Event Notification Research Articles

Auditoria interna para a estratificação do problema da qualidade das equipes de enfermagem na COVID-19

Objetivo: descrever o gerenciamento da rotina do trabalho do dia a dia para análise da qualidade das equipes de enfermagem, por meio de uma auditoria interna, para determinar as não conformidades no cuidado ao doente grave com a COVID-19. Método: trata-se de um relato de experiência da aplicação do modelo de gerenciamento da rotina do trabalho do dia a dia, na auditoria interna da UTI de um hospital universitário, no Rio de Janeiro. O estudo contou com quatro fases, a coleta de dados foi realizada por meio de entrevista com formulário, por uma enfermeira especialista no modelo de gestão da qualidade total japonês. Foi empregado o ciclo de Plan, Do, Check e Act (PCDA), a análise descritiva e a análise de Pareto. Resultados: mesmo após a supervisão das equipes interprofissionais de enfermagem pelas coordenadoras da assistência de enfermagem, 94% das equipes não modificaram seu comportamento e estavam em não conformidades, avaliadas pelas evoluções de enfermagem, aprazamento das prescrições médicas, roteiro de passagem de plantão e notificações de eventos adversos sensíveis à assistência de enfermagem. Considerações finais: apesar do controle de qualidade da assistência de enfermagem pelas enfermeiras gerentes ser efetivo, a auditoria interna mostrou que, direta ou indiretamente, as anomalias tinham relação com: a supervisão direta de enfermagem com uso ininterrupto de Equipamento de Proteção Individual (EPI); uso de estratégias de comunicação inefetivas; falta de rigor no processo de avaliação da admissão de novos profissionais de enfermagem; procedimentos operacionais padrões em desconformidade e a péssima capacitação realizada na admissão das equipes interprofissionais para atuar no tratamento da COVID-19 na UTI.

Cultura de segurança e notificação de eventos adversos em unidades de terapia intensiva

Introdução: A segurança do paciente envolve ações de prevenção e notificação de eventos adversos (EA), e deve constituir a cultura organizacional, incluindo atitudes seguras por parte da equipe, para garantir os melhores resultados possíveis ao paciente. Diante da magnitude do tema, este estudo teve como objetivo analisar a cultura de segurança da equipe de enfermagem de unidades de terapia intensiva (UTIs) de um hospital público. Metodologia: Trata-se de um estudo descritivo, longitudinal e de abordagem quantitativa, realizado em três UTIs, de um hospital de referência no sudoeste da Bahia. A pesquisa foi realizada em três etapas, na primeira etapa, foi aplicado o Questionário de Atitudes de Segurança (SAQ); na segunda etapa, realizou-se uma atividade de intervenção, para reforçar a importância da notificação de EA; e, na terceira etapa, houve acompanhamento por dois meses dessas notificações. Resultado: os escores do SAQ estavam abaixo da média recomendada de 75 pontos, apenas o domínio satisfação do trabalho obteve escore desejável. Ao analisar as diferenças entre as categorias enfermeiro e técnico de enfermagem, houve associação estatisticamente significante para o domínio percepção do estresse (p=0,039). Após a intervenção, foram registradas 152 notificações, sendo 117 (77%) relacionadas a eventos gerenciais. Conclusão: Pode-se perceber a fragilidade no que se refere à cultura de segurança nas UTIs e a necessidade de se investigar o estresse da equipe e de promover educação permanente para a melhoria no cuidado prestado na notificação dos EA e a melhoria dos processos de trabalho.

The Five Key Components for Building An Operational Business Intelligence Ecosystem

Business intelligence (BI) is a broad category of business information system that plays a vital role in decision making. Traditional BI systems are designed to support for decision making to strategic users. The components in the traditional BI system are limited analytical functionality and lack of monitoring of business performance, alert engine, self-service reports, operational analytics and decision models capabilities. Further, the need and usage of BI systems for operational decision making have significantly increased for a timely decision to all users in the organisations. Operational BI is not a merely a combination of operational and BI systems, but they constitute the whole complex components that cover overall functionalities from storage, process, monitor, visualise and delivering information to form an ecosystem. In this paper, the key components of an operational BI ecosystem are presented, and their workings explained. The methodology adopted for key component identification is based on modularity using cohesion and coupling parameters of software engineering. The proposed key components of the system are operational analytics, event notification monitoring, business performance management, operational reports and the portal. An orderly arrangement of these key components constitutes an operational BI ecosystem.

Small Patients and Tiny CAUTI Rates: Sustained CAUTI Reduction in a Children's Hospital

<h3>Background</h3> The pediatric catheter associated urinary tract infection (CAUTI) prevention team was formed in August 2015 to address a patient safety need. CAUTI rates, specifically in the pediatric intensive care unit (PICU), was consistently above national benchmarks, resulting in unnecessary harm to patients. <h3>Methods</h3> The CAUTI prevention team is a multidisciplinary team made up of bedside staff, physicians, and specialists. The team discusses metrics, bundle compliance and new products, and makes recommendations for Foley use and care. Education is provided regularly to bedside staff and physicians, with real time notification of CAUTI events. Since the development in 2015, the team has been able to move from general CAUTI education to specific and targeted reduction tactics. The team provides real-time notification to bedside staff to discuss Foleys in place greater than 2 days in order to facilitate removal. The team also provides weekly personalized utilization rates to ICU physicians for their own trending. Additionally, the team has expanded standardized patient bathing across the hospital, and developed tools for decreased discomfort and anxiety during catheterization processes. <h3>Results</h3> Since the team was formed in 2015, sustained improvement has been seen in CAUTI reduction with a 56% decrease hospital-wide and a 67% decrease specifically in the pediatric intensive care unit (PICU). Additionally, a process shift for Foley utilization in the PICU was seen in August 2016, and has been sustained to date. Prior to committee formation, Foley utilization was as high as 30%. In the last quarter, utilization averaged 10%, a 66% decrease. <h3>Conclusions</h3> The team has established, and more importantly sustained, standards for Foley use and care that have had significant impact on CAUTI rates in our hospital, preventing our patients from harm.

LoRa-Based Anomaly Detection Platform: Center and Sensor-Side

The implementation of a LoRa-based wireless sensor network, aiming to operate as an edge-based anomaly detection system is elaborated in this paper. The dominant prerequisites are defined as achieving a maximum possible sensing rate on edge, minimum Communication packet loss, the lowest possible false alarm, and the optimal resource management. In this regard, the developed sensor-side algorithm manages measurements accordingly to make effective communications with the center while transmitting either notification or requested compressed data packets. On the other side, a central algorithm keeps all the authorized sensors synchronized and updated. Besides, the center avoids network congestion primarily by queuing the received event notifications and later, by transmitting the data queries consecutively under supervision. The re-construction of the received anomaly-related data packets for further evaluations is another task to do by the center. Overall, the complementary proposal is experimentally tested and validated through the network operation in a worst-case scenario.

Adverse events encountered during clinical placements by undergraduate nursing students in Spain

BackgroundDuring clinical placements, nursing students are exposed to adverse events generated by the clinical tasks they must perform. ObjectivesTo describe the profile of adverse events encountered and the risks facing nursing students in clinical practice, as well as the severity and incidence of these events. DesignObservational retrospective longitudinal study. SettingClinical placements of undergraduate nursing students from the University of Málaga, in hospitals and primary health care. ParticipantsA total of 4284 undergraduate nursing students, enrolled during seven consecutive years (2011–2018). MethodsStudy data were obtained from students' notifications of adverse events during their clinical placements. The form for making this notification is available online, in the virtual campus for the practicum and notification is mandatory. ResultsA total of 1638 reports of adverse events were made during the study period. The adverse events most commonly reported were clinical accidents, followed by sharp and needle-stick injuries, and medication errors. By clinical settings, adverse events occurring in critical care were most frequently reported (35.9%). By the severity of the event, the largest proportion (32.4%) were classified as serious. By the risk of recurrence, 49.8% of the events reported were classified as accidents that “could happen again at some time”. In this respect, there were significant differences among the respondents, with fourth-year students reporting up to four times more events of this type than second and third-year students (p < 0.001). ConclusionsNursing students are subject to clinical safety-related events during their practices, mostly concerning medication errors and sharps and needlestick injuries. The pattern of these events changes over time, as students evolve in their competences. To improve clinical safety competencies among student nurses, priority attention should be paid to medication management, dose calculations and reactions to situations of aggression and violence in healthcare settings.

Vcash: A Novel Reputation Framework for Identifying Denial of Traffic Service in Internet of Connected Vehicles

Trust management of Internet of connected vehicles has been a hot topic during the recent years with the rapid development of UGV technologies. However, existing resolutions based on trustworthiness verification among vehicles make the traffic event transmission quite inefficient. In this paper, we assume that the deployed RSUs can provide efficient communication between any pair of RSU and vehicle, and propose Vcash, a reputation framework for identifying denial of traffic service, to resolve the trustworthiness problem in the application level of the Internet of connected vehicles. In our reputation framework, every vehicle communicates with the RSU directly for traffic event verification, and spread verified traffic event notification. We borrow the idea of market trading, and set up trading rules to restrict the malicious vehicle's spread of false message, and to encourage vehicles to contribute to the traffic event monitoring and verification. To evaluate the effectiveness of our reputation framework, we conduct simulation experiment. Our experiment results indicate that our proposal manages to avoid bogus event spread, and a vehicle in our framework has to contribute to the traffic event detection to normally employ the traffic service.

PNS216 VIOLENCE PROFILE IN BRAZIL: A DESCRIPTIVE ANALYSIS

Violence has gained more space in health discussions, mainly due its impact on individuals and collective health. In Brazil, violence is a compulsory notification event through Violence and Accident Surveillance System (VIVA), component of Notifiable Disease Information System (SINAN) since 2006. This study aims to describe its profile in 2017 according to records of violence compulsory notification. This descriptive research applied secondary data of violence collected from VIVA/SINAN database for 2017. Type of violence, age, gender and State of notification were defined as study variables. Those variables were analyzed by descriptive statistics. States were grouped according to respective Brazilian regions. In 2017, 307,307 cases of violence were reported at VIVA/SINAN. Most of victims were women (71.8%). Majority of cases occurred in individuals aging from 10 to 19 (26.0%). Violence notifications were more common in Southeast Brazilian region (51.6%), followed by South region (20.5%). Among the 11 types of violence categories presented at VIVA/SINAN, most frequent were physical violence (N=193,013; 62.8%), psychological/moral violence (N=75,968; 24.7%), and self-inflicted lesion (N=68,184; 22.2%). Considering only physical violence, this violence occurred more in Southeast Brazilian region (57.4%), in women (73.1%) aging from 20 to 29 years (24.7%). Least reported type of violence was human being trade, with 0.1% of notifications. Physical violence in women was the most common type of notified violence in VIVA/SINAN in 2017. Physical violence may imply on health services demand to treat possible event sequels and, thus, impact directly on pubic health.

Adverse event notification analysis through patient safety culture research

Objetivo: a avaliação da cultura de segurança do paciente permite aos hospitais identificar e gerir prospectivamente questões relevantes de segurança em suas rotinas de trabalho. Método: estudo quantitativo, transversal e descritivo, ocorrida no ano de 2017 na Unidade de Terapia Intensiva Adulta em um hospital privado, localizado em Niterói/RJ. A população foram os profissionais médicos e equipe de enfermagem, utilizando análise estatística por meio de programa R, com a interface Rcmdr. Resultados: baseados nas respostas às perguntas sobre notificação de eventos aplicada com a Pesquisa de Cultura de Segurança do Paciente a 97 profissionais, com uma taxa de resposta de 85,6%, correspondendo a 83 profissionais. Menos de 45% dos participantes da pesquisa sempre notificam um erro, engano ou falha, que afete ou não o paciente, 59,0% não fizeram nenhuma notificação nos últimos 12 meses antecedentes à pesquisa e não houve diferença significativa na quantidade de notificação que destacasse uma categoria profissional, graduados ou não. Discussão: houve maior adesão à notificação de eventos pelos com maior tempo de hospital e com maior tempo naquela terapia intensiva. Não se encontrou correlação do número de notificações relatadas com o tempo de profissão e com a carga horária de trabalho. Conclusão: no que tange à conscientização de incrementar a adesão à notificação de eventos, a análise realizada contribuiu para a melhoria da segurança do paciente.

Mobile and web technology to display notifications of academic events of the Universidad Francisco de Paula Santander by using the agile methodology for mobile development

The “Universidad Francisco de Paula Santander, Colombia” lacks a dynamic tool to give the academic community timely knowledge of events and information needs in an assertive manner and in a reasonable time. Based on the above and following the dissemination strategy designed by the “Centro de Comunicaciones y Medios Audiovisuales” to incorporate the use of technology to massify internal institutional information, is built the mobile application NotiUFPS for Android devices, which allows notifying all events that take place at the university, including the calendar of previous and academic calendar, with the compatibility of downloading information in pdf format. The application will make use of global positioning system, to send timely notifications and updated information of institutional events when the user is inside the university campus. NotiUFPS was developed using “Metodología Ágil para Dispositivos Móviles”, a methodology developed by the “Grupo de Investigación en Desarrollo e Ingeniería de Software, Universidad Francisco de Paula Santander, San José de Cúcuta, Colombia”, which consolidates development practices recognized as Scrum and XP.

WebObs: The Volcano Observatories Missing Link Between Research and Real-Time Monitoring

Volcanological observatories have common needs and often common practical issues for multi-disciplinary data monitoring applications. Real-time access to integrated data, technical metadata, modeling and estimation of uncertainties are fundamental for an efficient interpretation. But in fact, the heterogeneity of instruments or acquisition systems and the inherent problems to produce rapid models using real-time data lead to difficulties that may hinder crisis management. In an attempt to globally address these questions, the French volcanological and seismological observatories have developed a specific operational software system over the past 19 years. Based on GNU/Linux open source tools and a Web interface, the WebObs system mainly offers: (1) a modular database for equipment network management; (2) a dozen of evolving dedicated periodic tasks for each monitoring technique like seismology, deformations and geochemistry that use standard data formats with automated execution of periodic tasks that produce high-quality graphs on preset moving time intervals, data exports, optional event notifications including e-mail alerting, instruments status controls based on their data validity; (3) web-form interfaces for manual data input/editing and export; (4) a user request form to adjust the tasks parameters for a single execution and to produce customized graphs and data exports. This system hence constitute a web-based tool that perform integrated, centralized and automated real-time volcano monitoring. It has therefore become a strong support for data analysis and exchange between researchers, engineers, and technicians during periods of unrest as well as periods of long-term quiescence. WebObs is also widely open for development of interdisciplinary modeling and enhanced data processing. This allows scientists to test new methods with real-time data flux and to instantaneously share their results in the community.

Adverse events due to unnecessary radiation exposure in medical imaging reported in Finland

IntroductionAdverse events in radiology are quite rare, but they do occur. Radiation safety regulations and the law obligate organizations to report certain adverse events, harm and near misses, especially events related to patients' health and safety. The aim of this study was to describe and analyse incidents related to radiation safety issues reported in Finland. MethodsThe data were collected from incident reports documented by radiology personnel concerning notifications of abnormal events in medical imaging made to the Radiation and Nuclear Safety Authority between 2010 and 2017. During these eight years, 312 reports were submitted. Only events reported from radiology departments were included; nuclear medicine, radiotherapy and animal radiology cases were excluded. The final number of reports was 293 (94%). ResultsThe majority of the 293 approved reports were related to computed tomography (CT, 68.3%) and to X-ray examinations (27.6%). Altogether 82.9% of those irradiated were adults, most of whom were exposed to unnecessary radiation through CT (86.5%), 5.5% were children, and 4.4% pregnant women. The most common effective dose of unnecessary radiation was 1 mSv or less (89.7% of all examinations). The highest effective doses were reported in CT (from under 1 mSv–20 mSv and above). The reasons for the adverse events were incorrect identification (32%), incorrect procedure, site or side (30%); and human errors or errors of knowledge (20%). ConclusionAdverse events occurred especially in CT examinations. It is important to collect and analyse incident data, assess the harmful events, learn from them and aim to reduce adverse events. Implications for practiceThis study emphasizes the need for radiological personnel to obtain evidence-based information on adverse events and focus on training to improve patient safety.

DESVELANDO AS OCORRÊNCIAS DOS EVENTOS ADVERSOS PÓS- VACINAÇÃO

The aim was to analyze the notifications of adverse events after vaccination of the last five years in a city in the interior of Ceara, characterizing the occurrences of adverse events post-vaccine notified, as well as the identification and classification of cases. Retrospective documentary study with a quantitative approach, carried out between January and December 2018. 41 notification forms of adverse events after vaccination (AEFI) from January 2014 to June 2018 were used, provided by the municipality's epidemiological surveillance. The data were analyzed using simple descriptive analysis. The findings show that the age group most affected by PVAE were children aged 0 to 6 months and 29 days, female, mixed race and in routine vaccination. The pentavalent vaccine was the immunobiological one with the highest notification in cases of AEFI. Non-serious and local reactions were the most described manifestations. It was also observed non-conformities in filling out the notification forms, showing incomplete information and errors in filling in the fields, which can cause compromise of the real situation of adverse events after vaccination, in addition to difficulty in distinguishing which events are not associated with vaccines. It is necessary to constantly train health professionals on EAVP notification and its importance, to reduce errors and underreporting.

EFFECT OF THE ADMINISTRATIVE TRANSITION OF HOSPITAL MANAGEMENT ON THE SAFETY CULTURE IN SURGICAL UNITS

ABSTRACT Objective: to analyze the safety culture in surgical units of a teaching hospital in different periods of hospital management. Method: this is a descriptive and analytical study developed with health professionals working at a surgical center and at five surgical inpatient units in two different periods of hospital management in southern Brazil. The Hospital Survey on Patient Safety Culture questionnaire was answered by 73 professionals in period I (2014/2015) and by 158 professionals in period II (2017). The analysis was based on descriptive statistics and on inferential analysis and reliability analysis using Cronbach's alpha coefficient; the dimensions were considered strong when the percentage of positive answers was ≥75%. Results: the administrative transition had a positive influence on the “Staffing” and “Handoffs and transitions” dimensions and a negative influence on “Teamwork within units” (p&lt;0.001), with no difference in the remaining nine dimensions. In both periods, no dimension was considered strong; there were no changes with regard to the notification of adverse events and to the overall safety assessment; and the overall reliability of the instrument was satisfactory (0.89). Conclusion: the administrative transition of hospital management had little impact on the dimensions of the organizational safety culture, and there are still challenges in the progressive development of this predictor of patient safety.

RISK FACTORS IN MEDICATION ERRORS IN A HIGH-COMPLEXITY CHILEAN PUBLIC HOSPITAL

ABSTRACT Objective: to identify the risk factors in medication errors in a high-complexity chilean public hospital. Method: a research study with a quantitative approach; an exploratory, descriptive and cross-sectional study, with retrospective temporal cuts. The study population consisted of 50 reports of adverse events related with the medication administration process generated between 2014 and 2017 in the Medical and Surgery services of the Magallanes Clinical Hospital, Chile. The classification of the National Coordinating Council for Medication Error Reporting and Prevention was used for data collecting, performed during May and June 2018, and the data were analyzed by means of descriptive statistics. Results: among those involved in the medication errors, the following professions are predominant: nurses, 21 (42%); Medical and Surgery nursing technicians, 18 (36%), and nursing technicians working in the Pharmacy, 7 (14%). The most frequent medication errors were the following: medication transcription, 16 (32%); preparation, 13 (26%); and administration, 11 (22%). The following risk factors stand out in the notified cases: communication and interpretation problems, 13 (26%); incorrect interpretation of the prescription at dispensation, 7 (14%); factors associated with work organization such as insufficient compliance with the priority safety practices, 11 (22%), and individual factors, 9 (18%). Conclusion: more information is required about medication errors to identify the risk factors and to establish strategies for their prevention; consequently, the notification of adverse events must be promoted as a preventive measure.

Nachbarschaft als Beruf

The journal Sozialwirtschaft aktuell informs its readers quickly and concisely about new developments in the field of socio-economics. It focuses on essential information and comments on political, professional, legal and tax-related topics. In addition to short expert contributions, it provides announcements and corporate news. Its useful tips, personal details and notifications of events ensure the reader feels well informed at all times.

Factors associated with increased risk of death from covid-19: a survival analysis based on confirmed cases.

To perform a survival analysis of individuals diagnosed with COVID-19 identified by health information systems, analyzing the factors associated with the highest risk of death. Survival analysis of individuals notified with COVID-19 in Rio Grande do Norte State using data from the Health Information Systems for the surveillance of cases of and deaths from COVID-19. The dependent variable was the period until the outcome occurrence. The independent variables were sex, self-reported skin color, age group, residence in the capital, and the presence of comorbidities. For data analysis the Kaplan-Meyer method and Cox-time-dependent Regression Model for multivariate analysis were used, with the covariable "period since the event notification recorded in days". Highest risk of death were observed in individuals aged 80 or older (HR = 8.06; p < 0.001), male (HR = 1.45, p < 0.001), non-white skin color (HR = 1.13; p < 0.033) or with no information (HR = 1.29; p < 0.001), with comorbidities (HR = 10.44; p < 0.001) or presence of comorbidities not reported (HR = 10.87; p < 0.001). The highest risk of occurrence of deaths from COVID-19 was observed in older adults, especially those over 80, patients who have comorbidities, men, and of non-white skin color. From the identification of the profile of patients with a higher risk of death with the identification by the health system, specific strategies of health care must be taken to prevent the evolution to death in these cases.

Pandemic influenza preparedness in the WHO South-East Asia Region: a model for planning regional preparedness for other priority high-threat pathogens

Pandemic influenza preparedness has contributed significantly to building, strengthening and maintaining countries' core capacities to prepare for health emergencies. The Pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits (the PIP framework) was adopted by the World Health Assembly in 2011. The experiences and lessons learnt from the implementation of the PIP framework have provided insights that can be used to strengthen preparedness for epidemics of other priority high-threat pathogens in the World Health Organization (WHO) South-East Asia Region in line with obligations under the International Health Regulations, 2005 (IHR). Implementation has established policies, strategies, action plans, strengthened systems and operational readiness to promptly diagnose influenza virus strains with pandemic potential and ensure timely event notifications and management in compliance with the IHR. WHO collaborating centres and the annual bi-regional meeting of national influenza centres and influenza surveillance have strengthened the influenza laboratory diagnostic knowledge network in the region. After action reviews following influenza outbreaks have documented best practices, strengths, constraints and areas for improvement in pandemic preparedness. The pandemic in 2009 and recent seasonal influenza outbreaks have offered real-life scenarios for testing national pandemic influenza preparedness plans and deploying vaccines. The successful implementation of the PIP framework, along with strengthening of health systems and operational procedures and continued technical collaboration with global centres of excellence, should be tapped into to strengthen preparedness to respond to epidemics of other high-threat pathogens based on the influenza model. The political commitment reflected in the Delhi Declaration on Emergency Preparedness, signed by all ministers of health in September 2019 and supported by the Five-year regional strategic plan to strengthen public health preparedness and response - 2019-2023, should be a catalyst for guidance and support in developing a broad, long-term strategic plan for preparedness and response to high-threat pathogens in the region.

Patient Notification Events Due to Syringe Reuse and Mishandling of Injectable Medications by Health Care Personnel—United States, 2012–2018: Summary and Recommended Actions for Prevention and Response

ObjectivesTo summarize patient notifications resulting from unsafe injection practices by health care personnel in the United States and describe recommended actions for prevention and response. Patients and MethodsWe examined records of events involving communications to groups of patients, conducted from January 1, 2012, through December 31, 2018, in which bloodborne pathogen testing was recommended or offered because of potential exposure to unsafe injection practices by health care personnel in the United States. Information compiled included: health care setting(s), type of unsafe injection practice(s), number of patients notified, number of outbreak-associated infections, and whether evidence suggesting bloodborne pathogen transmission prompted the notification. We compared these numbers with a similar review conducted from January 1, 2001, through December 31, 2011. ResultsFrom 2012 through 2018, more than 66,748 patients were notified as part of 38 patient notification events. Twenty-one involved exposures in non-hospital settings. Twenty-five involved syringe and/or needle reuse in the context of routine patient care; 11 involved drug tampering by a health care provider. The majority of events (n=25) were prompted by identification of unsafe injection practices alone, absent any documented infections at the time of notification. Outbreak-associated hepatitis B virus and/or hepatitis C virus infections were documented for 11 of the events; 8 involved patient-to-patient transmission, and 3 involved provider-to-patient transmission. ConclusionsSince 2001, nearly 200,000 patients in the United States were notified about potential exposure to blood-contaminated medications or injection equipment. Facility leadership has an obligation to ensure adherence to safe injection practices and to respond properly if unsafe injection practices are identified.

Identification and Evaluation of Safety Signals of Drugs Currently under Development Using a Limited Data Set

A recent increase in the number of safety signals of varying quality being submitted to the national and industry databases calls for the development of formalized search and analysis algorithms. The aim of the study was to develop an approach to identification and evaluation of safety signals in the database of an expert institution containing notifications of serious adverse events (SAE) that occurred during clinical trials. A specific feature of this approach is that it can be used in limited databases which, unlike international databases containing millions of reports (VigiBase, EudraVigilance), preclude the use of statistical methods for measurement of disproportionality. The proposed approach consists in evaluation of several criteria: two discriminatory ones (the geographic location of the clinical trial site and the type of report — whether it belongs to clinical trial documents other than the CIOMS form), and four expert criteria (whether a serious adverse event is a serious adverse reaction, whether the serious adverse reaction is predictable or not, the degree of reliability of the cause-effect relationship, and the benefit-risk ratio). The application of this approach resulted in the development of the «Signals» module of the expert institution’s SAE database. The «Signals» module is designed to calculate the rating of safety signals which can be used for conclusive identification and management of safety signals, and provides basis for scientifically well-grounded expert decisions on the need for administrative action on the clinical trial or its further monitoring. The developed approach can be used in the industry, national, and international pre- and postauthorization pharmacovigilance databases.