with cancer patients from three clinical sites. Patients were eligible if they believed: something "went wrong" during their cancer care; the event could have been prevented; and the event caused, or could have caused, significant harm. Interviews focused on patients' perceptions of the event, its impact, and clinicians' responses to the event. Ninety-three of 416 patients queried believed something had gone wrong in their care that was preventable and caused or could have caused harm. Seventy-eight patients completed interviews. Of those interviewed, 28% described a problem with medical care, such as a delay in diagnosis or treatment; 47% described a communication problem, including problems with information exchange or manner; and 24% described problems with both medical care and communication. Perceived harms included physical and emotional harm, disruption of life, effect on family members, damaged physician-patient relationship, and financial expense. Few clinicians initiated discussion of the problematic events. Most patients did not formally report their concerns. Cancer patients who believe they experienced a preventable, harmful event during their cancer diagnosis or care often do not formally report their concerns. Systems are needed to encourage patients to report such events and to help physicians and health care systems respond effectively.

Decision support methods for the detection of adverse events in post-marketing data.

PubMed

Hauben, M; Bate, A

2009-04-01

Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

Evaluation of 'SAEFVIC', A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia.

PubMed

Clothier, Hazel J; Crawford, Nigel W; Russell, Melissa; Kelly, Heath; Buttery, Jim P

2017-06-01

Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community). The aim of this study was to evaluate Victoria's current AEFI surveillance system 'SAEFVIC' and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia. We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination. AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35-3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1-58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population. SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia.

Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets

PubMed Central

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

An Adverse Drug Event and Medication Error Reporting System for Ambulatory Care (MEADERS)

PubMed Central

Zafar, Atif; Hickner, John; Pace, Wilson; Tierney, William

2008-01-01

The Institute of Medicine (IOM) has identified the mitigation of Adverse Drug Events (ADEs) and Medication Errors (MEs) as top national priorities. Currently available reporting tools are fraught with inefficiencies that prevent widespread adoption into busy primary care practices. Using expert panel input we designed and built a new reporting tool that could be used in these settings with a variety of information technology capabilities. We pilot tested the system in four Practice Based Research Networks (PBRNs) comprising 24 practices. Over 10 weeks we recorded 507 reports, of which 370 were MEs and 137 were ADEs. Clinicians found the system easy to use, with the average time to generating a report under 4 minutes. By using streamlined interface design techniques we were successfully able to improve reporting rates of ADEs and MEs in these practices. PMID:18999053

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

PubMed

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 < 0.001) and especially inflammatory neuropsychiatric systemic lupus erythematosus ( B = 0.827; p < 0.001) had better clinical outcome, with change in disease activity being the only important predictor. The change in SF-36 MCS was also independently associated with neuropsychiatric systemic lupus erythematosus ( B = 5.783; p < 0.05) and inflammatory neuropsychiatric systemic lupus erythematosus ( B = 11.133; p < 0.001). Disease duration and change in disease activity were the only predictors in both cases. The change in SF-36 PCS was only negatively associated with age. Conclusion Inflammatory neuropsychiatric systemic lupus erythematosus events have better clinical outcome and meaningful improvement in SF-36 MCS than ischaemic neuropsychiatric systemic lupus erythematosus or non-neuropsychiatric systemic lupus erythematosus.

A Flight/Ground/Test Event Logging Facility

NASA Technical Reports Server (NTRS)

Dvorak, Daniel

1999-01-01

The onboard control software for spacecraft such as Mars Pathfinder and Cassini is composed of many subsystems including executive control, navigation, attitude control, imaging, data management, and telecommunications. The software in all of these subsystems needs to be instrumented for several purposes: to report required telemetry data, to report warning and error events, to verify internal behavior during system testing, and to provide ground operators with detailed data when investigating in-flight anomalies. Events can range in importance from purely informational events to major errors. It is desirable to provide a uniform mechanism for reporting such events and controlling their subsequent processing. Since radiation-hardened flight processors are several years behind the speed and memory of their commercial cousins, and since most subsystems require real-time control, and since downlink rates to earth can be very low from deep space, there are limits to how much of the data can be saved and transmitted. Some kinds of events are more important than others and should therefore be preferentially retained when memory is low. Some faults can cause an event to recur at a high rate, but this must not be allowed to consume the memory pool. Some event occurrences may be of low importance when reported but suddenly become more important when a subsequent error event gets reported. Some events may be so low-level that they need not be saved and reported unless specifically requested by ground operators.

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

PubMed Central

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

[Results of provisional use of a system for voluntary anonymous reporting of incidents that threaten patient safety in the emergency medical services of Asturias].

PubMed

Galván Núñez, Pablo; Santander Barrios, María Dolores; Villa Álvarez, María Cristina; Castro Delgado, Rafael; Alonso Lorenzo, Julio C; Arcos González, Pedro

2016-06-01

To describe the reported incidents and adverse events in the emergency medical services of Asturias, Spain, and assess their consequences, delays caused, and preventability. Prospective, observational study of incidents reported by the staff of the emergency medical services of Asturias after implementation of a system devised by the researchers. Incident reports were received for 0.48% (95% CI, 0.41%-0.54%) of the emergencies attended. Patient safety was compromised in 74.7% of the reported incidents. Problems arising in the emergency response coordination center (ERCC) accounted for 37.6% of the incidents, transport problems for 13.4%, vehicular problems for 10.8%, and communication problems for 8.8%. Seventy percent of the reported incidents caused delays in care; 55% of the reported incidents that put patients at risk (according to severity assessment code ratings) corresponded to problems related to human or material resources. A total of 88.1% of the incidents reported were considered avoidable. Some type of intervention was required to attenuate the effects of 46.2% of the adverse events reported. The measures that staff members most often proposed to prevent adverse events were to increase human and material resources (28.3%), establish protocols (14.5%), and comply with quality of care recommendations (9.7%). It is important to promote a culture of safety and incident reporting among health care staff in Asturias given the number of serious adverse events. Reporting is necessary for understanding the errors made and taking steps to prevent them. The ERCC is the point in the system where incidents are particularly likely to appear and be noticed and reported.

Performance Analysis: Work Control Events Identified January - August 2010

DOE Office of Scientific and Technical Information (OSTI.GOV)

De Grange, C E; Freeman, J W; Kerr, C E

2011-01-14

This performance analysis evaluated 24 events that occurred at LLNL from January through August 2010. The analysis identified areas of potential work control process and/or implementation weaknesses and several common underlying causes. Human performance improvement and safety culture factors were part of the causal analysis of each event and were analyzed. The collective significance of all events in 2010, as measured by the occurrence reporting significance category and by the proportion of events that have been reported to the DOE ORPS under the ''management concerns'' reporting criteria, does not appear to have increased in 2010. The frequency of reporting inmore » each of the significance categories has not changed in 2010 compared to the previous four years. There is no change indicating a trend in the significance category and there has been no increase in the proportion of occurrences reported in the higher significance category. Also, the frequency of events, 42 events reported through August 2010, is not greater than in previous years and is below the average of 63 occurrences per year at LLNL since 2006. Over the previous four years, an average of 43% of the LLNL's reported occurrences have been reported as either ''management concerns'' or ''near misses.'' In 2010, 29% of the occurrences have been reported as ''management concerns'' or ''near misses.'' This rate indicates that LLNL is now reporting fewer ''management concern'' and ''near miss'' occurrences compared to the previous four years. From 2008 to the present, LLNL senior management has undertaken a series of initiatives to strengthen the work planning and control system with the primary objective to improve worker safety. In 2008, the LLNL Deputy Director established the Work Control Integrated Project Team to develop the core requirements and graded elements of an institutional work planning and control system. By the end of that year this system was documented and implementation had begun. In 2009, training of the workforce began and as of the time of this report more than 50% of authorized Integration Work Sheets (IWS) use the activity-based planning process. In 2010, LSO independently reviewed the work planning and control process and confirmed to the Laboratory that the Integrated Safety Management (ISM) System was implemented. LLNL conducted a cross-directorate management self-assessment of work planning and control and is developing actions to respond to the issues identified. Ongoing efforts to strengthen the work planning and control process and to improve the quality of LLNL work packages are in progress: completion of remaining actions in response to the 2009 DOE Office of Health, Safety, and Security (HSS) evaluation of LLNL's ISM System; scheduling more than 14 work planning and control self-assessments in FY11; continuing to align subcontractor work control with the Institutional work planning and control system; and continuing to maintain the electronic IWS application. The 24 events included in this analysis were caused by errors in the first four of the five ISMS functions. The most frequent cause was errors in analyzing the hazards (Function 2). The second most frequent cause was errors occurring when defining the work (Function 1), followed by errors during the performance of work (Function 4). Interestingly, very few errors in developing controls (Function 3) resulted in events. This leads one to conclude that if improvements are made to defining the scope of work and analyzing the potential hazards, LLNL may reduce the frequency or severity of events. Analysis of the 24 events resulted in the identification of ten common causes. Some events had multiple causes, resulting in the mention of 39 causes being identified for the 24 events. The most frequent cause was workers, supervisors, or experts believing they understood the work and the hazards but their understanding was incomplete. The second most frequent cause was unclear, incomplete or confusing documents directing the work. Together, these two causes were mentioned 17 times and contributed to 13 of the events. All of the events with the cause of ''workers, supervisors, or experts believing they understood the work and the hazards but their understanding was incomplete'' had this error in the first two ISMS functions: define the work and analyze the hazard. This means that these causes result in the scope of work being ill-defined or the hazard(s) improperly analyzed. Incomplete implementation of these functional steps leads to the hazards not being controlled. The causes are then manifested in events when the work is conducted. The process to operate safely relies on accurately defining the scope of work. This review has identified a number of examples of latent organizational weakness in the execution of work control processes.« less

Idaho National Laboratory Quarterly Performance Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth

2014-11-01

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 60 reportable events (23 from the 4th Qtr FY14 and 37 from the prior three reporting quarters) as well as 58 other issue reports (including not reportable events and Significant Category A and B conditions) identified at INLmore » from July 2013 through October 2014. Battelle Energy Alliance (BEA) operates the INL under contract DE AC07 051D14517.« less

Idaho National Laboratory Quarterly Occurrence Analysis - 3rd Quarter FY-2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 73 reportable events (23 from the 3rd Qtr FY-16 and 50 from the prior three reporting quarters), as well as 45 other issue reports (including events found to be not reportable and Significant Category A and B conditions)more » identified at INL during the past 12 months (16 from this quarter and 29 from the prior three quarters).« less

Idaho National Laboratory Quarterly Occurrence Analysis - 1st Quarter FY 2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 74 reportable events (16 from the 1st Qtr FY-16 and 58 from the prior three reporting quarters), as well as 35 other issue reports (including events found to be not reportable and Significant Category A and B conditions)more » identified at INL during the past 12 months (15 from this quarter and 20 from the prior three quarters).« less

Idaho National Laboratory Quarterly Occurrence Analysis 4th Quarter FY 2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System, as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 84 reportable events (29 from the 4th quarter fiscal year 2016 and 55 from the prior three reporting quarters), as well as 39 other issue reports (including events found to be not reportable and Significant Category A and Bmore » conditions) identified at INL during the past 12 months (two from this quarter and 37 from the prior three quarters).« less

Idaho National Laboratory Quarterly Occurrence Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 85 reportable events (18 from the 4th Qtr FY-15 and 67 from the prior three reporting quarters), as well as 25 other issue reports (including events found to be not reportable and Significant Category A and B conditions)more » identified at INL during the past 12 months (8 from this quarter and 17 from the prior three quarters).« less

Mobile physician reporting of clinically significant events-a novel way to improve handoff communication and supervision of resident on call activities.

PubMed

Nabors, Christopher; Peterson, Stephen J; Aronow, Wilbert S; Sule, Sachin; Mumtaz, Arif; Shah, Tushar; Eskridge, Etta; Wold, Eric; Stallings, Gary W; Burak, Kathleen Kelly; Goldberg, Randy; Guo, Gary; Sekhri, Arunabh; Mathew, George; Khera, Sahil; Montoya, Jessica; Sharma, Mala; Paudel, Rajiv; Frishman, William H

2014-12-01

Reporting of clinically significant events represents an important mechanism by which patient safety problems may be identified and corrected. However, time pressure and cumbersome report entry procedures have discouraged the full participation of physicians. To improve the process, our internal medicine training program developed an easy-to-use mobile platform that combines the reporting process with patient sign-out. Between August 25, 2011, and January 25, 2012, our trainees entered clinically significant events into i-touch/i-phone/i-pad based devices functioning in wireless-synchrony with our desktop application. Events were collected into daily reports that were sent from the handoff system to program leaders and attending physicians to plan for rounds and to correct safety problems. Using the mobile module, residents entered 31 reportable events per month versus the 12 events per month that were reported via desktop during a previous 6-month study period. Advances in information technology now permit clinically significant events that take place during "off hours" to be identified and reported (via handoff) to next providers and to supervisors via collated reports. This information permits hospital leaders to correct safety issues quickly and effectively, while attending physicians are able to use information gleaned from the reports to optimize rounding plans and to provide additional oversight of trainee on call patient management decisions.

Department of Defense Suicide Event Report Calendar Year 2013 Annual Report

DTIC Science & Technology

2014-07-24

suicide attempt DoDSERs, the most common method was drug/alcohol overdose . Prescription and over-the- MARINE CORPS DoDSER RESULTS The DoDSER system...24 JUL 2014 2. REPORT TYPE 3. DATES COVERED 00-00-2014 to 00-00-2014 4. TITLE AND SUBTITLE Department of Defense Suicide Event Report Calendar...LEFT BLANK 1CALENDAR YEAR 2013 ANNUAL REPORT Chapter 1: Suicide Rates Chapter 1 SUICIDE RATES 3CALENDAR YEAR 2013 ANNUAL REPORT Chapter 2: DoDSER

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

PubMed

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.

Dynamic decision modeling for inland waterway disruptions : August 1, 2014 - December 31, 2016 : final research report.

DOT National Transportation Integrated Search

2017-01-31

Inland waterway system is an essential part of the U.S. transportation system, which provides efficient and economic freight transportation through 12,000 miles of navigable waterway. An unexpected event (such as a natural event or unscheduled mainte...

Effects of catastrophic events on transportation system management and operations : August 2003 northeast blackout, New York City

DOT National Transportation Integrated Search

2004-04-01

This report documents the actions taken by transportation agencies in response to the August 14, 2003, Blackout throughout the Northeast. It is part of a larger effort to examine the impacts of catastrophic events on transportation system facilities ...

Effects of catastrophic events on transportation system management and operations : Northridge earthquake -- January 17, 1994

DOT National Transportation Integrated Search

2002-04-22

This report documents the actions taken by transportation agencies in response to the earthquake in Northridge, California on January 17, 1994, and is part of a larger effort to examine the impacts of catastrophic events on transportation system faci...

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

PubMed

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.

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

PubMed

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

2018-05-01

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 period 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.

The use of an electronic medical record system for mandatory reporting of drug hypersensitivity reactions has been shown to improve the management of patients in the university hospital in Korea.

PubMed

Park, Chan Sun; Kim, Tae-Bum; Kim, Seoung Lan; Kim, Jae Youn; Yang, Kyung Ai; Bae, Yun-Jeong; Cho, You Sook; Moon, Hee-Bom

2008-09-01

This study was conducted to evaluate the effectiveness of a computerized surveillance system for adverse drug events (ADEs) reinforced with mandatory reporting of all past drug hypersensitivity reactions (DHSRs) and supervision of the processes by allergy specialists in a university hospital. All information on both prior and newly developed DHSRs was collected via the surveillance system described above and compared with the data from previous system based on voluntary reporting of DHSRs by attending physicians. The report rate of past DHSRs was greatly increased and the estimated incidence of new events decreased under the new system. The occurrence rate of new DHSRs during hospitalization, which were caused by the repeated administration of the agents previously suspected as culprit drugs enormously, decreased from 15% of previous system to 1% of new system. The mandatory reporting system for past DHSRs and the supervision by allergy specialists appear to be important in improving the management of patients with drug hypersensitivity and in preventing the occurrence of DHSRs in a general hospital.

Sky Event Reporting Metadata (VOEvent) Version 2.0

NASA Technical Reports Server (NTRS)

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

Canadian Adverse Events Following Immunization Surveillance System (CAEFISS): Annual report for vaccines administered in 2012

PubMed Central

Law, BJ; Laflèche, J; Ahmadipour, N; Anyoti, H

2014-01-01

Background To describe the adverse event following immunization (AEFI) reporting profile for vaccines administered in Canada during 2012 and surveillance trends relative to reports for vaccines administered from 2005 through 2011. Methods Analysis of data based on AEFI reports received by the Public Health Agency of Canada by April 30, 2013, for vaccines marketed in Canada and administered from January 1, 2005, through December 31, 2012. Results The AEFI reporting rate was 10.1 per 100,000 population in Canada for vaccines administered in 2012 and was inversely proportional to age. There was a trend of declining rates from 2005 (14.8) to 2012 overall and by age group. The vast majority of reports (94%−95%) were non-serious involving reactions at or near the vaccination site, rash and febrile events. Conclusion Canada has a strong pharmacovigilance system for vaccines with one of the highest AEFI reporting rates in developed countries. Vaccines marketed in Canada have a very good safety profile. This report enables comparisons across jurisdictions in Canada and globally. PMID:29769908

Twitter web-service for soft agent reporting in persistent surveillance systems

NASA Astrophysics Data System (ADS)

Rababaah, Haroun; Shirkhodaie, Amir

2010-04-01

Persistent surveillance is an intricate process requiring monitoring, gathering, processing, tracking, and characterization of many spatiotemporal events occurring concurrently. Data associated with events can be readily attained by networking of hard (physical) sensors. Sensors may have homogeneous or heterogeneous (hybrid) sensing modalities with different communication bandwidth requirements. Complimentary to hard sensors are human observers or "soft sensors" that can report occurrences of evolving events via different communication devices (e.g., texting, cell phones, emails, instant messaging, etc.) to the command control center. However, networking of human observers in ad-hoc way is rather a difficult task. In this paper, we present a Twitter web-service for soft agent reporting in persistent surveillance systems (called Web-STARS). The objective of this web-service is to aggregate multi-source human observations in hybrid sensor networks rapidly. With availability of Twitter social network, such a human networking concept can not only be realized for large scale persistent surveillance systems (PSS), but also, it can be employed with proper interfaces to expedite rapid events reporting by human observers. The proposed technique is particularly suitable for large-scale persistent surveillance systems with distributed soft and hard sensor networks. The efficiency and effectiveness of the proposed technique is measured experimentally by conducting several simulated persistent surveillance scenarios. It is demonstrated that by fusion of information from hard and soft agents improves understanding of common operating picture and enhances situational awareness.

Medication errors: an analysis comparing PHICO's closed claims data and PHICO's Event Reporting Trending System (PERTS).

PubMed

Benjamin, David M; Pendrak, Robert F

2003-07-01

Clinical pharmacologists are all dedicated to improving the use of medications and decreasing medication errors and adverse drug reactions. However, quality improvement requires that some significant parameters of quality be categorized, measured, and tracked to provide benchmarks to which future data (performance) can be compared. One of the best ways to accumulate data on medication errors and adverse drug reactions is to look at medical malpractice data compiled by the insurance industry. Using data from PHICO insurance company, PHICO's Closed Claims Data, and PHICO's Event Reporting Trending System (PERTS), this article examines the significance and trends of the claims and events reported between 1996 and 1998. Those who misread history are doomed to repeat the mistakes of the past. From a quality improvement perspective, the categorization of the claims and events is useful for reengineering integrated medication delivery, particularly in a hospital setting, and for redesigning drug administration protocols on low therapeutic index medications and "high-risk" drugs. Demonstrable evidence of quality improvement is being required by state laws and by accreditation agencies. The state of Florida requires that quality improvement data be posted quarterly on the Web sites of the health care facilities. Other states have followed suit. The insurance industry is concerned with costs, and medication errors cost money. Even excluding costs of litigation, an adverse drug reaction may cost up to $2500 in hospital resources, and a preventable medication error may cost almost $4700. To monitor costs and assess risk, insurance companies want to know what errors are made and where the system has broken down, permitting the error to occur. Recording and evaluating reliable data on adverse drug events is the first step in improving the quality of pharmacotherapy and increasing patient safety. Cost savings and quality improvement evolve on parallel paths. The PHICO data provide an excellent opportunity to review information that typically would not be in the public domain. The events captured by PHICO are similar to the errors and "high-risk" drugs described in the literature, the U.S. Pharmacopeia's MedMARx Reporting System, and the Sentinel Event reporting system maintained by the Joint Commission for the Accreditation of Healthcare Organizations. The information in this report serves to alert clinicians to the possibility of adverse events when treating patients with the reported drugs, thus allowing for greater care in their use and closer monitoring. Moreover, when using high-risk drugs, patients should be well informed of known risks, dosage should be titrated slowly, and therapeutic drug monitoring and laboratory monitoring should be employed to optimize therapy and minimize adverse effects.

Completeness of Methicillin-Resistant Staphylococcus aureus Bloodstream Infection Reporting From Outpatient Hemodialysis Facilities to the National Healthcare Safety Network, 2013.

PubMed

Nguyen, Duc B; See, Isaac; Gualandi, Nicole; Shugart, Alicia; Lines, Christi; Bamberg, Wendy; Dumyati, Ghinwa; Harrison, Lee H; Lesher, Lindsey; Nadle, Joelle; Petit, Susan; Ray, Susan M; Schaffner, William; Townes, John; Njord, Levi; Sievert, Dawn; Thompson, Nicola D; Patel, Priti R

2016-02-01

Reports of bloodstream infections caused by methicillin-resistant Staphylococcus aureus among chronic hemodialysis patients to 2 Centers for Disease Control and Prevention surveillance systems (National Healthcare Safety Network Dialysis Event and Emerging Infections Program) were compared to evaluate completeness of reporting. Many methicillin-resistant S. aureus bloodstream infections identified in hospitals were not reported to National Healthcare Safety Network Dialysis Event.

Safety of Medical Abortion Provided Through Telemedicine Compared With In Person.

PubMed

Grossman, Daniel; Grindlay, Kate

2017-10-01

To compare the proportion of medical abortions with a clinically significant adverse event among telemedicine and in-person patients at a clinic system in Iowa during the first 7 years of the service. We conducted a retrospective cohort study. We analyzed data on clinically significant adverse events (hospital admission, surgery, blood transfusion, emergency department treatment, and death) for all medical abortions performed by telemedicine or in person at a clinic system in Iowa between July 1, 2008, and June 30, 2015. Data on adverse events came from required reporting forms submitted to the mifepristone distributor. We calculated the prevalence of adverse events and 95% CIs comparing telemedicine with in-person patients. The analysis was designed as a noninferiority study. Assuming the prevalence of adverse events to be 0.3%, telemedicine provision was considered to be inferior to in-person provision if the prevalence were 0.6% or higher. The required sample size was 6,984 in each group (one-sided α=0.025, power 90%). To explore whether patients with adverse events presented to emergency departments and were not reported, we conducted a survey of the 119 emergency departments in Iowa, asking whether they had treated a woman with an adverse event in the prior year. During the study period, 8,765 telemedicine and 10,405 in-person medical abortions were performed. Forty-nine clinically significant adverse events were reported (no deaths or surgery; 0.18% of telemedicine patients with any adverse event [95% CI 0.11-0.29%] and 0.32% of in-person patients [95% CI 0.23-0.45%]). The difference in adverse event prevalence was 0.13% (95% CI -0.01% to 0.28%, P=.07). Forty-two emergency departments responded to the survey (35% response rate); none reported treating a woman with an adverse event after medical abortion. Adverse events are rare with medical abortion, and telemedicine provision is noninferior to in-person provision with regard to clinically significant adverse events.

Errors, near misses and adverse events in the emergency department: what can patients tell us?

PubMed

Friedman, Steven M; Provan, David; Moore, Shannon; Hanneman, Kate

2008-09-01

We sought to determine whether patients or their families could identify adverse events in the emergency department (ED), to characterize patient reports of errors and to compare patient reports to events recorded by health care providers. This was a prospective cohort study in a quaternary care inner city teaching hospital with approximately 40,000 annual visits. ED patients were recruited for participation in a standardized interview within 24 hours of ED discharge and a follow-up interview 3-7 days after discharge. Responses regarding events were tabulated and compared with physician and nurse notations in the medical record and hospital event reporting system. Of 292 eligible patients, 201 (69%) were interviewed within 24 hours of ED discharge, and 143 (71% of interviewees) underwent a follow-up interview 3-7 days after discharge. Interviewees did not differ from the base ED population in terms of age, sex or language. Analysis of patient interviews identified 10 adverse events (5% incident rate; 95% confidence interval [CI] 2.41%-8.96%), 8 near misses (4% incident rate; 95% CI 1.73%-7.69%) and no medical errors. Of the 10 adverse events, 6 (60%) were characterized as preventable (2 raters; kappa=0.78, standard error [SE] 0.20; 95% CI 0.39-1.00; p=0.01). Adverse events were primarily related to delayed or inadequate analgesia. Only 4 out of 8 (50%) near misses were intercepted by hospital personnel. The secondary interview elicited 2 out of 10 adverse events and 3 out of 8 near misses that had not been identified in the primary interview. No designation (0 out of 10) of an adverse event was recorded in the ED medical record or in the confidential hospital event reporting system. ED patients can identify adverse events affecting their care. Moreover, many of these events are not recorded in the medical record. Engaging patients and their family members in identification of errors may enhance patient safety.

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

PubMed

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.

A Centralized Display for Mission Monitoring

NASA Technical Reports Server (NTRS)

Trujillo, Anna C.

2004-01-01

Humans traditionally experience a vigilance decrement over extended periods of time on reliable systems. One possible solution to aiding operators in monitoring is to use polar-star displays that will show deviations from normal in a more salient manner. The primary objectives of this experiment were to determine if polar-star displays aid in monitoring and preliminary diagnosis of the aircraft state. This experiment indicated that the polar-star display does indeed aid operators in detecting and diagnosing system events. Subjects were able to notice system events earlier and they subjectively reported the polar-star display helped them in monitoring, noticing an event, and diagnosing an event. Therefore, these results indicate that the polar-star display used for monitoring and preliminary diagnosis improves performance in these areas for system related events.

Effects of catastrophic events on transportation system management and operations : Baltimore, MD - Howard Street Tunnel fire - July 18th, 2001.

DOT National Transportation Integrated Search

2002-07-01

This report documents the actions taken by transportation agencies in response to the earthquake in Northridge, : California on January 17, 1994, and is part of a larger effort to examine the impacts of catastrophic events on : transportation system ...

Effects of catastrophic events on transportation system management and operations : New York City -- September 11, 2001

DOT National Transportation Integrated Search

2002-04-01

This report documents the actions taken by transportation agencies in response to the terrorist attack in New York City on September 11, and is part of a larger effort to examine the impacts of catastrophic events on transportation system facilities ...

Asset Management Process (AMP) Improvement Project: Final Report of Findings and Recommendations

DTIC Science & Technology

2009-10-01

cannibalized components could no longer be sighted due to their re-use in other systems or equipment. Solution — A Rapid Improvement Event, or Kaizen , was...Property Loss Reporting domain’s lifecycle, the Green Belt recognized the opportunity for a Rapid Improvement Event (RIE), or Kaizen . A five-day RIE was

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

PubMed

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 different treatment groups, pilot studies are being undertaken with patients receiving pelvic radiotherapy and upper gastrointestinal surgery. ISRCTN88520246. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Event-based surveillance in Papua New Guinea: strengthening an International Health Regulations (2005) core capacity

PubMed Central

Dagina, Rosheila; Murhekar, Manoj; Rosewell, Alexander

2013-01-01

Under the International Health Regulations (2005), Member States are required to develop capacity in event-based surveillance (EBS). The Papua New Guinea National Department of Health established an EBS system during the influenza pandemic in August 2009. We review its performance from August 2009 to November 2012, sharing lessons that may be useful to other low-resource public health practitioners working in surveillance. We examined the EBS system’s event reporting, event verification and response. Characteristics examined included type of event, source of information, timeliness, nature of response and outcome. Sixty-one records were identified. The median delay between onset of the event and date of reporting was 10 days. The largest proportion of reports (39%) came from Provincial Health Offices, followed by direct reports from clinical staff (25%) and reports in the media (11%). Most (84%) of the events were substantiated to be true public health events, and 56% were investigated by the Provincial Health Office alone. A confirmed or probable etiology could not be determined in 69% of true events. EBS is a simple strategy that forms a cornerstone of public health surveillance and response particularly in low-resource settings such as Papua New Guinea. There is a need to reinforce reporting pathways, improve timeliness of reporting, expand sources of information, improve feedback and improve diagnostic support capacity. For it to be successful, EBS should be closely tied to response. PMID:24319609

Special event discrimination analysis: The TEXAR blind test and identification of the August 16, 1997 Kara Sea event. Final report, 13 September 1995--31 January 1998

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baumgardt, D.

1998-03-31

The International Monitoring System (IMS) for the Comprehensive Test Ban Treaty (CTBT) faces the serious challenge of being able to accurately and reliably identify seismic events in any region of the world. Extensive research has been performed in recent years on developing discrimination techniques which appear to classify seismic events into broad categories of source types, such as nuclear explosion, earthquake, and mine blast. This report examines in detail the problem of effectiveness of regional discrimination procedures in the application of waveform discriminants to Special Event identification and the issue of discriminant transportability.

Assessing the continuum of event-based biosurveillance through an operational lens.

PubMed

Corley, Courtney D; Lancaster, Mary J; Brigantic, Robert T; Chung, James S; Walters, Ronald A; Arthur, Ray R; Bruckner-Lea, Cynthia J; Calapristi, Augustin; Dowling, Glenn; Hartley, David M; Kennedy, Shaun; Kircher, Amy; Klucking, Sara; Lee, Eva K; McKenzie, Taylor; Nelson, Noele P; Olsen, Jennifer; Pancerella, Carmen; Quitugua, Teresa N; Reed, Jeremy Todd; Thomas, Carla S

2012-03-01

This research follows the Updated Guidelines for Evaluating Public Health Surveillance Systems, Recommendations from the Guidelines Working Group, published by the Centers for Disease Control and Prevention nearly a decade ago. Since then, models have been developed and complex systems have evolved with a breadth of disparate data to detect or forecast chemical, biological, and radiological events that have a significant impact on the One Health landscape. How the attributes identified in 2001 relate to the new range of event-based biosurveillance technologies is unclear. This article frames the continuum of event-based biosurveillance systems (that fuse media reports from the internet), models (ie, computational that forecast disease occurrence), and constructs (ie, descriptive analytical reports) through an operational lens (ie, aspects and attributes associated with operational considerations in the development, testing, and validation of the event-based biosurveillance methods and models and their use in an operational environment). A workshop was held in 2010 to scientifically identify, develop, and vet a set of attributes for event-based biosurveillance. Subject matter experts were invited from 7 federal government agencies and 6 different academic institutions pursuing research in biosurveillance event detection. We describe 8 attribute families for the characterization of event-based biosurveillance: event, readiness, operational aspects, geographic coverage, population coverage, input data, output, and cost. Ultimately, the analyses provide a framework from which the broad scope, complexity, and relevant issues germane to event-based biosurveillance useful in an operational environment can be characterized.

Idaho National Laboratory Quarterly Occurrence Analysis for the 1st Quarter FY2017

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Lisbeth Ann

This report is published quarterly by the Idaho National Laboratory (INL) Quality and Performance Management Organization. The Department of Energy (DOE) Occurrence Reporting and Processing System (ORPS), as prescribed in DOE Order 232.2, “Occurrence Reporting and Processing of Operations Information,” requires a quarterly analysis of events, both reportable and not reportable, for the previous 12 months. This report is the analysis of 82 reportable events (13 from the 1st quarter (Qtr) of fiscal year (FY) 2017 and 68 from the prior three reporting quarters), as well as 31 other issue reports (including events found to be not reportable and Significantmore » Category A and B conditions) identified at INL during the past 12 months (seven from this quarter and 24 from the prior three quarters).« less

The complexity of patient safety reporting systems in UK dentistry.

PubMed

Renton, T; Master, S

2016-10-21

Since the 'Francis Report', UK regulation focusing on patient safety has significantly changed. Healthcare workers are increasingly involved in NHS England patient safety initiatives aimed at improving reporting and learning from patient safety incidents (PSIs). Unfortunately, dentistry remains 'isolated' from these main events and continues to have a poor record for reporting and learning from PSIs and other events, thus limiting improvement of patient safety in dentistry. The reasons for this situation are complex.This paper provides a review of the complexities of the existing systems and procedures in relation to patient safety in dentistry. It highlights the conflicting advice which is available and which further complicates an overly burdensome process. Recommendations are made to address these problems with systems and procedures supporting patient safety development in dentistry.

Adverse drug event monitoring at the Food and Drug Administration.

PubMed

Ahmad, Syed Rizwanuddin

2003-01-01

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk.

Adverse Drug Event Monitoring at the Food and Drug Administration

PubMed Central

Ahmad, Syed Rizwanuddin

2003-01-01

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treating their patients. Despite its limitations, the spontaneous reporting system is an extremely valuable mechanism by which hazards with drugs that were not observed or recognized at the time of approval are identified. Physicians are strongly encouraged to submit reports of adverse outcomes with suspect drugs to the FDA, and their reports make a difference. The FDA is strengthening its postmarketing surveillance with access to new data sources that have the potential to further improve the identification, quantification, and subsequent management of drug risk. PMID:12534765

Drug-Associated Acute Kidney Injury Identified in the United States Food and Drug Administration Adverse Event Reporting System Database.

PubMed

Welch, Hanna K; Kellum, John A; Kane-Gill, Sandra L

2018-06-08

Acute kidney injury (AKI) is a common condition associated with both short-term and long-term consequences including dialysis, chronic kidney disease, and mortality. Although the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database is a powerful tool to examine drug-associated events, to our knowledge, no study has analyzed this database to identify the most common drugs reported with AKI. The objective of this study was to analyze AKI reports and associated medications in the FAERS database. Retrospective pharmacovigilance disproportionality analysis. FAERS database. We queried the FAERS database for reports of AKI from 2004 quarter 1 through 2015 quarter 3. Extracted drugs were assessed using published references and categorized as known, possible, or new potential nephrotoxins. The reporting odds ratio (ROR), a measure of reporting disproportionality, was calculated for the 20 most frequently reported drugs in each category. We retrieved 7,241,385 adverse event reports, of which 193,996 (2.7%) included a report of AKI. Of the AKI reports, 16.5% were known nephrotoxins, 18.6% were possible nephrotoxins, and 64.8% were new potential nephrotoxins. Among the most commonly reported drugs, those with the highest AKI ROR were aprotinin (7,614 reports; ROR 115.70, 95% confidence interval [CI] 110.63-121.01), sodium phosphate (1,687 reports; ROR 55.81, 95% CI 51.78-60.17), furosemide (1,743 reports; ROR 12.61, 95% CI 11.94-13.32), vancomycin (1,270 reports, ROR 12.19, 95% CI 11.45-12.99), and metformin (4,701 reports; ROR 10.65, 95% CI 10.31-11.00). The combined RORs for the 20 most frequently reported drugs with each nephrotoxin classification were 3.71 (95% CI 3.66-3.76) for known nephrotoxins, 2.09 (95% CI 2.06-2.12) for possible nephrotoxins, and 1.55 (95% CI 1.53-1.57) for new potential nephrotoxins. AKI was a common reason for adverse event reporting in the FAERS. Most AKI reports were generated for medications not recognized as nephrotoxic according to our classification system. This report provides data on medications needing further research to determine the risk of AKI with these new potential nephrotoxins. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Symptom-based categorization of in-flight passenger medical incidents.

PubMed

Mahony, Paul H; Myers, Julia A; Larsen, Peter D; Powell, David M C; Griffiths, Robin F

2011-12-01

The majority of in-flight passenger medical events are managed by cabin crew. Our study aimed to evaluate the reliability of cabin crew reports of in-flight medical events and to develop a symptom-based categorization system. All cabin crew in-flight passenger medical incident reports for an airline over a 9-yr period were examined retrospectively. Validation of incident descriptions were undertaken on a sample of 162 cabin crew reports where medically trained persons' reports were available for comparison using a three Round Delphi technique and testing concordance using Cohen's Kappa. A hierarchical symptom-based categorization system was designed and validated. The rate was 159 incidents per 106 passengers carried, or 70.4/113.3 incidents per 106 revenue passenger kilometres/miles, respectively. Concordance between cabin crew and medical reports was 96%, with a high validity rating (mean 4.6 on a 1-5 scale) and high Cohen's Kappa (0.94). The most common in-flight medical events were transient loss of consciousness (41%), nausea/vomiting/diarrhea (19.5%), and breathing difficulty (16%). Cabin crew records provide reliable data regarding in-flight passenger medical incidents, complementary to diagnosis-based systems, and allow the use of currently underutilized data. The categorization system provides a means for tracking passenger medical incidents internationally and an evidence base for cabin crew first aid training.

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

PubMed

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.

[Pharmacovigilance in Portugal: Activity of the Central Pharmacovigilance Unit].

PubMed

Batel-Marques, Francisco; Mendes, Diogo; Alves, Carlos; Penedones, Ana; Dias, Patricia; Martins, Angelina; Santiago, Luiz Miguel; Fontes-Ribeiro, Carlos; Caramona, Margarida; Macedo, Tice

2015-01-01

The aim of this study was to characterize the spontaneous reports of adverse events that were received by the Central Portugal Regional Pharmacovigilance Unit. Spontaneous reports received between 01/2001 and 12/2013 were considered. The annual reporting ratios were estimated. The cases were characterized according to their seriousness, previous description, causality assessment, origin and professional group of the reporter, type of adverse event and pharmacotherapeutic groups of the suspected drugs most frequently reported. The Pharmacovigilance Unit received 2408 reports that contained 5749 adverse events. In 2013, the reporting rate was estimated at 171 reports per million inhabitants. Fifty-five percent of the reports were assessed as serious. Ninety percent of the cases were assessed as being at least possibly related with the suspected drug. The suspected drugs most frequently reported were anti-infectives for systemic use (n = 809, 33%). The most frequently reported adverse events were "Skin and subcutaneous tissue disorders" (n = 1139, 20%). There were 154 (6.4%) reports resulting in life-threatening situations and/or death, and 88 (3.6%) containing at least one adverse event assessed as serious, unknown and certain or probable. The present results are in line with those found in other studies, namely the seriousness and type of the adverse events and the pharmacotherapeutic groups of the most frequently reported suspected drugs. In the last years, the Central Portugal Regional Pharmacovigilance Unit has registered a growth in the reporting rate in general, as well as an increase in the reporting of unknown and serious adverse drug reactions.

Towards cross-lingual alerting for bursty epidemic events.

PubMed

Collier, Nigel

2011-10-06

Online news reports are increasingly becoming a source for event-based early warning systems that detect natural disasters. Harnessing the massive volume of information available from multilingual newswire presents as many challanges as opportunities due to the patterns of reporting complex spatio-temporal events. In this article we study the problem of utilising correlated event reports across languages. We track the evolution of 16 disease outbreaks using 5 temporal aberration detection algorithms on text-mined events classified according to disease and outbreak country. Using ProMED reports as a silver standard, comparative analysis of news data for 13 languages over a 129 day trial period showed improved sensitivity, F1 and timeliness across most models using cross-lingual events. We report a detailed case study analysis for Cholera in Angola 2010 which highlights the challenges faced in correlating news events with the silver standard. The results show that automated health surveillance using multilingual text mining has the potential to turn low value news into high value alerts if informed choices are used to govern the selection of models and data sources. An implementation of the C2 alerting algorithm using multilingual news is available at the BioCaster portal http://born.nii.ac.jp/?page=globalroundup.

Current French system of post-marketing drug surveillance.

PubMed

Albengres, E; Gauthier, F; Tillement, J P

1990-07-01

The French system of drug surveillance is characterized by several original features: thirty regional centres are selected to cover all of France to collect, analyze and enter the adverse drug events in the national data bank. The system is based on a bank of well documented files submitted to a decision of imputation; the report of severe events by prescribers is mandatory; cases are collected either by spontaneous reporting (routine) or by direct request (intensive validation study); the system is being involved in studies of epidemiological type as carried out by the national system of health or a few societies of medicine as well as by the centres themselves in cooperative works on defined populations.

Development and validation of Aviation Causal Contributors for Error Reporting Systems (ACCERS).

PubMed

Baker, David P; Krokos, Kelley J

2007-04-01

This investigation sought to develop a reliable and valid classification system for identifying and classifying the underlying causes of pilot errors reported under the Aviation Safety Action Program (ASAP). ASAP is a voluntary safety program that air carriers may establish to study pilot and crew performance on the line. In ASAP programs, similar to the Aviation Safety Reporting System, pilots self-report incidents by filing a short text description of the event. The identification of contributors to errors is critical if organizations are to improve human performance, yet it is difficult for analysts to extract this information from text narratives. A taxonomy was needed that could be used by pilots to classify the causes of errors. After completing a thorough literature review, pilot interviews and a card-sorting task were conducted in Studies 1 and 2 to develop the initial structure of the Aviation Causal Contributors for Event Reporting Systems (ACCERS) taxonomy. The reliability and utility of ACCERS was then tested in studies 3a and 3b by having pilots independently classify the primary and secondary causes of ASAP reports. The results provided initial evidence for the internal and external validity of ACCERS. Pilots were found to demonstrate adequate levels of agreement with respect to their category classifications. ACCERS appears to be a useful system for studying human error captured under pilot ASAP reports. Future work should focus on how ACCERS is organized and whether it can be used or modified to classify human error in ASAP programs for other aviation-related job categories such as dispatchers. Potential applications of this research include systems in which individuals self-report errors and that attempt to extract and classify the causes of those events.

Ontology-Based Combinatorial Comparative Analysis of Adverse Events Associated with Killed and Live Influenza Vaccines

PubMed Central

Sarntivijai, Sirarat; Xiang, Zuoshuang; Shedden, Kerby A.; Markel, Howard; Omenn, Gilbert S.; Athey, Brian D.; He, Yongqun

2012-01-01

Vaccine adverse events (VAEs) are adverse bodily changes occurring after vaccination. Understanding the adverse event (AE) profiles is a crucial step to identify serious AEs. Two different types of seasonal influenza vaccines have been used on the market: trivalent (killed) inactivated influenza vaccine (TIV) and trivalent live attenuated influenza vaccine (LAIV). Different adverse event profiles induced by these two groups of seasonal influenza vaccines were studied based on the data drawn from the CDC Vaccine Adverse Event Report System (VAERS). Extracted from VAERS were 37,621 AE reports for four TIVs (Afluria, Fluarix, Fluvirin, and Fluzone) and 3,707 AE reports for the only LAIV (FluMist). The AE report data were analyzed by a novel combinatorial, ontology-based detection of AE method (CODAE). CODAE detects AEs using Proportional Reporting Ratio (PRR), Chi-square significance test, and base level filtration, and groups identified AEs by ontology-based hierarchical classification. In total, 48 TIV-enriched and 68 LAIV-enriched AEs were identified (PRR>2, Chi-square score >4, and the number of cases >0.2% of total reports). These AE terms were classified using the Ontology of Adverse Events (OAE), MedDRA, and SNOMED-CT. The OAE method provided better classification results than the two other methods. Thirteen out of 48 TIV-enriched AEs were related to neurological and muscular processing such as paralysis, movement disorders, and muscular weakness. In contrast, 15 out of 68 LAIV-enriched AEs were associated with inflammatory response and respiratory system disorders. There were evidences of two severe adverse events (Guillain-Barre Syndrome and paralysis) present in TIV. Although these severe adverse events were at low incidence rate, they were found to be more significantly enriched in TIV-vaccinated patients than LAIV-vaccinated patients. Therefore, our novel combinatorial bioinformatics analysis discovered that LAIV had lower chance of inducing these two severe adverse events than TIV. In addition, our meta-analysis found that all previously reported positive correlation between GBS and influenza vaccine immunization were based on trivalent influenza vaccines instead of monovalent influenza vaccines. PMID:23209624

10 CFR 50.73 - Licensee event report system.

Code of Federal Regulations, 2013 CFR

2013-01-01

... scram or reactor trip. (2) General containment isolation signals affecting containment isolation valves... plant design; or (2) Normal and expected wear or degradation. (x) Any event that posed an actual threat...

10 CFR 50.73 - Licensee event report system.

Code of Federal Regulations, 2014 CFR

2014-01-01

... scram or reactor trip. (2) General containment isolation signals affecting containment isolation valves... plant design; or (2) Normal and expected wear or degradation. (x) Any event that posed an actual threat...

10 CFR 50.73 - Licensee event report system.

Code of Federal Regulations, 2012 CFR

2012-01-01

... scram or reactor trip. (2) General containment isolation signals affecting containment isolation valves... plant design; or (2) Normal and expected wear or degradation. (x) Any event that posed an actual threat...

Future Performance Trend Indicators: A Current Value Approach to Human Resources Accounting. Report II: Internal Consistencies and Relationships to Performance in Organization VI. Technical Report.

ERIC Educational Resources Information Center

Pecorella, Patricia A.; Bowers, David G.

Conventional accounting systems provide no indication as to what conditions and events lead to reported outcomes, since they traditionally do not include measurements of the human organization and its relationship to events at the outcome stage. Human resources accounting is used to measure these additional types of data. This research is…

Extreme water-related weather events and waterborne disease.

PubMed

Cann, K F; Thomas, D Rh; Salmon, R L; Wyn-Jones, A P; Kay, D

2013-04-01

Global climate change is expected to affect the frequency, intensity and duration of extreme water-related weather events such as excessive precipitation, floods, and drought. We conducted a systematic review to examine waterborne outbreaks following such events and explored their distribution between the different types of extreme water-related weather events. Four medical and meteorological databases (Medline, Embase, GeoRef, PubMed) and a global electronic reporting system (ProMED) were searched, from 1910 to 2010. Eighty-seven waterborne outbreaks involving extreme water-related weather events were identified and included, alongside 235 ProMED reports. Heavy rainfall and flooding were the most common events preceding outbreaks associated with extreme weather and were reported in 55·2% and 52·9% of accounts, respectively. The most common pathogens reported in these outbreaks were Vibrio spp. (21·6%) and Leptospira spp. (12·7%). Outbreaks following extreme water-related weather events were often the result of contamination of the drinking-water supply (53·7%). Differences in reporting of outbreaks were seen between the scientific literature and ProMED. Extreme water-related weather events represent a risk to public health in both developed and developing countries, but impact will be disproportionate and likely to compound existing health disparities.

Lessons Learned from the Evolution of Mandatory Adverse Event Reporting Systems

DTIC Science & Technology

2005-05-01

related to treatment, such as nosocomial infections and unintended effects of drugs and medical devices, is collected by the Centers for Disease...Nontreatment-related events (such as criminal acts, specified statutory events, and nosocomial infection outbreaks) • Treatment and procedure...1.8 Ventilator death/injury 38 1.5 Anesthesia-related event 35 1.4 Infection -related event 34 1.4 Medical equipment-related 32 1.3 Maternal death

Effects of catastrophic events on transportation system management and operations : Howard Street tunnel fire Baltimore City, Maryland -- July 18, 2001

DOT National Transportation Integrated Search

2002-07-01

This report documents the actions taken by transportation agencies in response to the tunnel fire in Baltimore, Maryland on July 18, 2001, and is part of a larger effort to examine the impacts of catastrophic events on transportation system facilitie...

IDSR as a Platform for Implementing IHR in African Countries

PubMed Central

Kasolo, Francis; Yoti, Zabulon; Bakyaita, Nathan; Gaturuku, Peter; Katz, Rebecca; Fischer, Julie E.

2013-01-01

Of the 46 countries in the World Health Organization (WHO) African region (AFRO), 43 are implementing Integrated Disease Surveillance and Response (IDSR) guidelines to improve their abilities to detect, confirm, and respond to high-priority communicable and noncommunicable diseases. IDSR provides a framework for strengthening the surveillance, response, and laboratory core capacities required by the revised International Health Regulations [IHR (2005)]. In turn, IHR obligations can serve as a driving force to sustain national commitments to IDSR strategies. The ability to report potential public health events of international concern according to IHR (2005) relies on early warning systems founded in national surveillance capacities. Public health events reported through IDSR to the WHO Emergency Management System in Africa illustrate the growing capacities in African countries to detect, assess, and report infectious and noninfectious threats to public health. The IHR (2005) provide an opportunity to continue strengthening national IDSR systems so they can characterize outbreaks and respond to public health events in the region. PMID:24041192

10 CFR Appendix G to Part 73 - Reportable Safeguards Events

Code of Federal Regulations, 2010 CFR

2010-01-01

... vulnerability in a safeguard system that could allow unauthorized or undetected access to a protected area... the safeguards event log. (a) Any failure, degradation, or discovered vulnerability in a safeguards...

77 FR 67348 - Privacy Act of 1974; System of Records-Alternative Dispute Resolution (ADR) Center Case Tracking...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-09

... J2EE application that is platform independent and captures all information relating to Alternative Dispute Resolution case processing. It tracks, manages, and reports on all data, events, and procedures... records to indicate that it will be used: (1) To track, manage, and report on all data, events, and...

Application of Knowledge Discovery in Databases Methodologies for Predictive Models for Pregnancy Adverse Events

ERIC Educational Resources Information Center

Taft, Laritza M.

2010-01-01

In its report "To Err is Human", The Institute of Medicine recommended the implementation of internal and external voluntary and mandatory automatic reporting systems to increase detection of adverse events. Knowledge Discovery in Databases (KDD) allows the detection of patterns and trends that would be hidden or less detectable if analyzed by…

Solutions for Coding Societal Events

DTIC Science & Technology

2016-12-01

develop a prototype system for civil unrest event extraction, and (3) engineer BBN ACCENT (ACCurate Events from Natural Text ) to support broad use by...56 iv List of Tables Table 1: Features in similarity metric. Abbreviations are as follows. TG: text graph...extraction of a stream of events (e.g. protests, attacks, etc.) from unstructured text (e.g. news, social media). This technical report presents results

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

PubMed Central

Cunha, Mônica P. L.; Dórea, José G.; Marques, Rejane C.; Leão, Renata S.

2013-01-01

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. PMID:23509790

Limitations imposed on fire PRA methods as the result of incomplete and uncertain fire event data.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nowlen, Steven Patrick; Hyslop, J. S.

2010-04-01

Fire probabilistic risk assessment (PRA) methods utilize data and insights gained from actual fire events in a variety of ways. For example, fire occurrence frequencies, manual fire fighting effectiveness and timing, and the distribution of fire events by fire source and plant location are all based directly on the historical experience base. Other factors are either derived indirectly or supported qualitatively based on insights from the event data. These factors include the general nature and intensity of plant fires, insights into operator performance, and insights into fire growth and damage behaviors. This paper will discuss the potential methodology improvements thatmore » could be realized if more complete fire event reporting information were available. Areas that could benefit from more complete event reporting that will be discussed in the paper include fire event frequency analysis, analysis of fire detection and suppression system performance including incipient detection systems, analysis of manual fire fighting performance, treatment of fire growth from incipient stages to fully-involved fires, operator response to fire events, the impact of smoke on plant operations and equipment, and the impact of fire-induced cable failures on plant electrical circuits.« less

Using FDA reports to inform a classification for health information technology safety problems

PubMed Central

Ong, Mei-Sing; Runciman, William; Coiera, Enrico

2011-01-01

Objective To expand an emerging classification for problems with health information technology (HIT) using reports submitted to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Design HIT events submitted to MAUDE were retrieved using a standardized search strategy. Using an emerging classification with 32 categories of HIT problems, a subset of relevant events were iteratively analyzed to identify new categories. Two coders then independently classified the remaining events into one or more categories. Free-text descriptions were analyzed to identify the consequences of events. Measurements Descriptive statistics by number of reported problems per category and by consequence; inter-rater reliability analysis using the κ statistic for the major categories and consequences. Results A search of 899 768 reports from January 2008 to July 2010 yielded 1100 reports about HIT. After removing duplicate and unrelated reports, 678 reports describing 436 events remained. The authors identified four new categories to describe problems with software functionality, system configuration, interface with devices, and network configuration; the authors' classification with 32 categories of HIT problems was expanded by the addition of these four categories. Examination of the 436 events revealed 712 problems, 96% were machine-related, and 4% were problems at the human–computer interface. Almost half (46%) of the events related to hazardous circumstances. Of the 46 events (11%) associated with patient harm, four deaths were linked to HIT problems (0.9% of 436 events). Conclusions Only 0.1% of the MAUDE reports searched were related to HIT. Nevertheless, Food and Drug Administration reports did prove to be a useful new source of information about the nature of software problems and their safety implications with potential to inform strategies for safe design and implementation. PMID:21903979

Adverse event detection using the FDA post-marketing drug safety surveillance system: Cardiotoxicity associated with loperamide abuse and misuse.

PubMed

Swank, Kimberley A; Wu, Eileen; Kortepeter, Cindy; McAninch, Jana; Levin, Robert L

The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016. Forty-eight cases of serious cardiac adverse events associated with loperamide use composed the case series. The most frequently reported cardiac adverse events were syncope (n = 24), cardiac arrest (n = 13), QT-interval prolongation (n = 13), ventricular tachycardia (n = 10), and TdP (n = 7). There were 10 cases that resulted in death. Of the 48 cases, the most commonly reported reasons for use can be characterized as drug abuse (n = 22) and diarrhea treatment (n = 17). More than one-half of the 48 cases were reported after 2010. Of the 22 drug abuse cases, the median daily dose was 250 mg (range 70 mg to 1600 mg) and events occurred as early as 6 hours after a dose and as long as 18 months after initiation of loperamide. Thirteen of the 22 cases reported using loperamide for euphoric or analgesic effects, and 9 reported use to prevent opioid withdrawal symptoms. The FAERS case reports provide evidence to suggest that high doses of loperamide are associated with TdP and other serious cardiac adverse events. The majority of cases in this series occurred in the setting of drug abuse for the purpose of preventing opioid withdrawal or to produce euphoric effects. It is important for both clinicians and patients to be aware of this potential risk, because prompt therapy and discontinuation of the offending agent are often essential to management and prevention of loperamide-induced cardiac arrhythmias. Published by Elsevier Inc.

Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).

PubMed

Treister, Roi; Trudeau, Jeremiah J; Van Inwegen, Richard; Jones, Judith K; Katz, Nathaniel P

2016-12-01

Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials. The system was initially conceived and designed with input from experts and patients, followed by field-testing to assess its feasibility and content validity in both completed and ongoing clinical trials. The results suggest that MADDERS is a feasible system with initial validity. It showed higher rates of the triggering events in subjects taking medications with known abuse potential than in patients taking medications without abuse potential. Additionally, experts agreed on the classification of most abuse-related events in MADDERS. MADDERS is a new systematic approach to collect information on potentially abuse-related events in clinical trials and classify them. The system has demonstrated feasibility for implementation. Additional research is ongoing to further evaluate its validity. Currently, there are no validated tools to assess drug abuse potential during clinical trials. Because of its ease of implementation, its systematic approach, and its preliminary validation results, MADDERS could provide such a tool for clinical trials. (Am J Addict 2016;25:641-651). © 2016 American Academy of Addiction Psychiatry.

NASA aviation safety reporting system

NASA Technical Reports Server (NTRS)

1979-01-01

The human factors frequency considered a cause of or contributor to hazardous events onboard air carriers are examined with emphasis on distractions. Safety reports that have been analyzed, processed, and entered into the aviation safety reporting system data base are discussed. A sampling of alert bulletins and responses to them is also presented.

10 CFR 73.71 - Reporting of safeguards events.

Code of Federal Regulations, 2011 CFR

2011-01-01

... after discovery of the loss of any shipment of SNM or spent fuel, and within one hour after recovery of... Notification System, if the licensee is party to that system. If the Emergency Notification System is... service or other dedicated telephonic system or any other methods that will ensure that a report is...

10 CFR 73.71 - Reporting of safeguards events.

Code of Federal Regulations, 2010 CFR

2010-01-01

... after discovery of the loss of any shipment of SNM or spent fuel, and within one hour after recovery of... Notification System, if the licensee is party to that system. If the Emergency Notification System is... service or other dedicated telephonic system or any other methods that will ensure that a report is...

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

PubMed

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.

System Driven Workarounds

NASA Technical Reports Server (NTRS)

Connell, Linda; Wichner, David; Jakey, Abegael Marie

2013-01-01

The Aviation Safety Reporting System (ASRS) in a partnership between the National Aeronautics and Space Administration (NASA), the Federal Aviation Administration (FAA), participating carriers, and labor organizations. It is designed to improve the National Airspace System by collecting and studying reports detailing unsafe conditions and events in the aviation industry. Employees are able to report safety issues or concerns with confidentiality and without fear of discipline. Safety reports highlighting system driven workarounds for the aviation community highlight the human workaround for the complex aviation system.

Enhancing the Effectiveness of Significant Event Analysis: Exploring Personal Impact and Applying Systems Thinking in Primary Care

PubMed Central

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

Introduction: 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. Methods: 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. Results: 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 < .001), while most agreed that the Personal Booklet was practical (88/123, 71.5%) and relevant to dealing with related emotions (93/123, 75.6%). The Desk Pad tool helped focus the SEA on 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%). Discussion: 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. PMID:27583996

Enhancing the Effectiveness of Significant Event Analysis: Exploring Personal Impact and Applying Systems Thinking in Primary Care.

PubMed

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 < .001), while most agreed that the Personal Booklet was practical (88/123, 71.5%) and relevant to dealing with related emotions (93/123, 75.6%). The Desk Pad tool helped focus the SEA on 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.

77 FR 22322 - Common Formats for Patient Safety Data Collection and Event Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... Safety Databases (NPSD). The Common Formats include two general types of formats, generic and event... Common Formats. The inventory includes many systems from the private sector, including prominent academic...

Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010.

PubMed

Moro, Pedro L; Yue, Xin; Lewis, Paige; Haber, Penina; Broder, Karen

2011-11-21

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine was not licensed for use in adults aged ≥65 years due to lack of sufficient efficacy and safety data. To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged ≥65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns. We searched VAERS for US reports of adverse events (AEs) in subjects aged ≥65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports coded as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening-illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after Tdap compared with Td reports in subjects aged ≥65 years. VAERS received 243 reports following Tdap administered to persons aged ≥65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after Tdap compared with Td. Six of seven Tdap reports containing the term 'Cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. Our VAERS review of the 'off-label' use of Tdap vaccine in adults ≥65 years did not find any safety concerns that warrant further study. These data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted. Published by Elsevier Ltd.

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

PubMed

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.

Digital drug safety surveillance: monitoring pharmaceutical products in twitter.

PubMed

Freifeld, Clark C; Brownstein, John S; Menone, Christopher M; Bao, Wenjie; Filice, Ross; Kass-Hout, Taha; Dasgupta, Nabarun

2014-05-01

Traditional adverse event (AE) reporting systems have been slow in adapting to online AE reporting from patients, relying instead on gatekeepers, such as clinicians and drug safety groups, to verify each potential event. In the meantime, increasing numbers of patients have turned to social media to share their experiences with drugs, medical devices, and vaccines. The aim of the study was to evaluate the level of concordance between Twitter posts mentioning AE-like reactions and spontaneous reports received by a regulatory agency. We collected public English-language Twitter posts mentioning 23 medical products from 1 November 2012 through 31 May 2013. Data were filtered using a semi-automated process to identify posts with resemblance to AEs (Proto-AEs). A dictionary was developed to translate Internet vernacular to a standardized regulatory ontology for analysis (MedDRA(®)). Aggregated frequency of identified product-event pairs was then compared with data from the public FDA Adverse Event Reporting System (FAERS) by System Organ Class (SOC). Of the 6.9 million Twitter posts collected, 4,401 Proto-AEs were identified out of 60,000 examined. Automated, dictionary-based symptom classification had 86 % recall and 72 % precision [corrected]. Similar overall distribution profiles were observed, with Spearman rank correlation rho of 0.75 (p < 0.0001) between Proto-AEs reported in Twitter and FAERS by SOC. Patients reporting AEs on Twitter showed a range of sophistication when describing their experience. Despite the public availability of these data, their appropriate role in pharmacovigilance has not been established. Additional work is needed to improve data acquisition and automation.

Review of Safety Reports Involving Electronic Flight Bags.

DOT National Transportation Integrated Search

2010-04-01

Safety events in which Electronic Flight Bags (EFBs) were a factor are reviewed. Relevant reports were obtained from the public Aviation Safety Reporting System (ASRS) database and the National Transportation Safety Board (NTSB) accident report datab...

Adverse Event Reporting for Herbal Medicines: A Result of Market Forces

PubMed Central

Walji, Rishma; Boon, Heather; Barnes, Joanne; Austin, Zubin; Baker, G. Ross; Welsh, Sandy

2009-01-01

Herbal products are readily available over the counter in health food stores and are often perceived to be without risk. The current Canadian adverse event reporting system suffers from severe underreporting, resulting in a scarcity of safety data on herbal products. Twelve health food store personnel in the Greater Toronto Area were interviewed about their responses to herbal product–related adverse reactions. They generally fostered customer loyalty by offering generous return policies, which included collecting contact information to be sent to the manufacturers with the returned product. Thus, despite the public's lack of knowledge about the formal reporting system, adverse reaction information was directed to manufacturers whenever it resulted in a product return. The relationship between health food stores, industry and Health Canada provides a new opportunity to facilitate adverse event reporting. Additional information could be collected during the return process, and educational initiatives could be implemented to augment current post-market surveillance procedures for herbal products. PMID:20436811

Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.

PubMed

Arana, Jorge E; Harrington, Theresa; Cano, Maria; Lewis, Paige; Mba-Jonas, Adamma; Rongxia, Li; Stewart, Brock; Markowitz, Lauri E; Shimabukuro, Tom T

2018-03-20

The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26 years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination. We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions. VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distributed for all reports, and 19 per million for serious reports. Among 29 verified reports of death, there was no pattern of clustering of deaths by diagnosis, co-morbidities, age, or interval from vaccination to death. No new or unexpected safety concerns or reporting patterns of 4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is consistent with data from pre-licensure trials and postmarketing safety data. Published by Elsevier Ltd.

Evaluation of near-miss and adverse events in radiation oncology using a comprehensive causal factor taxonomy.

PubMed

Spraker, Matthew B; Fain, Robert; Gopan, Olga; Zeng, Jing; Nyflot, Matthew; Jordan, Loucille; Kane, Gabrielle; Ford, Eric

Incident learning systems (ILSs) are a popular strategy for improving safety in radiation oncology (RO) clinics, but few reports focus on the causes of errors in RO. The goal of this study was to test a causal factor taxonomy developed in 2012 by the American Association of Physicists in Medicine and adopted for use in the RO: Incident Learning System (RO-ILS). Three hundred event reports were randomly selected from an institutional ILS database and Safety in Radiation Oncology (SAFRON), an international ILS. The reports were split into 3 groups of 100 events each: low-risk institutional, high-risk institutional, and SAFRON. Three raters retrospectively analyzed each event for contributing factors using the American Association of Physicists in Medicine taxonomy. No events were described by a single causal factor (median, 7). The causal factor taxonomy was found to be applicable for all events, but 4 causal factors were not described in the taxonomy: linear accelerator failure (n = 3), hardware/equipment failure (n = 2), failure to follow through with a quality improvement intervention (n = 1), and workflow documentation was misleading (n = 1). The most common causal factor categories contributing to events were similar in all event types. The most common specific causal factor to contribute to events was a "slip causing physical error." Poor human factors engineering was the only causal factor found to contribute more frequently to high-risk institutional versus low-risk institutional events. The taxonomy in the study was found to be applicable for all events and may be useful in root cause analyses and future studies. Communication and human behaviors were the most common errors affecting all types of events. Poor human factors engineering was found to specifically contribute to high-risk more than low-risk institutional events, and may represent a strategy for reducing errors in all types of events. Copyright © 2017 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Provider experiences with negative-pressure wound therapy systems.

PubMed

Kaufman-Rivi, Diana; Hazlett, Antoinette C; Hardy, Mary Anne; Smith, Jacquelyn M; Seid, Heather B

2013-07-01

MedWatch, the Food and Drug Administration's (FDA's) nationwide adverse event reporting system, serves to monitor device performance after a medical device is approved or cleared for market. Through the MedWatch adverse event reporting system, the FDA receives Medical Device Reports of deaths and serious injuries with negative-pressure wound therapy (NPWT) systems, many of which are used in homes and in extended-care facilities. In response to reported events, this study was conducted to obtain additional information about device issues that healthcare professionals face in these settings, as well as challenges that caregivers might encounter using this technology at home. The study was exploratory and descriptive in nature. The FDA surveyed wound care specialists and professional home healthcare providers to learn about users' experiences with NPWT. In the first phase of the study, a semistructured questionnaire was developed for telephone interviews and self-administration. In the second phase, a web-based survey was adapted from the semistructured instrument. Respondent concerns primarily centered on issues not directly related to the NPWT devices: NPWT prescription, provider education in addition to patient training and appropriate wound management practices, notably ongoing wound assessment, and patient monitoring. Overall, respondents thought that there was a definite benefit to NPWT, regardless of the care setting, and that it was a safe therapy when prescribed and administered appropriately.

Collecting Self-Reported Data on Dating Abuse Perpetration From a Sample of Primarily Black and Hispanic, Urban-Residing, Young Adults: A Comparison of Timeline Followback Interview and Interactive Voice Response Methods.

PubMed

Rothman, Emily F; Heeren, Timothy; Winter, Michael; Dorfman, David; Baughman, Allyson; Stuart, Gregory

2016-12-01

Dating abuse is a prevalent and consequential public health problem. However, relatively few studies have compared methods of collecting self-report data on dating abuse perpetration. This study compares two data collection methods-(a) the Timeline Followback (TLFB) retrospective reporting method, which makes use of a written calendar to prompt respondents' recall, and (b) an interactive voice response (IVR) system, which is a prospective telephone-based database system that necessitates respondents calling in and entering data using their telephone keypads. We collected 84 days of data on young adult dating abuse perpetration using IVR from a total of 60 respondents. Of these respondents, 41 (68%) completed a TLFB retrospective report pertaining to the same 84-day period after that time period had ended. A greater number of more severe dating abuse perpetration events were reported via the IVR system. Participants who reported any dating abuse perpetration were more likely to report more frequent abuse perpetration via the IVR than the TLFB (i.e., may have minimized the number of times they perpetrated dating abuse on the TLFB). The TLFB method did not result in a tapering off of reported events past the first week as it has in prior studies, but the IVR method did result in a tapering off of reported events after approximately the sixth week. We conclude that using an IVR system for self-reports of dating abuse perpetration may not have substantial advantages over using a TLFB method, but researchers' choice of mode may vary by research question, resources, sample, and setting.

Confidential Clinician-reported Surveillance of Adverse Events Among Medical Inpatients

PubMed Central

Weingart, Saul N; Ship, Amy N; Aronson, Mark D

2000-01-01

BACKGROUND Although iatrogenic injury poses a significant risk to hospitalized patients, detection of adverse events (AEs) is costly and difficult. METHODS The authors developed a confidential reporting method for detecting AEs on a medicine unit of a teaching hospital. Adverse events were defined as patient injuries. Potential adverse events (PAEs) represented errors that could have, but did not result in harm. Investigators interviewed house officers during morning rounds and by e-mail, asking them to identify obstacles to high quality care and iatrogenic injuries. They compared house officer reports with hospital incident reports and patients' medical records. A multivariate regression model identified correlates of reporting. RESULTS One hundred ten events occurred, affecting 84 patients. Queries by e-mail (incidence rate ratio [IRR ]=0.16; 95% confidence interval [95% CI], 0.05 to 0.49) and on days when house officers rotated to a new service (IRR =0.12; 95% CI, 0.02 to 0.91) resulted in fewer reports. The most commonly reported process of care problems were inadequate evaluation of the patient (16.4%), failure to monitor or follow up (12.7%), and failure of the laboratory to perform a test (12.7%). Respondents identified 29 (26.4%) AEs, 52 (47.3%) PAEs, and 29 (26.4%) other house officer-identified quality problems. An AE occurred in 2.6% of admissions. The hospital incident reporting system detected only one house officer-reported event. Chart review corroborated 72.9% of events. CONCLUSIONS House officers detect many AEs among inpatients. Confidential peer interviews of front-line providers is a promising method for identifying medical errors and substandard quality. PMID:10940133

Grading dermatologic adverse events of cancer treatments: the Common Terminology Criteria for Adverse Events Version 4.0.

PubMed

Chen, Alice P; Setser, Ann; Anadkat, Milan J; Cotliar, Jonathan; Olsen, Elise A; Garden, Benjamin C; Lacouture, Mario E

2012-11-01

Dermatologic adverse events to cancer therapies have become more prevalent and may to lead to dose modifications or discontinuation of life-saving or prolonging treatments. This has resulted in a new collaboration between oncologists and dermatologists, which requires accurate cataloging and grading of side effects. The Common Terminology Criteria for Adverse Events Version 4.0 is a descriptive terminology and grading system that can be used for uniform reporting of adverse events. A proper understanding of this standardized classification system is essential for dermatologists to properly communicate with all physicians caring for patients with cancer. Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

STS-61 mission director's post-mission report

NASA Technical Reports Server (NTRS)

Newman, Ronald L.

1995-01-01

To ensure the success of the complex Hubble Space Telescope servicing mission, STS-61, NASA established a number of independent review groups to assess management, design, planning, and preparation for the mission. One of the resulting recommendations for mission success was that an overall Mission Director be appointed to coordinate management activities of the Space Shuttle and Hubble programs and to consolidate results of the team reviews and expedite responses to recommendations. This report presents pre-mission events important to the experience base of mission management, with related Mission Director's recommendations following the event(s) to which they apply. All Mission Director's recommendations are presented collectively in an appendix. Other appendixes contain recommendations from the various review groups, including Payload Officers, the JSC Extravehicular Activity (EVA) Section, JSC EVA Management Office, JSC Crew and Thermal Systems Division, and the STS-61 crew itself. This report also lists mission events in chronological order and includes as an appendix a post-mission summary by the lead Payload Deployment and Retrieval System Officer. Recommendations range from those pertaining to specific component use or operating techniques to those for improved management, review, planning, and safety procedures.

Safety management as a foundation for evidence-based aeromedical standards and reporting of medical events.

PubMed

Evans, Anthony D; Watson, Dougal B; Evans, Sally A; Hastings, John; Singh, Jarnail; Thibeault, Claude

2009-06-01

The different interpretations by States (countries) of the aeromedical standards established by the International Civil Aviation Organization has resulted in a variety of approaches to the development of national aeromedical policy, and consequently a relative lack of harmonization. However, in many areas of aviation, safety management systems have been recently introduced and may represent a way forward. A safety management system can be defined as "A systematic approach to managing safety, including the necessary organizational structures, accountabilities, policies, and procedures" (1). There are four main areas where, by applying safety management principles, it may be possible to better use aeromedical data to enhance flight safety. These are: 1) adjustment of the periodicity and content of routine medical examinations to more accurately reflect aeromedical risk; 2) improvement in reporting and analysis of routine medical examination data; 3) improvement in reporting and analysis of in-flight medical events; and 4) support for improved reporting of relevant aeromedical events through the promotion of an appropriate culture by companies and regulatory authorities. This paper explores how the principles of safety management may be applied to aeromedical systems to improve their contribution to safety.

Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation.

PubMed

Shaw, B E; Chapman, J; Fechter, M; Foeken, L; Greinix, H; Hwang, W; Phillips-Johnson, L; Korhonen, M; Lindberg, B; Navarro, W H; Szer, J

2013-11-01

Safety of living donors is critical to the success of blood, tissue and organ transplantation. Structured and robust vigilance and surveillance systems exist as part of some national entities, but historically no global systems are in place to ensure conformity, harmonisation and the recognition of rare adverse events (AEs). The World Health Assembly has recently resolved to require AE/reaction (AE/R) reporting both nationally and globally. The World Marrow Donor Association (WMDA) is an international organisation promoting the safety of unrelated donors and progenitor cell products for use in haematopoietic progenitor cell (HPC) transplantation. To address this issue, we established a system for collecting, collating, analysing, distributing and reacting to serious adverse events and reactions (SAE/R) in unrelated HPC donors. The WMDA successfully instituted this reporting system with 203 SAE/R reported in 2011. The committee generated two rapid reports, reacting to specific SAE/R, resulting in practice changing policies. The system has a robust governance structure, formal feedback to the WMDA membership and transparent information flows to other agencies, specialist physicians and transplant programs and the general public.

Use of Unstructured Event-Based Reports for Global Infectious Disease Surveillance

PubMed Central

Blench, Michael; Tolentino, Herman; Freifeld, Clark C.; Mandl, Kenneth D.; Mawudeku, Abla; Eysenbach, Gunther; Brownstein, John S.

2009-01-01

Free or low-cost sources of unstructured information, such as Internet news and online discussion sites, provide detailed local and near real-time data on disease outbreaks, even in countries that lack traditional public health surveillance. To improve public health surveillance and, ultimately, interventions, we examined 3 primary systems that process event-based outbreak information: Global Public Health Intelligence Network, HealthMap, and EpiSPIDER. Despite similarities among them, these systems are highly complementary because they monitor different data types, rely on varying levels of automation and human analysis, and distribute distinct information. Future development should focus on linking these systems more closely to public health practitioners in the field and establishing collaborative networks for alert verification and dissemination. Such development would further establish event-based monitoring as an invaluable public health resource that provides critical context and an alternative to traditional indicator-based outbreak reporting. PMID:19402953

Vaccinovigilance in Europe--need for timeliness, standardization and resources.

PubMed Central

Lankinen, Kari S.; Pastila, Satu; Kilpi, Terhi; Nohynek, Hanna; Mäkelä, P. Helena; Olin, Patrick

2004-01-01

OBJECTIVE: To identify gaps in the systems for reporting adverse events following immunization (AEFI) in Europe by means of an interactive database constructed using a standardized approach. METHODS: A comparative survey was conducted in 1999-2000, using structured questionnaires addressed to the government authorities responsible for national immunization programmes and drug safety surveillance in all European Union (EU) Member States and in Norway and Switzerland. FINDINGS: The reporting of adverse vaccine reactions (AVRs) is covered by regulations in 13 of the 17 countries. Four countries have a specialized expert group with responsibility for vaccine safety. Only six professionals work full-time on vaccine safety in the 17 countries; in four of these countries the person is medically qualified. Fourteen countries have centralized reporting systems; in 14 countries the responsible authority is the drug regulatory agency. AEFI are reported using the procedure used for adverse drug reactions (ADRs) in all except four countries. The reporting form is not usually designed for vaccines and important details may therefore not be requested. Clinical definitions for vaccine reactions are not available. Twelve countries have appropriate official definitions for events or reactions, but the list of reportable events varies considerably between countries. The assessment of adverse vaccine reactions (AVRs) is hampered by lack of exact denominator data. Feedback to the rapporteurs was provided in 13 countries, but its quality was highly variable. CONCLUSION: The database facilitated a simple comparison of vaccinovigilance systems across participating countries. Most of the problems identified related to the reporting and analysis of AEFI could be solved through standardization and intensified international collaboration. On a national level, functional vaccinovigilance systems should be the shared responsibility of the drug regulatory authority and the national immunization programme. The resources for development and management of vaccine safety systems should be urgently improved. PMID:15640918

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.

PubMed

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.

Extracting semantically enriched events from biomedical literature

PubMed Central

2012-01-01

Background Research into event-based text mining from the biomedical literature has been growing in popularity to facilitate the development of advanced biomedical text mining systems. Such technology permits advanced search, which goes beyond document or sentence-based retrieval. However, existing event-based systems typically ignore additional information within the textual context of events that can determine, amongst other things, whether an event represents a fact, hypothesis, experimental result or analysis of results, whether it describes new or previously reported knowledge, and whether it is speculated or negated. We refer to such contextual information as meta-knowledge. The automatic recognition of such information can permit the training of systems allowing finer-grained searching of events according to the meta-knowledge that is associated with them. Results Based on a corpus of 1,000 MEDLINE abstracts, fully manually annotated with both events and associated meta-knowledge, we have constructed a machine learning-based system that automatically assigns meta-knowledge information to events. This system has been integrated into EventMine, a state-of-the-art event extraction system, in order to create a more advanced system (EventMine-MK) that not only extracts events from text automatically, but also assigns five different types of meta-knowledge to these events. The meta-knowledge assignment module of EventMine-MK performs with macro-averaged F-scores in the range of 57-87% on the BioNLP’09 Shared Task corpus. EventMine-MK has been evaluated on the BioNLP’09 Shared Task subtask of detecting negated and speculated events. Our results show that EventMine-MK can outperform other state-of-the-art systems that participated in this task. Conclusions We have constructed the first practical system that extracts both events and associated, detailed meta-knowledge information from biomedical literature. The automatically assigned meta-knowledge information can be used to refine search systems, in order to provide an extra search layer beyond entities and assertions, dealing with phenomena such as rhetorical intent, speculations, contradictions and negations. This finer grained search functionality can assist in several important tasks, e.g., database curation (by locating new experimental knowledge) and pathway enrichment (by providing information for inference). To allow easy integration into text mining systems, EventMine-MK is provided as a UIMA component that can be used in the interoperable text mining infrastructure, U-Compare. PMID:22621266

Extracting semantically enriched events from biomedical literature.

PubMed

Miwa, Makoto; Thompson, Paul; McNaught, John; Kell, Douglas B; Ananiadou, Sophia

2012-05-23

Research into event-based text mining from the biomedical literature has been growing in popularity to facilitate the development of advanced biomedical text mining systems. Such technology permits advanced search, which goes beyond document or sentence-based retrieval. However, existing event-based systems typically ignore additional information within the textual context of events that can determine, amongst other things, whether an event represents a fact, hypothesis, experimental result or analysis of results, whether it describes new or previously reported knowledge, and whether it is speculated or negated. We refer to such contextual information as meta-knowledge. The automatic recognition of such information can permit the training of systems allowing finer-grained searching of events according to the meta-knowledge that is associated with them. Based on a corpus of 1,000 MEDLINE abstracts, fully manually annotated with both events and associated meta-knowledge, we have constructed a machine learning-based system that automatically assigns meta-knowledge information to events. This system has been integrated into EventMine, a state-of-the-art event extraction system, in order to create a more advanced system (EventMine-MK) that not only extracts events from text automatically, but also assigns five different types of meta-knowledge to these events. The meta-knowledge assignment module of EventMine-MK performs with macro-averaged F-scores in the range of 57-87% on the BioNLP'09 Shared Task corpus. EventMine-MK has been evaluated on the BioNLP'09 Shared Task subtask of detecting negated and speculated events. Our results show that EventMine-MK can outperform other state-of-the-art systems that participated in this task. We have constructed the first practical system that extracts both events and associated, detailed meta-knowledge information from biomedical literature. The automatically assigned meta-knowledge information can be used to refine search systems, in order to provide an extra search layer beyond entities and assertions, dealing with phenomena such as rhetorical intent, speculations, contradictions and negations. This finer grained search functionality can assist in several important tasks, e.g., database curation (by locating new experimental knowledge) and pathway enrichment (by providing information for inference). To allow easy integration into text mining systems, EventMine-MK is provided as a UIMA component that can be used in the interoperable text mining infrastructure, U-Compare.

Adverse event reporting in Czech long-term care facilities.

PubMed

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.

Unfold the Veil Covering News--A Case Study of English Language and Ideology in Both American and Chinese Press

ERIC Educational Resources Information Center

Gao, Li; You, Qi-Dongmeng

2013-01-01

By taking Systemic Functional Grammar (SFG) as research approach, this study analyzes and discusses two news reports related to the event that a Uyghur man was sentenced to death by the Intermediate People's Court in Xinjiang, a western province of China. Both news reports on that event are taken respectively from two newspapers published in…

Consumer server: A UNIX based event distributor in new CDF data acquisition system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abe, F.; Morita, Y.; Nomachi, M.

1994-12-31

Consumer Server is a program to handle event data and consumer trigger requests I/Os among Level 3 farm and consumer processes in CDF new data acquisition system. This program uses standard UNIX libraries and commercial network technologies to obtain higher portability. The authors describe the concept and configuration of the Consumer Server and report its performance.

Evaluation of the Health Protection Event-Based Surveillance for the London 2012 Olympic and Paralympic Games.

PubMed

Severi, E; Kitching, A; Crook, P

2014-06-19

The Health Protection Agency (HPA) (currently Public Health England) implemented the Health Protection Event-Based Surveillance (EBS) to provide additional national epidemic intelligence for the 2012 London Olympic and Paralympic Games (the Games). We describe EBS and evaluate the system attributes. EBS aimed at identifying, assessing and reporting to the HPA Olympic Coordination Centre (OCC) possible national infectious disease threats that may significantly impact the Games. EBS reported events in England from 2 July to 12 September 2012. EBS sourced events from reports from local health protection units and from screening an electronic application 'HPZone Dashboard' (DB). During this period, 147 new events were reported to EBS, mostly food-borne and vaccine-preventable diseases: 79 from regional units, 144 from DB (76 from both). EBS reported 61 events to the OCC: 21 of these were reported onwards. EBS sensitivity was 95.2%; positive predictive value was 32.8%; reports were timely (median one day; 10th percentile: 0 days - same day; 90th percentile: 3.6 days); completeness was 99.7%; stability was 100%; EBS simplicity was assessed as good; the daily time per regional or national unit dedicated to EBS was approximately 4 hours (weekdays) and 3 hours (weekends). OCC directors judged EBS as efficient, fast and responsive. EBS provided reliable, reassuring, timely, simple and stable national epidemic intelligence for the Games.

[Systemic safety following intravitreal injections of anti-VEGF].

PubMed

Baillif, S; Levy, B; Girmens, J-F; Dumas, S; Tadayoni, R

2018-03-01

The goal of this manuscript is to assess data suggesting that intravitreal injection of anti-vascular endothelial growth factors (anti-VEGFs) could result in systemic adverse events (AEs). The class-specific systemic AEs should be similar to those encountered in cancer trials. The most frequent AE observed in oncology, hypertension and proteinuria, should thus be the most common expected in ophthalmology, but their severity should be lower because of the much lower doses of anti-VEGFs administered intravitreally. Such AEs have not been frequently reported in ophthalmology trials. In addition, pharmacokinetic and pharmacodynamic data describing systemic diffusion of anti-VEGFs should be interpreted with caution because of significant inconsistencies reported. Thus, safety data reported in ophthalmology trials and pharmacokinetic/pharmacodynamic data provide robust evidence that systemic events after intravitreal injection are very unlikely. Additional studies are needed to explore this issue further, as much remains to be understood about local and systemic side effects of anti-VEGFs. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Improving linear accelerator service response with a real- time electronic event reporting system.

PubMed

Hoisak, Jeremy D P; Pawlicki, Todd; Kim, Gwe-Ya; Fletcher, Richard; Moore, Kevin L

2014-09-08

To track linear accelerator performance issues, an online event recording system was developed in-house for use by therapists and physicists to log the details of technical problems arising on our institution's four linear accelerators. In use since October 2010, the system was designed so that all clinical physicists would receive email notification when an event was logged. Starting in October 2012, we initiated a pilot project in collaboration with our linear accelerator vendor to explore a new model of service and support, in which event notifications were also sent electronically directly to dedicated engineers at the vendor's technical help desk, who then initiated a response to technical issues. Previously, technical issues were reported by telephone to the vendor's call center, which then disseminated information and coordinated a response with the Technical Support help desk and local service engineers. The purpose of this work was to investigate the improvements to clinical operations resulting from this new service model. The new and old service models were quantitatively compared by reviewing event logs and the oncology information system database in the nine months prior to and after initiation of the project. Here, we focus on events that resulted in an inoperative linear accelerator ("down" machine). Machine downtime, vendor response time, treatment cancellations, and event resolution were evaluated and compared over two equivalent time periods. In 389 clinical days, there were 119 machine-down events: 59 events before and 60 after introduction of the new model. In the new model, median time to service response decreased from 45 to 8 min, service engineer dispatch time decreased 44%, downtime per event decreased from 45 to 20 min, and treatment cancellations decreased 68%. The decreased vendor response time and reduced number of on-site visits by a service engineer resulted in decreased downtime and decreased patient treatment cancellations.

Developing a national system for dealing with adverse events following immunization.

PubMed Central

Mehta, U.; Milstien, J. B.; Duclos, P.; Folb, P. I.

2000-01-01

Although vaccines are among the safest of pharmaceuticals, the occasional severe adverse event or cluster of adverse events associated with their use may rapidly become a serious threat to public health. It is essential that national monitoring and reporting systems for vaccine safety are efficient and adequately coordinated with those that conventionally deal with non-vaccine pharmaceuticals. Equally important is the need for an enlightened and informed national system to be in place to deal with public concerns and rapid evaluation of the risk to public safety when adverse events occur. Described in this article is the outcome of efforts by the WHO Global Training Network to describe a simple national system for dealing with vaccine safety and with emergencies as they arise. The goals of a training programme designed to help develop such a system are also outlined. PMID:10743281

Inconsistency in the Reporting of Adverse Events in Total Ankle Arthroplasty: A Systematic Review of the Literature.

PubMed

Mercer, Jeff; Penner, Murray; Wing, Kevin; Younger, Alastair S E

2016-02-01

Systems for classifying complications have been proposed for many surgical subspecialties. The goal of this systematic review was to analyze the number and frequency of different terms used to identify complications in total ankle arthroplasty. We hypothesized that this terminology would be highly variable, supporting a need for a standardized system of reporting. Studies that met predefined inclusion/exclusion criteria were analyzed to identify terminology used to describe adverse events. All terms were then tabulated and quantified with regard to diversity and frequency of use across all included studies. Terms were also grouped into 10 categories, and the number of reported occurrences of each adverse event was calculated. A reporting tool was then developed. Of 572 unique terms used to describe adverse outcomes in 117 studies, 55.9% (320/572) were used in only a single study. The category that was most frequently reported was revision surgery, with 86% of papers reporting on this event using 115 different terms. Other categories included "additional non-revision surgeries" (74% of papers, 93 terms), "loosening/osteolysis" (63% of papers, 86 terms), "fractures" (60% of papers, 53 terms), "wound problems" (52% of papers, 27 terms), "infection" (52% of papers, 27 terms), "implant problems" (50% of papers, 57 terms), "soft tissue injuries" (31% of papers, 30 terms), "heterotopic ossification" (22% of papers, 17 terms), and "pain" (18% of papers, 11 terms). The reporting of complications and adverse outcomes for total ankle arthroplasty was highly variable. This lack of consistency impedes the accurate reporting and interpretation of data required for the development of cohesive, evidence-based treatment guidelines for end-stage ankle arthritis. Standardized reporting tools are urgently needed. This study presents a prototype worksheet for the standardized assessment and reporting of adverse events. Level-III, decision analyses, systematic review of Level III studies and above. © The Author(s) 2015.

National survey of US public transit agency experience with and response to extreme weather events.

DOT National Transportation Integrated Search

2016-09-01

Extreme weather events pose serious challenges public transit systems. They disrupt transit operations, impair service quality, increase threats to public safety, and damage infrastructure. This report presents findings from a June 2016 national surv...

Safety and Effectiveness of Mycophenolate in Systemic Sclerosis. A Systematic Review

PubMed Central

2015-01-01

Background Mycophenolate is increasingly being used in the rheumatic diseases. Its main adverse effects are gastrointestinal, myelosuppression, and infection. These may limit use in systemic sclerosis (SSc) since gastrointestinal involvement is common. The objective of this study is to evaluate gastrointestinal adverse events of mycophenolate in SSc. Secondarily we evaluated other adverse events, and the effectiveness of mycophenolate in skin and lung disease. Methods A literature search of Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL (inception-2013) was performed. Studies reporting use of mycophenolate in SSc patients, adverse events, modified Rodnan skin score (MRSS), forced vital capacity (FVC), or diffusing capacity of carbon monoxide (DLCO) were included. The primary outcome was gastrointestinal events occurring after the initiation of mycophenolate. Secondary safety outcomes included myelosuppression, infection, malignancy, and death after the initiation of mycophenolate. Results 617 citations were identified and 21 studies were included. 487 patients were exposed to mycophenolate. The mean disease duration ranged between 0.8-14.1 years. There were 18 deaths and 90 non-lethal adverse events. The non-lethal adverse events included 43 (47.7%) gastrointestinal events, 34 (26%) infections, 6 (5%) cytopenias and 2 (2%) malignancies. The most common gastrointestinal events included diarrhea (n=18 (14%)), nausea (n=12 (9%)), and abdominal pain (n=3 (2%)). The rate of discontinuation ranged between 8%-40%. Seven observational studies reported improvement or stabilization in FVC, and 5 studies report stabilization or improvement in MRSS. Conclusion Mycophenolate-associated gastrointestinal adverse events are common in SSc, but not severe enough to preclude its use. Observational data suggests mycophenolate may be effective in improving or stabilizing interstitial lung disease, and skin involvement. PMID:25933090

Reactor shutdown experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cletcher, J.W.

1995-10-01

This is a regular report of summary statistics relating to recent reactor shutdown experience. The information includes both number of events and rates of occurence. It was compiled from data about operating events that were entered into the SCSS data system by the Nuclear Operations Analysis Center at the Oak ridge National Laboratory and covers the six mont period of July 1 to December 31, 1994. Cumulative information, starting from May 1, 1994, is also reported. Updates on shutdown events included in earlier reports is excluded. Information on shutdowns as a function of reactor power at the time of themore » shutdown for both BWR and PWR reactors is given. Data is also discerned by shutdown type and reactor age.« less

Creating the Web-based Intensive Care Unit Safety Reporting System

PubMed Central

Holzmueller, Christine G.; Pronovost, Peter J.; Dickman, Fern; Thompson, David A.; Wu, Albert W.; Lubomski, Lisa H.; Fahey, Maureen; Steinwachs, Donald M.; Engineer, Lilly; Jaffrey, Ali; Morlock, Laura L.; Dorman, Todd

2005-01-01

In an effort to improve patient safety, researchers at the Johns Hopkins University designed and implemented a comprehensive Web-based Intensive Care Unit Safety Reporting System (ICUSRS). The ICUSRS collects data about adverse events and near misses from all staff in the ICU. This report reflects data on 854 reports from 18 diverse ICUs across the United States. Reporting is voluntary, and data collected is confidential, with patient, provider, and reporter information deidentified. Preliminary data include system factors reported, degree of patient harm, reporting times, and evaluations of the system. Qualitative and quantitative data are reported back to the ICU site study teams and frontline staff through monthly reports, case discussions, and a quarterly newsletter. PMID:15561794

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

PubMed Central

Park, Kyounghoon; Soukavong, Mick; Kim, Jungmee; Kwon, Kyoung-eun; Jin, Xue-mei; Lee, Joongyub; Yang, Bo Ram

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 defined a signal as any AE that satisfied all three indices. The signals were compared with drug labels of nine countries. Results 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. Conclusion 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. PMID:28332362

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

PubMed

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. © Copyright: Yonsei University College of Medicine 2017

A cost-effectiveness analysis of three components of a syndromic surveillance system for the early warning of epidemics in rural China.

PubMed

Ding, Yan; Sauerborn, Rainer; Xu, Biao; Shaofa, Nie; Yan, Weirong; Diwan, Vinod K; Dong, Hengjin

2015-11-14

Syndromic surveillance systems (SSSs) collect non-specific syndromes in early stages of disease outbreaks. This makes an SSS a promising tool for the early detection of epidemics. An Integrated Surveillance System in rural China (ISSC project), which added an SSS to the existing Chinese surveillance system for the early warning of epidemics, was implemented from April 2012 to March 2014 in Jiangxi and Hubei Provinces. This study aims to measure the costs and effectiveness of the three components of the SSS in the ISSC project. The central measures of the cost-effectiveness analysis of the three components of the syndromic surveillance system were: 1) the costs per reported event, respectively, at the health facilities, the primary schools and the pharmacies; and 2) the operating costs per surveillance unit per year, respectively, at the health facilities, the primary schools and the pharmacies. Effectiveness was expressed by reporting outputs which were numbers of reported events, numbers of raw signals, and numbers of verified signals. The reported events were tracked through an internal data base. Signal verification forms and epidemiological investigation reports were collected from local country centers for disease control and prevention. We adopted project managers' perspective for the cost analysis. Total costs included set-up costs (system development and training) and operating costs (data collection, quality control and signal verification). We used self-designed questionnaires to collect cost data and received, respectively, 369 and 477 facility and staff questionnaires through a cross-sectional survey with a purposive sampling following the ISSC project. All data were entered into Epidata 3.02 and exported to Stata for descriptive analysis. The number of daily reported events per unit was the highest at pharmacies, followed by health facilities and finally primary schools. Variances existed within the three groups and also between Jiangxi and Hubei. During a 15-month surveillance period, the number of raw signals for early warning in Jiangxi province (n = 36) was nine times of that in Hubei. Health facilities and primary schools had equal numbers of raw signals (n = 19), which was 9.5 times of that from pharmacies. Five signals were confirmed as outbreaks, of which two were influenza, two were chicken pox and one was mumps. The cost per reported event was the highest at primary schools, followed by health facilities and then pharmacies. The annual operating cost per surveillance unit was the highest at pharmacies, followed by health facilities and finally primary schools. Both the cost per reported event and the annual operating cost per surveillance unit in Jiangxi in each of the three groups were higher than their counterparts in Hubei. Health facilities and primary schools are better sources of syndromic surveillance data in the early warning of outbreaks. The annual operating costs of all the three components of the syndromic surveillance system in the ISSC Project were low compared to general government expenditures on health and average individual income in rural China.

Addressing the surveillance goal in the National Strategy for Suicide Prevention: the Department of Defense Suicide Event Report.

PubMed

Gahm, Gregory A; Reger, Mark A; Kinn, Julie T; Luxton, David D; Skopp, Nancy A; Bush, Nigel E

2012-03-01

The US National Strategy for Suicide Prevention (National Strategy) described 11 goals across multiple areas, including suicide surveillance. Consistent with these goals, the Department of Defense (DoD) has engaged aggressively in the area of suicide surveillance. The DoD's population-based surveillance system, the DoD Suicide Event Report (DoDSER) collects information on suicides and suicide attempts for all branches of the military. Data collected includes suicide event details, treatment history, military and psychosocial history, and psychosocial stressors at the time of the event. Lessons learned from the DoDSER program are shared to assist other public health professionals working to address the National Strategy objectives.

Screening Electronic Health Record-Related Patient Safety Reports Using Machine Learning.

PubMed

Marella, William M; Sparnon, Erin; Finley, Edward

2017-03-01

The objective of this study was to develop a semiautomated approach to screening cases that describe hazards associated with the electronic health record (EHR) from a mandatory, population-based patient safety reporting system. Potentially relevant cases were identified through a query of the Pennsylvania Patient Safety Reporting System. A random sample of cases were manually screened for relevance and divided into training, testing, and validation data sets to develop a machine learning model. This model was used to automate screening of remaining potentially relevant cases. Of the 4 algorithms tested, a naive Bayes kernel performed best, with an area under the receiver operating characteristic curve of 0.927 ± 0.023, accuracy of 0.855 ± 0.033, and F score of 0.877 ± 0.027. The machine learning model and text mining approach described here are useful tools for identifying and analyzing adverse event and near-miss reports. Although reporting systems are beginning to incorporate structured fields on health information technology and the EHR, these methods can identify related events that reporters classify in other ways. These methods can facilitate analysis of legacy safety reports by retrieving health information technology-related and EHR-related events from databases without fields and controlled values focused on this subject and distinguishing them from reports in which the EHR is mentioned only in passing. Machine learning and text mining are useful additions to the patient safety toolkit and can be used to semiautomate screening and analysis of unstructured text in safety reports from frontline staff.

Increasing the Operational Value of Event Messages

NASA Technical Reports Server (NTRS)

Li, Zhenping; Savkli, Cetin; Smith, Dan

2003-01-01

Assessing the health of a space mission has traditionally been performed using telemetry analysis tools. Parameter values are compared to known operational limits and are plotted over various time periods. This presentation begins with the notion that there is an incredible amount of untapped information contained within the mission s event message logs. Through creative advancements in message handling tools, the event message logs can be used to better assess spacecraft and ground system status and to highlight and report on conditions not readily apparent when messages are evaluated one-at-a-time during a real-time pass. Work in this area is being funded as part of a larger NASA effort at the Goddard Space Flight Center to create component-based, middleware-based, standards-based general purpose ground system architecture referred to as GMSEC - the GSFC Mission Services Evolution Center. The new capabilities and operational concepts for event display, event data analyses and data mining are being developed by Lockheed Martin and the new subsystem has been named GREAT - the GMSEC Reusable Event Analysis Toolkit. Planned for use on existing and future missions, GREAT has the potential to increase operational efficiency in areas of problem detection and analysis, general status reporting, and real-time situational awareness.

Methods developed to elucidate nursing related adverse events in Japan.

PubMed

Yamagishi, Manaho; Kanda, Katsuya; Takemura, Yukie

2003-05-01

Financial resources for quality assurance in Japanese hospitals are limited and few hospitals have quality monitoring systems of nursing service systems. However, recently its necessity has been recognized. This study has cost effectively used adverse event occurrence rates as indicators of the quality of nursing service, and audited methods of collecting data on adverse events to elucidate their approximate true numbers. Data collection was conducted in July, August and November 2000 at a hospital in Tokyo that administered both primary and secondary health care services (281 beds, six wards, average length of stay 23 days). We collected adverse events through incident reports, logs, check-lists, nurse interviews, medication error questionnaires, urine leucocyte tests, patient interviews and medical records. Adverse events included the unplanned removals of invasive lines, medication errors, falls, pressure sores, skin deficiencies, physical restraints, and nosocomial infections. After evaluating the time and useful outcomes of each source, it soon became clear that we could elucidate adverse events most consistently and cost-effectively through incident reports, check lists, nurse interviews, urine leucocyte tests and medication error questionnaires. This study suggests that many hospitals in Japan could monitor the quality of the nursing service using these sources.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

D.L. McGregor

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 decisionsmore » 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.« less

MEADERS: Medication Errors and Adverse Drug Event Reporting system.

PubMed

Zafar, Atif

2007-10-11

The Agency for Healthcare Research and Quality (AHRQ) recently funded the PBRN Resource Center to develop a system for reporting ambulatory medication errors. Our goal was to develop a usable system that practices could use internally to track errors. We initially performed a comprehensive literature review of what is currently available. Then, using a combination of expert panel meetings and iterative development we designed an instrument for ambulatory medication error reporting and createad a reporting system based both in MS Access 2003 and on the web using MS ASP.NET 2.0 technologies.

[Current movements of four serious adverse events induced by medicinal drugs based on spontaneous reports in Japan].

PubMed

Sudo, Chie; Azuma, Yu-ichiro; Maekawa, Keiko; Kaniwa, Nahoko; Sai, Kimie; Saito, Yoshiro

2011-01-01

Spontaneous reports on suspected serious adverse events caused by medicines from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated by the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety features. Although causal relationship between the medicine and the adverse event is not evaluated, and one incidence may be redundantly reported, this information would be useful to roughly grasp the current movements of drug-related serious adverse events, We searched open-source data of the spontaneous reports publicized by Pharmaceutical and Medical Devices Agency for 4 serious adverse events (interstitial lung disease, rhabdomyolysis, anaphylaxis, and Stevens-Johnson syndrome/toxic epidermal necrolysis) from 2004 to 2010 fiscal year (for 2010, from April 1 st to January 31th). Major drug-classes suspected to the adverse events were antineoplastics for interstitial lung disease, hyperlipidemia agents and psychotropics for rhabdomyolysis, antibiotics/chemotherapeutics, antineoplastics and intracorporeal diagnostic agents for anaphylaxis (anaphylactic shock, anaphylactic reactions, anaphylactoid shock and anaphylactoid reactions), and antibiotics/chemotherapeutics, antipyretics and analgesics, anti-inflammatory agents/common cold drugs, and antiepileptics for Stevens-Johnson syndrome/toxic epidermal necrolysis. These results would help understanding of current situations of the 4 drug-related serious adverse events in Japan.

Expanding the News Frame: The Systems Theory Perspective.

ERIC Educational Resources Information Center

Hendrickson, Laura J.; Tankard, James W., Jr.

1997-01-01

Outlines the main features of the systems perspective, focusing on general systems theory. Suggests that teaching future reporters to think of news events and issues in systems terms may be one approach to expanding the news frame. (PA)

Information extraction from Italian medical reports: An ontology-driven approach.

PubMed

Viani, Natalia; Larizza, Cristiana; Tibollo, Valentina; Napolitano, Carlo; Priori, Silvia G; Bellazzi, Riccardo; Sacchi, Lucia

2018-03-01

In this work, we propose an ontology-driven approach to identify events and their attributes from episodes of care included in medical reports written in Italian. For this language, shared resources for clinical information extraction are not easily accessible. The corpus considered in this work includes 5432 non-annotated medical reports belonging to patients with rare arrhythmias. To guide the information extraction process, we built a domain-specific ontology that includes the events and the attributes to be extracted, with related regular expressions. The ontology and the annotation system were constructed on a development set, while the performance was evaluated on an independent test set. As a gold standard, we considered a manually curated hospital database named TRIAD, which stores most of the information written in reports. The proposed approach performs well on the considered Italian medical corpus, with a percentage of correct annotations above 90% for most considered clinical events. We also assessed the possibility to adapt the system to the analysis of another language (i.e., English), with promising results. Our annotation system relies on a domain ontology to extract and link information in clinical text. We developed an ontology that can be easily enriched and translated, and the system performs well on the considered task. In the future, it could be successfully used to automatically populate the TRIAD database. Copyright © 2017 Elsevier B.V. All rights reserved.

DEFENSE MEDICAL SURVEILLANCE SYSTEM (DMSS)

EPA Science Inventory

AMSA operates the Defense Medical Surveillance System (DMSS), an executive information system whose database contains up-to-date and historical data on diseases and medical events (e.g., hospitalizations, ambulatory visits, reportable diseases, HIV tests, acute respiratory diseas...

Examining Wrong Eye Implant Adverse Events in the Veterans Health Administration With a Focus on Prevention: A Preliminary Report.

PubMed

Neily, Julia; Chomsky, Amy; Orcutt, James; Paull, Douglas E; Mills, Peter D; Gilbert, Christina; Hemphill, Robin R; Gunnar, William

2018-03-01

The study goals were to examine wrong intraocular lens (IOL) implant adverse events in the Veterans Health Administration (VHA), identify root causes and contributing factors, and describe system changes that have been implemented to address this challenge. This study represents collaboration between the VHA's National Center for Patient Safety (NCPS) and the National Surgery Office (NSO). This report includes 45 wrong IOL implant surgery adverse events reported to established VHA NCPS and NSO databases between July 1, 2006, and June 31, 2014. There are approximately 50,000 eye implant procedures performed each year in the VHA. Wrong IOL implant surgery adverse events are reported by VHA facilities to the NCPS and the NSO. Two authors (A.C. and J.N.) coded the reports for event type (wrong lens or expired lens) and identified the primary contributing factor (coefficient κ = 0.837). A descriptive analysis was conducted, which included the reported yearly event rate. The main outcome measure was the reported wrong IOL implant surgery adverse events. There were 45 reported wrong IOL implant surgery adverse events. Between 2011 and June 30, 2014, there was a significant downward trend (P = 0.02, R = 99.7%) at a pace of -0.08 (per 10,000 cases) every year. The most frequently coded primary contributing factor was incomplete preprocedure time-out (n = 12) followed by failure to perform double check of preprocedural calculations based upon original data and implant read-back at the time the surgical eye implant was performed (n = 10). Preventing wrong IOL implant adverse events requires diligence beyond performance of the preprocedural time-out. In 2013, the VHA has modified policy to ensure double check of preprocedural calculations and implant read-back with positive impact. Continued analysis of contributing human factors and improved surgical team communication are warranted.

Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis.

PubMed

Kunac, Desireé L; Tatley, Michael V

2011-01-01

Despite the traditional focus being adverse drug reactions (ADRs), pharmacovigilance centres have recently been identified as a potentially rich and important source of medication error data. To identify medication errors in the New Zealand Pharmacovigilance database (Centre for Adverse Reactions Monitoring [CARM]), and to describe the frequency and characteristics of these events. A retrospective analysis of the CARM pharmacovigilance database operated by the New Zealand Pharmacovigilance Centre was undertaken for the year 1 January-31 December 2007. All reports, excluding those relating to vaccines, clinical trials and pharmaceutical company reports, underwent a preventability assessment using predetermined criteria. Those events deemed preventable were subsequently classified to identify the degree of patient harm, type of error, stage of medication use process where the error occurred and origin of the error. A total of 1412 reports met the inclusion criteria and were reviewed, of which 4.3% (61/1412) were deemed preventable. Not all errors resulted in patient harm: 29.5% (18/61) were 'no harm' errors but 65.5% (40/61) of errors were deemed to have been associated with some degree of patient harm (preventable adverse drug events [ADEs]). For 5.0% (3/61) of events, the degree of patient harm was unable to be determined as the patient outcome was unknown. The majority of preventable ADEs (62.5% [25/40]) occurred in adults aged 65 years and older. The medication classes most involved in preventable ADEs were antibacterials for systemic use and anti-inflammatory agents, with gastrointestinal and respiratory system disorders the most common adverse events reported. For both preventable ADEs and 'no harm' events, most errors were incorrect dose and drug therapy monitoring problems consisting of failures in detection of significant drug interactions, past allergies or lack of necessary clinical monitoring. Preventable events were mostly related to the prescribing and administration stages of the medication use process, with the majority of errors 82.0% (50/61) deemed to have originated in the community setting. The CARM pharmacovigilance database includes medication errors, many of which were found to originate in the community setting and reported as ADRs. Error-prone situations were able to be identified, providing greater opportunity to improve patient safety. However, to enhance detection of medication errors by pharmacovigilance centres, reports should be prospectively reviewed for preventability and the reporting form revised to facilitate capture of important information that will provide meaningful insight into the nature of the underlying systems defects that caused the error.

Ground Operations and ASRS

NASA Technical Reports Server (NTRS)

Connell, Linda; Wichner, David; Jakey, Abegail Marie

2013-01-01

The Aviation Safety Reporting System (ASRS) in a partnership between the National Aeronautics and Space Administration (NASA), the Federal Aviation Administration (FAA), participating carriers, and labor organizations. It is designed to improve the National Airspace System by collecting and studying reports detailing unsafe conditions and events in the aviation industry. Employees are able to report safety issues or concerns with confidentiality and without fear of discipline

Integrating natural language processing expertise with patient safety event review committees to improve the analysis of medication events.

PubMed

Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R

2017-08-01

Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

10-Year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors.

PubMed

Lowe, Gregory; Costabile, Raymond A

2012-01-01

To ensure public safety all Food and Drug Administration (FDA)-approved medications undergo postapproval safety analysis. Phosphodiesterase type-5 inhibitors (PDE5-i) are generally regarded as safe and effective. We performed a nonindustry-sponsored analysis of FDA reports for sildenafil, tadalafil, and vardenafil to evaluate the reported cardiovascular and mortality events over the past 10 years. Summarized reports of adverse events (AEs) for each PDE5-i were requested from the Center for Drug Evaluation and Research within the FDA. These data are available under the Freedom of Information Act and document industry and nonindustry reports of AEs entered into the computerized system maintained by the Office of Surveillance and Epidemiology. The data were analyzed for the number of AE reports, number of objective cardiovascular events, and reported deaths. Overall, 14,818 AEs were reported for sildenafil. There were 1,824 (12.3%) reported deaths, and reports of cardiovascular AEs numbered 2,406 (16.2%). Tadalafil was associated with 5,548 AEs and 236 deaths were reported. Vardenafil was associated with 6,085 AEs and 121 reports of deaths. The percentage of reported severe cardiovascular disorders has stabilized at 10% to 15% of all AE reports for sildenafil and tadalafil and 5% to 10% for vardenafil. Only 10% of AE reports sent to the FDA for PDE5-i were from pharmaceutical manufacturers. Reports of deaths associated with PDE5-i remain around 5% of total reported events. Despite inherent limitations from evaluating FDA reports of AEs, it is important that these reports be reviewed outside pharmaceutical industry support in order to provide due diligence and transparency. Lowe G and Costabile RA. 10-year analysis of adverse event reports to the Food and Drug Administration for phosphodiesterase type-5 inhibitors. J Sex Med 2012;9:265-270. © 2011 International Society for Sexual Medicine.

Detecting, Monitoring, and Reporting Possible Adverse Drug Events Using an Arden-Syntax-based Rule Engine.

PubMed

Fehre, Karsten; Plössnig, Manuela; Schuler, Jochen; Hofer-Dückelmann, Christina; Rappelsberger, Andrea; Adlassnig, Klaus-Peter

2015-01-01

The detection of adverse drug events (ADEs) is an important aspect of improving patient safety. The iMedication system employs predefined triggers associated with significant events in a patient's clinical data to automatically detect possible ADEs. We defined four clinically relevant conditions: hyperkalemia, hyponatremia, renal failure, and over-anticoagulation. These are some of the most relevant ADEs in internal medical and geriatric wards. For each patient, ADE risk scores for all four situations are calculated, compared against a threshold, and judged to be monitored, or reported. A ward-based cockpit view summarizes the results.

Adverse drug event reporting systems: a systematic review

PubMed Central

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

2016-01-01

Aim 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. Methods 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. Results 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). Conclusion 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. PMID:27016266

Adverse drug event reporting systems: a systematic review.

PubMed

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.

Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, Vaccine Adverse Event Reporting System (VAERS), July 2005-June 2013.

PubMed

Haber, Penina; Moro, Pedro L; McNeil, Michael M; Lewis, Paige; Woo, Emily Jane; Hughes, Hayley; Shimabukuro, Tom T

2014-11-12

Trivalent live attenuated influenza vaccine (LAIV3) was licensed and recommended for use in 2003 in children and adults 2-49 years of age. Post-licensure safety data have been limited, particularly in adults. We searched Vaccine Adverse Event Reporting System (VAERS) for US reports after LAIV3 from July 1, 2005-June 30, 2013 (eight influenza seasons) in adults aged ≥ 18 years old. We conducted descriptive analyses and clinically reviewed serious reports (i.e., death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability) and reports of selected conditions of interest. We used empirical Bayesian data mining to identify adverse events (AEs) that were reported more frequently than expected. We calculated crude AE reporting rates to VAERS by influenza season. During the study period, VAERS received 1207 LAIV3 reports in adults aged 18-49 years old; 107 (8.9%) were serious, including four death reports. The most commonly reported events were expired drug administered (n=207, 17%), headache (n=192, 16%), and fever (n=133, 11%). The most common diagnostic categories for non-fatal serious reports were neurological (n=40, 39%), cardiovascular (n=14, 14%), and other non-infectious conditions (n=20, 19%). We noted a higher proportion of Guillain-Barré syndrome (GBS) and cardiovascular reports in the Department of Defense (DoD) population compared to the civilian population. Data mining detected disproportional reporting of ataxia (n=15); clinical review revealed that ataxia was a component of diverse clinical entities including GBS. Review of VAERS reports are reassuring, the only unexpected safety concern for LAIV3 identified was a higher than expected number of GBS reports in the DoD population, which is being investigated. Reports of administration of expired LAIV3 represent administration errors and indicate the need for education, training and screening regarding the approved indications. Published by Elsevier Ltd.

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

PubMed

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 <2 years of age; 2588 (13%) in persons 2-18 years and 5867 (29%) 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 <1 month, were nervous system disorders (15) among children aged 1-23 months; infections and infestation (8) among persons age 2-18 years blood and lymphatic systemic disorders; and general disorders and administration site conditions among persons age >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.

Detection of medical errors in kidney transplantation: a pilot study comparing proactive clinician debriefings to a hospital-wide incident reporting system.

PubMed

McElroy, Lisa M; Daud, Amna; Lapin, Brittany; Ross, Olivia; Woods, Donna M; Skaro, Anton I; Holl, Jane L; Ladner, Daniela P

2014-11-01

Rates of medical errors and adverse events remain high for patients who undergo kidney transplantation; they are particularly vulnerable because of the complexity of their disease and the kidney transplantation procedure. Although institutional incident-reporting systems are used in hospitals around the country, they often fail to capture a substantial proportion of medical errors. The goal of this study was to assess the ability of a proactive, web-based clinician safety debriefing to augment the information about medical errors and adverse events obtained via traditional incident reporting systems. Debriefings were sent to all individuals listed on operating room personnel reports for kidney transplantation surgeries between April 2010 and April 2011, and incident reports were collected for the same time period. The World Health Organization International Classification for Patient Safety was used to classify all issues reported. A total of 270 debriefings reported 334 patient safety issues (179 safety incidents, 155 contributing factors), and 57 incident reports reported 92 patient safety issues (56 safety incidents, 36 contributing factors). Compared with incident reports, more attending physicians completed the debriefings (32.0 vs 3.5%). The use of a proactive, web-based debriefing to augment an incident reporting system in assessing safety risks in kidney transplantation demonstrated increased information, more perspectives of a single safety issue, and increased breadth of participants. Copyright © 2014 Elsevier Inc. All rights reserved.

Decision-support information system to manage mass casualty incidents at a level 1 trauma center.

PubMed

Bar-El, Yaron; Tzafrir, Sara; Tzipori, Idan; Utitz, Liora; Halberthal, Michael; Beyar, Rafael; Reisner, Shimon

2013-12-01

Mass casualty incidents are probably the greatest challenge to a hospital. When such an event occurs, hospitals are required to instantly switch from their routine activity to conditions of great uncertainty and confront needs that exceed resources. We describe an information system that was uniquely designed for managing mass casualty events. The web-based system is activated when a mass casualty event is declared; it displays relevant operating procedures, checklists, and a log book. The system automatically or semiautomatically initiates phone calls and public address announcements. It collects real-time data from computerized clinical and administrative systems in the hospital, and presents them to the managing team in a clear graphic display. It also generates periodic reports and summaries of available or scarce resources that are sent to predefined recipients. When the system was tested in a nationwide exercise, it proved to be an invaluable tool for informed decision making in demanding and overwhelming situations such as mass casualty events.

Mechanisms of lithium transport in amorphous polyethylene oxide.

PubMed

Duan, Yuhua; Halley, J W; Curtiss, Larry; Redfern, Paul

2005-02-01

We report calculations using a previously reported model of lithium perchlorate in polyethylene oxide in order to understand the mechanism of lithium transport in these systems. Using an algorithm suggested by Voter, we find results for the diffusion rate which are quite close to experimental values. By analysis of the individual events in which large lithium motions occur during short times, we find that no single type of rearrangement of the lithium environment characterizes these events. We estimate the free energies of the lithium ion as a function of position during these events by calculation of potentials of mean force and thus derive an approximate map of the free energy as a function of lithium position during these events. The results are consistent with a Marcus-like picture in which the system slowly climbs a free energy barrier dominated by rearrangement of the polymer around the lithium ions, after which the lithium moves very quickly to a new position. Reducing the torsion forces in the model causes the diffusion rates to increase.

Organizational Modes of Severe Wind-producing Convective Systems over North China

NASA Astrophysics Data System (ADS)

Yang, Xinlin; Sun, Jianhua

2018-05-01

Severe weather reports and composite radar reflectivity data from 2010-14 over North China were used to analyze the distribution of severe convective wind (SCW) events and their organizational modes of radar reflectivity. The six organizational modes for SCW events (and their proportions) were cluster cells (35.4%), squall lines (18.4%), nonlinear-shaped systems (17.8%), broken lines (11.6%), individual cells (1.2%), and bow echoes (0.5%). The peak month for both squall lines and broken lines was June, whereas it was July for the other four modes. The highest numbers of SCW events were over the mountains, which were generally associated with disorganized systems of cluster cells. In contrast, SCW associated with linear systems occurred mainly over the plains, where stations recorded an average of less than one SCW event per year. Regions with a high frequency of SCW associated with nonlinear-shaped systems also experienced many SCW events associated with squall lines. Values of convective available potential energy, precipitable water, 0-3-km shear, and 0-6-km shear, were demonstrably larger over the plains than over the mountains, which had an evident effect on the organizational modes of SCW events. Therefore, topography may be an important factor in the organizational modes for SCW events over North China.

Data Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Powell, Danny H; Elwood Jr, Robert H

2011-01-01

Analysis of the material protection, control, and accountability (MPC&A) system is necessary to understand the limits and vulnerabilities of the system to internal threats. A self-appraisal helps the facility be prepared to respond to internal threats and reduce the risk of theft or diversion of nuclear material. The material control and accountability (MC&A) system effectiveness tool (MSET) fault tree was developed to depict the failure of the MPC&A system as a result of poor practices and random failures in the MC&A system. It can also be employed as a basis for assessing deliberate threats against a facility. MSET uses faultmore » tree analysis, which is a top-down approach to examining system failure. The analysis starts with identifying a potential undesirable event called a 'top event' and then determining the ways it can occur (e.g., 'Fail To Maintain Nuclear Materials Under The Purview Of The MC&A System'). The analysis proceeds by determining how the top event can be caused by individual or combined lower level faults or failures. These faults, which are the causes of the top event, are 'connected' through logic gates. The MSET model uses AND-gates and OR-gates and propagates the effect of event failure using Boolean algebra. To enable the fault tree analysis calculations, the basic events in the fault tree are populated with probability risk values derived by conversion of questionnaire data to numeric values. The basic events are treated as independent variables. This assumption affects the Boolean algebraic calculations used to calculate results. All the necessary calculations are built into the fault tree codes, but it is often useful to estimate the probabilities manually as a check on code functioning. The probability of failure of a given basic event is the probability that the basic event primary question fails to meet the performance metric for that question. The failure probability is related to how well the facility performs the task identified in that basic event over time (not just one performance or exercise). Fault tree calculations provide a failure probability for the top event in the fault tree. The basic fault tree calculations establish a baseline relative risk value for the system. This probability depicts relative risk, not absolute risk. Subsequent calculations are made to evaluate the change in relative risk that would occur if system performance is improved or degraded. During the development effort of MSET, the fault tree analysis program used was SAPHIRE. SAPHIRE is an acronym for 'Systems Analysis Programs for Hands-on Integrated Reliability Evaluations.' Version 1 of the SAPHIRE code was sponsored by the Nuclear Regulatory Commission in 1987 as an innovative way to draw, edit, and analyze graphical fault trees primarily for safe operation of nuclear power reactors. When the fault tree calculations are performed, the fault tree analysis program will produce several reports that can be used to analyze the MPC&A system. SAPHIRE produces reports showing risk importance factors for all basic events in the operational MC&A system. The risk importance information is used to examine the potential impacts when performance of certain basic events increases or decreases. The initial results produced by the SAPHIRE program are considered relative risk values. None of the results can be interpreted as absolute risk values since the basic event probability values represent estimates of risk associated with the performance of MPC&A tasks throughout the material balance area (MBA). The RRR for a basic event represents the decrease in total system risk that would result from improvement of that one event to a perfect performance level. Improvement of the basic event with the greatest RRR value produces a greater decrease in total system risk than improvement of any other basic event. Basic events with the greatest potential for system risk reduction are assigned performance improvement values, and new fault tree calculations show the improvement in total system risk. The operational impact or cost-effectiveness from implementing the performance improvements can then be evaluated. The improvements being evaluated can be system performance improvements, or they can be potential, or actual, upgrades to the system. The RIR for a basic event represents the increase in total system risk that would result from failure of that one event. Failure of the basic event with the greatest RIR value produces a greater increase in total system risk than failure of any other basic event. Basic events with the greatest potential for system risk increase are assigned failure performance values, and new fault tree calculations show the increase in total system risk. This evaluation shows the importance of preventing performance degradation of the basic events. SAPHIRE identifies combinations of basic events where concurrent failure of the events results in failure of the top event.« less

Innovations for the future of pharmacovigilance.

PubMed

Almenoff, June S

2007-01-01

Post-marketing pharmacovigilance involves the review and management of safety information from many sources. Among these sources, spontaneous adverse event reporting systems are among the most challenging and resource-intensive to manage. Traditionally, efforts to monitor spontaneous adverse event reporting systems have focused on review of individual case reports. The science of pharmacovigilance could be enhanced with the availability of systems-based tools that facilitate analysis of aggregate data for purposes of signal detection, signal evaluation and knowledge management. GlaxoSmithKline (GSK) recently implemented Online Signal Management (OSM) as a data-driven framework for managing the pharmacovigilance of marketed products. This pioneering work builds upon the strong history GSK has of innovation in this area. OSM is a software application co-developed by GSK and Lincoln Technologies that integrates traditional pharmacovigilance methods with modern quantitative statistical methods and data visualisation tools. OSM enables the rapid identification of trends from the individual adverse event reports received by GSK. OSM also provides knowledge-management tools to ensure the successful tracking of emerging safety issues. GSK has developed standard procedures and 'best practices' around the use of OSM to ensure the systematic evaluation of complex safety datasets. In summary, the implementation of OSM provides new tools and efficient processes to advance the science of pharmacovigilance.

Disclosing large scale adverse events in the US Veterans Health Administration: lessons from media responses.

PubMed

Maguire, E M; Bokhour, B G; Asch, S M; Wagner, T H; Gifford, A L; Gallagher, T H; Durfee, J M; Martinello, R A; Elwy, A R

2016-06-01

We examined print, broadcast and social media reports about health care systems' disclosures of large scale adverse events to develop future effective messaging. Directed content analysis. We systematically searched four communication databases, YouTube and Really Simple Syndication (RSS) feeds relating to six disclosures of lapses in infection control practices in the Department of Veterans Affairs occurring between 2009 and 2012. We assessed these with a coding frame derived from effective crisis and risk communication models. We identified 148 unique media reports. Some components of effective communication (discussion of cause, reassurance, self-efficacy) were more present than others (apology, lessons learned). Media about 'promoting secrecy' and 'slow response' appeared in reports when time from event discovery to patient notification was over 75 days. Elected officials' quotes (n = 115) were often negative (83%). Hospital officials' comments (n = 165) were predominantly neutral (92%), and focused on information sharing. Health care systems should work to ensure that they develop clear messages focused on what is not well covered by the media, including authentic apologies, remedial actions taken, and shorten the timeframe between event identification and disclosure to patients. Published by Elsevier Ltd.

Systematic Review of Adverse Effects: A Further Step towards Modernization of Acupuncture in China

PubMed Central

Wu, Junyi; Hu, Yanmei; Zhu, Yin; Yin, Ping; Xu, Shifen

2015-01-01

As a further step towards the modernization of acupuncture, the objective of this review was to figure out the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers. Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles. Qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world. PMID:26339265

Analysis of reactor trips originating in balance of plant systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stetson, F.T.; Gallagher, D.W.; Le, P.T.

1990-09-01

This report documents the results of an analysis of balance-of-plant (BOP) related reactor trips at commercial US nuclear power plants of a 5-year period, from January 1, 1984, through December 31, 1988. The study was performed for the Plant Systems Branch, Office of Nuclear Reactor Regulation, US Nuclear Regulatory Commission. The objectives of the study were: to improve the level of understanding of BOP-related challenges to safety systems by identifying and categorizing such events; to prepare a computerized data base of BOP-related reactor trip events and use the data base to identify trends and patterns in the population of thesemore » events; to investigate the risk implications of BOP events that challenge safety systems; and to provide recommendations on how to address BOP-related concerns in regulatory context. 18 refs., 2 figs., 27 tabs.« less

Piecing together the puzzle: Improving event content coverage for real-time sub-event detection using adaptive microblog crawling

PubMed Central

Tokarchuk, Laurissa; Wang, Xinyue; Poslad, Stefan

2017-01-01

In an age when people are predisposed to report real-world events through their social media accounts, many researchers value the benefits of mining user generated content from social media. Compared with the traditional news media, social media services, such as Twitter, can provide more complete and timely information about the real-world events. However events are often like a puzzle and in order to solve the puzzle/understand the event, we must identify all the sub-events or pieces. Existing Twitter event monitoring systems for sub-event detection and summarization currently typically analyse events based on partial data as conventional data collection methodologies are unable to collect comprehensive event data. This results in existing systems often being unable to report sub-events in real-time and often in completely missing sub-events or pieces in the broader event puzzle. This paper proposes a Sub-event detection by real-TIme Microblog monitoring (STRIM) framework that leverages the temporal feature of an expanded set of news-worthy event content. In order to more comprehensively and accurately identify sub-events this framework first proposes the use of adaptive microblog crawling. Our adaptive microblog crawler is capable of increasing the coverage of events while minimizing the amount of non-relevant content. We then propose a stream division methodology that can be accomplished in real time so that the temporal features of the expanded event streams can be analysed by a burst detection algorithm. In the final steps of the framework, the content features are extracted from each divided stream and recombined to provide a final summarization of the sub-events. The proposed framework is evaluated against traditional event detection using event recall and event precision metrics. Results show that improving the quality and coverage of event contents contribute to better event detection by identifying additional valid sub-events. The novel combination of our proposed adaptive crawler and our stream division/recombination technique provides significant gains in event recall (44.44%) and event precision (9.57%). The addition of these sub-events or pieces, allows us to get closer to solving the event puzzle. PMID:29107976

Piecing together the puzzle: Improving event content coverage for real-time sub-event detection using adaptive microblog crawling.

PubMed

Tokarchuk, Laurissa; Wang, Xinyue; Poslad, Stefan

2017-01-01

In an age when people are predisposed to report real-world events through their social media accounts, many researchers value the benefits of mining user generated content from social media. Compared with the traditional news media, social media services, such as Twitter, can provide more complete and timely information about the real-world events. However events are often like a puzzle and in order to solve the puzzle/understand the event, we must identify all the sub-events or pieces. Existing Twitter event monitoring systems for sub-event detection and summarization currently typically analyse events based on partial data as conventional data collection methodologies are unable to collect comprehensive event data. This results in existing systems often being unable to report sub-events in real-time and often in completely missing sub-events or pieces in the broader event puzzle. This paper proposes a Sub-event detection by real-TIme Microblog monitoring (STRIM) framework that leverages the temporal feature of an expanded set of news-worthy event content. In order to more comprehensively and accurately identify sub-events this framework first proposes the use of adaptive microblog crawling. Our adaptive microblog crawler is capable of increasing the coverage of events while minimizing the amount of non-relevant content. We then propose a stream division methodology that can be accomplished in real time so that the temporal features of the expanded event streams can be analysed by a burst detection algorithm. In the final steps of the framework, the content features are extracted from each divided stream and recombined to provide a final summarization of the sub-events. The proposed framework is evaluated against traditional event detection using event recall and event precision metrics. Results show that improving the quality and coverage of event contents contribute to better event detection by identifying additional valid sub-events. The novel combination of our proposed adaptive crawler and our stream division/recombination technique provides significant gains in event recall (44.44%) and event precision (9.57%). The addition of these sub-events or pieces, allows us to get closer to solving the event puzzle.

Event-Based Surveillance During EXPO Milan 2015: Rationale, Tools, Procedures, and Initial Results

PubMed Central

Manso, Martina Del; Caporali, Maria Grazia; Napoli, Christian; Linge, Jens P.; Mantica, Eleonora; Verile, Marco; Piatti, Alessandra; Pompa, Maria Grazia; Vellucci, Loredana; Costanzo, Virgilio; Bastiampillai, Anan Judina; Gabrielli, Eugenia; Gramegna, Maria; Declich, Silvia

2016-01-01

More than 21 million participants attended EXPO Milan from May to October 2015, making it one of the largest protracted mass gathering events in Europe. Given the expected national and international population movement and health security issues associated with this event, Italy fully implemented, for the first time, an event-based surveillance (EBS) system focusing on naturally occurring infectious diseases and the monitoring of biological agents with potential for intentional release. The system started its pilot phase in March 2015 and was fully operational between April and November 2015. In order to set the specific objectives of the EBS system, and its complementary role to indicator-based surveillance, we defined a list of priority diseases and conditions. This list was designed on the basis of the probability and possible public health impact of infectious disease transmission, existing statutory surveillance systems in place, and any surveillance enhancements during the mass gathering event. This article reports the methodology used to design the EBS system for EXPO Milan and the results of 8 months of surveillance. PMID:27314656

Evaluation of Epidemic Intelligence Systems Integrated in the Early Alerting and Reporting Project for the Detection of A/H5N1 Influenza Events

PubMed Central

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; on behalf of the Early Alerting, Reporting Project of the Global Health Security Initiative

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. PMID:23472077

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

PubMed

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.

Protecting the Homeland Report of the Defense Science Board Task Force on Defensive Information Operations. 2000 Summer Study. Volume II

DTIC Science & Technology

2001-03-01

between attacks and other events such as accidents, system failures, or hacking by thrill-seekers. This challenge is exacerbated by the speed of events in...International Telegraph and Telephone (CCITT) international standards body and is referred to as Signaling System # 7 ( SS7 ). Commerc" I Intelligent...point to fixed infrastructure "" Signaling Transfer Point (STP) - Packet switch in CCITT#7 Network STP ... SS7 * System Data Bases i Network

DoD Biometrics Collaboration Forum 25-27 Jan 2011. Event Report

DTIC Science & Technology

2011-03-01

GS-15 Level Staffing Marine Corps Action Tracking System ( MCATS ) Entered Staffing 21 December 2010 HQ USMC Receiving Staff Comments GO...SES Level Staffing MCATS TBD HQ USMC Assistant Commandant of the TBD HQ USMC 2011 DoD Biometrics Collaboration Forum Event Report 13...O-6/GS-15 Staffing MCATS Late March 2011 HQ USMC GO/SES Staffing MCATS Early April 2011 HQ USMC ACMC Signature TBD HQ USMC USMC

Decontamination of Subway Railcar and Related Materials ...

EPA Pesticide Factsheets

Report In the event of a biological incident in a transportation hub such as a subway system, effective remediation of railcars, subway tunnels and stations will require the use of various decontamination approaches. One potential decontamination tool that could be used in such an event is the fogging of sporicidal liquids. The study described in this report builds on previous fogging decontamination research, but with a focus on decontaminating subway railcars and related materials.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

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 themore » 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).« less

The Climate Science Special Report: Detection and Attribution

NASA Astrophysics Data System (ADS)

Wehner, M. F.

2017-12-01

The Climate Science Special Report reiterates previous findings about the human influence on global mean surface air temperature with the statement "…it is extremely likely that human activities, especially emissions of greenhouse gases, are the dominant cause of the observed warming since the mid 20th century. For the warming over the last century, there is no convincing alternative explanation supported by the extent of the observational evidence." This is a statement made with high confidence and supported by multiple lines of evidence. The report also assesses the latest developments in the field of probabilistic extreme event attribution—the quantification of the influence of anthropogenic climate change on individual extreme weather events—with a focus on those recent events within the United States that have been analyzed. Thirty different events within the US are reported on including heat waves, cold snaps, wet seasons, individual storms and droughts. Most but not all of the individual US events studied revealed an influence from human induced changes to the climate system.

Personal Electronic Devices and Their Interference with Aircraft Systems

NASA Technical Reports Server (NTRS)

Ross, Elden; Ely, Jay J. (Technical Monitor)

2001-01-01

A compilation of data on personal electronic devices (PEDs) attributed to having created anomalies with aircraft systems. Charts and tables display 14 years of incidents reported by pilots to the Aviation Safety Reporting System (ASRS). Affected systems, incident severity, sources of anomaly detection, and the most frequently identified PEDs are some of the more significant data. Several reports contain incidents of aircraft off course when all systems indicated on course and of critical events that occurred during landings and takeoffs. Additionally, PEDs that should receive priority in testing are identified.

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

PubMed

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.

Developmental regression and autism reported to the Vaccine Adverse Event Reporting System.

PubMed

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

2007-07-01

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 child's developmental history. Medical record review indicated that 27 of 31 (87%) children had autism/ASD and 19 (61.3%) had evidence of developmental regression (loss of social, language, or motor skills). The proportion of VAERS cases of autism with regression was greater than that reported in population-based studies, based on the subset of VAERS cases with medical record confirmation. This difference may reflect preferential reporting to VAERS of autism with regression. In other respects, the children in this study appear to be similar to other children with autism. Further research might determine whether the pathogenesis of autism with developmental regression differs from that of autism without regression.

Using Knowledge Base for Event-Driven Scheduling of Web Monitoring Systems

NASA Astrophysics Data System (ADS)

Kim, Yang Sok; Kang, Sung Won; Kang, Byeong Ho; Compton, Paul

Web monitoring systems report any changes to their target web pages by revisiting them frequently. As they operate under significant resource constraints, it is essential to minimize revisits while ensuring minimal delay and maximum coverage. Various statistical scheduling methods have been proposed to resolve this problem; however, they are static and cannot easily cope with events in the real world. This paper proposes a new scheduling method that manages unpredictable events. An MCRDR (Multiple Classification Ripple-Down Rules) document classification knowledge base was reused to detect events and to initiate a prompt web monitoring process independent of a static monitoring schedule. Our experiment demonstrates that the approach improves monitoring efficiency significantly.

Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.

PubMed

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.

Risk management in dermatology: an analysis of data available from several British-based reporting systems.

PubMed

Gawkrodger, D J

2011-03-01

The elimination or reduction of risk is a prime requirement of all healthcare workers. The matter has come to the fore in dermatological practice recently with the widespread use of effective drugs that have significant side-effects (e.g. retinoids, cytotoxic drugs, biologics), the increase in skin surgery, especially for skin cancer, and the extensive use of phototherapies. To examine the available database from different agencies to which adverse events may be reported over at least a 5-year time frame, categorize the risks, look forward to where as yet unidentified risks might exist, and draw conclusions to improve the safety of dermatological practice. This work came about through a request from the National Patient Safety Agency [to the Joint Specialty Committee of the British Association of Dermatologists (BAD) and Royal College of Physicians] for information on risks to patients receiving treatment or investigation for skin disease. Organizations in the U.K. that receive information about adverse events, whether caused by drugs or procedures in dermatological treatments, were approached for information about reported events over a 5-year (or, in one case, 10-year) time frame up to 2009. Data were received from the National Patient Safety Agency, the Medicines and Healthcare Products Regulatory Agency, the National Health Service Litigation Authority, the Medical Protection Society and the Medical Defence Union. In addition, the results of a survey conducted in 2010 by the BAD of its members concerning potential critical incident reporting were included. The received information was analysed according to category of event and conclusions drawn about how best to manage the risks that were identified. Adverse events were divided into the following categories, listed in order of the number of reports received: drug side-effects (biologics and retinoids), phototherapy dosage, drug monitoring (including initial screening), pregnancy prevention programmes, skin cancer follow-up (including acting on reports), dermatopathological reporting and conduct of dermatological surgery (including management of complications, equipment problems, use of lasers, cosmetic procedures and cryotherapy). Critical incidents reported by BAD members often concerned follow-up failures, e.g. of patients receiving systemic drugs or of those with skin cancer. Several of the reported adverse events concern systemic failures. Recommendations for risk reduction include the following points: better systems for drug monitoring (including regularity of attendance, provision of sufficient follow-up appointments, acting on results and adequacy of pregnancy prevention programmes); staff training and record keeping for phototherapy; acting on skin cancer multidisciplinary team meeting outcomes (including provision of sufficient follow-up appointments); and adequate training of staff in dermatological surgery including cryotherapy. Regular monitoring of the occurrence of such reports is needed to ensure safe practice and to identify early areas of new risk. © 2011 The Author. BJD © 2011 British Association of Dermatologists.

Hierarchy of temporal responses of multivariate self-excited epidemic processes

NASA Astrophysics Data System (ADS)

Saichev, Alexander; Maillart, Thomas; Sornette, Didier

2013-04-01

Many natural and social systems are characterized by bursty dynamics, for which past events trigger future activity. These systems can be modelled by so-called self-excited Hawkes conditional Poisson processes. It is generally assumed that all events have similar triggering abilities. However, some systems exhibit heterogeneity and clusters with possibly different intra- and inter-triggering, which can be accounted for by generalization into the "multivariate" self-excited Hawkes conditional Poisson processes. We develop the general formalism of the multivariate moment generating function for the cumulative number of first-generation and of all generation events triggered by a given mother event (the "shock") as a function of the current time t. This corresponds to studying the response function of the process. A variety of different systems have been analyzed. In particular, for systems in which triggering between events of different types proceeds through a one-dimension directed or symmetric chain of influence in type space, we report a novel hierarchy of intermediate asymptotic power law decays ˜ 1/ t 1-( m+1) θ of the rate of triggered events as a function of the distance m of the events to the initial shock in the type space, where 0 < θ < 1 for the relevant long-memory processes characterizing many natural and social systems. The richness of the generated time dynamics comes from the cascades of intermediate events of possibly different kinds, unfolding via random changes of types genealogy.

Arden Syntax Clinical Foundation Framework for Event Monitoring in Intensive Care Units: Report on a Pilot Study.

PubMed

de Bruin, Jeroen S; Zeckl, Julia; Adlassnig, Katharina; Blacky, Alexander; Koller, Walter; Rappelsberger, Andrea; Adlassnig, Klaus-Peter

2017-01-01

The creation of clinical decision support systems has received a strong impulse over the last years, but their integration into a clinical routine has lagged behind, partly due to a lack of interoperability and trust by physicians. We report on the implementation of a clinical foundation framework in Arden Syntax, comprising knowledge units for (a) preprocessing raw clinical data, (b) the determination of single clinical concepts, and (c) more complex medical knowledge, which can be modeled through the composition and configuration of knowledge units in this framework. Thus, it can be tailored to clinical institutions or patients' caregivers. In the present version, we integrated knowledge units for several infection-related clinical concepts into the framework and developed a clinical event monitoring system over the framework that employs three different scenarios for monitoring clinical signs of bloodstream infection. The clinical event monitoring system was tested using data from intensive care units at Vienna General Hospital, Austria.

Atlanta Centennial Olympic Games and Paralympic Games event study, 1996. Final report, July 1996--August 1996

DOE Office of Scientific and Technical Information (OSTI.GOV)

Amodei, R.; Bard, E.; Brong, B.

1998-11-01

The Atlanta metropolitan region was the location of one of the most ambitious Intelligent Transportation Systems (ITS) deployments in the United States. This deployment included several individual projects--a Central Transportation Management Center (TMC), six Traffic Control Centers (TCCs), one Transit Information Center (TIC), The Travel Information Showcase (TIS), and the extension of the Metropolitan Atlanta Rapid Transit Authority (MARTA) Rail network and the new high-occupancy vehicle (HOV) lanes on I-85 and I-75. The 1996 Atlanta Centennial Olympic Games and Paralympic Games created a focus for these projects. All of these systems were to be brought on-line in time for themore » Olympic Games. This report presents the findings of the 1996 Olympic and Paralympic Games Events Study--a compilation of findings of system performance, the benefits realized, and the lessons learned during their operations over the event period. The study assessed the performance of the various Travel Demand Management (TDM) plans employed for Olympic Games traffic management.« less

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

PubMed

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.

Automatic signal extraction, prioritizing and filtering approaches in detecting post-marketing cardiovascular events associated with targeted cancer drugs from the FDA Adverse Event Reporting System (FAERS).

PubMed

Xu, Rong; Wang, Quanqiu

2014-02-01

Targeted drugs dramatically improve the treatment outcomes in cancer patients; however, these innovative drugs are often associated with unexpectedly high cardiovascular toxicity. Currently, cardiovascular safety represents both a challenging issue for drug developers, regulators, researchers, and clinicians and a concern for patients. While FDA drug labels have captured many of these events, spontaneous reporting systems are a main source for post-marketing drug safety surveillance in 'real-world' (outside of clinical trials) cancer patients. In this study, we present approaches to extracting, prioritizing, filtering, and confirming cardiovascular events associated with targeted cancer drugs from the FDA Adverse Event Reporting System (FAERS). The dataset includes records of 4,285,097 patients from FAERS. We first extracted drug-cardiovascular event (drug-CV) pairs from FAERS through named entity recognition and mapping processes. We then compared six ranking algorithms in prioritizing true positive signals among extracted pairs using known drug-CV pairs derived from FDA drug labels. We also developed three filtering algorithms to further improve precision. Finally, we manually validated extracted drug-CV pairs using 21 million published MEDLINE records. We extracted a total of 11,173 drug-CV pairs from FAERS. We showed that ranking by frequency is significantly more effective than by the five standard signal detection methods (246% improvement in precision for top-ranked pairs). The filtering algorithm we developed further improved overall precision by 91.3%. By manual curation using literature evidence, we show that about 51.9% of the 617 drug-CV pairs that appeared in both FAERS and MEDLINE sentences are true positives. In addition, 80.6% of these positive pairs have not been captured by FDA drug labeling. The unique drug-CV association dataset that we created based on FAERS could facilitate our understanding and prediction of cardiotoxic events associated with targeted cancer drugs. Copyright © 2013 Elsevier Inc. All rights reserved.

Systemic Vulnerabilities to Suicide among Veterans from the Iraq and Afghanistan Conflicts: Review of Case Reports from a National Veterans Affairs Database

ERIC Educational Resources Information Center

Mills, Peter D.; Huber, Samuel J.; Watts, Bradley Vince; Bagian, James P.

2011-01-01

While suicide among recently returned veterans is of great concern, it is a relatively rare occurrence within individual hospitals and clinics. Root cause analysis (RCA) generates a detailed case report that can be used to identify system-based vulnerabilities following an adverse event. Review of a national database of RCA reports may identify…

Comparing data mining methods on the VAERS database.

PubMed

Banks, David; Woo, Emily Jane; Burwen, Dale R; Perucci, Phil; Braun, M Miles; Ball, Robert

2005-09-01

Data mining may enhance traditional surveillance of vaccine adverse events by identifying events that are reported more commonly after administering one vaccine than other vaccines. Data mining methods find signals as the proportion of times a condition or group of conditions is reported soon after the administration of a vaccine; thus it is a relative proportion compared across vaccines, and not an absolute rate for the condition. The Vaccine Adverse Event Reporting System (VAERS) contains approximately 150 000 reports of adverse events that are possibly associated with vaccine administration. We studied four data mining techniques: empirical Bayes geometric mean (EBGM), lower-bound of the EBGM's 90% confidence interval (EB05), proportional reporting ratio (PRR), and screened PRR (SPRR). We applied these to the VAERS database and compared the agreement among methods and other performance properties, particularly focusing on the vaccine-event combinations with the highest numerical scores in the various methods. The vaccine-event combinations with the highest numerical scores varied substantially among the methods. Not all combinations representing known associations appeared in the top 100 vaccine-event pairs for all methods. The four methods differ in their ranking of vaccine-COSTART pairs. A given method may be superior in certain situations but inferior in others. This paper examines the statistical relationships among the four estimators. Determining which method is best for public health will require additional analysis that focuses on the true alarm and false alarm rates using known vaccine-event associations. Evaluating the properties of these data mining methods will help determine the value of such methods in vaccine safety surveillance. (c) 2005 John Wiley & Sons, Ltd.

TU-CD-BRD-02: Henry Ford Hospital System Experience, with Focus On Motivating and Reviewing

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miller, B.

It has long been standard practice in radiation oncology to report internally when a patient’s treatment has not gone as planned and to report events to regulatory agencies when legally required. Most potential errors are caught early and never affect the patient. Quality assurance steps routinely prevent errors from reaching the patient, and these “near misses” are much more frequent than treatment errors. A growing number of radiation oncology facilities have implemented incident learning systems to report and analyze both errors and near misses. Using the term “incident learning” instead of “event reporting” emphasizes the need to use these experiencesmore » to change the practice and make future errors less likely and promote an educational, non-punitive environment. There are challenges in making such a system practical and effective. Speakers from institutions of different sizes and practice environments will share their experiences on how to make such a system work and what benefits their clinics have accrued. Questions that will be addressed include: How to create a system that is easy for front line staff to access How to motivate staff to report How to promote the system as positive and educational and not punitive or demeaning How to organize the team for reviewing and responding to reports How to prioritize which reports to discuss in depth How not to dismiss the rest How to identify underlying causes How to design corrective actions and implement change How to develop useful statistics and analysis tools How to coordinate a departmental system with a larger risk management system How to do this without a dedicated quality manager Some speakers’ experience is with in-house systems and some will share experience with the AAPM/ASTRO national Radiation Oncology Incident Learning System (RO-ILS). Reports intended to be of value nationally need to be comprehensible to outsiders; examples of useful reports will be shown. There will be ample time set aside for audience members to contribute to the discussion. Learning Objectives: Learn how to promote the use of an incident learning system in a clinic. Learn how to convert “event reporting” into “incident learning”. See examples of practice changes that have come out of learning systems. Learn how the RO-ILS system can be used as a primary internal learning system. Learn how to create succinct, meaningful reports useful to outside readers. Gary Ezzell chairs the AAPM committee overseeing RO-ILS and has received an honorarium from ASTRO for working on the committee reviewing RO-ILS reports. Derek Brown is a director of http://TreatSafely.org . Brett Miller has previously received travel expenses and an honorarium from Varian. Phillip Beron has nothing to report.« less

Asking the right questions to get the right answers: using cognitive interviews to review the acceptability, comprehension and clinical meaningfulness of patient self-report adverse event items in oncology patients.

PubMed

Holch, Patricia; Warrington, Lorraine; Potrata, Barbara; Ziegler, Lucy; Hector, Ceri; Keding, Ada; Harley, Clare; Absolom, Kate; Morris, Carolyn; Bamforth, Leon; Velikova, Galina

Standardized reporting of treatment-related adverse events (AE) is essential in clinical trials, usually achieved by using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) reported by clinicians. Patient-reported adverse events (PRAE) may add value to clinician assessments, providing patient perspective on subjective toxicity. We developed an online patient symptom report and self-management system for real-time reporting and managing AE during cancer treatment integrated with electronic patient records (eRAPID). As part of this program we developed a patient version of the CTCAE (version 4.0), rephrasing terminology into a self-report format. We explored patient understanding of these items via cognitive interviews. Sixty patients (33 female, 27 male) undergoing treatment were purposively sampled by age, gender and tumor group (median age 61.5, range 35-84, 12 breast, 12 gynecological, 13 colorectal, 12 lung and 11 renal). Twenty-one PRAE items were completed on a touch-screen computer. Subsequent audio-recorded cognitive interviews and thematic analysis explored patients' comprehension of items via verbal probing techniques during three interview rounds (n = 20 patients/round). In total 33 item amendments were made; 29% related to question comprehension, 68% response option and 3% order effects. These amendments to phrasing and language improved patient understanding but maintained CTCAE grading and key medical information. Changes were endorsed by members of a patient advisory group (N = 11). Item adaptations resulted in a bank of consistently interpreted self-report AE items for use in future research program. In-depth analysis of items through cognitive interviews is an important step towards developing an internationally valid system for PRAE, thus improving patient safety and experiences during cancer treatment.

Incident learning in pursuit of high reliability: implementing a comprehensive, low-threshold reporting program in a large, multisite radiation oncology department.

PubMed

Gabriel, Peter E; Volz, Edna; Bergendahl, Howard W; Burke, Sean V; Solberg, Timothy D; Maity, Amit; Hahn, Stephen M

2015-04-01

Incident learning programs have been recognized as cornerstones of safety and quality assurance in so-called high reliability organizations in industries such as aviation and nuclear power. High reliability organizations are distinguished by their drive to continuously identify and proactively address a broad spectrum of latent safety issues. Many radiation oncology institutions have reported on their experience in tracking and analyzing adverse events and near misses but few have incorporated the principles of high reliability into their programs. Most programs have focused on the reporting and retrospective analysis of a relatively small number of significant adverse events and near misses. To advance a large, multisite radiation oncology department toward high reliability, a comprehensive, cost-effective, electronic condition reporting program was launched to enable the identification of a broad spectrum of latent system failures, which would then be addressed through a continuous quality improvement process. A comprehensive program, including policies, work flows, and information system, was designed and implemented, with use of a low reporting threshold to focus on precursors to adverse events. In a 46-month period from March 2011 through December 2014, a total of 8,504 conditions (average, 185 per month, 1 per patient treated, 3.9 per 100 fractions [individual treatments]) were reported. Some 77.9% of clinical staff members reported at least 1 condition. Ninety-eight percent of conditions were classified in the lowest two of four severity levels, providing the opportunity to address conditions before they contribute to adverse events. Results after approximately four years show excellent employee engagement, a sustained rate of reporting, and a focus on low-level issues leading to proactive quality improvement interventions.

Reporting of adverse events following immunizations in Ghana - Using disproportionality analysis reporting ratios.

PubMed

Ankrah, Daniel N A; Darko, Delese M; Sabblah, George; Mantel-Teeuwisse, Aukje; Leufkens, Hubert M G

2018-01-02

Timely reporting of safety information post vaccination is pivotal for the success of any vaccination program. Reports of adverse events following immunization (AEFI) of 6 different vaccinations from Ghana were analysed for signals. De-identified data from active surveillance for AEFIs after 2009 AH1N1 influenza, yellow fever, meningitis, measles-rubella, pneumococcal-rotavirus and human papilloma virus vaccinations were used. All vaccinations occurred between January 2010 and December 2013. The ten most occurring events for each vaccination were captured and arranged using Medical Dictionary for Regulatory Authorities (MedDRA) Preferred Term (PT) and System Organ Classification (SOC) codes. Adverse event incidence rates were calculated for each vaccine type, and signals were generated using proportional reporting ratios (PRR). A total number of 5,141 reports were analysed ranging from 33 (human papilloma virus) to 1958 (measles-rubella). Between 22% and 55% of all AEFIs per vaccine type were collected on the day of vaccination. For each vaccine type, at least 87% of all reported AEFIs occurred in the first 7 days post-vaccination. Multiple reports were received per vaccine type. For the MR vaccine, urticarial recorded the highest attack rate of 6.6 (95% CI 6.2, 7.1) per 100,000 vaccines. The AEFI with the highest PRR for both human papilloma and measles-rubella vaccines was abdominal pain, recording a PRR of 8.15 (95% CI 3.46, 19.23) and 43.75 (95% CI 17.81, 107.45) respectively. These results underscore the competency of public health systems in sub-Saharan African countries (like Ghana) to identify most frequently occurring and important vaccine related safety issues.

Impact of an Event Reporting System on Resident Complication Reporting in Plastic Surgery Training: Addressing an ACGME and Plastic Surgery Milestone Project Core Competency.

PubMed

Parikh, Rajiv P; Snyder-Warwick, Alison; Naidoo, Sybill; Skolnick, Gary B; Patel, Kamlesh B

2017-11-01

The Accreditation Council for Graduate Medical Education and Plastic Surgery Milestone Project has identified practice-based learning and improvement, which involves systematically analyzing current practices and implementing changes, as a core competency in residency education. In surgical care, complication reporting is an essential component of practice-based learning and improvement as complications are analyzed in morbidity and mortality conference for quality improvement. Unfortunately, current methods for capturing a comprehensive profile of complications may significantly underestimate the true occurrence of complications. Therefore, the objectives of this study are to evaluate an intervention for complication reporting and compare this to current practice, in a plastic surgery training program. This is a preintervention and postintervention study evaluating resident reporting of complications on a plastic surgery service. The intervention was an online event reporting system developed by department leadership and patient safety experts. The cohorts consisted of all patients undergoing surgery during two separate 3-month blocks bridged by an implementation period. A trained reviewer recorded complications, and this served as the reference standard. Fisher's exact test was used for binary comparisons. There were 32 complications detected in 219 patients from June to August of 2015 and 35 complications in 202 patients from October to December of 2015. The proportion of complications reported in the preintervention group was nine of 32 (28.1 percent). After the intervention, this significantly increased to 32 of 35 (91.4 percent) (p < 0.001). An intervention using an event reporting system, supported by departmental leadership, led to significant improvements in complication reporting by plastic surgery residents.

Emergence of event cascades in inhomogeneous networks

NASA Astrophysics Data System (ADS)

Onaga, Tomokatsu; Shinomoto, Shigeru

2016-09-01

There is a commonality among contagious diseases, tweets, and neuronal firings that past events facilitate the future occurrence of events. The spread of events has been extensively studied such that the systems exhibit catastrophic chain reactions if the interaction represented by the ratio of reproduction exceeds unity; however, their subthreshold states are not fully understood. Here, we report that these systems are possessed by nonstationary cascades of event-occurrences already in the subthreshold regime. Event cascades can be harmful in some contexts, when the peak-demand causes vaccine shortages, heavy traffic on communication lines, but may be beneficial in other contexts, such that spontaneous activity in neural networks may be used to generate motion or store memory. Thus it is important to comprehend the mechanism by which such cascades appear, and consider controlling a system to tame or facilitate fluctuations in the event-occurrences. The critical interaction for the emergence of cascades depends greatly on the network structure in which individuals are connected. We demonstrate that we can predict whether cascades may emerge, given information about the interactions between individuals. Furthermore, we develop a method of reallocating connections among individuals so that event cascades may be either impeded or impelled in a network.

Variations of System IV period of the sulfur ions in the Io torus for the volcanic event in 2015 observed by the HISAKI/EXCEED

NASA Astrophysics Data System (ADS)

Ryo, A.; Misawa, H.; Tsuchiya, F.; Kagitani, M.; Yoshioka, K.; Yoshikawa, I.; Kimura, T.; Murakami, G.; Yamazaki, A.

2017-12-01

Previous ground-based and probe observations of Io plasma torus (IPT) in various wavelengths have detected a periodic variation which is longer than System III period (9.925 h). It has been called System IV period. Although various ideas to explain the origin of System IV period are proposed , little progress has been made. A previous study reported that the System IV period was 10.07 h during the Cassini's Jupiter flyby in 2000. This period was shorter than the typical period of 10.21h (Brown 1995). The Io's volcanic event just before Cassini's flyby might shorten the System IV period (Steffl et al., 2006). However, the certainty of this inference is not clear from the Cassini observation. Here, we analyzed time variations in intensities of EUV emissions from IPT obtained by the HISAKI satellite to understand the mechanism responsible for the System IV period and the influence of Io's volcanic event on IPT. The data used in this study was obtained from Dec. 2014 to the middle of May 2015. During this period, the Io's volcanic event from Jan. to Mar. 2015 was reported from the observation of Iogenic sodium emission (Yoneda et al., 2015). To find variations of the System IV period, the temporal variation of System III longitude at peak EUV intensity was derived by fitting light curves of three ion species (S II 76.5 nm + 126 nm, S III 68 nm, and S IV 65.7 nm + 140.5 nm). The System IV periods of S II before and after the Io's volcanic event were 10.16±0.008 h and 10.03±0.006 h, respectively. On the other hands, the System IV period of S II was 9.95±0.003 h during the Io's volcanic event. This is the first observational evidence which shows that the System IV period has shortened during the Io's volcanic event, which is consistent with the result from Cassini observation. Origin of the System IV period has been discussed with sub-corotation of plasma in IPT. Since the sub-corotation occurs due to mass loading of newly picked-up ions into IPT, it is expected that the System IV period becomes long during Io's volcanic event. However, the result shows the opposite feature and will give important information to constrain the origin of the System IV period. To verify above consideration, we will derive time variation in plasma parameters in IPT from the HISAKI data with plasma diagnosis analysis. This analysis will enable us to constrain the origin of the System IV period.

Can Natural Language Processing Improve the Efficiency of Vaccine Adverse Event Report Review?

PubMed

Baer, B; Nguyen, M; Woo, E J; Winiecki, S; Scott, J; Martin, D; Botsis, T; Ball, R

2016-01-01

Individual case review of spontaneous adverse event (AE) reports remains a cornerstone of medical product safety surveillance for industry and regulators. Previously we developed the Vaccine Adverse Event Text Miner (VaeTM) to offer automated information extraction and potentially accelerate the evaluation of large volumes of unstructured data and facilitate signal detection. To assess how the information extraction performed by VaeTM impacts the accuracy of a medical expert's review of the vaccine adverse event report. The "outcome of interest" (diagnosis, cause of death, second level diagnosis), "onset time," and "alternative explanations" (drug, medical and family history) for the adverse event were extracted from 1000 reports from the Vaccine Adverse Event Reporting System (VAERS) using the VaeTM system. We compared the human interpretation, by medical experts, of the VaeTM extracted data with their interpretation of the traditional full text reports for these three variables. Two experienced clinicians alternately reviewed text miner output and full text. A third clinician scored the match rate using a predefined algorithm; the proportion of matches and 95% confidence intervals (CI) were calculated. Review time per report was analyzed. Proportion of matches between the interpretation of the VaeTM extracted data, compared to the interpretation of the full text: 93% for outcome of interest (95% CI: 91-94%) and 78% for alternative explanation (95% CI: 75-81%). Extracted data on the time to onset was used in 14% of cases and was a match in 54% (95% CI: 46-63%) of those cases. When supported by structured time data from reports, the match for time to onset was 79% (95% CI: 76-81%). The extracted text averaged 136 (74%) fewer words, resulting in a mean reduction in review time of 50 (58%) seconds per report. Despite a 74% reduction in words, the clinical conclusion from VaeTM extracted data agreed with the full text in 93% and 78% of reports for the outcome of interest and alternative explanation, respectively. The limited amount of extracted time interval data indicates the need for further development of this feature. VaeTM may improve review efficiency, but further study is needed to determine if this level of agreement is sufficient for routine use.

The Use of Categorized Time-Trend Reporting of Radiation Oncology Incidents: A Proactive Analytical Approach to Improving Quality and Safety Over Time

DOE Office of Scientific and Technical Information (OSTI.GOV)

Arnold, Anthony, E-mail: anthony.arnold@sesiahs.health.nsw.gov.a; Delaney, Geoff P.; Cassapi, Lynette

Purpose: Radiotherapy is a common treatment for cancer patients. Although incidence of error is low, errors can be severe or affect significant numbers of patients. In addition, errors will often not manifest until long periods after treatment. This study describes the development of an incident reporting tool that allows categorical analysis and time trend reporting, covering first 3 years of use. Methods and Materials: A radiotherapy-specific incident analysis system was established. Staff members were encouraged to report actual errors and near-miss events detected at prescription, simulation, planning, or treatment phases of radiotherapy delivery. Trend reporting was reviewed monthly. Results: Reportsmore » were analyzed for the first 3 years of operation (May 2004-2007). A total of 688 reports was received during the study period. The actual error rate was 0.2% per treatment episode. During the study period, the actual error rates reduced significantly from 1% per year to 0.3% per year (p < 0.001), as did the total event report rates (p < 0.0001). There were 3.5 times as many near misses reported compared with actual errors. Conclusions: This system has allowed real-time analysis of events within a radiation oncology department to a reduced error rate through focus on learning and prevention from the near-miss reports. Plans are underway to develop this reporting tool for Australia and New Zealand.« less

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010-2015.

PubMed

Alshammari, Thamir M; Ata, Sondus I; Mahmoud, Mansour Adam; Alhawassi, Tariq M; Aljadhey, Hisham S

2018-01-01

To analyze and compare the signals of bleeding from the use of direct-acting oral anticoagulants (DOACs) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database over 5 years. Reports of bleeding and of events with related terms submitted to the FAERS between October 2010 and September 2015 were retrieved and then analyzed using the reporting odds ratio (ROR). The signals of bleeding associated with DOAC use were compared with the signals of bleeding associated with warfarin use utilizing the FAERS databases. A total of 1,518 reports linked dabigatran to bleeding, accounting for 2.7% of all dabigatran-related reports, whereas 93 reports linked rivaroxaban to bleeding, which accounted for 4.4% of all rivaroxaban-related reports. The concurrent proportion of bleeding-related reports for warfarin was 3.6%, with a total of 654 reports. The association of bleeding and of related terms with the use of all three medications was significant, albeit with different degrees of association. The ROR was 12.30 (95% confidence interval [CI] 11.65-12.97) for dabigatran, 15.61 (95% CI 14.42-16.90) for warfarin, and 18.86 (95% CI 15.31-23.23) for rivaroxaban. The signals of bleeding varied among the DOACs, and the bleeding signal was higher for rivaroxaban and lower for dabigatran compared to that for warfarin.

Causality Assessment of Serious Neurologic Adverse Events Following 2009 H1N1 Vaccination

PubMed Central

Williams, S Elizabeth; Pahud, Barbara A; Vellozzi, Claudia; Donofrio, Peter D; Dekker, Cornelia L; Halsey, Neal; Klein, Nicola P; Baxter, Roger P; Marchant, Colin D; LaRussa, Philip S; Barnett, Elizabeth D; Tokars, Jerome I; McGeeney, Brian E; Sparks, Robert C; Aukes, Laurie L.; Jakob, Kathleen; Coronel, Silvia; Sejvar, James J; Slade, Barbara A; Edwards, Kathryn M

2016-01-01

Background Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009–10 influenza season. Investigators in the Clinical Immunization Safety Assessment (CISA) Network sought to characterize these SAEs and to assess their possible causal relationship to vaccination. Methods Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) physicians reviewed all SAE reports (as defined by the Code of Federal Regulations, 21CFR§314.80) after receipt of H1N1 vaccine reported to VAERS between October 1st 2009 and March 31st 2010. Non-fatal SAE reports with neurologic presentation were referred to CISA investigators, who requested and reviewed additional medical records and clinical information as available. CISA investigators assessed the causal relationship between vaccination and the event using modified WHO criteria as defined. Results 212 VAERS reports of non-fatal serious neurological events were referred for CISA review. Case reports were equally distributed by gender (50.9% female) with an age range of 6 months to 83 years (median 38 years). The most frequent diagnoses reviewed were: Guillain-Barré Syndrome (37.3%), seizures (10.8%), cranial neuropathy (5.7%), and acute disseminated encephalomyelitis (3.8%). Causality assessment resulted in classification of 72 events as “possibly” related (33%), 108 as “unlikely” related (51%), and 20 as “unrelated” (9%) to H1N1 vaccination; none were classified as “probable” or “definite” and 12 were unclassifiable (6%). Conclusion The absence of a specific test to indicate whether a vaccine component contributes to the pathogenesis of an event occurring within a biologically plausible time period makes assessing causality difficult. The development of standardized protocols for providers to use in evaluation of adverse events following immunization, and rapid identification and follow-up of VAERS reports could improve causality assessment. PMID:21893148

Commonality of drug-associated adverse events detected by 4 commonly used data mining algorithms.

PubMed

Sakaeda, Toshiyuki; Kadoyama, Kaori; Minami, Keiko; Okuno, Yasushi

2014-01-01

Data mining algorithms have been developed for the quantitative detection of drug-associated adverse events (signals) from a large database on spontaneously reported adverse events. In the present study, the commonality of signals detected by 4 commonly used data mining algorithms was examined. A total of 2,231,029 reports were retrieved from the public release of the US Food and Drug Administration Adverse Event Reporting System database between 2004 and 2009. The deletion of duplicated submissions and revision of arbitrary drug names resulted in a reduction in the number of reports to 1,644,220. Associations with adverse events were analyzed for 16 unrelated drugs, using the proportional reporting ratio (PRR), reporting odds ratio (ROR), information component (IC), and empirical Bayes geometric mean (EBGM). All EBGM-based signals were included in the PRR-based signals as well as IC- or ROR-based ones, and PRR- and IC-based signals were included in ROR-based ones. The PRR scores of PRR-based signals were significantly larger for 15 of 16 drugs when adverse events were also detected as signals by the EBGM method, as were the IC scores of IC-based signals for all drugs; however, no such effect was observed in the ROR scores of ROR-based signals. The EBGM method was the most conservative among the 4 methods examined, which suggested its better suitability for pharmacoepidemiological studies. Further examinations should be performed on the reproducibility of clinical observations, especially for EBGM-based signals.

Improving Pediatric Adverse Drug Event Reporting through Clinical Pharmacy Services

PubMed Central

Crowther, David M.; Buck, Marcia L.; McCarthy, Michelle W.; Barton, Virginia W.

2011-01-01

OBJECTIVES The purpose of this study was to summarize adverse drug event (ADE) reporting and to characterize the type of healthcare practitioners involved in reporting over a 10-year period at a 120-bed university-affiliated children's hospital. METHODS The University of Virginia Children's Hospital ADE database was analyzed for records involving pediatric patients. Data from patients <18 years of age who were admitted to the University of Virginia Children's Hospital between January 1, 2000, and December 31, 2009, were analyzed. Data collected included drug name and therapeutic class of the suspected causative agent, description of the event, severity, causality, outcome, and the type of healthcare practitioner reporting the event. RESULTS A total of 863 ADEs were reported over the 10-year period. The 5 most common types reported were extravasation injury (10%), rash (8%), hypotension (5%), pruritus (5%), and renal failure (3%). A total of 196 (21%) cases were categorized as mild, 436 (47%) cases as moderate, and 296 (32%) cases as severe. Further characterization of extravasations was performed to identify trends relating to potential causes. In 45 (57%) reports, parenteral nutrition was identified as the causative agent. Full recovery was documented in 21 (47%) extravasations. Of the total events reported, 83% were reported by pharmacists, 16% by nurses, and <1% by other healthcare practitioners. CONCLUSIONS Results of this study are consistent with those of previous studies involving ADE reporting in children's hospitals. This consistency is due in part to system design and use of unit-based pharmacists as the primary reporters. PMID:22768013

Using Movement and Intentions to Understand Human Activity

ERIC Educational Resources Information Center

Zacks, Jeffrey M.; Kumar, Shawn; Abrams, Richard A.; Mehta, Ritesh

2009-01-01

During perception, people segment continuous activity into discrete events. They do so in part by monitoring changes in features of an ongoing activity. Characterizing these features is important for theories of event perception and may be helpful for designing information systems. The three experiments reported here asked whether the body…

Effects of catastrophic events on transportation system management and operations : August 2003 northeast blackout, Great Lakes region

DOT National Transportation Integrated Search

2004-05-01

This report documents the actions taken by transportation agencies in response to the August 14, 2003 blackout that affected the Northeastern United States. It is part of a larger effort to examine the impacts of catastrophic events on transportation...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ezzell, G.

It has long been standard practice in radiation oncology to report internally when a patient’s treatment has not gone as planned and to report events to regulatory agencies when legally required. Most potential errors are caught early and never affect the patient. Quality assurance steps routinely prevent errors from reaching the patient, and these “near misses” are much more frequent than treatment errors. A growing number of radiation oncology facilities have implemented incident learning systems to report and analyze both errors and near misses. Using the term “incident learning” instead of “event reporting” emphasizes the need to use these experiencesmore » to change the practice and make future errors less likely and promote an educational, non-punitive environment. There are challenges in making such a system practical and effective. Speakers from institutions of different sizes and practice environments will share their experiences on how to make such a system work and what benefits their clinics have accrued. Questions that will be addressed include: How to create a system that is easy for front line staff to access How to motivate staff to report How to promote the system as positive and educational and not punitive or demeaning How to organize the team for reviewing and responding to reports How to prioritize which reports to discuss in depth How not to dismiss the rest How to identify underlying causes How to design corrective actions and implement change How to develop useful statistics and analysis tools How to coordinate a departmental system with a larger risk management system How to do this without a dedicated quality manager Some speakers’ experience is with in-house systems and some will share experience with the AAPM/ASTRO national Radiation Oncology Incident Learning System (RO-ILS). Reports intended to be of value nationally need to be comprehensible to outsiders; examples of useful reports will be shown. There will be ample time set aside for audience members to contribute to the discussion. Learning Objectives: Learn how to promote the use of an incident learning system in a clinic. Learn how to convert “event reporting” into “incident learning”. See examples of practice changes that have come out of learning systems. Learn how the RO-ILS system can be used as a primary internal learning system. Learn how to create succinct, meaningful reports useful to outside readers. Gary Ezzell chairs the AAPM committee overseeing RO-ILS and has received an honorarium from ASTRO for working on the committee reviewing RO-ILS reports. Derek Brown is a director of http://TreatSafely.org . Brett Miller has previously received travel expenses and an honorarium from Varian. Phillip Beron has nothing to report.« less

TU-CD-BRD-00: Incident Learning / RO-ILS

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

2015-06-15

It has long been standard practice in radiation oncology to report internally when a patient’s treatment has not gone as planned and to report events to regulatory agencies when legally required. Most potential errors are caught early and never affect the patient. Quality assurance steps routinely prevent errors from reaching the patient, and these “near misses” are much more frequent than treatment errors. A growing number of radiation oncology facilities have implemented incident learning systems to report and analyze both errors and near misses. Using the term “incident learning” instead of “event reporting” emphasizes the need to use these experiencesmore » to change the practice and make future errors less likely and promote an educational, non-punitive environment. There are challenges in making such a system practical and effective. Speakers from institutions of different sizes and practice environments will share their experiences on how to make such a system work and what benefits their clinics have accrued. Questions that will be addressed include: How to create a system that is easy for front line staff to access How to motivate staff to report How to promote the system as positive and educational and not punitive or demeaning How to organize the team for reviewing and responding to reports How to prioritize which reports to discuss in depth How not to dismiss the rest How to identify underlying causes How to design corrective actions and implement change How to develop useful statistics and analysis tools How to coordinate a departmental system with a larger risk management system How to do this without a dedicated quality manager Some speakers’ experience is with in-house systems and some will share experience with the AAPM/ASTRO national Radiation Oncology Incident Learning System (RO-ILS). Reports intended to be of value nationally need to be comprehensible to outsiders; examples of useful reports will be shown. There will be ample time set aside for audience members to contribute to the discussion. Learning Objectives: Learn how to promote the use of an incident learning system in a clinic. Learn how to convert “event reporting” into “incident learning”. See examples of practice changes that have come out of learning systems. Learn how the RO-ILS system can be used as a primary internal learning system. Learn how to create succinct, meaningful reports useful to outside readers. Gary Ezzell chairs the AAPM committee overseeing RO-ILS and has received an honorarium from ASTRO for working on the committee reviewing RO-ILS reports. Derek Brown is a director of http://TreatSafely.org . Brett Miller has previously received travel expenses and an honorarium from Varian. Phillip Beron has nothing to report.« less

TU-CD-BRD-04: UCLA Experience, with Focus On Developing Metrics and Using RO-ILS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beron, P.

2015-06-15

It has long been standard practice in radiation oncology to report internally when a patient’s treatment has not gone as planned and to report events to regulatory agencies when legally required. Most potential errors are caught early and never affect the patient. Quality assurance steps routinely prevent errors from reaching the patient, and these “near misses” are much more frequent than treatment errors. A growing number of radiation oncology facilities have implemented incident learning systems to report and analyze both errors and near misses. Using the term “incident learning” instead of “event reporting” emphasizes the need to use these experiencesmore » to change the practice and make future errors less likely and promote an educational, non-punitive environment. There are challenges in making such a system practical and effective. Speakers from institutions of different sizes and practice environments will share their experiences on how to make such a system work and what benefits their clinics have accrued. Questions that will be addressed include: How to create a system that is easy for front line staff to access How to motivate staff to report How to promote the system as positive and educational and not punitive or demeaning How to organize the team for reviewing and responding to reports How to prioritize which reports to discuss in depth How not to dismiss the rest How to identify underlying causes How to design corrective actions and implement change How to develop useful statistics and analysis tools How to coordinate a departmental system with a larger risk management system How to do this without a dedicated quality manager Some speakers’ experience is with in-house systems and some will share experience with the AAPM/ASTRO national Radiation Oncology Incident Learning System (RO-ILS). Reports intended to be of value nationally need to be comprehensible to outsiders; examples of useful reports will be shown. There will be ample time set aside for audience members to contribute to the discussion. Learning Objectives: Learn how to promote the use of an incident learning system in a clinic. Learn how to convert “event reporting” into “incident learning”. See examples of practice changes that have come out of learning systems. Learn how the RO-ILS system can be used as a primary internal learning system. Learn how to create succinct, meaningful reports useful to outside readers. Gary Ezzell chairs the AAPM committee overseeing RO-ILS and has received an honorarium from ASTRO for working on the committee reviewing RO-ILS reports. Derek Brown is a director of http://TreatSafely.org . Brett Miller has previously received travel expenses and an honorarium from Varian. Phillip Beron has nothing to report.« less

TU-CD-BRD-03: UCSD Experience, with Focus On Implementing Change

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brown, D.

2015-06-15

It has long been standard practice in radiation oncology to report internally when a patient’s treatment has not gone as planned and to report events to regulatory agencies when legally required. Most potential errors are caught early and never affect the patient. Quality assurance steps routinely prevent errors from reaching the patient, and these “near misses” are much more frequent than treatment errors. A growing number of radiation oncology facilities have implemented incident learning systems to report and analyze both errors and near misses. Using the term “incident learning” instead of “event reporting” emphasizes the need to use these experiencesmore » to change the practice and make future errors less likely and promote an educational, non-punitive environment. There are challenges in making such a system practical and effective. Speakers from institutions of different sizes and practice environments will share their experiences on how to make such a system work and what benefits their clinics have accrued. Questions that will be addressed include: How to create a system that is easy for front line staff to access How to motivate staff to report How to promote the system as positive and educational and not punitive or demeaning How to organize the team for reviewing and responding to reports How to prioritize which reports to discuss in depth How not to dismiss the rest How to identify underlying causes How to design corrective actions and implement change How to develop useful statistics and analysis tools How to coordinate a departmental system with a larger risk management system How to do this without a dedicated quality manager Some speakers’ experience is with in-house systems and some will share experience with the AAPM/ASTRO national Radiation Oncology Incident Learning System (RO-ILS). Reports intended to be of value nationally need to be comprehensible to outsiders; examples of useful reports will be shown. There will be ample time set aside for audience members to contribute to the discussion. Learning Objectives: Learn how to promote the use of an incident learning system in a clinic. Learn how to convert “event reporting” into “incident learning”. See examples of practice changes that have come out of learning systems. Learn how the RO-ILS system can be used as a primary internal learning system. Learn how to create succinct, meaningful reports useful to outside readers. Gary Ezzell chairs the AAPM committee overseeing RO-ILS and has received an honorarium from ASTRO for working on the committee reviewing RO-ILS reports. Derek Brown is a director of http://TreatSafely.org . Brett Miller has previously received travel expenses and an honorarium from Varian. Phillip Beron has nothing to report.« less

Essential features of designating out-of-hospital cardiac arrest as a reportable event: a scientific statement from the American Heart Association Emergency Cardiovascular Care Committee; Council on Cardiopulmonary, Perioperative, and Critical Care; Council on Cardiovascular Nursing; Council on Clinical Cardiology; and Quality of Care and Outcomes Research Interdisciplinary Working Group.

PubMed

Nichol, Graham; Rumsfeld, John; Eigel, Brian; Abella, Benjamin S; Labarthe, Darwin; Hong, Yuling; O'Connor, Robert E; Mosesso, Vincent N; Berg, Robert A; Leeper, Barbara Bobbi; Weisfeldt, Myron L

2008-04-29

The 2010 impact goal of the American Heart Association is to reduce death rates from heart disease and stroke by 25% and to lower the prevalence of the leading risk factors by the same proportion. Much of the burden of acute heart disease is initially experienced out of hospital and can be reduced by timely delivery of effective prehospital emergency care. Many patients with an acute myocardial infarction die from cardiac arrest before they reach the hospital. A small proportion of those with cardiac arrest who reach the hospital survive to discharge. Current health surveillance systems cannot determine the burden of acute cardiovascular illness in the prehospital setting nor make progress toward reducing that burden without improved surveillance mechanisms. Accordingly, the goals of this article provide a brief overview of strategies for managing out-of-hospital cardiac arrest. We review existing surveillance systems for monitoring progress in reducing the burden of out-of-hospital cardiac arrest in the United States and make recommendations for filling significant gaps in these systems, including the following: 1. Out-of-hospital cardiac arrests and their outcomes through hospital discharge should be classified as reportable events as part of a heart disease and stroke surveillance system. 2. Data collected on patients' encounters with emergency medical services systems should include descriptions of the performance of cardiopulmonary resuscitation by bystanders and defibrillation by lay responders. 3. National annual reports on key indicators of progress in managing acute cardiovascular events in the out-of-hospital setting should be developed and made publicly available. Potential barriers to action on cardiac arrest include concerns about privacy, methodological challenges, and costs associated with designating cardiac arrest as a reportable event.

The contribution of the vaccine adverse event text mining system to the classification of possible Guillain-Barré syndrome reports.

PubMed

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

2013-01-01

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. To evaluate the ability of VaeTM to classify reports to the Vaccine Adverse Event Reporting System (VAERS) of possible Guillain-Barré Syndrome (GBS). 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. 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. 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.

Simulating adverse event spontaneous reporting systems as preferential attachment networks: application to the Vaccine Adverse Event Reporting System.

PubMed

Scott, J; Botsis, T; Ball, R

2014-01-01

Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases. Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limitations. We sought to develop a novel SRS simulation strategy based on plausible mechanisms for the growth of databases over time. We developed a simulation strategy based on the network principle of preferential attachment. We demonstrated how this strategy can be used to create simulations based on specific databases of interest, and provided an example of using such simulations to compare signal detection thresholds for a popular data mining algorithm. The preferential attachment simulations were generally structurally similar to our targeted SRS database, although they had fewer nodes of very high degree. The approach was able to generate signal-free SRS simulations, as well as mimicking specific known true signals. Explorations of different reporting thresholds for the FDA Vaccine Adverse Event Reporting System suggested that using proportional reporting ratio [PRR] > 3.0 may yield better signal detection operating characteristics than the more commonly used PRR > 2.0 threshold. The network analytic approach to SRS simulation based on the principle of preferential attachment provides an attractive framework for exploring the performance of safety signal detection algorithms. This approach is potentially more principled and versatile than existing simulation approaches. The utility of network-based SRS simulations needs to be further explored by evaluating other types of simulated signals with a broader range of data mining approaches, and comparing network-based simulations with other simulation strategies where applicable.

Acoustic Emission Sensing for Maritime Diesel Engine Performance and Health

DTIC Science & Technology

2016-05-01

diesel internal combustion engine operating condition and health. A commercial-off- the-shelf AE monitoring system and a purpose-built data acquisition...subjected to external events such as a combustion event, fluid flow or the opening and closing of valves. This document reports on the monitoring and...conjunction with injection- combustion processes and valve events. AE from misfire as the result of a fuel injector malfunction was readily detectable

FDA adverse Event Problem Codes: standardizing the classification of device and patient problems associated with medical device use.

PubMed

Reed, Terrie L; Kaufman-Rivi, Diana

2010-01-01

The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.

Increased capture of pediatric surgical complications utilizing a novel case-log web application to enhance quality improvement.

PubMed

Fisher, Jason C; Kuenzler, Keith A; Tomita, Sandra S; Sinha, Prashant; Shah, Paresh; Ginsburg, Howard B

2017-01-01

Documenting surgical complications is limited by multiple barriers and is not fostered in the electronic health record. Tracking complications is essential for quality improvement (QI) and required for board certification. Current registry platforms do not facilitate meaningful complication reporting. We developed a novel web application that improves accuracy and reduces barriers to documenting complications. We deployed a custom web application that allows pediatric surgeons to maintain case logs. The program includes a module for entering complication data in real time. Reminders to enter outcome data occur at key postoperative intervals to optimize recall of events. Between October 1, 2014, and March 31, 2015, frequencies of surgical complications captured by the existing hospital reporting system were compared with data aggregated by our application. 780 cases were captured by the web application, compared with 276 cases registered by the hospital system. We observed an increase in the capture of major complications when compared to the hospital dataset (14 events vs. 4 events). This web application improved real-time reporting of surgical complications, exceeding the accuracy of administrative datasets. Custom informatics solutions may help reduce barriers to self-reporting of adverse events and improve the data that presently inform pediatric surgical QI. Diagnostic study/Retrospective study. Level III - case control study. Copyright © 2017 Elsevier Inc. All rights reserved.

[Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception].

PubMed

Pérez-Vilar, S; Díez-Domingo, J; Gomar-Fayos, J; Pastor-Villalba, E; Sastre-Cantón, M; Puig-Barberà, J

2014-08-01

The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry. The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%. Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

The role of media and the Internet on vaccine adverse event reporting: a case study of human papillomavirus vaccination.

PubMed

Eberth, Jan M; Kline, Kimberly N; Moskowitz, David A; Montealegre, Jane R; Scheurer, Michael E

2014-03-01

This study aimed to determine the temporal association of print media coverage and Internet search activity with adverse events reports associated with the human papillomavirus vaccine Gardasil (HPV4) and the meningitis vaccine Menactra (MNQ) among United States adolescents. We used moderated linear regression to test the relationships between print media reports in top circulating newspapers, Internet search activity, and reports to the Vaccine Adverse Event Reporting System (VAERS) for HPV4 and MNQ during the first 2.5 years after Food and Drug Administration approval. Compared with MNQ, HPV4 had more coverage in the print media and Internet search activity, which corresponded with the frequency of VAERS reports. In February 2007, we observed a spike in print media for HPV4. Although media coverage waned, Internet search activity remained stable and predicted the rise in HPV4-associated VAERS reports. We demonstrate that media coverage and Internet search activity, in particular, may promote increased adverse event reporting. Public health officials who have long recognized the importance of proactive engagement with news media must now consider strategies for meaningful participation in Internet discussions. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

A systematic review of the safety of kava extract in the treatment of anxiety.

PubMed

Stevinson, Clare; Huntley, Alyson; Ernst, Edzard

2002-01-01

This paper systematically reviews the clinical evidence relating to the safety of extracts of the herbal anxiolytic kava (Piper methysticum). Literature searches were conducted in four electronic databases and the reference lists of all papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting schemes of the WHO and national drug safety bodies and ten manufacturers of kava preparations were contacted. Data from short-term post-marketing surveillance studies and clinical trials suggest that adverse events are, in general, rare, mild and reversible. However, published case reports indicate that serious adverse events are possible including dermatological reactions, neurological complications and, of greatest concern, liver damage. Spontaneous reporting schemes also suggest that the most common adverse events are mild, but that serious ones occur. Controlled trials suggest that kava extracts do not impair cognitive performance and vigilance or potentiate the effects of central nervous system depressants. However, a possible interaction with benzodiazepines has been reported. It is concluded that when taken as a short-term monotherapy at recommended doses, kava extracts appear to be well tolerated by most users. Serious adverse events have been reported and further research is required to determine the nature and frequency of such events.

Energy system contribution to 400-metre and 800-metre track running.

PubMed

Duffield, Rob; Dawson, Brian; Goodman, Carmel

2005-03-01

As a wide range of values has been reported for the relative energetics of 400-m and 800-m track running events, this study aimed to quantify the respective aerobic and anaerobic energy contributions to these events during track running. Sixteen trained 400-m (11 males, 5 females) and 11 trained 800-m (9 males, 2 females) athletes participated in this study. The participants performed (on separate days) a laboratory graded exercsie test and multiple race time-trials. The relative energy system contribution was calculated by multiple methods based upon measures of race VO2, accumulated oxygen deficit (AOD), blood lactate and estimated phosphocreatine degradation (lactate/PCr). The aerobic/anaerobic energy system contribution (AOD method) to the 400-m event was calculated as 41/59% (male) and 45/55% (female). For the 800-m event, an increased aerobic involvement was noted with a 60/40% (male) and 70/30% (female) respective contribution. Significant (P < 0.05) negative correlations were noted between race performance and anaerobic energy system involvement (lactate/PCr) for the male 800-m and female 400-m events (r = - 0.77 and - 0.87 respectively). These track running data compare well with previous estimates of the relative energy system contributions to the 400-m and 800-m events. Additionally, the relative importance and speed of interaction of the respective metabolic pathways has implications to training for these events.

EpxMedTracking: Feasibility Evaluation of an SMS-Based Medication Adherence Tracking System in Community Practice

PubMed Central

Tricarico, Christopher; Peters, Robert; Som, Avik; Javaherian, Kavon

2017-01-01

Background Medication adherence remains a difficult problem to both assess and improve in patients. It is a multifactorial problem that goes beyond the commonly cited reason of forgetfulness. To date, eHealth (also known as mHealth and telehealth) interventions to improve medication adherence have largely been successful in improving adherence. However, interventions to date have used time- and cost-intensive strategies or focused solely on medication reminding, leaving much room for improvement in using a modality as flexible as eHealth. Objective Our objective was to develop and implement a fully automated short message service (SMS)-based medication adherence system, EpxMedTracking, that reminds patients to take their medications, explores reasons for missed doses, and alerts providers to help address problems of medication adherence in real time. Methods EpxMedTracking is a fully automated bidirectional SMS-based messaging system with provider involvement that was developed and implemented through Epharmix, Inc. Researchers analyzed 11 weeks of de-identified data from patients cared for by multiple provider groups in routine community practice for feasibility and functionality. Patients included were those in the care of a provider purchasing the EpxMedTracking tool from Epharmix and were enrolled from a clinic by their providers. The primary outcomes assessed were the rate of engagement with the system, reasons for missing doses, and self-reported medication adherence. Results Of the 25 patients studied over the 11 weeks, 3 never responded and subsequently opted out or were deleted by their provider. No other patients opted out or were deleted during the study period. Across the 11 weeks of the study period, the overall weekly engagement rate was 85.9%. There were 109 total reported missed doses including “I forgot” at 33 events (30.3%), “I felt better” at 29 events (26.6%), “out of meds” at 20 events (18.4%), “I felt sick” at 19 events (17.4%), and “other” at 3 events (2.8%). We also noted an increase in self-reported medication adherence in patients using the EpxMedTracking system. Conclusions EpxMedTracking is an effective tool for tracking self-reported medication adherence over time. It uniquely identifies actionable reasons for missing doses for subsequent provider intervention in real time based on patient feedback. Patients enrolled on EpxMedTracking also self-report higher rates of medication adherence over time while on the system. PMID:28506954

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

PubMed

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.

Computer Simulation as an Aid for Management of an Information System.

ERIC Educational Resources Information Center

Simmonds, W. H.; And Others

The aim of this study was to develop methods, based upon computer simulation, of designing information systems and illustrate the use of these methods by application to an information service. The method developed is based upon Monte Carlo and discrete event simulation techniques and is described in an earlier report - Sira report R412 Organizing…

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.

PubMed

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.

A flare event of the long-period RS Canum Venaticorum system IM Pegasi

NASA Technical Reports Server (NTRS)

Buzasi, Derek L.; Ramsey, Lawrence W.; Huenemoerder, David P.

1987-01-01

The characteristics of a flare event detected on the long-period RS CVn system IM Pegasi are reported. The low-resolution spectrum show enhancements of up to a factor of five in some emission lines. All of the ultraviolet emission lines normally visible are enhanced significantly more than the normal 30 rotational modulation. Emission fluxes of both the quiescent and flare event are used to construct models of the density and temperature variation with height. These models reveal a downward shift of the transition region during the flare. Scaled models of the quiet and flaring solar outer atmosphere are used to estimate the filling factor of the flare event at about 30 percent of the stellar surface. The pattern of line enhancements in the flare is the same as a previous event in Lambda Andromeda observed previously.

The Evaluation of a Temporal Reasoning System in Processing Clinical Discharge Summaries

PubMed Central

Zhou, Li; Parsons, Simon; Hripcsak, George

2008-01-01

Context TimeText is a temporal reasoning system designed to represent, extract, and reason about temporal information in clinical text. Objective To measure the accuracy of the TimeText for processing clinical discharge summaries. Design Six physicians with biomedical informatics training served as domain experts. Twenty discharge summaries were randomly selected for the evaluation. For each of the first 14 reports, 5 to 8 clinically important medical events were chosen. The temporal reasoning system generated temporal relations about the endpoints (start or finish) of pairs of medical events. Two experts (subjects) manually generated temporal relations for these medical events. The system and expert-generated results were assessed by four other experts (raters). All of the twenty discharge summaries were used to assess the system’s accuracy in answering time-oriented clinical questions. For each report, five to ten clinically plausible temporal questions about events were generated. Two experts generated answers to the questions to serve as the gold standard. We wrote queries to retrieve answers from system’s output. Measurements Correctness of generated temporal relations, recall of clinically important relations, and accuracy in answering temporal questions. Results The raters determined that 97% of subjects’ 295 generated temporal relations were correct and that 96.5% of the system’s 995 generated temporal relations were correct. The system captured 79% of 307 temporal relations determined to be clinically important by the subjects and raters. The system answered 84% of the temporal questions correctly. Conclusion The system encoded the majority of information identified by experts, and was able to answer simple temporal questions. PMID:17947618

The role of citizen science in monitoring small-scale pollution events.

PubMed

Hyder, Kieran; Wright, Serena; Kirby, Mark; Brant, Jan

2017-07-15

Small-scale pollution events involve the release of potentially harmful substances into the marine environment. These events can affect all levels of the ecosystem, with damage to both fauna and flora. Numerous reporting structures are currently available to document spills, however there is a lack of information on small-scale events due to their magnitude and patchy distribution. To this end, volunteers may provide a useful tool in filling this data gap, especially for coastal environments with a high usage by members of the public. The potential for citizen scientists to record small-scale pollution events is explored using the UK as an example, with a focus on highlighting methods and issues associated with using this data source. An integrated monitoring system is proposed which combines citizen science and traditional reporting approaches. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Surveillance for waterborne disease outbreaks and other health events associated with recreational water --- United States, 2007--2008.

PubMed

Hlavsa, Michele C; Roberts, Virginia A; Anderson, Ayana R; Hill, Vincent R; Kahler, Amy M; Orr, Maureen; Garrison, Laurel E; Hicks, Lauri A; Newton, Anna; Hilborn, Elizabeth D; Wade, Timothy J; Beach, Michael J; Yoder, Jonathan S

2011-09-23

Since 1978, CDC, the U.S. Environmental Protection Agency, and the Council of State and Territorial Epidemiologists have collaborated on the Waterborne Disease and Outbreak Surveillance System (WBDOSS) for collecting and reporting data on waterborne disease outbreaks associated with recreational water. This surveillance system is the primary source of data concerning the scope and health effects of waterborne disease outbreaks in the United States. In addition, data are collected on other select recreational water--associated health events, including pool chemical--associated health events and single cases of Vibrio wound infection and primary amebic meningoencephalitis (PAM). Data presented summarize recreational water--associated outbreaks and other health events that occurred during January 2007--December 2008. Previously unreported data on outbreaks that have occurred since 1978 also are presented. The WBDOSS database includes data on outbreaks associated with recreational water, drinking water, water not intended for drinking (excluding recreational water), and water use of unknown intent. Public health agencies in the states, the District of Columbia, U.S. territories, and Freely Associated States are primarily responsible for detecting and investigating waterborne disease outbreaks and voluntarily reporting them to CDC using a standard form. Only data on outbreaks associated with recreational water are summarized in this report. Data on other recreational water--associated health events reported to CDC, the Agency for Toxic Substances and Disease Registry (ATSDR), and the U.S. Consumer Product Safety Commission (CPSC) also are summarized. A total of 134 recreational water--associated outbreaks were reported by 38 states and Puerto Rico for 2007--2008. These outbreaks resulted in at least 13,966 cases. The median outbreak size was 11 cases (range: 2--5,697 cases). A total of 116 (86.6%) outbreaks were associated with treated recreational water (e.g., pools and interactive fountains) and resulted in 13,480 (96.5%) cases. Of the 134 outbreaks, 81 (60.4%) were outbreaks of acute gastrointestinal illness (AGI); 24 (17.9%) were outbreaks of dermatologic illnesses, conditions, or symptoms; and 17 (12.7%) were outbreaks of acute respiratory illness. Outbreaks of AGI resulted in 12,477 (89.3%) cases. The etiology was laboratory-confirmed for 105 (78.4%) of the 134 outbreaks. Of the 105 outbreaks with a laboratory-confirmed etiology, 68 (64.8%) were caused by parasites, 22 (21.0%) by bacteria, five (4.8%) by viruses, nine (8.6%) by chemicals or toxins, and one (1.0%) by multiple etiology types. Cryptosporidium was confirmed as the etiologic agent of 60 (44.8%) of 134 outbreaks, resulting in 12,154 (87.0%) cases; 58 (96.7%) of these outbreaks, resulting in a total of 12,137 (99.9%) cases, were associated with treated recreational water. A total of 32 pool chemical--associated health events that occurred in a public or residential setting were reported to WBDOSS by Maryland and Michigan. These events resulted in 48 cases of illness or injury; 26 (81.3%) events could be attributed at least partially to chemical handling errors (e.g., mixing incompatible chemicals). ATSDR's Hazardous Substance Emergency Events Surveillance System received 92 reports of hazardous substance events that occurred at aquatic facilities. More than half of these events (55 [59.8%]) involved injured persons; the most frequently reported primary contributing factor was human error. Estimates based on CPSC's National Electronic Injury Surveillance System (NEISS) data indicate that 4,574 (95% confidence interval [CI]: 2,703--6,446) emergency department (ED) visits attributable to pool chemical--associated injuries occurred in 2008; the most frequent diagnosis was poisoning (1,784 ED visits [95% CI: 585--2,984]). NEISS data indicate that pool chemical--associated health events occur frequently in residential settings. A total of 236 Vibrio wound infections were reported to be associated with recreational water exposure; 36 (48.6%) of the 74 hospitalized vibriosis patients and six (66.7%) of the nine vibriosis patients who died had V. vulnificus infections. Eight fatal cases of PAM occurred after exposure to warm untreated freshwater. The 134 recreational water--associated outbreaks reported for 2007--2008 represent a substantial increase over the 78 outbreaks reported for 2005--2006 and the largest number of outbreaks ever reported to WBDOSS for a 2-year period. Outbreaks, especially the largest ones, were most frequently associated with treated recreational water and characterized by AGI. Cryptosporidium remains the leading etiologic agent. Pool chemical--associated health events occur frequently but are preventable. Data on other select recreational water--associated health events further elucidate the epidemiology of U.S. waterborne disease by highlighting less frequently implicated types of recreational water (e.g., oceans) and detected types of recreational water--associated illness (i.e., not AGI). CDC uses waterborne disease outbreak surveillance data to 1) identify the types of etiologic agents, recreational water venues, and settings associated with waterborne disease outbreaks; 2) evaluate the adequacy of regulations and public awareness activities to promote healthy and safe swimming; and 3) establish public health priorities to improve prevention efforts, guidelines, and regulations at the local, state, and federal levels.

DEAP-3600 Data Acquisition System

NASA Astrophysics Data System (ADS)

Lindner, Thomas

2015-12-01

DEAP-3600 is a dark matter experiment using liquid argon to detect Weakly Interacting Massive Particles (WIMPs). The DEAP-3600 Data Acquisition (DAQ) has been built using a combination of commercial and custom electronics, organized using the MIDAS framework. The DAQ system needs to suppress a high rate of background events from 39Ar beta decays. This suppression is implemented using a combination of online firmware and software-based event filtering. We will report on progress commissioning the DAQ system, as well as the development of the web-based user interface.

TED: a novel man portable infrared detection and situation awareness system

NASA Astrophysics Data System (ADS)

Tidhar, Gil; Manor, Ran

2007-04-01

Infrared Search and Track (IRST) and threat warning systems are used in vehicle mounted or in fixed land positions. Migration of this technology to the man portable applications proves to be difficult due to the tight constraints of power consumption, dimensions, weight and due to the high video rate requirements. In this report we provide design details of a novel transient event detection (TED) system, capable of detection of blasts and gun shot events in a very wide field of view, while used by an operator in motion

Wide coverage biomedical event extraction using multiple partially overlapping corpora

PubMed Central

2013-01-01

Background Biomedical events are key to understanding physiological processes and disease, and wide coverage extraction is required for comprehensive automatic analysis of statements describing biomedical systems in the literature. In turn, the training and evaluation of extraction methods requires manually annotated corpora. However, as manual annotation is time-consuming and expensive, any single event-annotated corpus can only cover a limited number of semantic types. Although combined use of several such corpora could potentially allow an extraction system to achieve broad semantic coverage, there has been little research into learning from multiple corpora with partially overlapping semantic annotation scopes. Results We propose a method for learning from multiple corpora with partial semantic annotation overlap, and implement this method to improve our existing event extraction system, EventMine. An evaluation using seven event annotated corpora, including 65 event types in total, shows that learning from overlapping corpora can produce a single, corpus-independent, wide coverage extraction system that outperforms systems trained on single corpora and exceeds previously reported results on two established event extraction tasks from the BioNLP Shared Task 2011. Conclusions The proposed method allows the training of a wide-coverage, state-of-the-art event extraction system from multiple corpora with partial semantic annotation overlap. The resulting single model makes broad-coverage extraction straightforward in practice by removing the need to either select a subset of compatible corpora or semantic types, or to merge results from several models trained on different individual corpora. Multi-corpus learning also allows annotation efforts to focus on covering additional semantic types, rather than aiming for exhaustive coverage in any single annotation effort, or extending the coverage of semantic types annotated in existing corpora. PMID:23731785

The knowledge, attitude and behaviours of nurses about pharmacovigilance, adverse drug reaction and adverse event reporting in a state hospital

PubMed Central

Vural, Fisun; Ciftci, Seval; Vural, Birol

2015-01-01

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. PMID:28058321

Surveillance and early warning systems of infectious disease in China: From 2012 to 2014.

PubMed

Zhang, Honglong; Wang, Liping; Lai, Shengjie; Li, Zhongjie; Sun, Qiao; Zhang, Peng

2017-07-01

Appropriate surveillance and early warning of infectious diseases have very useful roles in disease control and prevention. In 2004, China established the National Notifiable Infectious Disease Surveillance System and the Public Health Emergency Event Surveillance System to report disease surveillance and events on the basis of data sources from the National Notifiable Infectious Disease Surveillance System, China Infectious Disease Automated-alert and Response System in this country. This study provided a descriptive summary and a data analysis, from 2012 to 2014, of these 3 key surveillance and early warning systems of infectious disease in China with the intent to provide suggestions for system improvement and perfection. Copyright © 2017 John Wiley & Sons, Ltd.

Impact of hospital type II violent events: use of psychotropic drugs and mental health services.

PubMed

Dement, John M; Lipscomb, Hester J; Schoenfisch, Ashley L; Pompeii, Lisa A

2014-06-01

While violence can adversely affect mental health of victims, repercussions of violence against workers is not as well characterized. We explored relationships between workplace violent events perpetrated by patients or visitors (Type II) against hospital employees and the employee use of psychotropic medications or mental health services using a data system that linked violent events with health claims. Significant associations were observed between reported Type II workplace violent events and employee prescription claims for anti-depressants and anxiolytics combined (RR = 1.45, 95% CI = 1.01-2.33) and anti-depressants alone (RR = 1.65, 95% CI = 1.10-2.48). No significant association between reported violent events and health claims for treatment of depression or anxiety was observed. Type II violence experienced by hospital workers may lead to increased use of psychotropic drugs, particularly anti-depressants but also anxiolytics. Our results suggest an important role of employee assistance programs in mitigating the psychological consequences of workplace violent events. © 2014 Wiley Periodicals, Inc.

Asymmetric Fireballs in Symmetric Collisions

DOE PAGES

Bialas, A.; Bzdak, A.; Zalewski, K.

2013-01-01

Here, this contribution reports on the results obtained in the two recently published papers demonstrating that data of the STAR Collaboration show a substantial asymmetric component in the rapidity distribution of the system created in central Au-Au collisions, implying that boost invariance is violated on the event-by-event basis even at the mid c.m. rapidity.

Apollo experience report: Command and service module sequential events control subsystem

NASA Technical Reports Server (NTRS)

Johnson, G. W.

1975-01-01

The Apollo command and service module sequential events control subsystem is described, with particular emphasis on the major systems and component problems and solutions. The subsystem requirements, design, and development and the test and flight history of the hardware are discussed. Recommendations to avoid similar problems on future programs are outlined.

Effects of catastrophic events on transportation system management and operations : the Pentagon and the national capital region -- September 11, 2001

DOT National Transportation Integrated Search

2002-04-01

The report documents the actions taken by transportation agencies in response to the terrorist attack on the Pentagon in Arlington, Va. on September 11, and is part of a larger effort to examine the impacts of catastrophic events on transportation sy...

76 FR 4463 - Privacy Act of 1974; Report of Modified or Altered System of Records

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... occupationally related mortality or morbidity is occurring. In the event of litigation where the defendant is: (a... diseases and which provides for the confidentiality of the information. In the event of litigation..., limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection...

78 FR 71620 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... devices in clinical use. This system is called the Medical Product Safety Network (MedSun). FDA is seeking... the user facilities participating in MedSun, to obtain a demographic profile of the facilities, and... collecting data on the electronic adverse event report form, MedSun collects additional information from...

Infectious Disease Surveillance in the 21st Century: An Integrated Web-Based Surveillance and Case Management System

PubMed Central

Haney, Gillian; Cocoros, Noelle; Cranston, Kevin; DeMaria, Alfred

2014-01-01

The Massachusetts Virtual Epidemiologic Network (MAVEN) was deployed in 2006 by the Massachusetts Department of Public Health, Bureau of Infectious Disease to serve as an integrated, Web-based disease surveillance and case management system. MAVEN replaced program-specific, siloed databases, which were inaccessible to local public health and unable to integrate electronic reporting. Disease events are automatically created without human intervention when a case or laboratory report is received and triaged in real time to state and local public health personnel. Events move through workflows for initial notification, case investigation, and case management. Initial development was completed within 12 months and recent state regulations mandate the use of MAVEN by all 351 jurisdictions. More than 300 local boards of health are using MAVEN, there are approximately one million events, and 70 laboratories report electronically. MAVEN has demonstrated responsiveness and flexibility to emerging diseases while also streamlining routine surveillance processes and improving timeliness of notifications and data completeness, although the long-term resource requirements are significant. PMID:24587547

"MedTRIS" (Medical Triage and Registration Informatics System): A Web-based Client Server System for the Registration of Patients Being Treated in First Aid Posts at Public Events and Mass Gatherings.

PubMed

Gogaert, Stefan; Vande Veegaete, Axel; Scholliers, Annelies; Vandekerckhove, Philippe

2016-10-01

First aid (FA) services are provisioned on-site as a preventive measure at most public events. In Flanders, Belgium, the Belgian Red Cross-Flanders (BRCF) is the major provider of these FA services with volunteers being deployed at approximately 10,000 public events annually. The BRCF has systematically registered information on the patients being treated in FA posts at major events and mass gatherings during the last 10 years. This information has been collected in a web-based client server system called "MedTRIS" (Medical Triage and Registration Informatics System). MedTRIS contains data on more than 200,000 patients at 335 mass events. This report describes the MedTRIS architecture, the data collected, and how the system operates in the field. This database consolidates different types of information with regards to FA interventions in a standardized way for a variety of public events. MedTRIS allows close monitoring in "real time" of the situation at mass gatherings and immediate intervention, when necessary; allows more accurate prediction of resources needed; allows to validate conceptual and predictive models for medical resources at (mass) public events; and can contribute to the definition of a standardized minimum data set (MDS) for mass-gathering health research and evaluation. Gogaert S , Vande veegaete A , Scholliers A , Vandekerckhove P . "MedTRIS" (Medical Triage and Registration Informatics System): a web-based client server system for the registration of patients being treated in first aid posts at public events and mass gatherings. Prehosp Disaster Med. 2016;31(5):557-562.

Detecting NEO Impacts using the International Monitoring System

NASA Astrophysics Data System (ADS)

Brown, Peter G.; Dube, Kimberlee; Silber, Elizabeth

2014-11-01

As part of the verification regime for the Comprehensive Nuclear Test Ban Treaty an International Monitoring System (IMS) consisting of seismic, hydroacoustic, infrasound and radionuclide technologies has been globally deployed beginning in the late 1990s. The infrasound network sub-component of the IMS consists of 47 active stations as of mid-2014. These microbarograph arrays detect coherent infrasonic signals from a range of sources including volcanoes, man-made explosions and bolides. Bolide detections from IMS stations have been reported since ~2000, but with the maturation of the network over the last several years the rate of detections has increased substantially. Presently the IMS performs semi-automated near real-time global event identification on timescales of 6-12 hours as well as analyst verified event identification having time lags of several weeks. Here we report on infrasound events identified by the IMS between 2010-2014 which are likely bolide impacts. Identification in this context refers to an event being included in one of the event bulletins issued by the IMS. In this untargeted study we find that the IMS globally identifies approximately 16 events per year which are likely bolide impacts. Using data released since the beginning of 2014 of US Government sensor detections (as given at http://neo.jpl.nasa.gov/fireballs/ ) of fireballs we find in a complementary targeted survey that the current IMS system is able to identify ~25% of fireballs with E > 0.1 kT energy. Using all 16 US Government sensor fireballs listed as of July 31, 2014 we are able to detect infrasound from 75% of these events on at least one IMS station. The high ratio of detection/identification is a product of the stricter criteria adopted by the IMS for inclusion in an event bulletin as compared to simple station detection.We discuss energy comparisons between infrasound-estimated energies based on amplitudes and periods and estimates provided by US Government sensors. Specific impact events of interest will be discussed as well as the utility of the global IMS infrasound system for location and timing of future NEAs detected prior to impact.

Reporting of Perioperative Adverse Events by Pediatric Anesthesiologists at a Tertiary Children's Hospital: Targeted Interventions to Increase the Rate of Reporting.

PubMed

Williams, Glyn D; Muffly, Matthew K; Mendoza, Julianne M; Wixson, Nina; Leong, Kit; Claure, Rebecca E

2017-11-01

Incident reporting systems (IRSs) are important patient safety tools for identifying risks and opportunities for improvement. A major IRS limitation is underreporting of incidents. Perioperative anesthesia IRSs have been established at multiple pediatric institutions and a national pediatric anesthesia IRS for perioperative serious adverse events (SAEs) is maintained by Wake Up Safe (WUS), a patient safety organization dedicated to pediatric anesthesia quality improvement. A confidential, electronic, perioperative IRS was instituted at our tertiary children's hospital, which is a WUS member. The primary study aim was to increase the rate of incident reporting by anesthesiologists at our institution through a series of interventions. The secondary aim was to characterize our reporting behavior relative to national practice by referencing SAE data from WUS. Perioperative adverse events reported over a 71-month period (November 2010 to September 2016) were categorized and the monthly reporting rates determined. Effects of 6 interventions targeted to increase the reporting rate were analyzed using control charts. Intervention 5 involved interviewing pediatric anesthesiologists to ascertain incident reporting barriers and motivators. A key driver diagram was developed and used to guide an improvement initiative. Incidents that fulfilled WUS criteria for SAEs were identified and categorized. SAE reporting rates over a 27-month period for 12 WUS member institutions were determined. 2689 perioperative adverse events were noted in 1980 of 72,384 anesthetics. Mean monthly adverse event case rate was 273 (95% confidence interval, 250-297) per 10,000 anesthetics. A subgroup involving 54,469 cases had 529 SAEs in 440 anesthetics; a mean monthly SAE case rate of 80 (95% confidence interval, 69-91) per 10,000 anesthetics. Cardiac, respiratory, and airway events predominated. Relative to WUS peer members, our institution is a high-reporting outlier. The rate of incident reporting per 10,000 anesthetics was sustainably increased from 149 ± 35 to 387 ± 73 (mean ± SD) after implementing mandatory IRS data entry and Intervention 5 quality improvement initiative. Barriers to reporting included concern for punitive repercussions, feelings of incompetence, poor education about what constitutes an event, lack of feedback, and the perception that reporting had no value. These were addressed by IRS education, cultivation of a culture of safety where reporting is encouraged, reporter feedback, and better inclusion of anesthesiologists in patient safety work. Electronic mandatory IRS data entry and an initiative to understand and address reporting barriers and motivators were associated with sustained increases in the adverse event reporting rate. These strategies to minimize underreporting enhance IRS value for learning and may be generalizable.

Cabin Safety Issues Related to Pre-Departure and Inflight Issues

NASA Technical Reports Server (NTRS)

Connell, Linda

2014-01-01

The Aviation Safety Reporting System (ASRS) in a partnership between the National Aeronautics and Space Administration (NASA), the Federal Aviation Administration (FAA), participating carriers, and labor organizations. It is designed to improve the National Airspace System by collecting and studying reports detailing unsafe conditions and events in the aviation industry. Employees are able to report safety issues or concerns with confidentiality and without fear of discipline. Safety reports highlighting the human element in cabin safety issues and concerns.

Dynamic Event Tree advancements and control logic improvements

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alfonsi, Andrea; Rabiti, Cristian; Mandelli, Diego

The RAVEN code has been under development at the Idaho National Laboratory since 2012. Its main goal is to create a multi-purpose platform for the deploying of all the capabilities needed for Probabilistic Risk Assessment, uncertainty quantification, data mining analysis and optimization studies. RAVEN is currently equipped with three different sampling categories: Forward samplers (Monte Carlo, Latin Hyper Cube, Stratified, Grid Sampler, Factorials, etc.), Adaptive Samplers (Limit Surface search, Adaptive Polynomial Chaos, etc.) and Dynamic Event Tree (DET) samplers (Deterministic and Adaptive Dynamic Event Trees). The main subject of this document is to report the activities that have been donemore » in order to: start the migration of the RAVEN/RELAP-7 control logic system into MOOSE, and develop advanced dynamic sampling capabilities based on the Dynamic Event Tree approach. In order to provide to all MOOSE-based applications a control logic capability, in this Fiscal Year an initial migration activity has been initiated, moving the control logic system, designed for RELAP-7 by the RAVEN team, into the MOOSE framework. In this document, a brief explanation of what has been done is going to be reported. The second and most important subject of this report is about the development of a Dynamic Event Tree (DET) sampler named “Hybrid Dynamic Event Tree” (HDET) and its Adaptive variant “Adaptive Hybrid Dynamic Event Tree” (AHDET). As other authors have already reported, among the different types of uncertainties, it is possible to discern two principle types: aleatory and epistemic uncertainties. The classical Dynamic Event Tree is in charge of treating the first class (aleatory) uncertainties; the dependence of the probabilistic risk assessment and analysis on the epistemic uncertainties are treated by an initial Monte Carlo sampling (MCDET). From each Monte Carlo sample, a DET analysis is run (in total, N trees). The Monte Carlo employs a pre-sampling of the input space characterized by epistemic uncertainties. The consequent Dynamic Event Tree performs the exploration of the aleatory space. In the RAVEN code, a more general approach has been developed, not limiting the exploration of the epistemic space through a Monte Carlo method but using all the forward sampling strategies RAVEN currently employs. The user can combine a Latin Hyper Cube, Grid, Stratified and Monte Carlo sampling in order to explore the epistemic space, without any limitation. From this pre-sampling, the Dynamic Event Tree sampler starts its aleatory space exploration. As reported by the authors, the Dynamic Event Tree is a good fit to develop a goal-oriented sampling strategy. The DET is used to drive a Limit Surface search. The methodology that has been developed by the authors last year, performs a Limit Surface search in the aleatory space only. This report documents how this approach has been extended in order to consider the epistemic space interacting with the Hybrid Dynamic Event Tree methodology.« less

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

PubMed

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.

Global Combat Support System - Army Did Not Comply With Treasury and DoD Financial Reporting Requirements

DTIC Science & Technology

2014-09-03

Compliance Validation: Logistics Modernization Program System Third Deployment—Selected Requirements,” July 2012 AAA Report No. A-2012-0090- FFM , “Audit... FFM , “General Fund Enterprise Business System— Federal Financial Management Improvement Act Compliance: Examination of Requirements Through Test Event...1.4.0,” September 2010 AAA Report No. A-2010-0220- FFM , “Examination of Federal Financial Management Improvement Act Compliance—Requirements

Intussusception after monovalent rotavirus vaccine-United States, Vaccine Adverse Event Reporting System (VAERS), 2008-2014.

PubMed

Haber, Penina; Parashar, Umesh D; Haber, Michael; DeStefano, Frank

2015-09-11

In 2006 and 2008, two new rotavirus vaccines (RotaTeq [RV5] and Rotarix [RV1]) were introduced in the United States. US data on intussusception have been mostly related to RV5, with limited data on RV1. We assessed intussusception events following RV1 reported to the Vaccine Adverse Event Reporting System (VAERS), a US national passive surveillance system, during February 2008-December 2014. We conducted a self-controlled risk interval analysis using Poisson regression to estimate the daily reporting ratio (DRR) of intussusception after the first 2 doses of RV1 comparing average daily reports 3-6 versus 0-2 days after vaccination. We calculated the excess risk of intussusception per 100,000 vaccinations based on DRRs and background rates of intussusception. Sensitivity analyses were conducted to assess effects of differential reporting completeness and inaccuracy of baseline rates. VAERS received 108 confirmed insusceptible reports after RV1. A significant clustering was observed on days 3-8 after does1 (p=0.001) and days 2-7 after dose 2 (p=0.001). The DRR comparing the 3-6 day and the 0-2 day periods after RV1 dose 1 was 7.5 (95% CI=2.3, 24.6), translating to an excess risk of 1.6 (95% CI=0.3, 5.8) per 100,000 vaccinations. The DRR was elevated but not significant after dose 2 (2.4 [95% CI=0.8,7.5]). The excess risk ranged from 1.2 to 2.8 per 100,000 in sensitivity analysis. We observed a significant increased risk of intussusception 3-6 days after dose 1 of RV1. The estimated small number of intussusception cases attributable to RV1 is outweighed by the benefits of rotavirus vaccination. Published by Elsevier Ltd.

WikiLeaks and Iraq Body Count: the sum of parts may not add up to the whole-a comparison of two tallies of Iraqi civilian deaths.

PubMed

Carpenter, Dustin; Fuller, Tova; Roberts, Les

2013-06-01

Introduction The number of civilians killed in Iraq following the 2003 invasion has proven difficult to measure and contentious in recent years. The release of the Wikileaks War Logs (WL) has created the potential to conduct a sensitivity analysis of the commonly-cited Iraq Body Count's (IBC's) tally, which is based on press, government, and other public sources. Hypothesis The 66,000 deaths reported in the Wikileaks War Logs are mostly the same events as those previously reported in the press and elsewhere as tallied by iraqbodycount.org. A systematic random sample of 2500 violent fatal War Log incidents was selected and evaluated to determine whether these incidents were also found in IBC's press-based listing. Each selected event was ranked on a scale of 0 (no match present) to 3 (almost certainly matched) with regard to the likelihood it was listed in the IBC database. Of the two thousand four hundred and nine War Log records, 488 (23.8%) were found to have likely matches in IBC records. Events that killed more people were far more likely to appear in both datasets, with 94.1% of events in which ≥20 people were killed being likely matches, as compared with 17.4% of singleton killings. Because of this skew towards the recording of large events in both datasets, it is estimated that 2035 (46.3%) of the 4394 deaths reported in the Wikileaks War Logs had been previously reported in IBC. Passive surveillance systems, widely seen as incomplete, may also be selective in the types of events detected in times of armed conflict. Bombings and other events during which many people are killed, and events in less violent areas, appear to be detected far more often, creating a skewed image of the mortality profile in Iraq. Members of the press and researchers should be hesitant to draw conclusions about the nature or extent of violence from passive surveillance systems of low or unknown sensitivity.

SCADA data and the quantification of hazardous events for QMRA.

PubMed

Nilsson, P; Roser, D; Thorwaldsdotter, R; Petterson, S; Davies, C; Signor, R; Bergstedt, O; Ashbolt, N

2007-01-01

The objective of this study was to assess the use of on-line monitoring to support the QMRA at water treatment plants studied in the EU MicroRisk project. SCADA data were obtained from three Catchment-to-Tap Systems (CTS) along with system descriptions, diary records, grab sample data and deviation reports. Particular attention was paid to estimating hazardous event frequency, duration and magnitude. Using Shewart and CUSUM we identified 'change-points' corresponding to events of between 10 min and >1 month duration in timeseries data. Our analysis confirmed it is possible to quantify hazardous event durations from turbidity, chlorine residual and pH records and distinguish them from non-hazardous variability in the timeseries dataset. The durations of most 'events' were short-term (0.5-2.3 h). These data were combined with QMRA to estimate pathogen infection risk arising from such events as chlorination failure. While analysis of SCADA data alone could identify events provisionally, its interpretation was severely constrained in the absence of diary records and other system information. SCADA data analysis should only complement traditional water sampling, rather than replace it. More work on on-line data management, quality control and interpretation is needed before it can be used routinely for event characterization.

Occupational injury and illness recording and reporting requirements--NAICS update and reporting revisions. Final rule.

PubMed

2014-09-18

OSHA is issuing a final rule to update the appendix to its Injury and Illness Recording and Reporting regulation. The appendix contains a list of industries that are partially exempt from requirements to keep records of work-related injuries and illnesses due to relatively low occupational injury and illness rates. The updated appendix is based on more recent injury and illness data and lists industry groups classified by the North American Industry Classification System (NAICS). The current appendix lists industries classified by Standard Industrial Classification (SIC). The final rule also revises the requirements for reporting work-related fatality, injury, and illness information to OSHA. The current regulation requires employers to report work-related fatalities and in-patient hospitalizations of three or more employees within eight hours of the event. The final rule retains the requirement for employers to report work-related fatalities to OSHA within eight hours of the event but amends the regulation to require employers to report all work-related in-patient hospitalizations, as well as amputations and losses of an eye, to OSHA within 24 hours of the event.

Root cause analysis of critical events in neurosurgery, New South Wales.

PubMed

Perotti, Vanessa; Sheridan, Mark M P

2015-09-01

Adverse events reportedly occur in 5% to 10% of health care episodes. Not all adverse events are the result of error; they may arise from systemic faults in the delivery of health care. Catastrophic events are not only physically devastating to patients, but they also attract medical liability and increase health care costs. Root cause analysis (RCA) has become a key tool for health care services to understand those adverse events. This study is a review of all the RCA case reports involving neurosurgical patients in New South Wales between 2008 and 2013. The case reports and data were obtained from the Clinical Excellence Commission database. The data was then categorized by the root causes identified and the recommendations suggested by the RCA committees. Thirty-two case reports were identified in the RCA database. Breaches in policy account for the majority of root causes identified, for example, delays in transfer of patients or wrong-site surgery, which always involved poor adherence to correct patient and site identification procedures. The RCA committees' recommendations included education for staff, and improvements in rostering and procedural guidelines. RCAs have improved the patient safety profile; however, the RCA committees have no power to enforce any recommendation or ensure compliance. A single RCA may provide little learning beyond the unit and staff involved. However, through aggregation of RCA data and dissemination strategies, health care workers can learn from adverse events and prevent future events from occurring. © 2015 Royal Australasian College of Surgeons.

Interrater reliability of the injury reporting of the injury surveillance system used in international athletics championships.

PubMed

Edouard, Pascal; Junge, Astrid; Kiss-Polauf, Marianna; Ramirez, Christophe; Sousa, Monica; Timpka, Toomas; Branco, Pedro

2018-03-01

The quality of epidemiological injury data depends on the reliability of reporting to an injury surveillance system. Ascertaining whether all physicians/physiotherapists report the same information for the same injury case is of major interest to determine data validity. The aim of this study was therefore to analyse the data collection reliability through the analysis of the interrater reliability. Cross-sectional survey. During the 2016 European Athletics Advanced Athletics Medicine Course in Amsterdam, all national medical teams were asked to complete seven virtual case reports on a standardised injury report form using the same definitions and classifications of injuries as the international athletics championships injury surveillance protocol. The completeness of data and the Fleiss' kappa coefficients for the inter-rater reliability were calculated for: sex, age, event, circumstance, location, type, assumed cause and estimated time-loss. Forty-one team physicians and physiotherapists of national medical teams participated in the study (response rate 89.1%). Data completeness was 96.9%. The Fleiss' kappa coefficients were: almost perfect for sex (k=1), injury location (k=0.991), event (k=0.953), circumstance (k=0.942), and age (k=0.870), moderate for type (k=0.507), fair for assumed cause (k=0.394), and poor for estimated time-loss (k=0.155). The injury surveillance system used during international athletics championships provided reliable data for "sex", "location", "event", "circumstance", and "age". More caution should be taken for "assumed cause" and "type", and even more for "estimated time-loss". This injury surveillance system displays satisfactory data quality (reliable data and high data completeness), and thus, can be recommended as tool to collect epidemiology information on injuries during international athletics championships. Copyright © 2018 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Self-expansion and smoking abstinence.

PubMed

Xu, Xiaomeng; Floyd, Anna H L; Westmaas, J Lee; Aron, Arthur

2010-04-01

Helping smokers quit is important as smoking is the number one preventable cause of death in the U.S. Smoking activates the mesolimbic dopamine reward system which is also responsible for pleasure associated with other behaviors, including engaging in novel, exciting and/or challenging (i.e., self-expanding) events. We hypothesized that the reward activation achieved by experiencing self-expanding events can supplant the reinforcement normally provided by smoking and can thus facilitate quitting. We investigated this hypothesis among 74 current and 66 former smokers who reported the self-expanding events they experienced for the 2 months prior to their most successful or final, quit attempt, respectively. Former smokers, compared to current smokers, reported significantly more self-expanding events and that the events were more helpful to their quitting. For current smokers, there was a significant moderate-to-large positive correlation between number of self-expanding events and number of days subsequently abstained from smoking. The results support the proposition that experiencing self-expanding activities or events can be beneficial for smoking abstinence. 2009 Elsevier Ltd. All rights reserved.

Logistic Regression Likelihood Ratio Test Analysis for Detecting Signals of Adverse Events in Post-market Safety Surveillance.

PubMed

Nam, Kijoeng; Henderson, Nicholas C; Rohan, Patricia; Woo, Emily Jane; Russek-Cohen, Estelle

2017-01-01

The Vaccine Adverse Event Reporting System (VAERS) and other product surveillance systems compile reports of product-associated adverse events (AEs), and these reports may include a wide range of information including age, gender, and concomitant vaccines. Controlling for possible confounding variables such as these is an important task when utilizing surveillance systems to monitor post-market product safety. A common method for handling possible confounders is to compare observed product-AE combinations with adjusted baseline frequencies where the adjustments are made by stratifying on observable characteristics. Though approaches such as these have proven to be useful, in this article we propose a more flexible logistic regression approach which allows for covariates of all types rather than relying solely on stratification. Indeed, a main advantage of our approach is that the general regression framework provides flexibility to incorporate additional information such as demographic factors and concomitant vaccines. As part of our covariate-adjusted method, we outline a procedure for signal detection that accounts for multiple comparisons and controls the overall Type 1 error rate. To demonstrate the effectiveness of our approach, we illustrate our method with an example involving febrile convulsion, and we further evaluate its performance in a series of simulation studies.

Central collecting and evaluating of major accidents and near-miss-events in the Federal Republic of Germany--results, experiences, perspectives.

PubMed

Uth, Hans-Joachim; Wiese, Norbert

2004-07-26

Lessons learnt from accidents are essential sources for updating state of the art requirements in process safety. To improve this input by a systematic way in the FRG, a central body for collecting and evaluating major accident (ZEMA) was established in 1993. ZEMA is part of the Federal Environmental Agency. All events which are to be notified due to the German Regulation on Major Accidents (Störfall-Verordnung) are centrally collected, analysed (deducing lessons learnt) and documented by ZEMA. The bureau is also responsible for the dissemination of the lessons learnt to all stake holders. This work is done in co-operation with the German Major-Accident Hazard Commission (Störfallkommission) and other international bodies like European MAHB. At the time being, over 375 events from 1980 to 2002 are registered in Germany. For each event, a separate data sheet is published in annual reports, first started in 1993. All information is also available at. A summary evaluation on the events from 1993 to 1999 is presented and some basic lessons learnt are shown. The results from root cause analysis underline the importance of maintenance, detailed knowledge of chemical properties, human factor issues and the role of safety organisation especially connected with subcontractors. The German notification system is described in detail and some experience with the system is reported. Keeping in mind that collecting reports from notified major accidents is only a small amount compared with all the events which might be interesting to learn from, the German Major-Accident Hazard Commission has established a separate body, the subcommittee "Incident Evaluation", which is in charge with collecting and evaluating of minor and near-miss events. Since 1994, a concept for the registration and evaluation of those non-notifiable events was developed. From 2000 on, the concept has been put into operation. Its main elements are; 1. reporting of the incident by the plant operator to an information collecting point of its trust, 2. passing the anonymous report to the "Incident Evaluation" subcommittee, 3. evaluation and classification whether the incident is safety relevant or not and, 4. publishing the relevant information to all interested stake holders, preparing of summary evaluation results in certain areas. Up to now, two brochures on "waste gas pipes" and "obstructions of pipes" were published.

Use of Circadian Lighting System to improve night shift alertness and performance of NRC Headquarters Operations Officers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baker, T.L.; Morisseau, D.; Murphy, N.M.

1995-04-01

The Nuclear Regulatory Commission`s (NRC) Headquarters Operations Officers (HOOs) receive and respond to events reported in the nuclear industry on a 24-hour basis. The HOOs have reported reduced alertness on the night shift, leading to a potential deterioration in their on-shift cognitive performance during the early morning hours. For some HOOs, maladaptation to the night shift was also reported to be the principal cause of: (a) reduced alertness during the commute to and from work, (b) poor sleep quality, and (c) personal lifestyle problems. ShiftWork Systems, Inc. (SWS) designed and installed a Circadian Lighting System (CLS) at both the Bethesdamore » and Rockville HOO stations with the goal of facilitating the HOOs physiological adjustment to their night shift schedules. The data indicate the following findings: less subjective fatigue on night shifts; improved night shift alertness and mental performance; higher HOO confidence in their ability to assess event reports; longer, deeper and more restorative day sleep after night duty shifts; swifter adaptation to night work; and a safer commute, particularly for those with extensive drives.« less

Review of safety reports involving electronic flight bags

DOT National Transportation Integrated Search

2009-04-27

Electronic Flight Bags (EFBs) are a relatively new device used by pilots. Even so, 37 safety-related events involving EFBs were identified from the public online Aviation Safety Reporting System (ASRS) database as of June 2008. In addition, two accid...

Feasibility of Patient Reporting of Symptomatic Adverse Events via the PRO-CTCAE in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

PubMed Central

Basch, Ethan; Pugh, Stephanie L; Dueck, Amylou C; Mitchell, Sandra A; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J; Gatewood, Marcha; Reeve, Bryce B; Mendoza, Tito R; O’Mara, Ann; Denicoff, Andrea; Minasian, Lori; Bennett, Antonia V; Setser, Ann; Schrag, Deborah; Roof, Kevin; Moore, Joan K; Gergel, Thomas; Stephans, Kevin; Rimner, Andreas; DeNittis, Albert; Bruner, Deborah Watkins

2017-01-01

Purpose To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials Patients enrolled in Trial XXXX (XXXX) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly x4 during treatment; 12-weeks post-treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results Among 226 study sites participating in Trial XXXX, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients of which 34 (43%) required tablet computers to be provided. All 152 patients in Trial XXXX agreed to self-report using the PRO-CTCAE (median age 66; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range 30–240), and median time for CRAs to teach a patient to self-report was 10 minutes (range 2–60). Compliance was high, particularly during active treatment when patients self-reported at 86% of expected time points, although compliance was lower post-treatment (72%). Common reasons for non-compliance were institutional errors such as forgetting to provide computers to participants; patients missing clinic visits; internet connectivity; and patients feeling “too sick”. Conclusions Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic adverse events at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between-visits, and by employing central compliance monitoring. These approaches are being incorporated into ongoing studies. PMID:28463161

A computer aided treatment event recognition system in radiation therapy.

PubMed

Xia, Junyi; Mart, Christopher; Bayouth, John

2014-01-01

To develop an automated system to safeguard radiation therapy treatments by analyzing electronic treatment records and reporting treatment events. CATERS (Computer Aided Treatment Event Recognition System) was developed to detect treatment events by retrieving and analyzing electronic treatment records. CATERS is designed to make the treatment monitoring process more efficient by automating the search of the electronic record for possible deviations from physician's intention, such as logical inconsistencies as well as aberrant treatment parameters (e.g., beam energy, dose, table position, prescription change, treatment overrides, etc). Over a 5 month period (July 2012-November 2012), physicists were assisted by the CATERS software in conducting normal weekly chart checks with the aims of (a) determining the relative frequency of particular events in the authors' clinic and (b) incorporating these checks into the CATERS. During this study period, 491 patients were treated at the University of Iowa Hospitals and Clinics for a total of 7692 fractions. All treatment records from the 5 month analysis period were evaluated using all the checks incorporated into CATERS after the training period. About 553 events were detected as being exceptions, although none of them had significant dosimetric impact on patient treatments. These events included every known event type that was discovered during the trial period. A frequency analysis of the events showed that the top three types of detected events were couch position override (3.2%), extra cone beam imaging (1.85%), and significant couch position deviation (1.31%). The significant couch deviation is defined as the number of treatments where couch vertical exceeded two times standard deviation of all couch verticals, or couch lateral/longitudinal exceeded three times standard deviation of all couch laterals and longitudinals. On average, the application takes about 1 s per patient when executed on either a desktop computer or a mobile device. CATERS offers an effective tool to detect and report treatment events. Automation and rapid processing enables electronic record interrogation daily, alerting the medical physicist of deviations potentially days prior to performing weekly check. The output of CATERS could also be utilized as an important input to failure mode and effects analysis.

Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial.

PubMed

Maggioni, Aldo P; Caterson, Ian; Coutinho, Walmir; Finer, Nick; Gaal, Luc Van; Sharma, Arya M; Torp-Pedersen, Christian; Bacher, Peter; Shepherd, Gillian; Sun, Rui; James, Philip

2008-11-01

Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment of tolerability. A total of 10,742 patients received sibutramine and 3.1% of these discontinued due to an adverse event; issues affecting more than 10 patients were drug intolerance, headache, insomnia, nausea, dry mouth, and constipation-, tachycardia-, and hypertension-related events. Serious adverse events, most commonly associated with the System Organ Class, Cardiac disorders, were reported by 2.7% of patients; however, the majority was not considered sibutramine-related. Adverse events relating to high blood pressure and/or pulse rate, whether reported as adverse events leading to discontinuation, or serious adverse events were reported by less than 0.2% of patients. No serious or individual events leading to discontinuation occurred in more than 25 patients. There were 15 (0.1%) deaths; 10 were attributed to a cardiovascular cause. Discontinuations for adverse events were lower than anticipated. Serious adverse events generally reflected sibutramine's known pharmacology or were related to cardiac disorders already present in this high-risk population. When compared with epidemiological data, overall mortality rate was low and sibutramine was well tolerated in this mainly off-label population. No new safety issues were detected.

Surface Movement Incidents Reported to the NASA Aviation Safety Reporting System

NASA Technical Reports Server (NTRS)

Connell, Linda J.; Hubener, Simone

1997-01-01

Increasing numbers of aircraft are operating on the surface of airports throughout the world. Airport operations are forecast to grow by more that 50%, by the year 2005. Airport surface movement traffic would therefore be expected to become increasingly congested. Safety of these surface operations will become a focus as airport capacity planning efforts proceed toward the future. Several past events highlight the prevailing risks experienced while moving aircraft during ground operations on runways, taxiways, and other areas at terminal, gates, and ramps. The 1994 St. Louis accident between a taxiing Cessna crossing an active runway and colliding with a landing MD-80 emphasizes the importance of a fail-safe system for airport operations. The following study explores reports of incidents occurring on an airport surface that did not escalate to an accident event. The Aviation Safety Reporting System has collected data on surface movement incidents since 1976. This study sampled the reporting data from June, 1993 through June, 1994. The coding of the data was accomplished in several categories. The categories include location of airport, phase of ground operation, weather /lighting conditions, ground conflicts, flight crew characteristics, human factor considerations, and airport environment. These comparisons and distributions of variables contributing to surface movement incidents can be invaluable to future airport planning, accident prevention efforts, and system-wide improvements.

Using movement and intentions to understand human activity.

PubMed

Zacks, Jeffrey M; Kumar, Shawn; Abrams, Richard A; Mehta, Ritesh

2009-08-01

During perception, people segment continuous activity into discrete events. They do so in part by monitoring changes in features of an ongoing activity. Characterizing these features is important for theories of event perception and may be helpful for designing information systems. The three experiments reported here asked whether the body movements of an actor predict when viewers will perceive event boundaries. Body movements were recorded using a magnetic motion tracking system and compared with viewers' segmentation of his activity into events. Changes in movement features were strongly associated with segmentation. This was more true for fine-grained than for coarse-grained boundaries, and was strengthened when the stimulus displays were reduced from live-action movies to simplified animations. These results suggest that movement variables play an important role in the process of segmenting activity into meaningful events, and that the influence of movement on segmentation depends on the availability of other information sources.

Monitoring drug safety in Astrakhan, Russia.

PubMed

Kirilochev, O O; Dorfman, I P; Umerova, A R

2015-01-01

The problem of drug safety will never disappear as new drugs are delivered in increasing numbers. They have high biological activity and adverse drug reactions (ADR) [1]. Currently, adverse drug reactions are the fourth leading cause of death for patients.There are databases of ADRs (Vigibase, Eudravigilance), but we know that ADR manifestations may vary in different countries and regions, due to the demographic, genetic characteristics of the population and the quality of manufactured drugs [2]. In this regard, the study of the ADR at the regional level is very relevant. We aimed to optimize the work on monitoring drug safety in Astrakhan region through pharmacoepidemiological research and development of computer database for analysis of information coming to the center for drug safety monitoring (CDSM). 1. To study the rates of ADR reporting and the structure in the Astrakhan region at the regional center for drug safety monitoring.2. To analyze the outcomes of registered adverse drug reactions.3. To determine the causality of adverse drug reactions.4. To identify reports on the ineffectiveness of drugs.5. To analyze the rates and structure of ADR reporting for drugs prescribed off-label. We studied spontaneous adverse event reporting. The adverse event reports received by the regional CDSM for the period of 2010 to 2014 was analyzed. The groups of drugs were categorized according by Anatomical Therapeutic Chemical classification system. The data were analyzed using Microsoft Office Excel. The likelihood of whether an ADR was actually due to the drugs was assessed with the Naranjo algorithm. The analysis of the results showed that the establishment of the CDSM in September 2010, contributed to improvement of drug safety monitoring in health facilities of the region. Noteworthy was the increasing the number of adverse event reports in 2011 and 2012, compared with the beginning of the year 2010, when the CDSM was not yet functioning.The decrease of adverse event reporting in 2013 and 2014 was due to the fact that doctors in the region had access to better ADR drug information. Along with the increasing number of adverse event reporting we also noted the increase in the number of health facilities that monitored drug safety. The number of health facilities that reported, doubled from 2010 to 2014. We observed the increase in the number of adverse event reports submitted by pharmaceutical companies. General anti-infective drugs for systemic use (class J) were the most common cause of all registered ADRs (44%). Drugs for treatment of tuberculosis (group J04A) were the cause of adverse drug reactions in 34% of reports. ADRs associated with drugs used for treating diseases of cardiovascular system accounted for 16% of case-reports; drugs belonging to the group of Alimentary tract and metabolism (class A) and to the group of Nervous System (class A) were reported to cause ADRs in 10% of cases each. Type A adverse drug reactions, which are usually a consequence of a drug's primary pharmacological effect, were detected in 45% of cases. These reactions were often registered for drugs affecting cardiovascular system (class C), nervous system (class N), dlood and blood forming organs (class B). Type B ADRs were reported in 54% of cases. These were "idiosyncratic" reactions, which could not be predicted on the basis of the drug's main pharmacological action, were not dose-related and were severe [3]. The most frequent cause of type B adverse drug reactions was the General anti-infective medicines for systemic use (Class J). The fatality rate associated with ADRs was 0.3%. Type A adverse drug reactions resulted in death in 38% of cases. Type B ADR (anaphylactic shock) accounted for 62% of the patient's deaths. The Naranjo scale determined the causality of ADRs. The "definite" ADRs were detected in 14% of reports, "probable" - in 47%, and "possible" - in 39% of cases. The rate of reporting associated with ineffectiveness of drugs amounted to 1%. Most often the lack of therapeutic effect was reported in patients receiving drugs of class C (Cardiovascular system, 31% of all cases of inefficiency of drugs). These drugs were used in accordance with their official instructions for use. The proportion of ADR reports for drugs prescribed off-label was 1.4%. The results substantiate the need to continue drug safety monitoring in the Astrakhan region. We plan to further improve the software for ADR analysis.

When bad things happen: adverse event reporting and disclosure as patient safety and risk management tools in the neonatal intensive care unit.

PubMed

Donn, Steven M; McDonnell, William M

2012-01-01

The Institute of Medicine has recommended a change in culture from "name and blame" to patient safety. This will require system redesign to identify and address errors, establish performance standards, and set safety expectations. This approach, however, is at odds with the present medical malpractice (tort) system. The current system is outcomes-based, meaning that health care providers and institutions are often sued despite providing appropriate care. Nevertheless, the focus should remain to provide the safest patient care. Effective peer review may be hindered by the present tort system. Reporting of medical errors is a key piece of peer review and education, and both anonymous reporting and confidential reporting of errors have potential disadvantages. Diagnostic and treatment errors continue to be the leading sources of allegations of malpractice in pediatrics, and the neonatal intensive care unit is uniquely vulnerable. Most errors result from systems failures rather than human error. Risk management can be an effective process to identify, evaluate, and address problems that may injure patients, lead to malpractice claims, and result in financial losses. Risk management identifies risk or potential risk, calculates the probability of an adverse event arising from a risk, estimates the impact of the adverse event, and attempts to control the risk. Implementation of a successful risk management program requires a positive attitude, sufficient knowledge base, and a commitment to improvement. Transparency in the disclosure of medical errors and a strategy of prospective risk management in dealing with medical errors may result in a substantial reduction in medical malpractice lawsuits, lower litigation costs, and a more safety-conscious environment. Thieme Medical Publishers, Inc.

A new approach to power quality and electricity reliability monitoring-case study illustrations of the capabilities of the I-GridTM system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Divan, Deepak; Brumsickle, William; Eto, Joseph

2003-04-01

This report describes a new approach for collecting information on power quality and reliability and making it available in the public domain. Making this information readily available in a form that is meaningful to electricity consumers is necessary for enabling more informed private and public decisions regarding electricity reliability. The system dramatically reduces the cost (and expertise) needed for customers to obtain information on the most significant power quality events, called voltage sags and interruptions. The system also offers widespread access to information on power quality collected from multiple sites and the potential for capturing information on the impacts ofmore » power quality problems, together enabling a wide variety of analysis and benchmarking to improve system reliability. Six case studies demonstrate selected functionality and capabilities of the system, including: Linking measured power quality events to process interruption and downtime; Demonstrating the ability to correlate events recorded by multiple monitors to narrow and confirm the causes of power quality events; and Benchmarking power quality and reliability on a firm and regional basis.« less

Evaluation of Local Media Surveillance for Improved Disease Recognition and Monitoring in Global Hotspot Regions

PubMed Central

Schwind, Jessica S.; Wolking, David J.; Brownstein, John S.; Mazet, Jonna A. K.; Smith, Woutrina A.

2014-01-01

Digital disease detection tools are technologically sophisticated, but dependent on digital information, which for many areas suffering from high disease burdens is simply not an option. In areas where news is often reported in local media with no digital counterpart, integration of local news information with digital surveillance systems, such as HealthMap (Boston Children’s Hospital), is critical. Little research has been published in regards to the specific contribution of local health-related articles to digital surveillance systems. In response, the USAID PREDICT project implemented a local media surveillance (LMS) pilot study in partner countries to monitor disease events reported in print media. This research assessed the potential of LMS to enhance digital surveillance reach in five low- and middle-income countries. Over 16 weeks, select surveillance system attributes of LMS, such as simplicity, flexibility, acceptability, timeliness, and stability were evaluated to identify strengths and weaknesses in the surveillance method. Findings revealed that LMS filled gaps in digital surveillance network coverage by contributing valuable localized information on disease events to the global HealthMap database. A total of 87 health events were reported through the LMS pilot in the 16-week monitoring period, including 71 unique reports not found by the HealthMap digital detection tool. Furthermore, HealthMap identified an additional 236 health events outside of LMS. It was also observed that belief in the importance of the project and proper source selection from the participants was crucial to the success of this method. The timely identification of disease outbreaks near points of emergence and the recognition of risk factors associated with disease occurrence continue to be important components of any comprehensive surveillance system for monitoring disease activity across populations. The LMS method, with its minimal resource commitment, could be one tool used to address the information gaps seen in global ‘hot spot’ regions. PMID:25333618

Test report for single event effects of the 80386DX microprocessor

NASA Technical Reports Server (NTRS)

Watson, R. Kevin; Schwartz, Harvey R.; Nichols, Donald K.

1993-01-01

The Jet Propulsion Laboratory Section 514 Single Event Effects (SEE) Testing and Analysis Group has performed a series of SEE tests of certain strategic registers of Intel's 80386DX CHMOS 4 microprocessor. Following a summary of the test techniques and hardware used to gather the data, we present the SEE heavy ion and proton test results. We also describe the registers tested, along with a system impact analysis should these registers experience a single event upset.

The Orbit of Transneptunian Binary Manwe and Thorondor and Their Upcoming Mutual Events

NASA Technical Reports Server (NTRS)

Grundy, W. M.; Benecchi, S. D.; Porter, S. B.; Noll, K. S.

2014-01-01

A new Hubble Space Telescope observation of the 7:4 resonant transneptunian binary system (385446) Manwe has shown that, of two previously reported solutions for the orbit of its satellite Thorondor, the prograde one is correct. The orbit has a period of 110.18 +/- 0.02 days, semimajor axis of 6670 +/- 40 km, and an eccentricity of 0.563 +/- 0.007. It will be viewable edge-on from the inner Solar System during 2015- 2017, presenting opportunities to observe mutual occultation and eclipse events. However, the number of observable events will be small, owing to the long orbital period and expected small sizes of the bodies relative to their separation. This paper presents predictions for events observable from Earth-based telescopes and discusses the associated uncertainties and challenges.

Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: reports to VAERS.

PubMed

Halsey, Neal A; Griffioen, Mari; Dreskin, Stephen C; Dekker, Cornelia L; Wood, Robert; Sharma, Devindra; Jones, James F; LaRussa, Philip S; Garner, Jenny; Berger, Melvin; Proveaux, Tina; Vellozzi, Claudia; Broder, Karen; Setse, Rosanna; Pahud, Barbara; Hrncir, David; Choi, Howard; Sparks, Robert; Williams, Sarah Elizabeth; Engler, Renata J; Gidudu, Jane; Baxter, Roger; Klein, Nicola; Edwards, Kathryn; Cano, Maria; Kelso, John M

2013-12-09

Hypersensitivity disorders following vaccinations are a cause for concern. To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines. A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines. US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010. Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event. Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 698 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine. Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males. Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions. Copyright © 2013 Elsevier Ltd. All rights reserved.

Serious adverse events and visual outcomes of rescue therapy using adjunct bevacizumab to laser and surgery for retinopathy of prematurity. The Indian Twin Cities Retinopathy of Prematurity Screening database Report number 5.

PubMed

Jalali, Subhadra; Balakrishnan, Divya; Zeynalova, Zarifa; Padhi, Tapas Ranjan; Rani, Padmaja Kumari

2013-07-01

To report serious adverse events and long-term outcomes of initial experience with intraocular bevacizumab in retinopathy of prematurity (ROP). Consecutive vascularly active ROP cases treated with bevacizumab, in addition to laser and surgery, were analysed retrospectively from a prospective computerised ROP database. Primary efficacy outcome was regression of new vessels. Secondary outcomes included the anatomic and visual status. Serious systemic and ocular adverse events were documented. 24 ROP eyes in 13 babies, received single intraocular bevacizumab for severe stage 3 plus after failed laser (seven eyes), stage 4A plus (eight eyes), and stage 4B/5 plus (nine eyes). Drug was injected intravitreally in 23 eyes and intracamerally in one eye. New vessels regressed in all eyes. Vision salvage in 14 of 24 eyes and no serious neurodevelopmental abnormalities were noted up to 60 months (mean 30.7 months) follow-up. Complications included macular hole and retinal breaks causing rhegmatogenous retinal detachment (one eye); bilateral, progressive vascular attenuation, perivascular exudation and optic atrophy in one baby, and progression of detachment bilaterally to stage 5 in one baby with missed follow-up. One baby who received intracameral injection developed hepatic dysfunction. One eye of this baby also showed a large choroidal rupture. Though intraocular bevacizumab, along with laser and surgery salvaged vision in many otherwise progressive cases of ROP, vigilance and reporting of serious adverse events is essential for future rationalised use of the drug. We report one systemic and four ocular adverse events that require consideration in future use of the drug.

Application of taxonomy theory, Volume 1: Computing a Hopf bifurcation-related segment of the feasibility boundary. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zaborszky, J.; Venkatasubramanian, V.

1995-10-01

Taxonomy Theory is the first precise comprehensive theory for large power system dynamics modeled in any detail. The motivation for this project is to show that it can be used, practically, for analyzing a disturbance that actually occurred on a large system, which affected a sizable portion of the Midwest with supercritical Hopf type oscillations. This event is well documented and studied. The report first summarizes Taxonomy Theory with an engineering flavor. Then various computational approaches are sighted and analyzed for desirability to use with Taxonomy Theory. Then working equations are developed for computing a segment of the feasibility boundarymore » that bounds the region of (operating) parameters throughout which the operating point can be moved without losing stability. Then experimental software incorporating large EPRI software packages PSAPAC is developed. After a summary of the events during the subject disturbance, numerous large scale computations, up to 7600 buses, are reported. These results are reduced into graphical and tabular forms, which then are analyzed and discussed. The report is divided into two volumes. This volume illustrates the use of the Taxonomy Theory for computing the feasibility boundary and presents evidence that the event indeed led to a Hopf type oscillation on the system. Furthermore it proves that the Feasibility Theory can indeed be used for practical computation work with very large systems. Volume 2, a separate volume, will show that the disturbance has led to a supercritical (that is stable oscillation) Hopf bifurcation.« less

More About The Video Event Trigger

NASA Technical Reports Server (NTRS)

Williams, Glenn L.

1996-01-01

Report presents additional information about system described in "Video Event Trigger" (LEW-15076). Digital electronic system processes video-image data to generate trigger signal when image shows significant change, such as motion, or appearance, disappearance, change in color, brightness, or dilation of object. Potential uses include monitoring of hallways, parking lots, and other areas during hours when supposed unoccupied, looking for fires, tracking airplanes or other moving objects, identification of missing or defective parts on production lines, and video recording of automobile crash tests.

Post-licensure safety surveillance of zoster vaccine live (Zostavax®) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015.

PubMed

Miller, Elaine R; Lewis, Paige; Shimabukuro, Tom T; Su, John; Moro, Pedro; Woo, Emily Jane; Jankosky, Christopher; Cano, Maria

2018-03-26

Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged ≥50 years and recommended by the CDC for persons ≥60 years. We analyzed U.S. reports of adverse events (AEs) following ZVL submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system to monitor vaccine safety, for persons vaccinated May 1, 2006, through January 31, 2015. We conducted descriptive analysis, clinical reviews of reports with selected pre-specified conditions, and empirical Bayesian data mining. VAERS received 23,092 reports following ZVL, of which 22,120 (96%) were classified as non-serious. Of reports where age was documented (n = 18,817), 83% were in persons aged ≥60 years. Reporting rates of AEs were 106 and 4.4 per 100,000 ZVL doses distributed for all reports and serious reports, respectively. When ZVL was administered alone among persons aged ≥50 years, injection site erythema (27%), HZ (17%), injection site swelling (17%), and rash (14%) were the most commonly reported symptoms among non-serious reports; HZ (29%), pain (18%), and rash (16%) were the most commonly reported symptoms among serious reports. Six reports included laboratory evidence of vaccine-strain varicella-zoster virus (Oka/Merck strain) infection; AEs included HZ, HZ- or varicella-like illness, and local reaction with vesicles. In our review of reports of death with sufficient information to determine cause (n = 46, median age 75 years), the most common causes were heart disease (n = 28), sepsis (n = 4), and stroke (n = 3). Empirical Bayesian data mining did not detect new or unexpected safety signals. Findings from our safety review of ZVL are consistent with those from pre-licensure clinical trials and other post-licensure assessments. Transient injection-site reactions, HZ, and rashes were most frequently reported to VAERS following ZVL. Overall, our results are reassuring regarding the safety of ZVL.

Acute kidney injury during concomitant use of valacyclovir and loxoprofen: detecting drug-drug interactions in a spontaneous reporting system.

PubMed

Yue, Zhihua; Shi, Jinhai; Jiang, Pengli; Sun, He

2014-11-01

Little is known about the effects of drug-drug interactions between valacyclovir and non-steroidal anti-inflammatory drugs (NSAIDs). In this study, we analysed the adverse event 'acute kidney injury (AKI)' resulting from a possible interaction between loxoprofen (a non-selective NSAID) and valacyclovir in reports received by FDA Adverse Event Reporting System (AERS) database between January 2004 and June 2012. Adverse event reports of elderly patients aged ≥65 years old were included in the study. Exposure categories were divided into three index groups (only valacyclovir or loxoprofen was used, and both drugs were concomitantly used) and a reference group (neither valacyclovir nor loxoprofen were used). Case/non-case AKI reports associated with these drugs were recorded and analysed by the reporting odds ratio (ROR). In total, 447 002 reports were included in the study. The ROR, adjusted for year of reporting, age and sex, for an AKI in elderly patients who used only valacyclovir or loxoprofen compared with elderly patients who used neither valacyclovir nor loxoprofen was 4.6 (95%CI: 4.1-5.2) and 1.4 (95%CI: 1.2-1.6), respectively, while the adjusted ROR was 26.0 (95%CI: 19.2-35.3) when both drugs were concomitantly used. Case reports in AERS are suggestive that interactions between valacyclovir and loxoprofen resulting in AKI may occur, while this association needs to be analysed by other methods in more detail in order to determine the real strength of the relationship. Copyright © 2014 John Wiley & Sons, Ltd.

Mechanism-based Pharmacovigilance over the Life Sciences Linked Open Data Cloud.

PubMed

Kamdar, Maulik R; Musen, Mark A

2017-01-01

Adverse drug reactions (ADR) result in significant morbidity and mortality in patients, and a substantial proportion of these ADRs are caused by drug-drug interactions (DDIs). Pharmacovigilance methods are used to detect unanticipated DDIs and ADRs by mining Spontaneous Reporting Systems, such as the US FDA Adverse Event Reporting System (FAERS). However, these methods do not provide mechanistic explanations for the discovered drug-ADR associations in a systematic manner. In this paper, we present a systems pharmacology-based approach to perform mechanism-based pharmacovigilance. We integrate data and knowledge from four different sources using Semantic Web Technologies and Linked Data principles to generate a systems network. We present a network-based Apriori algorithm for association mining in FAERS reports. We evaluate our method against existing pharmacovigilance methods for three different validation sets. Our method has AUROC statistics of 0.7-0.8, similar to current methods, and event-specific thresholds generate AUROC statistics greater than 0.75 for certain ADRs. Finally, we discuss the benefits of using Semantic Web technologies to attain the objectives for mechanism-based pharmacovigilance.

Reporting natural health product related adverse drug reactions: is it the pharmacist's responsibility?

PubMed

Walji, Rishma; Boon, Heather; Barnes, Joanne; Welsh, Sandy; Austin, Zubin; Baker, G Ross

2011-12-01

Herbal medicines and other natural health products (NHPs) are sold in Canadian pharmacies as over-the-counter products, yet there is limited information on their safety and adverse effect profile. Signals of safety concerns associated with medicines can arise through analysis of reports of suspected adverse drug reactions (ADRs) submitted to national pharmacovigilance centres by health professionals, including pharmacists and the public. However, typically such systems experience substantial under-reporting for NHPs. The objective of this paper is to explore pharmacists' experiences with and responses to receiving or identifying reports of suspected ADRs associated with NHPs from pharmacy customers. A qualitative study in which in-depth, semi-structured interviews were conducted with 12 community pharmacists in Toronto, Canada. Pharmacists generally did not submit reports of adverse events associated with NHPs to the national ADR reporting system and cited several barriers, including lack of time, complexity of the reporting process and lack of knowledge about NHPs. Pharmacists who accepted responsibility for adverse event reporting appeared to have different perceptions of their professional role: they saw themselves as 'knowledge generators', contributing to overall healthcare knowledge. Reporting behaviour for suspected ADRs associated with NHPs may be explained by a pharmacist's perception of his/her professional role and perceptions of the relative importance of generating knowledge to share in the wider system of health care. © 2011 The Authors. IJPP © 2011 Royal Pharmaceutical Society.

Primary prevention of cardiovascular disease in patients with systemic lupus erythematosus: case series and literature review.

PubMed

Fasano, S; Margiotta, D P; Navarini, L; Pierro, L; Pantano, I; Riccardi, A; Afeltra, A; Valentini, G

2017-12-01

Background Systemic lupus erythematosus is associated with an increased risk of cardiovascular disease. Low-dose aspirin, hydroxychloroquine and statins have been suggested to play a prophylactic role of cardiovascular events. This study is devoted to reviewing the literature on the topic and assessing the effects of these drugs in preventing a first cardiovascular event in a two-centre Italian series. Methods A PubMed search on cardiovascular prevention in systemic lupus erythematosus was performed. Moreover, systemic lupus erythematosus patients admitted to two centres from 2000-2015, who at admission had not experienced any cardiovascular event, were investigated. Aspirin, hydroxychloroquine and statin use, and the occurrence of any cardiovascular event, were recorded at each visit. Kaplan-Meier and Cox regression analyses were performed to evaluate the role of traditional, disease-related cardiovascular risk factors and of each of the three drugs in the occurrence of new cardiovascular events. Results The literature search produced conflicting results. Two hundred and ninety-one systemic lupus erythematosus patients were included in the study and followed for a median of eight years. During follow-up, 16 cardiovascular events occurred. At multivariate analysis, taking aspirin (hazard ratio: 0.24) and hydroxychloroquine for more than five years (hazard ratio: 0.27) reduced, while antiphospholipid antibody positivity (hazard ratio: 4.32) increased, the risk of a first cardiovascular event. No effect of statins emerged. Conclusion Our study confirms an additive role of aspirin and hydroxychloroquine in the primary prophylaxis of cardiovascular events in Italian patients with systemic lupus erythematosus. The lack of any detected effect in previous reports may depend on the design of studies and their short follow-up period.

75 FR 177 - Agency Information Collection; Activity Under OMB Review; Confidential Close Call Reporting System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-04

...; (2) events that happen infrequently but have the potential for high consequences (e.g., a train in... consequence from occurring. Such information is used to develop new training programs, identify root causes of... are submitted when there is a qualifying event, i.e., a close call occurs within a pilot site. The...

78 FR 39571 - Airworthiness Directives; The Boeing Company Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... 2800, Aircraft Fuel System. (e) Unsafe Condition This AD was prompted by reports of two in-service... system, followed by loss of fuel system suction feed capability on one engine, and in-flight shutdown of... and correct loss of the engine fuel suction feed capability of the fuel system, which, in the event of...

Multi-Hundred Watt Radioisotope Thermoelectric Generator Program, LES 8/9 Program, MJS Program. Bi-monthly progress report, 1 July--31 August 1975

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1975-01-01

Significant events, activities and achievements on the MHW LES 8/9 and MJS Programs for the reporting period are reported. Topics discussed include safety systems, isotope heat source, converter, product assurance, hardware fabrication, acceptance testing, and ground support equipment. (TFD)

Blowout Prevention System Events and Equipment Component Failures : 2016 SafeOCS Annual Report

DOT National Transportation Integrated Search

2017-09-22

The SafeOCS 2016 Annual Report, produced by the Bureau of Transportation Statistics (BTS), summarizes blowout prevention (BOP) equipment failures on marine drilling rigs in the Outer Continental Shelf. It includes an analysis of equipment component f...

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

PubMed

Zhao, Wenle; Pauls, Keith

2016-04-01

Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality. © The Author(s) 2015.

Zero-inflated Poisson model based likelihood ratio test for drug safety signal detection.

PubMed

Huang, Lan; Zheng, Dan; Zalkikar, Jyoti; Tiwari, Ram

2017-02-01

In recent decades, numerous methods have been developed for data mining of large drug safety databases, such as Food and Drug Administration's (FDA's) Adverse Event Reporting System, where data matrices are formed by drugs such as columns and adverse events as rows. Often, a large number of cells in these data matrices have zero cell counts and some of them are "true zeros" indicating that the drug-adverse event pairs cannot occur, and these zero counts are distinguished from the other zero counts that are modeled zero counts and simply indicate that the drug-adverse event pairs have not occurred yet or have not been reported yet. In this paper, a zero-inflated Poisson model based likelihood ratio test method is proposed to identify drug-adverse event pairs that have disproportionately high reporting rates, which are also called signals. The maximum likelihood estimates of the model parameters of zero-inflated Poisson model based likelihood ratio test are obtained using the expectation and maximization algorithm. The zero-inflated Poisson model based likelihood ratio test is also modified to handle the stratified analyses for binary and categorical covariates (e.g. gender and age) in the data. The proposed zero-inflated Poisson model based likelihood ratio test method is shown to asymptotically control the type I error and false discovery rate, and its finite sample performance for signal detection is evaluated through a simulation study. The simulation results show that the zero-inflated Poisson model based likelihood ratio test method performs similar to Poisson model based likelihood ratio test method when the estimated percentage of true zeros in the database is small. Both the zero-inflated Poisson model based likelihood ratio test and likelihood ratio test methods are applied to six selected drugs, from the 2006 to 2011 Adverse Event Reporting System database, with varying percentages of observed zero-count cells.

Seismic Characterization of the Newberry and Cooper Basin EGS Sites

NASA Astrophysics Data System (ADS)

Templeton, D. C.; Wang, J.; Goebel, M.; Johannesson, G.; Myers, S. C.; Harris, D.; Cladouhos, T. T.

2015-12-01

To aid in the seismic characterization of Engineered Geothermal Systems (EGS), we enhance traditional microearthquake detection and location methodologies at two EGS systems: the Newberry EGS site and the Habanero EGS site in the Cooper Basin of South Australia. We apply the Matched Field Processing (MFP) seismic imaging technique to detect new seismic events using known discrete microearthquake sources. Events identified using MFP typically have smaller magnitudes or occur within the coda of a larger event. Additionally, we apply a Bayesian multiple-event location algorithm, called MicroBayesLoc, to estimate the 95% probability ellipsoids for events with high signal-to-noise ratios (SNR). Such probability ellipsoid information can provide evidence for determining if a seismic lineation is real, or simply within the anticipated error range. At the Newberry EGS site, 235 events were reported in the original catalog. MFP identified 164 additional events (an increase of over 70% more events). For the relocated events in the Newberry catalog, we can distinguish two distinct seismic swarms that fall outside of one another's 95% probability error ellipsoids.This work performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344.

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

PubMed

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.

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

PubMed

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.

Analysis of Adverse Events in Identifying GPS Human Factors Issues

NASA Technical Reports Server (NTRS)

Adams, Catherine A.; Hwoschinsky, Peter V.; Adams, Richard J.

2004-01-01

The purpose of this study was to analyze GPS related adverse events such as accidents and incidents (A/I), Aviation Safety Reporting System (ASRS) reports and Pilots Deviations (PDs) to create a framework for developing a human factors risk awareness program. Although the occurrence of directly related GPS accidents is small the frequency of PDs and ASRS reports indicated there is a growing problem with situational awareness in terminal airspace related to different types of GPs operational issues. This paper addresses the findings of the preliminary research and a brief discussion of some of the literature on related GPS and automation issues.

Development and Assessment of Memorial Sloan Kettering Cancer Center’s Surgical Secondary Events Grading System

PubMed Central

Strong, Vivian E.; Selby, Luke V.; Sovel, Mindy; Disa, Joseph J.; Hoskins, William; DeMatteo, Ronald; Scardino, Peter; Jaques, David P.

2015-01-01

Background Studying surgical secondary events is an evolving effort with no current established system for database design, standard reporting, or definitions. Using the Clavien-Dindo classification as a guide, in 2001 we developed a Surgical Secondary Events database based on grade of event and required intervention to begin prospectively recording and analyzing all surgical secondary events (SSE). Study Design Events are prospectively entered into the database by attending surgeons, house staff, and research staff. In 2008 we performed a blinded external audit of 1,498 operations that were randomly selected to examine the quality and reliability of the data. Results 1,498 of 4,284 operations during the 3rd quarter of 2008 were audited. 79% (N=1,180) of the operations did not have a secondary event while 21% (N=318) of operations had an identified event. 91% (1,365) of operations were correctly entered into the SSE database. 97% (129/133) of missed secondary events were Grades I and II. Three Grade III (2%) and one Grade IV (1%) secondary event were missed. There were no missed Grade 5 secondary events. Conclusion Grade III – IV events are more accurately collected than Grade I – II events. Robust and accurate secondary events data can be collected by clinicians and research staff and these data can safely be used for quality improvement projects and research. PMID:25319579

Development and assessment of Memorial Sloan Kettering Cancer Center's Surgical Secondary Events grading system.

PubMed

Strong, Vivian E; Selby, Luke V; Sovel, Mindy; Disa, Joseph J; Hoskins, William; Dematteo, Ronald; Scardino, Peter; Jaques, David P

2015-04-01

Studying surgical secondary events is an evolving effort with no current established system for database design, standard reporting, or definitions. Using the Clavien-Dindo classification as a guide, in 2001 we developed a Surgical Secondary Events database based on grade of event and required intervention to begin prospectively recording and analyzing all surgical secondary events (SSE). Events are prospectively entered into the database by attending surgeons, house staff, and research staff. In 2008 we performed a blinded external audit of 1,498 operations that were randomly selected to examine the quality and reliability of the data. Of 4,284 operations, 1,498 were audited during the third quarter of 2008. Of these operations, 79 % (N = 1,180) did not have a secondary event while 21 % (N = 318) had an identified event; 91 % of operations (1,365) were correctly entered into the SSE database. Also 97 % (129 of 133) of missed secondary events were grades I and II. There were 3 grade III (2 %) and 1 grade IV (1 %) secondary event that were missed. There were no missed grade 5 secondary events. Grade III-IV events are more accurately collected than grade I-II events. Robust and accurate secondary events data can be collected by clinicians and research staff, and these data can safely be used for quality improvement projects and research.

The FIFA Women's World Cup in Germany 2011--a practical example for tailoring an event-specific enhanced infectious disease surveillance system.

PubMed

Takla, Anja; Velasco, Edward; Benzler, Justus

2012-07-31

Mass gatherings require a decision from public health authorities on how to monitor infectious diseases during the event. The appropriate level of enhanced surveillance depends on parameters like the scale of the event (duration, spatial distribution, season), participants' origin, amount of public attention, and baseline disease activity in the host country. For the FIFA Men's World Cup 2006, Germany implemented enhanced surveillance. As the scale of the FIFA Women's World Cup (June 26 - July 17, 2011) was estimated to be substantially smaller in size, visitors and duration, it was not feasible to simply adopt the previously implemented measures. Our aim was therefore to develop a strategy to tailor an event-specific enhanced surveillance for this smaller-scale mass gathering. Based on the enhanced surveillance measures during the Men's Cup, we conducted a needs assessment with the district health authorities in the 9 host cities in March 2011. Specific measures with a majority consent were implemented. After the event, we surveyed the 9 district and their corresponding 7 state health authorities to evaluate the implemented measures. All 9 district health authorities participated in the pre-event needs assessment. The majority of sites consented to moving from weekly to daily (Monday-Friday) notification reporting of routine infectious diseases, receiving regular feedback on those notification reports and summaries of national/international World Cup-relevant epidemiological incidents, e.g. outbreaks in countries of participating teams. In addition, we decided to implement twice-weekly reports of "unusual events" at district and state level. This enhanced system would commence on the first day and continue to one day following the tournament. No World Cup-related infectious disease outbreaks were reported during this time period. Eight of 9 district and 6 of 8 state health authorities participated in the final evaluation. The majority perceived the implemented measures as adequate. Our approach to tailor an event-specific enhanced surveillance concept worked well. Involvement of the participating stakeholders early-on in the planning phase secured ownership of and guaranteed support for the chosen strategy. The enhanced surveillance for this event resulted as a low-level surveillance. However, we included mechanisms for rapid upscaling if the situation would require adaptations.

29 CFR 4043.35 - Bankruptcy or similar settlement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.35 Bankruptcy or similar settlement. (a) Reportable event. A reportable event occurs for a plan when... has actual knowledge of the reportable event. ...

29 CFR 4043.35 - Bankruptcy or similar settlement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.35 Bankruptcy or similar settlement. (a) Reportable event. A reportable event occurs for a plan when... has actual knowledge of the reportable event. ...

29 CFR 4043.35 - Bankruptcy or similar settlement.

Code of Federal Regulations, 2012 CFR

2012-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.35 Bankruptcy or similar settlement. (a) Reportable event. A reportable event occurs for a plan when... has actual knowledge of the reportable event. ...

29 CFR 4043.35 - Bankruptcy or similar settlement.

Code of Federal Regulations, 2013 CFR

2013-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.35 Bankruptcy or similar settlement. (a) Reportable event. A reportable event occurs for a plan when... has actual knowledge of the reportable event. ...

29 CFR 4043.35 - Bankruptcy or similar settlement.

Code of Federal Regulations, 2014 CFR

2014-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.35 Bankruptcy or similar settlement. (a) Reportable event. A reportable event occurs for a plan when... has actual knowledge of the reportable event. ...

Formulation and Optimization of Robust Sensor Placement Problems for Drinking Water Contamination Warning Systems

DOE PAGES

Watson, Jean-Paul; Murray, Regan; Hart, William E.

2009-11-13

We report that the sensor placement problem in contamination warning system design for municipal water distribution networks involves maximizing the protection level afforded by limited numbers of sensors, typically quantified as the expected impact of a contamination event; the issue of how to mitigate against high-consequence events is either handled implicitly or ignored entirely. Consequently, expected-case sensor placements run the risk of failing to protect against high-consequence 9/11-style attacks. In contrast, robust sensor placements address this concern by focusing strictly on high-consequence events and placing sensors to minimize the impact of these events. We introduce several robust variations of themore » sensor placement problem, distinguished by how they quantify the potential damage due to high-consequence events. We explore the nature of robust versus expected-case sensor placements on three real-world large-scale distribution networks. We find that robust sensor placements can yield large reductions in the number and magnitude of high-consequence events, with only modest increases in expected impact. Finally, the ability to trade-off between robust and expected-case impacts is a key unexplored dimension in contamination warning system design.« less

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

PubMed

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 (p<0.001). Of the events with human failures (n=186), the most common related process 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, p<0.001) was associated with increased patient harm, whereas the presence of omission (OR 0.12, p<0.001) was associated with less patient harm. This study shows a need to reduce human failures to prevent patient harm during intra-hospital transportation. We suggest that the transportation team pay specific attention to the sub-process 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.

Policy on Counting Superseded Checklists in StATS

EPA Pesticide Factsheets

As we proceed with implementing the State Authorization Tracking System (StATS), and develop management reports based on data in StATS, we continue to identify issues dealing with what events should or should not be counted in the system.

Evaluation and improvement of the inquest system on work accidents (TOT)

NASA Astrophysics Data System (ADS)

Lepistoe, Jukka

1992-11-01

A project to evaluate and improve the work accident inquest system TOT (Finnish acronym) is reported. The study began with visits to workplaces where mortal accidents had occurred. Inquest reports, accident information dissemination, and the use of inquest reports, were examined. The study showed that work-related accidental deaths had a warning value, due to the gravity of the event, that could be exploited in the prevention field. The inquest system was shown to operate stably, all elements operating at least satisfactorily, and no improvement objective could be distinguished as more urgent than another. Improvement possibilities in the general system operation and in the capacity of workplaces to use inquest reports were shown.

How Safe Are Common Analgesics for the Treatment of Acute Pain for Children? A Systematic Review.

PubMed

Hartling, Lisa; Ali, Samina; Dryden, Donna M; Chordiya, Pritam; Johnson, David W; Plint, Amy C; Stang, Antonia; McGrath, Patrick J; Drendel, Amy L

2016-01-01

Background . Fear of adverse events and occurrence of side effects are commonly cited by families and physicians as obstructive to appropriate use of pain medication in children. We examined evidence comparing the safety profiles of three groups of oral medications, acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids, to manage acute nonsurgical pain in children (<18 years) treated in ambulatory settings. Methods . A comprehensive search was performed to July 2015, including review of national data registries. Two reviewers screened articles for inclusion, assessed methodological quality, and extracted data. Risks (incidence rates) were pooled using a random effects model. Results . Forty-four studies were included; 23 reported on adverse events. Based on limited current evidence, acetaminophen, ibuprofen, and opioids have similar nausea and vomiting profiles. Opioids have the greatest risk of central nervous system adverse events. Dual therapy with a nonopioid/opioid combination resulted in a lower risk of adverse events than opioids alone. Conclusions . Ibuprofen and acetaminophen have similar reported adverse effects and notably less adverse events than opioids. Dual therapy with a nonopioid/opioid combination confers a protective effect for adverse events over opioids alone. This research highlights challenges in assessing medication safety, including lack of more detailed information in registry data, and inconsistent reporting in trials.

Accounting Profession: Oversight, Auditor Independence, and Financial Reporting Issues

DTIC Science & Technology

2002-05-03

oversight of the accounting profession, auditor independence, and selected financial reporting matters. The sudden and largely unexpected bankruptcy of the...Enron Corporation (Enron) and other large corporations financial reporting restatements have raised questions about the soundness of the current self...regulatory and financial reporting systems and resulted in substantial losses to employees, shareholders, and other investors. These events have also

Lifetime exposure to traumatic events among adolescents in contact with the Nigerian juvenile justice systems compared with a comparison group of secondary school students.

PubMed

Atilola, Olayinka; Omigbodun, Olayinka; Bella-Awusah, Tolulope

2014-05-01

There are some knowledge gaps in what is known about pre-contact exposure to traumatic events among adolescents within the juvenile justice system. Data often focus on psychological sequelae without describing the traumatic events. In addition, there are few data from sub-Saharan Africa where juvenile justice inmates are often minor offenders and may themselves have been victims of abuse and neglect. To present detailed data on the lifetime prevalence rate and pattern of traumatic events among a cohort of adolescents in juvenile justice custody in Nigeria and to compare inmates who are 'offenders' with those who are 'victims'. Inmates of a borstal and a remand home comprised the study group and age- and gender-matched adolescents from two government schools were the secondary comparison group. The trauma-checklist of the Current and Lifetime Version of the Kiddies Schedule for Affective Disorders and Schizophrenia was used as a guide in assessing traumatic events. Of a total of 408 adolescents, 204 were recruited from the two juvenile justice institutions and 204 from secondary schools. Ninety per cent of participants were male and the mean (SD) age was 15·9 (2·8) years. The prevalence rate of lifetime exposure to traumatic events among the juvenile justice offenders was 88·7% compared with 48·5% of the comparison group (P = 0·001). The most commonly reported specific lifetime traumatic event was physical abuse (52·8%). The institutionalised adolescents were significantly more likely to report lifetime exposure to almost all the traumatic events assessed. Apart from the perpetrators of violent crime, there was no statistically significant difference in the prevalence and pattern of lifetime exposure to traumatic events between the offenders and the victims. This study provides further evidence that exposure to traumatic events is a fact of life for inmates of juvenile institutions, irrespective of whether they are offenders or victims. The implications for reform of the Nigerian juvenile justice system are discussed.

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.

PubMed

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.

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

PubMed

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.

Expanding veterinary biosurveillance in Washington, DC: The creation and utilization of an electronic-based online veterinary surveillance system.

PubMed

Hennenfent, Andrew; DelVento, Vito; Davies-Cole, John; Johnson-Clarke, Fern

2017-03-01

To enhance the early detection of emerging infectious diseases and bioterrorism events using companion animal-based surveillance. Washington, DC, small animal veterinary facilities (n=17) were surveyed to determine interest in conducting infectious disease surveillance. Using these results, an electronic-based online reporting system was developed and launched in August 2015 to monitor rates of canine influenza, canine leptospirosis, antibiotic resistant infections, canine parvovirus, and syndromic disease trends. Nine of the 10 facilities that responded expressed interest conducting surveillance. In September 2015, 17 canine parvovirus cases were reported. In response, a campaign encouraging regular veterinary preventative care was launched and featured on local media platforms. Additionally, during the system's first year of operation it detected 5 canine leptospirosis cases and 2 antibiotic resistant infections. No canine influenza cases were reported and syndromic surveillance compliance varied, peaking during National Special Security Events. Small animal veterinarians and the general public are interested in companion animal disease surveillance. The system described can serve as a model for establishing similar systems to monitor disease trends of public health importance in pet populations and enhance biosurveillance capabilities. Copyright © 2017 Elsevier B.V. All rights reserved.

Why System Safety Professionals Should Read Accident Reports

NASA Technical Reports Server (NTRS)

Holloway, C. M.; Johnson, C. W.

2006-01-01

System safety professionals, both researchers and practitioners, who regularly read accident reports reap important benefits. These benefits include an improved ability to separate myths from reality, including both myths about specific accidents and ones concerning accidents in general; an increased understanding of the consequences of unlikely events, which can help inform future designs; a greater recognition of the limits of mathematical models; and guidance on potentially relevant research directions that may contribute to safety improvements in future systems.

Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal Detection.

PubMed

Pacurariu, Alexandra C; Straus, Sabine M; Trifirò, Gianluca; Schuemie, Martijn J; Gini, Rosa; Herings, Ron; Mazzaglia, Giampiero; Picelli, Gino; Scotti, Lorenza; Pedersen, Lars; Arlett, Peter; van der Lei, Johan; Sturkenboom, Miriam C; Coloma, Preciosa M

2015-12-01

Spontaneous reporting systems (SRSs) remain the cornerstone of post-marketing drug safety surveillance despite their well-known limitations. Judicious use of other available data sources is essential to enable better detection, strengthening and validation of signals. In this study, we investigated the potential of electronic healthcare records (EHRs) to be used alongside an SRS as an independent system, with the aim of improving signal detection. A signal detection strategy, focused on a limited set of adverse events deemed important in pharmacovigilance, was performed retrospectively in two data sources-(1) the Exploring and Understanding Adverse Drug Reactions (EU-ADR) database network and (2) the EudraVigilance database-using data between 2000 and 2010. Five events were considered for analysis: (1) acute myocardial infarction (AMI); (2) bullous eruption; (3) hip fracture; (4) acute pancreatitis; and (5) upper gastrointestinal bleeding (UGIB). Potential signals identified in each system were verified using the current published literature. The complementarity of the two systems to detect signals was expressed as the percentage of the unilaterally identified signals out of the total number of confirmed signals. As a proxy for the associated costs, the number of signals that needed to be reviewed to detect one true signal (number needed to detect [NND]) was calculated. The relationship between the background frequency of the events and the capability of each system to detect signals was also investigated. The contribution of each system to signal detection appeared to be correlated with the background incidence of the events, being directly proportional to the incidence in EU-ADR and inversely proportional in EudraVigilance. EudraVigilance was particularly valuable in identifying bullous eruption and acute pancreatitis (71 and 42 % of signals were correctly identified from the total pool of known associations, respectively), while EU-ADR was most useful in identifying hip fractures (60 %). Both systems contributed reasonably well to identification of signals related to UGIB (45 % in EudraVigilance, 40 % in EU-ADR) but only fairly for signals related to AMI (25 % in EU-ADR, 20 % in EudraVigilance). The costs associated with detection of signals were variable across events; however, it was often more costly to detect safety signals in EU-ADR than in EudraVigilance (median NNDs: 7 versus 5). An EHR-based system may have additional value for signal detection, alongside already established systems, especially in the presence of adverse events with a high background incidence. While the SRS appeared to be more cost effective overall, for some events the costs associated with signal detection in the EHR might be justifiable.

Active and passive surveillance of enoxaparin generics: a case study relevant to biosimilars.

PubMed

Grampp, Gustavo; Bonafede, Machaon; Felix, Thomas; Li, Edward; Malecki, Michael; Sprafka, J Michael

2015-03-01

This retrospective analysis assessed the capability of active and passive safety surveillance systems to track product-specific safety events in the USA for branded and generic enoxaparin, a complex injectable subject to immune-related and other adverse events (AEs). Analysis of heparin-induced thrombocytopenia (HIT) incidence was performed on benefit claims for commercial and Medicare supplemental-insured individuals newly treated with enoxaparin under pharmacy benefit (1 January 2009 - 30 June 2012). Additionally, spontaneous reports from the FDA AE Reporting System were reviewed to identify incidence and attribution of enoxaparin-related reports to specific manufacturers. Specific, dispensed products were identifiable from National Drug Codes only in pharmacy-benefit databases, permitting sensitive comparison of HIT incidence in nearly a third of patients treated with brand or generic enoxaparin. After originator medicine's loss of exclusivity, only 5% of spontaneous reports were processed by generic manufacturers; reports attributable to specific generics were approximately ninefold lower than expected based on market share. Claims data were useful for active surveillance of enoxaparin generics dispensed under pharmacy benefits but not for products administered under medical benefits. These findings suggest that the current spontaneous reporting system will not distinguish product-specific safety signals for products distributed by multiple manufacturers, including biosimilars.

Dietary supplements: physician knowledge and adverse event reporting.

PubMed

Cellini, Matthew; Attipoe, Selasi; Seales, Paul; Gray, Robert; Ward, Andrew; Stephens, Mark; Deuster, Patricia A

2013-01-01

Dietary supplement (DS) use among US military personnel is widespread. Many consume several different DS with multiple ingredients one or more times each week, representing a potential public health concern. The overall purpose of the study was to assess the knowledge and behaviors of health professionals and physicians regarding patterns of DS use and possible adverse events (AE) associated with DS use. We also determined how providers address the issue of DS with patients and evaluated provider knowledge regarding reporting systems. Two prospective, cross-sectional, web-based questionnaires were administered. First, health care providers who accessed the Natural Medicines Comprehensive Database to gather evidenced-based information on DS and herbal products were queried. Second, physicians who had graduated from the Uniformed Services University were sent a web-based questionnaire regarding DS knowledge, AE knowledge and reporting, and communication with patients about DS. The frequencies of responses were evaluated. Although 60% of the military physicians who responded to the questionnaires believed they had observed AE in association with a DS, only 18% actually reported them. Three of four physician respondents (approximately 73%) did not know how or where to report AE associated with DS. The majority of physicians (66%) routinely asked most of their patients about DS use, and 65% did not have a reliable source of information for herbal and DS products. Information gaps in DS information and AE reporting were identified. A centralized AE reporting system could serve to identify potentially harmful DS for further evaluation. Health professionals need to remain vigilant for AE associated with DS use and better informed on how to report these events.

Recent Advances in Macrocyclic Fluorescent Probes for Ion Sensing.

PubMed

Wong, Joseph K-H; Todd, Matthew H; Rutledge, Peter J

2017-01-25

Small-molecule fluorescent probes play a myriad of important roles in chemical sensing. Many such systems incorporating a receptor component designed to recognise and bind a specific analyte, and a reporter or transducer component which signals the binding event with a change in fluorescence output have been developed. Fluorescent probes use a variety of mechanisms to transmit the binding event to the reporter unit, including photoinduced electron transfer (PET), charge transfer (CT), Förster resonance energy transfer (FRET), excimer formation, and aggregation induced emission (AIE) or aggregation caused quenching (ACQ). These systems respond to a wide array of potential analytes including protons, metal cations, anions, carbohydrates, and other biomolecules. This review surveys important new fluorescence-based probes for these and other analytes that have been reported over the past five years, focusing on the most widely exploited macrocyclic recognition components, those based on cyclam, calixarenes, cyclodextrins and crown ethers; other macrocyclic and non-macrocyclic receptors are also discussed.

System Architecture for Temporal Information Extraction, Representation and Reasoning in Clinical Narrative Reports

PubMed Central

Zhou, Li; Friedman, Carol; Parsons, Simon; Hripcsak, George

2005-01-01

Exploring temporal information in narrative Electronic Medical Records (EMRs) is essential and challenging. We propose an architecture for an integrated approach to process temporal information in clinical narrative reports. The goal is to initiate and build a foundation that supports applications which assist healthcare practice and research by including the ability to determine the time of clinical events (e.g., past vs. present). Key components include: (1) a temporal constraint structure for temporal expressions and the development of an associated tagger; (2) a Natural Language Processing (NLP) system for encoding and extracting medical events and associating them with formalized temporal data; (3) a post-processor, with a knowledge-based subsystem to help discover implicit information, that resolves temporal expressions and deals with issues such as granularity and vagueness; and (4) a reasoning mechanism which models clinical reports as Simple Temporal Problems (STPs). PMID:16779164

Implementation and Impact of an Automated Group Monitoring and Feedback System to Promote Hand Hygiene Among Health Care Personnel

PubMed Central

Conway, Laurie J.; Riley, Linda; Saiman, Lisa; Cohen, Bevin; Alper, Paul; Larson, Elaine L.

2015-01-01

Article-at-a-Glance Background Despite substantial evidence to support the effectiveness of hand hygiene for preventing health care–associated infections, hand hygiene practice is often inadequate. Hand hygiene product dispensers that can electronically capture hand hygiene events have the potential to improve hand hygiene performance. A study on an automated group monitoring and feedback system was implemented from January 2012 through March 2013 at a 140-bed community hospital. Methods An electronic system that monitors the use of sanitizer and soap but does not identify individual health care personnel was used to calculate hand hygiene events per patient-hour for each of eight inpatient units and hand hygiene events per patient-visit for the six outpatient units. Hand hygiene was monitored but feedback was not provided during a six-month baseline period and three-month rollout period. During the rollout, focus groups were conducted to determine preferences for feedback frequency and format. During the six-month intervention period, graphical reports were e-mailed monthly to all managers and administrators, and focus groups were repeated. Results After the feedback began, hand hygiene increased on average by 0.17 events/patient-hour in inpatient units (interquartile range = 0.14, p = .008). In outpatient units, hand hygiene performance did not change significantly. A variety of challenges were encountered, including obtaining accurate census and staffing data, engendering confidence in the system, disseminating information in the reports, and using the data to drive improvement. Conclusions Feedback via an automated system was associated with improved hand hygiene performance in the short term. PMID:25252389

Implementation and impact of an automated group monitoring and feedback system to promote hand hygiene among health care personnel.

PubMed

Conway, Laurie J; Riley, Linda; Saiman, Lisa; Cohen, Bevin; Alper, Paul; Larson, Elaine L

2014-09-01

Despite substantial evidence to support the effectiveness of hand hygiene for preventing health care-associated infections, hand hygiene practice is often inadequate. Hand hygiene product dispensers that can electronically capture hand hygiene events have the potential to improve hand hygiene performance. A study on an automated group monitoring and feedback system was implemented from January 2012 through March 2013 at a 140-bed community hospital. An electronic system that monitors the use of sanitizer and soap but does not identify individual health care personnel was used to calculate hand hygiene events per patient-hour for each of eight inpatient units and hand hygiene events per patient-visit for the six outpatient units. Hand hygiene was monitored but feedback was not provided during a six-month baseline period and three-month rollout period. During the rollout, focus groups were conducted to determine preferences for feedback frequency and format. During the six-month intervention period, graphical reports were e-mailed monthly to all managers and administrators, and focus groups were repeated. After the feedback began, hand hygiene increased on average by 0.17 events/patient-hour in inpatient units (interquartile range = 0.14, p = .008). In outpatient units, hand hygiene performance did not change significantly. A variety of challenges were encountered, including obtaining accurate census and staffing data, engendering confidence in the system, disseminating information in the reports, and using the data to drive improvement. Feedback via an automated system was associated with improved hand hygiene performance in the short-term.

Case report of vasovagal syncope associated with single pulse transcranial magnetic stimulation in a healthy adult participant.

PubMed

Gillick, Bernadette T; Rich, Tonya; Chen, Mo; Meekins, Gregg D

2015-12-01

Non-invasive brain stimulation-related seizures or syncopal events are rare. However, we report on a syncopal event in a healthy female during a transcranial magnetic stimulation single-pulse testing session. A 47-year-old healthy female presented for a transcranial magnetic stimulation session involving single-pulse assessment of cortical excitability. During the session, the participant appeared to have a brief event involving fainting and myoclonic jerks of the upper extremities. Orthostatic assessment was performed after the event and physician evaluation determined that this was a vasovagal syncopal event. The ethical aspects of this neurophysiology testing protocol were reviewed by the University of Minnesota Institutional Review Board (IRB), and formal IRB approval was deemed unnecessary for single-pulse assessment of healthy control participants not directly involved in a research study. Informed consent was obtained by the participant, including review of potential adverse events. Although rare and rarely reported, vasovagal syncopal events surrounding non-invasive brain stimulation do occur. Thorough pre-screening should incorporate assessment of history of syncope and a plan for risk mitigation if such an event should occur. A complete assessment of the impact of stimulation on the autonomic nervous system is unknown. As such studies expand into patients with myriad neurologic diagnoses, further studies on this effect, in both healthy control and patient populations, are warranted. Such knowledge could contribute to identification of the optimal study participant, and improvements in techniques of stimulation administration.

Analysis of benzonatate overdoses among adults and children from 1969-2010 by the United States Food and Drug Administration.

PubMed

McLawhorn, Melinda W; Goulding, Margie R; Gill, Rajdeep K; Michele, Theresa M

2013-01-01

To augment the December 2010 United States Food and Drug Administration (FDA) Drug Safety Communication on accidental ingestion of benzonatate in children less than 10 years old by summarizing data on emergency department visits, benzonatate exposure, and reports of benzonatate overdoses from several data sources. Retrospective review of adverse-event reports and drug utilization data of benzonatate. The FDA Adverse Event Reporting System (AERS) database (1969-2010), the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES, 2004-2009), and the IMS commercial data vendor (2004-2009). Any patient who reported an adverse event with benzonatate captured in the AERS or NEISS-CADES database or received a prescription for benzonatate according to the IMS commercial data vendor. Postmarketing adverse events with benzonatate were collected from the AERS database, emergency department visits due to adverse events with benzonatate were collected from the NEISS-CADES database, and outpatient drug utilization data were collected from the IMS commercial data vendor. Of 31 overdose cases involving benzonatate reported in the AERS database, 20 had a fatal outcome, and five of these fatalities occurred from accidental ingestions in children 2 years of age and younger. The NEISS-CADES database captured emergency department visits involving 12 cases of overdose from accidental benzonatate ingestions in children aged 1-3 years. Signs and symptoms of overdose included seizures, cardiac arrest, coma, brain edema or anoxic encephalopathy, apnea, tachycardia, and respiratory arrest and occurred in some patients within 15 minutes of ingestion. Dispensed benzonatate prescriptions increased by approximately 52% from 2004 to 2009. Although benzonatate has a long history of safe use, accumulating cases of fatal overdose, especially in children, prompted the FDA to notify health care professionals about the risks of benzonatate overdose. Pharmacists may have a role in preventing benzonatate overdoses by counseling patients on signs and symptoms of benzonatate overdose, the need for immediate medical care, and safe storage and disposal of benzonatate. © 2013 Pharmacotherapy Publications, Inc.

Observations of ionospheric electric fields above atmospheric weather systems

NASA Technical Reports Server (NTRS)

Farrell, W. M.; Aggson, T. L.; Rodgers, E. B.; Hanson, W. B.

1994-01-01

We report on the observations of a number of quasi-dc electric field events associated with large-scale atmospheric weather formations. The observations were made by the electric field experiment onboard the San Marco D satellite, operational in an equatorial orbit from May to December 1988. Several theoretical studies suggest that electric fields generated by thunderstorms are present at high altitudes in the ionosphere. In spite of such favorable predictions, weather-related events are not often observed since they are relatively weak. We shall report here on a set of likely E field candidates for atmospheric-ionospheric causality, these being observed over the Indonesian Basin, northern South America, and the west coast of Africa; all known sites of atmospheric activity. As we shall demonstrate, individual events often be traced to specific active weather features. For example, a number of events were associated with spacecraft passages near Hurricane Joan in mid-October 1988. As a statistical set, the events appear to coincide with the most active regions of atmospheric weather.

Continuous glucose monitoring detected hypoglycaemia in the Treating to Target in Type 2 Diabetes Trial (4-T).

PubMed

Levy, J C; Davies, M J; Holman, R R

2017-09-01

Hypoglycaemia is a significant risk in insulin treated type 2 diabetes and has been associated with future risk of cardiovascular events. We compared the frequency of low-glucose events using continuous glucose monitoring (CGM) with that of self-reported hypoglycemic events at the end of the first and third years of the Treating to Target in Type 2 Diabetes Trial (4-T), which compared biphasic, prandial and basal insulin regimens added to sulfonylurea and metformin. CGM using a Medtronic Gold system was performed in a subgroup of 4-T participants. CGM detected low-glucose events were defined at thresholds of ≤3.0 (CGM3.0) and ≤2.2 (CGM2.2) mmol/l. Of the 110 participants, 106 and 70 had CGM analysable data at the end of years 1 and 3 respectively. In both years, the frequency of CGM detected low glucose events was several fold higher than that of self-reported hypoglycaemia (symptoms with blood glucose less than 3.1mmol/l [<56mg/dl]). At the end of the first year, CGM3.0 and CGM2.2 mean (95%CI) event frequencies, expressed at events per participant per year, were 120 (85, 155) and 41 (21, 61) compared with 17 (8, 29) self-reported events during CGM, each p=0.001. The disparity at the end of the third year was similar. These data demonstrate the likely under-reporting of hypoglycaemia and of potential hypoglycaemia unawareness in clinical trials. The clinical implications of these findings need to be explored further (ISRCTN No ISRCTN51125379). Copyright © 2017. Published by Elsevier B.V.

29 CFR 4043.31 - Extraordinary dividend or stock redemption.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.31 Extraordinary dividend or stock redemption. (a) Reportable event. A reportable event...) Extraordinary dividends and stock redemptions. The reportable event described in section 4043(c)(11) of ERISA...

Paraesthesia after local anaesthetics: an analysis of reports to the FDA Adverse Event Reporting System.

PubMed

Piccinni, Carlo; Gissi, Davide B; Gabusi, Andrea; Montebugnoli, Lucio; Poluzzi, Elisabetta

2015-07-01

This study was aimed to evaluate the possible alert signals of paraesthesia by local anaesthetics, focusing on those used in dentistry. A case/non-case study of spontaneous adverse events recorded in FAERS (FDA Adverse Event Reporting System) between 2004 and 2011 was performed. Cases were represented by the reports of reactions grouped under the term 'Paraesthesias and dysaesthesias' involving local anaesthetics (ATC: N01B*); non-cases were all other reports of the same drugs. Reporting odds ratios (ROR) with the relevant 95% confidence intervals (95CI) were calculated. Alert signal was considered when number of cases >3 and lower limit of ROR 95CI > 1. To estimate the specificity of signals for dentistry, the analysis was restricted to the specific term "Oral Paraesthesia" and to reports concerning dental practice. Overall, 528 reports of 'Paraesthesias and dysaesthesias' were retrieved, corresponding to 573 drug-reaction pairs (247 lidocaine, 99 bupivacaine, 85 articaine, 30 prilocaine, 112 others). The signal was significant only for articaine (ROR=18.38; 95CI = 13.95-24.21) and prilocaine (2.66; 1.82-3.90). The analysis of the specific term "Oral Paraesthesia" retrieved 82 reports corresponding to 90 drug-reaction pairs (37 articaine, 19 lidocaine, 14 prilocaine, 7 bupivacaine, 13 others) and confirmed the signal for articaine (58.77; 37.82-91.31) and prilocaine (8.73; 4.89-15.57). The analysis of reports concerning dental procedures retrieved a signal for articaine, both for any procedures (8.84; 2.79-27.97) and for non-surgical ones (15.79; 1.87-133.46). In conclusion, among local anaesthetics, only articaine and prilocaine generated a signal of paraesthesia, especially when used in dentistry. © 2015 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

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

PubMed Central

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

Syndromic surveillance for evaluating the occurrence of healthcare-associated infections in equine hospitals.

PubMed

Ruple-Czerniak, A A; Aceto, H W; Bender, J B; Paradis, M R; Shaw, S P; Van Metre, D C; Weese, J S; Wilson, D A; Wilson, J; Morley, P S

2014-07-01

Methods that can be used to estimate rates of healthcare-associated infections and other nosocomial events have not been well established for use in equine hospitals. Traditional laboratory-based surveillance is expensive and cannot be applied in all of these settings. To evaluate the use of a syndromic surveillance system for estimating rates of occurrence of healthcare-associated infections among hospitalised equine cases. Multicentre, prospective longitudinal study. This study included weaned equids (n = 297) that were admitted for gastrointestinal disorders at one of 5 participating veterinary referral hospitals during a 12-week period in 2006. A survey form was completed by the primary clinician to summarise basic case information, procedures and treatments the horse received, and whether one or more of 7 predefined nosocomial syndromes were recognised at any point during hospitalisation. Adjusted rates of nosocomial events were estimated using Poisson regression. Risk factors associated with the risk of developing a nosocomial event were analysed using multivariable logistic regression. Among the study population, 95 nosocomial events were reported to have occurred in 65 horses. Controlling for differences among hospitals, 19.7% (95% confidence interval, 14.5-26.7) of the study population was reported to have had at least one nosocomial event recognised during hospitalisation. The most commonly reported nosocomial syndromes that were unrelated to the reason for hospitalisation were surgical site inflammation and i.v. catheter site inflammation. Syndromic surveillance systems can be standardised successfully for use across multiple hospitals without interfering with established organisational structures, in order to provide useful estimates of rates related to healthcare-associated infections. © 2013 EVJ Ltd.

A Participatory System for Preventing Pandemics of Animal Origins: Pilot Study of the Participatory One Health Disease Detection (PODD) System

PubMed Central

Yano, Terdsak; Phornwisetsirikun, Somphorn; Susumpow, Patipat; Visrutaratna, Surasing; Chanachai, Karoon; Phetra, Polawat; Chaisowwong, Warangkhana; Trakarnsirinont, Pairat; Hemwan, Phonpat; Kaewpinta, Boontuan; Singhapreecha, Charuk; Kreausukon, Khwanchai; Charoenpanyanet, Arisara ; Robert, Chongchit Sripun; Robert, Lamar; Rodtian, Pranee; Mahasing, Suteerat; Laiya, Ekkachai; Pattamakaew, Sakulrat; Tankitiyanon, Taweesart; Sansamur, Chalutwan

2018-01-01

Background Aiming for early disease detection and prompt outbreak control, digital technology with a participatory One Health approach was used to create a novel disease surveillance system called Participatory One Health Disease Detection (PODD). PODD is a community-owned surveillance system that collects data from volunteer reporters; identifies disease outbreak automatically; and notifies the local governments (LGs), surrounding villages, and relevant authorities. This system provides a direct and immediate benefit to the communities by empowering them to protect themselves. Objective The objective of this study was to determine the effectiveness of the PODD system for the rapid detection and control of disease outbreaks. Methods The system was piloted in 74 LGs in Chiang Mai, Thailand, with the participation of 296 volunteer reporters. The volunteers and LGs were key participants in the piloting of the PODD system. Volunteers monitored animal and human diseases, as well as environmental problems, in their communities and reported these events via the PODD mobile phone app. LGs were responsible for outbreak control and provided support to the volunteers. Outcome mapping was used to evaluate the performance of the LGs and volunteers. Results LGs were categorized into one of the 3 groups based on performance: A (good), B (fair), and C (poor), with the majority (46%,34/74) categorized into group B. Volunteers were similarly categorized into 4 performance groups (A-D), again with group A showing the best performance, with the majority categorized into groups B and C. After 16 months of implementation, 1029 abnormal events had been reported and confirmed to be true reports. The majority of abnormal reports were sick or dead animals (404/1029, 39.26%), followed by zoonoses and other human diseases (129/1029, 12.54%). Many potentially devastating animal disease outbreaks were detected and successfully controlled, including 26 chicken high mortality outbreaks, 4 cattle disease outbreaks, 3 pig disease outbreaks, and 3 fish disease outbreaks. In all cases, the communities and animal authorities cooperated to apply community contingency plans to control these outbreaks, and community volunteers continued to monitor the abnormal events for 3 weeks after each outbreak was controlled. Conclusions By design, PODD initially targeted only animal diseases that potentially could emerge into human pandemics (eg, avian influenza) and then, in response to community needs, expanded to cover human health and environmental health issues. PMID:29563079

One Health and Cyanobacteria in Freshwater Systems: Animal Illnesses and Deaths Are Sentinel Events for Human Health Risks

PubMed Central

Hilborn, Elizabeth D.; Beasley, Val R.

2015-01-01

Harmful cyanobacterial blooms have adversely impacted human and animal health for thousands of years. Recently, the health impacts of harmful cyanobacteria blooms are becoming more frequently detected and reported. However, reports of human and animal illnesses or deaths associated with harmful cyanobacteria blooms tend to be investigated and reported separately. Consequently, professionals working in human or in animal health do not always communicate findings related to these events with one another. Using the One Health concept of integration and collaboration among health disciplines, we systematically review the existing literature to discover where harmful cyanobacteria-associated animal illnesses and deaths have served as sentinel events to warn of potential human health risks. We find that illnesses or deaths among livestock, dogs and fish are all potentially useful as sentinel events for the presence of harmful cyanobacteria that may impact human health. We also describe ways to enhance the value of reports of cyanobacteria-associated illnesses and deaths in animals to protect human health. Efficient monitoring of environmental and animal health in a One Health collaborative framework can provide vital warnings of cyanobacteria-associated human health risks. PMID:25903764

One health and cyanobacteria in freshwater systems: animal illnesses and deaths are sentinel events for human health risks.

PubMed

Hilborn, Elizabeth D; Beasley, Val R

2015-04-20

Harmful cyanobacterial blooms have adversely impacted human and animal health for thousands of years. Recently, the health impacts of harmful cyanobacteria blooms are becoming more frequently detected and reported. However, reports of human and animal illnesses or deaths associated with harmful cyanobacteria blooms tend to be investigated and reported separately. Consequently, professionals working in human or in animal health do not always communicate findings related to these events with one another. Using the One Health concept of integration and collaboration among health disciplines, we systematically review the existing literature to discover where harmful cyanobacteria-associated animal illnesses and deaths have served as sentinel events to warn of potential human health risks. We find that illnesses or deaths among livestock, dogs and fish are all potentially useful as sentinel events for the presence of harmful cyanobacteria that may impact human health. We also describe ways to enhance the value of reports of cyanobacteria-associated illnesses and deaths in animals to protect human health. Efficient monitoring of environmental and animal health in a One Health collaborative framework can provide vital warnings of cyanobacteria-associated human health risks.

The influence of negative life events on hippocampal and amygdala volumes in old age: a life-course perspective.

PubMed

Gerritsen, L; Kalpouzos, G; Westman, E; Simmons, A; Wahlund, L O; Bäckman, L; Fratiglioni, L; Wang, H X

2015-04-01

Psychosocial stress has been related to changes in the nervous system, with both adaptive and maladaptive consequences. The aim of this study was to examine the relationship of negative events experienced throughout the entire lifespan and hippocampal and amygdala volumes in older adults. In 466 non-demented old adults (age range 60-96 years, 58% female), hippocampal and amygdala volumes were segmented using Freesurfer. Negative life events and the age at which these events occurred were assessed by means of a structured questionnaire. Using generalized linear models, hippocampal and amygdala volumes were estimated with life events as independent variables. The statistical analyses were adjusted for age, gender, intracranial volume, lifestyle factors, cardiovascular risk factors, depressive symptoms, and cognitive functioning. Total number of negative life events and of late-life events, but not of early-life, early-adulthood, or middle-adulthood events, was related to larger amygdala volume. There were interactions of early-life events with age and gender. Participants who reported two or more early-life events had significantly smaller amygdala and hippocampal volumes with increasing age. Furthermore, smaller hippocampal volume was found in men who reported two or more early-life events, but not in women. These results suggest that the effect of negative life events on the brain depends on the time when the events occurred, with the strongest effects observed during the critical time periods of early and late life.

Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study.

PubMed

Robinson, Susan N; Neyens, David M; Diller, Thomas

Most hospitals use occurrence reporting systems that facilitate identifying serious events that lead to root cause investigations. Thus, the events catalyze improvement efforts to mitigate patient harm. A serious limitation is that only a few of the occurrences are investigated. A challenge is leveraging the data to generate knowledge. The goal is to present a methodology to supplement these incident assessment efforts. The framework affords an enhanced understanding of patient safety through the use of control charts to monitor non-harm and harm incidents simultaneously. This approach can identify harm and non-harm reporting rates and also can facilitate monitoring occurrence trends. This method also can expedite identifying changes in workflow, processes, or safety culture. Although unable to identify root causes, this approach can identify changes in near real time. This approach also supports evaluating safety or policy interventions that may not be observable in annual safety climate surveys.

The nuts and bolts of pills and portions: the functions of a drug safety working group.

PubMed

Nath, Noleen S; Jones, Ellen H; Stride, Peter; Premaratne, Manuja; Thaker, Darshit; Lim, Ivan

2011-11-01

Hospitalised patients commonly experience adverse drug events (ADEs) and medication errors. Runciman reported that ADEs in hospitals account for 20% of reported adverse events and contribute to 27% of deaths where death followed an adverse event. Hughes recommends multidisciplinary hospital drug committees to assess performance and raise standards. The new Code of Conduct of the Medical Board of Australia recommends participation in systems for surveillance and monitoring of adverse events, and to improve patient safety. We describe the functions and role of a Drug Safety Working Group (DSWG) in a suburban hospital, which aims to audit and promote a culture of prescribing and medication administration that is prudent and cautious to minimise the risk of harm to patients. We believe that regular prescription monitoring and feedback to Resident Medical Officers (RMOs) improves medication management in our hospital.

When the Sky Falls NASA's Response to Bright Bolide Events Over Continental USA

NASA Technical Reports Server (NTRS)

Blaauw, R. C.; Cooke, W. J.; Kingery, A. M.; Moser, D. E.

2015-01-01

Being the only U.S. Government entity charged with monitoring the meteor environment, the Meteoroid Environment Office (MEO) has deployed a network of allsky and wide field meteor cameras, along with the appropriate software tools to quickly analyze data from these systems. However, the coverage of this network is still quite limited, forcing the incorporation of data from other cameras posted to the internet in analyzing many of the fireballs reported by the public and media. Information on these bright events often needs to be reported to NASA Headquarters by noon the following day; thus a procedure has been developed that determines the analysis process for a given fireball event based on the types and amount of data available. The differences between these analysis processes are shown by looking at four meteor events that the MEO responded to, all of which were large enough to produce meteorites.

29 CFR 4043.27 - Distribution to a substantial owner.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.27 Distribution to a substantial owner. (a) Reportable event. A reportable event occurs for... does not exceed the limitation (as of the date the reportable event occurs) under section 415(b)(1)(A...

29 CFR 4043.27 - Distribution to a substantial owner.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.27 Distribution to a substantial owner. (a) Reportable event. A reportable event occurs for... does not exceed the limitation (as of the date the reportable event occurs) under section 415(b)(1)(A...

29 CFR 4043.27 - Distribution to a substantial owner.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.27 Distribution to a substantial owner. (a) Reportable event. A reportable event occurs for... does not exceed the limitation (as of the date the reportable event occurs) under section 415(b)(1)(A...

29 CFR 4043.27 - Distribution to a substantial owner.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.27 Distribution to a substantial owner. (a) Reportable event. A reportable event occurs for... does not exceed the limitation (as of the date the reportable event occurs) under section 415(b)(1)(A...

29 CFR 4043.27 - Distribution to a substantial owner.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.27 Distribution to a substantial owner. (a) Reportable event. A reportable event occurs for... does not exceed the limitation (as of the date the reportable event occurs) under section 415(b)(1)(A...

Development of a Bayesian Belief Network Runway Incursion and Excursion Model

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2014-01-01

In a previous work, a statistical analysis of runway incursion (RI) event data was conducted to ascertain the relevance of this data to the top ten Technical Challenges (TC) of the National Aeronautics and Space Administration (NASA) Aviation Safety Program (AvSP). The study revealed connections to several of the AvSP top ten TC and identified numerous primary causes and contributing factors of RI events. The statistical analysis served as the basis for developing a system-level Bayesian Belief Network (BBN) model for RI events, also previously reported. Through literature searches and data analysis, this RI event network has now been extended to also model runway excursion (RE) events. These RI and RE event networks have been further modified and vetted by a Subject Matter Expert (SME) panel. The combined system-level BBN model will allow NASA to generically model the causes of RI and RE events and to assess the effectiveness of technology products being developed under NASA funding. These products are intended to reduce the frequency of runway safety incidents/accidents, and to improve runway safety in general. The development and structure of the BBN for both RI and RE events are documented in this paper.

Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System.

PubMed

Koff, Matthew D; Brown, Jeremiah R; Marshall, Emily J; O'Malley, A James; Jensen, Jens T; Heard, Stephen O; Longtine, Karen; O'Neill, Melissa; Longtine, Jaclyn; Houston, Donna; Robison, Cindy; Moulton, Eric; Patel, Hetal M; Loftus, Randy W

2016-08-01

BACKGROUND Healthcare provider hands are an important source of intraoperative bacterial transmission events associated with postoperative infection development. OBJECTIVE To explore the efficacy of a novel hand hygiene improvement system leveraging provider proximity and individual and group performance feedback in reducing 30-day postoperative healthcare-associated infections via increased provider hourly hand decontamination events. DESIGN Randomized, prospective study. SETTING Dartmouth-Hitchcock Medical Center in New Hampshire and UMass Memorial Medical Center in Massachusetts. PATIENTS Patients undergoing surgery. METHODS Operating room environments were randomly assigned to usual intraoperative hand hygiene or to a personalized, body-worn hand hygiene system. Anesthesia and circulating nurse provider hourly hand decontamination events were continuously monitored and reported. All patients were followed prospectively for the development of 30-day postoperative healthcare-associated infections. RESULTS A total of 3,256 operating room environments and patients (1,620 control and 1,636 treatment) were enrolled. The mean (SD) provider hand decontamination event rate achieved was 4.3 (2.9) events per hour, an approximate 8-fold increase in hand decontamination events above that of conventional wall-mounted devices (0.57 events/hour); P<.001. Use of the hand hygiene system was not associated with a reduction in healthcare-associated infections (odds ratio, 1.07 [95% CI, 0.82-1.40], P=.626). CONCLUSIONS The hand hygiene system evaluated in this study increased the frequency of hand decontamination events without reducing 30-day postoperative healthcare-associated infections. Future work is indicated to optimize the efficacy of this hand hygiene improvement strategy. Infect Control Hosp Epidemiol 2016;37:888-895.

Initial Evaluation of Signal-Based Bayesian Monitoring

NASA Astrophysics Data System (ADS)

Moore, D.; Russell, S.

2016-12-01

We present SIGVISA (Signal-based Vertically Integrated Seismic Analysis), a next-generation system for global seismic monitoring through Bayesian inference on seismic signals. Traditional seismic monitoring systems rely on discrete detections produced by station processing software, discarding significant information present in the original recorded signal. By modeling signals directly, our forward model is able to incorporate a rich representation of the physics underlying the signal generation process, including source mechanisms, wave propagation, and station response. This allows inference in the model to recover the qualitative behavior of geophysical methods including waveform matching and double-differencing, all as part of a unified Bayesian monitoring system that simultaneously detects and locates events from a network of stations. We report results from an evaluation of SIGVISA monitoring the western United States for a two-week period following the magnitude 6.0 event in Wells, NV in February 2008. During this period, SIGVISA detects more than twice as many events as NETVISA, and three times as many as SEL3, while operating at the same precision; at lower precisions it detects up to five times as many events as SEL3. At the same time, signal-based monitoring reduces mean location errors by a factor of four relative to detection-based systems. We provide evidence that, given only IMS data, SIGVISA detects events that are missed by regional monitoring networks, indicating that our evaluations may even underestimate its performance. Finally, SIGVISA matches or exceeds the detection rates of existing systems for de novo events - events with no nearby historical seismicity - and detects through automated processing a number of such events missed even by the human analysts generating the LEB.

The threat simulation theory of the evolutionary function of dreaming: Evidence from dreams of traumatized children.

PubMed

Valli, Katja; Revonsuo, Antti; Pälkäs, Outi; Ismail, Kamaran Hassan; Ali, Karzan Jalal; Punamäki, Raija-Leena

2005-03-01

The threat simulation theory of dreaming (TST) () states that dream consciousness is essentially an ancient biological defence mechanism, evolutionarily selected for its capacity to repeatedly simulate threatening events. Threat simulation during dreaming rehearses the cognitive mechanisms required for efficient threat perception and threat avoidance, leading to increased probability of reproductive success during human evolution. One hypothesis drawn from TST is that real threatening events encountered by the individual during wakefulness should lead to an increased activation of the system, a threat simulation response, and therefore, to an increased frequency and severity of threatening events in dreams. Consequently, children who live in an environment in which their physical and psychological well-being is constantly threatened should have a highly activated dream production and threat simulation system, whereas children living in a safe environment that is relatively free of such threat cues should have a weakly activated system. We tested this hypothesis by analysing the content of dream reports from severely traumatized and less traumatized Kurdish children and ordinary, non-traumatized Finnish children. Our results give support for most of the predictions drawn from TST. The severely traumatized children reported a significantly greater number of dreams and their dreams included a higher number of threatening dream events. The dream threats of traumatized children were also more severe in nature than the threats of less traumatized or non-traumatized children.

Laboratory-Based Prospective Surveillance for Community Outbreaks of Shigella spp. in Argentina

PubMed Central

Viñas, María R.; Tuduri, Ezequiel; Galar, Alicia; Yih, Katherine; Pichel, Mariana; Stelling, John; Brengi, Silvina P.; Della Gaspera, Anabella; van der Ploeg, Claudia; Bruno, Susana; Rogé, Ariel; Caffer, María I.; Kulldorff, Martin; Galas, Marcelo

2013-01-01

Background To implement effective control measures, timely outbreak detection is essential. Shigella is the most common cause of bacterial diarrhea in Argentina. Highly resistant clones of Shigella have emerged, and outbreaks have been recognized in closed settings and in whole communities. We hereby report our experience with an evolving, integrated, laboratory-based, near real-time surveillance system operating in six contiguous provinces of Argentina during April 2009 to March 2012. Methodology To detect localized shigellosis outbreaks timely, we used the prospective space-time permutation scan statistic algorithm of SaTScan, embedded in WHONET software. Twenty three laboratories sent updated Shigella data on a weekly basis to the National Reference Laboratory. Cluster detection analysis was performed at several taxonomic levels: for all Shigella spp., for serotypes within species and for antimicrobial resistance phenotypes within species. Shigella isolates associated with statistically significant signals (clusters in time/space with recurrence interval ≥365 days) were subtyped by pulsed field gel electrophoresis (PFGE) using PulseNet protocols. Principal Findings In three years of active surveillance, our system detected 32 statistically significant events, 26 of them identified before hospital staff was aware of any unexpected increase in the number of Shigella isolates. Twenty-six signals were investigated by PFGE, which confirmed a close relationship among the isolates for 22 events (84.6%). Seven events were investigated epidemiologically, which revealed links among the patients. Seventeen events were found at the resistance profile level. The system detected events of public health importance: infrequent resistance profiles, long-lasting and/or re-emergent clusters and events important for their duration or size, which were reported to local public health authorities. Conclusions/Significance The WHONET-SaTScan system may serve as a model for surveillance and can be applied to other pathogens, implemented by other networks, and scaled up to national and international levels for early detection and control of outbreaks. PMID:24349586

Laboratory-based prospective surveillance for community outbreaks of Shigella spp. in Argentina.

PubMed

Viñas, María R; Tuduri, Ezequiel; Galar, Alicia; Yih, Katherine; Pichel, Mariana; Stelling, John; Brengi, Silvina P; Della Gaspera, Anabella; van der Ploeg, Claudia; Bruno, Susana; Rogé, Ariel; Caffer, María I; Kulldorff, Martin; Galas, Marcelo

2013-01-01

To implement effective control measures, timely outbreak detection is essential. Shigella is the most common cause of bacterial diarrhea in Argentina. Highly resistant clones of Shigella have emerged, and outbreaks have been recognized in closed settings and in whole communities. We hereby report our experience with an evolving, integrated, laboratory-based, near real-time surveillance system operating in six contiguous provinces of Argentina during April 2009 to March 2012. To detect localized shigellosis outbreaks timely, we used the prospective space-time permutation scan statistic algorithm of SaTScan, embedded in WHONET software. Twenty three laboratories sent updated Shigella data on a weekly basis to the National Reference Laboratory. Cluster detection analysis was performed at several taxonomic levels: for all Shigella spp., for serotypes within species and for antimicrobial resistance phenotypes within species. Shigella isolates associated with statistically significant signals (clusters in time/space with recurrence interval ≥365 days) were subtyped by pulsed field gel electrophoresis (PFGE) using PulseNet protocols. In three years of active surveillance, our system detected 32 statistically significant events, 26 of them identified before hospital staff was aware of any unexpected increase in the number of Shigella isolates. Twenty-six signals were investigated by PFGE, which confirmed a close relationship among the isolates for 22 events (84.6%). Seven events were investigated epidemiologically, which revealed links among the patients. Seventeen events were found at the resistance profile level. The system detected events of public health importance: infrequent resistance profiles, long-lasting and/or re-emergent clusters and events important for their duration or size, which were reported to local public health authorities. The WHONET-SaTScan system may serve as a model for surveillance and can be applied to other pathogens, implemented by other networks, and scaled up to national and international levels for early detection and control of outbreaks.

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

PubMed

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

2018-06-01

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 < .01). Inconsistent 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.

Gender differences in life events prior to onset of major depressive disorder: the moderating effect of age.

PubMed

Harkness, Kate L; Alavi, Nazanin; Monroe, Scott M; Slavich, George M; Gotlib, Ian H; Bagby, R Michael

2010-11-01

Theoretical models attempting to explain why approximately twice as many women as men suffer from depression often involve the role of stressful life events. However, detailed empirical evidence regarding gender differences in rates of life events that precede onset of depression is lacking, due in part to the common use of checklist assessments of stress that have been shown to possess poor validity. The present study reports on a combined sample of 375 individuals drawn from 4 studies in which all participants were diagnosed with major depressive disorder and assessed with the Life Events and Difficulties Schedule (Bifulco et al., 1989), a state-of-the-art contextual interview and life stress rating system. Women reported significantly more severe and nonsevere, independent and dependent, and other-focused and subject-focused life events prior to onset of depression than did men. Further, these relations were significantly moderated by age, such that gender differences in rates of most types of events were found primarily in young adulthood. These results are discussed in term of their implications for understanding the etiological role of stressful life events in depression. PsycINFO Database Record (c) 2010 APA, all rights reserved

Intrathecal Pump Exposure to Electromagnetic Interference: A Report of Device Interrogation following Multiple ECT Sessions.

PubMed

Bicket, Mark C; Hanna, George M

2016-02-01

Intrathecal drug delivery systems represent an increasingly common treatment modality for patients with a variety of conditions, including chronic pain and spasticity. Pumps rely on electronic programming to properly control and administer highly concentrated medications. Electromagnetic interference (EMI) is a known exposure that may cause a potential patient safety issue stemming from direct patient injury, pump damage, or changes to pump operation or flow rate. The objective of our case report was to describe an approach to evaluating a patient with a pump prior to and following exposure to EMI from electroconvulsive therapy (ECT), as well as to document findings from device interrogations associated with this event. Case report. Academic university-based pain management center. We present the case of a patient with an intrathecal pump who underwent multiple exposures to EMI in the form of 42 ECT sessions. Interrogation of the intrathecal drug delivery system revealed no safety issues following ECT sessions. At no time were error messages, unintentional changes in event logs, unintentional changes in pump settings, or evidence of pump stall or over-infusion noted. Communication with multiple entities (patient, family, consulting physicians, and device manufacturer) and maintaining vigilance through device interrogation both before and after EMI exposure are appropriate safeguards to mitigate the risk and detect potential adverse events of EMI with intrathecal drug delivery systems. Given the infrequent reports of device exposure to ECT, best practices may be derived from experience with EMI exposure from magnetic resonance imaging (MRI). Although routine EMI exposure to intrathecal drug delivery systems should be avoided, we describe one patient with repeated exposure to ECT without apparent complication.

Deaths, injuries, and evacuations from acute hazardous materials releases.

PubMed Central

Binder, S

1989-01-01

We examined reports from three surveillance systems of 587 acute releases of hazardous materials in 1986. These releases resulted in at least 115 deaths, 2,254 injuries, and 111 evacuations. Only eight (1 percent) of the 587 events were common to all three systems. Estimates of the public health consequences of hazardous materials releases could be improved by enforcing existing laws, modifying report forms, and validating collected information. PMID:2751024

Defense Departmental Reporting System-Budgetary Was Not Effectively Implemented for the Army General Fund

DTIC Science & Technology

2012-05-31

or events. Unsupported journal vouchers increase the risk of materially misstated balances reported on the AGF financial statements. DFAS...with U.S. generally accepted accounting principles and that the Army automated systems did not support material amounts on the financial statements...files, abnormal balance detection , journal vouchers, and reconciliations between Army and OMB SF 133s and the Statements of Budgetary Resources

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

PubMed

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.

Age, cumulative trauma and stressful life events, and post-traumatic stress symptoms among older adults in prison: do subjective impressions matter?

PubMed

Maschi, Tina; Morgen, Keith; Zgoba, Kristen; Courtney, Deborah; Ristow, Jennifer

2011-10-01

The aging prison population in the United States presents a significant public health challenge with high rates of trauma and mental health issues that the correctional system alone is ill-prepared to address. The purpose of this study was to examine the relationship of age, objective, and subjective measures of trauma and stressful life events and post-traumatic stress symptoms among older adults in prison. Data were gathered from 334 prisoners (aged 55+) housed in the New Jersey Department of Corrections, as of September 2010. An anonymous self-report, self-administered survey was mailed to the total population of 1,000 prisoners aged 55 years and older. Objective and subjective trauma was measured using the Life Stressors Checklist-Revised (LSC-R), and post-traumatic stress symptoms were measured using the Civilian Version of the Post-traumatic Stress Scale. Results of a path analysis revealed that past year subjective impressions of traumatic and stressful life events had a positive and significant relationship to current post-traumatic stress symptoms. Age was found to have a significant and inverse relationship to subjective traumatic and stressful life events. That is, younger participants reported higher levels of cumulative traumatic and stressful life events and past year subjective ratings of being bothered by these past events. These findings have significance for interdisciplinary/interprofessional practice and appropriate institutional and community care, including reentry planning of older adults in the criminal justice system.

Electronic Learning: Perspectives on Maintaining an Educational Relationship through Electronic Communication.

ERIC Educational Resources Information Center

Keenan, Thomas P.

Fifty gifted teenagers from across Canada, who were taught the Honeywell MULTICS "mail" and "forum" systems, were allowed free reign on an electronic communication system for several months. This paper reports on the students' use of the system, and on some of the interesting and unusual events which occurred during the course…

29 CFR 4043.26 - Inability to pay benefits when due.

Code of Federal Regulations, 2014 CFR

2014-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.26 Inability to pay benefits when due. (a) Reportable event. A reportable event occurs when a plan is...) Waivers. Notice is waived unless the reportable event occurs during a plan year for which the plan is...

29 CFR 4043.26 - Inability to pay benefits when due.

Code of Federal Regulations, 2012 CFR

2012-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.26 Inability to pay benefits when due. (a) Reportable event. A reportable event occurs when a plan is...) Waivers. Notice is waived unless the reportable event occurs during a plan year for which the plan is...

29 CFR 4043.26 - Inability to pay benefits when due.

Code of Federal Regulations, 2011 CFR

2011-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.26 Inability to pay benefits when due. (a) Reportable event. A reportable event occurs when a plan is...) Waivers. Notice is waived unless the reportable event occurs during a plan year for which the plan is...

29 CFR 4043.26 - Inability to pay benefits when due.

Code of Federal Regulations, 2013 CFR

2013-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.26 Inability to pay benefits when due. (a) Reportable event. A reportable event occurs when a plan is...) Waivers. Notice is waived unless the reportable event occurs during a plan year for which the plan is...

29 CFR 4043.26 - Inability to pay benefits when due.

Code of Federal Regulations, 2010 CFR

2010-07-01

... REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.26 Inability to pay benefits when due. (a) Reportable event. A reportable event occurs when a plan is...) Waivers. Notice is waived unless the reportable event occurs during a plan year for which the plan is...

Flight Tests of the Turbulence Prediction and Warning System (TPAWS)

NASA Technical Reports Server (NTRS)

Hamilton, David W.; Proctor, Fred H.; Ahmad, Nashat N.

2012-01-01

Flight tests of the National Aeronautics and Space Administration's Turbulence Prediction And Warning System (TPAWS) were conducted in the Fall of 2000 and Spring of 2002. TPAWS is a radar-based airborne turbulence detection system. During twelve flights, NASA's B-757 tallied 53 encounters with convectively induced turbulence. Analysis of data collected during 49 encounters in the Spring of 2002 showed that the TPAWS Airborne Turbulence Detection System (ATDS) successfully detected 80% of the events at least 30 seconds prior to the encounter, achieving FAA recommended performance criteria. Details of the flights, the prevailing weather conditions, and each of the turbulence events are presented in this report. Sensor and environmental characterizations are also provided.

An expert system for scheduling requests for communications Links between TDRSS and ERBS

NASA Technical Reports Server (NTRS)

Mclean, David R.; Littlefield, Ronald G.; Beyer, David S.

1987-01-01

An ERBS-TDRSS Contact Planning System (ERBS-TDRSS CPS) is described which uses a graphics interface and the NASA Transportable Interference Engine. The procedure involves transfer of the ERBS-TDRSS Ground Track Orbit Prediction data to the ERBS flight operations area, where the ERBS-TDRSS CPS automatically generates requests for TDRSS service. As requested events are rejected, alternative context sensitive strategies are employed to generate new requested events until a schedule is completed. A report generator builds schedule requests for separate ERBS-TDRSS contacts.

Acute renal failure with sodium-glucose-cotransporter-2 inhibitors: Analysis of the FDA adverse event report system database.

PubMed

Perlman, A; Heyman, S N; Matok, I; Stokar, J; Muszkat, M; Szalat, A

2017-12-01

Sodium-glucose-cotransporter-2 (SGLT2) inhibitors have recently been approved for the treatment of type II diabetes mellitus (T2DM). It has been proposed that these agents could induce acute renal failure (ARF) under certain conditions. This study aimed to evaluate the association between SGLT2-inhibitors and ARF in the FDA adverse event report system (FAERS) database. We analyzed adverse event cases submitted to FAERS between January 2013 and September 2016. ARF cases were identified using a structured medical query. Medications were identified using both brand and generic names. During the period evaluated, 18,915 reports (out of a total of 3,832,015 registered in FAERS) involved the use of SGLT2-inhibitors. SGLT2-inhibitors were reportedly associated with ARF in 1224 of these cases (6.4%), and were defined as the "primary" or "secondary" cause of the adverse event in 96.8% of these cases. The proportion of reports with ARF among reports with SGLT2 inhibitor was almost three-fold higher compared to reports without these drugs (ROR 2.88, 95% CI 2.71-3.05, p < 0.001). The proportion of ARF reports among cases with SGLT2-inhibitors was significantly greater than the proportion of ARF among cases with T2DM without SGLT2-inhibitors (ROR 1.68, 95% CI 1.57-1.8, p < 0.001). Among the SGLT2-inhibitors, canagliflozin was associated with a higher proportion of reports of renal failure (7.3%), compared to empagliflozin and dapagliflozin (4.7% and 4.8% respectively, p < 0.001). SGLT2-inhibitors are associated with an increase in the proportion of reports of ARF compared to other medications. SGLT2-inhibitor agents may differ from one another in their respective risk for ARF. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Basch, Ethan, E-mail: ebasch@med.unc.edu; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina; Pugh, Stephanie L.

Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visitsmore » when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies.« less

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial.

PubMed

Basch, Ethan; Pugh, Stephanie L; Dueck, Amylou C; Mitchell, Sandra A; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J; Gatewood, Marcha; Reeve, Bryce B; Mendoza, Tito R; O'Mara, Ann M; Denicoff, Andrea M; Minasian, Lori M; Bennett, Antonia V; Setser, Ann; Schrag, Deborah; Roof, Kevin; Moore, Joan K; Gergel, Thomas; Stephans, Kevin; Rimner, Andreas; DeNittis, Albert; Bruner, Deborah Watkins

2017-06-01

To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling "too sick." Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be obviated by allowing patients to self-report electronically between visits, and by using central compliance monitoring. These approaches are being incorporated into ongoing studies. Copyright © 2017 Elsevier Inc. All rights reserved.

Energy drinks and their adverse health effects: A systematic review of the current evidence.

PubMed

Ali, Fahad; Rehman, Hiba; Babayan, Zaruhi; Stapleton, Dwight; Joshi, Divya-Devi

2015-04-01

With the rising consumption of so-called energy drinks over the last few years, there has been a growing body of literature describing significant adverse health events after the ingestion of these beverages. To gain further insight about the clinical spectrum of these adverse events, we conducted a literature review. Using PubMed and Google-Scholar, we searched the literature from January 1980 through May 2014 for articles on the adverse health effects of energy drinks. A total of 2097 publications were found. We then excluded molecular and industry-related studies, popular media reports, and case reports of isolated caffeine toxicity, yielding 43 reports. Energy drink consumption is a health issue primarily of the adolescent and young adult male population. It is linked to increased substance abuse and risk-taking behaviors. The most common adverse events affect the cardiovascular and neurological systems. The most common ingredient in energy drinks is caffeine, and it is believed that the adverse events are related to its effects, as well as potentiating effects of other stimulants in these drinks. Education, regulation, and further studies are required.

A Systematic Review of Waterborne Disease Outbreaks Associated with Small Non-Community Drinking Water Systems in Canada and the United States.

PubMed

Pons, Wendy; Young, Ian; Truong, Jenifer; Jones-Bitton, Andria; McEwen, Scott; Pintar, Katarina; Papadopoulos, Andrew

2015-01-01

Reports of outbreaks in Canada and the United States (U.S.) indicate that approximately 50% of all waterborne diseases occur in small non-community drinking water systems (SDWSs). Summarizing these investigations to identify the factors and conditions contributing to outbreaks is needed in order to help prevent future outbreaks. The objectives of this study were to: 1) identify published reports of waterborne disease outbreaks involving SDWSs in Canada and the U.S. since 1970; 2) summarize reported factors contributing to outbreaks, including water system characteristics and events surrounding the outbreaks; and 3) identify terminology used to describe SDWSs in outbreak reports. Three electronic databases and grey literature sources were searched for outbreak reports involving SDWSs throughout Canada and the U.S. from 1970 to 2014. Two reviewers independently screened and extracted data related to water system characteristics and outbreak events. The data were analyzed descriptively with 'outbreak' as the unit of analysis. From a total of 1,995 citations, we identified 50 relevant articles reporting 293 unique outbreaks. Failure of an existing water treatment system (22.7%) and lack of water treatment (20.2%) were the leading causes of waterborne outbreaks in SDWSs. A seasonal trend was observed with 51% of outbreaks occurring in summer months (p<0.001). There was large variation in terminology used to describe SDWSs, and a large number of variables were not reported, including water source and whether water treatment was used (missing in 31% and 66% of reports, respectively). More consistent reporting and descriptions of SDWSs in future outbreak reports are needed to understand the epidemiology of these outbreaks and to inform the development of targeted interventions for SDWSs. Additional monitoring of water systems that are used on a seasonal or infrequent basis would be worthwhile to inform future protection efforts.

A Systematic Review of Waterborne Disease Outbreaks Associated with Small Non-Community Drinking Water Systems in Canada and the United States

PubMed Central

Jones-Bitton, Andria; McEwen, Scott; Pintar, Katarina; Papadopoulos, Andrew

2015-01-01

Background Reports of outbreaks in Canada and the United States (U.S.) indicate that approximately 50% of all waterborne diseases occur in small non-community drinking water systems (SDWSs). Summarizing these investigations to identify the factors and conditions contributing to outbreaks is needed in order to help prevent future outbreaks. Objectives The objectives of this study were to: 1) identify published reports of waterborne disease outbreaks involving SDWSs in Canada and the U.S. since 1970; 2) summarize reported factors contributing to outbreaks, including water system characteristics and events surrounding the outbreaks; and 3) identify terminology used to describe SDWSs in outbreak reports. Methods Three electronic databases and grey literature sources were searched for outbreak reports involving SDWSs throughout Canada and the U.S. from 1970 to 2014. Two reviewers independently screened and extracted data related to water system characteristics and outbreak events. The data were analyzed descriptively with ‘outbreak’ as the unit of analysis. Results From a total of 1,995 citations, we identified 50 relevant articles reporting 293 unique outbreaks. Failure of an existing water treatment system (22.7%) and lack of water treatment (20.2%) were the leading causes of waterborne outbreaks in SDWSs. A seasonal trend was observed with 51% of outbreaks occurring in summer months (p<0.001). There was large variation in terminology used to describe SDWSs, and a large number of variables were not reported, including water source and whether water treatment was used (missing in 31% and 66% of reports, respectively). Conclusions More consistent reporting and descriptions of SDWSs in future outbreak reports are needed to understand the epidemiology of these outbreaks and to inform the development of targeted interventions for SDWSs. Additional monitoring of water systems that are used on a seasonal or infrequent basis would be worthwhile to inform future protection efforts. PMID:26513152

Earfold Implantable Clip System for Correction of Prominent Ears: Analysis of Safety in 403 Patients

PubMed Central

Sojitra, Nilesh; Glumicic, Sinisa; Vlok, Jacobus A.; O’Toole, Greg; Hannan, S. Alam; Sabbagh, Walid

2018-01-01

Background: The Earfold system, a new treatment for the correction of prominent ears, consists of 3 components: the Earfold implant, the Earfold introducer, and the Prefold positioner. Methods: This is an interim report based on an ongoing analysis of safety in a series of patients treated for prominent ears with the Earfold implant between February 2013 and September 2014. Safety was assessed based on adverse event reports and the need for implant revision; follow-up is ongoing. Results: Seven surgeons used 1,200 Earfold implants to treat 403 patients (ages, 7–70 years; 63% male); the time since the initial implant procedure now ranges from 30 to 48 months. To date, 145 patients (36%) have returned for a follow-up visit (mean, 7.7 months [range, 1–34 months]). Adverse events requiring intervention have affected 39 of 403 (9.7%) patients; these include implant revisions (n = 17 [4.2%], most often due to implant visibility), skin erosion over the implant (n = 15 [3.7%]), and infection (n = 7 [1.7%]). Bleeding, recurrence of prominence, hematoma, deformity, or adverse scarring did not occur. Conclusions: This interim analysis has shown that Earfold prominent ear correction system is associated with relatively few adverse events that require intervention; a small number of patients experienced infection, implant extrusion, or implant visibility that required revision. Most adverse events were related to either patient selection or technical errors at implantation. It is expected that with continued use of Earfold by surgeons experienced in otoplasty, the adverse event incidence will decrease. PMID:29464160

29 CFR 4043.33 - Application for minimum funding waiver.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.33 Application for minimum funding waiver. (a) Reportable event. A reportable event for a...

29 CFR 4043.33 - Application for minimum funding waiver.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.33 Application for minimum funding waiver. (a) Reportable event. A reportable event for a...

29 CFR 4043.33 - Application for minimum funding waiver.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.33 Application for minimum funding waiver. (a) Reportable event. A reportable event for a...

29 CFR 4043.33 - Application for minimum funding waiver.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.33 Application for minimum funding waiver. (a) Reportable event. A reportable event for a...

29 CFR 4043.33 - Application for minimum funding waiver.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.33 Application for minimum funding waiver. (a) Reportable event. A reportable event for a...

The FIFA Women’s World Cup in Germany 2011 – A practical example for tailoring an event-specific enhanced infectious disease surveillance system

PubMed Central

2012-01-01

Background Mass gatherings require a decision from public health authorities on how to monitor infectious diseases during the event. The appropriate level of enhanced surveillance depends on parameters like the scale of the event (duration, spatial distribution, season), participants’ origin, amount of public attention, and baseline disease activity in the host country. For the FIFA Men’s World Cup 2006, Germany implemented enhanced surveillance. As the scale of the FIFA Women’s World Cup (June 26 – July 17, 2011) was estimated to be substantially smaller in size, visitors and duration, it was not feasible to simply adopt the previously implemented measures. Our aim was therefore to develop a strategy to tailor an event-specific enhanced surveillance for this smaller-scale mass gathering. Methods Based on the enhanced surveillance measures during the Men’s Cup, we conducted a needs assessment with the district health authorities in the 9 host cities in March 2011. Specific measures with a majority consent were implemented. After the event, we surveyed the 9 district and their corresponding 7 state health authorities to evaluate the implemented measures. Results All 9 district health authorities participated in the pre-event needs assessment. The majority of sites consented to moving from weekly to daily (Monday-Friday) notification reporting of routine infectious diseases, receiving regular feedback on those notification reports and summaries of national/international World Cup-relevant epidemiological incidents, e.g. outbreaks in countries of participating teams. In addition, we decided to implement twice-weekly reports of “unusual events” at district and state level. This enhanced system would commence on the first day and continue to one day following the tournament. No World Cup-related infectious disease outbreaks were reported during this time period. Eight of 9 district and 6 of 8 state health authorities participated in the final evaluation. The majority perceived the implemented measures as adequate. Conclusions Our approach to tailor an event-specific enhanced surveillance concept worked well. Involvement of the participating stakeholders early-on in the planning phase secured ownership of and guaranteed support for the chosen strategy. The enhanced surveillance for this event resulted as a low-level surveillance. However, we included mechanisms for rapid upscaling if the situation would require adaptations. PMID:22849632

[Adverse events self-declaration system and influenza vaccination coverage of healthcare workers in a tertiary hospital].

PubMed

Velasco Munoz, Cesar; Sequera, Víctor-Guillermo; Vilajeliu, Alba; Aldea, Marta; Mena, Guillermo; Quesada, Sebastiana; Varela, Pilar; Olivé, Victoria; Bayas, José M; Trilla, Antoni

2016-02-19

During the influenza vaccination campaign 2011-2012 we established a self-declaration system of adverse events (AEs) in healthcare workers (HCW). The aim of this study is to describe the vaccinated population and analyse vaccination coverage and self-declared AEs after the voluntary flu vaccination in a university hospital in Barcelona. Observational study. We used the HCW immunization record to calculate the vaccination coverage. We collected AEs using a voluntary, anonymous, self-administered survey during the 2011-2012 flu vaccination campaign. We performed a logistic regression model to determine the associated factors to declare AEs. The influenza vaccination coverage in HCW was 30.5% (n=1,507/4,944). We received completed surveys from 358 vaccinated HCW (23.8% of all vaccinated). We registered AEs in 186 respondents to the survey (52.0% of all respondents). Of these, 75.3% (n=140) reported local symptoms after the flu vaccination, 9.7% (n=18) reported systemic symptoms and 15.1% (n=28) both local and systemic symptoms. No serious AEs were self-reported. Female sex and aged under 35 were both factors associated with declaring AEs. Our self-reporting system did not register serious AEs in HCW, resulting in an opportunity to improve HCW trust in flu vaccination. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Vaccine Safety

MedlinePlus

... Search Form Controls Cancel Submit Search The CDC Vaccine Safety Note: Javascript is disabled or is not ... CDC.gov . Recommend on Facebook Tweet Share Compartir Vaccine Adverse Events Reporting System (VAERS) New website and ...

29 CFR 4043.22 - Amendment decreasing benefits payable.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.22 Amendment decreasing benefits payable. (a) Reportable event. A reportable event occurs... contributions with respect to any participant may be decreased. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.21 - Tax disqualification and title I noncompliance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.21 Tax disqualification and title I noncompliance. (a) Reportable event. A reportable event... with title I of ERISA. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.22 - Amendment decreasing benefits payable.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.22 Amendment decreasing benefits payable. (a) Reportable event. A reportable event occurs... contributions with respect to any participant may be decreased. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.21 - Tax disqualification and title I noncompliance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.21 Tax disqualification and title I noncompliance. (a) Reportable event. A reportable event... with title I of ERISA. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.22 - Amendment decreasing benefits payable.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.22 Amendment decreasing benefits payable. (a) Reportable event. A reportable event occurs... contributions with respect to any participant may be decreased. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.21 - Tax disqualification and title I noncompliance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.21 Tax disqualification and title I noncompliance. (a) Reportable event. A reportable event... with title I of ERISA. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.21 - Tax disqualification and title I noncompliance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.21 Tax disqualification and title I noncompliance. (a) Reportable event. A reportable event... with title I of ERISA. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.21 - Tax disqualification and title I noncompliance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.21 Tax disqualification and title I noncompliance. (a) Reportable event. A reportable event... with title I of ERISA. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.22 - Amendment decreasing benefits payable.

Code of Federal Regulations, 2013 CFR

2013-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.22 Amendment decreasing benefits payable. (a) Reportable event. A reportable event occurs... contributions with respect to any participant may be decreased. (b) Waivers. Notice is waived for this event. ...

29 CFR 4043.22 - Amendment decreasing benefits payable.

Code of Federal Regulations, 2011 CFR

2011-07-01

... TERMINATIONS REPORTABLE EVENTS AND CERTAIN OTHER NOTIFICATION REQUIREMENTS Post-Event Notice of Reportable Events § 4043.22 Amendment decreasing benefits payable. (a) Reportable event. A reportable event occurs... contributions with respect to any participant may be decreased. (b) Waivers. Notice is waived for this event. ...