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Dissertations / Theses on the topic 'Adverse events reporting'

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Published: 26 July 2021

Last updated: 29 July 2025

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1

Zeeshan, Muhammad Fazal. "Use of an Electronic Reporting System to Determine Adverse Event Rates, Adverse Event Costs, and the Relationship of Adverse Events with Patients’ Body Mass Index." The Ohio State University, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=osu1372765526.

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2

Patel, Rachna. "Pharmacists’ Attitudes towards Reporting Adverse Drug Events in the United Kingdom." The University of Arizona, 2009. http://hdl.handle.net/10150/623981.

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Class of 2009 Abstract<br>OBJECTIVES: To determine the likelihood of pharmacists in England of reporting adverse drug reactions (ADR), whether they are aware of the reporting processes, and what they believe the reasons for not reporting may be. METHODS: A survey containing five different scenarios of ADRs was distributed to licensed, community pharmacists around Surrey, England. The responses were analyzed using rates and chi-square. RESULTS: A total of 47 surveys were returned to the researcher. Of those, 72% of the participants were likely to report the adverse drug reaction in the scenar

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3

Leeder, Ciera. "Epidemiology of Patient Safety Events in an Academic Teaching Hospital." Thesis, Université d'Ottawa / University of Ottawa, 2016. http://hdl.handle.net/10393/34294.

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Background: Adverse events are poor health outcomes caused by medical care rather than the underlying disease process. Voluntary reporting is a key component to adverse event reduction; however, incident reporting systems contain many limitations. The Patient Safety Learning System (PSLS) is an electronic incident reporting system with several unique features that were designed to address the weaknesses of previous systems, including a process for physician assessment of reported events to determine their significance. The primary objectives for this study were to determine the positive pre

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4

Yenyi, Samuel Errie. "Influence of Low Rate of Reporting of Adverse Events Following Immunization on Immunization Dropout." ScholarWorks, 2019. https://scholarworks.waldenu.edu/dissertations/6709.

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Immunization protects millions of children. Yet, many children drop out of immunization in Jigawa State of north Nigeria. This cross-sectional quantitative correlational study based on the Health Belief Model was designed to determine whether the dropout from routine immunization (RI) was influenced by low rate of reporting of adverse events following immunization (AEFI) to health facilities by caregivers. Primary data was collected from 307 caregivers with dropout children using structured interviewer-administered questionnaire. The data were analyzed using logistic regression and descriptive

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Bezerra, Milena Pontes Portela. "Study of adverse events in an accredited secondary hospital of CearÃ: an approach to risk management." Universidade Federal do CearÃ, 2011. http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=7401.

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CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior<br>Study of adverse events in an accredited secondary hospital of CearÃ: an approach to risk management. Author: Milena Pontes Portela Beserra. Supervisor: ProfÂ. DrÂ Marta Maria de FranÃa Fonteles. [Master degreeâs dissertation. Post Graduation in Pharmaceutical Science. Department of Pharmacy â Federal University of CearÃ]. BACKGROUND: Hospital Risk Management acts in the prevention, detection, control or eliminate risks that could cause harm to patients, in Brazil this concept was implemented in 2001 by the National Agency for Sani

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Lamb, James Alexander. "Under-reporting of Adverse Drug Reactions to the Food & Drug Administration." ScholarWorks, 2018. https://scholarworks.waldenu.edu/dissertations/6055.

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This study examined the potential significant differences in the distribution of adverse drug reactions (ADRs) by reporter (consumer versus physician) and patient outcome at case and event level. This study also contains exploratory questions to evaluate reporting of ADRs by consumers versus physician by system organ class (SOC) and reporter demographics within the United States Food & Drug Administration Adverse Event Reporting System (FAERS). The theoretical foundation applied in this quantitative study was the social amplification of risk framework. Data from the second quarter of 2016 were

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7

Leitão, Ana Lúcia Pedrosa. "Notificação de incidentes e eventos adversos em neonatologia : adaptação de um sistema de notificação numa unidade de cuidados intermédios neonatal." Master's thesis, Universidade Nova de Lisboa. Escola Nacional de Saúde Pública, 2011. http://hdl.handle.net/10362/9422.

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RESUMO - A segurança do doente é um tema que tem sido amplamente estudado por todo o mundo. Com o desenvolvimento do conhecimento, das técnicas e o advento das learning organizations é possível detectar as áreas onde existe potencial risco, conhecer o número de incidentes de forma sistemática, promover a evolução das técnicas nas áreas mais urgentes, determinar o impacto de todos os incidentes e eventos adversos, aprender com eles e promover modificações nas organizações. A neonatologia não foi excepção, pelo que se pretende a criação e validação de um sistema de notificação de eventos advers

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8

Rozental, Alexander. "Negative effects of Internet-based cognitive behavior therapy : Monitoring and reporting deterioration and adverse and unwanted events." Doctoral thesis, Stockholms universitet, Klinisk psykologi, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:su:diva-135382.

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Internet-based cognitive behavior therapy (ICBT) has the potential of providing many patients with an effective form of psychological treatment. However, despite helping to improve mental health and well-being, far from everyone seem to benefit. In some cases, negative effects may also emerge. The overall aim of the present thesis was to establish the occurrence and characteristics of such incidents in ICBT using a combination of quantitative and qualitative methods. Study I determined deterioration, non-response, and adverse and unwanted events in a sample of 133 patients undergoing ICBT for

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9

Alhammad, Ali M. "FACTORS INFLUENCING PHARMACISTS’ DECISION TO REPORT ADVERSE EVENTS RELATED TO DIETARY SUPPLEMENTS." VCU Scholars Compass, 2012. http://scholarscompass.vcu.edu/etd/2849.

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Background: The increasing consumption of dietary supplements (DS) has drawn the attention of regulatory agencies, researchers and healthcare professionals. The US Food and Drug Administration (FDA) does not require premarketing assessment of DS considering them safe unless proven otherwise. However, the reporting rate of DS adverse events (DS-AE) is low. Objective: To describe pharmacists’ attitudes and knowledge of DS and DS information resources, and to determine the importance of selected attributes in pharmacists’ decisions to report a DS-AE. Methods: A convenience sample of practicing ph

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10

Lima, Sara Silveira. "Sistema de notificação de eventos adversos : contributos para a melhoria da segurança do doente." Master's thesis, Universidade Nova de Lisboa. Escola Nacional de Saúde Pública, 2011. http://hdl.handle.net/10362/9417.

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RESUMO - Este estudo insere-se na temática dos sistemas de notificação de eventos adversos. Pretende-se compreender a necessidade e importância de implementação de um sistema de notificação de Eventos Adversos num hospital E.P.E. (entidade pública empresarial) de Lisboa. Apresenta como objectivo geral: •Identificar as principais características que um Sistema de Notificação de Eventos Adversos, Erros e Incidentes deve ter e com base nisso propor um formulário de notificação que assente numa lógica de aprendizagem e não numa perspectiva de culpabilização. Trata-se de um estudo explorató

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11

Ivanovic, Jelena. "Quality and Patient Safety in Surgery: Clinical Applications and Critical Appraisal of a Prospective, Standardized, and Comprehensive System for Monitoring and Reporting Post-operative Adverse Events." Thesis, Université d'Ottawa / University of Ottawa, 2015. http://hdl.handle.net/10393/32742.

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Evaluation of quality of surgical care begins with the Donabedian triad focusing on structure, process, and outcomes. Outcomes, which are inherently patient-centered, are most easily and commonly measured, and are indeed fundamental to evaluating the quality of surgical care. Specifically, post-operative adverse events (AEs) remain the most frequently measured and reported outcomes, as they represent harm to the patient; and thus, are often used as a means for comparing institutional, as well as, individual surgeon performance. The importance of rigorous recording of clearly defined AEs, altho

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12

Batra, Sonia. "The Impact of the Sentinel Initiative and FAERS Surveillance System on Consumer Safety." ScholarWorks, 2016. https://scholarworks.waldenu.edu/dissertations/2438.

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The U.S. Food and Drug Administration (FDA) uses the FDA Adverse Event Reporting System (FAERS) to monitor adverse events resulting from pharmaceutical drug use. However, this system has limitations such as not allowing real-time data collection. To address these limitations, the FDA launched the Sentinel Initiative in 2008. This comparative case study was conducted to describe perceptions of investigating the efficacy of the Sentinel Initiative compared with the FAERS. The study was based on the theory of preemption as it emphasized the need for efficient means for providing unquestionable pr

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13

Mühlhans, Susann [Verfasser]. "Enhancing vaccine safety monitoring and the accurate reporting and differential diagnosis of adverse events in clinical research and the pediatric acute care setting / Susann Mühlhans." Berlin : Medizinische Fakultät Charité - Universitätsmedizin Berlin, 2016. http://d-nb.info/1111558760/34.

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14

Hedlund, Lina, and Mikael Hultebrand. "En kartläggning över inrapporterade avvikelser inom operationssjukvård mellan åren 2011-2015." Thesis, Umeå universitet, Institutionen för omvårdnad, 2015. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-116801.

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Bakgrund: Globalt inom hälso- och sjukvården skadas årligen tusentals patienter, somliga med dödligt utfall. Majoriteten av dessa skador sker inom den perioperativa vården där operationssjuksköterskan har ett ansvar att minimera risken för att en vårdskada ska uppkomma. En viktig del inom patientsäkerhets- och förbättringsarbetet är avvikelserapportering och detta är således ett viktigt ämne för vidare forskning. Syfte: Studiens syfte var att kartlägga inrapporterade avvikelser inom operationssjukvård samt att undersöka eventuellt samband mellan tidpunkt och avvikelseområde. Metod: Kvantitativ

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15

Wilson, Barbara. "Clinical adverse event reporting : development and validation of an attitude scale." Thesis, University of York, 2004. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.428045.

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16

Pham, Minh H. "Signal Detection of Adverse Drug Reaction using the Adverse Event Reporting System: Literature Review and Novel Methods." Scholar Commons, 2018. http://scholarcommons.usf.edu/etd/7218.

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One of the objectives of the U.S. Food and Drug Administration is to protect the public health through post-marketing drug safety surveillance, also known as Pharmacovigilance. An inexpensive and efficient method to inspect post-marketing drug safety is to use data mining algorithms on electronic health records to discover associations between drugs and adverse events. The purpose of this study is two-fold. First, we review the methods and algorithms proposed in the literature for identifying association drug interactions to an adverse event and discuss their advantages and drawbacks. Second,

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17

Tang, Huaxiu. "Detecting Adverse Drug Reactions in Electronic Health Records by using the Food and Drug Administration’s Adverse Event Reporting System." University of Cincinnati / OhioLINK, 2016. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1470753258.

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18

Pinheiro, Luis Correia. "Vigilância activa de eventos após vacinação." Master's thesis, Faculdade de Ciências Médicas. Universidade Nova de Lisboa, 2008. http://hdl.handle.net/10362/4843.

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A vigilância de efeitos indesejáveis após a vacinação é complexa. Existem vários actores de confundimento que podem dar origem a associações espúrias, meramente temporais mas que podem provocar uma percepção do risco alterada e uma consequente desconfiança generalizada acerca do uso das vacinas. Com efeito as vacinas são medicamentos complexos com características únicas cuja vigilância necessita de abordagens metodológicas desenvolvidas para esse propósito. Do exposto se entende que, desde o desenvolvimento da farmacovigilância se tem procurado desenvolver novas metodologias que sejam conco

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19

Costa, Cinthia Ferreira. "Segurança do paciente e a gestão de incidentes em hospitais paulistanos." reponame:Repositório Institucional do FGV, 2018. http://hdl.handle.net/10438/24655.

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Submitted by Cinthia Ferreira Costa (cinthiac.costa@gmail.com) on 2018-09-03T13:17:52Z No. of bitstreams: 1 TA_Cinthia Costa_versão final.pdf: 765367 bytes, checksum: f616f7fa6b7603c5ba1ac56f1db7dfbf (MD5)<br>Approved for entry into archive by Simone de Andrade Lopes Pires (simone.lopes@fgv.br) on 2018-09-03T19:51:28Z (GMT) No. of bitstreams: 1 TA_Cinthia Costa_versão final.pdf: 765367 bytes, checksum: f616f7fa6b7603c5ba1ac56f1db7dfbf (MD5)<br>Approved for entry into archive by Suzane Guimarães (suzane.guimaraes@fgv.br) on 2018-09-04T14:41:02Z (GMT) No. of bitstreams: 1 TA_Cinthia Costa_ve

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20

Arana, Jorge E. "Comparison of Post-Licensure Safety Surveillance of 13-Valent Pneumococcal Conjugate Vaccine and 7-Valent Pneumococcal Conjugate Vaccine: Data from the Vaccine Advere Event Reporting System (Vaers)." Digital Archive @ GSU, 2011. http://digitalarchive.gsu.edu/iph_theses/159.

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Comparison of Post-licensure safety surveillance of 13-Valent Pneumococcal Conjugate vaccine and 7-Valent Pneumococcal Conjugate vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS). Background: On February 24, 2010, Food and Drug Administration (FDA) licensed a 13-valent pneumococcal conjugate vaccine (Prevnar 13®, [PCV13]) for use among children aged 6 weeks--71 months. The Advisory Committee on Immunization Practices (ACIP) recommended PCV13 routine vaccination of all children aged 2--59 months, children aged 60--71 months with underlying medical conditions, with PCV13

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21

Chen, Yan. "Comparisons and applications of quantitative signal detections for adverse drug reactions (ADRs) an empirical study based On The food And drug administration (FDA) adverse event reporting system (AERS) and a large medical claims database /." Cincinnati, Ohio : University of Cincinnati, 2008. http://www.ohiolink.edu/etd/view.cgi?acc_num=ucin1203534085.

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Thesis (Ph.D. of Pharmacy Practice and Administrative Sciences)--University of Cincinnati, 2008.<br>Advisor: Jeff Guo PhD. Title from electronic thesis title page (viewed May 9, 2008). Keywords: data mining algorithms; adverse drug reactions; adverse event reporting system; signal detection; case-control study; antipsychotic; bipolar disorder. Includes abstract. Includes bibliographical references.

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22

CHEN, YAN. "Comparisons and Applications of Quantitative Signal Detections for Adverse Drug Reactions (ADRs): An Empirical Study Based On The Food And Drug Administration (FDA) Adverse Event Reporting System (AERS) And A Large Medical Claims Database." University of Cincinnati / OhioLINK, 2008. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1203534085.

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23

Zoghby, Matthew Gabriel. "The reporting of adverse events in Johannesburg academic emergency departments." Thesis, 2019. https://hdl.handle.net/10539/29517.

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A dissertation submitted to the Faculty of Health Science, University of the Witwatersrand, in fulfillment of the requirements for the degree of Master of Medicine (Emergency Medicine). Johannesburg February 2019<br>Background. Adverse events (AE) are a common occurrence in healthcare systems; however, the frequency of AEs occurring in South Africa and especially Emergency Departments (ED) is unknown. Objectives. To describe the frequency of AEs experienced by Healthcare providers (HCP) and the frequency of formal reporting thereafter over a 12-month period. Methods. A cross sectional d

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24

Trinh, Caroline. "Documentation of adverse events in the department of anesthesiology: a single institution experience." Thesis, 2020. https://hdl.handle.net/2144/41735.

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Studies indicate that voluntary reporting detects relatively few adverse events (AEs) (Ehland et al., 1999, Cooper et al., 1984). At Boston Children’s Hospital (BCH), several systems exist to document AEs. First, anesthesiologists document clinical care and AEs in the patient medical record (the Anesthesia Information Management System (AIMS)). Second, in an effort to capture AEs, the Department of Anesthesiology, Critical Care and Pain Medicine developed an internal tool, the Anesthesia System for Clinical Event Tracking (ASCENT), which is integrated into clinicians’ electronic documentation.

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25

Pequegnat, Victoria. "An analysis of health information technology-related adverse events: technology-induced errors and vendor reported solutions." Thesis, 2019. http://hdl.handle.net/1828/11027.

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Health information technology has been widely accepted as having the potential to decrease the prevalence of adverse events and improve workflows and communication between healthcare workers. However, the emergence of health technologies has introduced a new type of medical error. Technology-induced errors are a type of medical error that can result from the use of health information technology in all stages of the health information systems life cycle. The purpose of this study is to identify what types of technology-induced errors are present in the key health information technology vendo

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26

Gavaza, Paul 1972. "Using the theory of planned behavior to predict Texas pharmacists' intention to report serious adverse drug events." Thesis, 2010. http://hdl.handle.net/2152/ETD-UT-2010-05-747.

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The purpose of this dissertation was to use the theory of planned behavior (TPB) to predict Texas pharmacists’ intention to report serious adverse drug effects (ADEs) to the Food and Drug Administration (FDA). The study explored the utility of the TPB model constructs (attitude [A], subjective norm [SN], perceived behavioral control [PBC]), as well as past reporting behavior (PRB), and perceived moral obligation (PMO) to predict pharmacists’ intention to report serious ADEs to the FDA. The study also determined if the pharmacists’ A, SN and PBC were related to practice characteristics and demo

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27

Parrella, Adriana. "Postmarketing vaccine safety passive surveillance: an exploratory study of parent and healthcare provider reporting of adverse events following immunisation (AEFI)." Thesis, 2014. http://hdl.handle.net/2440/99567.

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Monitoring the safety of new and exisiting vaccines following licensure is a critical component of maintaining public confidence in immunisation and is an integral part of national immunisation programs. In Australia the process relies predominantly on the passive surveillance of adverse events following immunisation (AEFI) via spontaneous voluntary reports of AEFI by healthcare professionals, vaccine manufacturers and the public to state or federal health authorities. The aim of this thesis was to investigate factors that promote or inhibit parental and healthcare professional reporting of AE

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28

Schrommová, Tereza. "Analýza spotřeby a spontánního hlášení nežádoucích účinků vakcín proti lidskému papilomaviru." Master's thesis, 2021. http://www.nusl.cz/ntk/nusl-448328.

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Analysis of utilisation and spontaneous adverse events reports related to human papillomavirus vaccines Author: Tereza Schrommová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University INTRODUCTION: HPV vaccination is one of the most effective types of prevention against the human papillomavirus infection that can lower the probability of its incidence up to 80-90 %. Besides the benefits of vaccination, there can also occur among many individuals certain risks and adverse effects. Spontaneous adverse event

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Ryndová, Vendula. "Analýza spontánního hlášení nežádoucích účinků hormonální antikoncepce a hormonální substituční terapie." Master's thesis, 2021. http://www.nusl.cz/ntk/nusl-448423.

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Analysis of spontaneous adverse drug reactions reporting hormonal contraception and hormone replacement therapy Author: Vendula Ryndová Supervisor: PharmDr. Kateřina Malá, Ph.D. Consultant: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University Introduction: Hormonal contraception (HC) is the most widely used method to prevent pregnancy worldwide. In addition to pregnancy planning and other non-contraceptional benefits, it also has certain risks. Hormone replacement therapy (HRT) is used primarily for treatment of es

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Ferrarotto, Felicia. "Signaling potential gender effect in a spontaneous reporting system : cardiac effects associated with the use of antibiotics." Thèse, 2008. http://hdl.handle.net/1866/8079.

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Nel, Steven Robert. "Factors influencing adverse event and error reporting in anaesthesiology." Thesis, 2017. http://hdl.handle.net/10539/23396.

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A research report submitted to the faculty of Health Sciences, University of the Witwatersrand, Johannesburg, in partial fulfilment of the requirements for the degree of Master of Science in Medicine in Anaesthesiology Johannesburg, 2017<br>Background Adverse events and errors are a widespread cause of morbidity and mortality in the health care environment. Adverse event and error reporting systems have been shown to potentially reduce the occurrence of these events, however there is still significant underreporting. Little is known regarding the barriers to reporting of adverse events

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Ye, Na 1983. "Vaccine-adverse event association analysis on the VAERS database." Thesis, 2011. http://hdl.handle.net/2152/ETD-UT-2011-05-3293.

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The Vaccine Adverse Event Reporting System (VAERS) received thousands of reports of adverse events that occurred after vaccine administrations from the post-marketing vaccine safety surveillance. However, the causality between vaccines and reported adverse events cannot be taken for granted. In this report several data mining methods were applied to VAERS database that is coded in MedDRA terms to discover possible associations between vaccines and adverse events. Efforts were devoted to identify events that are reported more frequently after administering one vaccine than other vaccines using

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33

Lo, Chiao-Feng, and 羅喬楓. "Co-Training and Ensemble Learning for Duplicate Detection in Adverse Drug Event Reporting Systems." Thesis, 2013. http://ndltd.ncl.edu.tw/handle/74533117604020370925.

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碩士<br>國立高雄大學<br>資訊工程學系碩士班<br>101<br>Adverse drug reactions detection is a very important topic in the public health as well as the development of modern pharmaceutical industry. Since the number of samples in clinical trials is not enough to identify potential adverse drug reactions before the drugs are approved for marketing, many countries have established various spontaneous reporting systems (SRSs) to facilitate postmarketing surveillance of listed drugs and collect enough data for detecting unknown adverse drug reactions. Unfortunately, due to data in SRSs coming from different sources of

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Shen, Wen-Hsin, and 沈文歆. "What Determines a Healthcare Professional’s Intention to Use a Adverse Event Reporting System? An Empirical Evaluation of the Revised Technology Acceptance Model." Thesis, 2007. http://ndltd.ncl.edu.tw/handle/40376439486210484497.

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碩士<br>國立中山大學<br>醫務管理研究所<br>95<br>Objective: Today, many healthcare organizations have implemented health care reporting systems in the hope of learning from experience to prevent or reduce adverse events, medical errors or accidents. However, most applications have failed or not been implemented as predicted. This study presents an extended technology acceptance model (TAM) that integrates subjective norm, trust, and management support into the TAM to investigate what determines healthcare professional reporting system acceptance. Design: The proposed model was empirically tested using data co

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