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Sample records for treatment-emergent adverse events

  1. Vaccine Adverse Events

    Science.gov (United States)

    ... for Biologics Evaluation & Research Vaccine Adverse Events Vaccine Adverse Events Share Tweet Linkedin Pin it More sharing ... in the primary immunization series in infants Report Adverse Event Report a Vaccine Adverse Event Contact FDA ( ...

  2. [Adverse events prevention ability].

    Science.gov (United States)

    Aparo, Ugo Luigi; Aparo, Andrea

    2007-03-01

    The issue of how to address medical errors is the key to improve the health care system performances. Operational evidence collected in the last five years shows that the solution is only partially linked to future technological developments. Cultural and organisational changes are mandatory to help to manage and drastically reduce the adverse events in health care organisations. Classical management, merely based on coordination and control, is inadequate. Proactive, self-organising network based structures must be put in place and managed using adaptive, fast evolving management tools.

  3. Adverse Event Reporting System (AERS)

    Data.gov (United States)

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

  4. CDC Wonder Vaccine Adverse Event Reporting System

    Data.gov (United States)

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

  5. Adverse event development in clinical oncology trials

    NARCIS (Netherlands)

    Walraven, I.; Aaronson, N.; Sonke, J.-J.; Verheij, M.; Belderbos, J.

    Gita Thanarajasingam and colleagues' Article1 in The Lancet Oncology reports on a novel longitudinal approach for adverse event analysis and reporting. Comprehensive adverse event reporting in clinical oncology trials is essential to monitor tolerability of new cancer treatments. In view of the

  6. Adverse event reporting tool for sedation

    African Journals Online (AJOL)

    SASA Refresher Text: Adverse event reporting tool for sedation. 60. 2012;18(1). South Afr J Anaesth Analg. Sedation practice today is experiencing revolutionary changes. One of them is a re-evaluation of what is defined as an adverse event during sedation. The World Health Organization (WHO) and the US Food and.

  7. Adverse events following immunization: Knowledge and experience ...

    African Journals Online (AJOL)

    more concerned with adverse events following immunization (AEFI) than with the threat of the disease itself. Aim: To asses the knowledge of AEFI among mothers and also to determining the prevalence, the most common antigen associated with AEFI and mother's responses to the adverse reactions. Method: This is a ...

  8. Identifying Adverse Drug Events by Relational Learning.

    Science.gov (United States)

    Page, David; Costa, Vítor Santos; Natarajan, Sriraam; Barnard, Aubrey; Peissig, Peggy; Caldwell, Michael

    2012-07-01

    The pharmaceutical industry, consumer protection groups, users of medications and government oversight agencies are all strongly interested in identifying adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken by millions of patients. As a result, in many cases adverse drug events (ADEs) are observed in the broader population that were not identified during clinical trials. Therefore, there is a need for continued, post-marketing surveillance of drugs to identify previously-unanticipated ADEs. This paper casts this problem as a reverse machine learning task , related to relational subgroup discovery and provides an initial evaluation of this approach based on experiments with an actual EMR/EHR and known adverse drug events.

  9. Adverse events related to blood transfusion

    Science.gov (United States)

    Sahu, Sandeep; Hemlata; Verma, Anupam

    2014-01-01

    The acute blood transfusion reactions are responsible for causing most serious adverse events. Awareness about various clinical features of acute and delayed transfusion reactions with an ability to assess the serious reactions on time can lead to a better prognosis. Evidence-based medicine has changed today's scenario of clinical practice to decrease adverse transfusion reactions. New evidence-based algorithms of transfusion and improved haemovigilance lead to avoidance of unnecessary transfusions perioperatively. The recognition of adverse events under anaesthesia is always challenging. The unnecessary blood transfusions can be avoided with better blood conservation techniques during surgery and with anaesthesia techniques that reduce blood loss. Better and newer blood screening methods have decreased the infectious complications to almost negligible levels. With universal leukoreduction of red blood cells (RBCs), selection of potential donors such as use of male donors only plasma and restriction of RBC storage, most of the non-infectious complications can be avoided. PMID:25535415

  10. [Adverse event sheets, a quality improvement tool].

    Science.gov (United States)

    Didry, Pascale; Lapp, Aymeric

    2017-05-01

    The declaration of adverse events comprises a written nurse report which helps to improve the quality and safety of care. Submitted to professionals from the quality department, this report will be used to perform an analysis of the causes and must therefore be descriptive and objective. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  11. Adverse events while awaiting myocardial revascularization

    DEFF Research Database (Denmark)

    Head, Stuart J.; da Costa, Bruno R.; Beumer, Berend

    2017-01-01

    OBJECTIVES: The aim of the current study was to estimate adverse event rates while awaiting myocardial revascularization and review criteria for prioritizing patients. METHODS: A PubMed search was performed on 19 January 2015, to identify English-language, original, observational studies reportin...

  12. Evaluation of the adverse events following immunizations ...

    African Journals Online (AJOL)

    Introduction: Vaccines safety are monitored by looking for Adverse Events Following Immunizations (AEFIs). A review of the 2014 Harare City consolidated monthly return form (T5) revealed that 28 AEFIs were seen in 2014. However, only 21 were reported through the system. We therefore evaluated the Harare City AEFI ...

  13. Vaccine Adverse Events: Separating Myth from Reality.

    Science.gov (United States)

    Spencer, Jeanne P; Trondsen Pawlowski, Ruth H; Thomas, Stephanie

    2017-06-15

    Vaccines are one of the most successful medical advances in modern times. Most vaccine-preventable illnesses are unfamiliar to modern parents. Because of this, parents are increasingly questioning the necessity of immunizing their children, especially because no vaccine is completely free of adverse effects or the risk of complications. Family physicians should be aware of the risks and benefits of recommended immunizations. Thimerosal is currently used only in multidose vials of influenza vaccine, and exposure through vaccines is not associated with adverse neurologic outcomes. The measles, mumps, and rubella vaccine is not associated with autism. Vaccines are associated with local reactions, such as pain and erythema. The rotavirus vaccine minimally increases the rate of intussusception, whereas other vaccines minimally increase the risk of syncope. Although immunization with the human papillomavirus vaccine is recommended for all boys and girls, vaccination rates remain low. Physicians should guide parents to credible resources if they are considering vaccine refusal. If a recommended vaccine is refused, proper documentation is essential. The Vaccine Adverse Event Reporting System and National Vaccine Injury Compensation Program track adverse events and allow compensation for documented harms from vaccinations.

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

    Science.gov (United States)

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

    2007-06-01

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

  15. The outsider adverse event in transfusion: Inflammation.

    Science.gov (United States)

    Hod, Eldad A; Godbey, Elizabeth A

    2016-01-01

    In order to maintain adequate inventories of red blood cells (RBCs) for transfusion, RBC units are refrigerator-stored for variable amounts of time prior to transfusion. A subset of RBCs is damaged during prolonged storage. Clearance of these damaged RBCs is hypothesized to induce an inflammatory response in the transfusion recipient. However, there is controversy over whether RBC transfusions are in fact associated with inflammation, and more generally, whether current standards for maximal RBC storage times are safe. We will explore the evidence for and against this outsider adverse event in transfusion: whether certain RBC transfusions do or do not cause inflammation. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  16. Disclosure of Adverse Events in Pediatrics.

    Science.gov (United States)

    2016-12-01

    Despite increasing attention to issues of patient safety, preventable adverse events (AEs) continue to occur, causing direct and consequential injuries to patients, families, and health care providers. Pediatricians generally agree that there is an ethical obligation to inform patients and families about preventable AEs and medical errors. Nonetheless, barriers, such as fear of liability, interfere with disclosure regarding preventable AEs. Changes to the legal system, improved communications skills, and carefully developed disclosure policies and programs can improve the quality and frequency of appropriate AE disclosure communications. Copyright © 2016 by the American Academy of Pediatrics.

  17. Recording Adverse Events Following Joint Arthroplasty: Financial Implications and Validation of an Adverse Event Assessment Form.

    Science.gov (United States)

    Lee, Matthew J; Mohamed, Khalid M S; Kelly, John C; Galbraith, John G; Street, John; Lenehan, Brian J

    2017-09-01

    In Ireland, funding of joint arthroplasty procedures has moved to a pay-by-results national tariff system. Typically, adverse clinical events are recorded via retrospective chart-abstraction methods by administrative staff. Missed or undocumented events not only affect the quality of patient care but also may unrealistically skew budgetary decisions that impact fiscal viability of the service. Accurate recording confers clinical benefits and financial transparency. The aim of this study was to compare a prospectively implemented adverse events form with the current national retrospective chart-abstraction method in terms of pay-by-results financial implications. An adverse events form adapted from a similar validated model was used to prospectively record complications in 51 patients undergoing total hip or knee arthroplasties. Results were compared with the same cohort using an existing data abstraction method. Both data sets were coded in accordance with current standards for case funding. Overall, 114 events were recorded during the study through prospective charting of adverse events, compared with 15 events documented by customary method (a significant discrepancy). Wound drainage (15.8%) was the most common complication, followed by anemia (7.9%), lower respiratory tract infections (7.9%), and cardiac events (7%). A total of €61,956 ($67,778) in missed funding was calculated as a result. This pilot study demonstrates the ability to improve capture of adverse events through use of a well-designed assessment form. Proper perioperative data handling is a critical aspect of financial subsidies, enabling optimal allocation of funds. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Consumer reporting of adverse events following immunization

    Science.gov (United States)

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

    2014-01-01

    Surveillance of adverse events following immunisation (AEFI) is an essential component of vaccine safety monitoring. The most commonly utilized passive surveillance systems rely predominantly on reporting by health care providers (HCP). We reviewed adverse event reports received in Victoria, Australia since surveillance commencement in July 2007, to June 2013 (6 years) to ascertain the contribution of consumer (vaccinee or their parent/guardian) reporting to vaccine safety monitoring and to inform future surveillance system development directions. Categorical data included were: reporter type; serious and non-serious AEFI category; and, vaccinee age group. Chi-square test and 2-sample test of proportions were used to compare categories; trend changes were assessed using linear regression. Consumer reporting increased over the 6 years, reaching 21% of reports received in 2013 (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. PMID:25483686

  19. Patterns in neurosurgical adverse events: endovascular neurosurgery.

    Science.gov (United States)

    Wong, Judith M; Ziewacz, John E; Panchmatia, Jaykar R; Bader, Angela M; Pandey, Aditya S; Thompson, B Gregory; Frerichs, Kai; Gawande, Atul A

    2012-11-01

    As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in endovascular neurosurgery concerning the frequency of adverse events in practice, their patterns, and current methods of reducing the occurrence of these events. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Based on a review of the literature, thromboembolic events appeared to be the most common adverse events in endovascular neurosurgery, with a reported incidence ranging from 2% to 61% depending on aneurysm rupture status and mode of detection of the event. Intraprocedural and periprocedural prevention and rescue regimens are advocated to minimize this risk; however, evidence on the optimal use of anticoagulant and antithrombotic agents is limited. Furthermore, it is unknown what proportion of eligible patients receive any prophylactic treatment. Groin-site hematoma is the most common access-related complication. Data from the cardiac literature indicate an overall incidence of 9% to 32%, but data specific to neuroendovascular therapy are scant. Manual compression, compression adjuncts, and closure devices are used with varying rates of success, but no standardized protocols have been tested on a broad scale. Contrast-induced nephropathy is one of the more common causes of hospital-acquired renal insufficiency, with an incidence of 30% in high-risk patients after contrast administration. Evidence from medical fields supports the use of various preventive strategies. Intraprocedural vessel rupture is infrequent, with the reported incidence ranging from 1% to 9%, but it is potentially devastating. Improvements in device technology combined with proper endovascular technique play an important role in reducing

  20. Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events

    DEFF Research Database (Denmark)

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

    New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse...... event co-occurrences. We analyzed the similarity of adverse event profiles of 2347 patients extracted from EMRs from a mental health center in Denmark. The patients were clustered based on their adverse event profiles and the similarities were presented as a network. The set of adverse events in each...... main patient cluster was evaluated. Co-occurrences of adverse events in patients (p-value patients typically had a most distinguishing adverse event. Examination of the co-occurrences of adverse events in patients led...

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

    Data.gov (United States)

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

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

    Data.gov (United States)

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

  3. Seamless prevention of adverse events from tattooing

    DEFF Research Database (Denmark)

    Serup, Jørgen

    2015-01-01

    The boom in tattooing has been paralleled by more frequent adverse events, which may be localised in the skin or systemic and manifested clinically or latent. Infections, allergic reactions from red-coloured tattoos and papulo-nodular reactions from black tattoos dominate. Mild complaints are very...... common, with 1/5 of all tattooed individuals having acquired sensitivity to sunlight in the tattooed skin. The potential risk of cancer due to potential carcinogens in some tattoo inks has hitherto not manifested in clinical reports, despite the millions of people who have been tattooed over many decades....... A risk of death from tattooing remains associated with severe infection, i.e. sepsis. Preventive strategies may rely on focused preventions, and sterility and preservation of ink is essential, rational and knowledge-based. The chemical and particle contents of ink nanoparticles cannot be unrestricted...

  4. Adverse events regional feasibility study: indicative findings.

    Science.gov (United States)

    Davis, P; Lay-Yee, R; Schug, S; Briant, R; Scott, A; Johnson, S; Bingley, W

    2001-05-11

    To identify substantive findings of potential clinical and managerial significance from a regional feasibility study of adverse events (AEs). A standardised protocol using structured implicit review was applied to 142 AEs generated in an audit study of three public hospitals in the Auckland region for admissions in 1995. Areas of potential significance addressed were: timing, location and impact of AEs; preventability; and clinical context and predictability. 142 cases were identified as AEs (10.7% of 1,326 screened records). In 102 cases, 7.7% of all screened records, it was considered to be more likely than not that health care management contributed to the AE. About half the reported AEs occurred before the index admission, the majority outside hospital. Over half of all events resulted in disability that was resolved within a month. An average 6.7 extra days stay in hospital were attributable to AEs. For 60% of AEs the evidence for preventability was either low or nonexistent. Areas of potential prevention were predominantly educational. Over half of all AEs occurred in a surgical context. Medical AEs were more likely to have occurred outside hospital, to be drug-related, to be associated with an acute admission, to be classified as highly preventable, and to have a greater impact on hospital stay. Although the data generated by a feasibility study must be treated with caution, the pattern of results is consistent with comparable Australian findings and is of potential clinical and managerial significance.

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

    Science.gov (United States)

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

    2017-12-01

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

  6. [Analysis on the concepts related to adverse events and adverse reactions of acupuncture].

    Science.gov (United States)

    Wang, Chuan; Liu, Baoyan; Liu, Yan; He, Liyun; Li, Hongjiao; Liu, Jia

    2018-01-12

    With the increasing popularity of acupuncture therapy in the world, the safety of acupuncture has attracted more attention. The objective and impartial assessment of the safety of acupuncture becomes very important. The "adverse events of acupuncture" and "adverse reactions of acupuncture" are the common concepts in the research of acupuncture safety. In the paper, on the basis of the conceptual characteristics of "adverse events" and "adverse reactions" and in combination with the particular characteristics of acupuncture itself, the connation and features of the concepts of the "adverse events of acupuncture" and "adverse reactions of acupuncture" are analyzed. The interaction and differences are summarized. Both "adverse events of acupuncture" and "adverse reactions of acupuncture" are in the category of adverse medical events. The "adverse events of acupuncture" includes the damages induced by acupuncture therapy and also those without relationship with acupuncture therapy. The "adverse reactions of acupuncture" refers to the adverse outcomes induced by acupuncture therapy specially. It has the definite relationship with acupuncture therapy. Hence, the application of "adverse reactions of acupuncture" is more objective and accurate in the assessment of acupuncture safety.

  7. Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment.

    Science.gov (United States)

    Degenhardt, Brian F; Johnson, Jane C; Brooks, William J; Norman, Lisa

    2018-03-01

    Although adverse events in various types of manual therapy have been previously investigated, little is known about the incidence and types of adverse events that occur after osteopathic manipulative treatment (OMT). To estimate the incidence and characterize the types of adverse events that patients report after OMT and prior to leaving the office to increase the likelihood of identifying adverse events caused by OMT. As part of a prospective study evaluating the use and effectiveness of OMT, patients assessed how they felt immediately after OMT compared with before OMT using a 5-point ordinal rating scale (much better, better, about the same, worse, much worse). For patients who indicated they felt their condition had changed, a follow-up, open-ended question asked them to describe how it had changed. Patients who felt worse or much worse were considered to have experienced an adverse event. Two reviewers independently coded the types of adverse events based on the descriptions provided by the patients. Generalized logistic regression models were used to calculate incidence rates and 95% CIs for the types of adverse events. These models were also used to calculate the ORs and 95% CIs for associations of adverse events with demographic characteristics and with individual OMT techniques after accounting for demographic characteristics. Immediately after OMT, 884 patients provided data at 1847 office visits (663 [76%] women; 794 [92%] identified as white; mean [SD] age, 51.8 [15.8] years). Patients reported they felt worse or much worse immediately after OMT at 45 office visits; the incidence rate for adverse events was 2.5% (95% CI, 1.3%-4.7%). Pain/discomfort was the most commonly identified type of adverse event (16 [0.9%]; 95% CI, 0.5%-1.6%). Insufficient information was provided to determine the type of adverse event at 20 office visits. Women reported adverse events more frequently than men (OR, 13.9; 95% CI, 1.7-115.6; P=.01). The incidence of adverse events

  8. [Adverse events management. Methods and results of a development project].

    Science.gov (United States)

    Rabøl, Louise Isager; Jensen, Elisabeth Brøgger; Hellebek, Annemarie H; Pedersen, Beth Lilja

    2006-11-27

    This article describes the methods and results of a project in the Copenhagen Hospital Corporation (H:S) on preventing adverse events. The aim of the project was to raise awareness about patients' safety, test a reporting system for adverse events, develop and test methods of analysis of events and propagate ideas about how to prevent adverse events. H:S developed an action plan and a reporting system for adverse events, founded an organization and developed an educational program on theories and methods of learning from adverse events for both leaders and employees. During the three-year period from 1 January 2002 to 31 December 2004, the H:S staff reported 6011 adverse events. In the same period, the organization completed 92 root cause analyses. More than half of these dealt with events that had been optional to report, the other half events that had been mandatory to report. The number of reports and the front-line staff's attitude towards reporting shows that the H:S succeeded in founding a safety culture. Future work should be centred on developing and testing methods that will prevent adverse events from happening. The objective is to suggest and complete preventive initiatives which will help increase patient safety.

  9. Text mining electronic health records to identify hospital adverse events

    DEFF Research Database (Denmark)

    Gerdes, Lars Ulrik; Hardahl, Christian

    2013-01-01

    Manual reviews of health records to identify possible adverse events are time consuming. We are developing a method based on natural language processing to quickly search electronic health records for common triggers and adverse events. Our results agree fairly well with those obtained using manual...... reviews, and we therefore believe that it is possible to develop automatic tools for monitoring aspects of patient safety....

  10. Challenges in coding adverse events in clinical trials

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C

    2012-01-01

    Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation....... Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding....

  11. Recent life events and psychosis: The role of childhood adversities.

    Science.gov (United States)

    Mansueto, Giovanni; Faravelli, Carlo

    2017-10-01

    Life events are commonly reported to be related to psychosis. However, less attention has been given to the role that recent events play on psychosis, in relation to exposure to childhood adversity. The current study aimed to evaluate the relationship between recent events and psychosis, taking into account the role of early adversities. 78 psychotic patients and 156 controls were enrolled. Childhood adversity was evaluated using a validated semi-structured interview and the Childhood Experience of Care and Abuse Questionnaire. Recent events were recorded using a semi-structured interview with a normative and contextual approach. The diagnosis of psychosis was made according to Jablenski's criteria. Chi-square, t-test, odds ratio, and binary logistic regression statistical analyses were performed. Psychotic patients reported an excess of recent events. The occurrence of more than one recent event increased the risk of psychosis; there was a cumulative effect between recent and childhood events on psychosis. Recent events were significantly related to psychosis, even in the absence of childhood adversity or when adjusted for it. Our findings suggested that the effect of recent events on psychosis may be amplified by previous exposure to early adversity. Recent events alone, could be also linked to psychosis independently of childhood adversity. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Frequently asked questions on seven rare adverse events following immunization.

    Science.gov (United States)

    D'alò, G L; Zorzoli, E; Capanna, A; Gervasi, G; Terracciano, E; Zaratti, L; Franco, E

    2017-03-01

    Routine mass immunization programs have contributed greatly to the control of infectious diseases and to the improvement of the health of populations. Over the last decades, the rise of antivaccination movements has threatened the advances made in this field to the point that vaccination coverage rates have decreased and outbreaks of vaccine-preventable diseases have resurfaced. One of the critical points of the immunization debate revolves around the level of risk attributable to vaccination, namely the possibility of experiencing serious and possibly irreversible adverse events. Unfortunately, the knowledge about adverse events, especially rare ones, is usually incomplete at best and the attribution of a causal relationship with vaccinations is subject to significant uncertainties. The aim of this paper is to provide a narrative review of seven rare or very rare adverse events: hypotonic hyporesponsive episode, multiple sclerosis, apnea in preterm newborns, Guillain-Barré syndrome, vasculitides, arthritis/ arthralgia, immune thrombocytopenic purpura. We have selected these adverse events based on our experience of questions asked by health care workers involved in vaccination services. Information on the chosen adverse events was retrieved from Medline using appropriate search terms. The review is in the form of questions and answers for each adverse event, with a view to providing useful and actionable concepts while not ignoring the uncertainties that remain. We also highlight in the conclusion possible future improvements to adverse event detection and assessment that could help identify individuals at higher risk against the probable future backdrop of ever-greater abandonment of compulsory vaccination policies.

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

    Science.gov (United States)

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

    2017-10-13

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

  14. Management of Carfilzomib-Associated Cardiac Adverse Events.

    Science.gov (United States)

    Mikhael, Joseph

    2016-05-01

    Carfilzomib is a proteasome inhibitor that is approved for use as a single agent in patients with relapsed and refractory multiple myeloma and when used in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma (1-3 prior lines of therapy). Cardiac and cardiopulmonary adverse events have been reported to be associated with carfilzomib-based treatment regimens. This article discusses the cardiac-related adverse events that have been reported in clinical studies of carfilzomib and presents a single institution perspective on the prevention and management of cardiac adverse events following treatment with this agent. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Nurse-perceived Patient Adverse Events and Nursing Practice Environment

    Directory of Open Access Journals (Sweden)

    Jeong-Hee Kang

    2014-09-01

    Full Text Available Objectives: To evaluate the occurrence of patient adverse events in Korean hospitals as perceived by nurses and examine the correlation between patient adverse events with the nurse practice environment at nurse and hospital level. Methods: In total, 3096 nurses working in 60 general inpatient hospital units were included. A two-level logistic regression analysis was performed. Results: At the hospital level, patient adverse events included patient falls (60.5%, nosocomial infections (51.7%, pressure sores (42.6% and medication errors (33.3%. Among the hospital-level explanatory variables associated with the nursing practice environment, ‘physician- nurse relationship’ correlated with medication errors while ‘education for improving quality of care’ affected patient falls. Conclusions: The doctor-nurse relationship and access to education that can improve the quality of care at the hospital level may help decrease the occurrence of patient adverse events.

  16. Scanning and vicarious learning from adverse events in health care

    Directory of Open Access Journals (Sweden)

    2001-01-01

    Full Text Available Studies have shown that serious adverse clinical events occur in approximately 3%-10% of acute care hospital admissions, and one third of these adverse events result in permanent disability or death. These findings have led to calls for national medical error reporting systems and for greater organizational learning by hospitals. But do hospitals and hospital personnel pay enough attention to such risk information that they might learn from each other's failures or adverse events? This paper gives an overview of the importance of scanning and vicarious learning from adverse events. In it I propose that health care organizations' attention and information focus, organizational affinity, and absorptive capacity may each influence scanning and vicarious learning outcomes. Implications for future research are discussed.

  17. Preventing Medication Error Based on Knowledge Management Against Adverse Event

    OpenAIRE

    Hastuti, Apriyani Puji; Nursalam, Nursalam; Triharini, Mira

    2017-01-01

    Introductions: Medication error is one of many types of errors that could decrease the quality and safety of healthcare. Increasing number of adverse events (AE) reflects the number of medication errors. This study aimed to develop a model of medication error prevention based on knowledge management. This model is expected to improve knowledge and skill of nurses to prevent medication error which is characterized by the decrease of adverse events (AE). Methods: This study consisted of two sta...

  18. [Adverse events in neonatology, contribution of a standardised register].

    Science.gov (United States)

    Normand, Marie-Madeleine; Ejarque Albuquerque, Margarida; Grouazel, Anne-Laure; Cottereau, Marie-Noëlle

    Despite the recommendation to report all adverse events to the risk management unit, such reporting is far from consistent. An internal, standardised register of adverse events, was put in place in a neonatology unit for six months. An analysis of the reports has led to the reorganisation of the unit and practices as part of a drive to improve the quality of care. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  19. Adverse events associated with fluoroscopically guided zygapophyseal joint injections.

    Science.gov (United States)

    Plastaras, Chris; McCormick, Zachary; Macron, Donald; Garvan, Cynthia; Joshi, Anand; Chimes, Gary; Smeal, Wesley; Rittenberg, Joshua

    2014-01-01

    In spite of the widespread performance of intra-articular zygapophyseal joint (IAZJ) injections, we know of no systematic analysis to date that examines the risks and types of adverse events when IAZJ injections are performed. To describe the type, incidence, and factors contributing to adverse events associated with fluoroscopically guided IAZJ injections. A retrospective, cohort study of English-speaking adults aged 18 - 90 years who underwent fluoroscopically guided IAZJ injections between March 8, 2004, and April 19, 2007. Following IAZJ injections, 3 senior researchers recorded the presence and type of adverse events. The relationship of adverse events with age, gender, fluoroscopy time, vital signs, and trainee presence was analyzed with Fisher's exact or Wilcoxon rank sum 2-sided tests. Frequency of immediate (during or immediately after the procedure) or delayed (within 24 - 72 hours following the procedure) adverse events. Tertiary, academic, outpatient physical medicine and rehabilitation interventional spine clinic. One hundred ninety-one patients (111 men) underwent 239 procedures. The mean and standard deviation (SD) of subject age was 56.4 (16.6) years ranging from 20 to 89. The mean and SD of pre-procedure 11-point Visual Analog Pain Scale was 5.5 (2.2) ranging from 0 to 10, and for post-procedure was 2.6 (2.6) ranging from 0 to 10. Trainees were involved in 52.3% of procedures. Reported immediate adverse events were vasovagal reaction (3.8%, n = 9) and steroid clogged needle (0.4%, n = 1). Follow-up data were available for 185/239 procedures (77.4%). There were 35 adverse events reported at mean follow-up interval of 1.8 days, of which the most frequent were injection site soreness (6.0%, n = 11), pain exacerbation (4.3%, n = 8), sleeplessness (2.2%, n = 4), and transient headache (1.6%, n = 3). Patient gender, age, trainee involvement, pre-procedural pain score, systolic or diastolic blood pressure, pulse, hemoglobin saturation as measured by pulse

  20. Mitigating adverse event reporting bias in spine surgery.

    Science.gov (United States)

    Auerbach, Joshua D; McGowan, Kevin B; Halevi, Marci; Gerling, Michael C; Sharan, Alok D; Whang, Peter G; Maislin, Greg

    2013-08-21

    Recent articles in the lay press and literature have raised concerns about the ability to report honest adverse event data from industry-sponsored spine surgery studies. To address this, clinical trials may utilize an independent Clinical Events Committee (CEC) to review adverse events and readjudicate the severity and relatedness accordingly. We are aware of no prior study that has quantified either the degree to which investigator bias is present in adverse event reporting or the effect that an independent CEC has on mitigating this potential bias. The coflex Investigational Device Exemption study is a prospective randomized controlled trial comparing coflex (Paradigm Spine) stabilization with lumbar spinal fusion to treat spinal stenosis and spondylolisthesis. Investigators classified the severity of adverse events (mild, moderate, or severe) and their relationship to the surgery and device (unrelated, unlikely, possibly, probably, or definitely). An independent CEC, composed of three spine surgeons without affiliation to the study sponsor, reviewed and reclassified all adverse event reports submitted by the investigators. The CEC reclassified the level of severity, relation to the surgery, and/or relation to the device in 394 (37.3%) of 1055 reported adverse events. The proportion of adverse events that underwent reclassification was similar in the coflex and fusion groups (37.9% compared with 36.0%, p = 0.56). The CEC was 5.3 (95% confidence interval [CI], 2.6 to 10.7) times more likely to upgrade than downgrade the adverse event. The CEC was 7.3 (95% CI, 5.1 to 10.6) times more likely to upgrade than downgrade the relationship to the surgery and 11.6 (95% CI, 7.5 to 18.8) times more likely to upgrade than downgrade the relationship to the device. The status of the investigator's financial interest in the company had little effect on the reclassification of adverse events. Thirty-seven percent of adverse events were reclassified by the CEC; the large majority

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

    DEFF Research Database (Denmark)

    Vinther, Siri; Klarskov, Pia; Borgeskov, Hanne

    2017-01-01

    INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region...

  2. Practical management of adverse events related to apomorphine therapy

    DEFF Research Database (Denmark)

    Bhidayasiri, Roongroj; Garcia Ruiz, Pedro J; Henriksen, Tove

    2016-01-01

    early enough. As such, proper clinician and patient awareness of the potential adverse effects is important to minimize their impact on the overall clinical utility of this efficacious antiparkinsonian agent. In this paper, we review the key local and systemic adverse effects reported during apomorphine......The potential for adverse events is often cited as a barrier to the use of subcutaneous apomorphine therapy (intermittent injections and continuous infusion) in the management of Parkinson's disease. However, with proactive management most adverse effects are manageable if reported and tackled...... titration, initiation and long-term treatment, and discuss practical management strategies....

  3. Practical management of adverse events related to apomorphine therapy.

    Science.gov (United States)

    Bhidayasiri, Roongroj; Garcia Ruiz, Pedro J; Henriksen, Tove

    2016-12-01

    The potential for adverse events is often cited as a barrier to the use of subcutaneous apomorphine therapy (intermittent injections and continuous infusion) in the management of Parkinson's disease. However, with proactive management most adverse effects are manageable if reported and tackled early enough. As such, proper clinician and patient awareness of the potential adverse effects is important to minimize their impact on the overall clinical utility of this efficacious antiparkinsonian agent. In this paper, we review the key local and systemic adverse effects reported during apomorphine titration, initiation and long-term treatment, and discuss practical management strategies. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Y-90 microsphere therapy: prevention of adverse events.

    Science.gov (United States)

    Schultz, Cheryl C; Campbell, Janice; Bakalyar, Donovan; Beauvais, Michele; Feng, Wenzheng; Savin, Michael

    2009-08-01

    Thirty-three (33) events that were inconsistent with intended treatment for 471 Y-90 microsphere deliveries were analyzed from 2001 to 2007. Each occurrence was categorized, based on root-cause analysis, as a device/product defect and/or operator error event. Events were further categorized, if there was an adverse outcome, as spill/leak, termination, recatheterization, dose deviation, and/or a regulatory medical event. Of 264 Y-90 Therasphere (MDS Nordion, Ottawa, Ontario, Canada) treatments, 15 events were reported (5.7%). Of 207 Y-90 SIR-Spheres (Sirtex, Wilmington, MA) treatments, 18 events were reported (8.7%). Twenty-five (25) of 33 events (76%) were device/product defects: 73% for Therasphere (11 of 15) and 78% for SIR-Spheres (14 of 18). There were 31 adverse outcomes associated with 33 events: 15 were leaks and/or spills, 9 resulted in termination of the dose administration, 3 resulted in recatheterization for dose compensation, 2 were dose deviations (doses differing from the prescribed between 10% and 20%), and 2 were reported as regulatory medical events. Fifty-five (55) corrective actions were taken: 39 (71%) were related to the manufacturer and 16 (29%) were hospital based. This process of analyzing each event and measuring our outcomes has been effective at minimizing adverse events and improving patient safety.

  5. The automation of clinical trial serious adverse event reporting workflow.

    Science.gov (United States)

    London, Jack W; Smalley, Karl J; Conner, Kyle; Smith, J Bruce

    2009-10-01

    The reporting of serious adverse events is a requirement when conducting a clinical trial involving human subjects, necessary for the protection of the participants. The reporting process is a multi-step procedure, involving a number of individuals from initiation to final review, and must be completed in a timely fashion. The purpose of this project was to automate the adverse event reporting process, replacing paper-based processes with computer-based processes, so that personnel effort and time required for serious adverse event reporting was reduced, and the monitoring of reporting performance and adverse event characteristics was facilitated. Use case analysis was employed to understand the reporting workflow and generate software requirements. The automation of the workflow was then implemented, employing computer databases, web-based forms, electronic signatures, and email communication. In the initial year (2007) of full deployment, 588 SAE reports were processed by the automated system, eSAEy. The median time from initiation to Principal Investigator electronic signature was trials adverse reporting procedures are applicable in general, specific workflow details may not be relevant at other institutions. The system facilitated analysis of individual investigator reporting performance, as well as the aggregation and analysis of the nature of reported adverse events.

  6. CNS adverse events associated with antimalarial agents. Fact or fiction?

    NARCIS (Netherlands)

    Phillips-Howard, P. A.; ter Kuile, F. O.

    1995-01-01

    CNS adverse drug events are dramatic, and case reports have influenced clinical opinion on the use of antimalarials. Malaria also causes CNS symptoms, thus establishing causality is difficult. CNS events are associated with the quinoline and artemisinin derivatives. Chloroquine, once considered too

  7. Intraoperative adverse events associated with extremely preterm cesarean deliveries.

    Science.gov (United States)

    Bertholdt, Charline; Menard, Sophie; Delorme, Pierre; Lamau, Marie-Charlotte; Goffinet, François; Le Ray, Camille

    2018-05-01

    At the same time as survival is increasing among premature babies born before 26 weeks of gestation, the rates of cesarean deliveries before 26 weeks is also rising. Our purpose was to compare the frequency of intraoperative adverse events during cesarean deliveries in two gestational age groups: 24-25 weeks and 26-27 weeks. This single-center retrospective cohort study included all women with cesarean deliveries performed before 28 +0 weeks from 2007 through 2015. It compared the frequency of intraoperative adverse events between two groups: those at 24-25 weeks of gestation and at 26-27 weeks. Intraoperative adverse events were a classical incision, transplacental incision, difficulty in fetal extraction (explicitly mentioned in the surgical report), postpartum hemorrhage (≥500 mL of blood loss), and injury to internal organs. A composite outcome including at least one of these events enabled us to analyze the risk factors for intraoperative adverse events with univariate and multivariable analysis. Stratified analyses by the indication for the cesarean were performed. We compared 74 cesarean deliveries at 24-25 weeks of gestation and 214 at 26-27 weeks. Intraoperative adverse events occurred at higher rates in the 24-25-week group (63.5 vs. 30.8%, p cesarean. These results should help obstetricians and women making decisions about cesarean deliveries at these extremely low gestational ages. © 2018 Nordic Federation of Societies of Obstetrics and Gynecology.

  8. A database in ACCESS for assessing vaccine serious adverse events

    Directory of Open Access Journals (Sweden)

    Thomas RE

    2015-04-01

    Full Text Available Roger E Thomas,1 Dave Jackson2,3 1Department of Family Medicine, G012 Health Sciences Centre, University of Calgary Medical School, Calgary, AB, Canada; 2Independent Research Consultant, Calgary, AB, Canada; 3Database Consultant, University of Calgary, Calgary, AB, Canada Purpose: To provide a free flexible database for use by any researcher for assessing reports of adverse events after vaccination. Results: A database was developed in Microsoft ACCESS to assess reports of serious adverse events after yellow fever vaccination using Brighton Collaboration criteria. The database is partly automated (if data panels contain identical data fields the data are automatically also entered into those fields. The purpose is to provide the database free for developers to add additional panels to assess other vaccines. Keywords: serious adverse events after vaccination, database, process to assess vaccine-associated events 

  9. Cadec: A corpus of adverse drug event annotations.

    Science.gov (United States)

    Karimi, Sarvnaz; Metke-Jimenez, Alejandro; Kemp, Madonna; Wang, Chen

    2015-06-01

    CSIRO Adverse Drug Event Corpus (Cadec) is a new rich annotated corpus of medical forum posts on patient-reported Adverse Drug Events (ADEs). The corpus is sourced from posts on social media, and contains text that is largely written in colloquial language and often deviates from formal English grammar and punctuation rules. Annotations contain mentions of concepts such as drugs, adverse effects, symptoms, and diseases linked to their corresponding concepts in controlled vocabularies, i.e., SNOMED Clinical Terms and MedDRA. The quality of the annotations is ensured by annotation guidelines, multi-stage annotations, measuring inter-annotator agreement, and final review of the annotations by a clinical terminologist. This corpus is useful for studies in the area of information extraction, or more generally text mining, from social media to detect possible adverse drug reactions from direct patient reports. The corpus is publicly available at https://data.csiro.au.(1). Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Adverse event reporting for botulinum toxin type A.

    Science.gov (United States)

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

    2005-12-01

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

  11. Role of systems pharmacology in understanding drug adverse events

    Science.gov (United States)

    Berger, Seth I.; Iyengar, Ravi

    2011-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Andréia Guerra Siman

    2017-10-01

    Full Text Available Abstract OBJECTIVE Understanding the practice of reporting adverse events by health professionals. METHOD A qualitative case study carried out in a teaching hospital with participants of the Patient Safety Center and the nursing team. The collection took place from May to December 2015, and was conducted through interviews, observation and documentary research to treat the data using Content Analysis. RESULTS 31 professionals participated in the study. Three categories were elaborated: The practice of reporting adverse events; Barriers in the effective practice of notifications; The importance of reporting adverse events. CONCLUSION Notification was permeated by gaps in knowledge, fear of punishment and informal communication, generating underreporting. It is necessary to improve the interaction between leaders and professionals, with an emphasis on communication and educational practice.

  13. Serious adverse events reported for anti-obesity medicines

    DEFF Research Database (Denmark)

    Aagaard, L; Hallgreen, C E; Hansen, Ebba Holme

    2016-01-01

    BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti-obesity medici......BACKGROUND: Use of anti-obesity medicines has been linked with serious cardiac and psychiatric adverse events (AEs). Spontaneous reports can provide information about serious, rare and unknown AEs occurring after time of marketing. In Europe, information about AEs reported for anti......-obesity medicines can be accessed in the EudraVigilance database (EV). Therefore, we aimed to identify and characterise adverse events (AEs) associated with use of anti-obesity medicines in Europe. METHODS: AE reports submitted for anti-obesity medicines (Anatomical Therapeutic Chemical [ATC] group A08A) from 2007...

  14. Adverse events in children and adolescents treated with quetiapine

    DEFF Research Database (Denmark)

    Jakobsen, Klaus D; Wallach-Kildemoes, Helle; Bruhn, Christina H

    2017-01-01

    Quetiapine is a low-affinity dopamine D2 receptor antagonist, approved for the treatment of bipolar disorder and schizophrenia in children and adolescents by the Food and Drug Administration, but not by European Medicine Agency. Although knowledge of adverse drug reactions in children...... and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark. The aim of this case study is to discuss adverse drug events (ADEs) spontaneously reported to the Danish Medicines Agency on quetiapine used in the pediatric population in relation to adversive drug reactions (ADRs) reported...

  15. ANABOLIC ANDROGENIC STEROIDS AND ADVERSE EVENTS OF THEIR APPLICATION

    Directory of Open Access Journals (Sweden)

    Nina Đukanović

    2011-08-01

    Full Text Available Anabolic androgenic steroids are synthetic compounds originating from testosterone. Their main effects are the control of development and expression of male secondary sexual characteristics, which are known as androgenic effects, and encourage muscle growth or anabolic effects. Anabolic androgenic steroids are most commonly used illegal substances. Besides these physiological effects, which are achieved using therapeutic doses of these preparations, higher doses than recommended, especially over the longer term, may be associated with the emergence of numerous adverse events. Adverse events may be registered in almost all organs and organ systems, but usually include changes in the reproductive system, skin, liver and cardiovascular system.

  16. Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis.

    Science.gov (United States)

    Prochaska, Judith J; Hilton, Joan F

    2012-05-04

    To examine the risk of treatment emergent, cardiovascular serious adverse events associated with varenicline use for tobacco cessation. Meta-analysis comparing study effects using four summary estimates. Medline, Cochrane Library, online clinical trials registries, and reference lists of identified articles. We included randomised controlled trials of current tobacco users of adult age comparing use of varenicline with an inactive control and reporting adverse events. We defined treatment emergent, cardiovascular serious adverse events as occurring during drug treatment or within 30 days of discontinuation, and included any ischaemic or arrhythmic adverse cardiovascular event (myocardial infarction, unstable angina, coronary revascularisation, coronary artery disease, arrhythmias, transient ischaemic attacks, stroke, sudden death or cardiovascular related death, or congestive heart failure). We identified 22 trials; all were double blinded and placebo controlled; two included participants with active cardiovascular disease and 11 enrolled participants with a history of cardiovascular disease. Rates of treatment emergent, cardiovascular serious adverse events were 0.63% (34/5431) in the varenicline groups and 0.47% (18/3801) in the placebo groups. The summary estimate for the risk difference, 0.27% (95% confidence interval -0.10 to 0.63; P = 0.15), based on all 22 trials, was neither clinically nor statistically significant. For comparison, the relative risk (1.40, 0.82 to 2.39; P = 0.22), Mantel-Haenszel odds ratio (1.41, 0.82 to 2.42; P = 0.22), and Peto odds ratio (1.58, 0.90 to 2.76; P = 0.11), all based on 14 trials with at least one event, also indicated a non-significant difference between varenicline and placebo groups. This meta--analysis--which included all trials published to date, focused on events occurring during drug exposure, and analysed findings using four summary estimates-found no significant increase in cardiovascular serious adverse events

  17. When Clinicians Drop Out and Start Over after Adverse Events.

    Science.gov (United States)

    Rodriquez, Jason; Scott, Susan D

    2018-03-01

    The impact of adverse clinical events on health care workers has become a growing topic of research. Previous research has confirmed that after adverse clinical events, clinical staff often feel as though they failed not only their patient but also themselves, resulting in second-guessing of their clinical skills, competencies, and even career choices. This exploratory study reports on the experiences of health care providers who changed career paths as a consequence of an adverse clinical event. The authors designed a 39-question survey capturing personal and professional demographics, participant recall of the clinical event, insights into their lived experiences, health care institutions' response(s) to the event, decision-making influences relating to future employment, and insights into interventional strategies. Consistent with prior research, clinicians reported a pattern of inadequate social support after the event. Results further show the salience of emotional labor as a driving force among those who changed roles. In clinicians' own assessments about the lasting impact of the event, many felt less joy and meaning in their new clinical roles, but others thrived by rededicating their careers toward implementing patient safety initiatives and enhancing peer-support networks. Clinicians reported a desire for more transparency and support to help them recover. Clinicians aligned their emotional displays to be consistent with organizational expectations, resulting in suppressed feelings of guilt and shame that may have contributed to burnout, changed roles, or even premature retirement. Study findings highlight the need to develop better support systems for clinicians who are party to an adverse clinical event. Copyright © 2017 The Joint Commission. Published by Elsevier Inc. All rights reserved.

  18. Management of adverse events associated with idelalisib treatment: expert panel opinion.

    Science.gov (United States)

    Coutré, Steven E; Barrientos, Jacqueline C; Brown, Jennifer R; de Vos, Sven; Furman, Richard R; Keating, Michael J; Li, Daniel; O'Brien, Susan M; Pagel, John M; Poleski, Martin H; Sharman, Jeff P; Yao, Nai-Shun; Zelenetz, Andrew D

    2015-01-01

    Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor approved for the treatment of several types of blood cancer. Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box warning for fatal and/or severe diarrhea or colitis, hepatotoxicity, pneumonitis and intestinal perforation. An expert panel was convened to review the pathology of these treatment-emergent adverse events (TEAEs) to propose key management tools for patients receiving idelalisib therapy. This article provides an overview of idelalisib TEAEs reported in clinical trials, and a summary of the panel's recommendations for identification and management of idelalisib treatment-emergent diarrhea or colitis as well as a discussion of transaminitis and pneumonitis. For idelalisib-related diarrhea or colitis (including unresolved grade 2 and grade ≥ 3), after exclusion of infectious causes, the panel recommends individualized treatment with budesonide or oral or intravenous steroid therapy.

  19. Adverse cardiac events in out-patients initiating clozapine treatment

    DEFF Research Database (Denmark)

    Rohde, C; Polcwiartek, C; Kragholm, K

    2018-01-01

    OBJECTIVE: Using national Danish registers, we estimated rates of clozapine-associated cardiac adverse events. Rates of undiagnosed myocarditis were estimated by exploring causes of death after clozapine initiation. METHOD: Through nationwide health registers, we identified all out-patients initi......OBJECTIVE: Using national Danish registers, we estimated rates of clozapine-associated cardiac adverse events. Rates of undiagnosed myocarditis were estimated by exploring causes of death after clozapine initiation. METHOD: Through nationwide health registers, we identified all out...... the maximum rate of clozapine-associated fatal myocarditis to 0.28%. CONCLUSION: Cardiac adverse effects in Danish out-patients initiating clozapine treatment are extremely rare and these rates appear to be comparable to those observed for other antipsychotic drugs....

  20. Perioperative adverse airway events in cleft lip and palate repair ...

    African Journals Online (AJOL)

    Background: Airway-related problems account for the majority of anaesthetic morbidity in paediatric anaesthesia, but more so for cleft lip and palate repair. The aim of this study was to assess the frequency, pattern, management and outcome of adverse airway events during the perioperative period in cleft lip and palate ...

  1. Radiation-associated adverse events after childhood cancer

    NARCIS (Netherlands)

    van Dijk, I.W.E.M.

    2014-01-01

    With improved survival rates, childhood cancer survivors are confronted with treatment-related adverse events, especially when radiation therapy was involved. After the introduction (Chapter 1), the Chapters 2 and 3 present the EKZ/AMC childhood cancer survivor cohort and the methodology of using

  2. Adverse Life Events and Mental Health in Middle Adolescence

    Science.gov (United States)

    Flouri, Eirini; Kallis, Constantinos

    2011-01-01

    This study's aim was to search for the appropriate functional form of the effect of proximal cumulative contextual risk (PCCR), measured with number of adverse life events experienced in the last 6 months, on adolescent psychopathology and prosocial behavior, measured with the Strengths and Difficulties Questionnaire. The study sample was 171 year…

  3. High rate of adverse events following circumcision of young male ...

    African Journals Online (AJOL)

    (94) refusing circumcision by the TK technique; 34 men were randomised to the FG group and 35 to the TK group, and 32 and 24 patients were circumcised by the FG and TK methods respectively, of whom 29 and 19 respectively attended the post-circumcision visit. All 12 adverse event sheets corresponded to the TK group ...

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

    African Journals Online (AJOL)

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

  5. Adverse events following HPV vaccination, Alberta 2006-2014.

    Science.gov (United States)

    Liu, Xianfang C; Bell, Christopher A; Simmonds, Kimberley A; Svenson, Lawrence W; Russell, Margaret L

    2016-04-04

    In Canada, private purchase of human papilloma virus (HPV) vaccines has been possible since 2006. In Alberta, Canada, a publicly funded quadrivalent HPV vaccine program began in the 2008/2009 school year. There have been concerns about adverse events, including venous thromboembolism (VTE) associated with HPV vaccines. We describe the frequencies of adverse events following HPV vaccination among Alberta females aged 9 years or older and look at VTE following HPV vaccination. We used the Alberta Immunization and Adverse Reaction to Immunization (Imm/ARI) repository (publicly funded vaccine), the population-based Pharmaceutical Information Network (PIN) information system (dispensing of a vaccine), and the Alberta Morbidity and Ambulatory Care Abstract reporting system (MACAR) for June 1, 2006-November 19, 2014. Deterministic data linkage used unique personal identifiers. We identified all reported adverse events following immunization (AEFI) and all emergency department (ED) utilization or hospitalizations within 42 days of immunization. We calculated the frequency of AEFI by type, rates per 100,000 doses of HPV vaccine administered and the frequencies of ICD-10-CA codes for hospitalizations and emergency department visits. Over the period 195,270 females received 528,913 doses of HPV vaccine. Of those receiving at least one dose, 192 reported one or more AEFI events (198 AEFI events), i.e., 37.4/100,000 doses administered (95% CI 32.5-43.0). None were consistent with VTE. Of the women who received HPV vaccine 958 were hospitalized and 19,351 had an ED visit within 42 days of immunization. Four women who had an ED visit and hospitalization event were diagnosed with VTE. Three of these had other diagnoses known to be associated with VTE; the fourth woman had VTE among ED diagnoses but not among those for the hospitalization. Rates of AEFI after HPV immunization in Alberta are low and consistent with types of events seen elsewhere. Copyright © 2016 The Authors

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

    Science.gov (United States)

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

    2015-08-26

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

  7. Association between alcohol abuse, childhood adverse events and suicide

    Directory of Open Access Journals (Sweden)

    Vida Ana Politakis

    2017-11-01

    Full Text Available Background: Negative life events present a risk for suicidal behaviour. The occurrence of suicidal behaviour also depends on type of negative life events, time of their appearance and the support person has in their environment, and can be part of a process triggered by a stressful event. the aim of the study was to investigate adverse childhood events, parental alcoholism and alcohol abuse in association with suicidal behaviour of suicide victims. Methods: A case-control study was conducted involving 90 individuals from Slovenian population who committed suicide and 90 age-sex matched controls drawn from the living population. Data were collected by means of semi-structured interviews with key informants by the principles of psychological autopsy. Results: Alcohol abuse was reported more ofen for suicide victims than for controls. The same was true for severe deprivation in childhood and alcoholism of one or both parents. Differences between groups in separation from one or both parents, death of one or both parents, reported parental divorce in childhood or sexual abuse in childhood were not observed. Conclusions: We should conclude that negative events in childhood and alcohol abuse in adulthood of suicide victims could be related to suicidal behaviour in population with higher suicide rate. When planning measures for the prevention of suicidal behaviour, adverse events in childhood and alcohol abuse should not be neglected to plan measures to prevent such events accordingly and to raise awareness about the dangers of alcohol abuse for suicidal behaviour.

  8. Sharing adverse drug event data using business intelligence technology.

    Science.gov (United States)

    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.

  9. BCG and Adverse Events in the Context of Leprosy

    Directory of Open Access Journals (Sweden)

    Renate Richardus

    2018-04-01

    Full Text Available BackgroundNotwithstanding its beneficial immunoprophylactic outcomes regarding leprosy and childhood TB, BCG vaccination may cause adverse events, particularly of the skin. However, this local hyper-immune reactivity cannot be predicted before vaccination, nor is its association with protection against leprosy known. In this study we investigated the occurrence of adverse events after BCG (revaccination in contacts of leprosy patients and analyzed whether the concomitant systemic anti-mycobacterial immunity was associated with these skin manifestations.MethodsWithin a randomized controlled BCG vaccination trial in Bangladesh, 14,828 contacts of newly diagnosed leprosy patients received BCG vaccination between 2012 and 2017 and were examined for adverse events 8 to 12 weeks post-vaccination. From a selection of vaccinated contacts, venous blood was obtained at follow-up examination and stimulated with Mycobacterium leprae (M. leprae antigens in overnight whole-blood assays (WBA. M. leprae phenolic glycolipid-I-specific antibodies and 32 cytokines were determined in WBAs of 13 individuals with and 13 individuals without adverse events after vaccination.ResultsOut of the 14,828 contacts who received BCG vaccination, 50 (0.34% presented with adverse events, mainly (80% consisting of skin ulcers. Based on the presence of BCG scars, 30 of these contacts (60% had received BCG in this study as a booster vaccination. Similar to the pathological T-cell immunity observed for tuberculoid leprosy patients, contacts with adverse events at the site of BCG vaccination showed elevated IFN-γ levels in response to M. leprae-specific proteins in WBA. However, decreased levels of sCD40L in serum and GRO (CXCL1 in response to M. leprae simultaneously indicated less T-cell regulation in these individuals, potentially causing uncontrolled T-cell immunity damaging the skin.ConclusionSkin complications after BCG vaccination present surrogate markers for protective

  10. Adverse Drug Event Prevention: 2014 Action Plan Conference.

    Science.gov (United States)

    Ducoffe, Aaron R; Baehr, Avi; Peña, Juliet C; Rider, Briana B; Yang, Sandra; Hu, Dale J

    2016-09-01

    Adverse drug events (ADEs) have been highlighted as a national patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion in August 2014. The following October, the ADE Prevention: 2014 Action Plan Conference provided an opportunity for federal agencies, national experts, and stakeholders to coordinate and collaborate in the initiative to reduce preventable ADEs. The single-day conference included morning plenary sessions focused on the surveillance, evidence-based prevention, incentives and oversights, and additional research needs of the drug classes highlighted in the ADE Action Plan: anticoagulants, diabetes agents, and opioids. Afternoon breakout sessions allowed for facilitated discussions on measures for tracking national progress in ADE prevention and the identification of opportunities to ensure safe and high-quality health care and medication use. © The Author(s) 2015.

  11. Ezetimibe: Use, costs, and adverse events in Australia.

    Science.gov (United States)

    Hollingworth, Samantha A; Ostino, Remo; David, Michael C; Martin, Jennifer H; Tett, Susan E

    2017-02-01

    To analyze the subsidized use and reported adverse events of ezetimibe, used to lower cholesterol, in Australia over the 11 years following its inclusion on the Pharmaceutical Benefits Scheme (PBS) in 2004. Pharmacoepidemiological analysis of dispensed prescriptions from Medicare Australia. Adverse event data were obtained from the Therapeutic Goods Administration. Use was measured by the defined daily dose (DDD) per 1000 population per day for each calendar year. Adverse events were counted by organ class system. Total ezetimibe use rose to 8.46 DDD/1000 population/d in the 11 years to 2015. Ezetimibe as a sole active ingredient was the most commonly dispensed formulation followed by the two combination products containing ezetimibe and 40 mg or 80 mg simvastatin. The average yearly increase in utilization was 19% with a 24% annual increase in costs to government (2006-2015) to $169.0 million in 2015. There were substantial differences in ezetimibe use between states, with no relationship to deaths from ischaemic heart disease (IHD) in each jurisdiction. The major reported adverse events were musculoskeletal and connective tissue disorders and gastrointestinal disorders. Ezetimibe use has increased rapidly in Australia since receiving public subsidy. Although the indications for subsidy are very restricted, there appears to have been widespread use, not explained by differential geographical IHD death rates. Latest guidelines still question the value of ezetimibe, so further discussion about whether the public spending on this medication for any potential improvement in population health outcomes is justified. © 2016 John Wiley & Sons Ltd.

  12. Vitex agnus castus: a systematic review of adverse events.

    Science.gov (United States)

    Daniele, Claudia; Thompson Coon, Joanna; Pittler, Max H; Ernst, Edzard

    2005-01-01

    Vitex agnus castus L. (VAC) [Verbenaceae] is a deciduous shrub that is native to Mediterranean Europe and Central Asia. Traditionally, VAC fruit extract has been used in the treatment of many female conditions, including menstrual disorders (amenorrhoea, dysmenorrhoea), premenstrual syndrome (PMS), corpus luteum insufficiency, hyperprolactinaemia, infertility, acne, menopause and disrupted lactation. The German Commission E has approved the use of VAC for irregularities of the menstrual cycle, premenstrual disturbances and mastodynia. Clinical reviews are available for the efficacy of VAC in PMS, cycle disorders, hyperprolactinaemia and mastalgia, but so far no systematic review has been published on adverse events or drug interactions associated with VAC. Therefore, this review was conducted to evaluate all the available human safety data of VAC monopreparations. Literature searches were conducted in six electronic databases, in references lists of all identified papers and in departmental files. Data from spontaneous reporting schemes of the WHO and national drug safety bodies were also included. Twelve manufacturers of VAC-containing preparations and five herbalist organisations were contacted for additional information. No language restrictions were imposed. Combination preparations including VAC or homeopathic preparations of VAC were excluded. Data extraction of key data from all articles reporting adverse events or interactions was performed independently by at least two reviewers, regardless of study design. Data from clinical trials, postmarketing surveillance studies, surveys, spontaneous reporting schemes, manufacturers and herbalist organisations indicate that the adverse events following VAC treatment are mild and reversible. The most frequent adverse events are nausea, headache, gastrointestinal disturbances, menstrual disorders, acne, pruritus and erythematous rash. No drug interactions were reported. Use of VAC should be avoided during pregnancy or

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

    Science.gov (United States)

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

    2016-05-01

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

  14. An evolutionary approach to realism-based adverse event representations.

    Science.gov (United States)

    Ceusters, W; Capolupo, M; de Moor, G; Devlies, J; Smith, B

    2011-01-01

    Part of the ReMINE project involved the creation of an ontology enabling computer-assisted decision support for optimal adverse event management. The ontology was required to satisfy the following requirements: 1) to be able to account for the distinct and context-dependent ways in which authoritative sources define the term 'adverse event', 2) to allow the identification of relevant risks against patient safety (RAPS) on the basis of the disease history of a patient as documented in electronic health records, and 3) to be compatible with present and future ontologies developed under the Open Biomedical Ontology (OBO) Foundry framework. We used as feeder ontologies the Basic Formal Ontology, the Foundational Model of Anatomy, the Ontology for General Medical Science, the Information Artifact Ontology and the Ontology of Mental Health. We further used relations defined according to the pattern set forth in the OBO Relation Ontology. In light of the intended use of the ontology for the representation of adverse events that have actually occurred and therefore are registered in a database, we also applied the principles of referent tracking. We merged the upper portions of the mentioned feeder ontologies and introduced 22 additional representational units of which 13 are generally applicable in biomedicine and nine in the adverse event context. We provided for each representational unit a textual definition that can be translated into equivalent formal definitions. The resulting ontology satisfies all of the requirements set forth. Merging the feeder ontologies, although all designed under the OBO Foundry principles, brought new insight into what the representational units of such ontologies actually denote.

  15. Categorizing errors and adverse events for learning: a provider perspective.

    Science.gov (United States)

    Ginsburg, Liane R; Chuang, You-Ta; Richardson, Julia; Norton, Peter G; Berta, Whitney; Tregunno, Deborah; Ng, Peggy

    2009-01-01

    There is little agreement in the literature as to what types of patient safety events (PSEs) should be the focus for learning, change and improvement, and we lack clear and universally accepted definitions of error. In particular, the way front-line providers or managers understand and categorize different types of errors, adverse events and near misses and the kinds of events this audience believes to be valuable for learning are not well understood. Focus groups of front-line providers, managers and patient safety officers were used to explore how people in healthcare organizations understand and categorize different types of PSEs in the context of bringing about learning from such events. A typology of PSEs was developed from the focus group data and then mailed, along with a short questionnaire, to focus group participants for member checking and validation. Four themes emerged from our data: (1) incidence study categories are problematic for those working in organizations; (2) preventable events should be the focus for learning; (3) near misses are an important but complex category, differentiated based on harm potential and proximity to patients; (4) staff disagree on whether events causing severe harm or events with harm potential are most valuable for learning. A typology of PSEs based on these themes and checked by focus group participants indicates that staff and their managers divide events into simple categories of minor and major events, which are differentiated based on harm or harm potential. Confusion surrounding patient safety terminology detracts from the abilities of providers to talk about and reflect on a range of PSEs, and from opportunities to enhance learning, reduce event reoccurrence and improve patient safety at the point of care.

  16. Adverse drug events caused by serious medication administration errors.

    Science.gov (United States)

    Kale, Abhivyakti; Keohane, Carol A; Maviglia, Saverio; Gandhi, Tejal K; Poon, Eric G

    2012-11-01

    To determine how often serious or life-threatening medication administration errors with the potential to cause harm (potential adverse drug events) result in actual harm (adverse drug events (ADEs)) in the hospital setting. Retrospective chart review of clinical events following observed medication administration errors. Medication errors are common at the medication administration stage for inpatients. While many errors can cause harm, it is unclear exactly how often. In a previous study where 14 041 medication administrations were directly observed, 1271 medication administration errors were discovered, of which 133 had the potential to cause serious or life-threatening harm and were considered serious or life-threatening potential adverse drug events. As a follow-up, clinical reviewers conducted detailed chart review of serious or life-threatening potential ADEs to determine if they caused an ADE. Reviewers assessed severity of the ADE and attribution to the error. Ten (7.5% (95% CI 6.98 to 8.01)) actual ADEs resulted from the 133 serious and life-threatening potential ADEs, of which 6 resulted in significant, three in serious, and one life threatening injury. Therefore 4 (3% (95% CI 2.12 to 3.6)) of serious or life threatening potential ADEs led to serious or life threatening ADEs. Half of the ADEs were caused by dosage or monitoring errors for anti-hypertensives. Unintercepted potential ADEs at the medication administration stage can cause serious patient harm. At hospitals where 6 million doses are administered per year, about 4000 preventable ADEs would be attributable to medication administration errors annually.

  17. Adverse Events in Children Receiving General Anaesthesia with Laryngeal Mask Airway Insertion

    Directory of Open Access Journals (Sweden)

    Sindhu Khatiwada

    2015-06-01

    Conclusions: The commonest adverse event in children is related to respiratory system. Adverse events occur more frequently in the operating room, mostly immediately after removal of laryngeal mask airway. Respiratory events are more frequent in children below five years whereas cardiac events are more frequent in children above five years. Keywords: adverse events; children; laryngeal mask airway; laryngospasm; perioperative.

  18. Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events

    DEFF Research Database (Denmark)

    Sachs, Mikkel Lindskov; Sporrong, Sofia Kälvemark; Colding-Jørgensen, Morten

    2017-01-01

    BACKGROUND: Increasingly, patients are expected to influence decisions previously reserved for regulatory agencies, pharmaceutical companies, and healthcare professionals. Individual patients have previously represented their patient population when rare, serious adverse events (AEs) were weighed...... as part of a benefit-risk assessment. However, the degree of heterogeneity of the patient population is critical for how accurately they can be represented by individuals. OBJECTIVES: This study aims to explore patients' risk perception of rare, serious adverse effects of medicines with regard to blood......, perceptions of the terms rare and serious, and overall levels of risk aversion. A thematic analysis of the interviews, including a consensus discussion, was carried out. RESULTS: Interestingly, respondents rarely made a clear distinction between medicines-induced AEs and complications related to disease...

  19. Ketamine for Pain Management-Side Effects & Potential Adverse Events.

    Science.gov (United States)

    Allen, Cheryl A; Ivester, Julius R

    2017-12-01

    An old anesthetic agent, ketamine is finding new use in lower doses for analgesic purposes. There are concerns stemming from its potential side effects-specifically psychomimetic effects. These side effects are directly related to dose amount. The doses used for analgesic purposes are much lower than those used for anesthesia purposes. A literature review was performed to ascertain potential side effects and/or adverse events when using ketamine for analgesia purposes. The search included CINAHL, PubMed, and Ovid using the search terms "ketamine," "ketamine infusion," "pain," "adverse events," "practice guideline," and "randomized controlled trial." Searches were limited to full-text, peer-reviewed articles and systematic reviews. Initially 1,068 articles were retrieved. The search was then narrowed by using the Boolean connector AND with various search term combinations. After adjusting for duplication, article titles and abstracts were reviewed, leaving 25 articles for an in-depth analysis. Specific exclusion criteria were then applied. The literature supports the use of ketamine for analgesic purposes, and ketamine offers a nonopioid option for the management of some pain conditions. Because ketamine is still classified as an anesthetic agent, health care institutions should develop their own set of policies and protocols for the administration of ketamine. By using forethought and understanding of the properties of ketamine, appropriate care may be planned to mitigate potential side effects and adverse events so that patients are appropriately cared for and their pain effectively managed. Copyright © 2017 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  20. Adverse events with continuous doxapram infusion against late postoperative hypoxaemia

    DEFF Research Database (Denmark)

    Rosenberg, J; Kristensen, P A; Pedersen, M H

    1996-01-01

    OBJECTIVE: A randomized double-blind controlled trial of doxapram versus placebo against late postoperative hypoxaemia was planned to include 40 patients (2 x 20). RESULTS: After inclusion of 18 patients a serious adverse event was encountered with development of a brain stem infarction in a 90-y...... promising, further studies on the effect of continuous nocturnal postoperative doxapram infusion on levels of arterial oxygen saturation should be postponed until more knowledge about the pharmacokinetics of doxapram in this particular clinical situation has been gathered....

  1. [Adverse events and near misses in medical imaging].

    Science.gov (United States)

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

    2011-01-01

    In 2000, the Institute of Medicine's report, To Err Is Human: Building a Safer Health System, caught the public attention documenting the magnitude of the medical error problem and the inherent patient safety: medical errors cause between 44,000 and 98,000 deaths annually in the United States. Currently, there is a growing interest in risk management on the medical field, particularly in the management of adverse events. It has been mainly due to the commitment of the World Health Organization, that this field of research has gained increasing the attention it deserves. Medical imaging is one of the high risk fields for the occurrence of errors, especially due to the multiplicity of techniques, the several stakeholders and the complexity of the whole circuit that involves the conduct of studies. Many of the methods used to analyze patient safety were adapted from risk-management techniques in high-risk industries (e.g. chemical, nuclear power and aviation industry). It is recognized that we can learn more from our mistakes than from our successes and the reporting systems in these industries have provided a valuable contribution to error prevention and risk management techniques. At a minimum, adverse events reporting systems can help to identify hazards and risks, providing important information on the system aspects that should be improved. However, the accumulation of potentially relevant data contributes little to healthcare services improvement. It is crucial to apply models to identify the underlying system failures, the root causes, and enhance the sharing of knowledge and experience. In this paper, it is suggested a solution to reduce adverse events, by identifying and eliminating the root causes that are in their source. How the Eindhoven Classification Model was adapted and extended specifically for the Medical Imaging field is also presented. The proposed approach includes the root causes analysis and introduces incomplete information concepts through

  2. Serious adverse events associated with yellow fever vaccine.

    Science.gov (United States)

    de Menezes Martins, Reinaldo; Fernandes Leal, Maria da Luz; Homma, Akira

    2015-01-01

    Yellow fever vaccine was considered one of the safest vaccines, but in recent years it was found that it could rarely cause invasive and disseminated disease in some otherwise healthy individuals, with high lethality. After extensive studies, although some risk factors have been identified, the real cause of causes of this serious adverse event are largely unknown, but findings point to individual host factors. Meningoencephalitis, once considered to happen only in children less than 6 months of age, has also been identified in older children and adults, but with good prognosis. Efforts are being made to develop a safer yellow fever vaccine, and an inactivated vaccine or a vaccine prepared with the vaccine virus envelope produced in plants are being tested. Even with serious and rare adverse events, yellow fever vaccine is the best way to avoid yellow fever, a disease of high lethality and should be used routinely in endemic areas, and on people from non-endemic areas that could be exposed, according to a careful risk-benefit analysis.

  3. Management of sorafenib-related adverse events: a clinician's perspective.

    Science.gov (United States)

    Brose, Marcia S; Frenette, Catherine T; Keefe, Stephen M; Stein, Stacey M

    2014-02-01

    Sorafenib, a tyrosine kinase inhibitor, is approved for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC). It is being evaluated in phase II and III clinical trials, which include treatment as a single agent (locally advanced/metastatic radioactive iodine-refractory differentiated thyroid cancer [DTC]), as part of multimodality care (HCC), and in combination with chemotherapeutic agents (metastatic breast cancer). Sorafenib-related adverse events (AEs) that commonly occur across these tumor types include hand-foot skin reaction (HSFR), rash, upper and lower gastrointestinal (GI) distress (ie, diarrhea), fatigue, and hypertension. These commonly range from grade 1 to 3, per the Common Terminology Criteria for Adverse Events (CTCAE), and often occur early in treatment. The goal for the management of these AEs is to prevent, treat, and/or minimize their effects, thereby enabling patients to remain on treatment and improve their quality of life. Proactive management, along with ongoing patient education (before and during sorafenib treatment), can help to effectively manage symptoms, often without the need for sorafenib dose modification or drug holidays. Effective management techniques for common sorafenib-related AEs, as well other important disease sequelae not directly related to treatment, are presented. Recommendations and observations are based on physician/author experience and recommendations from published literature. Copyright © 2014 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Ronald N. Kostoff

    2016-11-01

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

  5. Ontology-Based Vaccine Adverse Event Representation and Analysis.

    Science.gov (United States)

    Xie, Jiangan; He, Yongqun

    2017-01-01

    Vaccine is the one of the greatest inventions of modern medicine that has contributed most to the relief of human misery and the exciting increase in life expectancy. In 1796, an English country physician, Edward Jenner, discovered that inoculating mankind with cowpox can protect them from smallpox (Riedel S, Edward Jenner and the history of smallpox and vaccination. Proceedings (Baylor University. Medical Center) 18(1):21, 2005). Based on the vaccination worldwide, we finally succeeded in the eradication of smallpox in 1977 (Henderson, Vaccine 29:D7-D9, 2011). Other disabling and lethal diseases, like poliomyelitis and measles, are targeted for eradication (Bonanni, Vaccine 17:S120-S125, 1999).Although vaccine development and administration are tremendously successful and cost-effective practices to human health, no vaccine is 100% safe for everyone because each person reacts to vaccinations differently given different genetic background and health conditions. Although all licensed vaccines are generally safe for the majority of people, vaccinees may still suffer adverse events (AEs) in reaction to various vaccines, some of which can be serious or even fatal (Haber et al., Drug Saf 32(4):309-323, 2009). Hence, the double-edged sword of vaccination remains a concern.To support integrative AE data collection and analysis, it is critical to adopt an AE normalization strategy. In the past decades, different controlled terminologies, including the Medical Dictionary for Regulatory Activities (MedDRA) (Brown EG, Wood L, Wood S, et al., Drug Saf 20(2):109-117, 1999), the Common Terminology Criteria for Adverse Events (CTCAE) (NCI, The Common Terminology Criteria for Adverse Events (CTCAE). Available from: http://evs.nci.nih.gov/ftp1/CTCAE/About.html . Access on 7 Oct 2015), and the World Health Organization (WHO) Adverse Reactions Terminology (WHO-ART) (WHO, The WHO Adverse Reaction Terminology - WHO-ART. Available from: https://www.umc-products.com/graphics/28010.pdf

  6. Adverse events with use of antiepileptic drugs: a prescription and event symmetry analysis

    DEFF Research Database (Denmark)

    Tsiropoulos, Ioannis; Andersen, Morten; Hallas, Jesper

    2009-01-01

    PURPOSE: To assess adverse events with use of antiepileptic drugs (AEDs) by the method of sequence symmetry analysis. METHODS: We used data from two population-based sources in Funen County, Denmark (population 2006: 479 000); prescription data from Odense University Pharmacoepidemiological Datab...

  7. Adverse Events in Facial Implant Surgery and Associated Malpractice Litigation.

    Science.gov (United States)

    Rayess, Hani M; Svider, Peter; Hanba, Curtis; Patel, Vivek Sagar; Carron, Michael; Zuliani, Giancarlo

    2018-01-18

    Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects. To better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation. A cross-sectional study reviewed complications following facial implants. The procedures reviewed were performed on patients at locations throughout the United States from January 2006 to December 2016. Data collection was completed in March 2017. The Manufacturer and User Facility Device Experience database, which contains medical device reports submitted to the US Food and Drug Administration (FDA), was searched for complications that occurred from January 2006 to December 2016 involving facial implants made by Implantech, MEDPOR, Stryker, KLS Martin, and Synthes. Furthermore, the Thomson Reuters Westlaw legal database was searched for relevant litigation. The complications of facial implants were analyzed in relation to the location of implant and severity of complication. Litigation was analyzed to determine which factors determine outcome. Thirty-nine instances of adverse events reported to the FDA were identified. Sixteen (41%) involved malar implants, followed by 12 chin implants (31%). The most common complications included infection (18 [46%]), implant migration (9 [23%]), swelling (7 [18%]), and extrusion (4 [10%]). Thirty-two patients (83%) had to have their implants removed. Infection occurred at a mean (SD) of 83.3 (68.8) days following the surgery. One-third of complications involved either migration or extrusion. The mean (range) time to migration or extrusion was 381.1 (10-2400) days. In 12 malpractice cases identified in publicly available court proceedings, alleged inadequate informed consent and requiring additional surgical intervention (ie, removal) were the most commonly cited factors. Infection and implant migration or extrusion are

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

    Science.gov (United States)

    Ali, Ayad K; Hartzema, Abraham G

    2012-01-01

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

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

    Science.gov (United States)

    ... Reporting Program MedWatch: The FDA Safety Information and Adverse Event Reporting Program Share Tweet Linkedin Pin it ... approved information that can help patients avoid serious adverse events. Potential Signals of Serious Risks/New Safety ...

  10. Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis.

    Science.gov (United States)

    Lancaster, Lisa H; de Andrade, Joao A; Zibrak, Joseph D; Padilla, Maria L; Albera, Carlo; Nathan, Steven D; Wijsenbeek, Marlies S; Stauffer, John L; Kirchgaessler, Klaus-Uwe; Costabel, Ulrich

    2017-12-31

    Pirfenidone is one of two approved therapies for the treatment of idiopathic pulmonary fibrosis (IPF). Randomised controlled clinical trials and subsequent post hoc analyses have demonstrated that pirfenidone reduces lung function decline, decreases mortality and improves progression-free survival. Long-term extension trials, registries and real-world studies have also shown similar treatment effects with pirfenidone. However, for patients with IPF to obtain the maximum benefits of pirfenidone treatment, the potential adverse events (AEs) associated with pirfenidone need to be managed. This review highlights the well-known and established safety profile of pirfenidone based on randomised controlled clinical trials and real-world data. Key strategies for preventing and managing the most common pirfenidone-related AEs are described, with the goal of maximising adherence to pirfenidone with minimal AEs. Copyright ©ERS 2017.

  11. Inappropriate prescribing and adverse drug events in older people.

    LENUS (Irish Health Repository)

    Hamilton, Hilary J

    2009-01-01

    Inappropriate prescribing (IP) in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs), morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  12. Inappropriate prescribing and adverse drug events in older people

    Directory of Open Access Journals (Sweden)

    Gallagher Paul F

    2009-01-01

    Full Text Available Abstract Inappropriate prescribing (IP in older patients is highly prevalent and is associated with an increased risk of adverse drug events (ADEs, morbidity, mortality and healthcare utilisation. Consequently, IP is a major safety concern and with changing population demographics, it is likely to become even more prevalent in the future. IP can be detected using explicit or implicit prescribing indicators. Theoretically, the routine clinical application of these IP criteria could represent an inexpensive and time efficient method to optimise prescribing practice. However, IP criteria must be sensitive, specific, have good inter-rater reliability and incorporate those medications most commonly associated with ADEs in older people. To be clinically relevant, use of prescribing appropriateness tools must translate into positive patient outcomes, such as reduced rates of ADEs. To accurately measure these outcomes, a reliable method of assessing the relationship between the administration of a drug and an adverse clinical event is required. The Naranjo criteria are the most widely used tool for assessing ADE causality, however, they are often difficult to interpret in the context of older patients. ADE causality criteria that allow for the multiple co-morbidities and prescribed medications in older people are required. Ultimately, the current high prevalence of IP and ADEs is unacceptable. IP screening criteria need to be tested as an intervention to assess their impact on the incidence of ADEs in vulnerable older patients. There is a role for IP screening tools in everyday clinical practice. These should enhance, not replace good clinical judgement, which in turn should be based on sound pharmacogeriatric training.

  13. Adverse Events in Children Receiving General Anaesthesia with Laryngeal Mask Airway Insertion

    OpenAIRE

    Sindhu Khatiwada; Balkrishna Bhattarai; Krishna Pokharel; Asish Subedi

    2015-01-01

    Introduction: Perioperative adverse events are more common in children compared to adult population. Reporting an adverse event proves effective in identifying problems and helps in prevention and early management. Our objective was to identify the types, incidence, and the time of occurrence of perioperative adverse event. We also aimed to find out whether the occurrence of the types of adverse events differs in children below and above five years. Methods: This was a prospectiv...

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

    Directory of Open Access Journals (Sweden)

    Ali AK

    2012-05-01

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

  15. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Science.gov (United States)

    2011-01-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Postmarketing Adverse Event... announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting... pandemic, industry and FDA workforces may be reduced while reporting of adverse events related to...

  16. 78 FR 71620 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

    Science.gov (United States)

    2013-11-29

    ...] Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for... regarding the Adverse Event Program for medical devices. DATES: Submit either electronic or written comments... techniques, when appropriate, and other forms of information technology. Adverse Event Program for Medical...

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Akiho Fukuda

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

  19. [Analysis of short-term respiratory adverse events in 183 bronchial thermoplasty procedures].

    Science.gov (United States)

    Nong, Y; Lin, J T; Su, N; Chen, X; Zhao, Q; Han, C Y; Qiu, R F

    2017-03-12

    Objective: To analyze the short-term (3 weeks) adverse respiratory events after bronchial thermoplasty(BT) in patients with severe asthma. Methods: The China-Japan Friendship Hospital recruited 62 patients with severe asthma for BT treatment from March 2014 to July 2016, with a total of 183 BT procedures. The data of adverse respiratory events within 3 weeks after procedure were collected to analyze the factors that might potentially influence the occurrence of adverse events. Results: Forty-three patients (69.4%) experienced adverse respiratory events within 3 weeks after treatment. Totally 153 adverse respiratory events occurred after 87 procedures(47.5%). The main adverse events were cough (15 events, 8.20%), sputum production (37 events, 20.22%), temporary PEF reduction (37 events, 20.22%), chest distress (12 events, 6.56%), blood in sputum (11 events, 6.01%), asthma exacerbation (10 events, 5.46%), and pneumonia(6 events, 3.28%). Most events were relieved or resolved with standard therapy in 1 week. No severe adverse events including tracheal intubation, malignant arrhythmias or death occurred within 3 weeks after procedure. The baseline eosinophil percentage in induced sputum and blood, operation times, and preoperative FEV(1) (% predicted) might influence the occurrence of adverse events after treatment. Patients with preoperative FEV(1) (% predicted) ≥60% had lower risk of adverse events. Conclusion: BT showed a good security profile in treating patients with severe asthma within 3 weeks after procedure.

  20. Dermatologic adverse events associated with chemotherapy and targeted anticancer therapy

    Directory of Open Access Journals (Sweden)

    Maria Kowalska

    2016-05-01

    Full Text Available Chemotherapeutic agents and drugs used for targeted tumor therapy often cause undesirable side effects of the skin which typically are toxic cutaneous reactions (toxicity grade 1 to 4. The first group of drugs that cause toxicities affecting the skin are inhibitors of epidermal growth factor receptor (EGFR. They cause a variety of skin changes (PRIDE syndrome, which are mainly manifested by papulopustular rash, also referred to as acneiform rash, occurring in 44–74% of patients. Another drug which causes cutaneous toxicities is inhibitor of CTLA4 (cytotoxic T lymphocyte-associated protein 4, which is represented by ipilimumab, used in the treatment of metastatic melanoma. The most common dermatological adverse event, observed in 40–64% of patients receiving ipilimumab, is generalized maculopapular rash with pruritus and dry skin, and in some cases vitiligo is also observed. BRAF and MEK inhibitors introduced for the treatment of advanced melanoma also cause skin rashes. BRAF inhibitors also affecting the proliferation of keratinocytes stimulate hypertrophic changes and cause the whole spectrum of lesions from benign and keratoacanthoma to squamous cell carcinoma. A hedgehog pathway inhibitor (vismodegib is used for the treatment of metastatic basal cell carcinoma. The most common adverse events it causes are reversible alopecia and dysgeusia, but it can also cause the development of keratoacanthoma and squamous cell carcinoma. Among the most common side effects of chemotherapy and targeted therapy are toxic changes within the hands and feet (hand-foot skin reaction – HFSR that early manifest as a neurological symptoms (numbness, paresthesia, and skin symptoms (erythematous swelling changes, blisters, hyperkeratosis occur later. Anti-cancer drugs can also cause serious skin diseases such as Stevens-Johnson syndrome (SJS, toxic epidermal necrolysis (TEN and DRESS (drug rash with eosinophilia and systemic symptoms, whose course and prognosis

  1. [MedDRA and its applications in statistical analysis of adverse events].

    Science.gov (United States)

    Lu, Meng-jie; Liu, Yu-xiu

    2015-11-01

    Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.

  2. Adverse Events in Children Receiving General Anaesthesia with Laryngeal Mask Airway Insertion.

    Science.gov (United States)

    Khatiwada, S; Bhattarai, B; Pokharel, K; Subedi, A

    2015-01-01

    Perioperative adverse events are more common in children compared to adult population. Reporting an adverse event proves effective in identifying problems and helps in prevention and early management. Our objective was to identify the types, incidence, and the time of occurrence of perioperative adverse event. We also aimed to find out whether the occurrence of the types of adverse events differ in children below and above five years. This was a prospective study in 242, ASA Physical Status I and II children aged day one to 14 years, receiving general anesthesia with laryngeal mask airway for various elective surgeries. Adverse events observed in the perioperative period were recorded. Adverse events related to respiratory system (n=26, 55%) were the most common followed by cardiovascular system (n= 14, 30%). Adverse events were observed in 24(10%) children in the operating room and in 20 (8%) children in the post anaesthesia care unit. In the operating room, majority (14 of 27, 52%) of the events occurred immediately after removal of laryngeal mask airway. Respiratory events were more common in children below five years (p=0.007), whereas cardiac events were more common in children above five years (p=0.02). The commonest adverse event in children is related to respiratory system. Adverse events occur more frequently in the operating room, mostly immediately after removal of laryngeal mask airway. Respiratory events are more frequent in children below five years whereas cardiac events are more frequent in children above five years.

  3. Vasculitis as an adverse event following immunization - Systematic literature review.

    Science.gov (United States)

    Bonetto, Caterina; Trotta, Francesco; Felicetti, Patrizia; Alarcón, Graciela S; Santuccio, Carmela; Bachtiar, Novilia Sjafri; Brauchli Pernus, Yolanda; Chandler, Rebecca; Girolomoni, Giampiero; Hadden, Robert D M; Kucuku, Merita; Ozen, Seza; Pahud, Barbara; Top, Karina; Varricchio, Frederick; Wise, Robert P; Zanoni, Giovanna; Živković, Saša; Bonhoeffer, Jan

    2016-12-12

    Several types of vasculitis have been observed and reported in temporal association with the administration of various vaccines. A systematic review of current evidence is lacking. This systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI). We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population. The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis. Existing literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization. Published by Elsevier Ltd.

  4. Adverse events following immunization: real causality and myths.

    Science.gov (United States)

    Principi, Nicola; Esposito, Susanna

    2016-06-01

    To assure the highest safety of immunization programs, detect adverse events following immunization (AEFIs), eliminate concerns, and reduce the risk of low vaccination coverage, authorities in industrialized countries have collected years of reports of suspected AEFIs and have systematically assessed their clinical importance. In this paper, the methods used to assess vaccine safety and the results obtained by the analysis of reports, studies, and meta-analyses are discussed. Severe AEFIs are rare, and all evaluations of safety of vaccines recommended for both children and adults have demonstrated that the advantages of vaccines are always significantly higher than the problems that they cause, and there is no need to modify recommendations. However, the definition of AEFI is dependent on the vaccines themselves, complicating the definition of an AEFI and explaining why doubts and concerns have been raised. Presently, disease epidemiology data collected in healthy people and in subjects with underlying disease, general vaccine coverage, and the vaccination status of subjects with AEFIs are managed by many independent institutions. Only strict co-operation between these institutions will lead to the successful identification of AEFIs and to a reduction of the weight of anti-vaccine arguments.

  5. Pertussis outbreak in Polish shooters with adverse event analysis

    Directory of Open Access Journals (Sweden)

    Monika Skrzypiec-Spring

    2017-04-01

    Full Text Available In addition to different injuries, infections are the most common reason for giving up training altogether or reducing its volume and intensity, as well as a lack of opportunities to participate in sports competitions. Nowadays, a slow but constant re‑emergence of pertussis, especially among teenagers and young adults, including athletes, can be observed. This paper describes an outbreak of pertussis among professional Polish shooters, focusing on the transmission of Bordetella pertussis infection between members of the national team, its influence on performance capacity and adverse event analysis. From 9 June, 2015 to 31 July, 2015, a total of 4 confirmed and suspected cases of pertussis were reported among members of the Polish Sport Shooting National Team, their relatives and acquaintances. Pertussis significantly decreased exercise performance of the first athlete, a 35-year-old woman, interrupted her training, and finally resulted in failure to win a medal or quota place. Pertussis also significantly decreased performance of the second athlete, a 25-year-old shooter. The other cases emerged in their families. Whooping cough is a real threat to athletes and should be prevented. Preventive measures include appropriate immunization, constant medical supervision, as well as early isolation, diagnostic tests and treatment of all infected sport team members. Regular administration of booster doses of the acellular pertussis vaccine (Tdpa every 5 years seems reasonable.

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

    Science.gov (United States)

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

    2013-01-01

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

  7. [The pathology of adverse events with immune checkpoint inhibitors].

    Science.gov (United States)

    Koelzer, V H; Glatz, K; Bubendorf, L; Weber, A; Gaspert, A; Cathomas, G; Lugli, A; Zippelius, A; Kempf, W; Mertz, K D

    2017-05-01

    Immunotherapy has gained importance with the development of new effective cancer treatments. Immune checkpoint inhibitors (ICI) are monoclonal antibodies that promote T‑cell mediated tumor immune rejection. Checkpoint blockade also carries the risk of inducing autoimmune reactions ("immune related adverse events", irAEs). The diagnosis and classification of irAEs constitute a new and important field in pathology. Practice-oriented review of the diagnosis and classification of irAEs. Structured, selective literature review based on PubMed und UpToDate ® online. The most common irAEs affect the skin, the gastrointestinal tract, the liver, and the respiratory system. The correct diagnosis and classification of irAEs by an interdisciplinary care team is essential for appropriate therapy and the prevention of long-term sequelae. Other important irAEs affect the endocrine organs, the heart, the joints, the kidneys and the nervous system. Because of their rarity and/or limited options for bioptic diagnosis, only limited data on the morphology and pathophysiology of these irAEs are currently available. Autopsies carried out after ICI therapy constitute an important element of quality control and allow better documentation of the incidence and pathogenesis of irAEs. Pathology plays a central role in the diagnosis and treatment of irAEs. Future studies may contribute to a better mechanistic understanding of irAEs for individualized knowledge-based risk assessment.

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

    Science.gov (United States)

    Hong, Su; Li, QiuJie

    2017-04-01

    To investigate the impact of nurses' perception of patient safety culture and adverse event reporting, and demographic factors on adverse event reporting in Chinese hospitals. Accurate and timely adverse event reporting is integral in promoting patient safety and professional learning around the incident. In a cross-sectional survey, a sample of 919 nurses completed a structured questionnaire composed of two validated instruments measuring nurses' perception of patient safety culture and adverse event reporting. Associations between the variables were examined using multiple linear regression analysis. The positive response rates of five dimensions of the Patient Safety Culture Assessment Scale varied from 47.55% to 80.62%. The accuracy rate of Adverse Event Reporting Perception Scale was 63.16%. Five hundred and thirty-one (58.03%) nurses did not report adverse event in past 12 months. Six variables were found to be associated with nurses' adverse event reporting: total work experience (P = 0.003), overall patient safety culture score (P teamwork climate (P importance or reporting (P = 0.002). The results confirmed that improvements in the patient safety culture and nurses' perception of adverse event reporting were related to an increase in voluntary adverse event reporting. The knowledge of adverse event reporting should be integrated into the patient safety curriculum. Interventions that target a specific domain are necessary to improve the safety culture. © 2017 John Wiley & Sons Ltd.

  9. Severity of cerebral palsy and likelihood of adverse events after botulinum toxin A injections.

    Science.gov (United States)

    Swinney, Caitlyn M; Bau, Karen; Burton, Karen L Oakley; O'Flaherty, Stephen J; Bear, Natasha L; Paget, Simon P

    2018-05-01

    To determine the incidence of common adverse events after botulinum toxin A (BoNT-A) injections in children with cerebral palsy (CP) and to identify whether the severity of CP influences the incidence of adverse events. This was an observational study of patients attending a BoNT-A clinic at a tertiary paediatric hospital (2010-2014). Data examined included procedural adverse events at the time of injection and at follow-up. Systemic adverse events were defined as lower respiratory tract illnesses, generalized weakness, dysphagia, and death. Severity of CP was categorized by the Gross Motor Function Classification System (GMFCS). The relationships between GMFCS and adverse events were analysed using negative binomial regression models. In total, 591 children underwent 2219 injection episodes. Adverse events were reported during the procedure (130 [6%] injection episodes) and at follow-up (492 [22%] injection episodes). There were significantly increased rates of systemic adverse events in injection episodes involving children in GMFCS level IV (incidence rate ratio [IRR] 3.92 [95% confidence interval] 1.45-10.57]) and GMFCS level V (IRR 7.37 [95% confidence interval 2.90-18.73]; p<0.001). Adverse events after BoNT-A injections are common but mostly mild and self-limiting. Children in GMFCS levels IV and V are at increased risk of systemic adverse events. The relationship between CP severity and BoNT-A adverse events is complex and further research is required to better understand this relationship. Adverse events reported at the time of botulinum toxin A injection occurred in 6% of injection episodes. Adverse events were reported at follow-up in 22% of injection episodes. Children in Gross Motor Function Classification System (GMFCS) levels IV and V have increased rates of systemic adverse events. Children in GMFCS levels IV and V report less local weakness and pain. © 2018 Mac Keith Press.

  10. [Intraoperative adverse events in minor oral surgery. Risk analysis].

    Science.gov (United States)

    Reich, W; Maurer, P; Schubert, J

    2005-11-01

    The aim of this prospective study was to evaluate oral surgical procedures performed as day surgery under local anesthesia. We examined patients' general condition, and besides checking for intraoperative complications we analyzed postoperative bleeding in patients with hemostatic disorders. The patient population consisted of 1540 patients (797 female, 743 male), who underwent a total of 2055 minor oral surgical procedures over a 5-year period (1998-2002). Before the treatment started a data file was made for each patient, which contained information on his or her past medical history, concomitant medication, why the operation was indicated, premedication, anesthetic and surgical techniques applied, and postoperative treatment. Systemic pathologies influencing surgical decisions were found in 316 patients (20.5%), affecting 676 interventions (32.9%). In 109 patients (5.3% of the 2055) altered hemostasis was found. The surgical procedures recorded were: (operative) tooth extraction (n=394), interventions for surgical conservation of teeth (n=272), treatment for cysts (n=140), surgical revisions (n=46) and preprosthetic surgery (n=19). Passing complications, mostly systemic in nature, occurred during 27 sessions of local anesthesia (1.3%). There were 87 adverse events intraoperatively (4,2%), most of which were confined to the surgical field; specifically 15% of these complications took the form of hemorrhage. We observed no significant correlation between the occurrence of intraoperative complications and patients' gender, predisposing systemic pathologies including bleeding disorders, or age. Postoperative hemorrhage was observed significantly more frequently in patients with impaired hemostasis and required admission to hospital for inpatient treatment in 2 cases. According to our investigation, oral surgery can be performed in patients with compromised general condition with as few intraoperative complications as in patients with no general medical problems

  11. Adverse respiratory events in a post-anesthesia care unit.

    Science.gov (United States)

    Xará, Daniela; Santos, Alice; Abelha, Fernando

    2015-02-01

    Adverse respiratory events (ARE) are a leading causes of postoperative morbidity and mortality. This study investigated the incidence and determinants of postoperative ARE. This observational prospective study was conducted in a post anesthesia care unit (PACU). A total of 340 adult subjects were admitted consecutively, and AREs were measured after elective surgery. Population demographics, perioperative parameters, ARE occurrence, and length of stay in the postoperative PACU and in hospital were recorded. Data were analyzed descriptively using the Mann-Whitney U-test and the Chi-square or Fisher's exact test. Multivariate analyses were carried outusing logistic binary regression, and the odds ratio (OR) and 95% confidence interval (CI) were calculated. Postoperative AREs occurred in 67 subjects (19.7%). AREs were more frequent after high-risk procedures (42% vs 24%; P=.003), in patients undergoing major surgery (37% vs 25%; P=.041), those receiving general anesthesia (85% vs 67%; P=.004), and in patients administered intraoperative muscle relaxants (79% vs 55%; P<.001) and neostigmine (69% vs 49%; P=.002). Hypoactive emergence (13% vs 5%; P=.015) and residual neuromuscular blockade (46% versus 11%; P<.001) were more frequent in subjects with postoperative ARE. On multivariate analyses, residual neuromuscular blockade was an independent risk factor for ARE in the PACU (OR 6.4; CI 3.0-13.4; P<.001). ARE is an important and common postoperative complication. Residual neuromuscular blockade was an independent risk factor for ARE in the PACU. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

  12. Early adverse events of per-oral endoscopic myotomy.

    Science.gov (United States)

    Werner, Yuki B; von Renteln, Daniel; Noder, Tania; Schachschal, Guido; Denzer, Ulrike W; Groth, Stefan; Nast, Jan F; Kersten, Jan F; Petzoldt, Martin; Adam, Gerhard; Mann, Oliver; Repici, Alessandro; Hassan, Cesare; Rösch, Thomas

    2017-04-01

    The recently developed technique of per-oral endoscopic myotomy (POEM) has been shown to be effective for the therapy of esophageal motility disorders. Limited information is available about POEM adverse events (AEs). POEM was performed on 241 patients (58% male; mean age, 47.4 ± 16.4 years) under general anesthesia over 61 months. The main outcome was the rate of intra- and post-procedural AEs. Post-procedural checks comprised clinical and laboratory examinations and endoscopy, with further follow-ups performed at 3, 6, and 12 months. Of the 241 procedures, 238 were successfully completed (mean procedure time, 100.2 ± 39.5 min). Reasons for abortion were excessive submucosal fibrosis preventing submucosal tunneling. Three patients had severe procedural-related AEs (SAE rate, 1.2%); 1 case of pneumothorax required intra-procedural drainage, and 2 patients had delayed SAEs (1 ischemic gastric cardia perforation and 1 hemothorax, both leading to surgery). The overall rate of minor AEs was 31.1%, mainly prolonged intra-procedural bleeding (>15 min hemostasis) and defects of the mucosa overlying the tunnel; none led to clinically relevant signs or symptoms. Patients experiencing any AE had a significantly prolonged hospital stay (P = .037) and a trend toward prolonged procedure time (P = .094). Neck/upper thoracic emphysema and free abdominal air were noted in 31.5% and 35.7%, respectively (95.3% drained), but without relevant sequelae. POEM has a low rate of SAEs; minor AEs are more frequent but lack a consistent definition. Therefore, based on our experience and literature analysis, we suggest a classification of AEs for POEM. (Clinical trials registration number: NCT01405417.). Copyright © 2017. Published by Elsevier Inc.

  13. Severity and workload related to adverse events in the ICU.

    Science.gov (United States)

    Serafim, Clarita Terra Rodrigues; Dell'Acqua, Magda Cristina Queiroz; Castro, Meire Cristina Novelli E; Spiri, Wilza Carla; Nunes, Hélio Rubens de Carvalho

    2017-01-01

    To analyze whether an increase in patient severity and nursing workload are correlated to a greater incidence of adverse events (AEs) in critical patients. A prospective single cohort study was performed on a sample of 138 patients hospitalized in an intensive care unit (ICU). A total of 166 AEs, occurred, affecting 50.7% of the patients. Increased patient severity presented a direct relationship to the probability of AEs occurring. However, nursing workload did not present a statistically significant relationship with the occurrence of AEs. The results cast light on the importance of using evaluation tools by the nursing personnel in order to optimize their daily activities and focus on patient safety. Analisar se o aumento da gravidade do paciente e a carga de trabalho de enfermagem está relacionado à maior incidência de Eventos Adversos (EAs) em pacientes críticos. Estudo de coorte única, prospectivo, com amostra de 138 pacientes internados em uma Unidade de Terapia Intensiva (UTI). Ao todo, foram evidenciados 166 EAs, que acometeram 50,7% dos pacientes. O aumento da gravidade do paciente apresentou relação direta com a chance de ocorrência de EAs. Entretanto, a carga de trabalho de enfermagem não apresentou relação estatisticamente significativa, na ocorrência de EAs. Os resultados permitem refletir acerca da importância da equipe de enfermagem, em utilizar instrumentos de avaliação, com o objetivo de melhorar e planejar suas ações diárias, com foco na segurança do paciente.

  14. The effect of hospitalist discontinuity on adverse events.

    Science.gov (United States)

    O'Leary, Kevin J; Turner, Jonathan; Christensen, Nicholas; Ma, Madeleine; Lee, Jungwha; Williams, Mark V; Hansen, Luke O

    2015-03-01

    Patient-physician continuity is difficult to achieve in hospital settings because of the need to provide care continuously. The impact of hospital physician discontinuity on patient safety is unknown. To determine the association between hospital physician continuity and the incidence of adverse events (AEs). Retrospective observational study using multivariable models to adjust for patient characteristics. Patients admitted to a nonteaching hospitalist service in a large academic hospital between March 1, 2009 and December 31, 2011. Two measures of continuity were used. The Number of Physicians Index (NPI) was the total number of unique hospitalists caring for a patient. The Usual Provider of Care (UPC) Index was the proportion of encounters with the most frequently encountered hospitalist. Outcome measures were AEs detected by automated queries of information systems and confirmed by 2 physician researchers. Our analysis included data from 474 hospitalizations. In unadjusted models, each 1-unit increase in the NPI (ie, less continuity) was significantly associated with the incidence of 1 or more AEs (odds ratio = 1.75; P < 0.001). However, UPC was not associated with incidence of AEs. Across all adjusted models, neither NPI nor UPC was significantly associated with the incidence of AEs. The direction of the effect of discontinuity on AEs was also inconsistent across models. Hospitalist physician continuity does not appear to be associated with the incidence of AEs. Because hospital care is provided by teams of clinicians, future research should evaluate the impact of team complexity and dynamics on patient outcomes. © 2014 Society of Hospital Medicine.

  15. Adverse events following immunization in patients with primary immunodeficiencies.

    Science.gov (United States)

    Sarmiento, Juan David; Villada, Fabio; Orrego, Julio Cesar; Franco, Jose Luis; Trujillo-Vargas, Claudia M

    2016-03-18

    Adverse events following immunization (AEFI) requires special consideration in patients with primary immunodeficiency diseases (PID) because they may represent a "red flag" for the initial diagnosis and may cause disease complications. Therefore, the definition of appropriate vaccination schemes is a major issue in PID. The aim of this study is to describe the AEFI in a cohort of PID patients. Medical records from 379 PID patients were included. AEFI severity was classified according to the WHO 1999 guidelines. Causality was assessed using the Clinical Immunization Safety Assessment (CISA) 2009 criteria. Evidence of AEFI was found in 26 medical records and represented a total of 29 reactions. Most of the AEFI were observed in patients with idiopathic hypogammaglobulinemia (IHG), chronic granulomatous disease (CGD) and severe combined immunodeficiency (SCID), representing 10, 4 and 4 cases, respectively. A total of 21 reactions were associated with replicative vaccines, 7 of which were serious cases related to Bacille Calmette-Guérin (BCG). BCG was also the vaccine more often associated with definitive AEFI in PID. In addition to BCG-related complications, seizures were the most serious AEFI among PID patients. Our study included a large cohort of PID patients and confirmed an increased risk of serious AEFI in these populations. The design and implementation of neonatal screening strategies for the early detection of congenital lymphopenias and other PID are urgently needed to avoid serious complications of the BCG vaccine usually applied immediately after birth. Our findings also support the use of the acellular pertussis vaccine to minimize the appearance of seizures in PID patients vaccinated with diphtheria, pertussis and tetanus (DPT). Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Association of Adverse Events With Antibiotic Use in Hospitalized Patients.

    Science.gov (United States)

    Tamma, Pranita D; Avdic, Edina; Li, David X; Dzintars, Kathryn; Cosgrove, Sara E

    2017-09-01

    Estimates of the incidence of overall antibiotic-associated adverse drug events (ADEs) in hospitalized patients are generally unavailable. To describe the incidence of antibiotic-associated ADEs for adult inpatients receiving systemic antibiotic therapy. Retrospective cohort of adult inpatients admitted to general medicine wards at an academic medical center. At least 24 hours of any parenteral or oral antibiotic therapy. Medical records of 1488 patients were examined for 30 days after antibiotic initiation for the development of the following antibiotic-associated ADEs: gastrointestinal, dermatologic, musculoskeletal, hematologic, hepatobiliary, renal, cardiac, and neurologic; and 90 days for the development of Clostridium difficile infection or incident multidrug-resistant organism infection, based on adjudication by 2 infectious diseases trained clinicians. In 1488 patients, the median age was 59 years (interquartile range, 49-69 years), and 758 (51%) participants were female. A total of 298 (20%) patients experienced at least 1 antibiotic-associated ADE. Furthermore, 56 (20%) non-clinically indicated antibiotic regimens were associated with an ADE, including 7 cases of C difficile infection. Every additional 10 days of antibiotic therapy conferred a 3% increased risk of an ADE. The most common ADEs were gastrointestinal, renal, and hematologic abnormalities, accounting for 78 (42%), 45 (24%), and 28 (15%) 30-day ADEs, respectively. Notable differences were identified between the incidence of ADEs associated with specific antibiotics. Although antibiotics may play a critical role when used appropriately, our findings underscore the importance of judicious antibiotic prescribing to reduce the harm that can result from antibiotic-associated ADEs.

  17. Comparing Methods for Estimating Direct Costs of Adverse Drug Events.

    Science.gov (United States)

    Gyllensten, Hanna; Jönsson, Anna K; Hakkarainen, Katja M; Svensson, Staffan; Hägg, Staffan; Rehnberg, Clas

    2017-12-01

    To estimate how direct health care costs resulting from adverse drug events (ADEs) and cost distribution are affected by methodological decisions regarding identification of ADEs, assigning relevant resource use to ADEs, and estimating costs for the assigned resources. ADEs were identified from medical records and diagnostic codes for a random sample of 4970 Swedish adults during a 3-month study period in 2008 and were assessed for causality. Results were compared for five cost evaluation methods, including different methods for identifying ADEs, assigning resource use to ADEs, and for estimating costs for the assigned resources (resource use method, proportion of registered cost method, unit cost method, diagnostic code method, and main diagnosis method). Different levels of causality for ADEs and ADEs' contribution to health care resource use were considered. Using the five methods, the maximum estimated overall direct health care costs resulting from ADEs ranged from Sk10,000 (Sk = Swedish krona; ~€1,500 in 2016 values) using the diagnostic code method to more than Sk3,000,000 (~€414,000) using the unit cost method in our study population. The most conservative definitions for ADEs' contribution to health care resource use and the causality of ADEs resulted in average costs per patient ranging from Sk0 using the diagnostic code method to Sk4066 (~€500) using the unit cost method. The estimated costs resulting from ADEs varied considerably depending on the methodological choices. The results indicate that costs for ADEs need to be identified through medical record review and by using detailed unit cost data. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  18. Adverse events resulting from lasers used in urology.

    Science.gov (United States)

    Althunayan, Abdulaziz M; Elkoushy, Mohamed A; Elhilali, Mostafa M; Andonian, Sero

    2014-02-01

    To collate world reports of adverse events (AEs) resulting from lasers used in urology. The Manufacturer and User Facility Device Experience (MAUDE) database of the United States Food and Drug Administration (FDA) was searched using the term "Laser for gastro-urology use." In addition, the Rockwell Laser Industries (RLI) Laser Accident Database was searched for the following types of lasers: neodymium-doped yttrium aluminum garnet (Nd:YAG), holmium:yttrium aluminum garnet (Ho:YAG), potassium titanyl phosphate (KTP), diode and thulium:YAG (Tm:YAG). Both databases were last accessed on October 1, 2012. Overall, there were 433 AEs; 166 in MAUDE database (1992-2012) and 267 in RLI database (1964-2005). Most of the AEs (198/433 or 46%) resulted from generator failure or fiber tip breaking. Whereas there were 20 (4.6%) AEs harming medical operators, there were 159 (37%) AEs harming nonmedical operators using Nd:YAG, KTP, and diode lasers. Eye injuries ranging from mild corneal abrasions to total vision loss were reported in 164 AEs with the use of Nd:YAG, KTP, and diode lasers. Overall, there were 36 (8.3%) AEs resulting in patient harm, including 7 (1.6%) mortalities, 3 deaths from ureteral perforation using the Ho:YAG laser, and 4 deaths from air emboli using the Nd:YAG laser. Other reported patient injuries included bladder perforation resulting in urinary diversion in a patient, in addition to minor skin burns, internal burns, and bleeding in others. There were no AEs reported with the use of Tm:YAG laser. Most of the AEs reported relate to equipment failure. There were no eye injuries reported with the use of Ho:YAG lasers. Caution must be exercised when using lasers in urology, including wearing appropriate eye protection when using Nd:YAG, KTP, and diode lasers.

  19. Quality indicators of preventable adverse drug events in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard

    interventions against medication errors. Methods: A systematic literature review of the available literature on preventable adverse A systematic literature review of the available literature on preventable adverse drug events was conducted to describe the incidence and characteristics of preventable adverse......Summary Background: Preventable adverse drug events are caused by errors in the medication use Preventable adverse drug events are caused by errors in the medication use process, and are of particular interest when designing interventions to improve the quality of medication therapy. Type 2...... diabetes became the case because a large proportion of patients are undertreated and not monitored as recommended; yet, the epidemiology of preventable adverse drug events in type 2 diabetes is largely unknown. The aims of the studies were to develop quality indicators for preventable adverse drug events...

  20. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2011-03-01

    Full Text Available Abstract Background In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. Methods This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Results Among the 1968 patients, 74 patients (3.76% suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Conclusions Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs were related to the patients' gender and age and the local

  1. Self-immolation and its adverse life-events risk factors: results from an Iranian population

    OpenAIRE

    Ahmadi, Alireza; Schwebel, David C.; Bazargan-Hejazi, Shahrzad; Taliee, Kobra; Karim, Hosein; Mohammadi, Reza

    2015-01-01

    Abstract: Background: Despite considerable loss of life by deliberate self-burning in low and middle-income countries, few scholars have examined psychiatric factors such as adverse life events that may be related to self-immolation. Methods: This case-control study investigated adverse life-events as risk factors for self-immolation patients admitted to a burn center serving the western region of Iran. Variables inves-tigated included the following adverse life-events: unplanned pregna...

  2. [Analysis on the adverse events of cupping therapy in the application].

    Science.gov (United States)

    Zhou, Xin; Ruan, Jing-wen; Xing, Bing-feng

    2014-10-01

    The deep analysis has been done on the cases of adverse events and common injury of cupping therapy encountered in recent years in terms of manipulation and patient's constitution. The adverse events of cupping therapy are commonly caused by improper manipulation of medical practitioners, ignoring contraindication and patient's constitution. Clinical practitioners should use cupping therapy cautiously, follow strictly the rules of standard manipulation and medical core system, pay attention to the contraindication and take strict precautions against the occurrence of adverse events.

  3. Incidence and determinants of medication errors and adverse drug events among hospitalized children in West Ethiopia

    OpenAIRE

    Dedefo, Mohammed Gebre; Mitike, Abraham Haileamlak; Angamo, Mulugeta Tarekegn

    2016-01-01

    Background Medication errors cause a large number of adverse drug events with negative patient health outcomes and are a major public-health burden contributing to 18.7?56?% of all adverse drug events among hospitalized patients. The aim of this study was to assess the incidence and determinants of medication errors and adverse drug events among hospitalized children. Methods A prospective observational study was conducted among hospitalized children in the pediatrics ward of Nekemte Referral...

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

    Directory of Open Access Journals (Sweden)

    Toshiyuki Sakaeda

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

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

    Science.gov (United States)

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

    2017-07-05

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

  6. Guidelines for submitting adverse event reports for publication

    NARCIS (Netherlands)

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

    2009-01-01

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

  7. Adverse events recording in electronic health record systems in primary care.

    Science.gov (United States)

    de Hoon, Sabine E M; Hek, Karin; van Dijk, Liset; Verheij, Robert A

    2017-12-06

    Adequate record keeping of medication adverse events in electronic health records systems is important for patient safety. Events that remain unrecorded cannot be communicated from one health professional to another. In the absence of a gold standard, we investigate the variation between Dutch general practices in the extent to which they record medication adverse events. Data were derived from electronic health records (EHR) of Dutch general practices participating in NIVEL Primary Care Database (NIVEL-PCD) in 2014, including 308 general practices with a total practice population of 1,256,049 listed patients. Medication adverse events were defined as recorded ICPC-code A85 (adverse effect medical agent). Between practice variation was studied using multilevel logistic regression analysis corrected for age, gender, number of different medicines prescriptions and number of chronic diseases. In 2014 there were 8330 patients with at least one medication adverse event recorded. This corresponds to 6.9 medication adverse events per 1000 patients and is higher for women, elderly, patients with polypharmacy and for patients with comorbidity. Corrected for these patient characteristics the median odds ratio (MOR = 1.92) suggests an almost twofold difference between general practices in recorded medication adverse events. Our results suggest that improvement in terms of uniformity in recording medication adverse events is possible, preventing potential damage for patients. We suggest that creating a learning health system by individual practice feedback on the number of recordings of adverse events would help practitioners to improve their recording habits.

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

    Science.gov (United States)

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

    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.

  9. Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Su Golder

    2016-09-01

    Full Text Available We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events.Studies were identified from 15 databases (including MEDLINE and Embase and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs and/or risk ratios (RRs for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals in 15

  10. Parent-Reported Errors and Adverse Events in Hospitalized Children

    Science.gov (United States)

    Khan, Alisa; Furtak, Stephannie L.; Melvin, Patrice; Rogers, Jayne E.; Schuster, Mark A.; Landrigan, Christopher P.

    2017-01-01

    IMPORTANCE Limited data exist regarding the incidence and nature of patient- and family-reported medical errors, particularly in pediatrics. OBJECTIVE To determine the frequency with which parents experience patient safety incidents and the proportion of reported incidents that meet standard definitions of medical errors and preventable adverse events (AEs). DESIGN, SETTING, AND PARTICIPANTS We conducted a prospective cohort study from May 2013 to October 2014 within 2 general pediatric units at a children’s hospital. Included in the study were English-speaking parents (N = 471) of randomly selected inpatients (ages 0–17 years) prior to discharge. Parents reported via written survey whether their child experienced any safety incidents during hospitalization. Two physician reviewers classified incidents as medical errors, other quality issues, or exclusions (κ = 0.64; agreement = 78%). They then categorized medical errors as harmful (ie, preventable AEs) or nonharmful (κ = 0.77; agreement = 89%). We analyzed errors/AEs using descriptive statistics and explored predictors of parent-reported errors using bivariate statistics. We subsequently reviewed patient medical records to determine the number of parent-reported errors that were present in the medical record. We obtained demographic/clinical data from hospital administrative records. MAIN OUTCOMES AND MEASURES Medical errors and preventable AEs. RESULTS The mean (SD) age of the 383 parents surveyed was 36.6 (8.9) years; most respondents (n = 266) were female. Of 383 parents surveyed (81%response rate), 34 parents (8.9%) reported 37 safety incidents. Among these, 62%(n = 23, 6.0 per 100 admissions) were determined to be medical errors on physician review, 24%(n = 9) were determined to be other quality problems, and 14%(n = 5) were determined to be neither. Thirty percent (n = 7, 1.8 per 100 admissions) of medical errors caused harm (ie, were preventable AEs). On bivariate analysis, children with medical

  11. Development and validation of a taxonomy of adverse handover events in hospital settings

    DEFF Research Database (Denmark)

    Andersen, Henning Boje; Siemsen, Inger Margrete D.; Petersen, Lene Funck

    2015-01-01

    Patient Safety Database, 200 events) and 47 interviews with staff conducted at a large hospital in the Capital Region (232 events). The most prevalent causes of adverse events are inadequate competence (30 %), inadequate infrastructure (22 %) and busy ward (18 %). Inter-rater reliability (kappa) was 0...... a tool for analyzing adverse handover events to identify frequent causes among reported handover failures. In turn, this provides a basis for selecting safety measures including handover protocols and training programmes....

  12. [Assessing the economic impact of adverse events in Spanish hospitals by using administrative data].

    Science.gov (United States)

    Allué, Natalia; Chiarello, Pietro; Bernal Delgado, Enrique; Castells, Xavier; Giraldo, Priscila; Martínez, Natalia; Sarsanedas, Eugenia; Cots, Francesc

    2014-01-01

    To evaluate the incidence and costs of adverse events registered in an administrative dataset in Spanish hospitals from 2008 to 2010. A retrospective study was carried out that estimated the incremental cost per episode, depending on the presence of adverse events. Costs were obtained from the database of the Spanish Network of Hospital Costs. This database contains data from 12 hospitals that have costs per patient records based on activities and clinical records. Adverse events were identified through the Patient Safety Indicators (validated in the Spanish Health System) created by the Agency for Healthcare Research and Quality together with indicators of the EuroDRG European project. This study included 245,320 episodes with a total cost of 1,308,791,871€. Approximately 17,000 patients (6.8%) experienced an adverse event, representing 16.2% of the total cost. Adverse events, adjusted by diagnosis-related groups, added a mean incremental cost of between €5,260 and €11,905. Six of the 10 adverse events with the highest incremental cost were related to surgical interventions. The total incremental cost of adverse events was € 88,268,906, amounting to an additional 6.7% of total health expenditure. Assessment of the impact of adverse events revealed that these episodes represent significant costs that could be reduced by improving the quality and safety of the Spanish Health System. Copyright © 2013 SESPAS. Published by Elsevier Espana. All rights reserved.

  13. Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

    Directory of Open Access Journals (Sweden)

    Fabiana Rossi Varallo

    2014-03-01

    Full Text Available OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%, fatigue (12.3%, and chest pain (9.0%. Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

  14. Adverse events of modern antifungal drugs during treatment of invasive fungal infections

    Directory of Open Access Journals (Sweden)

    N. V. Dmitrieva

    2013-01-01

    Full Text Available Characteristics of adverse events of modern antimycotics by organ systems and comparative frequency between different medicines and their groups are presented. The examples of incompatibility of antifungal drugs with other pharmacological groups are discussed. Records of adverse events and drug compatibility will allow the practitioner to prevent and timely cure possible complications, should they arise.

  15. Adverse events attributed to traditional Korean medical practices: 1999-2010.

    Science.gov (United States)

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

    2013-08-01

    To investigate adverse events attributed to traditional medical treatments in the Republic of Korea. 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. 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). 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.

  16. Monitoring adverse events in hospitals: how safe are hospitals for patients?

    NARCIS (Netherlands)

    Baines, R.J.

    2018-01-01

    This thesis aims to assess trends in adverse event and preventable adverse event rates in hospitals in the Netherlands through the time period 2004 –2012. Furthermore patient safety for specific care processes and patient groups are assessed. Patient safety has been high on the international agenda

  17. The Rate of Adverse Events Related to Hypnosis During Clinical Trials.

    Science.gov (United States)

    Bollinger, Jared W

    2018-04-01

    The rate of adverse events associated with medical and psychological interventions is important to regulators who oversee clinical research. There have been relatively few reports on the frequency of adverse events associated with hypnosis. The current article collected data from a publically available register (ClinicalTrials.gov) on adverse events reported during clinical trials that used hypnosis. The rate of serious adverse events likely attributable to hypnosis was 0%. The rate of other adverse events was 0.47%. This rate was similar to previous reports. However, several trials in the register that used hypnosis did not report adverse event data. For the trials that did report adverse events, there was substantial variability in reporting. Another limitation was the lack of generalizability as all studies included in the analysis used hypnosis to treat side-effects related to medical conditions or procedures as opposed to psychiatric conditions. Future clinical trials using hypnosis should use more precise assessment methods to report adverse events, especially when tested in samples with mental health disorders.

  18. Teaching dental students about patient communication following an adverse event: a pilot educational module.

    Science.gov (United States)

    Raja, Sheela; Rajagopalan, Chelsea F; Patel, Janki; Van Kanegan, Kevin

    2014-05-01

    Adverse events are an important but understudied area in dentistry. Most dentists will face the issue of an adverse event several times in their clinical careers. The authors implemented a six-hour pilot educational module at one dental school to improve fourth-year dental students' knowledge and confidence in communicating with patients about adverse events. Based on results from the twenty-nine students who completed both the pre- and posttests, the module significantly increased the students' knowledge of the key concepts involved in adverse events. However, the module did not improve the students' confidence that they would be able to implement these communication skills in clinical situations. Based on these results, this article discusses how future educational efforts can be modified to better prepare students for the communication challenges associated with adverse events.

  19. Trials of testosterone replacement reporting cardiovascular adverse events

    Directory of Open Access Journals (Sweden)

    Thiago Gagliano-Jucá

    2018-01-01

    Full Text Available The numbers of testosterone prescriptions written have increased several-fold worldwide, but the incidence of pathological hypogonadism due to hypothalamic, pituitary, and testicular disease has remained unchanged. Most of these prescriptions are being dispensed to middle-aged and older men who have experienced age-related decline in serum testosterone levels; a subset of the population in which benefits of testosterone replacement is at best, modest. Recently, some randomized controlled trials have reported increased cardiovascular events in men (mainly older men and those with prevalent cardiovascular disease with testosterone use, and a few recent meta-analyses have confirmed these findings. In this review, we discuss trials of testosterone therapy that have reported higher cardiovascular events, relevant trials that have not reported increased cardiovascular events and large trials that have focused on cardiovascular risk (mainly atherosclerosis progression as their main outcome. We also review findings from meta-analyses that have evaluated cardiovascular events in various testosterone trials. Finally, we discuss some potential mechanisms by which testosterone use might result in an increased cardiovascular risk. As none of the trials conducted to date were adequately powered to evaluate cardiovascular events, no firm conclusions can be drawn regarding the cardiovascular safety of testosterone therapy at this time. In the interim, we hope that this review will help practitioners make informed decisions regarding the care of their patients.

  20. Could chiropractors screen for adverse drug events in the community? Survey of US chiropractors

    Directory of Open Access Journals (Sweden)

    Bero Lisa

    2010-11-01

    Full Text Available Abstract Background The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians. Methods Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients. Results Over half of responding chiropractors (62% reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe. Conclusions Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed.

  1. Could chiropractors screen for adverse drug events in the community? Survey of US chiropractors.

    Science.gov (United States)

    Smith, Monica; Bero, Lisa; Carber, Lynne

    2010-11-17

    The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS) was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians. Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients. Over half of responding chiropractors (62%) reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe. Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed.

  2. Blunt splenic injury: are early adverse events related to trauma, nonoperative management, or surgery?

    Science.gov (United States)

    Frandon, Julien; Rodiere, Mathieu; Arvieux, Catherine; Vendrell, Anne; Boussat, Bastien; Sengel, Christian; Broux, Christophe; Bricault, Ivan; Ferretti, Gilbert; Thony, Frédéric

    2015-01-01

    We aimed to compare clinical outcomes and early adverse events of operative management (OM), nonoperative management (NOM), and NOM with splenic artery embolization (SAE) in blunt splenic injury (BSI) and identify the prognostic factors. Medical records of 136 consecutive patients with BSI admitted to a trauma center from 2005 to 2010 were retrospectively reviewed. Patients were separated into three groups: OM, NOM, and SAE. We focused on associated injuries and early adverse events. Multivariate analysis was performed on 23 prognostic factors to find predictors. The total survival rate was 97.1%, with four deaths all occurred in the OM group. The spleen salvage rate was 91% in NOM and SAE. At least one adverse event was observed in 32.8%, 62%, and 96% of patients in NOM, SAE, and OM groups, respectively (P events: simplified acute physiology score 2 ≥25 for almost all adverse events, age ≥50 years for acute respiratory syndrome, limb fracture for secondary bleeding, thoracic injury for pleural drainage, and at least one associated injury for pseudocyst. Adverse events were not related to the type of BSI management. Patients with BSI present worse outcome and more adverse events in OM, but this is related to the severity of injury. The main predictor of adverse events remains the severity of injury.

  3. Analysis of economic and social costs of adverse events associated with blood transfusions in Spain.

    Science.gov (United States)

    Ribed-Sánchez, Borja; González-Gaya, Cristina; Varea-Díaz, Sara; Corbacho-Fabregat, Carlos; Bule-Farto, Isabel; Pérez de-Oteyza, Jaime

    2018-02-16

    To calculate, for the first time, the direct and social costs of transfusion-related adverse events in order to include them in the National Healthcare System's budget, calculation and studies. In Spain more than 1,500 patients yearly are diagnosed with such adverse events. Blood transfusion-related adverse events recorded yearly in Spanish haemovigilance reports were studied retrospectively (2010-2015). The adverse events were coded according to the classification of Diagnosis-Related Groups. The direct healthcare costs were obtained from public information sources. The productivity loss (social cost) associated with adverse events was calculated using the human capital and hedonic salary methodologies. In 2015, 1,588 patients had adverse events that resulted in direct health care costs (4,568,914€) and social costs due to hospitalization (200,724€). Three adverse reactions resulted in patient death (at a social cost of 1,364,805€). In total, the cost of blood transfusion-related adverse events was 6,134,443€ in Spain. For the period 2010-2015: the trends show a reduction in the total amount of transfusions (2 vs. 1.91M€; -4.4%). The number of adverse events increased (822 vs. 1,588; +93%), as well as their related direct healthcare cost (3.22 vs. 4.57M€; +42%) and the social cost of hospitalization (110 vs 200M€; +83%). Mortality costs decreased (2.65 vs. 1.36M€; -48%). This is the first time that the costs of post-transfusion adverse events have been calculated in Spain. These new figures and trends should be taken into consideration in any cost-effectiveness study or trial of new surgical techniques or sanitary policies that influence blood transfusion activities. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  4. Sacral Nerve Stimulation for Constipation: Suboptimal Outcome and Adverse Events

    DEFF Research Database (Denmark)

    Maeda, Yasuko; Lundby, Lilli; Buntzen, Steen

    2010-01-01

    Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events.......Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events....

  5. Summarizing the incidence of adverse events using volcano plots and time intervals.

    Science.gov (United States)

    Zink, Richard C; Wolfinger, Russell D; Mann, Geoffrey

    2013-01-01

    Adverse event incidence analyses are a critical component for describing the safety profile of any new intervention. The results typically are presented in lengthy summary tables. For therapeutic areas where patients have frequent adverse events, analysis and interpretation are made more difficult by the sheer number and variety of events that occur. Understanding the risk in these instances becomes even more crucial. We describe a space-saving graphical summary that overcomes the limitations of traditional presentations of adverse events and improves interpretability of the safety profile. We present incidence analyses of adverse events graphically using volcano plots to highlight treatment differences. Data from a clinical trial of patients experiencing an aneurysmal subarachnoid hemorrhage are used for illustration. Adjustments for multiplicity are illustrated. Color is used to indicate the treatment with higher incidence; bubble size represents the total number of events that occur in the treatment arms combined. Adjustments for multiple comparisons are displayed in a manner to indicate clearly those events for which the difference between treatment arms is statistically significant. Furthermore, adverse events can be displayed by time intervals, with multiple volcano plots or animation to appreciate changes in adverse event risk over time. Such presentations can emphasize early differences across treatments that may resolve later or highlight events for which treatment differences may become more substantial with longer follow-up. Treatment arms are compared in a pairwise fashion. Volcano plots are space-saving tools that emphasize important differences between the adverse event profiles of two treatment arms. They can incorporate multiplicity adjustments in a manner that is straightforward to interpret and, by using time intervals, can illustrate how adverse event risk changes over the course of a clinical trial.

  6. Systematic review on the prevalence, frequency and comparative value of adverse events data in social media

    Science.gov (United States)

    Golder, Su; Norman, Gill; Loke, Yoon K

    2015-01-01

    Aim The aim of this review was to summarize the prevalence, frequency and comparative value of information on the adverse events of healthcare interventions from user comments and videos in social media. Methods A systematic review of assessments of the prevalence or type of information on adverse events in social media was undertaken. Sixteen databases and two internet search engines were searched in addition to handsearching, reference checking and contacting experts. The results were sifted independently by two researchers. Data extraction and quality assessment were carried out by one researcher and checked by a second. The quality assessment tool was devised in-house and a narrative synthesis of the results followed. Results From 3064 records, 51 studies met the inclusion criteria. The studies assessed over 174 social media sites with discussion forums (71%) being the most popular. The overall prevalence of adverse events reports in social media varied from 0.2% to 8% of posts. Twenty-nine studies compared the results from searching social media with using other data sources to identify adverse events. There was general agreement that a higher frequency of adverse events was found in social media and that this was particularly true for ‘symptom’ related and ‘mild’ adverse events. Those adverse events that were under-represented in social media were laboratory-based and serious adverse events. Conclusions Reports of adverse events are identifiable within social media. However, there is considerable heterogeneity in the frequency and type of events reported, and the reliability or validity of the data has not been thoroughly evaluated. PMID:26271492

  7. Systematic review on the prevalence, frequency and comparative value of adverse events data in social media.

    Science.gov (United States)

    Golder, Su; Norman, Gill; Loke, Yoon K

    2015-10-01

    The aim of this review was to summarize the prevalence, frequency and comparative value of information on the adverse events of healthcare interventions from user comments and videos in social media. A systematic review of assessments of the prevalence or type of information on adverse events in social media was undertaken. Sixteen databases and two internet search engines were searched in addition to handsearching, reference checking and contacting experts. The results were sifted independently by two researchers. Data extraction and quality assessment were carried out by one researcher and checked by a second. The quality assessment tool was devised in-house and a narrative synthesis of the results followed. From 3064 records, 51 studies met the inclusion criteria. The studies assessed over 174 social media sites with discussion forums (71%) being the most popular. The overall prevalence of adverse events reports in social media varied from 0.2% to 8% of posts. Twenty-nine studies compared the results from searching social media with using other data sources to identify adverse events. There was general agreement that a higher frequency of adverse events was found in social media and that this was particularly true for 'symptom' related and 'mild' adverse events. Those adverse events that were under-represented in social media were laboratory-based and serious adverse events. Reports of adverse events are identifiable within social media. However, there is considerable heterogeneity in the frequency and type of events reported, and the reliability or validity of the data has not been thoroughly evaluated. © 2015 The British Pharmacological Society.

  8. Adverse events of open A1 pulley release for idiopathic trigger finger.

    Science.gov (United States)

    Bruijnzeel, Hanneke; Neuhaus, Valentin; Fostvedt, Sigrid; Jupiter, Jesse B; Mudgal, Chaitanya S; Ring, David C

    2012-08-01

    To classify and report adverse events of trigger finger release in a large cohort of patients. We retrospectively reviewed 1,598 trigger finger releases performed by 12 surgeons in 984 patients between 2001 and 2011. Adverse events were classified based on a system derived from the Centers for Disease Control and Prevention criteria and clinical experience. Risk factors for various adverse events were sought in bivariate and multivariable statistical analysis. At the latest follow-up, 66 patients (7%), or 84 operated trigger digits (5%), experienced a documented adverse event. The most common adverse events were recovery issues in 46 patients (3%) (such as postoperative symptoms treated with steroid injection or slow recovery of motion treated with hand therapy), wound problems in 30 patients (2%) (consisting of suture abscess, superficial infection, or wound separation), persistent postoperative triggering in 10 patients (0.6%), and recurrent triggering in 4 patients (0.3%). Diabetes mellitus was associated with wound problems, slow recovery of motion, and recurrence. Concomitant carpal tunnel release on the same side was associated with slow recovery. Fourteen patients, less than 1%, in this cohort experienced an adverse event, such as persistent or recurrent triggering, requiring secondary surgery. No nerve injury or deep infection occurred in our cohort. One in 15 patients experienced a minor transient or treatable adverse event, and patients with diabetes were at greater risk. Therapeutic IV. Copyright © 2012 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  9. National Immunization Information Hotline: Calls concerning adverse events, 1998-2000.

    Science.gov (United States)

    Gust, D A; Gangarosa, P; Hibbs, B; Pollard, R; Wallach, G; Chen, R T

    2004-01-01

    Data from the National Immunization Information Hotline (NIIH) concerning vaccine adverse event inquiries were analyzed from 1998 to 2000 (total n = 23,841 [public n = 14,330; health care professionals n = 9,511]). Approximately 20% of calls from the public from 1998 to 2000 concerned vaccine adverse events. These calls increased 199.5% from 1998 (n = 422) to 1999 (n = 1,264), then declined 12.4% from 1999 to 2000 (n = 1,107). A Lexus Nexus search showed that the number of news stories mentioning vaccine safety showed a similar pattern. Women were more likely to call the NIIH concerning vaccine adverse events than men, and persons 40-59 years old and persons 60 years old and over were less likely to call about vaccine adverse events than those 20-39 years. The parallel trends in news stories mentioning vaccine safety and calls to the NIIH concerning adverse events suggests that news stories may stimulate questions about vaccine safety. Understanding that news stories may elicit questions about vaccine adverse events and examining the characteristics of persons who ask vaccine adverse event questions may guide future informational interventions toward those most in need.

  10. Adverse event assessment of antimuscarinics for treating overactive bladder: a network meta-analytic approach.

    Directory of Open Access Journals (Sweden)

    Thomas M Kessler

    Full Text Available BACKGROUND: Overactive bladder (OAB affects the lives of millions of people worldwide and antimuscarinics are the pharmacological treatment of choice. Meta-analyses of all currently used antimuscarinics for treating OAB found similar efficacy, making the choice dependent on their adverse event profiles. However, conventional meta-analyses often fail to quantify and compare adverse events across different drugs, dosages, formulations, and routes of administration. In addition, the assessment of the broad variety of adverse events is dissatisfying. Our aim was to compare adverse events of antimuscarinics using a network meta-analytic approach that overcomes shortcomings of conventional analyses. METHODS: Cochrane Incontinence Group Specialized Trials Register, previous systematic reviews, conference abstracts, book chapters, and reference lists of relevant articles were searched. Eligible studies included randomized controlled trials comparing at least one antimuscarinic for treating OAB with placebo or with another antimuscarinic, and adverse events as outcome measures. Two authors independently extracted data. A network meta-analytic approach was applied allowing for joint assessment of all adverse events of all currently used antimuscarinics while fully maintaining randomization. RESULTS: 69 trials enrolling 26'229 patients were included. Similar overall adverse event profiles were found for darifenacin, fesoterodine, transdermal oxybutynin, propiverine, solifenacin, tolterodine, and trospium chloride but not for oxybutynin orally administered when currently used starting dosages were compared. CONCLUSIONS: The proposed generally applicable transparent network meta-analytic approach summarizes adverse events in an easy to grasp way allowing straightforward benchmarking of antimuscarinics for treating OAB in clinical practice. Most currently used antimuscarinics seem to be equivalent first choice drugs to start the treatment of OAB except for

  11. Quality indicators of preventable adverse drug events in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard

    population receiving oral antihyperglycaemic treatment (9,791 persons) was set up, and indicator positives identified (Articles no. 2 and 3). The third step in the model consisted of a risk assessment of preventable adverse drug events, including an assessment of clinical areas that need quality improvement...... events are common in primary care, with many resulting in hospitalisation. Projected to a Danish setting, 216,000 patients will experience a preventable adverse drug event each year, and 162,000 of these patients will need hospital admission. Quality improvement interventions should target errors......Summary Background: Preventable adverse drug events are caused by errors in the medication use Preventable adverse drug events are caused by errors in the medication use process, and are of particular interest when designing interventions to improve the quality of medication therapy. Type 2...

  12. Transient paralysis during acupuncture therapy: a case report of an adverse event.

    Science.gov (United States)

    Beable, Anne

    2013-09-01

    A patient with apparently well-controlled epilepsy with a painful musculoskeletal condition was treated successfully with two sessions of acupuncture. However, 4 h after the first treatment and during the second, an adverse event involving impairment of consciousness occurred. The patient subsequently experienced an increased frequency of complex partial seizures resulting in the loss of his driving licence. A detailed retrospective review of the past medical history indicated that the patient probably had comorbidities in the form of rapid eye movement sleep behaviour disorder and dysfunctional somatosensory/vestibular processing. Acupuncture may have triggered the adverse event via shared neurosubstrates. This adverse event raises possible implications regarding safe clinical acupuncture practice.

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

    DEFF Research Database (Denmark)

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

    2006-01-01

    OBJECTIVE: To investigate GPs' attitudes to and willingness to report and learn from adverse events and to study how a reporting system should function. DESIGN: Survey. SETTING: General practice in Denmark. MAIN OUTCOME MEASURES: GPs' attitudes to exchange of experience with colleagues and others...... a positive attitude to reporting adverse events to a database if the system granted legal and administrative immunity to reporters. The majority preferred a reporting system located at a research institute. CONCLUSION: GPs have a very positive attitude towards discussing and reporting adverse events....... This project encourages further research and pilot projects testing concrete reporting systems....

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

    Science.gov (United States)

    2017-07-14

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

  15. Validating administrative data for the detection of adverse events in older hospitalized patients

    Directory of Open Access Journals (Sweden)

    Ackroyd-Stolarz S

    2014-08-01

    Full Text Available Stacy Ackroyd-Stolarz,1,2 Susan K Bowles,3–5 Lorri Giffin6 1Performance Excellence Portfolio, Capital District Health Authority, Halifax, Nova Scotia, Canada; 2Department of Emergency Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; 3Geriatric Medicine, Capital District Health Authority, Halifax, Nova Scotia, Canada; 4College of Pharmacy and Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; 5Department of Pharmacy at Capital District Health Authority, Halifax, Nova Scotia, Canada; 6South Shore Family Health, Bridgewater, Nova Scotia, Canada Abstract: Older hospitalized patients are at risk of experiencing adverse events including, but not limited to, hospital-acquired pressure ulcers, fall-related injuries, and adverse drug events. A significant challenge in monitoring and managing adverse events is lack of readily accessible information on their occurrence. Purpose: The objective of this retrospective cross-sectional study was to validate diagnostic codes for pressure ulcers, fall-related injuries, and adverse drug events found in routinely collected administrative hospitalization data. Methods: All patients 65 years of age or older discharged between April 1, 2009 and March 31, 2011 from a provincial academic health sciences center in Canada were eligible for inclusion in the validation study. For each of the three types of adverse events, a random sample of 50 patients whose records were positive and 50 patients whose records were not positive for an adverse event was sought for review in the validation study (n=300 records in total. A structured health record review was performed independently by two health care providers with experience in geriatrics, both of whom were unaware of the patient's status with respect to adverse event coding. A physician reviewed 40 records (20 reviewed by each health care provider to establish interrater agreement. Results: A total of 39 pressure ulcers, 56 fall

  16. ACCEPT: Introduction of the Adverse Condition and Critical Event Prediction Toolbox

    Science.gov (United States)

    Martin, Rodney A.; Santanu, Das; Janakiraman, Vijay Manikandan; Hosein, Stefan

    2015-01-01

    The prediction of anomalies or adverse events is a challenging task, and there are a variety of methods which can be used to address the problem. In this paper, we introduce a generic framework developed in MATLAB (sup registered mark) called ACCEPT (Adverse Condition and Critical Event Prediction Toolbox). ACCEPT is an architectural framework designed to compare and contrast the performance of a variety of machine learning and early warning algorithms, and tests the capability of these algorithms to robustly predict the onset of adverse events in any time-series data generating systems or processes.

  17. Incidence and preventability of adverse events requiring intensive care admission: a systematic review.

    Science.gov (United States)

    Vlayen, Annemie; Verelst, Sandra; Bekkering, Geertruida E; Schrooten, Ward; Hellings, Johan; Claes, Neree

    2012-04-01

    Adverse events are unintended patient injuries or complications that arise from health care management resulting in death, disability or prolonged hospital stay. Adverse events that require critical care are a considerable financial burden to the health care system, but also their global impact on patients and society is probably underestimated. The objectives of this systematic review were to synthesize the best available evidence regarding the estimates of the incidence and preventability of adverse events that necessitate intensive care admission, to determine the type and consequences [mortality, length of intensive care unit (ICU) stay and costs] of these adverse events. MEDLINE (from 1966 to present), EMBASE (from 1974 to present) and CENTRAL (version 1-2010) were searched for studies reporting on unplanned admissions on ICUs. Several other sources were searched for additional studies. Only quantitative studies that used chart review for the detection of adverse events requiring intensive care admission were considered for eligibility. For the purposes of this systematic review, ICUs were defined as specialized hospital facilities which provide continuous monitoring and intensive care for acutely ill patients. Studies that were published in the English, Dutch, German, French or Spanish language were eligible for inclusion. Two reviewers independently extracted data and assessed the methodological quality of the included studies. A total of 27 studies were reviewed. Meta-analysis of the data was not appropriate because of methodological and statistical heterogeneity between studies; therefore, results are presented in a descriptive way. The percentage of surgical and medical adverse events that required ICU admission ranged from 1.1% to 37.2%. ICU readmissions varied from 0% to 18.3%. Preventability of the adverse events varied from 17% to 76.5%. Preventable adverse events are further synthesized by type of event. Consequences of the adverse events included a

  18. Rural patients' experiences of the open disclosure of adverse events.

    Science.gov (United States)

    Piper, Donella; Iedema, Rick; Bower, Kate

    2014-08-01

    To analyse rural patients' and their families' experiences of open disclosure and offer recommendations to improve disclosure in rural areas. Retrospective qualitative study based on a subset of 13 semistructured, in-depth interviews with rural patients from a larger dataset. The larger data set form a nationwide, multisite, retrospective-qualitative study that included 100 semistructured, in-depth interviews with 119 patients and family members who were involved in high-severity health care incidents and incident disclosure. The larger study is known as the '100 Patient Stories' study. Interviews were transcribed verbatim and analysed by one analyst (D.P.) for recurrent experiences and concerns. Acute care. A sub-set of 13 of the 100 participants from the '100 Patient Stories' study who identified as experiencing an adverse incident in a rural or regional area. Patients' and family members' perceptions and experiences of health care incident disclosure, as expressed in interviews. Rural patients and clinicians experience additional challenges to metropolitan patients and clinicians in their experiences of health care incidents. These additional barriers include: a lack of resources at small hospitals; delays in diagnosis and transfer; distance between services; and a lack of communication between providers. These challenges impact not only upon how patients and their families experience incidents, but also how open disclosure is implemented. This analysis of 13 of the 100 Patient Stories interviews provides guidance to rural health services on how to conduct open disclosure. © 2014 National Rural Health Alliance Inc.

  19. Evaluation of thromboembolic events in cancer patients receiving bevacizumab according to the Japanese Adverse Drug Event Report database.

    Science.gov (United States)

    Matsumura, Chikako; Chisaki, Yugo; Sakimoto, Satoko; Sakae, Honoka; Yano, Yoshitaka

    2018-01-01

    Purpose We aimed to examine the risk factors, time of onset, incidence rates, and outcomes of thromboembolic events induced by bevacizumab in patients with cancer using the Japanese Adverse Drug Event Report (JADER) database of the Pharmaceuticals and Medical Devices Agency. Methods Adverse event data recorded in the JADER database between January 2004 and January 2015 were used. After screening the data using the generic drug name bevacizumab, patient data were classified into two groups by age and five groups by cancer type. The histories of disorders were also categorized. Arterial thromboembolic event and venous thromboembolic event were classified as "favorable" or "unfavorable" outcomes. Results In total, 6076 patients were reported to have developed adverse events during the sample period, of which 233 and 453 developed arterial thromboembolic event and venous thromboembolic event, respectively. Logistic analysis suggested that the presence of cancer was a significant risk factor for both arterial thromboembolic event and venous thromboembolic event. Age (≥70 years), histories of either hypertension or diabetes mellitus were also risk factors for arterial thromboembolic event. Median cumulative times of onset for arterial thromboembolic event and venous thromboembolic event were 60 and 80 days, respectively, and were not significantly different by the log-rank test. By the chi-square test, the rate of unfavorable outcomes was found to be higher after developing arterial thromboembolic event than after venous thromboembolic event. Conclusion Thromboembolism is a leading cause of mortality in patients with cancer. Patients should be monitored for the symptoms of thromboembolic events right from the initial stages of bevacizumab treatment.

  20. The cause multiplicity and the multiple cause style of adverse events in Japanese nuclear power plants

    International Nuclear Information System (INIS)

    Miyazaki, Takamasa

    2008-01-01

    An adverse event in a nuclear power plant occurs due to either one cause or multiple causes. To consider ways of preventing adverse events, it is useful to clarify whether events are caused by single or multiple causes. In this study, the multiple causes is expressed using the cause multiplicity and the multiple cause style. Classified causes of adverse events in Japanese nuclear power plants were analyzed, with the following results: the cause multiplicity of serious adverse events is higher than that of minor adverse events, and the multiple cause style can be expressed by combining two styles: series type and parallel type. Also, for a multiple cause event, a new method of displaying the event is presented as a cause-chain chart where the cause items are arranged in a sequential way and are connected considering the mutual relations among the causes. This new display method shows the whole flow of issues concerning the event more simply than the conventional display method of the chain of phenomena, and would be useful for considering the terminating point of the chain of causes. (author)

  1. How transformational leadership appears in action with adverse events? A study for Finnish nurse manager.

    Science.gov (United States)

    Liukka, Mari; Hupli, Markku; Turunen, Hannele

    2017-12-26

    The aim of this study was to determine whether elements of transformational leadership are present in nursing managers' actions following adverse events. Transformational leadership exerts a positive influence on organisational culture and patient safety. Eleven nursing managers were interviewed individually using a semi-structured format. Data were analysed using inductive content analysis. Four themes emerged relating to nursing managers' actions following adverse events: patient-centredness as a principle for common action, courage to reform operational models to prevent future adverse events, nursing staff's encouragement of open and blame-free discussion, and challenge to recognize adverse events. Nursing managers must understand their responsibilities and the importance of making it clear to staff that patient-centredness should be evident in all health care actions. Nursing managers must also recognize the need to ensure that staff treat patients' interests as the top priority. If an adverse event occurs, the situation should be discussed with the nursing staff and any unique aspects of the event must be accounted for. Nursing managers must have the skill to motivate and empower staff to find new ways to work, to prevent adverse events and to promote patient safety. © 2017 John Wiley & Sons Ltd.

  2. Detection of adverse events of transfusion in a teaching hospital in Ghana.

    Science.gov (United States)

    Owusu-Ofori, A K; Owusu-Ofori, S P; Bates, I

    2017-06-01

    Monitoring the whole chain of events from the blood donors to recipients, documenting any undesirable or untoward effects and introducing measures to prevent their recurrence if possible are components of haemovigilance systems. Only few sub-Saharan African countries have haemovigilance systems, and there are very little data on adverse events of transfusion. Adverse events monitoring is an integral part of a haemovigilance system. Our study aimed to establish the incidence and types of adverse events of transfusions in Ghana and to identify interventions to improve effectiveness. This prospective observational 1-year study enrolled 372 recipients of 432 transfusions in a Ghanaian teaching hospital. Vital signs were monitored at 15, 30 and 60 min intervals during the transfusion, then 8 h until 24 h post-transfusion. Three investigators independently classified any new signs and symptoms according to Serious Hazards of Transfusion definitions. The adverse events incidence was 21·3% (92/432), predominantly mild acute transfusion reactions (84%). A total of 20 transfusions (4·6%) were stopped before completion, 60% of them for mild febrile reactions, which could have been managed with transfusion in situ. This prospective study indicates a high incidence of adverse events of transfusion in Kumasi, Ghana. The significant numbers of discontinued transfusions suggest that guidelines on how to manage transfusion reactions would help preserve scarce blood stocks. Gradual implementation of a haemovigilance system, starting with monitoring adverse transfusion events, is a pragmatic approach in resource-limited settings. © 2017 British Blood Transfusion Society.

  3. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian

    2014-01-01

    improve patient safety if coupled with training and organisational support2. Insight into the nature of reported critical incidents and adverse events can be used in writing in situ simulation scenarios and thus lead to interventions that enhance patient safety. The patient safety literature emphasises...... well-developed non-technical skills in preventing medical errors3. Furthermore, critical incidents and adverse events reporting systems comprise a knowledgebase to gain in-depth insights into patient safety issues. This study explores the use of critical incidents and adverse events reports to inform...... in situ simulation to improve patient safety. Design and purpose The study uses a case study design of in situ simulation training tailored to two emergency departments in the Central Denmark Region. We aim to: - Develop a model that integrates critical incidents and adverse events, a contextual needs...

  4. [What to do in case of adverse event in recipient at the French National Blood Service?].

    Science.gov (United States)

    Leconte des Floris, M-F; Pourcelot, L; Hauser, L; Hervé, I; Waller, C; Bardiaux, L; Morel, P

    2012-11-01

    One of the main goals of haemovigilance is to gather and analyze adverse events in recipients of blood products in order to improve blood safety. The French National Blood Service has a specific role in the management of immediate adverse events: to alert to quarantine the potentially dangerous blood products from the same donation(s), to provide blood testing for the etiologic assessment and to give transfusion advice to patients. The updating of the recipient's computer file allows a better monitoring for both immediate and delayed adverse events. Finally, the French National Blood Service's correspondent of haemovigilance is responsible for donor's inquiries, especially in cases of transfusion related to bacterial contamination, severe allergy, suspicion of transfusion acute related lung injury and viral seroconversion. The management effectiveness for adverse events requires a strong collaboration between all members of the haemovigilance network. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

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

    Science.gov (United States)

    Mann, Justin M

    2015-01-01

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

  6. Analysis of adverse events as a contribution to safety culture in the context of practice development

    Science.gov (United States)

    Hoffmann, Susanne; Frei, Irena Anna

    2017-01-01

    Background: Analysing adverse events is an effective patient safety measure. Aim: We show, how clinical nurse specialists have been enabled to analyse adverse events with the „Learning from Defects-Tool“ (LFD-Tool). Method: Our multi-component implementation strategy addressed both, the safety knowledge of clinical nurse specialists and their attitude towards patient safety. The culture of practice development was taken into account. Results: Clinical nurse specialists relate competency building on patient safety due to the application of the LFD-tool. Applying the tool, fosters the reflection of adverse events in care teams. Conclusion: Applying the „Learning from Defects-Tool“ promotes work-based learning. Analysing adverse events with the „Learning from Defects-Tool“ contributes to the safety culture in a hospital.

  7. Adverse Condition and Critical Event Prediction in Cranfield Multiphase Flow Facility

    DEFF Research Database (Denmark)

    Egedorf, Søren; Shaker, Hamid Reza

    2017-01-01

    Today's complex processes and plants are vulnerable to different faults, misconfiguration, non-holistic and improper control and management which cause abnormal behavior and might eventually result in poor and sub-optimal operation, dissatisfaction, damage to the plant, to personnel and resources......, or even to the environment. To cope with these, adverse condition and critical event prediction plays an important role. Adverse Condition and Critical Event Prediction Toolbox (ACCEPT) is a tool which has been recently developed by NASA to allow for a timely prediction of an adverse event, with low false...... alarm and missed detection rates. While ACCEPT has shown to be an effective tool in some applications, its performance has not yet been evaluated on practical well-known benchmark examples. In this paper, ACCEPT is used for adverse condition and critical event prediction in a multiphase flow facility...

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

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

    2017-12-01

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

  10. Mental health in retired professional football players: 12-month incidence, adverse life events and support

    NARCIS (Netherlands)

    van Ramele, Serena; Aoki, Haruhito; Kerkhoffs, Gino M. M. J.; Gouttebarge, Vincent

    2017-01-01

    Objectives: The primary aim was to explore the incidence of symptoms of common mental disorders (CMD; distress, sleep disturbance, anxiety/depression, adverse alcohol use) in retired professional football players and to explore the association between adverse life events and the onset of symptoms of

  11. Association between adverse life events and addictive behaviors among male and female adolescents.

    Science.gov (United States)

    Lee, Grace P; Storr, Carla L; Ialongo, Nicholas S; Martins, Silvia S

    2012-01-01

    Adverse life events have been associated with gambling and substance use as they can serve as forms of escapism. Involvement in gambling and substance use can also place individuals in adversely stressful situations. To explore potential male-female differences in the association between addictive behavior and adverse life events among an urban cohort of adolescents. The study sample comprised of 515 adolescent participants in a randomized prevention trial. With self-reported data, four addictive behavior groups were created: nonsubstance users and nongamblers, substance users only, gamblers only, and substance users and gamblers. Multinomial logistic regression analyses with interaction terms of sex and adverse life events were conducted. Adverse life events and engaging in at least one addictive behavior were common for both sexes. Substance users and gamblers had more than twice the likelihood of nonsubstance users and nongamblers to experience any event as well as events of various domains (ie, relationship, violence, and instability). Neither relationship nor instability events' associations with the co-occurrence of substance use and gambling significantly differed between sexes. Conversely, females exposed to violence events were significantly more likely than similarly exposed males to report the co-occurrence of substance use and gambling. Findings from the current study prompt future studies to devote more attention to the development of effective programs that teach adaptive coping strategies to adolescents, particularly to females upon exposure to violence. Copyright © American Academy of Addiction Psychiatry.

  12. Retrospective analysis of 53 cases of medical supplies quality adverse event

    OpenAIRE

    Cheng-zu LUO

    2014-01-01

    Medical supplies are the basic material for medical work in the hospital, and in relation to the patient's life.This paper analyzed retrospectively 53 cases of medical supplies quality adverse event in our hospital from 2011 to 2012.Accordingly, it was discussed how to improve the whole quality control system of medical supplies, how to ensure clinical safety, and how to reduce the incidence of adverse events.

  13. Retrospective analysis of 53 cases of medical supplies quality adverse event

    Directory of Open Access Journals (Sweden)

    Cheng-zu LUO

    2014-04-01

    Full Text Available Medical supplies are the basic material for medical work in the hospital, and in relation to the patient's life.This paper analyzed retrospectively 53 cases of medical supplies quality adverse event in our hospital from 2011 to 2012.Accordingly, it was discussed how to improve the whole quality control system of medical supplies, how to ensure clinical safety, and how to reduce the incidence of adverse events.

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

    OpenAIRE

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

    2016-01-01

    Introduction 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. Objectives Our objective was to explore the process for reporting ADEs in US hospitals, ambulatory ...

  15. Comparison of patient and surgeon perceptions of adverse events after adult spinal deformity surgery.

    Science.gov (United States)

    Hart, Robert A; Cabalo, Adam; Bess, Shay; Akbarnia, Behrooz A; Boachie-Adjei, Oheneba; Burton, Douglas; Cunningham, Matthew E; Gupta, Munish; Hostin, Richard; Kebaish, Khaled; Klineberg, Eric; Mundis, Gregory; Shaffrey, Christopher; Smith, Justin S; Wood, Kirkham

    2013-04-20

    Survey based on complication scenarios. To assess and compare perceived potential impacts of various perioperative adverse events by both surgeons and patients. Incidence of adverse events after adult spinal deformity surgery remains substantial. Patient-centered outcomes tools measuring the impact of these events have not been developed. An important first step is to assess the perceptions of surgeons and patients regarding the impact of these events on surgical outcome and quality of life. Descriptions of 22 potential adverse events of surgery (heart attack, stroke, spinal cord injury, nerve root injury, cauda equina injury, blindness, dural tear, blood transfusion, deep vein thrombosis, pulmonary embolism, superficial infection, deep infection, lung failure, urinary tract infection, nonunion, adjacent segment disease, persistent deformity, implant failure, death, renal failure, gastrointestinal complications, and sexual dysfunction) were presented to 14 spinal surgeons and 16 adult patients with spinal deformity. Impact scores were assigned to each complication on the basis of perceptions of overall severity, satisfaction with surgery, and effect on quality of life. Impact scores were compared between surgeons and patients with a Wilcoxon/Kruskal-Wallis test. Mean impact scores varied from 0.9 (blood transfusion) to 10.0 (death) among surgeons and 2.3 (urinary tract infection) to 9.2 (stroke) among patients. Patients' scores were consistently higher (P < 0.05) than surgeons in all 3 categories for 6 potential adverse events: stroke, lung failure, heart attack, pulmonary embolism, dural tear, and blood transfusion. Three additional complications (renal failure, non-union, and deep vein thrombosis) were rated higher in 1 or 2 categories by patients. There was substantial variation in how both surgeons and patients perceived impacts of various adverse events after spine surgery. Patients generally perceived the impact of adverse events to be greater than surgeons

  16. Signal detection to identify serious adverse events (neuropsychiatric events in travelers taking mefloquine for chemoprophylaxis of malaria

    Directory of Open Access Journals (Sweden)

    Naing C

    2012-08-01

    Full Text Available Cho Naing,1,3 Kyan Aung,1 Syed Imran Ahmed,2 Joon Wah Mak31School of Medical Sciences, 2School of Pharmacy and Health Sciences, 3School of Postgraduate Studies and Research, International Medical University, Kuala Lumpur, MalaysiaBackground: For all medications, there is a trade-off between benefits and potential for harm. It is important for patient safety to detect drug-event combinations and analyze by appropriate statistical methods. Mefloquine is used as chemoprophylaxis for travelers going to regions with known chloroquine-resistant Plasmodium falciparum malaria. As such, there is a concern about serious adverse events associated with mefloquine chemoprophylaxis. The objective of the present study was to assess whether any signal would be detected for the serious adverse events of mefloquine, based on data in clinicoepidemiological studies.Materials and methods: We extracted data on adverse events related to mefloquine chemoprophylaxis from the two published datasets. Disproportionality reporting of adverse events such as neuropsychiatric events and other adverse events was presented in the 2 × 2 contingency table. Reporting odds ratio and corresponding 95% confidence interval [CI] data-mining algorithm was applied for the signal detection. The safety signals are considered significant when the ROR estimates and the lower limits of the corresponding 95% CI are ≥2.Results: Two datasets addressing adverse events of mefloquine chemoprophylaxis (one from a published article and one from a Cochrane systematic review were included for analyses. Reporting odds ratio 1.58, 95% CI: 1.49–1.68 based on published data in the selected article, and 1.195, 95% CI: 0.94–1.44 based on data in the selected Cochrane review. Overall, in both datasets, the reporting odds ratio values of lower 95% CI were less than 2.Conclusion: Based on available data, findings suggested that signals for serious adverse events pertinent to neuropsychiatric event were

  17. Adverse Childhood and Recent Negative Life Events: Contrasting Associations With Cognitive Decline in Older Persons.

    Science.gov (United States)

    Korten, Nicole C M; Penninx, Brenda W J H; Pot, Anne Margriet; Deeg, Dorly J H; Comijs, Hannie C

    2014-06-01

    To examine whether persons who experienced adverse childhood events or recent negative life events have a worse cognitive performance and faster cognitive decline and the role of depression and apolipoprotein E-∊4 in this relationship. The community-based sample consisted of 10-year follow-up data of 1312 persons participating in the Longitudinal Aging Study Amsterdam (age range 65-85 years). Persons who experienced adverse childhood events showed a faster 10-year decline in processing speed but only when depressive symptoms were experienced. Persons with more recent negative life events showed slower processing speed at baseline but no faster decline. Childhood adversity may cause biological or psychological vulnerability, which is associated with both depressive symptoms and cognitive decline in later life. The accumulation of recent negative life events did not affect cognitive functioning over a longer time period. © The Author(s) 2014.

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

    Directory of Open Access Journals (Sweden)

    Mélanie Courtot

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

  19. Clinical review: insulin pump-associated adverse events in adults and children.

    Science.gov (United States)

    Ross, P L; Milburn, J; Reith, D M; Wiltshire, E; Wheeler, B J

    2015-12-01

    Insulin pumps are a vital and rapidly developing tool in the treatment of type 1 diabetes mellitus in both adults and children. Many studies have highlighted outcomes and assessed their potential advantages, but much of the data on adverse outcomes are limited and often based on outdated technology. We aimed to review and summarize the available literature on insulin pump-associated adverse events in adults and children. A literature search was undertaken using PubMed, EMBASE, and the Cochrane library. Articles were then screened by title, followed by abstract, and full text as needed. A by-hand search of reference lists in identified papers was also utilised. All searches were limited to English language material, but no time limits were used. Current and past literature regarding insulin pump-associated adverse events is discussed, including potential metabolic and non-metabolic adverse events, in particular: pump malfunction; infusion set/site issues; and cutaneous problems. We show that even with modern technology, adverse events are common, occurring in over 40 % of users per year, with a minority, particularly in children, requiring hospital management. Hyperglycaemia and ketosis are now the most common consequences of adverse events and are usually associated with infusion set failure. This differs from older technology where infected infusion sites predominated. This timely review covers all potential insulin pump-associated adverse events, including their incidence, features, impacts, and contributory factors such as the pump user. The importance of ongoing anticipatory education and support for patients and families using this intensive insulin technology is highlighted, which if done well should improve the overall experience of pump therapy for users, and hopefully reduce the incidence and impact of severe adverse events.

  20. Biological stress systems, adverse life events and the onset of chronic multisite musculoskeletal pain : a six-year cohort study

    NARCIS (Netherlands)

    Generaal, E.; Vogelzangs, N.; Macfarlane, G.J.; Geenen, R.; de Geus, E.; Smit, J.H.; Penninx, B.W.; Dekker, J.

    2015-01-01

    Background Dysregulated biological stress systems and adverse life events, both independently and in interaction, have been hypothesized to initiate chronic pain. Objectives We examine whether (i) function of biological stress systems, (ii) adverse life events, and (iii) their combination predict

  1. Reporting of serious adverse events during cancer clinical trials to the institutional review board: an evaluation by the research on adverse drug events and reports (RADAR) project.

    Science.gov (United States)

    Belknap, S M; Georgopoulos, C H; Lagman, J; Weitzman, S A; Qualkenbush, L; Yarnold, P R; Edwards, B J; McKoy, J M; Trifilio, S M; West, D P

    2013-12-01

    Global introspection is considered an unreliable method for attribution of causality of serious adverse events (SAEs), yet remains widely used for cancer drug clinical trials. Here, we compare structured case abstraction (SCA) to the routine method for detecting, evaluating, and reporting ADEs during cancer drug clinical trials to an Institutional Review Board (IRB). We obtained all SAE reports (2001-2008) received by one IRB for six clinical trials involving bevacizumab or oxaliplatin for treatment of gastrointestinal cancers. We compared the routine IRB SAE method to SCA for adverse event detection and causality attribution. Of 205 adverse events, 182 events (75%) were not reported; of these, 6 (20%) of 30 SAEs requiring an IRB report were unreported. For the 10 item Naranjo score, the amount of information useful for causality attribution was higher with SCA than the routine method (6.0 vs. 2.4 items, P < .0001). One-fifth of SAEs requiring an IRB report were unreported to the IRB via the routine method. SCA provided more useful information as to whether an SAE was caused by a cancer drug exposure. Our results suggest that SCA may improve SAE detection and the accuracy of attribution of causality during cancer drug clinical trials. © 2013, The American College of Clinical Pharmacology.

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

    Science.gov (United States)

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

    2017-03-27

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

  3. The relationship between patient safety culture and adverse events: a questionnaire survey.

    Science.gov (United States)

    Wang, Xue; Liu, Ke; You, Li-ming; Xiang, Jia-gen; Hu, Hua-gang; Zhang, Li-feng; Zheng, Jing; Zhu, Xiao-wen

    2014-08-01

    Patient safety culture is an important factor in the effort to reduce adverse events in the hospital and improve patient safety. A few studies have shown the relationship between patient safety culture and adverse events, yet no such research has been reported in China. This study aimed to describe nurses' perception of patient safety culture and frequencies of adverse events, and examine the relationship between them. This study was a descriptive, correlated study. We selected 28 inpatient units and emergency departments in 7 level-3 general hospitals from 5 districts in Guangzhou, China, and we surveyed 463 nurses. The Hospital Survey on Patient Safety Culture was used to measure nurses' perception of patient safety culture, and the frequencies of adverse events which happened frequently in hospital were estimated by nurses. We used multiple logistic regression models to examine the relationship between patient safety culture scores and estimated frequencies of each type of adverse event. The Positive Response Rates of 12 dimensions of the Hospital Survey on Patient Safety Culture varied from 23.6% to 89.7%. There were 47.8-75.6% nurses who estimated that these adverse events had happened in the past year. After controlling for all nurse related factors, a higher mean score of "Organizational Learning-Continuous Improvement" was significantly related to lower the occurrence of pressure ulcers (OR=0.249), prolonged physical restraint (OR=0.406), and complaints (OR=0.369); a higher mean score of "Frequency of Event Reporting" was significantly related to lower the occurrence of medicine errors (OR=0.699) and pressure ulcers (OR=0.639). The results confirmed the hypothesis that an improvement in patient safety culture was related to a decrease in the occurrence of adverse events. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Adverse Drug Events and Medication Errors in African Hospitals: A Systematic Review.

    Science.gov (United States)

    Mekonnen, Alemayehu B; Alhawassi, Tariq M; McLachlan, Andrew J; Brien, Jo-Anne E

    2018-03-01

    Medication errors and adverse drug events are universal problems contributing to patient harm but the magnitude of these problems in Africa remains unclear. The objective of this study was to systematically investigate the literature on the extent of medication errors and adverse drug events, and the factors contributing to medication errors in African hospitals. We searched PubMed, MEDLINE, EMBASE, Web of Science and Global Health databases from inception to 31 August, 2017 and hand searched the reference lists of included studies. Original research studies of any design published in English that investigated adverse drug events and/or medication errors in any patient population in the hospital setting in Africa were included. Descriptive statistics including median and interquartile range were presented. Fifty-one studies were included; of these, 33 focused on medication errors, 15 on adverse drug events, and three studies focused on medication errors and adverse drug events. These studies were conducted in nine (of the 54) African countries. In any patient population, the median (interquartile range) percentage of patients reported to have experienced any suspected adverse drug event at hospital admission was 8.4% (4.5-20.1%), while adverse drug events causing admission were reported in 2.8% (0.7-6.4%) of patients but it was reported that a median of 43.5% (20.0-47.0%) of the adverse drug events were deemed preventable. Similarly, the median mortality rate attributed to adverse drug events was reported to be 0.1% (interquartile range 0.0-0.3%). The most commonly reported types of medication errors were prescribing errors, occurring in a median of 57.4% (interquartile range 22.8-72.8%) of all prescriptions and a median of 15.5% (interquartile range 7.5-50.6%) of the prescriptions evaluated had dosing problems. Major contributing factors for medication errors reported in these studies were individual practitioner factors (e.g. fatigue and inadequate knowledge

  5. Adverse childhood and recent negative life events: contrasting associations with cognitive decline in older persons

    NARCIS (Netherlands)

    Korten, N.C.M.; Penninx, B.W.J.H.; Pot, A.M.; Deeg, D.; Comijs, H.C.

    2014-01-01

    Objective: To examine whether persons who experienced adverse childhood events or recent negative life events have a worse cognitive performance and faster cognitive decline and the role of depression and apolipoprotein E-e4 in this relationship. Methods: The community-based sample consisted of

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

    Science.gov (United States)

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

    2017-11-01

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

  7. Safety in the operating room during orthopedic trauma surgery-incidence of adverse events related to technical equipment and logistics

    NARCIS (Netherlands)

    van Delft, E. A. K.; Schepers, T.; Bonjer, H. J.; Kerkhoffs, G. M. M. J.; Goslings, J. C.; Schep, N. W. L.

    2017-01-01

    Safety in the operating room is widely debated. Adverse events during surgery are potentially dangerous for the patient and staff. The incidence of adverse events during orthopedic trauma surgery is unknown. Therefore, we performed a study to quantify the incidence of these adverse events. Primary

  8. Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems

    Science.gov (United States)

    Pham, Julius Cuong; Williams, Tamara L; Sparnon, Erin M; Cillie, Tam K; Scharen, Hilda F; Marella, William M

    2016-01-01

    BACKGROUND: In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems. METHODS: We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy. RESULTS: A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure. CONCLUSIONS: Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of

  9. Is the efficacy of antidepressants in panic disorder mediated by adverse events? A mediational analysis.

    Science.gov (United States)

    Bighelli, Irene; Borghesani, Anna; Barbui, Corrado

    2017-01-01

    It has been hypothesised that the perception of adverse events in placebo-controlled antidepressant clinical trials may induce patients to conclude that they have been randomized to the active arm of the trial, leading to the breaking of blind. This may enhance the expectancies for improvement and the therapeutic response. The main objective of this study is to test the hypothesis that the efficacy of antidepressants in panic disorder is mediated by the perception of adverse events. The present analysis is based on a systematic review of published and unpublished randomised trials comparing antidepressants with placebo for panic disorder. The Baron and Kenny approach was applied to investigate the mediational role of adverse events in the relationship between antidepressants treatment and efficacy. Fourteen placebo-controlled antidepressants trials were included in the analysis. We found that: (a) antidepressants treatment was significantly associated with better treatment response (ß = 0.127, 95% CI 0.04 to 0.21, p = 0.003); (b) antidepressants treatment was not associated with adverse events (ß = 0.094, 95% CI -0.05 to 0.24, p = 0.221); (c) adverse events were negatively associated with treatment response (ß = 0.035, 95% CI -0.06 to -0.05, p = 0.022). Finally, after adjustment for adverse events, the relationship between antidepressants treatment and treatment response remained statistically significant (ß = 0.122, 95% CI 0.01 to 0.23, p = 0.039). These findings do not support the hypothesis that the perception of adverse events in placebo-controlled antidepressant clinical trials may lead to the breaking of blind and to an artificial inflation of the efficacy measures. Based on these results, we argue that the moderate therapeutic effect of antidepressants in individuals with panic disorder is not an artefact, therefore reflecting a genuine effect that doctors can expect to replicate under real-world conditions.

  10. Prior adversities predict posttraumatic stress reactions in adolescents following the Oslo Terror events 2011.

    Science.gov (United States)

    Nordanger, Dag Ø; Breivik, Kyrre; Haugland, Bente Storm; Lehmann, Stine; Mæhle, Magne; Braarud, Hanne Cecilie; Hysing, Mari

    2014-01-01

    Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents' proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care.

  11. An analysis of risk factors and adverse events in ambulatory surgery

    Directory of Open Access Journals (Sweden)

    Kent C

    2014-06-01

    Full Text Available Christopher Kent, Julia Metzner, Laurent BollagDepartment of Anesthesiology and Pain Medicine, University of Washington Medical Center, Seattle, WA, USAAbstract: Care for patients undergoing ambulatory procedures is a broad and expanding area of anesthetic and surgical practice. There were over 35 million ambulatory surgical procedures performed in the US in 2006. Ambulatory procedures are diverse in both type and setting, as they span the range from biopsies performed under local anesthesia to intra-abdominal laparoscopic procedures, and are performed in offices, freestanding ambulatory surgery centers, and ambulatory units of hospitals. The information on adverse events from these varied settings comes largely from retrospective reviews of sources, such as quality-assurance databases and closed malpractice claims. Very few if any ambulatory procedures are emergent, and in comparison to the inpatient population, ambulatory surgical patients are generally healthier. They are still however subject to most of the same types of adverse events as patients undergoing inpatient surgery, albeit at a lower frequency. The only adverse events that could be considered to be unique to ambulatory surgery are those that arise out of the circumstance of discharging a postoperative patient to an environment lacking skilled nursing care. There is limited information on these types of discharge-related adverse events, but the data that are available are reviewed in an attempt to assist the practitioner in patient selection and discharge decision making. Among ambulatory surgical patients, particularly those undergoing screening or cosmetic procedures, expectations from all parties involved are high, and a definition of adverse events can be expanded to include any occurrence that interrupts the rapid throughput of patients or interferes with early discharge and optimal patient satisfaction. This review covers all types of adverse events, but focuses on the more

  12. Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data.

    Science.gov (United States)

    Luo, Jake; Eldredge, Christina; Cho, Chi C; Cisler, Ron A

    2016-10-17

    Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans. The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age of the clinical trials patients and participants. Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41%, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76%. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09%, significantly higher (Pgroup. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older patients (older than 40 years) were more likely to observe a diverse range of adverse events (Page group (older

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

    Science.gov (United States)

    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.

  14. Correlates of adverse childhood events among adults with schizophrenia spectrum disorders.

    Science.gov (United States)

    Rosenberg, Stanley D; Lu, Weili; Mueser, Kim T; Jankowski, Mary Kay; Cournos, Francine

    2007-02-01

    Multiple studies have found that childhood adversity is related to a range of poor mental health, substance abuse, poor physical health, and poor social functioning outcomes in the general population of adults. However, despite the high rates of childhood adversity in schizophrenia, the clinical correlates of these events have not been systematically evaluated. This study evaluated the relationship between adverse experiences in childhood and functional, clinical, and health outcomes among adults with schizophrenia. The authors surveyed 569 adults with schizophrenia regarding adverse childhood events (including physical abuse, sexual abuse, parental mental illnesses, loss of a parent, parental separation or divorce, witnessing domestic violence, and foster or kinship care). The relationships between cumulative exposure to these events and psychiatric, physical, and functional outcomes were evaluated. Increased exposure to adverse childhood events was strongly related to psychiatric problems (suicidal thinking, hospitalizations, distress, and posttraumatic stress disorder), substance abuse, physical health problems (HIV infection), medical service utilization (physician visits), and poor social functioning (homelessness or criminal justice involvement). The findings extend the results of research in the general population by suggesting that childhood adversity contributes to worse mental health, substance abuse, worse physical health, and poor functional outcomes in schizophrenia.

  15. Statistical and graphical approaches for disproportionality analysis of spontaneously-reported adverse events in pharmacovigilance.

    Science.gov (United States)

    Zink, Richard C; Huang, Qin; Zhang, Lu-Yong; Bao, Wen-Jun

    2013-05-01

    Combine disproportionality analysis with dynamically interactive graphics to understand spontaneously-reported adverse events in pharmacovigilance. Four statistical methods, including Reporting Odds Ratio, Proportional Reporting Ratio, Multi-Item Gamma Poisson Shrinker and Bayesian Confidence Propagation Neural Network that are used for computing disproportionality are described. Tree maps and other graphical techniques are used to display the disproportionality results. Spontaneously-reported adverse events in pharmacovigilance are collected from physicians, patients, or the medical literature by regulatory agencies, pharmaceutical companies and device manufacturers to monitor the safety of a product once it reaches the market. In order to identify potential safety-signals, disproportionality analysis methods compare the rate at which a particular event of interest co-occurs with a given drug with the rate this event occurs without the drug in the event database. Tree maps are employed to interactively display the adverse events for particular drugs and compare the adverse events among the drugs. Interactive graphical displays of disproportionality allow the analyst to quickly identify safety signals and perform additional follow-up analyses. Combining statistical methods with dynamically interactive graphics affords insights into the data inaccessible by traditional analysis methods. Copyright © 2013 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2012-08-01

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

  17. Adverse events of anti-tumor necrosis factor α therapy in ankylosing spondylitis.

    Directory of Open Access Journals (Sweden)

    Qiang Tong

    Full Text Available This study aims to investigate the prevalence of short-term and long-term adverse events associated with tumor necrosis factor-α (TNF-α blocker treatment in Chinese Han patients suffering from ankylosing spondylitis (AS.The study included 402 Chinese Han AS patients treated with TNF-α blockers. Baseline data was collected. All patients were monitored for adverse events 2 hours following administration. Long-term treatment was evaluated at 8, 12, 52 and 104 weeks follow-up for 172 patients treated with TNF-α blockers.Short-term adverse events occurred in 20.15% (81/402, including rash (3.5%; 14/402, pruritus (1.2%; 5/402, nausea (2.2%; 9/402, headache (0.7%; 3/402, skin allergies (4.0%; 16/402, fever (0.5%; 2/402, palpitations (3.0%; 12/402, dyspnea (0.5%; 2/402, chest pain (0.2%; 1/402, [corrected] abdominal pain (1.0%; 4/402, hypertension (2.2%; 9/402, papilledema (0.5%; 2/402, laryngeal edema (0.2%; 1/402 and premature ventricular contraction (0.2%; 1/402. Long-term adverse events occurred in 59 (34.3%; 59/172 patients, including pneumonia (7.6%; 13/172, urinary tract infections (9.9%; 17/172, otitis media (4.7%; 8/172, tuberculosis are (3.5%; 6/172 [corrected], abscess (1.2%; 2/172, oral candidiasis (0.6%; 1/172, elevation of transaminase (1.7%; 3/172, anemia (1.2%; 2/172, hematuresis (0.6%; 1/172, constipation (2.3%; 4/172, weight loss (0.6%; 1/172, exfoliative dermatitis (0.6%; 1/172. CRP, ESR and disease duration were found to be associated with an increased risk of immediate and long-term adverse events (P<0.05. Long-term treatment with Infliximab was associated with more adverse events than rhTNFR-Fc (P<0.01.This study reports on the prevalence of adverse events in short-term and long-term treatment with TNF-α blocker monotherapy in Chinese Han AS patients. Duration of disease, erythrocyte sedimentation rate, and c-reactive protein serum levels were found to be associated with increased adverse events with anti-TNF-α therapy. Long

  18. Towards Large-scale Twitter Mining for Drug-related Adverse Events.

    Science.gov (United States)

    Bian, Jiang; Topaloglu, Umit; Yu, Fan

    2012-10-29

    Drug-related adverse events pose substantial risks to patients who consume post-market or Drug-related adverse events pose substantial risks to patients who consume post-market or investigational drugs. Early detection of adverse events benefits not only the drug regulators, but also the manufacturers for pharmacovigilance. Existing methods rely on patients' "spontaneous" self-reports that attest problems. The increasing popularity of social media platforms like the Twitter presents us a new information source for finding potential adverse events. Given the high frequency of user updates, mining Twitter messages can lead us to real-time pharmacovigilance. In this paper, we describe an approach to find drug users and potential adverse events by analyzing the content of twitter messages utilizing Natural Language Processing (NLP) and to build Support Vector Machine (SVM) classifiers. Due to the size nature of the dataset (i.e., 2 billion Tweets), the experiments were conducted on a High Performance Computing (HPC) platform using MapReduce, which exhibits the trend of big data analytics. The results suggest that daily-life social networking data could help early detection of important patient safety issues.

  19. Oral adverse events to radiotherapy in geriatric patients with head and neck cancer. INOR. 2008

    International Nuclear Information System (INIS)

    Garcia Heredia, Gilda L.; Miranda Tarrago, Josefa; Lence Anta, Juan; Chong Chu, Ivon

    2009-01-01

    For every million people newly diagnosed with cancer, up to 400,000 may have oral complications. The trend toward increasing age of the population and the need to keep patients in good oral health requires prior dental care in patients with cancer who are subjected to various treatments onco specific. We tried to show adverse reactions early and late treatment related radiation the existing oral health status in patients with head and neck cancer. We performed a prospective study of patients diagnosed with head and neck cancer treated with radiation in the period from January to December 2008, at the National Institute of Oncology and Radiobiology. 100 patients were examined. Adverse events were collected and their intensity, classified according to CTC version 3.1. 70 patients were initially evaluated as being deficient in the oral health status. Xerostomia and mucositis immediate adverse events were more frequent and intense, while the caries postradiation and consequential events were delayed with greater frequency. We found an association between oral health status and the occurrence of adverse events, which resulted in treatment interruptions. The persistent oral conditions determine the duration and intensity of adverse events mouth of Radiotherapy, which leads to treatment interruptions, with implications for therapeutic results. (Author)

  20. Incidence and determinants of medication errors and adverse drug events among hospitalized children in West Ethiopia.

    Science.gov (United States)

    Dedefo, Mohammed Gebre; Mitike, Abraham Haileamlak; Angamo, Mulugeta Tarekegn

    2016-07-07

    Medication errors cause a large number of adverse drug events with negative patient health outcomes and are a major public-health burden contributing to 18.7-56 % of all adverse drug events among hospitalized patients. The aim of this study was to assess the incidence and determinants of medication errors and adverse drug events among hospitalized children. A prospective observational study was conducted among hospitalized children in the pediatrics ward of Nekemte Referral Hospital from February 24 to March 28, 2014. Data were collected by using checklist guided observation and review of medication order sheets, medication administration records, and other medical charts of the patients. To identify the independent predictors of medication errors and adverse drug events, backward logistic regression analysis was used. Statistical significance was considered at p-value Nekemte Referral Hospital. In particular, children with multiple medications and longer hospital stays, and those with co-morbidities and longer hospital stays, were at greater risk for medication errors and adverse drug events, respectively.

  1. Adverse event reporting in Slovenia - the influence of safety culture, supervisors and communication

    Directory of Open Access Journals (Sweden)

    Birk Karin

    2016-01-01

    Full Text Available Background/Aim. The provision of safe healthcare is considered a priority in European Union (EU member states. Along with other preventative measures in healthcare, the EU also strives to eliminate the “causes of harm to human health”. The aim of this survey was to determine whether safety culture, supervisors and communication between co-workers influence the number of adverse event reports submitted to the heads of clinical departments and to the management of an institution. Methods. This survey is based on cross-sectional analysis. It was carried out in the largest Slovenian university hospital. We received 235 completed questionnaires. Respondents included professionals in the fields of nursingcare, physiotherapy, occupational therapy and radiological technology. Results. Safety culture influences the number of adverse event reports submitted to the head of a clinical department from the organizational point of view. Supervisors and communication between co-workers do not influence the number of adverse event reports. Conclusion. It can be concluded that neither supervisors nor the level of communication between co-workers influence the frequency of adverse event reporting, while safety culture does influence it from an organizational point of view. The presumed factors only partly influence the number of submitted adverse event reports, thus other causes of under-reporting must be sought elsewhere.

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2017-09-01

    Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pbrand and generics for all three drugs of interest (Breslow-Day Pbrands 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.

  4. Automatic detection of adverse events to predict drug label changes using text and data mining techniques.

    Science.gov (United States)

    Gurulingappa, Harsha; Toldo, Luca; Rajput, Abdul Mateen; Kors, Jan A; Taweel, Adel; Tayrouz, Yorki

    2013-11-01

    The aim of this study was to assess the impact of automatically detected adverse event signals from text and open-source data on the prediction of drug label changes. Open-source adverse effect data were collected from FAERS, Yellow Cards and SIDER databases. A shallow linguistic relation extraction system (JSRE) was applied for extraction of adverse effects from MEDLINE case reports. Statistical approach was applied on the extracted datasets for signal detection and subsequent prediction of label changes issued for 29 drugs by the UK Regulatory Authority in 2009. 76% of drug label changes were automatically predicted. Out of these, 6% of drug label changes were detected only by text mining. JSRE enabled precise identification of four adverse drug events from MEDLINE that were undetectable otherwise. Changes in drug labels can be predicted automatically using data and text mining techniques. Text mining technology is mature and well-placed to support the pharmacovigilance tasks. Copyright © 2013 John Wiley & Sons, Ltd.

  5. Psychosocial Working Environment and Risk of Adverse Cardiac Events in Patients Treated for Coronary Heart Disease.

    Science.gov (United States)

    Biering, Karin; Andersen, Johan Hviid; Lund, Thomas; Hjollund, Niels Henrik

    2015-12-01

    During the last decades a possible association between psychosocial working environment and increased risk of coronary heart disease (CHD) has been debated and moderate evidence supports that high psychological demands, lack of social support and iso-strain (the combination of high job strain and lack of social support) is associated with primary CHD. Whether psychosocial working environment plays a role as risk factor for new cardiac events and readmissions in patients with existing cardiovascular disease is less studied. A cohort of patients psychosocial working environment. Patients were followed in the Danish National Patient Registry and the Danish Civil Registration System for 3+ years to identify adverse cardiac events and death. We analysed the association between psychosocial working environment and adverse cardiac events by Cox Regression. A number of 528 patients had returned to work 12 weeks after PCI, while 97 were still sick-listed. We identified 12 deaths and 211 other events during follow-up. We found no statistically significant associations between psychosocial working environment and risk of adverse cardiac events and readmissions or mortality. The psychosocial working environment was not associated with adverse cardiac events.

  6. Work-related adverse events leaving their mark: a cross-sectional study among Dutch gynecologists.

    Science.gov (United States)

    Baas, Melanie A M; Scheepstra, Karel W F; Stramrood, Claire A I; Evers, Ruth; Dijksman, Lea M; van Pampus, Maria G

    2018-03-22

    Health care professionals who are frequently coping with traumatic events have an increased risk of developing a posttraumatic stress disorder. Research among physicians is scarce, and obstetrician-gynecologists may have a higher risk. Work-related traumatic events and posttraumatic stress disorder among obstetricians-gynecologists and the (desired) type of support were studied. A questionnaire was emailed to all members of the Dutch Society of Obstetrics and Gynaecology, which included residents, attending, retired and non-practicing obstetricians-gynecologists. The questionnaire included questions about personal experiences and opinions concerning support after work-related events, and a validated questionnaire for posttraumatic stress disorder. The response rate was 42.8% with 683 questionnaires eligible for analysis. 12.6% of the respondents have experienced a work-related traumatic event, of which 11.8% met the criteria for current posttraumatic stress disorder. This revealed an estimated prevalence of 1.5% obstetricians-gynecologists with current posttraumatic stress disorder. 12% reported to have a support protocol or strategy in their hospital after adverse events. The most common strategies to cope with emotional events were: to seek support from colleagues, to seek support from family or friends, to discuss the case in a complication meeting or audit and to find distraction. 82% would prefer peer-support with direct colleagues after an adverse event. This survey implies that work-related events can be traumatic and subsequently can lead to posttraumatic stress disorder. There is a high prevalence rate of current posttraumatic stress disorder among obstetricians-gynecologists. Often there is no standardized support after adverse events. Most obstetrician-gynecologists prefer peer-support with direct colleagues after an adverse event. More awareness must be created during medical training and organized support must be implemented.

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

    Science.gov (United States)

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

    2017-01-01

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

  8. Left atrial area index predicts adverse cardiovascular events in patients with unstable angina pectoris.

    Science.gov (United States)

    Li, Yi-Fan; Li, Wei-Hong; Li, Zhao-Ping; Feng, Xin-Heng; Xu, Wei-Xian; Chen, Shao-Min; Gao, Wei

    2016-08-01

    The left atrial size has been considered as a useful marker of adverse cardiovascular outcomes. However, it is not well known whether left atrial area index (LAAI) has predictive value for prognosis in patients with unstable angina pectoris (UAP). This study was aimed to assess the association between LAAI and outcomes in UAP patients. We enrolled a total of 391 in-hospital patients diagnosed as UAP. Clinical and echocardiographic data at baseline were collected. The patients were followed for the development of adverse cardiovascular (CV) events, including hospital readmission for angina pectoris, acute myocardial infarction (AMI), congestive heart failure (CHF), stroke and all-cause mortality. During a mean follow-up time of 26.3 ± 8.6 months, 98 adverse CV events occurred (84 hospital readmission for angina pectoris, four AMI, four CHF, one stroke and five all-cause mortality). In a multivariate Cox model, LAAI [OR: 1.140, 95% CI: 1.016-1.279, P = 0.026], diastolic blood pressure (OR: 0.976, 95% CI: 0.956-0.996, P = 0.020) and pulse pressure (OR: 1.020, 95% CI: 1.007-1.034, P = 0.004) were independent predictors for adverse CV events in UAP patients. LAAI is a predictor of adverse CV events independent of clinical and other echocardiographic parameters in UAP patients.

  9. What to do in the event of an adverse anaesthetic event or medical ...

    African Journals Online (AJOL)

    An “adverse event” is harm, injury or a complication. It may or may not result from error. A “medical error” can be serious (has the potential to cause permanent injury or is transient, but potentially constitutes life-threatening harm), minor (does not cause harm or have the potential to do so), a “near miss” (an error that could ...

  10. Prevalence of Negative Life Events and Chronic Adversities in European Pre- and Primary-School Children

    DEFF Research Database (Denmark)

    Vanaelst, Barbara; Huybrechts, Inge; De Bourdeaudhuij, Ilse

    2012-01-01

    Background: Children are not always recognized as being susceptible to stress, although childhood stressors may originate from multiple events in their everyday surroundings with negative effects on children’s health. Methods: As there is a lack of large-scale, European prevalence data on childho...... demonstrated the importance of not only studying traumatic events but also of focusing on the early familial and social environment in childhood stress research and indicated the importance of recording or monitoring childhood adversities....

  11. Early prediction of adverse events in enhanced recovery based upon the host systemic inflammatory response.

    Science.gov (United States)

    Lane, J C; Wright, S; Burch, J; Kennedy, R H; Jenkins, J T

    2013-02-01

    Early identification of patients experiencing postoperative complications is imperative for successful management. C-reactive protein (CRP) is a nonspecific marker of inflammation used in many specialties to monitor patient condition. The role of CRP measurement early in the elective postoperative colorectal patient is unclear, particularly in the context of enhanced recovery (ERAS). Five hundred and thirty-three consecutive patients who underwent elective colorectal surgery between October 2008 and October 2010 within an established ERAS programme were studied. Patients were separated into a development group of 265 patients and a validation group of 268 patients by chronological order. CRP and white cell count were added to a prospectively maintained ERAS database. The primary outcome of the study was all adverse events (including infective complications, postoperative organ dysfunction and prolonged length of stay) during the initial hospital admission. Significant predictors for adverse events on univariate analysis were submitted to multivariate regression analysis and the resulting model applied to the validation group. The validity and predictive accuracy of the regression model was assessed using receiver operating characteristic curve/area under the curve (AUC) analysis. CRP levels >150 mg/l on postoperative day 2 and a rising CRP on day 3 were independently associated with all adverse events during the hospital admission. A weighted model was applied to the validation group yielding an AUC of 0.65 (95% CI 0.58-0.73) indicating, at best, modest discrimination and predictive accuracy for adverse events. Measurement of CRP in patients after elective colorectal surgery in the first few days after surgery within ERAS can assist in identifying those at risk of adverse events and a prolonged hospital stay. A CRP value of >150 mg/l on day 2 and a rising CRP on day 3 should alert the surgeon to an increased likelihood of such events. © 2012 The Authors

  12. Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system.

    Science.gov (United States)

    Alguacil-Ramos, A M; Muelas-Tirado, J; Garrigues-Pelufo, T M; Portero-Alonso, A; Diez-Domingo, J; Pastor-Villalba, E; Lluch-Rodrigo, J A

    2016-06-01

    The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out. More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events. SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  13. Adverse events of gastric electrical stimulators recorded in the Manufacturer and User Device Experience (MAUDE) Registry.

    Science.gov (United States)

    Bielefeldt, Klaus

    2017-01-01

    The role of gastric electrical stimulation for patients with refractory symptoms of gastroparesis remains controversial. Open label studies suggest benefit while randomized controlled trials did not demonstrate differences between active and sham intervention. Using a voluntary reporting system of the Federal Drug Administration, we examined the type and frequency of adverse events. We conducted an electronic search of the Manufacturer and User Device Experience (MAUDE) databank using the keyword 'Enterra' for the time between January of 2001 and October of 2015. We abstracted information about the year of stimulator implantation, the year and type of adverse effect, the resulting intervention and outcome if available. A total of 1587 entries described adverse effects related the GES. Only 36 of the reports listed perioperative complications. The vast majority described problems that could be classified as patient concerns, local complications, or system failure. The most common problem related lack or loss of efficacy, followed by pain or complications affecting the pocket site. A subset of 801 reports provided information about the time between system implant and registration of concerns, which gradually declined over time. More than one third (35.7%) of the reported adverse events prompted surgical correction. The number of voluntarily reported adverse events and the high likelihood of repeated surgical interventions clearly demonstrate the potential downside of gastric electrical stimulation. Physicians considering this intervention will need to carefully weigh these risks and include this information when counseling or consenting patients. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. JADE: a tool for medical researchers to explore adverse drug events using health claims data.

    Science.gov (United States)

    Edlinger, D; Sauter, S K; Rinner, C; Neuhofer, L M; Wolzt, M; Grossmann, W; Endel, G; Gall, W

    2014-01-01

    The objective of our project was to create a tool for physicians to explore health claims data with regard to adverse drug reactions. The Java Adverse Drug Event (JADE) tool should enable the analysis of prescribed drugs in connection with diagnoses from hospital stays. We calculated the number of days drugs were taken by using the defined daily doses and estimated possible interactions between dispensed drugs using the Austria Codex, a database including drug-drug interactions. The JADE tool was implemented using Java, R and a PostgreSQL database. Beside an overview of the study cohort which includes selection of gender and age groups, selected statistical methods like association rule learning, logistic regression model and the number needed to harm have been implemented. The JADE tool can support physicians during their planning of clinical trials by showing the occurrences of adverse drug events with population based information.

  15. Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder

    DEFF Research Database (Denmark)

    Holmskov, Mathilde; Storebø, Ole Jakob; Moreira-Maia, Carlos R

    2017-01-01

    OBJECTIVES: To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review. METHODS AND FINDINGS......: We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were...... summarised as risk ratios (RR) with 95% confidence intervals (CI) using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA) was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse...

  16. Patient record review of the incidence, consequences, and causes of diagnostic adverse events

    NARCIS (Netherlands)

    Zwaan, L.; de Bruijne, M.; Wagner, C.; Thijs, A.; Smits, M.; van der Wal, G.; Timmermans, D.R.M.

    2010-01-01

    Background: Diagnostic errors often result in patient harm. Previous studies have shown that there is large variability in results in different medical specialties. The present study explored diagnostic adverse events (DAEs) across all medical specialties to determine their incidence and to gain

  17. Patient record review of the incidence, consequences, and causes of diagnostic adverse events.

    NARCIS (Netherlands)

    Zwaan, L.; Bruijne, M. de; Wagner, C.; Thijs, A.; Smits, M.; Wal, G. van der; Timmermans, D.R.M.

    2010-01-01

    Background: Diagnostic errors often result in patient harm. Previous studies have shown that there is large variability in results in different medical specialties. The present study explored diagnostic adverse events (DAEs) across all medical specialties to determine their incidence and to gain

  18. Cutaneous adverse events associated with disease-modifying treatment in multiple sclerosis: A systematic review

    NARCIS (Netherlands)

    D.M.W. Balak (Deepak); G. Hengstman (Gerald); A. Çakmak (Aysun); H.B. Thio (Bing)

    2012-01-01

    textabstractGlatiramer acetate and interferon-beta are approved first-line disease-modifying treatments (DMTs) for multiple sclerosis (MS). DMTs can be associated with cutaneous adverse events, which may influence treatment adherence and patient quality of life. In this systematic review, we aimed

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

    Science.gov (United States)

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

    2007-01-01

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

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

    NARCIS (Netherlands)

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

    2014-01-01

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

  1. Bad news: The influence of news coverage and Google searches on Gardasil adverse event reporting.

    Science.gov (United States)

    Faasse, Kate; Porsius, Jarry T; Faasse, Jonathan; Martin, Leslie R

    2017-12-14

    Human papilloma virus vaccines are a safe and effective tool for reducing HPV infections that can cause cervical cancer. However, uptake of these vaccines has been suboptimal, with many people holding negative beliefs and misconceptions. Such beliefs have been linked with the experience of unpleasant side effects following medical treatment, and media coverage may heighten such concerns. The present study sought to assess the influence of news coverage (number of news articles per month) on adverse event reporting in response to Gardasil vaccination in New Zealand over a 7.5-year period, and whether the influence of news coverage was mediated by internet search activity (Google search volumes). Multiple linear regression analyses and simple mediation analyses were used, controlling for year and number of vaccinations delivered. News coverage in the previous month, and Google search volumes in the same month, were significant predictors of adverse event reporting, after accounting for vaccination rates and year. Concurrent Google search volumes partially mediated the effect of prior news coverage. The results suggest that some of the adverse events reported were not related to the vaccination itself, but to news coverage and internet search volumes, which may have contributed to public concerns about potentially unpleasant or harmful outcomes. These findings have implications for the importance of psychological and social factors in adverse event reporting, and the role of the news media in disseminating health information. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Pilot study of preoperative heart rate variability and adverse events in children emerging from anesthesia.

    Science.gov (United States)

    Elwood, Tom; Cecchin, Frank; Low, Jasmine I; Bradford, Heidi M; Goldstein, Brahm

    2005-01-01

    To assess correlations between preoperative heart rate variability (a noninvasive measure of autonomic cardiac activity) and adverse respiratory events during anesthesia emergence in children. Case control study. Tertiary care pediatric operating room. Sixty-one children, aged 8 months to 13 yrs. None. Heart rate power spectra were obtained from two 5-min immediate-preoperative electrocardiographs with an orthostatic posture change interposed and (n = 32) from a 24-hr preoperative Holter monitor. Observers recorded emergence from standardized anesthesia for coughing, laryngospasm, and desaturation. Low-frequency/high-frequency ratios (LF/HF) were derived from power spectra of heart rate variability. The orthostatic change in heart rate variability derived from brief preoperative recordings was significantly different if adverse events occurred during emergence from anesthesia (LF/HF standing/LF/HF supine = 1.3 vs. 2.8, p = .019). Holter-derived heart rate variability had no correlation with adverse events. Receiver operating characteristic analysis showed a sensitivity of 85% and specificity of 52% for predicting adverse events with preoperative recordings. This study provides new information regarding pathophysiology in children with upper respiratory infection. The magnitude of difference demonstrated is insufficient to propose this method as a preoperative screening test.

  3. [Causes of underreporting of occupational injuries and adverse events in Chile].

    Science.gov (United States)

    Luengo, Carolina; Paravic, Tatiana; Valenzuela, Sandra

    2016-02-01

    Objective To describe the causes of underreporting of occupational injuries and adverse events as identified in the international literature and by key informants in the area of health and risk prevention in Chile. Methods The study uses a qualitative descriptive approach. This includes a systematized literature review that follows the SALSA method (Search, Appraisal, Synthesis and Analysis) and is in line with the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). In addition, interviews were conducted with informants in the area of health and risk prevention in Chile. Results The leading causes of underreporting of occupational injuries as described in the literature and by key informants were economic factors and ignorance. With regard to adverse events, the principal causes indicated were fear of sanctions, limited support provided by the authorities, lack of knowledge, and excessive workload. Conclusions It is important to continue working to strengthen the reporting of occupational injuries and adverse events and to implement measures aimed at minimizing factors that appear to be the leading causes of underreporting. In the case of occupational injuries, this means making sure that economic factors are not an impediment but rather an incentive to reporting. With respect to adverse events, steps should be taken to eliminate the fear of sanctions and to develop recommendations, focusing more on systemic improvements than on individuals, to promote joint learning. In both cases it will be necessary to combat ignorance through continuous, systematic training and support.

  4. Targeted therapies for renal cell carcinoma: review of adverse event management strategies.

    NARCIS (Netherlands)

    Eisen, T.; Sternberg, C.N.; Robert, C.; Mulders, P.F.; Pyle, L.; Zbinden, S.; Izzedine, H.; Escudier, B.

    2012-01-01

    With the advent of targeted agents for the treatment of renal cell carcinoma (RCC), overall survival has improved, and patients are being treated continuously for increasingly long periods of time. This has raised challenges in the management of adverse events (AEs) associated with the six targeted

  5. Determination of the frequency and direct cost of the adverse drug events in Argentina.

    Science.gov (United States)

    Izquierdo, Estela; Rodríguez, Claudio; Pampliega, Eneas; Filinger, Ester

    2009-05-01

    To determine the frequency and the direct costs of adverse drug reactions, in an ambulatory population of the City of Buenos Aires, Argentina and its area of influence. A retrospective study was done during a period of three months on approximately 300.000 residents of the Buenos Aires area, gathering data according to the selected variables by means of the electronic capture of prescriptions dispensed in pharmacies of the area. This method enables the detection and registration of potential conflicts that may arise between a prescribed drug and factors such as: patient's demographic, clinical and drug profile. The analysis unit was defined as the happening of a moderate or severe adverse event reported by the system. The selected variables were the incidence of these effects and the direct cost was calculated as the value of the drugs that induced the adverse event. The events were classified according to the following interactions: a) drug-drug, b) drug-pediatrics, c) drug-gender, d) drug-pregnancy and abuse of controlled substances. The observed frequency shows great variability and the shortage of available data for ambulatory populations. We found 6.74% of reported events over the total of processed items, which generated an additional cost equivalent to 4.58% of the total pharmaceutical expenses. This study has only evaluated the cost occurred by the use of a drug that will lead to an adverse reaction. Moderate and severe reactions were included regardless of the important indirect costs, hospitalization costs, tests, physician fees, etc.

  6. Adverse Events Associated with Methimazole Therapy of Graves' Disease in Children

    Directory of Open Access Journals (Sweden)

    Kerry Stephenson

    2010-01-01

    Full Text Available Objective. Graves' disease is the most common cause of hyperthyroidism in the pediatric population. Antithyroid medications used in children and adults include propylthiouracil (PTU and methimazole (MMI. At our center we have routinely used MMI for Graves' disease therapy. Our goals are to provide insights into adverse events that can be associated with MMI use. Methods. We reviewed the adverse events associated with MMI use in our last one hundred consecutive pediatric patients treated with this medication. Results. The range in the patient age was 3.5 to 18 years. The patients were treated with an average daily dose of MMI of 0.3±0.2 mg/kg/day. Adverse events attributed to the use of the medication were seen in 19 patients at 17±7 weeks of therapy. The most common side effects included pruritus and hives, which were seen in 8 patients. Three patients developed diffuse arthralgia and joint pain. Two patients developed neutropenia. Three patients developed Stevens-Johnson syndrome, requiring hospitalization in 1 child. Cholestatic jaundice was observed in 1 patient. No specific risk-factors for the development of adverse events were identified. Conclusions. MMI use in children is associated with a low but real risk of minor and major side effects.

  7. An Educational Program to Prevent Adverse Events in Neonates : a Randomised Trial.

    Science.gov (United States)

    2016-10-20

    Intensive Care Units, Neonatal; Misadventures to Patients During Surgical and Medical Care; Catheter-related Bloodstream Infection (CRBSI) Nos; Quality of Healthcare; Ventilator Adverse Event; Nosocomial Pneumonia; Immature Newborn; Skin Lesion; Extravasation Injury; Nasal Injury; Intubation Complication; Medication Administered in Error; IV Catheter Nos Deep Venous Thrombosis

  8. The Relationship between Adverse Childhood Events, Resiliency and Health among Children with Autism

    Science.gov (United States)

    Rigles, Bethany

    2017-01-01

    Previous research has shown a negative relationship between adverse childhood events (ACEs) and health and resiliency among the general population, but has not examined these associations among children with autism. Purpose: To determine the prevalence of ACEs among children with autism and how ACEs are associated with resiliency and health.…

  9. Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

    NARCIS (Netherlands)

    de Vries, Sieta T.; Mol, Peter G. M.; de Zeeuw, Dick; Haaijer-Ruskamp, Flora M.; Denig, Petra

    2013-01-01

    Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to

  10. [Active surveillance evaluation of anti-HPV vaccine adverse events in Umbria region].

    Science.gov (United States)

    Gianfredi, V; Paoloni, M C; Villarini, M; Moretti, M

    2017-01-01

    The study is a part of the "Active surveillance of adverse events following HPV vaccination" project conducted in order to actively register all common adverse events in girls 9-26 years after anti-HPV vaccination. It is a multicenter cohort study which included 12 Regions and 87 local health authorities, coordinated by the National Centre for Epidemiology, Surveillance and Health Promotion (CNESPS) ISS. We included all adolescents, 12 years old, actively contacted for HPV vaccination, as well as all women aged 9-26 years who recived, in the period under review, the same vaccination at the local health authorities in Spoleto. Out of 147 girls enrolled in the program, only 102 have reported the diary filled after the first vaccine dose, 62 and 88 respectively after the second and third dose. The filled diaries shown that adverse events, if any, have occurred almost exclusively during the first 5 days of vaccination, with a strong prevalence of local reactions (erythema, pain and swelling at the injection site) followed by headache and muscles pain. Even though the results show a high number of reported adverse events, mainly due to the detection method (active surveillance), they are mild or moderate in almost all the cases. This is in line with that seen in previous trials.

  11. Characteristics of Herbal Medicine Users and Adverse Events Experienced in South Korea: A Survey Study.

    Science.gov (United States)

    Jang, Soobin; Kim, Kyeong Han; Sun, Seung-Ho; Go, Ho-Yeon; Lee, Eun-Kyung; Jang, Bo-Hyoung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2017-01-01

    Background. This survey aimed to investigate the characteristics of users and nonusers of herbal medicine and the adverse events experienced due to herbal medicines in South Korea. Methods. The questionnaire consisted of safety, using experience, using type, usage and nonusage reason, purchase location, and adverse events of herbal medicine. The survey was administered by online. Results. Of the total 1,134 respondents, 726 (64.0%) considered herbal medicine safe, and 693 (61.1%) answered that they have taken herbal medicines within the past year. Most common place to purchase them was "TKM hospital or clinic" (63.6%), and most participants (72.2%) took a decoction from a TKM institution. The biggest reason for taking them was for "health improvement" (57.3%), and the reasons for not using them was "medication not necessary" (63.7%). Among those who took herbal medicines, 46 experienced adverse events, and the most frequently reported symptoms were digestive disorders (52.2%). Of the 46 participants who experienced adverse events, 20 (43.5%) were treated by TKM doctors. Conclusions. This study suggests that regulation of herbal medicines is needed in order to resolve problems related to the safety of herbal medicines.

  12. Adverse events of herbal food supplements for body weight reduction: systematic review.

    Science.gov (United States)

    Pittler, M H; Schmidt, K; Ernst, E

    2005-05-01

    Herbal weight-loss supplements are marketed with claims of effectiveness. Our earlier systematic review identified data from double-blind, randomized controlled trials for a number of herbal supplements. The aim of this systematic review was to assess all clinical evidence of adverse events of herbal food supplements for body weight reduction for which effectiveness data from rigorous clinical trials exist. We assessed Ephedra sinica, Garcinia cambogia, Paullinia cupana, guar gum, Plantago psyllium, Ilex paraguariensis and Pausinystalia yohimbe. Literature searches were conducted on Medline, Embase, Amed and The Cochrane Library. Data were also requested from the spontaneous reporting scheme of the World Health Organization. We hand-searched relevant medical journals and our own files. There were no restrictions regarding the language of publication. The results show that adverse events including hepatic injury and death have been reported with the use of some herbal food supplements. For herbal ephedra and ephedrine-containing food supplements an increased risk of psychiatric, autonomic or gastrointestinal adverse events and heart palpitations has been reported. In conclusion, adverse events are reported for a number of herbal food supplements, which are used for reducing body weight. Although the quality of the data does not justify definitive attribution of causality in most cases, the reported risks are sufficient to shift the risk-benefit balance against the use of most of the reviewed herbal weight-loss supplements. Exceptions are Garcinia cambogia and yerba mate, which merit further investigation.

  13. Predictors of adverse events following chiropractic care for patients with neck pain

    NARCIS (Netherlands)

    Rubinstein, S.M.; Leboeuf-Yde, C.; Knol, D.L.; de Koekkoek, T.E.; Pfeifle, C.E.; van Tulder, M.W.

    2008-01-01

    Objective: This study examines which variables may predict adverse events in subjects undergoing chiropractic treatment for neck pain. Methods: This was a prospective, multi-center, cohort study. All new patients, 18 to 65 years of age with neck pain of any duration, who had not undergone

  14. Systemic adverse events following rituximab therapy in patients with Graves' disease

    DEFF Research Database (Denmark)

    El Fassi, D; Nielsen, Claus Henrik; Junker, Michael Peter

    2011-01-01

    Background and aim: Rituximab (RTX) therapy has shown promising results in Graves´ disease (GD), with or without ophthalmopathy. We examined the occurrence of adverse events in GD patients treated with RTX. Subjects and methods: Ten patients received RTX and methimazole, while ten patients receiv...

  15. Association of perioperative blood transfusion and adverse events after operative treatment of proximal humerus fractures.

    Science.gov (United States)

    Kozanek, Michal; Menendez, Mariano E; Ring, David

    2015-02-01

    The purpose of this study was to assess the relationship between perioperative blood transfusion for proximal humerus fracture and inpatient mortality, adverse events, prolonged hospital stay, and nonroutine disposition. Among the >55,000 patients with an operatively treated proximal humerus fracture identified in the Nationwide Inpatient Sample between 2008 and 2011, 17% received a perioperative blood transfusion. Multivariable logistic regression analyses addressed the association of blood transfusion with inpatient mortality, adverse events, hospital stay, and nonroutine discharge, accounting for comorbidities and other known confounders. Perioperative blood transfusion for fracture of the proximal humerus was not associated with inhospital death, but it was independently associated with inpatient adverse events (odds ratio (OR) 4.4, 95% confidence interval (CI) 4.2-4.6), prolonged hospital stay (OR 2.8, 95% CI 2.7-2.9), and increased nonroutine discharge (OR 1.8, 95% CI 1.7-1.9). Inpatients with fracture of the proximal humerus who receive transfusion are not more likely to die in hospital, but they do stay longer, experience more adverse events, and are less likely to be discharged home. Additional study is merited to determine if the judicious use of blood transfusion in the perioperative period can decrease inpatient morbidity and health-care resource utilisation. Level II, Retrospective Design, Prognosis Study. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. Variation in the rates of adverse events between hospitals and hospital departments.

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Spreeuwenberg, P.; Wagner, C.; Wal, G. van der; Groenewegen, P.P.

    2011-01-01

    Objective: The objective of this study was to analyze the variation in the rates of adverse events (AEs), and preventable AEs, between hospitals and hospital departments in order to investigate the room for improvement in reducing AEs at both levels. In addition, we explored the extent to which

  17. Variation in rates of adverse events between hospitals and hospital departments

    NARCIS (Netherlands)

    Zegers, M.; Bruijne, M.C. de; Spreeuwenberg, P.; Wagner, C.; van der Wal, G.; Groenewegen, P.P.

    2011-01-01

    Objective. The objective of this study was to analyze the variation in the rates of adverse events (AEs), and preventable AEs, between hospitals and hospital departments in order to investigate the room for improvement in reducing AEs at both levels. In addition, we explored the extent to which

  18. The Adverse Events and Hemodynamic Effects of Adenosine-Based Cardiac MRI

    Energy Technology Data Exchange (ETDEWEB)

    Voigtlander, Thomas; Magedanz, Annett; Schmermund, Axel [Cardiovascular Center Bethanien (CCB), Frankfurt (Germany); Bramlage, Peter [Technical University of Dresden, Dresden (Germany); Elsaesser, Amelie [University of Mainz, Mainz (Germany); Kauczor, Hans-Ulrich; Mohrs, Oliver K. [University of Heidelberg, Heidelberg (Germany)

    2011-08-15

    We wanted to prospectively assess the adverse events and hemodynamic effects associated with an intravenous adenosine infusion in patients with suspected or known coronary artery disease and who were undergoing cardiac MRI. One hundred and sixty-eight patients (64 {+-} 9 years) received adenosine (140 {mu}g/kg/min) during cardiac MRI. Before and during the administration, the heart rate, systemic blood pressure, and oxygen saturation were monitored using a MRI-compatible system. We documented any signs and symptoms of potential adverse events. In total, 47 out of 168 patients (28%) experienced adverse effects, which were mostly mild or moderate. In 13 patients (8%), the adenosine infusion was discontinued due to intolerable dyspnea or chest pain. No high grade atrioventricular block, bronchospasm or other life-threatening adverse events occurred. The hemodynamic measurements showed a significant increase in the heart rate during adenosine infusion (69.3 {+-} 11.7 versus 82.4 {+-} 13.0 beats/min, respectively; p < 0.001). A significant but clinically irrelevant increase in oxygen saturation occurred during adenosine infusion (96 {+-} 1.9% versus 97 {+-} 1.3%, respectively; p < 0.001). The blood pressure did not significantly change during adenosine infusion (systolic: 142.8 {+-} 24.0 versus 140.9 {+-} 25.7 mmHg; diastolic: 80.2 {+-} 12.5 mmHg versus 78.9 {+-} 15.6, respectively). This study confirms the safety of adenosine infusion during cardiac MRI. A considerable proportion of all patients will experience minor adverse effects and some patients will not tolerate adenosine infusion. However, all adverse events can be successfully managed by a radiologist. The increased heart rate during adenosine infusion highlights the need to individually adjust the settings according to the patient, e.g., the number of slices of myocardial perfusion imaging.

  19. The Adverse Events and Hemodynamic Effects of Adenosine-Based Cardiac MRI

    International Nuclear Information System (INIS)

    Voigtlander, Thomas; Magedanz, Annett; Schmermund, Axel; Bramlage, Peter; Elsaesser, Amelie; Kauczor, Hans-Ulrich; Mohrs, Oliver K.

    2011-01-01

    We wanted to prospectively assess the adverse events and hemodynamic effects associated with an intravenous adenosine infusion in patients with suspected or known coronary artery disease and who were undergoing cardiac MRI. One hundred and sixty-eight patients (64 ± 9 years) received adenosine (140 μg/kg/min) during cardiac MRI. Before and during the administration, the heart rate, systemic blood pressure, and oxygen saturation were monitored using a MRI-compatible system. We documented any signs and symptoms of potential adverse events. In total, 47 out of 168 patients (28%) experienced adverse effects, which were mostly mild or moderate. In 13 patients (8%), the adenosine infusion was discontinued due to intolerable dyspnea or chest pain. No high grade atrioventricular block, bronchospasm or other life-threatening adverse events occurred. The hemodynamic measurements showed a significant increase in the heart rate during adenosine infusion (69.3 ± 11.7 versus 82.4 ± 13.0 beats/min, respectively; p < 0.001). A significant but clinically irrelevant increase in oxygen saturation occurred during adenosine infusion (96 ± 1.9% versus 97 ± 1.3%, respectively; p < 0.001). The blood pressure did not significantly change during adenosine infusion (systolic: 142.8 ± 24.0 versus 140.9 ± 25.7 mmHg; diastolic: 80.2 ± 12.5 mmHg versus 78.9 ± 15.6, respectively). This study confirms the safety of adenosine infusion during cardiac MRI. A considerable proportion of all patients will experience minor adverse effects and some patients will not tolerate adenosine infusion. However, all adverse events can be successfully managed by a radiologist. The increased heart rate during adenosine infusion highlights the need to individually adjust the settings according to the patient, e.g., the number of slices of myocardial perfusion imaging.

  20. Electronic approaches to making sense of the text in the adverse event reporting system.

    Science.gov (United States)

    Benin, Andrea L; Fodeh, Samah Jamal; Lee, Kyle; Koss, Michele; Miller, Perry; Brandt, Cynthia

    2016-08-01

    Health care organizations working to eliminate preventable harm and to improve patient safety must have robust programs to collect and to analyze data on adverse events in order to use the information to affect improvement. Such adverse event reporting systems are based on frontline personnel reporting issues that arise in the course of their daily work. Limitations in how existing software systems handle these reports mean that use of this potentially rich information is resource intensive and prone to variable results. The aim of this study was to develop an electronic approach to processing the text in medical event reports that would be reliable enough to be used to improve patient safety. At Connecticut Children's Medical Center, staff manually enter reports of adverse events into a web-based software tool. We evaluated the ability of 2 electronic methods-rule-based query and semi-supervised machine learning-to identify specific types of events ("use cases") versus a reference standard. Rule-based query was tested on 5 use cases and machine learning on a subset of 2 using 9164 events reported from February 2012-January 2014. Machine learning found 93% of the weight-based errors and 92% of the errors in patient-identification. Rule-based query had accuracy of 99% or greater, high precision, and high recall for all use cases. Electronic approaches to streamlining the use of adverse event reports are feasible to automate and valuable for categorizing this important data for use in improving patient safety. © 2016 American Society for Healthcare Risk Management of the American Hospital Association.

  1. Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network.

    Science.gov (United States)

    LaRussa, Philip S; Edwards, Kathryn M; Dekker, Cornelia L; Klein, Nicola P; Halsey, Neal A; Marchant, Colin; Baxter, Roger; Engler, Renata J M; Kissner, Jennifer; Slade, Barbara A

    2011-05-01

    The Clinical Immunization Safety Assessment (CISA) Network is a collaboration between the Centers for Disease Control and Prevention (CDC) and 6 academic medical centers to provide support for immunization safety assessment and research. The CISA Network was established by the CDC in 2001 with 4 primary goals: (1) develop research protocols for clinical evaluation, diagnosis, and management of adverse events following immunization (AEFI); (2) improve the understanding of AEFI at the individual level, including determining possible genetic and other risk factors for predisposed people and subpopulations at high risk; (3) develop evidence-based algorithms for vaccination of people at risk of serious AEFI; and (4) serve as subject-matter experts for clinical vaccine-safety inquiries. CISA Network investigators bring in-depth clinical, pathophysiologic, and epidemiologic expertise to assessing causal relationships between vaccines and adverse events and to understanding the pathogenesis of AEFI. CISA Network researchers conduct expert reviews of clinically significant adverse events and determine the validity of the recorded diagnoses on the basis of clinical and laboratory criteria. They also conduct special studies to investigate the possible pathogenesis of adverse events, assess relationships between vaccines and adverse events, and maintain a centralized repository for clinical specimens. The CISA Network provides specific clinical guidance to both health care providers who administer vaccines and those who evaluate and treat patients with possible AEFI. The CISA Network plays an important role in providing critical immunization-safety data and expertise to inform vaccine policy-makers. The CISA Network serves as a unique resource for vaccine-safety monitoring efforts conducted at the CDC.

  2. Platelet density per monocyte predicts adverse events in patients after percutaneous coronary intervention.

    Science.gov (United States)

    Rutten, Bert; Roest, Mark; McClellan, Elizabeth A; Sels, Jan W; Stubbs, Andrew; Jukema, J Wouter; Doevendans, Pieter A; Waltenberger, Johannes; van Zonneveld, Anton-Jan; Pasterkamp, Gerard; De Groot, Philip G; Hoefer, Imo E

    2016-01-01

    Monocyte recruitment to damaged endothelium is enhanced by platelet binding to monocytes and contributes to vascular repair. Therefore, we studied whether the number of platelets per monocyte affects the recurrence of adverse events in patients after percutaneous coronary intervention (PCI). Platelet-monocytes complexes with high and low median fluorescence intensities (MFI) of the platelet marker CD42b were isolated using cell sorting. Microscopic analysis revealed that a high platelet marker MFI on monocytes corresponded with a high platelet density per monocyte while a low platelet marker MFI corresponded with a low platelet density per monocyte (3.4 ± 0.7 vs 1.4 ± 0.1 platelets per monocyte, P=0.01). Using real-time video microscopy, we observed increased recruitment of high platelet density monocytes to endothelial cells as compared with low platelet density monocytes (P=0.01). Next, we classified PCI scheduled patients (N=263) into groups with high, medium and low platelet densities per monocyte and assessed the recurrence of adverse events. After multivariate adjustment for potential confounders, we observed a 2.5-fold reduction in the recurrence of adverse events in patients with a high platelet density per monocyte as compared with a low platelet density per monocyte [hazard ratio=0.4 (95% confidence interval, 0.2-0.8), P=0.01]. We show that a high platelet density per monocyte increases monocyte recruitment to endothelial cells and predicts a reduction in the recurrence of adverse events in patients after PCI. These findings may imply that a high platelet density per monocyte protects against recurrence of adverse events.

  3. [Adverse events caused by activated charcoal in an emergency services survey].

    Science.gov (United States)

    Burillo Putze, G; Díaz Acosta, J; Matos Castro, S; Herranz Duarte, J I; Benito Lozano, M; Jurado Sánchez, M A; de la Fuente García, C; Expósito Rodríguez, M; Jiménez Sosa, A

    2015-01-01

    There are few studies in Spain on the use of activated charcoal (AC) in acute poisoning via the digestive tract, and more specifically on its protocol and adverse events following its administration. The aim of this article is to know the experience in the use of AC by doctors and nurses of the Spanish emergency services. Survey developed using Google Docs to health professionals in emergency services. Three hundred and sixty-four questionnaires were received, 52% of them from doctors. Catheterization prior to the use of AC in 74.5% of patients was performed, and did not use a catheter in 13%. The application of AC was considered correct in 37.4%, and overall it was used in 92.4% of cases. The lateral safety position was used in 46.2%, antiemetics in 86.5% and isolation of the airway in case of coma (GCS<8) in 60%. The most described adverse events were vomiting of AC (61%), epixtasis when the catheter was positioned (51.1%), and its incorrect positioning (36%). Inhaling vomit occurred in 11.8% and inhaling carbon in 4.7%. Seven point one percent stated that the adverse events had been life-threatening to patients. No relation was found between the protocol and serious or life-threatening adverse events, nor between these latter and clinical safety measures. The incidence of adverse events according to the information provided by professionals in this survey of clinical practice might be higher than the incidence found in the literature.

  4. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    , especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. CONCLUSION: Data on adverse events in tables...

  5. Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation

    Directory of Open Access Journals (Sweden)

    Deyo Richard A

    2006-06-01

    Full Text Available Abstract Background Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1 specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2 quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery. Methods We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases. Results During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%. Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35, but agreement was substantial (kappa ≥ 0.61 for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted

  6. Adverse drug events associated with the antidotes for methanol and ethylene glycol poisoning: a comparison of ethanol and fomepizole.

    Science.gov (United States)

    Lepik, Katherine J; Levy, Adrian R; Sobolev, Boris G; Purssell, Roy A; DeWitt, Christopher R; Erhardt, Gunnar D; Kennedy, James R; Daws, Derek E; Brignall, Jane L

    2009-04-01

    We investigate adverse drug events associated with antidotes ethanol and fomepizole in methanol or ethylene glycol poisonings. An "adverse drug event" is harm associated with normal or incorrect drug use. We describe type, frequency, severity, seriousness, and onset time of adverse drug events and test the hypothesis that fomepizole results in fewer adverse drug events than ethanol. This cohort study included patients aged 13 years or older, hospitalized between 1996 and 2005 for methanol or ethylene glycol poisoning (identified by International Classification of Diseases, Ninth Revision or 10th Revision codes) and treated with at least 1 dose of ethanol or fomepizole. Two abstractors separately reviewed each chart, identifying new clinical events during antidote treatment. Three toxicologists determined, by consensus, which events were adverse drug events. The primary outcome was at least 1 adverse drug event, expressed as adverse drug event rate per person-day of antidote treatment. Association between time to first adverse drug event and antidote type was modeled by Cox regression, adjusted for confounders. Two hundred twenty-three charts were reviewed and 172 analyzed. Toxicologists identified at least 1 adverse drug event in 74 of 130 (57%) ethanol-treated and 5 of 42 (12%) fomepizole-treated cases. Central nervous system symptoms accounted for most adverse drug events (48% ethanol-treated, 2% fomepizole-treated). Severe adverse drug events occurred in 26 of 130 (20%) ethanol-treated (coma, extreme agitation, cardiovascular) and 2 of 42 (5%) fomepizole-treated (coma, cardiovascular). Serious (life-threatening) adverse drug events occurred in 11 of 130 (8%) ethanol-treated (respiratory depression, hypotension) and 1 of 42 (2%) fomepizole-treated (hypotension, bradycardia) cases. Median adverse drug event onset was within 3 hours after the start of either antidote. Ethanol and fomepizole adverse drug event rates were 0.93 and 0.13 adverse drug events per

  7. A perspective from clinical and business ethics on adverse events in hospitalized patients.

    Science.gov (United States)

    Wagner, J T; Meier, C; Higdon, T

    1997-11-01

    Adverse events occur in a significant, but undetermined, number of hospitalized patients. These types of patient injuries are more often the result of faulty systems than human maleficence. A culture exists among health care providers that discourages the reporting of such events and resists the implementation of formal efforts to eliminate them. This resistance serves to perpetuate the problem. Both business and clinical ethics argue that sound reasons exist for hospitals to reduce, if not eliminate, adverse events. To do so is cost effective, particularly in a managed care environment. It is also at the heart of responsible professional behavior. Physicians are afforded an opportunity to be at the forefront in this quality improvement effort.

  8. An electronic trigger based on care escalation to identify preventable adverse events in hospitalised patients.

    Science.gov (United States)

    Bhise, Viraj; Sittig, Dean F; Vaghani, Viralkumar; Wei, Li; Baldwin, Jessica; Singh, Hardeep

    2018-03-01

    Methods to identify preventable adverse events typically have low yield and efficiency. We refined the methods of Institute of Healthcare Improvement's Global Trigger Tool (GTT) application and leveraged electronic health record (EHR) data to improve detection of preventable adverse events, including diagnostic errors. We queried the EHR data repository of a large health system to identify an 'index hospitalization' associated with care escalation (defined as transfer to the intensive care unit (ICU) or initiation of rapid response team (RRT) within 15 days of admission) between March 2010 and August 2015. To enrich the record review sample with unexpected events, we used EHR clinical data to modify the GTT algorithm and limited eligible patients to those at lower risk for care escalation based on younger age and presence of minimal comorbid conditions. We modified the GTT review methodology; two physicians independently reviewed eligible 'e-trigger' positive records to identify preventable diagnostic and care management events. Of 88 428 hospitalisations, 887 were associated with care escalation (712 ICU transfers and 175 RRTs), of which 92 were flagged as trigger-positive and reviewed. Preventable adverse events were detected in 41 cases, yielding a trigger positive predictive value of 44.6% (reviewer agreement 79.35%; Cohen's kappa 0.573). We identified 7 (7.6%) diagnostic errors and 34 (37.0%) care management-related events: 24 (26.1%) adverse drug events, 4 (4.3%) patient falls, 4 (4.3%) procedure-related complications and 2 (2.2%) hospital-associated infections. In most events (73.1%), there was potential for temporary harm. We developed an approach using an EHR data-based trigger and modified review process to efficiently identify hospitalised patients with preventable adverse events, including diagnostic errors. Such e-triggers can help overcome limitations of currently available methods to detect preventable harm in hospitalised patients. © Article

  9. Shattering world assumptions: A prospective view of the impact of adverse events on world assumptions.

    Science.gov (United States)

    Schuler, Eric R; Boals, Adriel

    2016-05-01

    Shattered Assumptions theory (Janoff-Bulman, 1992) posits that experiencing a traumatic event has the potential to diminish the degree of optimism in the assumptions of the world (assumptive world), which could lead to the development of posttraumatic stress disorder. Prior research assessed the assumptive world with a measure that was recently reported to have poor psychometric properties (Kaler et al., 2008). The current study had 3 aims: (a) to assess the psychometric properties of a recently developed measure of the assumptive world, (b) to retrospectively examine how prior adverse events affected the optimism of the assumptive world, and (c) to measure the impact of an intervening adverse event. An 8-week prospective design with a college sample (N = 882 at Time 1 and N = 511 at Time 2) was used to assess the study objectives. We split adverse events into those that were objectively or subjectively traumatic in nature. The new measure exhibited adequate psychometric properties. The report of a prior objective or subjective trauma at Time 1 was related to a less optimistic assumptive world. Furthermore, participants who experienced an intervening objectively traumatic event evidenced a decrease in optimistic views of the world compared with those who did not experience an intervening adverse event. We found support for Shattered Assumptions theory retrospectively and prospectively using a reliable measure of the assumptive world. We discuss future assessments of the measure of the assumptive world and clinical implications to help rebuild the assumptive world with current therapies. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  10. Perampanel with concomitant levetiracetam and topiramate: Post hoc analysis of adverse events related to hostility and aggression.

    Science.gov (United States)

    Chung, Steve; Williams, Betsy; Dobrinsky, Cindy; Patten, Anna; Yang, Haichen; Laurenza, Antonio

    2017-10-01

    In 4 Phase III registration trials (3 in patients with partial seizures, N=1480; 1 in patients with PGTCS, N=163), perampanel administered to patients already receiving 1-3 concomitant antiepileptic drugs (AEDs) demonstrated statistically superior efficacy compared to placebo in reducing seizure frequency. However, use of perampanel in these studies was associated with a risk of psychiatric and behavioral adverse reactions, including aggression, hostility, irritability, anger, and homicidal ideation and threats. The present study is a post hoc analysis of pooled data from these 4 trials to determine if concomitant treatment with levetiracetam and/or topiramate increased the risk of hostility- and aggression-related AEs. Treatment-emergent AEs (TEAEs) were determined using a "Narrow & Broad" search based on the Medical Dictionary for Regulatory Activities (MedDRA) standard MedDRA query (SMQ) for hostility- and aggression-related events. The rate of hostility- and aggression-related TEAEs was observed to be similar among perampanel-treated patients: a) receiving levetiracetam (N=340) compared to those not receiving levetiracetam (N=779); b) receiving topiramate (N=223) compared to those not receiving topiramate (N=896); and c) receiving both levetiracetam and topiramate (N=47) compared to those not receiving levetiracetam and topiramate (N=1072). Severe and serious TEAEs related to hostility and aggression were rare and occurred at a similar rate regardless of concomitant levetiracetam and/or topiramate therapy. Taken together, these results suggest that concomitant treatment with levetiracetam and/or topiramate has no appreciable effect on the occurrence of hostility- or aggression-related TEAEs in patients receiving perampanel. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  11. Patients at high risk of adverse events from intravenous contrast media after computed tomography examination

    Energy Technology Data Exchange (ETDEWEB)

    Reddan, Donal [University College Galway Hospitals, Unit 7, Merlin Park Hospital, Galway (Ireland)]. E-mail: donal.reddan@mailn.hse.ie

    2007-05-15

    Adverse reactions to iodinated contrast media (CM) may occur and require prompt recognition and treatment. Although adverse reactions to radiocontrast agents cannot be eliminated, an important first step toward reducing their incidence is to identify patients at greatest risk. Prior to examinations using CM, patients should be adequately assessed by obtaining thorough medical histories and using simple screening tests. Studies have demonstrated that patients with a history of asthma, allergy, hyperthyroidism, and previous reaction to CM are at risk for severe reactions to iodinated CM. Renal adverse reactions reportedly occur more frequently in patients with pre-existing chronic kidney disease, especially those with diabetic nephropathy. Patients with congestive heart failure, dehydration, older age, and those who use nephrotoxic medications are also at risk for developing contrast-associated nephropathy. The occurrence of adverse events may be further increased in patients with multiple risk factors. As the number of patients undergoing computed tomography procedures continues to increase, it is essential for physicians to be able to identify patients at risk for adverse events of CM. Patient-related risk factors are discussed and simple tools for risk stratification presented.

  12. Psychological coping and recurrent major adverse cardiac events following acute coronary syndrome.

    Science.gov (United States)

    Messerli-Bürgy, Nadine; Molloy, Gerard J; Poole, Lydia; Wikman, Anna; Kaski, Juan Carlos; Steptoe, Andrew

    2015-09-01

    Depressed mood and stress are associated with recurrent adverse outcomes following acute coronary syndrome (ACS), but the impact of psychological coping style has not been evaluated in detail. We tested the relationship between task-oriented coping and event-free survival following ACS. We followed 158 patients with ACS for an average of 59.8 months for major adverse cardiac outcomes. Psychological coping was assessed with the Coping Inventory of Stressful Situations. Compared with patients in the lower half of the distribution, those reporting higher task-oriented coping had a reduced hazard of adverse cardiac events (hazard ratio (HR) = 0.28, 95% CI 0.11-0.68, P = 0.005) independently of demographic, clinical and behavioural covariates. The combination of low task-oriented coping and high depressive symptoms showed a strong association with adverse outcomes (HR = 6.25, 95% CI 1.88-20.82, P = 0.003). The tendency to cope using task-oriented strategies may promote event-free survival following ACS. © The Royal College of Psychiatrists 2015.

  13. Prognostic significance of adverse events in patients with hepatocellular carcinoma treated with sorafenib.

    Science.gov (United States)

    Granito, Alessandro; Marinelli, Sara; Negrini, Giulia; Menetti, Saverio; Benevento, Francesca; Bolondi, Luigi

    2016-03-01

    Sorafenib is the standard treatment for patients with hepatocellular carcinoma (HCC) with advanced stage disease. Although its effectiveness has been demonstrated by randomized clinical trials and confirmed by field practice studies, reliable markers predicting therapeutic response have not yet been identified. Like other tyrosine kinase inhibitors, treatment with sorafenib is burdened by the development of adverse effects, the most frequent being cutaneous toxicity, diarrhoea, arterial hypertension and fatigue. In recent years, several studies have analysed the correlation between off-target effects and sorafenib efficacy in patients with HCC. In this review, an overview of the studies assessing the prognostic significance of sorafenib-related adverse events is provided.

  14. Patient-reported health as a prognostic factor for adverse events following percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Biering K

    2014-01-01

    Full Text Available Karin Biering,1 Hans Erik Bøtker,2 Troels Niemann,3 Niels Henrik Hjollund4,51Department of Occupational Medicine, Regional Hospital West Jutland, Herning, 2Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, 3Department of Cardiology, Regional Hospital West Jutland, Herning, 4WestChronic, Regional Hospital West Jutland, Herning, 5Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, DenmarkObjective: A relation may exist between self-reported health and adverse events in coronary heart disease. Previous studies have been vulnerable to possible selection bias. In the study reported here, we examined the association between self-rated health and adverse events in terms of cardiac events, cardiac readmissions, and all-cause mortality in a complete cohort of patients treated with percutaneous coronary intervention (PCI.Study design and setting: A cohort of patients with coronary heart disease treated with PCI was followed up with questionnaires 4 weeks after PCI to measure self-rated health and in registers to identify adverse events. Of 1,752 eligible patients under 67 years, 26 died during the first 4 weeks. A total of 224 patients were excluded from the analysis because they were readmitted with a cardiac diagnosis before answering the first questionnaire. We received complete SF-12 Health Survey component summaries from 984 of the remaining 1,502 patients. We used multiple imputation to establish a complete cohort, including nonrespondents.Results: During follow-up, 83 patients died, 220 patients experienced a new cardiac event, and 526 patients experienced a hospital readmission related to coronary heart disease. Poor self-rated health was related to cardiac events, cardiac readmission, and all-cause mortality. The associations were stronger for all-cause mortality than for events and readmissions. Physical health was more important than mental health, but both revealed an exposure–response pattern

  15. Rasagiline meta-analysis: a spotlight on clinical safety and adverse events when treating Parkinson's disease.

    Science.gov (United States)

    Solís-García del Pozo, Julián; Mínguez-Mínguez, Sara; de Groot, Piet W J; Jordán, Joaquín

    2013-07-01

    Rasagiline (Azilect, AGN 1135) is a selective irreversible inhibitor of monoamine oxidase B (MAO-B). MAO-B regulates the brain concentrations of important neurotransmitters that are related to movement, emotion, and cognition. Oral rasagiline, as monotherapy or as adjunctive therapy to levodopa, was effective in the symptomatic treatment of adult patients with Parkinson's disease participating in double-blind, placebo-controlled, international studies. This article reviews the reported adverse effects of rasagiline. A MEDLINE search was performed for all articles from 1990 to present, which reported any adverse effects from rasagiline or related references. We conducted an analysis of the adverse effects of rasagiline based on the reported clinical studies. Furthermore, we compared the incidence of adverse events in clinical trials for rasagiline and placebo. Among the most frequently reported adverse effects for rasagiline as monotherapy are headache, dizziness, and insomnia. Depression, dizziness, somnolence, and other sleep disorders are reported when used in combination therapy. Our analysis demonstrates that the most frequently reported adverse effects in trials did not occur more often with rasagiline than placebo. In conclusion, rasagiline is a well-tolerated MAO-B inhibitor that may help to achieve the desired level of clinical benefit in Parkinson's disease.

  16. Augmentation therapy with alpha1-antitrypsin: patterns of use and adverse events.

    Science.gov (United States)

    Stoller, James K; Fallat, Robert; Schluchter, Mark D; O'Brien, Ralph G; Connor, Jason T; Gross, Nicholas; O'Neil, Kevin; Sandhaus, Robert; Crystal, Ronald G

    2003-05-01

    To describe patterns of prescribing augmentation therapy, and types and rates of adverse events in the National Heart, Lung, and Blood Institute Registry for Individuals with Severe Deficiency of Alpha(1)-Antitrypsin. Observational cohort study with follow-up visits every 6 to 12 months for up to 7 years. The rate and dosing frequency with which Registry participants were prescribed to receive augmentation therapy by their managing physicians, and the type and frequency of adverse events, classified in two ways: severity of self-reported symptoms, and actions taken as a consequence of the symptom. Over the course of Registry follow-up, 66% (n = 747) of the participants received augmentation therapy at some time. In keeping with recommendations made in the 1989 American Thoracic Society (ATS) statement, 75% of participants with airflow obstruction at first visit (defined as FEV(1) or = 80% predicted (14%) also received augmentation therapy. Among those with COPD for whom augmentation therapy was not prescribed, financial constraints were the reported cause in 30%. Observed patterns also varied from approved practice, in that dosing frequencies other than the US Food and Drug Administration-approved, once-weekly regimen were frequently prescribed. The overall rate of reported adverse events was 0.02 per patient-month, with 83% of participants reporting no events. This overall rate was composed of 16% considered mild events, 76% moderate events, and 9% severe events. We conclude that augmentation therapy was generally well tolerated and, consistent with ATS guidelines, physicians generally did not prescribe augmentation therapy for subjects with FEV(1) > or = 80% predicted. However, the large percentage of subjects with FEV(1) <80% predicted not receiving augmentation therapy and the frequent use of 2- to 3-week or monthly dosing reflects variation of practice from suggested treatment guidelines.

  17. Ontology-based time information representation of vaccine adverse events in VAERS for temporal analysis.

    Science.gov (United States)

    Tao, Cui; He, Yongqun; Yang, Hannah; Poland, Gregory A; Chute, Christopher G

    2012-12-20

    The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS) provides a valuable data source for post-vaccination adverse event analyses. The structured data in the system has been widely used, but the information in the write-up narratives is rarely included in these kinds of analyses. In fact, the unstructured nature of the narratives makes the data embedded in them difficult to be used for any further studies. We developed an ontology-based approach to represent the data in the narratives in a "machine-understandable" way, so that it can be easily queried and further analyzed. Our focus is the time aspect in the data for time trending analysis. The Time Event Ontology (TEO), Ontology of Adverse Events (OAE), and Vaccine Ontology (VO) are leveraged for the semantic representation of this purpose. A VAERS case report is presented as a use case for the ontological representations. The advantages of using our ontology-based Semantic web representation and data analysis are emphasized. We believe that representing both the structured data and the data from write-up narratives in an integrated, unified, and "machine-understandable" way can improve research for vaccine safety analyses, causality assessments, and retrospective studies.

  18. Ontology-based time information representation of vaccine adverse events in VAERS for temporal analysis

    Directory of Open Access Journals (Sweden)

    Tao Cui

    2012-12-01

    Full Text Available Abstract Background The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS provides a valuable data source for post-vaccination adverse event analyses. The structured data in the system has been widely used, but the information in the write-up narratives is rarely included in these kinds of analyses. In fact, the unstructured nature of the narratives makes the data embedded in them difficult to be used for any further studies. Results We developed an ontology-based approach to represent the data in the narratives in a “machine-understandable” way, so that it can be easily queried and further analyzed. Our focus is the time aspect in the data for time trending analysis. The Time Event Ontology (TEO, Ontology of Adverse Events (OAE, and Vaccine Ontology (VO are leveraged for the semantic representation of this purpose. A VAERS case report is presented as a use case for the ontological representations. The advantages of using our ontology-based Semantic web representation and data analysis are emphasized. Conclusions We believe that representing both the structured data and the data from write-up narratives in an integrated, unified, and “machine-understandable” way can improve research for vaccine safety analyses, causality assessments, and retrospective studies.

  19. Impact of extended-duration shifts on medical errors, adverse events, and attentional failures.

    Directory of Open Access Journals (Sweden)

    Laura K Barger

    2006-12-01

    Full Text Available A recent randomized controlled trial in critical-care units revealed that the elimination of extended-duration work shifts (> or =24 h reduces the rates of significant medical errors and polysomnographically recorded attentional failures. This raised the concern that the extended-duration shifts commonly worked by interns may contribute to the risk of medical errors being made, and perhaps to the risk of adverse events more generally. Our current study assessed whether extended-duration shifts worked by interns are associated with significant medical errors, adverse events, and attentional failures in a diverse population of interns across the United States.We conducted a Web-based survey, across the United States, in which 2,737 residents in their first postgraduate year (interns completed 17,003 monthly reports. The association between the number of extended-duration shifts worked in the month and the reporting of significant medical errors, preventable adverse events, and attentional failures was assessed using a case-crossover analysis in which each intern acted as his/her own control. Compared to months in which no extended-duration shifts were worked, during months in which between one and four extended-duration shifts and five or more extended-duration shifts were worked, the odds ratios of reporting at least one fatigue-related significant medical error were 3.5 (95% confidence interval [CI], 3.3-3.7 and 7.5 (95% CI, 7.2-7.8, respectively. The respective odds ratios for fatigue-related preventable adverse events, 8.7 (95% CI, 3.4-22 and 7.0 (95% CI, 4.3-11, were also increased. Interns working five or more extended-duration shifts per month reported more attentional failures during lectures, rounds, and clinical activities, including surgery and reported 300% more fatigue-related preventable adverse events resulting in a fatality.In our survey, extended-duration work shifts were associated with an increased risk of significant medical

  20. Adverse events in families with hypertrophic or dilated cardiomyopathy and mutations in the MYBPC3 gene

    Directory of Open Access Journals (Sweden)

    Lehrke Stephanie

    2008-10-01

    Full Text Available Abstract Background Mutations in MYBPC3 encoding myosin binding protein C belong to the most frequent causes of hypertrophic cardiomyopathy (HCM and may also lead to dilated cardiomyopathy (DCM. MYBPC3 mutations initially were considered to cause a benign form of HCM. The aim of this study was to examine the clinical outcome of patients and their relatives with 18 different MYBPC3 mutations. Methods 87 patients with HCM and 71 patients with DCM were screened for MYBPC3 mutations by denaturing gradient gel electrophoresis and sequencing. Close relatives of mutation carriers were genotyped for the respective mutation. Relatives with mutation were then evaluated by echocardiography and magnetic resonance imaging. A detailed family history regarding adverse clinical events was recorded. Results In 16 HCM (18.4% and two DCM (2.8% index patients a mutation was detected. Seven mutations were novel. Mutation carriers exhibited no additional mutations in genes MYH7, TNNT2, TNNI3, ACTC and TPM1. Including relatives of twelve families, a total number of 42 mutation carriers was identified of which eleven (26.2% had at least one adverse event. Considering the twelve families and six single patients with mutations, 45 individuals with cardiomyopathy and nine with borderline phenotype were identified. Among the 45 patients, 23 (51.1% suffered from an adverse event. In eleven patients of seven families an unexplained sudden death was reported at the age between 13 and 67 years. Stroke or a transient ischemic attack occurred in six patients of five families. At least one adverse event occurred in eleven of twelve families. Conclusion MYBPC3 mutations can be associated with cardiac events such as progressive heart failure, stroke and sudden death even at younger age. Therefore, patients with MYBPC3 mutations require thorough clinical risk assessment.

  1. Serious Neurological Adverse Events after Ivermectin-Do They Occur beyond the Indication of Onchocerciasis?

    Science.gov (United States)

    Chandler, Rebecca E

    2018-02-01

    Serious neurological adverse events have been reported from large scale community-based ivermectin treatment campaigns against Onchocerciasis volvulus in Africa. The mechanism of these events has been debated in the literature, largely focusing on the role of concomitant infection with Loa loa versus the presence of mdr-1 gene variants in humans allowing ivermectin penetration into the central nervous system. A case series of serious neurological adverse events occurring with the use of ivermectin outside of the onchocerciasis indication has been identified in VigiBase, an international database of suspected adverse drug reactions. Forty-eight cases have been reported from multiple countries in which ivermectin has been prescribed for multiple indications; clinical review excluded 20 cases with more probable explanations or other exclusion criteria. Within the remaining 28 cases, there is supportive evidence for a causative role of ivermectin including presence of the drug in brain tissue in one case and recurrence of symptoms on repeated exposure in three cases. This series suggests that serious neurological adverse events observed with the use of ivermectin in the treatment of onchocerciasis may not be entirely explained by concomitant high burden loiasis infections. By comparison with the extensive post marketing experience with ivermectin in the successful treatment of parasitic infections, the number of reported cases suggests that such events are likely rare. However, elucidation of individual-level risk factors could contribute to therapeutic decisions that can minimize harms. Further investigation into the potential for drug-drug interactions and explorations of polymorphisms in the mdr-1 gene are recommended.

  2. Incidence and management of life-threatening adverse events during cardiac catheterization for congenital heart disease.

    Science.gov (United States)

    Lin, C Huie; Hegde, Sanjeet; Marshall, Audrey C; Porras, Diego; Gauvreau, Kimberlee; Balzer, David T; Beekman, Robert H; Torres, Alejandro; Vincent, Julie A; Moore, John W; Holzer, Ralf; Armsby, Laurie; Bergersen, Lisa

    2014-01-01

    Continued advancements in congenital cardiac catheterization and interventions have resulted in increased patient and procedural complexity. Anticipation of life-threatening events and required rescue measures is a critical component to preprocedural preparation. We sought to determine the incidence and nature of life-threatening adverse events in congenital and pediatric cardiac catheterization, risk factors, and resources necessary to anticipate and manage events. Data from 8905 cases performed at the 8 participating institutions of the Congenital Cardiac Catheterization Project on Outcomes were captured between 2007 and 2010 [median 1,095/site (range 133-3,802)]. The incidence of all life-threatening events was 2.1 % [95 % confidence interval (CI) 1.8-2.4 %], whereas mortality was 0.28 % (95 % CI 0.18-0.41 %). Fifty-seven life-threatening events required cardiopulmonary resuscitation, whereas 9 % required extracorporeal membrane oxygenation. Use of a risk adjustment model showed that age events. Using this model, standardized life-threatening event ratios were calculated, thus showing that one institution had a life-threatening event rate greater than expected. Congenital cardiac catheterization and intervention can be performed safely with a low rate of life-threatening events and mortality; preprocedural evaluation of risk may optimize preparation of emergency rescue and bailout procedures. Risk predictors (age < 1, hemodynamic vulnerability, and procedure risk category) can enhance preprocedural patient risk stratification and planning.

  3. Differences in the reporting rates of serious allergic adverse events from intravenous iron by country and population.

    Science.gov (United States)

    Bailie, George R; Verhoef, Jan-Jaap

    2012-02-01

    Previous studies have compared rates of adverse events between intravenous (IV) iron preparations; however, there has been no comparison of adverse event rates by country and population. To compare rates of adverse events to IV iron products by country and population. All adverse events reported from 18 countries from January 1, 2003 to June 30, 2009 were obtained for iron dextran (ID), iron sucrose (IS), IS similars (ISS), and sodium ferric gluconate (FG). Rates of all adverse events and serious adverse events (anaphylaxis plus other serious allergic reactions) were calculated as number of events per gram of iron sold (gFe) per million inhabitants (mil) × 10-3. Odds ratios (ORs) were calculated for the risks of adverse events between products. Iron use ranged from 1 gFe/mil (Poland) to 48,674 gFe/mil (Italy). Rates of all adverse events (reports/gFe/mil × 10-3) varied: for IS, it ranged from 0 (Poland, Austria, Czech Republic) to 1,222 (Ireland); for FG, from 3.3 (Czech Republic) to 183.6 (United States); for ID, from 0.9 (Turkey) to 46,875 (Switzerland). There were no reports of adverse events in ISS. In a subset of countries that used 2 or more iron products and had more than 1 serious adverse event, rates (reports/gFe/mil × 10-3) of all adverse events and serious adverse events were lowest for IS (39.8 and 1.7), intermediate for FG (54.8 and 4.5), and greatest for ID (337.7 and 20.5). IS had lower risks for all adverse events (OR, 0.63; PID. FG had lower risks for all adverse events (OR, 0.20; PID. Considerable international variation existed in the extent and choice of iron product and adverse event reporting, suggesting under-reporting in some instances. Clinicians should appreciate the differential risks between available products, and should critically review local reporting practices.

  4. Adverse Health Events Related to Self-Medication Practices Among Elderly: A Systematic Review.

    Science.gov (United States)

    Locquet, Médéa; Honvo, Germain; Rabenda, Véronique; Van Hees, Thierry; Petermans, Jean; Reginster, Jean-Yves; Bruyère, Olivier

    2017-05-01

    Older adults often resort to self-medication to relieve symptoms of their current illnesses; however, the risks of this practice are multiplied in old age. In particular, this age group is more vulnerable to adverse drug events because of the physiological changes that occur due to senescence. The aim of the study was to obtain an overview of the adverse health events related to self-medication among subjects aged 60 years and over through a systematic review of the literature. A study of relevant articles was conducted among databases (MEDLINE, PsycINFO, and EBM Reviews-Cochrane Database of Systematic Reviews). Eligibility criteria were established and applied by two investigators to include suitable studies. The results and outcomes of interest were detailed in a descriptive report. The electronic search identified 4096 references, and the full texts of 74 were reviewed, of which four were retained in the analysis: three had a cross-sectional design and one prospectively followed elderly subjects. The first study showed a 26.7% prevalence of adverse drug reactions (ADRs) among elders, the second study found a 75% prevalence of side effects, and, finally, a prospective study showed an ADR incidence of 4.5% among self-medicated elders. These studies showed that adverse health events related to self-medication are relatively frequently reported. They also highlighted that analgesics and anti-inflammatory drugs are the most self-medicated products, while vitamins and dietary supplements also appear to be frequently self-administered, but by older individuals. Studies on self-medication in the elderly and its adverse health effects are clearly lacking. There is a need to perform prospective studies on this topic to gain a clear understanding of the extent of this problem and to enhance the awareness of health professionals to better inform seniors.

  5. Estimating risk of adverse cardiac event after vascular surgery using currently available online calculators.

    Science.gov (United States)

    Moses, Danielle A; Johnston, Lily E; Tracci, Margaret C; Robinson, William P; Cherry, Kenneth J; Kern, John A; Upchurch, Gilbert R

    2018-01-01

    The decision to proceed with vascular surgical interventions requires evaluation of cardiac risk. Recently, several online risk calculators were created to predict outcomes and to lead to a more informed conversation between surgeons and patients. The objective of this study was to compare and further validate these online calculators with actual adverse cardiac outcomes at a single institution. All patients from January 2011 through December 2015 undergoing carotid endarterectomy (CEA), infrainguinal lower extremity bypass, open abdominal aortic aneurysm (AAA) repair, and endovascular aneurysm repair (EVAR) on the vascular surgical service were included using the Society for Vascular Surgery Vascular Quality Initiative database at our health system. Additional information was collected through retrospective chart review. Each patient was entered through three online risk calculators: (1) the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) estimates the risk of cardiac arrest and myocardial infarction (MI); (2) the Revised Cardiac Risk Index (RCRI) estimates risk of MI, pulmonary edema, ventricular fibrillation, primary cardiac arrest, and complete heart block; and (3) the Vascular Study Group of New England (VSGNE) Cardiac Risk Index estimates risk of postoperative MI only. Observed adverse cardiac events (ACEs) were compared with expected values for each calculator using a χ 2 goodness-of-fit test. Institutional Review Board exemption was obtained. A total of 856 cases were included: 350 CEAs, 210 infrainguinal bypasses, 77 open AAA repairs, and 219 EVARs. For CEA, no risk calculator showed statistically significant variation from the observed values (NSQIP, P = .45; RCRI, P = .17; VSGNE, P = .24). For infrainguinal bypass, NSQIP slightly underpredicted adverse events (P = .054), RCRI strongly underpredicted (P = .002), and VSGNE showed no difference (P = .42). For open AAA repair, NSQIP (P = .51) and VSGNE (P = .98

  6. Challenges in disclosure of adverse events and errors in surgery; perspectives from sub-Saharan Africa.

    Science.gov (United States)

    Ibrahim, Abdulrasheed; Garba, Ekundayo Stephen; Asuku, Malachy Eneye

    2012-01-01

    Surgery in sub-Saharan Africa is widely known to be done against a background of poverty and illiteracy, late presentation with complicated pathologies, and a desperate lack of infrastructure. In addition, patient autonomy and self determination are highly flavored by cultural practices and religious beliefs. Any of these factors can influence the pattern and disclosure of adverse events and errors. The impact of these in the relationships between surgeons and patients, and between health institutions and patients must be considered as it may affect disclosure and response to errors. This article identifies the peculiar socioeconomic and cultural challenges that may hinder disclosure and proposes strategies for instituting disclosure of errors and adverse events services in Sub-Saharan Africa.

  7. Injectable and topical neurotoxins in dermatology: Indications, adverse events, and controversies.

    Science.gov (United States)

    Giordano, Cerrene N; Matarasso, Seth L; Ozog, David M

    2017-06-01

    The use of neuromodulators for therapeutic and cosmetic indications has proven to be remarkably safe. While aesthetic and functional adverse events are uncommon, each anatomic region has its own set of risks of which the physician and patient must be aware before treatment. The therapeutic usages of botulinum toxins now include multiple specialties and multiple indications. New aesthetic indications have also developed, and there has been an increased utilization of combination therapies to combat the effects of global aging. In the second article in this continuing medical education series, we review the prevention and treatment of adverse events, therapeutic and novel aesthetic indications, controversies, and a brief overview of combination therapies. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  8. Dictionary construction and identification of possible adverse drug events in Danish clinical narrative text

    DEFF Research Database (Denmark)

    Eriksson, Robert; Jensen, Peter Bjødstrup; Pletscher-Frankild, Sune

    2013-01-01

    Objective Drugs have tremendous potential to cure and relieve disease, but the risk of unintended effects is always present. Healthcare providers increasingly record data in electronic patient records (EPRs), in which we aim to identify possible adverse events (AEs) and, specifically, possible...... adverse drug events (ADEs).Materials and methods Based on the undesirable effects section from the summary of product characteristics (SPC) of 7446 drugs, we have built a Danish ADE dictionary. Starting from this dictionary we have developed a pipeline for identifying possible ADEs in unstructured...... clinical narrative text. We use a named entity recognition (NER) tagger to identify dictionary matches in the text and post-coordination rules to construct ADE compound terms. Finally, we apply post-processing rules and filters to handle, for example, negations and sentences about subjects other than...

  9. Lymphoma Therapy and Adverse Events: Nursing Strategies for Thinking Critically and Acting Decisively.

    Science.gov (United States)

    Goodrich, Amy; Wagner-Johnston, Nina; Delibovi, Dana

    2017-02-01

    Multiple treatment options, combined with disease heterogeneity, have created nursing challenges in the management of adverse events (AEs) during antilymphoma therapy. Testing has revealed that less than half of participating nurses correctly graded peripheral neuropathy and neutropenia related to antilymphoma regimens. This article identifies nursing challenges in the management of AEs associated with therapy for lymphomas and describes how strategies in critical thinking can help meet those challenges. A comprehensive literature search in oncology nursing, nursing education, and critical thinking was conducted; participant responses to pre- and post-tests at nursing education programs were evaluated; and a roundtable meeting of authors was convened. Oncology nurses can cultivate critical thinking skills, practice thinking critically in relation to team members and patients, leverage information from the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events, and manage workflow to allow more opportunity for critical thinking.

  10. Act to keep patients safe: device-related adverse event reporting.

    Science.gov (United States)

    Schoem, Scott R; Shah, Udayan K

    2010-05-01

    Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events. Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.

  11. Amenorrhea as a rare drug-related adverse event associated with everolimus for pancreatic neuroendocrine tumors.

    Science.gov (United States)

    Kawaguchi, Yoshiaki; Maruno, Atsuko; Kawashima, Yohei; Ito, Hiroyuki; Ogawa, Masami; Mine, Tetsuya

    2014-11-14

    The patient was an asymptomatic 43-year-old woman. Abdominal ultrasonography and enhanced computed tomography showed a tumor lesion accompanied by multiple cystic changes in the liver and the pancreatic tail. Endoscopic ultrasound-fine needle aspiration was performed on the pancreatic tumor lesion and revealed pancreatic neuroendocrine tumor (PNET). As it was unresectable due to multiple liver metastases, the decision was made to initiate treatment with everolimus and transcatheter arterial chemoembolization. The patient ceased menstruating after the start of everolimus administration. When the administration was discontinued due to interstitial lung disease, menstruation resumed, but then again stopped with everolimus resumption. An association between everolimus and amenorrhea was highly suspected. Amenorrhea occurred as a rare adverse event of everolimus. As the younger women might be included in PNETs patients, we should put this adverse event into consideration.

  12. Negative Emotionality and Disconstraint Influence PTSD Symptom Course via Exposure to New Major Adverse Life Events

    Science.gov (United States)

    Sadeh, Naomi; Miller, Mark W.; Wolf, Erika J.; Harkness, Kate L.

    2015-01-01

    Identifying the factors that influence stability and change in chronic posttraumatic stress disorder (PTSD) is important for improving clinical outcomes. Using a cross-lagged design, we analyzed the reciprocal effects of personality and PTSD symptoms over time and their effects on stress exposure in a sample of 222 trauma-exposed veterans (ages 23 – 68; 90.5% male). Personality functioning and PTSD were measured approximately 4 years apart, and self-reported exposure to major adverse life events during the interim was also assessed. Negative emotionality positively predicted future PTSD symptoms, and this effect was partially mediated by exposure to new events. Constraint (negatively) indirectly affected PTSD via its association with exposure to new events. There were no significant effects of positive emotionality nor did PTSD symptom severity exert influences on personality over time. Results indicate that high negative affect and disconstraint influence the course of PTSD symptoms by increasing exposure to stressful life events. PMID:25659969

  13. Application of traditional indexes and adverse events in the ophthalmologic perioperative medical quality evaluation during 2010-2012.

    Science.gov (United States)

    Bian, Yong-Na; Shi, Jian; She, Jun-Jun; Wu, Jie; Gao, Jian-Min

    2015-01-01

    To evaluate the medical quality of ophthalmologic perioperative period during 2010-2012 in our hospital. The relevant data of perioperative period were collected in our hospital during 2010-2012, and the medical quality of perioperative period was evaluated by using the traditional evaluation indexes and adverse events. Whereby, the traditional indicators include vision changes, improving of intraocular pressure, diagnostic accordance rate before and after operation, cure improvement rate, successful rescue rate, and incidence of surgical complications, etc. Adverse events are associated with ophthalmologic perioperative events including pressure sores, postoperative wound infection, drug adverse events, and equipment related adverse events. There were 1483, 1662 and 1931 ophthalmic operations in our hospital in the year 2010, 2011 and 2012, respectively. From traditional index analysis, the proportions of vision improvement for each year were 96.43%, 96.76% and 97.32%, respectively; the rates of intraocular pressure improvement were 87.50%, 85.72% and 90.17%, respectively (P 0.05). It is the same case with drugs and medical devices adverse events (P >0.05). Traditional indicators reflect an excellent operation of the perioperative ophthalmologic quality, whereas adverse events analysis indicates some underlying problems. Compared with the traditional indexes for medical quality evaluation, the index of adverse events is more reasonable and easier to make an objective evaluation for medical quality of ophthalmologic perioperation, facilitating further refine analysis. Reasonable application of the adverse events indicators helps hospital to make the detailed quality control measures.

  14. Serious adverse events in a hospital using early warning score - what went wrong?

    DEFF Research Database (Denmark)

    Petersen, John Asger; Mackel, Rebecca; Antonsen, Kristian

    2014-01-01

    AIM: To evaluate the performance of a new early warning score (EWS) system by reviewing all serious adverse events in our hospital over a 6-month time period. METHOD: All incidents of unexpected death (UD), cardiac arrest (CA) and unanticipated intensive care unit admission(UICU) of adult patients...... of EWS were recorded in 87, 94 and 75% of UICU, CA and UD. Patients were monitored according to the escalation protocol in 13, 31 and 13% of UICU, CA and UD. Nurses escalated care and contacted physicians in 64% and 60% of events of UICU and the corresponding proportions for CO were 58% and 55%. On call...

  15. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.

    Science.gov (United States)

    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

    2011-10-26

    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 2009-2010 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. 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 1, 2009 and March 31, 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. 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%). 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

  16. Trauma-Focused Treatment in PTSD Patients With Psychosis: Symptom Exacerbation, Adverse Events, and Revictimization.

    Science.gov (United States)

    van den Berg, David P G; de Bont, Paul A J M; van der Vleugel, Berber M; de Roos, Carlijn; de Jongh, Ad; van Minnen, Agnes; van der Gaag, Mark

    2016-05-01

    Most clinicians refrain from trauma treatment for patients with psychosis because they fear symptom exacerbation and relapse. This study examined the negative side effects of trauma-focused (TF) treatment in patients with psychosis and posttraumatic stress disorder (PTSD). Analyses were conducted on data from a single-blind randomized controlled trial comparing TF treatment (N = 108; 8 sessions prolonged exposure or eye movement desensitization) and waiting list (WL; N = 47) among patients with a lifetime psychotic disorder and current chronic PTSD. Symptom exacerbation, adverse events, and revictimization were assessed posttreatment and at 6-month follow-up. Also investigated were symptom exacerbation after initiation of TF treatment and the relationship between symptom exacerbation and dropout. Any symptom exacerbation (PTSD, paranoia, or depression) tended to occur more frequently in the WL condition. After the first TF treatment session, PTSD symptom exacerbation was uncommon. There was no increase of hallucinations, dissociation, or suicidality during the first 2 sessions. Paranoia decreased significantly during this period. Dropout was not associated with symptom exacerbation. Compared with the WL condition, fewer persons in the TF treatment condition reported an adverse event (OR = 0.48, P = .032). Surprisingly, participants receiving TF treatment were significantly less likely to be revictimized (OR = 0.40, P = .035). In these participants, TF treatment did not result in symptom exacerbation or adverse events. Moreover, TF treatment was associated with significantly less exacerbation, less adverse events, and reduced revictimization compared with the WL condition. This suggests that conventional TF treatment protocols can be safely used in patients with psychosis without negative side effects. © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email

  17. Adverse events in surgical inpatients: A comparative analysis of public hospitals in Victoria

    OpenAIRE

    Katharina Hauck; Xueyan Zhao; Terri Jackson

    2010-01-01

    We compare adverse event rates for surgical inpatients across 36 public hospitals in the state of Victoria, Australia, conditioning on differences in patient complexity across hospitals. We estimate separate models for elective and emergency patients which stay at least one night in hospitals, using fixed effects complementary log-log models to estimate AEs as a function of patient and episode characteristics, and hospital effects. We use 4 years of patient level administrative hospital data ...

  18. Prevalence of Adverse Intraoperative Events during Obesity Surgery and Their Sequelae

    Science.gov (United States)

    Greenstein, Alexander J; Wahed, Abdus S; Adeniji, Abidemi; Courcoulas, Anita P; Dakin, Greg; Flum, David R; Harrison, Vincent; Mitchell, James E; O'Rourke, Robert; Pomp, Alfons; Pender, John; Ramanathan, Ramesh; Wolfe, Bruce M

    2013-01-01

    BACKGROUND Adverse intraoperative events (AIEs) during surgery are a well-known entity. A better understanding of the incidence of AIEs and their relationship with outcomes is helpful for surgeon preparation and preoperative patient counseling. The goals of this study are to describe the incidence of AIEs during bariatric surgery and examine their impact on major adverse complications. STUDY DESIGN The study included 5,882 subjects who had bariatric surgery in the Longitudinal Assessment of Bariatric Surgery study between March 2005 and April 2009. Prospectively collected AIEs included organ injuries, anesthesia-related events, anastomotic revisions, and equipment failure. The relationship between AIEs and a composite end point of 30-day major adverse complications (ie, death, venous thromboembolism, percutaneous, endoscopic, or operative reintervention and failure to be discharged from the hospital within 30 days from surgery) was evaluated using a multivariable relative risk model adjusting for factors known to influence their risk. RESULTS There were 1,608 laparoscopic adjusted gastric banding, 3,770 laparoscopic Roux-en-Y gastric bypass operations, and 504 open Roux-en-Y gastric bypass operations. Adverse intraoperative events occurred in 5% of the overall sample and were most frequent during open Roux-en-Y gastric bypass (7.3%), followed by laparoscopic Roux-en-Y gastric bypass (5.5%) and laparoscopic adjusted gastric banding (3%). The rate of composite end point was 8.8% in the AIE group compared with 3.9% among those without an AIE (p complication than those without an event (relative risk = 1.90; 95% CI, 1.26–2.88; p = 0.002), independent of the type of procedure (open or laparoscopic). CONCLUSIONS Incidence of an AIE is not infrequent during bariatric surgery and is associated with much higher risk of major complication. Additional study is needed to assess the association between specific AIEs and short-term complications. PMID:22634116

  19. Could chiropractors screen for adverse drug events in the community? Survey of US chiropractors

    OpenAIRE

    Smith, Monica; Bero, Lisa; Carber, Lynne

    2010-01-01

    Abstract Background The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS) was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potentia...

  20. Analysis of Adverse Events Associated With Adult Moderate Procedural Sedation Outside the Operating Room.

    Science.gov (United States)

    Karamnov, Sergey; Sarkisian, Natalia; Grammer, Rebecca; Gross, Wendy L; Urman, Richard D

    2017-09-01

    Moderate sedation outside the operating room is performed for a variety of medical and surgical procedures. It involves the administration of different drug combinations by nonanesthesia professionals. Few data exist on risk stratification and patient outcomes in the adult population. Current literature suggests that sedation can be associated with significant adverse outcomes. The aims of this study were to evaluate the nature of adverse events associated with moderate sedation and to examine their relation to patient characteristics and outcomes. In this retrospective review, 52 cases with moderate sedation safety incidents were identified out of approximately 143,000 cases during an 8-year period at a tertiary care medical center. We describe types of adverse events and the severity of associated harm. We used bivariate and multivariate analyses to examine the links between event types and both patient and procedure characteristics. The most common adverse event and unplanned intervention were oversedation leading to apnea (57.7% of cases) and the use of reversal agents (55.8%), respectively. Oversedation, hypoxemia, reversal agent use, and prolonged bag-mask ventilation were most common in cardiology (84.6%, 53.9%, 84.6%, and 38.5% of cases, respectively) and gastroenterology (87.5%, 75%, 87.5%, and 50%) suites. Miscommunication was reported most frequently in the emergency department (83.3%) and on the inpatient floor (69.2%). Higher body mass index was associated with increased rates of hypoxemia and intubation but lower rates of hypotension. Advanced age boosted the rates of oversedation, hypoxemia, and reversal agent use. Women were more likely than men to experience oversedation, hypotension, prolonged bag-mask ventilation, and reversal agent use. Patient harm was associated with age, body mass index, comorbidities, female sex, and procedures in the gastroenterology suite. Providers should take into account patient characteristics and procedure types when

  1. Patient safety culture and nurse-reported adverse events in outpatient hemodialysis units.

    Science.gov (United States)

    Thomas-Hawkins, Charlotte; Flynn, Linda

    2015-01-01

    Patient safety culture is an important quality indicator in health care facilities and has been associated with key patient outcomes in hospitals. The purpose of this analysis was to examine relationships between patient safety culture and nurse-reported adverse patient events in outpatient hemodialysis facilities. A cross-sectional correlational, mailed survey design was used. The analytic sample consisted of 422 registered nurses who worked in outpatient dialysis facilities in the United States. The Handoff and Transitions and the Overall Patient Safety Grade scales of the Agency for Healthcare Research and Quality's (AHRQ) Hospital Patient on Safety Survey were modified and used to measure patient safety culture in outpatient dialysis facilities. Nurse-reported adverse patient events was measured as a series of questions designed to capture the frequency with which nurses report that 13 adverse events occur in the outpatient dialysis facility setting. Handoff and transitions safety during patient shift change in dialysis centers was perceived negatively by a majority of nurses. On the other hand, a majority of nurses rated the overall patient safety culture in their dialysis facility as good to excellent. All relationships between patient safety culture items and adverse patient events were in the expected direction. Negative ratings of handoffs and transitions safety were independently associated with increased odds of frequent occurrences of vascular access thrombosis and patient complaints. Negative ratings of overall patient safety culture in dialysis units were independently associated with increased odds of frequent occurrences of medication errors by nurses, patient hospitalization, vascular access infection, and patient complaints. Findings from this analysis indicate that a positive patient safety culture is an important antecedent for optimal patient outcomes in ambulatory care settings.

  2. Dietary supplement adverse events: report of a one-year poison center surveillance project.

    Science.gov (United States)

    Haller, Christine; Kearney, Tom; Bent, Stephen; Ko, Richard; Benowitz, Neal; Olson, Kent

    2008-06-01

    The safety and efficacy of dietary supplements is of growing concern to regulators, health-care providers and consumers. Few scientific data exist on clinical effects and potential toxicities of marketed products. Harmful supplements may not be identified for months or years with existing adverse event monitoring mechanisms. Retrospective review of poison center statistics to capture supplement-associated toxicity also has limitations. We collaborated with the FDA Center for Food Safety and Nutrition (CFSAN) to conduct a 1-year prospective surveillance study of dietary supplement-related poison control center calls in 2006. Prompt follow-up of symptomatic cases, laboratory analysis of implicated dietary supplements, and causality assessment by a case review expert panel were performed. Of 275 dietary supplements calls, 41% involved symptomatic exposures; and two-thirds were rated as probably or possibly related to supplement use. Eight adverse events required hospital admission. Sympathomimetic toxicity was most common, with caffeine products accounting for 47%, and yohimbe products accounting for 18% of supplement-related symptomatic cases. Suspected drug-herb interactions occurred in 6 cases, including yohimbe co-ingested with buproprion (1) and methamphetamine (3), and additive anticoagulant/antiplatelet effects of NSAIDs taken with fish oils (1) and ginkgo (1). Laboratory analysis identified a pharmacologically active substance in 4 cases; supplement toxicity was ruled unlikely when analytical testing was negative in 5 cases. Most supplement-related adverse events were minor. Clinically significant toxic effects were most frequently reported with caffeine and yohimbe-containing products. Active surveillance of poison control center reports of dietary supplement adverse events enables rapid detection of potentially harmful products, which may facilitate regulatory oversight.

  3. Evaluating predictive pharmacogenetic signatures of adverse events in colorectal cancer patients treated with fluoropyrimidines.

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    Barbara A Jennings

    Full Text Available The potential clinical utility of genetic markers associated with response to fluoropyrimidine treatment in colorectal cancer patients remains controversial despite extensive study. Our aim was to test the clinical validity of both novel and previously identified markers of adverse events in a broad clinical setting. We have conducted an observational pharmacogenetic study of early adverse events in a cohort study of 254 colorectal cancer patients treated with 5-fluorouracil or capecitabine. Sixteen variants of nine key folate (pharmacodynamic and drug metabolising (pharmacokinetic enzymes have been analysed as individual markers and/or signatures of markers. We found a significant association between TYMP S471L (rs11479 and early dose modifications and/or severe adverse events (adjusted OR = 2.02 [1.03; 4.00], p = 0.042, adjusted OR = 2.70 [1.23; 5.92], p = 0.01 respectively. There was also a significant association between these phenotypes and a signature of DPYD mutations (Adjusted OR = 3.96 [1.17; 13.33], p = 0.03, adjusted OR = 6.76 [1.99; 22.96], p = 0.002 respectively. We did not identify any significant associations between the individual candidate pharmacodynamic markers and toxicity. If a predictive test for early adverse events analysed the TYMP and DPYD variants as a signature, the sensitivity would be 45.5 %, with a positive predictive value of just 33.9 % and thus poor clinical validity. Most studies to date have been under-powered to consider multiple pharmacokinetic and pharmacodynamic variants simultaneously but this and similar individualised data sets could be pooled in meta-analyses to resolve uncertainties about the potential clinical utility of these markers.

  4. Mixed-realism simulation of adverse event disclosure: an educational methodology and assessment instrument.

    Science.gov (United States)

    Matos, Francisco M; Raemer, Daniel B

    2013-04-01

    Physicians have an ethical duty to disclose adverse events to patients or families. Various strategies have been reported for teaching disclosure, but no instruments have been shown to be reliable for assessing them.The aims of this study were to report a structured method for teaching adverse event disclosure using mixed-realism simulation, develop and begin to validate an instrument for assessing performance, and describe the disclosure practice of anesthesiology trainees. Forty-two anesthesiology trainees participated in a 2-part exercise with mixed-realism simulation. The first part took place using a mannequin patient in a simulated operating room where trainees became enmeshed in a clinical episode that led to an adverse event and the second part in a simulated postoperative care unit where the learner is asked to disclose to a standardized patient who systematically moves through epochs of grief response. Two raters scored subjects using an assessment instrument we developed that combines a 4-element behaviorally anchored rating scale (BARS) and a 5-stage objective rating scale. The performance scores for elements within the BARS and the 5-stage instrument showed excellent interrater reliability (Cohen's κ = 0.7), appropriate range (mean range for BARS, 4.20-4.47; mean range for 5-stage instrument, 3.73-4.46), and high internal consistency (P realism simulation that engages learners in an adverse event and allows them to practice disclosure to a structured range of patient responses. We have developed a reliable 2-part instrument with strong psychometric properties for assessing disclosure performance.

  5. Bispectral Index Monitoring Reduces the Dosage of Propofol and Adverse Events in Sedation for Endobronchial Ultrasound.

    Science.gov (United States)

    Quesada, Natividad; Júdez, Diego; Martínez Ubieto, Javier; Pascual, Ana; Chacón, Enrique; De Pablo, Francisco; Mincholé, Elisa; Bello, Salvador

    2016-01-01

    Current guidelines recommend monitoring the anesthetic depth of sedation during respiratory endoscopy by using clinical scales despite their subjective nature and the potential change in the level of sedation caused by frequent stimulation. Monitoring by means of the bispectral index (BIS) has shown its utility in reducing the use of drugs and their adverse events in general anesthesia, but evidence in prolonged sedation is insufficient. Our objective was to evaluate BIS in patients undergoing endobronchial ultrasound (EBUS). A randomized cohort study of 90 patients with mediastinal lymph node involvement and/or lung or mediastinal lesions for whom EBUS was indicated, comparing the modified observer's assessment of alertness/sedation scale clinical evaluation (n = 45) versus the BIS evaluation (n = 45) of sedation with propofol-remifentanil, was conducted in order to evaluate the clinical parameters, doses used, adverse events, and tolerance of the procedure. We found a shorter waking time and a significantly lower dose of total propofol in the BIS group. Significantly fewer overall adverse events were recorded in the BIS group and included desaturation, hypotension, and bradypnea. Tolerance was better in the BIS group. No significant differences were found in terms of cough, memory of the procedure, or the level of difficulty of EBUS on the part of the pulmonologists. BIS monitoring of sedation in EBUS makes it possible to reduce the dosage of propofol, thereby shortening the waking time and reducing adverse events. This form of monitoring should be taken into consideration in the future for systematic use in prolonged sedation, as in the case of EBUS. © 2016 S. Karger AG, Basel.

  6. Comments concerning the real risk of sexual adverse events secondary to the use of 5-ARIs

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    Furio Pirozzi Farina

    2016-01-01

    Full Text Available Treatment-induced sexual dysfunctions (SD are a recurrent and controversial topic in recent literature on the adverse events related to the use of 5-alpha-reductase inhibitors (5ARIs (1, 2. In order to deal adequately with the various aspects of this topic, it is necessary to first cover some of the steps that allow a better definition and understanding of the subject.

  7. Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

    Energy Technology Data Exchange (ETDEWEB)

    Showalter, Timothy N., E-mail: tns3b@virginia.edu [Department of Radiation Oncology, University of Virginia, Charlottesville, Virginia (United States); Hegarty, Sarah E. [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Rabinowitz, Carol [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Maio, Vittorio [Jefferson School of Population Health, Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Hyslop, Terry [Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, North Carolina (United States); Dicker, Adam P. [Department of Radiation Oncology, Kimmel Cancer Center & Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Louis, Daniel Z. [Center for Research in Medical Education and Health Care, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania (United States)

    2015-03-15

    Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However

  8. Assessing Adverse Events of Postprostatectomy Radiation Therapy for Prostate Cancer: Evaluation of Outcomes in the Regione Emilia-Romagna, Italy

    International Nuclear Information System (INIS)

    Showalter, Timothy N.; Hegarty, Sarah E.; Rabinowitz, Carol; Maio, Vittorio; Hyslop, Terry; Dicker, Adam P.; Louis, Daniel Z.

    2015-01-01

    Purpose: Although the likelihood of radiation-related adverse events influences treatment decisions regarding radiation therapy after prostatectomy for eligible patients, the data available to inform decisions are limited. This study was designed to evaluate the genitourinary, gastrointestinal, and sexual adverse events associated with postprostatectomy radiation therapy and to assess the influence of radiation timing on the risk of adverse events. Methods: The Regione Emilia-Romagna Italian Longitudinal Health Care Utilization Database was queried to identify a cohort of men who received radical prostatectomy for prostate cancer during 2003 to 2009, including patients who received postprostatectomy radiation therapy. Patients with prior radiation therapy were excluded. Outcome measures were genitourinary, gastrointestinal, and sexual adverse events after prostatectomy. Rates of adverse events were compared between the cohorts who did and did not receive postoperative radiation therapy. Multivariable Cox proportional hazards models were developed for each class of adverse events, including models with radiation therapy as a time-varying covariate. Results: A total of 9876 men were included in the analyses: 2176 (22%) who received radiation therapy and 7700 (78%) treated with prostatectomy alone. In multivariable Cox proportional hazards models, the additional exposure to radiation therapy after prostatectomy was associated with increased rates of gastrointestinal (rate ratio [RR] 1.81; 95% confidence interval [CI] 1.44-2.27; P<.001) and urinary nonincontinence events (RR 1.83; 95% CI 1.83-2.80; P<.001) but not urinary incontinence events or erectile dysfunction. The addition of the time from prostatectomy to radiation therapy interaction term was not significant for any of the adverse event outcomes (P>.1 for all outcomes). Conclusion: Radiation therapy after prostatectomy is associated with an increase in gastrointestinal and genitourinary adverse events. However

  9. The average cost of measles cases and adverse events following vaccination in industrialised countries

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    Kou Ulla

    2002-09-01

    Full Text Available Abstract Background Even though the annual incidence rate of measles has dramatically decreased in industrialised countries since the implementation of universal immunisation programmes, cases continue to occur in countries where endemic measles transmission has been interrupted and in countries where adequate levels of immunisation coverage have not been maintained. The objective of this study is to develop a model to estimate the average cost per measles case and per adverse event following measles immunisation using the Netherlands (NL, the United Kingdom (UK and Canada as examples. Methods Parameter estimates were based on a review of the published literature. A decision tree was built to represent the complications associated with measles cases and adverse events following imminisation. Monte-Carlo Simulation techniques were used to account for uncertainty. Results From the perspective of society, we estimated the average cost per measles case to be US$276, US$307 and US$254 for the NL, the UK and Canada, respectively, and the average cost of adverse events following immunisation per vaccinee to be US$1.43, US$1.93 and US$1.51 for the NL, UK and Canada, respectively. Conclusions These average cost estimates could be combined with incidence estimates and costs of immunisation programmes to provide estimates of the cost of measles to industrialised countries. Such estimates could be used as a basis to estimate the potential economic gains of global measles eradication.

  10. Wheeze as an Adverse Event in Pediatric Vaccine and Drug Randomized Controlled Trials: A Systematic Review

    Science.gov (United States)

    Marangu, Diana; Kovacs, Stephanie; Walson, Judd; Bonhoeffer, Jan; Ortiz, Justin R.; John-Stewart, Grace; Horne, David J.

    2016-01-01

    Introduction Wheeze is an important sign indicating a potentially severe adverse event in vaccine and drug trials, particularly in children. However, there are currently no consensus definitions of wheeze or associated respiratory compromise in randomized controlled trials (RCTs). Objective To identify definitions and severity grading scales of wheeze as an adverse event in vaccine and drug RCTs enrolling children Vaccines made up the majority (90%) of interventions, particularly influenza vaccines (65%). Only 15 trials provided explicit definitions of wheeze. Of 24 studies that described severity, 11 described wheeze severity in the context of an explicit wheeze definition. The remaining 13 studies described wheeze severity where wheeze was defined as part of a respiratory illness or a wheeze equivalent. Wheeze descriptions were elicited from caregiver reports (14%), physical examination by a health worker (45%) or a combination (41%). There were 21/58 studies in which wheeze definitions included combined caregiver report and healthcare worker assessment. The use of these two methods appeared to have the highest combined sensitivity and specificity. Conclusion Standardized wheeze definitions and severity grading scales for use in pediatric vaccine or drug trials are lacking. Standardized definitions of wheeze are needed for assessment of possible adverse events as new vaccines and drugs are evaluated. PMID:26319071

  11. Mining severe drug-drug interaction adverse events using Semantic Web technologies: a case study.

    Science.gov (United States)

    Jiang, Guoqian; Liu, Hongfang; Solbrig, Harold R; Chute, Christopher G

    2015-01-01

    Drug-drug interactions (DDIs) are a major contributing factor for unexpected adverse drug events (ADEs). However, few of knowledge resources cover the severity information of ADEs that is critical for prioritizing the medical need. The objective of the study is to develop and evaluate a Semantic Web-based approach for mining severe DDI-induced ADEs. We utilized a normalized FDA Adverse Event Report System (AERS) dataset and performed a case study of three frequently prescribed cardiovascular drugs: Warfarin, Clopidogrel and Simvastatin. We extracted putative DDI-ADE pairs and their associated outcome codes. We developed a pipeline to filter the associations using ADE datasets from SIDER and PharmGKB. We also performed a signal enrichment using electronic medical records (EMR) data. We leveraged the Common Terminology Criteria for Adverse Event (CTCAE) grading system and classified the DDI-induced ADEs into the CTCAE in the Web Ontology Language (OWL). We identified 601 DDI-ADE pairs for the three drugs using the filtering pipeline, of which 61 pairs are in Grade 5, 56 pairs in Grade 4 and 484 pairs in Grade 3. Among 601 pairs, the signals of 59 DDI-ADE pairs were identified from the EMR data. The approach developed could be generalized to detect the signals of putative severe ADEs induced by DDIs in other drug domains and would be useful for supporting translational and pharmacovigilance study of severe ADEs.

  12. An analysis of potential costs of adverse events based on Drug Programs in Poland. Pulmonology focus

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    Szkultecka-Debek Monika

    2014-06-01

    Full Text Available The project was performed within the Polish Society for Pharmacoeconomics (PTFE. The objective was to estimate the potential costs of treatment of side effects, which theoretically may occur as a result of treatment of selected diseases. We analyzed the Drug Programs financed by National Health Fund in Poland in 2012 and for the first analysis we selected those Programs where the same medicinal products were used. We based the adverse events selection on the Summary of Product Characteristics of the chosen products. We extracted all the potential adverse events defined as frequent and very frequent, grouping them according to therapeutic areas. This paper is related to the results in the pulmonology area. The events described as very common had an incidence of ≥ 1/10, and the common ones ≥ 1/100, <1/10. In order to identify the resources used, we performed a survey with the engagement of clinical experts. On the basis of the collected data we allocated direct costs incurred by the public payer. We used the costs valid in December 2013. The paper presents the estimated costs of treatment of side effects related to the pulmonology disease area. Taking into account the costs incurred by the NHF and the patient separately e calculated the total spending and the percentage of each component cost in detail. The treatment of adverse drug reactions generates a significant cost incurred by both the public payer and the patient.

  13. Adverse events following yellow fever immunization: Report and analysis of 67 neurological cases in Brazil.

    Science.gov (United States)

    Martins, Reinaldo de Menezes; Pavão, Ana Luiza Braz; de Oliveira, Patrícia Mouta Nunes; dos Santos, Paulo Roberto Gomes; Carvalho, Sandra Maria D; Mohrdieck, Renate; Fernandes, Alexandre Ribeiro; Sato, Helena Keico; de Figueiredo, Patricia Mandali; von Doellinger, Vanessa Dos Reis; Leal, Maria da Luz Fernandes; Homma, Akira; Maia, Maria de Lourdes S

    2014-11-20

    Neurological adverse events following administration of the 17DD substrain of yellow fever vaccine (YEL-AND) in the Brazilian population are described and analyzed. Based on information obtained from the National Immunization Program through passive surveillance or intensified passive surveillance, from 2007 to 2012, descriptive analysis, national and regional rates of YFV associated neurotropic, neurological autoimmune disease, and reporting rate ratios with their respective 95% confidence intervals were calculated for first time vaccinees stratified on age and year. Sixty-seven neurological cases were found, with the highest rate of neurological adverse events in the age group from 5 to 9 years (2.66 per 100,000 vaccine doses in Rio Grande do Sul state, and 0.83 per 100,000 doses in national analysis). Two cases had a combination of neurotropic and autoimmune features. This is the largest sample of YEL-AND already analyzed. Rates are similar to other recent studies, but on this study the age group from 5 to 9 years of age had the highest risk. As neurological adverse events have in general a good prognosis, they should not contraindicate the use of yellow fever vaccine in face of risk of infection by yellow fever virus. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Medication errors and adverse drug events in kidney transplant recipients: incidence, risk factors, and clinical outcomes.

    Science.gov (United States)

    Taber, David J; Pilch, Nicole A; Bratton, Charles F; McGillicuddy, John W; Chavin, Kenneth D; Baliga, Prabhakar K

    2012-12-01

    To determine the incidence, risk factors, and clinical outcomes associated with clinically significant medication errors or adverse drug events in kidney transplant recipients. Retrospective observational study. Transplant center at an academic medical center. A total of 476 adults who received kidney transplants between June 2006 and July 2009. Severe or significant medication errors and adverse drug events (medication-related problems [MRPs]) were identified by medical record review. Only patient-induced medication errors (e.g., took wrong dose or frequency of drug, took drug not prescribed) were captured. Clinical outcomes included patient and graft survival, infections (including cytomegalovirus), readmissions, and acute rejection episodes. Thirty-seven (8%) of the 476 patients developed a clinically significant MRP. Univariate and confirmatory multivariate analyses revealed that female sex, African-American race, pretransplantation diabetes mellitus, delayed graft function, and retransplant recipients were independent risk factors for developing an MRP. Patients with MRPs had significantly higher rates of acute rejection (11% vs 30%, p=0.004), cytomegalovirus infection (15% vs 30%, p=0.033), and 30-day readmissions (5% vs 16%, p=0.018). Graft survival was also significantly lower in patients who had MRPs (pmedication errors and associated adverse drug events were common in kidney transplant recipients. General and transplant-specific risk factors were associated with the development of these MRPs, and MRPs were associated with increased risk of rejection and graft loss. © 2012 Pharmacotherapy Publications, Inc.

  15. Facilitating adverse drug event detection in pharmacovigilance databases using molecular structure similarity: application to rhabdomyolysis

    Science.gov (United States)

    Vilar, Santiago; Harpaz, Rave; Chase, Herbert S; Costanzi, Stefano; Rabadan, Raul

    2011-01-01

    Background Adverse drug events (ADE) cause considerable harm to patients, and consequently their detection is critical for patient safety. The US Food and Drug Administration maintains an adverse event reporting system (AERS) to facilitate the detection of ADE in drugs. Various data mining approaches have been developed that use AERS to detect signals identifying associations between drugs and ADE. The signals must then be monitored further by domain experts, which is a time-consuming task. Objective To develop a new methodology that combines existing data mining algorithms with chemical information by analysis of molecular fingerprints to enhance initial ADE signals generated from AERS, and to provide a decision support mechanism to facilitate the identification of novel adverse events. Results The method achieved a significant improvement in precision in identifying known ADE, and a more than twofold signal enhancement when applied to the ADE rhabdomyolysis. The simplicity of the method assists in highlighting the etiology of the ADE by identifying structurally similar drugs. A set of drugs with strong evidence from both AERS and molecular fingerprint-based modeling is constructed for further analysis. Conclusion The results demonstrate that the proposed methodology could be used as a pharmacovigilance decision support tool to facilitate ADE detection. PMID:21946238

  16. The Evaluation of a Pulmonary Display to Detect Adverse Respiratory Events Using High Resolution Human Simulator

    Science.gov (United States)

    Wachter, S. Blake; Johnson, Ken; Albert, Robert; Syroid, Noah; Drews, Frank; Westenskow, Dwayne

    2006-01-01

    Objective Authors developed a picture-graphics display for pulmonary function to present typical respiratory data used in perioperative and intensive care environments. The display utilizes color, shape and emergent alerting to highlight abnormal pulmonary physiology. The display serves as an adjunct to traditional operating room displays and monitors. Design To evaluate the prototype, nineteen clinician volunteers each managed four adverse respiratory events and one normal event using a high-resolution patient simulator which included the new displays (intervention subjects) and traditional displays (control subjects). Between-group comparisons included (i) time to diagnosis and treatment for each adverse respiratory event; (ii) the number of unnecessary treatments during the normal scenario; and (iii) self-reported workload estimates while managing study events. Measurements Two expert anesthesiologists reviewed video-taped transcriptions of the volunteers to determine time to treat and time to diagnosis. Time values were then compared between groups using a Mann-Whitney-U Test. Estimated workload for both groups was assessed using the NASA-TLX and compared between groups using an ANOVA. P-values < 0.05 were considered significant. Results Clinician volunteers detected and treated obstructed endotracheal tubes and intrinsic PEEP problems faster with graphical rather than conventional displays (p < 0.05). During the normal scenario simulation, 3 clinicians using the graphical display, and 5 clinicians using the conventional display gave unnecessary treatments. Clinician-volunteers reported significantly lower subjective workloads using the graphical display for the obstructed endotracheal tube scenario (p < 0.001) and the intrinsic PEEP scenario (p < 0.03). Conclusion Authors conclude that the graphical pulmonary display may serve as a useful adjunct to traditional displays in identifying adverse respiratory events. PMID:16929038

  17. The longitudinal relation between accumulation of adverse life events and body mass index from early adolescence to young adulthood

    NARCIS (Netherlands)

    Elsenburg, Leonie K.; Smidt, Nynke; Liefbroer, Aart C.

    2017-01-01

    Objective: Stressors, such as adverse life events, can cause weight changes through behavioral and biological mechanisms. Whether the accumulation of adverse life events is related to body mass index (BMI) across multiple time points from early adolescence to young adulthood has not been

  18. A Hospital Nursing Adverse Events Reporting System Project: An Approach Based on the Systems Development Life Cycle.

    Science.gov (United States)

    Cao, Yingjuan; Ball, Marion

    2017-01-01

    Based on the System Development Life Cycle, a hospital based nursing adverse event reporting system was developed and implemented which integrated with the current Hospital Information System (HIS). Besides the potitive outcomes in terms of timeliness and efficiency, this approach has brought an enormous change in how the nurses report, analyze and respond to the adverse events.

  19. The Longitudinal Relation Between Accumulation of Adverse Life Events and Body Mass Index From Early Adolescence to Young Adulthood

    NARCIS (Netherlands)

    Elsenburg, L.; Smidt, N.; Liefbroer, A.C.

    2017-01-01

    Objective: Stressors, such as adverse life events, can cause weight changes through behavioral and biological mechanisms. Whether the accumulation of adverse life events is related to body mass index (BMI) across multiple time points from early adolescence to young adulthood has not been

  20. The Longitudinal Relation Between Accumulation of Adverse Life Events and Body Mass Index From Early Adolescence to Young Adulthood

    NARCIS (Netherlands)

    Elsenburg, Leonie K.; Smidt, Nynke; Liefbroer, Aart C.

    Objective: Stressors, such as adverse life events, can cause weight changes through behavioral and biological mechanisms. Whether the accumulation of adverse life events is related to body mass index (BMI) across multiple time points from early adolescence to young adulthood has not been

  1. Standardized reporting of adverse events after microvascular decompression of cranial nerves; a population-based single-institution consecutive series

    DEFF Research Database (Denmark)

    Bartek, Jiri; Gulati, Sasha; Unsgård, Geirmund

    2016-01-01

    OBJECTIVE: To investigate frequencies of adverse events occurring within 30 days after microvascular decompression (MVD) surgery using a standardized report form of adverse events. METHODS: We conducted a retrospective review of 98 adult patients (≥16 years) treated with MVD between 1 January 199...

  2. Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments.

    Science.gov (United States)

    Tfelt-Hansen, Peer; Lindqvist, Janus Kaufmann; Do, Thien Phu

    2018-01-01

    Background In 2008, the International Headache Society published guidelines on the "evaluation and registration of adverse events in clinical drug trials on migraine". They listed seven recommendations for reporting adverse events in randomized controlled trials on migraine. The present study aimed to evaluate adherence to these recommendations, and based on the results, to recommend improvements. Methods We searched the PubMed/MEDLINE database to identify controlled trials on migraine drugs published from 2010 to 2015. For each trial, we noted whether five of the recommended parameters were presented. In addition, we noted whether adverse events were reported in abstracts. Results We identified 73 trials; 51 studied acutely administered drugs and 22 studied prophylactic drugs for migraine. The number of patients with any adverse events were reported in 74% of acute-administration and 86% of prophylactic drug trials. Only 30 (41%) of the 73 studies reported adverse events with data in the abstracts, and 27 (37%) abstracts did not mention adverse events. Conclusion Adverse events, both frequency and symptoms, should be reported to allow a fair judgement of benefit/tolerability ratio when randomized controlled trials in migraine treatment are published. Clinically significant adverse events should be included in the abstract of every randomized controlled trial in migraine treatment.

  3. Predictive factors for reporting adverse events following spinal manipulation in randomized clinical trials - secondary analysis of a systematic review.

    Science.gov (United States)

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

    2017-08-01

    While spinal manipulative therapy (SMT) is recommended for the treatment of spinal disorders, concerns exist about adverse events associated with the intervention. Adequate reporting of adverse events in clinical trials would allow for more accurate estimations of incidence statistics through meta-analysis. However, it is not currently known if there are factors influencing adverse events reporting following SMT in randomized clinical trials (RCTs). Thus our objective was to investigate predictive factors for the reporting of adverse events in published RCTs involving SMT. The Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included: sample size; publication date relative to the 2010 CONSORT statement; risk of bias; the region treated; and number of intervention sessions. 7398 records were identified, of which 368 articles were eligible for inclusion. A total of 140 (38.0%) articles reported on adverse events. Articles were more likely to report on adverse events if they possessed larger sample sizes, were published after the 2010 CONSORT statement, had a low risk of bias and involved multiple intervention sessions. The region treated was not a significant predictor for reporting on adverse events. Predictors for reporting on adverse events included larger sample size, publication after the 2010 CONSORT statement, low risk of bias and trials involving multiple intervention sessions. We recommend that researchers focus on developing robust methodologies and participant follow-up regimens for RCTs involving SMT. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Review of published cases of adverse cardiovascular events after ingestion of energy drinks.

    Science.gov (United States)

    Goldfarb, Michael; Tellier, Claudia; Thanassoulis, George

    2014-01-01

    Energy drink (ED) consumption has been linked to several adverse event reports, but there is limited data on related cardiovascular (CV) complications. We describe clinical characteristics, ED consumption profile, co-ingestions, and results of cardiovascular testing in a series of cardiovascular event reports temporally related to ED consumption from the literature. We searched PubMed and Embase for case reports in peer-reviewed journals from January 1, 1980, to February 1, 2013, in which an acute CV event was associated temporally with ED consumption. We identified 14 eligible articles involving 15 cases (5 atrial arrhythmias, 5 ventricular arrhythmias, 1 QT prolongation, 4 ST-segment elevations). Two additional cases of cardiac arrest from our institution are included. Of these 17 cases of ED-related acute CV events (13 male cases; 15 cases aged cases. Of the 11 cases related to a serious event (i.e., cardiac arrest, ventricular arrhythmia, or ST-segment elevations), 5 reported acute heavy ED consumption, 4 reported co-ingestions with alcohol or other drugs, and 2 were found to have a channelopathy. Potential mechanisms of ED-related cardiac events are reviewed. In conclusion, several adverse CV events after consuming ED have been reported in the literature. Although causality cannot be inferred from our series, physicians should routinely inquire about ED consumption in relevant cases, and vulnerable consumers such as youth should be advised that caution is warranted with heavy consumption and/or with concomitant alcohol or drug ingestion. Copyright © 2014 Elsevier Inc. All rights reserved.

  5. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    2016-08-01

    Full Text Available Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal, which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of

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

    Science.gov (United States)

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

    2017-10-01

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

  7. Adverse events among high-risk participants in a home-based walking study: a descriptive study

    Directory of Open Access Journals (Sweden)

    Holleman Robert G

    2007-05-01

    Full Text Available Abstract Background For high-risk individuals and their healthcare providers, finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult. More information on the prevalence and influence of adverse events is needed to improve providers' ability to prescribe effective and safe exercise programs for their patients. Methods This study describes the type and severity of adverse events reported by participants with cardiovascular disease or at-risk for cardiovascular disease that occurred during an unsupervised, home-based walking study. This multi-site, randomized controlled trial tested the feasibility of a diet and lifestyle activity intervention over 1.5 years. At month 13, 274 eligible participants (male veterans were recruited who were ambulatory, BMI > 28, and reporting one or more cardiovascular disease risk factors. All participants attended five, face-to-face dietitian-delivered counseling sessions during the six-month intervention. Participants were randomized to three study arms: 1 time-based walking goals, 2 simple pedometer-based walking goals, and 3 enhanced pedometer-based walking goals with Internet-mediated feedback. Two physicians verified adverse event symptom coding. Results Enrolled participants had an average of five medical comorbidities. During 1110 person months of observation, 87 of 274 participants reported 121 adverse events. One serious study-related adverse event (atrial fibrillation was reported; the individual resumed study participation within three days. Non-serious, study related adverse events made up 12% of all symptoms – predominantly minor musculoskeletal events. Serious, non-study related adverse events represented 32% of all symptoms while non-serious, non-study related adverse events made up 56% of symptoms. Cardiovascular disease events represented over half of the non-study related adverse event symptoms followed by musculoskeletal complaints

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

    Science.gov (United States)

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

    2013-11-01

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

  9. Late gadolinium enhancement by magnetic resonance explains adverse cardiac events in individuals with ventricular arrhythmia

    International Nuclear Information System (INIS)

    Courtis, J.; Vasallo, J.; Arabia, L.; Dimitroff, M.; Gonzalez, A.; Tibaldi, M.

    2012-01-01

    Objective: To determine whether the presence of late gadolinium enhancement (LGE) by cardiovascular magnetic resonance (CMR) predict adverse cardiac events in patients with ventricular arrhythmia. Methods: We selected 74 consecutive patients with symptomatic ventricular arrhythmia (premature ventricular contractions and ventricular tachycardia) and left ventricular ejection fraction (LVEF) >55% sent to CMR for evaluation of structural heart disease previously undetected by other complementary methods. LGE, systolic function and volumes of both ventricles were analyzed. At follow-up was assessed a combined end point: hospitalization for ventricular arrhythmia, appropriate implantable cardioverter-defibrillator therapy and cardiac death. Results: During a median follow up of 575 days (interquartile range 24-1120 days) and by analyzing the population according to the presence (n=9, 12%) or not (n=65, 88%) LGE was observed that the group with positive Gd had lower LVEF (58% vs. 66% respectively, p=0.01) and larger volumes (EDV: 185 ml vs. 123 ml respectively, p=0.01 and ESV: 81 ml vs. 42 ml respectively, p=0.01) than the other group. Two (22%) patients in the LGE + group vs. one (4%) of those without LGE showed the combined endpoint (p=0.01) and when performing a logistic regression analysis it was found that the LGE is a predictor of adverse cardiac events analyzed (p=0.029). Conclusions: In this consecutive series of patients with ventricular arrhythmia we demonstrate a strong association between myocardial LGE and adverse cardiac events; this supports the hypothesis that myocardial fibrosis is an important arrhythmogenic substrate. In addition, almost all individuals without LGE were free of events during follow-up suggesting that it is possible to identify through the CMR low-risk individuals who can be treated conservatively. (authors) [es

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

    Science.gov (United States)

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

    2015-06-22

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

  11. Is fasting safe? A chart review of adverse events during medically supervised, water-only fasting.

    Science.gov (United States)

    Finnell, John S; Saul, Bradley C; Goldhamer, Alan C; Myers, Toshia R

    2018-02-20

    Evidence suggests that fasting, during which only water is consumed, results in potentially health promoting physiological effects. However, peer-reviewed research assessing the safety of water-only fasting is lacking. To address this, we conducted a chart review to describe adverse events (AEs) that occurred during medically supervised, water-only fasting. Electronic charts from patient visits to a residential medical facility from 2006 to 2011 were reviewed. Patients who were at least 21 years of age and water-only fasted for ≥2 consecutive days with a refeeding period equal to half of the fast length were included. Out of 2539 charts, 768 visits met our inclusion and exclusion criteria. AEs were abstracted from chart notes and classified according to CTCAE (v4.03) and MedDRA (v12.1) terminology. Descriptive analysis of AEs is reported. During the protocol period, the highest grade AE (HGAE) in 555 visits was a grade 2 event or lower, in 212 visits it was a grade 3 event, in 1 visit it was a grade 4 event, and there were no grade 5 events. There were 2 (0.002%) visits with a serious adverse event (SAE). The majority of AEs identified were mild (n = 4490, 75%) in nature and known reactions to fasting. To our knowledge, this is the most comprehensive analysis of AEs experienced during medically supervised, water-only fasting conducted to date. Overall, our data indicate that the majority of AEs experienced were mild to moderate and known reactions to fasting. This suggests that the protocol used in this study can be safely implemented in a medical setting with minimal risk of a SAE.

  12. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches.

    Science.gov (United States)

    Funt, David; Pavicic, Tatjana

    2015-01-01

    The ever-expanding range of dermal filler products for aesthetic soft tissue augmentation is of benefit for patients and physicians, but as indications and the number of procedures performed increase, the number of complications will likely also increase. To describe potential adverse events associated with dermal fillers and to provide structured and clear guidance on their treatment and avoidance. Reports of dermal filler complications in the medical literature were reviewed and, based on the publications retrieved and the authors' extensive experience, recommendations for avoiding and managing complications are provided. Different dermal fillers have widely varying properties, associated risks, and injection requirements. All dermal fillers have the potential to cause complications. Most are related to volume and technique, though some are associated with the material itself. The majority of adverse reactions are mild and transient, such as bruising and trauma-related edema. Serious adverse events are rare, and most are avoidable with proper planning and technique. For optimum outcomes, aesthetic physicians should have a detailed understanding of facial anatomy; the individual characteristics of available fillers; their indications, contraindications, benefits, and drawbacks; and ways to prevent and avoid potential complications.

  13. 3D Pharmacophoric Similarity improves Multi Adverse Drug Event Identification in Pharmacovigilance

    Science.gov (United States)

    Vilar, Santiago; Tatonetti, Nicholas P.; Hripcsak, George

    2015-03-01

    Adverse drugs events (ADEs) detection constitutes a considerable concern in patient safety and public health care. For this reason, it is important to develop methods that improve ADE signal detection in pharmacovigilance databases. Our objective is to apply 3D pharmacophoric similarity models to enhance ADE recognition in Offsides, a pharmacovigilance resource with drug-ADE associations extracted from the FDA Adverse Event Reporting System (FAERS). We developed a multi-ADE predictor implementing 3D drug similarity based on a pharmacophoric approach, with an ADE reference standard extracted from the SIDER database. The results showed that the application of our 3D multi-type ADE predictor to the pharmacovigilance data in Offsides improved ADE identification and generated enriched sets of drug-ADE signals. The global ROC curve for the Offsides ADE candidates ranked with the 3D similarity score showed an area of 0.7. The 3D predictor also allows the identification of the most similar drug that causes the ADE under study, which could provide hypotheses about mechanisms of action and ADE etiology. Our method is useful in drug development, screening potential adverse effects in experimental drugs, and in drug safety, applicable to the evaluation of ADE signals selected through pharmacovigilance data mining.

  14. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches

    Directory of Open Access Journals (Sweden)

    Funt D

    2013-12-01

    Full Text Available David Funt,1 Tatjana Pavicic21Mount Sinai Hospital, Department of Plastic Surgery, New York, NY, USA; 2Department of Dermatology and Allergy, Ludwig-Maximilian University of Munich, Munich, GermanyBackground: The ever-expanding range of dermal filler products for aesthetic soft tissue augmentation is of benefit for patients and physicians, but as indications and the number of procedures performed increase, the number of complications will likely also increase.Objective: To describe potential adverse events associated with dermal fillers and to provide structured and clear guidance on their treatment and avoidance.Methods: Reports of dermal filler complications in the medical literature were reviewed and, based on the publications retrieved and the authors' extensive experience, recommendations for avoiding and managing complications are provided.Results: Different dermal fillers have widely varying properties, associated risks, and injection requirements. All dermal fillers have the potential to cause complications. Most are related to volume and technique, though some are associated with the material itself. The majority of adverse reactions are mild and transient, such as bruising and trauma-related edema. Serious adverse events are rare, and most are avoidable with proper planning and technique.Conclusion: For optimum outcomes, aesthetic physicians should have a detailed understanding of facial anatomy; the individual characteristics of available fillers; their indications, contraindications, benefits, and drawbacks; and ways to prevent and avoid potential complications.Keywords: aesthetic medicine, complications

  15. Frequency and Impact of Adverse Events in Inpatients: A Nationwide Analysis of Episodes between 2000 and 2015.

    Science.gov (United States)

    Sousa-Pinto, Bernardo; Marques, Bernardo; Lopes, Fernando; Freitas, Alberto

    2018-01-26

    Despite being a potential cause of morbidity and economic costs, adverse events remain insufficiently studied. Therefore, we aimed to assess the frequency and impact of adverse events among inpatients. We analysed an administrative database containing a registration of all hospitalisations occurring in Portuguese public hospitals between 2000 and 2015. We identified all episodes with a registration of adverse events, and classified them into three categories, namely (1) misadventures of surgical and medical care, (2) complications of surgical or medical procedures, and (3) adverse drug events (including adverse drug reactions, poisoning events, and late effects). These episodes were compared over their length of stay, in-hospital mortality, and hospital costs with an equal number of hospitalisations matched for patients' and episodes' characteristics. Between 2000 and 2015, 5.8% (n = 861,372) of all Portuguese hospitalisations had a registration of at least one adverse event. Hospitalisations with registration of adverse events had a median length of stay of 8 days, median hospitalisation costs of 3060.7 Euro, and an in-hospital mortality of 6.7%. Hospitalisations with registration of misadventures of care, complications of procedures and adverse drug reactions had significantly higher lengths of stay and hospitalisation costs than their matched controls. In-hospital mortality was significantly higher for episodes of misadventures of care and complications of procedures, but lower for adverse drug events hospitalisations. Therefore, adverse events are common among inpatients, and have an important clinical and economic impact. Administrative databases may be useful in their epidemiological assessment.

  16. Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care

    DEFF Research Database (Denmark)

    Thomsen, Linda Aagaard; Winterstein, Almut G; Søndergaard, Birthe

    2007-01-01

    OBJECTIVE: To estimate the incidence and describe characteristics of preventable adverse drug events (pADEs) in ambulatory care. DATA SOURCES: Studies were searched in PubMed (1966-March 2007), International Pharmaceutical Abstracts (1970-December 2006), the Cochrane database of systematic reviews...... (1993-March 2007), EMBASE (1980-February 2007), and Web of Science (1945-March 2007). Key words included medication error, adverse drug reaction, iatrogenic disease, outpatient, ambulatory care, primary health care, general practice, patient admission, hospitalization, observational study, retrospective....../pADE incidence, (2) clinical outcomes, (3) associated drug groups, and/or (4) underlying medication errors were included. Study country, year and design, sample size, follow-up time, ADE/pADE identification method, proportion of ADEs/pADEs and ADEs/pADEs requiring hospital admission, and frequency distribution...

  17. Rare adverse events due to house dust mite sublingual immunotherapy in pediatric practice: two case reports.

    Science.gov (United States)

    Galip, Nilufer; Bahceciler, Nerin

    2015-01-01

    Sublingual route, a noninjective way of allergen administration appears to be associated with a lower incidence of severe systemic reactions compared with the subcutaneous route. Local adverse reactions are reported which resolve spontaneously within a few days without need for discontinuation of treatment. Hereby, we report two pediatric cases, one with persistent asthma and the other one with persistent allergic rhinitis. Both were treated by house dust mite sublingual immunotherapy, one of whom developed severe wheezing (grade 2 systemic reaction based on World Allergy Organization subcutaneous systemic reaction grading system) and the other intractable vomiting (grade 3 local reaction based on World Allergy Organization sublingual immunotherapy local adverse events grading system) at the end of the build-up phase which repeated on re-administration of the same dose. Both of those two cases completed their 3-year immunotherapy successfully by patient-based adjustment of the highest tolerated dose of the maintenance.

  18. Gender differences in the pathway from adverse life events to adolescent emotional and behavioural problems via negative cognitive errors.

    Science.gov (United States)

    Flouri, Eirini; Panourgia, Constantina

    2011-06-01

    The aim of this study was to test for gender differences in how negative cognitive errors (overgeneralizing, catastrophizing, selective abstraction, and personalizing) mediate the association between adverse life events and adolescents' emotional and behavioural problems (measured with the Strengths and Difficulties Questionnaire). The sample consisted of 202 boys and 227 girls (aged 11-15 years) from three state secondary schools in disadvantaged areas in one county in the South East of England. Control variables were age, ethnicity, special educational needs, exclusion history, family structure, family socio-economic disadvantage, and verbal cognitive ability. Adverse life events were measured with Tiet et al.'s (1998) Adverse Life Events Scale. For both genders, we assumed a pathway from adverse life events to emotional and behavioural problems via cognitive errors. We found no gender differences in life adversity, cognitive errors, total difficulties, peer problems, or hyperactivity. In both boys and girls, even after adjustment for controls, cognitive errors were related to total difficulties and emotional symptoms, and life adversity was related to total difficulties and conduct problems. The life adversity/conduct problems association was not explained by negative cognitive errors in either gender. However, we found gender differences in how adversity and cognitive errors produced hyperactivity and internalizing problems. In particular, life adversity was not related, after adjustment for controls, to hyperactivity in girls and to peer problems and emotional symptoms in boys. Cognitive errors fully mediated the effect of life adversity on hyperactivity in boys and on peer and emotional problems in girls.

  19. Apologies following an adverse medical event: The importance of focusing on the consumer's needs.

    Science.gov (United States)

    Allan, Alfred; McKillop, Dianne; Dooley, Julian; Allan, Maria M; Preece, David A

    2015-09-01

    The lack of a theoretical framework limits educators' ability to train health practitioners how to disclose, and apologise for adverse medical events. The multidimensional theory of apology proposes apologies consist of one or more components which can either be self-focused (focused on the apologiser's needs) or other-focused (focused on the needs of the consumer). We investigated whether the inclusion of other-focused elements in an apology enhanced its impact in a health setting. 251 participants responded to a video-recording of an actor portraying a surgeon apologising to a patient for an adverse event. In one condition the apology was exclusively self-focused and in the other it was both self and other-focused. The self-focused apology was viewed more positively than negatively, but the apology that included additional other-focused elements elicited a more favourable reaction; it was seen as more sincere and as denoting more sorriness. Practitioners can enhance the impact of their apologies by including other-focused elements, that is, demonstrate they understand the impact the event had on the consumers, express remorse for causing harm, and offer, or take action, to address the intangible harm caused. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  20. Racial and Ethnic Disparities in Adverse Drug Events: A Systematic Review of the Literature.

    Science.gov (United States)

    Baehr, Avi; Peña, Juliet C; Hu, Dale J

    2015-12-01

    The 2014 National Action Plan for Adverse Drug Event Prevention has recognized adverse drug events (ADEs) as a national priority in order to facilitate a nationwide reduction in patient harms from these events. Throughout this effort, it will be integral to identify populations that may be at particular risk in order to improve care for these patients. We have undertaken a systematic review to evaluate the evidence regarding racial or ethnic disparities in ADEs with particular emphasis on anticoagulants, diabetes agents, and opioids due to the clinical significance and preventability of ADEs associated with these medication classes. From an initial search yielding 3302 studies, we identified 40 eligible studies. Twenty-seven of these included studies demonstrated the presence of a racial or ethnic disparity. There was no consistent evidence for racial or ethnic disparities in the eight studies of ADEs in general. Asians were most frequently determined to be at higher risk of anticoagulant-related ADEs, and black patients were most frequently determined to be at higher risk for diabetes agents-related ADEs. Whites were most frequently identified as at increased risk for opioid-related ADEs. However, few of these studies were specifically designed to evaluate racial or ethnic disparities, lacking a standardized approach to racial/ethnic categorization as well as control for potential confounders. We suggest the need for targeted interventions to reduce ADEs in populations that may be at increased risk, and we suggest strategies for future research.

  1. Do prescription stimulants increase the risk of adverse cardiovascular events?: A systematic review

    Directory of Open Access Journals (Sweden)

    Westover Arthur N

    2012-06-01

    Full Text Available Abstract Background There is increasing concern that prescription stimulants may be associated with adverse cardiovascular events such as stroke, myocardial infarction, and sudden death. Public health concerns are amplified by increasing use of prescription stimulants among adults. Methods The objective of this study was to conduct a systematic review of the evidence of an association between prescription stimulant use and adverse cardiovascular outcomes. PUBMED, MEDLINE, EMBASE and Google Scholar searches were conducted using key words related to these topics (MESH: ADHD; Adults; Amphetamine; Amphetamines; Arrhythmias, Cardiac; Cardiovascular Diseases; Cardiovascular System; Central Nervous Stimulants; Cerebrovascular; Cohort Studies; Case–control Studies; Death; Death, Sudden, Cardiac; Dextroamphetamine; Drug Toxicity; Methamphetamine; Methylphenidate; Myocardial Infarction; Stimulant; Stroke; Safety. Eligible studies were population-based studies of children, adolescents, or adults using prescription stimulant use as the independent variable and a hard cardiovascular outcome as the dependent variable. Results Ten population-based observational studies which evaluated prescription stimulant use with cardiovascular outcomes were reviewed. Six out of seven studies in children and adolescents did not show an association between stimulant use and adverse cardiovascular outcomes. In contrast, two out of three studies in adults found an association. Conclusions Findings of an association between prescription stimulant use and adverse cardiovascular outcomes are mixed. Studies of children and adolescents suggest that statistical power is limited in available study populations, and the absolute risk of an event is low. More suggestive of a safety signal, studies of adults found an increased risk for transient ischemic attack and sudden death/ventricular arrhythmia. Interpretation was limited due to differences in population, cardiovascular outcome

  2. Identifying adverse drug event information in clinical notes with distributional semantic representations of context.

    Science.gov (United States)

    Henriksson, Aron; Kvist, Maria; Dalianis, Hercules; Duneld, Martin

    2015-10-01

    For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  3. Adverse events due to suspected nickel hypersensitivity in patients with essure micro-inserts.

    Science.gov (United States)

    Zurawin, Robert K; Zurawin, Jonathan L

    2011-01-01

    To review reported adverse events associated with suspected nickel hypersensitivity and subsequent clinical outcomes in patients with Essure implants and to evaluate the correlation of nickel allergy-related adverse events with positive results of nickel patch testing. Case series (Canadian Task Force classification II-3). Reports of suspected nickel hypersensitivity reported from 2001 through July 21, 2010, were collected from de-identified data obtained from the MAUDE (Manufacturer and User Facility Device Experience) database and reports to the manufacturer directly from treating physicians, and published results for the 650 patients in the Phase II and Pivotal trials. Clinical outcomes and symptom resolution, when available, were obtained from de-identified information provided by the treating physicians to the manufacturer. Patients were not directly contacted for the study, and patient files were not reviewed. Patch testing was performed at the discretion of the treating physicians. Results were reported as positive or negative, without mention of the method or brand of patch testing used. Even considering the possibility of underreporting by several orders of magnitude, the reported incidence of adverse events suspected to be related to nickel hypersensitivity in patients with Essure micro-inserts is extremely small (0.01%). The incidence of confirmed nickel reactions is even smaller. This very low incidence of clinical reactions is consistent with data from other nickel-containing implantable devices and is reassuring, raising the question of whether nickel reactions are clinically relevant in the use of nitinol-containing micro-inserts for hysteroscopic sterilization. Copyright © 2011 AAGL. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2012-01-01

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

  5. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in indiv......OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  6. Adverse drug events leading to emergency department visits at an eye hospital: A brief report.

    Science.gov (United States)

    Alizadeh, Safa; Mohebbi, Niayesh; Gholami, Kheirollah; Jabbarvand, Mahmoud

    2017-06-01

    To evaluate adverse drug events (ADEs) resulting in emergency department visits in an eye hospital. Emergency department visits at Farabi Eye Hospital were assessed for a 7-day period. The patients' eye disorders and drug history were evaluated to detect ADEs. Of 1631 emergency visits, 5 (0.3%, 95% CI: 0.13-0.71%) were drug related. Tetracaine eye drops accounted for 4 (80%, 95% CI: 38-96%) cases with corneal involvement. The other case was an intense conjunctival injection due to naphazoline eye drops. ADEs should be considered in differential diagnosis of ocular emergency problems and preventive measure should be considered.

  7. [Analysis on the adverse events following immunization of 10 infants death after hepatitis B vaccination].

    Science.gov (United States)

    Wang, Fu-Zhen; Cui, Fu-Qiang; Liu, Da-Wei

    2009-02-01

    To evaluate the safety of Hepatitis B vaccine by analyzing the 10 infants death after Hepatitis B vaccination. Collect the reporting data from the public health emergencies report system of China Disease Prevention and Control System. In the 10 death cases after hepatitis B vaccination, 2 cases would be acute anaphylactic shock caused by the vaccination, and the other 8 death cases were not related to vaccination. The hepatitis B vaccine of China were safety, there were very few death cases of allergic reactions following hepatitis B vaccination. We should standardize the vaccination in order to reduce the adverse events following immunization.

  8. Vaccine adverse event monitoring systems across the European Union countries: time for unifying efforts.

    LENUS (Irish Health Repository)

    Zanoni, Giovanna

    2009-05-26

    A survey conducted among 26 European Countries within the Vaccine European New Integrated Collaboration Effort (VENICE) project assessed the status of organization in prevention and management of adverse events following immunization (AEFI) and level of interconnection, with the aim at individuating points of strength and weakness. The emerging picture is for a strong political commitment to control AEFIs in Member States (MS), but with consistent heterogeneity in procedures, regulations and capacity of systems to collect, analyze and use data, although with great potentialities. Suggestions are posed by authors to promote actions for unifying strategies and policies among MS.

  9. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

    DEFF Research Database (Denmark)

    Maiers, Michele; Evans, Roni; Hartvigsen, Jan

    2015-01-01

    Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE...... was high among the 241 randomized participants. Non-serious AE were reported by 130/194 participants. AE were reported by three times as many participants in supervised plus home exercise, and nearly twice as many as in SMT with home exercise, as in home exercise alone. The majority of AE were...

  10. Cost analysis of adverse events associated with non-small cell lung cancer management in France

    Directory of Open Access Journals (Sweden)

    Chouaid C

    2017-07-01

    Full Text Available Christos Chouaid,1 Delphine Loirat,2 Emilie Clay,3 Aurélie Millier,3 Chloé Godard,4 Amira Fannan,4 Laurie Lévy-Bachelot,4 Eric Angevin5 1Chest Department, Centre Hospitalier Intercommunal Créteil, Créteil, France; 2Institut Curie, Paris, France; 3Creativ-Ceutical, Paris, France; 4MSD France, Courbevoie, France; 5Institut Gustave Roussy, Villejuif, France Background: Adverse events (AEs related to medical treatments in non-small cell lung cancer (NSCLC are frequent and need an appropriate costing in health economic models. Nevertheless, data on costs associated with AEs in NSCLC are scarce, particularly since the development of immunotherapy with specific immune-related AEs.Objective: To estimate the costs of grades 3 and 4 AEs related to NSCLC treatments including immunotherapy in France.Methods: Grades 3 and 4 AEs related to treatment and reported in at least 1% of patients in Phase III clinical trials for erlotinib, ramucirumab plus docetaxel, docetaxel, pemetrexed plus carboplatin plus bevacizumab, platinum-based chemotherapies, nivolumab and pembrolizumab were identified. When no cost evaluation was reported in literature, estimates on standard treatments and medical resource use for each AE were obtained thanks to an expert panel. Total cost per AE was calculated from a French national health insurance perspective and updated in 2017 Euros. Hospital stay costs were estimated based on public and private weighted tariffs and data from the French Medical Information System (Programme de Médicalisation des Systèmes d’Information. Costs of tests, consultations and treatments were calculated based on national reimbursement tariffs.Results: Overall, costs of grades 3 and 4 AEs related to treatment ranged from €46 per event to €7,742 per year. Fourteen out of 24 AEs identified had a mean estimated cost over €2,000. The highest mean costs were related to type 1 diabetes (€7,742 per year followed by pneumonitis (€5,786 per event

  11. Association between CACNA1C gene polymorphisms and ritodrine-induced adverse events in preterm labor patients.

    Science.gov (United States)

    Baek, Min Young; Hwang, Han Sung; Park, Jin Young; Chung, Jee Eun; Lee, Kyung Eun; Lee, Gwan Yung; Seong, Jin Won; Yee, Jeong; Kim, Young Ju; Gwak, Hye Sun

    2017-07-01

    As a tocolytic agent, ritodrine has been used in European and Asian countries but has lost popularity due to safety concerns. This study aimed to investigate the relationship between adverse drug events caused by ritodrine and the CACNA1C polymorphisms in preterm labor patients. Data were collected from medical records including maternal age, gestational age, body mass index, dilation score, effacement score, modified Bishop score, maximum infusion rate, and adverse drug events. Five single-nucleotide polymorphisms of the CACNA1C gene (rs10774053, rs215994, rs215976, rs2239128, and rs2041135) were analyzed. One hundred eighty-six patients were included, 33 of whom had adverse drug events. A allele carriers of rs10774053 showed about 0.293-fold lower adverse drug events than GG genotype carriers (p = 0.012, absolute risk reduction = 16.5%) after adjusting for other confounding variables; the number needed to genotype for preventing one patient with GG genotype from suffering higher incidence of adverse drug events was calculated to be 14.6. Increase in maximum infusion rate of 1 mL/h was associated with a 1.03-fold (95% CI 1.01~1.06, p = 0.005) increased risk of adverse drug events. None of the patients with a CC genotype of rs215994 had adverse drug events, whereas 22.1% of the T allele carriers had adverse drug events. This study showed that CACNA1C gene polymorphisms could alter the probability of adverse drug event risk when ritodrine is used in preterm labor.

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

    Science.gov (United States)

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

    2003-01-24

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

  13. Adverse events in critical care: Search and active detection through the Trigger Tool.

    Science.gov (United States)

    Molina, Francisco J; Rivera, Paula T; Cardona, Alejandro; Restrepo, Diana C; Monroy, Oralia; Rodas, Daniel; Barrientos, Juan G

    2018-02-04

    To investigate the incidence of disadvantageous events by using the Global Trigger Tool in an intensive care unit (ICU). A retrospective descriptive study was performed in a 12-bed university ICU in the city of Medellin, Colombia. Clinical charts of hospitalized patients were reviewed, between January 1 and December 31, 2016, with the following inclusion criteria: subjects aged over 18 years, with at least 24 h of hospitalization and who had a complete medical history that could be accessed. Interventions: Trained reviewers conducted a retrospective examination of medical charts searching for clue events that elicit investigation, in order to detect an unfavorable event. Measurements: Information was processed through SPSS software version 21; for numerical variables, the mean was reported with standard deviation (SD). Percentages were calculated for qualitative variables. Two hundred and forty-four triggers occurred, with 82.4% of subjects having presented with at least one and an average of 3.37 (SD 3.47). A total of 178 adverse events (AEs) took place in 48 individuals, with an incidence of 52.1%. On average, four events per patient were recorded, and for each unfortunate event, 1.98 triggers were presented. The most frequent displeasing issues were: pressure ulcers (17.6%), followed by complications or reactions to medical devices (4.3%), and lacerations or skin defects (3.7%); the least frequent was delayed diagnosis or treatment (0.56%). Thirty-eight point four percent of mishap events caused temporary damage that required intervention, and 48.9% of AEs were preventable. Comparison between AEs and admission diagnoses found that hypertension and sepsis were the only diagnoses that had statistical significance ( P = 0.042 and 0.022, respectively). Almost half of the unfavorable issues were classified as avoidable, which leaves a very wide field of work in terms of preventative activities.

  14. Post-operative serious adverse events in a mixed surgical population

    DEFF Research Database (Denmark)

    Hansen, M S; Petersen, E E; Dahl, J B

    2016-01-01

    BACKGROUND: The number of surgical procedures is increasing, and knowledge of surgical risk factors, post-operative mortality and serious adverse events (SAE) is essential. The aim with our study was to determine the risk of a composite outcome of post-operative: death; myocardial infarction.......9% (5.4-6.5), respectively. Mortality within longest follow-up as well as 90 and 180 days post-operatively was 3.6% (3.1-4.0), 1.7% (1.4-2.0), and 2.2% (1.9-2.6), respectively. CONCLUSION: We found a risk of one or more events in the composite outcome within 342 days after inclusion of the last patients...

  15. Adverse Events of Massage Therapy in Pain-Related Conditions: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Ping Yin

    2014-01-01

    Full Text Available Pain-related massage, important in traditional Eastern medicine, is increasingly used in the Western world. So the widening acceptance demands continual safety assessment. This review is an evaluation of the frequency and severity of adverse events (AEs reported mainly for pain-related massage between 2003 and 2013. Relevant all-languages reports in 6 databases were identified and assessed by two coauthors. During the 11-year period, 40 reports of 138 AEs were associated with massage. Author, year of publication, country of occurrence, participant related (age, sex or number of patients affected, the details of manual therapy, and clinician type were extracted. Disc herniation, soft tissue trauma, neurologic compromise, spinal cord injury, dissection of the vertebral arteries, and others were the main complications of massage. Spinal manipulation in massage has repeatedly been associated with serious AEs especially. Clearly, massage therapies are not totally devoid of risks. But the incidence of such events is low.

  16. Metabolic syndrome and the risk of adverse cardiovascular events after an acute coronary syndrome.

    Science.gov (United States)

    Cavallari, Ilaria; Cannon, Christopher P; Braunwald, Eugene; Goodrich, Erica L; Im, KyungAh; Lukas, Mary Ann; O'Donoghue, Michelle L

    2018-01-01

    Background The incremental prognostic value of assessing the metabolic syndrome has been disputed. Little is known regarding its prognostic value in patients after an acute coronary syndrome. Design and methods The presence of metabolic syndrome (2005 International Diabetes Federation) was assessed at baseline in SOLID-TIMI 52, a trial of patients within 30 days of acute coronary syndrome (median follow-up 2.5 years). The primary endpoint was major coronary events (coronary heart disease death, myocardial infarction or urgent coronary revascularization). Results At baseline, 61.6% ( n = 7537) of patients met the definition of metabolic syndrome, 34.7% (n = 4247) had diabetes and 29.3% had both ( n = 3584). The presence of metabolic syndrome was associated with increased risk of major coronary events (adjusted hazard ratio (adjHR) 1.29, p definition, only diabetes (adjHR 1.48, p metabolic syndrome was numerically but not significantly associated with the risk of major coronary events (adjHR 1.13, p = 0.06). Conversely, diabetes was a strong independent predictor of major coronary events in the absence of metabolic syndrome (adjHR 1.57, p metabolic syndrome identified patients at highest risk of adverse outcomes but the incremental value of metabolic syndrome was not significant relative to diabetes alone (adjHR 1.07, p = 0.54). Conclusions After acute coronary syndrome, diabetes is a strong and independent predictor of adverse outcomes. Assessment of the metabolic syndrome provides only marginal incremental value once the presence or absence of diabetes is established.

  17. Impact of Prodromal Symptoms on Future Adverse Cardiac-Related Events: A Systematic Review.

    Science.gov (United States)

    O'Keefe-McCarthy, Sheila; Ready, Linda

    2016-01-01

    predictive of adverse cardiac events and cardiac interventions. There is some preliminary evidence to suggest that prodromal symptoms of headache, sleep disturbance, and anxiety may predict ACS symptom presentation during an acute cardiac event. Future research is warranted that would examine prospectively the predictive value of prodromal headache, sleep disturbance, and anxiety within this cardiovascular population on major adverse cardiac events. Preemptive screening for cardiac-related prodromal symptoms in men and women should be considered as a standard in clinical practice. This may potentiate early diagnosis, effective risk modification, timely pain management, and treatment intervention and decrease CHD-related morbidity and mortality.

  18. Adverse Event Incidences following Facial Plastic Surgery Procedures: Incorporating FACE-Q Data to Improve Patient Preparation.

    Science.gov (United States)

    Fleury, Christopher M; Schwitzer, Jonathan A; Hung, Rex W; Baker, Stephen B

    2018-01-01

    Before creation and validation of the FACE-Q by Pusic et al., adverse event types and incidences following facial cosmetic procedures were objectively measured and reported by physicians, potentially leading to misrepresentation of the true patient experience. This article analyzes and compares adverse event data from both FACE-Q and recent review articles, incorporating patient-reported adverse event data to improve patient preparation for facial cosmetic procedures. FACE-Q adverse event data were extracted from peer-reviewed validation articles for face lift, rhinoplasty, and blepharoplasty, and these data were compared against adverse effect risk data published in recent Continuing Medical Education/Maintenance of Certification and other articles regarding the same procedures. The patient-reported adverse event data sets and the physician-reported adverse event data sets do contain overlapping elements, but each data set also contains unique elements. The data sets represent differing viewpoints. Furthermore, patient-reported outcomes from the FACE-Q provided incidence data that were otherwise previously not reported. In the growing facial cosmetic surgery industry, patient perspective is critical as a determinant of success; therefore, incorporation of evidence-based patient-reported outcome data will not only improve patient expectations and overall experience, but will also reveal adverse event incidences that were previously unknown. Given that there is incomplete overlap between patient-reported and physician-reported adverse events, presentation of both data sets in the consultation setting will improve patient preparation. Furthermore, use of validated tools such as the FACE-Q will allow surgeons to audit themselves critically.

  19. An automated standardized system for managing adverse events in clinical research networks.

    Science.gov (United States)

    Richesson, Rachel L; Malloy, Jamie F; Paulus, Kathleen; Cuthbertson, David; Krischer, Jeffrey P

    2008-01-01

    Multi-site clinical protocols and clinical research networks require tools to manage and monitor adverse events (AEs). To be successful, these tools must be designed to comply with applicable regulatory requirements, reflect current data standards, international directives and advances in pharmacovigilance, and be convenient and adaptable to multiple needs. We describe an Adverse Event Data Management System (AEDAMS) that is used across multiple study designs in the various clinical research networks and multi-site studies for which we provide data and technological support. Investigators enter AE data using a standardized and structured web-based data collection form. The automated AEDAMS forwards the AE information to individuals in designated roles (investigators, sponsors, Data Safety and Monitoring Boards) and manages subsequent communications in real time, as the entire reporting, review and notification is done by automatically generated emails. The system was designed to adhere to timelines and data requirements in compliance with Good Clinical Practice (International Conference on Harmonisation E6) reporting standards and US federal regulations, and can be configured to support AE management for many types of study designs and adhere to various domestic or international reporting requirements. This tool allows AEs to be collected in a standard way by multiple distributed users, facilitates accurate and timely AE reporting and reviews, and allows the centralized management of AEs. Our design justification and experience with the system are described.

  20. Dictionary construction and identification of possible adverse drug events in Danish clinical narrative text.

    Science.gov (United States)

    Eriksson, Robert; Jensen, Peter Bjødstrup; Frankild, Sune; Jensen, Lars Juhl; Brunak, Søren

    2013-01-01

    Drugs have tremendous potential to cure and relieve disease, but the risk of unintended effects is always present. Healthcare providers increasingly record data in electronic patient records (EPRs), in which we aim to identify possible adverse events (AEs) and, specifically, possible adverse drug events (ADEs). Based on the undesirable effects section from the summary of product characteristics (SPC) of 7446 drugs, we have built a Danish ADE dictionary. Starting from this dictionary we have developed a pipeline for identifying possible ADEs in unstructured clinical narrative text. We use a named entity recognition (NER) tagger to identify dictionary matches in the text and post-coordination rules to construct ADE compound terms. Finally, we apply post-processing rules and filters to handle, for example, negations and sentences about subjects other than the patient. Moreover, this method allows synonyms to be identified and anatomical location descriptions can be merged to allow appropriate grouping of effects in the same location. The method identified 1 970 731 (35 477 unique) possible ADEs in a large corpus of 6011 psychiatric hospital patient records. Validation was performed through manual inspection of possible ADEs, resulting in precision of 89% and recall of 75%. The presented dictionary-building method could be used to construct other ADE dictionaries. The complication of compound words in Germanic languages was addressed. Additionally, the synonym and anatomical location collapse improve the method. The developed dictionary and method can be used to identify possible ADEs in Danish clinical narratives.

  1. Preventing drug-related adverse events following hospital discharge: the role of the pharmacist

    Directory of Open Access Journals (Sweden)

    Nicholls J

    2017-02-01

    Full Text Available Justine Nicholls,1 Craig MacKenzie,1 Rhiannon Braund2 1Dunedin Hospital Pharmacy, 2School of Pharmacy, University of Otago, Dunedin, New Zealand Abstract: Transition of care (ToC points, and in particular hospital admission and discharge, can be associated with an increased risk of adverse drug events (ADEs and other drug-related problems (DRPs. The growing recognition of the pharmacist as an expert in medication management, patient education and communication makes them well placed to intervene. There is evidence to indicate that the inclusion of pharmacists in the health care team at ToC points reduces ADEs and DRPs and improves patient outcomes. The objectives of this paper are to outline the following using current literature: 1 the increased risk of medication-related problems at ToC points; 2 to highlight some strategies that have been successful in reducing these problems; and 3 to illustrate how the role of the pharmacist across all facets of care can contribute to the reduction of ADEs, particularly for patients at ToC points. Keywords: pharmacist, adverse drug events, drug-related problems, transitions of care, hospital discharge

  2. [Preventive measures against human error based on the classification of the adverse events].

    Science.gov (United States)

    Nishimura, Kenji

    2014-01-01

    It is impossible to entirely eliminate human error; however, systematic attempts have been made to comprehensively minimize accidents originating in human error. It appears that the "work classification" we proposed previously is not able to reduce adverse events, fifty percent of which were duty confirmation failures. We have therefore reviewed and classified the causes of human error from the perspective of working conditions to create a simpler and more preventative strategy. Text-mining analysis was applied to speech part classification to reveal areas with room for improvement. In an objective approach, a conduct code was created and put into practice, based on the common features revealed from a classification of human error in the examples investigated. The average number of accidents per year was reduced from 36 to 24, and those due to human error per year were reduced from 17.6 to 11. This objective approach appears to achieve a reduction of adverse events, including those caused by human error. However, these results were obtained over only one year, in a single-center analysis, and thus, widespread and continuous enforcement would be needed to demonstrate the validity of this objective approach to the prevention of human error.

  3. Heart Failure: Diagnosis, Severity Estimation and Prediction of Adverse Events Through Machine Learning Techniques

    Directory of Open Access Journals (Sweden)

    Evanthia E. Tripoliti

    2017-01-01

    Full Text Available Heart failure is a serious condition with high prevalence (about 2% in the adult population in developed countries, and more than 8% in patients older than 75 years. About 3–5% of hospital admissions are linked with heart failure incidents. Heart failure is the first cause of admission by healthcare professionals in their clinical practice. The costs are very high, reaching up to 2% of the total health costs in the developed countries. Building an effective disease management strategy requires analysis of large amount of data, early detection of the disease, assessment of the severity and early prediction of adverse events. This will inhibit the progression of the disease, will improve the quality of life of the patients and will reduce the associated medical costs. Toward this direction machine learning techniques have been employed. The aim of this paper is to present the state-of-the-art of the machine learning methodologies applied for the assessment of heart failure. More specifically, models predicting the presence, estimating the subtype, assessing the severity of heart failure and predicting the presence of adverse events, such as destabilizations, re-hospitalizations, and mortality are presented. According to the authors' knowledge, it is the first time that such a comprehensive review, focusing on all aspects of the management of heart failure, is presented.

  4. Chlorhexidine with or without alcohol against biofilm formation: efficacy, adverse events and taste preference.

    Science.gov (United States)

    Santos, Gabriela Otero Dos; Milanesi, Fernanda Carpes; Greggianin, Bruna Frizon; Fernandes, Marilene Issa; Oppermann, Rui Vicente; Weidlich, Patricia

    2017-05-04

    In recent years, different chlorhexidine formulations have been tested, including an alcohol-free alternative, but the effect of this solution on early biofilm formation is not clear. A crossover, randomized, double-blind clinical trial was conducted to evaluate the effect of two chlorhexidine solutions against supra- and subgingival biofilm formation (NCT#02656251). Thirty-five participants were randomized and asked to rinse twice daily with 15 ml of an alcohol-containing 0.12% chlorhexidine solution, an alcohol-free 0.12% chlorhexidine solution, or placebo. The study was conducted in three experimental periods of 4 days each, with a 10-day washout between the periods. All the experimental periods followed the same protocol, except that the solutions were switched. Biofilm distribution was evaluated every 24 hours by the Plaque-Free Zone Index, during 96 hours. Adverse events were self-reported and sensory evaluation was performed using a hedonic scale. Compared to the placebo, the chlorhexidine solutions resulted in a significantly higher number of surfaces free of plaque over 96 hours (p chlorhexidine solution was associated with a lower incidence of adverse events, compared with alcohol-containing chlorhexidine (p chlorhexidine (p = 0.007), and had a similar inhibitory effect on the formation of supra- and subgingival biofilms.

  5. e-Prescription: An e-Health System for Preventing Adverse Drug Events in Community Healthcare

    Directory of Open Access Journals (Sweden)

    Irma M. Puspitasari

    2012-03-01

    Full Text Available The paper describes development activities of an e-health system for community health center (Puskesmas with integrated adverse drug events e-prescription module, consist of system design and development, human resource development, e-health system realization, laboratory and implementation test of e-health system. Some e-readiness evaluations were conducted, through a number of field visits and questionnaires. The results had been used in the e-health system design and development, installation of the internet access infrastructure, and implementation of the education and hands-on training for the medical and administrative staff of the healthcare units. After completing the e-health system design and development as well as system realization and laboratory tests stages, a series of field implementation and experiments have been successfully conducted at Puskesmas Babakansari in Bandung. A number of users feed back have been obtained and used for further improvements on both of the software and hardware modules. The e-health system with integrated e-prescription module has successfully developed and shown its expected functions in: patient registration, medical record, paperless prescription, producing the required reports and preventing possible adverse drug events.

  6. National Action Plan for Adverse Drug Event Prevention: Recommendations for Safer Outpatient Opioid Use.

    Science.gov (United States)

    Ducoffe, Aaron R; York, Andrew; Hu, Dale J; Perfetto, Deborah; Kerns, Robert D

    2016-12-01

    Adverse drug events (ADEs) have been highlighted as a major patient safety and public health challenge by the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan), which was released by the Office of Disease Prevention and Health Promotion (ODPHP) in August 2014. The ADE Action Plan focuses on surveillance, evidence-based prevention, incentives, and oversights, additional research needs as well as possible measures and metrics to track progress of ADE prevention within three drug classes: anticoagulants, diabetes agents, and opioids.Objectives and Recommendations. With outpatient opioid prescriptions being a great concern among many healthcare providers, this article focuses on recommendations from the ADE Action Plan to help guide safer opioid use in healthcare delivery settings. Its aim is to discuss current federal methods in place to prevent opioid ADEs while also providing evidence to encourage providers and hospitals to innovate new systems and practices to increase prevention. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. 2016. This work is written by US Government employees and is in the public domain in the US.

  7. Neurologic Adverse Events Associated with Voriconazole Therapy: Report of Two Pediatric Cases

    Directory of Open Access Journals (Sweden)

    Sevliya Öcal Demir

    2016-01-01

    Full Text Available Although voriconazole, a triazole antifungal, is a safe drug, treatment with this agent is associated with certain adverse events such as hepatic, neurologic, and visual disturbances. The current report presents two cases, one a 9-year-old boy and the other a 17-year-old girl, who experienced neurologic side effects associated with voriconazole therapy. Our aim is to remind readers of the side effects of voriconazole therapy in order to prevent unnecessary investigations especially for psychological and ophthalmologic problems. The first case was a 9-year-old boy with cystic fibrosis and invasive aspergillosis that developed photophobia, altered color sensation, and fearful visual hallucination. The second case was a 17-year-old girl with cystic fibrosis and allergic bronchopulmonary aspergillosis, and she experienced photophobia, fatigue, impaired concentration, and insomnia, when the dose of voriconazole therapy was increased from 12 mg/kg/day to 16 mg/kg/day. The complaints of the two patients disappeared after discontinuation of voriconazole therapy. Our experience in these patients reminded us of the importance of being aware of the neurologic adverse events associated with voriconazole therapy in establishing early diagnosis and initiating prompt treatment. In addition, although serum voriconazole concentration was not measured in the present cases, therapeutic drug monitoring for voriconazole seems to be critically important in preventing neurologic side effects in pediatric patients.

  8. Development of an adverse events reporting form for Korean folk medicine.

    Science.gov (United States)

    Park, Jeong Hwan; Choi, Sun-Mi; Moon, Sujeong; Kim, Sungha; Kim, Boyoung; Kim, Min-Kyeoung; Lee, Sanghun

    2017-05-01

    We developed an adverse events (AEs) reporting form for Korean folk medicine. The first version of the form was developed and tested in the clinical setting for spontaneous reporting of AEs. Additional revisions to the reporting form were made based on collected data and expert input. We developed an AEs reporting form for Korean folk medicine. The items of this form were based on patient information, folk medicine properties, and AEs. For causality assessment, folk medicine properties such as classification, common and vernacular names, scientific name, part used, harvesting time, storage conditions, purchasing route, product licensing, prescription, persons with similar exposure, any remnant of raw natural products collected from the patient, and cautions or contraindications were added. This is the first reporting form for AEs that incorporates important characteristics of Korean folk medicine. This form would have an important role in reporting adverse events for Korean folk medicine. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

  9. Family history predicts major adverse cardiovascular events (MACE) in young adults with psoriasis

    DEFF Research Database (Denmark)

    Egeberg, Alexander; Bruun, Louise E; Mallbris, Lotus

    2016-01-01

    BACKGROUND: Patients with psoriasis may have increased risk of major adverse cardiovascular (CV) events (MACE), and a family history of CV disease (CVD) is an independent risk factor for MACE. OBJECTIVE: We investigated the risk of first-time MACE in patients with psoriasis with or without a fami....... The findings call for increased focus on a family history of CVD in CV risk assessment of patients with psoriasis.......BACKGROUND: Patients with psoriasis may have increased risk of major adverse cardiovascular (CV) events (MACE), and a family history of CV disease (CVD) is an independent risk factor for MACE. OBJECTIVE: We investigated the risk of first-time MACE in patients with psoriasis with or without a family...... history of CVD. METHODS: Between January 1, 1997, and December 31, 2011, we identified 2,722,375 individuals, including 25,774 and 4504 patients with mild and severe psoriasis, through administrative registers. Incidence rate ratios were estimated by Poisson regression. RESULTS: Mean baseline age was 26...

  10. Oral Cholera Vaccine Coverage, Barriers to Vaccination, and Adverse Events following Vaccination, Haiti, 2013.

    Science.gov (United States)

    Tohme, Rania A; François, Jeannot; Wannemuehler, Kathleen; Iyengar, Preetha; Dismer, Amber; Adrien, Paul; Hyde, Terri B; Marston, Barbara J; Date, Kashmira; Mintz, Eric; Katz, Mark A

    2015-06-01

    In 2013, the first government-led oral cholera vaccination (OCV) campaign in Haiti was implemented in Petite Anse and Cerca Carvajal. To evaluate vaccination coverage, barriers to vaccination, and adverse events following vaccination, we conducted a cluster survey. We enrolled 1,121 persons from Petite Anse and 809 persons from Cerca Carvajal, categorized by 3 age groups (1-4, 5-14, >15 years). Two-dose OCV coverage was 62.5% in Petite Anse and 76.8% in Cerca Carvajal. Two-dose coverage was lowest among persons >15 years of age. In Cerca Carvajal, coverage was significantly lower for male than female respondents (69% vs. 85%; p<0.001). No major adverse events were reported. The main reason for nonvaccination was absence during the campaign. Vaccination coverage after this campaign was acceptable and comparable to that resulting from campaigns implemented by nongovernmental organizations. Future campaigns should be tailored to reach adults who are not available during daytime hours.

  11. Hepatitis B infection reported with cancer chemotherapy: analyzing the US FDA Adverse Event Reporting System.

    Science.gov (United States)

    Sanagawa, Akimasa; Hotta, Yuji; Kataoka, Tomoya; Maeda, Yasuhiro; Kondo, Masahiro; Kawade, Yoshihiro; Ogawa, Yoshihiro; Nishikawa, Ryohei; Tohkin, Masahiro; Kimura, Kazunori

    2018-04-16

    We conducted data mining using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database on spontaneously reported adverse events to evaluate the association between anticancer drug therapy and hepatitis B infection. Reports of hepatitis B infection were retrieved from the FAERS database. The reporting odds ratio (ROR) was used to estimate the association between hepatitis B infection and various anticancer agents and drug combinations. We detected statistically significant risk signals of hepatitis B for 33 of 64 anticancer agents by ROR (26 cytotoxicity drugs and seven molecular-targeted drugs). We focused on molecular-targeted drugs and assessed the risk of hepatitis B from specific anticancer drug combinations. The frequency of hepatitis B infection was significantly high for drugs such as rituximab, bortezomib, imatinib, and everolimus. The addition of cyclophosphamide, doxorubicin, and fludarabine to drug combinations additively enhanced the frequency of hepatitis B infection. There were no reports on hepatitis B infection associated with trastuzumab or azacitidine monotherapy. However, trastuzumab-containing regimens (e.g., combinations with docetaxel or paclitaxel) were correlated with the incidence of hepatitis B infection, similar to azacitidine monotherapy. Our findings suggest that the concomitant use of anticancer drugs, such as trastuzumab, taxane, and azacitidine, may contribute to the risk of hepatitis B infection. The unique signals detected from the public database might provide clues to eliminate the threat of HBV in oncology. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  12. Defining molecular initiating events in the adverse outcome pathway framework for risk assessment.

    Science.gov (United States)

    Allen, Timothy E H; Goodman, Jonathan M; Gutsell, Steve; Russell, Paul J

    2014-12-15

    Consumer and environmental safety decisions are based on exposure and hazard data, interpreted using risk assessment approaches. The adverse outcome pathway (AOP) conceptual framework has been presented as a logical sequence of events or processes within biological systems which can be used to understand adverse effects and refine current risk assessment practices in ecotoxicology. This framework can also be applied to human toxicology and is explored on the basis of investigating the molecular initiating events (MIEs) of compounds. The precise definition of the MIE has yet to reach general acceptance. In this work we present a unified MIE definition: an MIE is the initial interaction between a molecule and a biomolecule or biosystem that can be causally linked to an outcome via a pathway. Case studies are presented, and issues with current definitions are addressed. With the development of a unified MIE definition, the field can look toward defining, classifying, and characterizing more MIEs and using knowledge of the chemistry of these processes to aid AOP research and toxicity risk assessment. We also present the role of MIE research in the development of in vitro and in silico toxicology and suggest how, by using a combination of biological and chemical approaches, MIEs can be identified and characterized despite a lack of detailed reports, even for some of the most studied molecules in toxicology.

  13. Oral Cholera Vaccine Coverage, Barriers to Vaccination, and Adverse Events following Vaccination, Haiti, 20131

    Science.gov (United States)

    François, Jeannot; Wannemuehler, Kathleen; Iyengar, Preetha; Dismer, Amber; Adrien, Paul; Hyde, Terri B.; Marston, Barbara J.; Date, Kashmira; Mintz, Eric; Katz, Mark A.

    2015-01-01

    In 2013, the first government-led oral cholera vaccination (OCV) campaign in Haiti was implemented in Petite Anse and Cerca Carvajal. To evaluate vaccination coverage, barriers to vaccination, and adverse events following vaccination, we conducted a cluster survey. We enrolled 1,121 persons from Petite Anse and 809 persons from Cerca Carvajal, categorized by 3 age groups (1–4, 5–14, >15 years). Two-dose OCV coverage was 62.5% in Petite Anse and 76.8% in Cerca Carvajal. Two-dose coverage was lowest among persons >15 years of age. In Cerca Carvajal, coverage was significantly lower for male than female respondents (69% vs. 85%; p<0.001). No major adverse events were reported. The main reason for nonvaccination was absence during the campaign. Vaccination coverage after this campaign was acceptable and comparable to that resulting from campaigns implemented by nongovernmental organizations. Future campaigns should be tailored to reach adults who are not available during daytime hours. PMID:25988350

  14. The natural history of recovery for the healthcare provider "second victim" after adverse patient events.

    Science.gov (United States)

    Scott, S D; Hirschinger, L E; Cox, K R; McCoig, M; Brandt, J; Hall, L W

    2009-10-01

    When patients experience unexpected events, some health professionals become "second victims". These care givers feel as though they have failed the patient, second guessing clinical skills, knowledge base and career choice. Although some information exists, a complete understanding of this phenomenon is essential to design and test supportive interventions that achieve a healthy recovery. The purpose of this article is to report interview findings with 31 second victims. After institutional review board approval, second victim volunteers representing different professional groups were solicited for private, hour-long interviews. The semistructured interview covered demographics, participant recount of event, symptoms experienced and recommendations for improving institutional support. After interviews, transcripts were analyzed independently for themes, followed by group deliberation and reflective use with current victims. Participants experienced various symptoms that did not differ by sex or professional group. Our analysis identified six stages that delineate the natural history of the second victim phenomenon. These are (1) chaos and accident response, (2) intrusive reflections, (3) restoring personal integrity, (4) enduring the inquisition, (5) obtaining emotional first aid and (6) moving on. We defined the characteristics and typical questions second victims are desperate to have answered during these stages. Several reported that involvement in improvement work or patient safety advocacy helped them to once again enjoy their work. We now believe the post-event trajectory is largely predictable. Institutional programs could be developed to successfully screen at-risk professionals immediately after an event, and appropriate support could be deployed to expedite recovery and mitigate adverse career outcomes.

  15. Psychiatric adverse events during treatment with brodalumab: Analysis of psoriasis clinical trials.

    Science.gov (United States)

    Lebwohl, Mark G; Papp, Kim A; Marangell, Lauren B; Koo, John; Blauvelt, Andrew; Gooderham, Melinda; Wu, Jashin J; Rastogi, Shipra; Harris, Susan; Pillai, Radhakrishnan; Israel, Robert J

    2018-01-01

    Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. Data were evaluated from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions of patients with moderate-to-severe psoriasis. The analysis included 4464 patients with 9161.8 patient-years of brodalumab exposure. The follow-up time-adjusted incidence rates of SIB events were comparable between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years). In the brodalumab group, 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate; all patients had underlying psychiatric disorders or stressors. There was no comparator arm past week 52. Controlled study periods were not powered to detect differences in rare events such as suicide. Comparison with controls and the timing of events do not indicate a causal relationship between SIB and brodalumab treatment. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  16. Quantifying the Economic Impact of Provider Volume Through Adverse Events: The Case of Sports Medicine.

    Science.gov (United States)

    Scott, Daniel J; Sherman, Seth; Dhawan, Aman; Cole, Brian J; Bach, Bernard R; Mather, Richard C

    2015-03-01

    Procedures performed by surgeons with higher provider volumes offer advantages both to the individual patient and the health system, with studies documenting fewer adverse events, shorter surgical times, and decreased reoperation rates. With workforce requirements for surgeons growing, it is increasingly necessary to establish the most efficient structure of this workforce. Substantial economic savings are realized when procedures are performed by high-volume providers as compared with low-volume providers in the areas of readmission, prolonged admission, and subsequent surgery. Economic and decision analysis; Level of evidence, 2. This study utilized decision modeling to estimate the cost savings to high-volume providers in sports medicine. Simple decision models were constructed for 3 common procedures: anterior cruciate ligament (ACL) reconstruction, rotator cuff repair, and total shoulder arthroplasty. Outcome probabilities for adverse events (readmission, prolonged admission, and subsequent surgery) and costs were taken from the literature. A Monte Carlo simulation reflecting the incidence of these procedures in the United States was performed to estimate the total nationwide cost of these procedures, and the impact of both negative and positive policies on this cost were examined using sensitivity analysis. The costs per case attributable to adverse outcomes for ACL reconstruction (in 2010 US$) were $496, $781, and $868 for high-, medium-, and low-volume providers, respectively. For rotator cuff repair, these numbers were $523, $640, and $872, and for total shoulder arthroplasty, $1692, $1876, and $2021, respectively. Sensitivity analysis revealed that a 50% increase in the number of these 3 procedures performed by high-volume surgeons could save the health system $23.1 million. If all procedures were performed by high-volume surgeons, the health system could save $72 million. The hypothesis was accepted; higher provider volumes for surgeons do convey

  17. Early adverse life events are associated with altered brain network architecture in a sex- dependent manner

    Directory of Open Access Journals (Sweden)

    Arpana Gupta, PhD

    2017-12-01

    Full Text Available Introduction: Early adverse life events (EALs increase the risk for chronic medical and psychiatric disorders by altering early neurodevelopment. The aim of this study was to examine associations between EALs and network properties of core brain regions in the emotion regulation and salience networks, and to test the influence of sex on these associations. Methods: Resting-state functional and diffusion tensor magnetic resonance imaging were obtained in healthy individuals (61 men, 63 women. Functional and anatomical network properties of centrality and segregation were calculated for the core regions of the two networks using graph theory. Moderator analyses were applied to test hypotheses. Results: The type of adversity experienced influences brain wiring differently, as higher general EALs were associated with decreased functional and anatomical centrality in salience and emotion regulation regions, while physical and emotional EALs were associated with increased anatomical centrality and segregation in emotion regulation regions. Sex moderated the associations between EALs and measures of centrality; with decreased centrality of salience and emotion regulation regions with increased general EALs in females, and increased centrality in salience regions with higher physical and emotional EALs in males. Increased segregation of salience regions was associated with increased general EALs in males. Centrality of the amygdala was associated with physical symptoms, and segregation of salience regions was correlated with higher somatization in men only. Conclusions: Emotion regulation and salience regions are susceptible to topological brain restructuring associated with EALs. The male and female brains appear to be differently affected by specific types of EALs. Keywords: Early adverse traumatic life events, Centrality, Segregation, Network metrics, Moderating effects of sex, Emotion regulation network, Salience network

  18. [Adverse Events of Sublingual Immunotherapy in 207 Patients with Japanese Cedar Pollinosis].

    Science.gov (United States)

    Ogawa, Yukiko; Yuta, Atsushi; Arikata, Masahiko; Kozaki, Hideaki; Ohta, Nobuo; Suzuki, Yusuke; Shimizu, Takeshi

    2015-12-01

    Sublingual immunotherapy (SLIT) for Japanese cedar pollinosis is effective, however, caution must be exercised against allergen-specific adverse events (AEs) during SLIT. The purpose of this study was to clarify the AEs of SLIT in a large cohort of patients with Japanese cedar pollinosis. We conducted a detailed survey, by both questionnaires and direct interviews, of 207 patients receiving SLIT at our clinic. Eighty-four of the 207 patients (40.5%) developed AEs, with AEs involving the oral cavity and throat being the most common (56 patients; 27.1%). Sixteen patients (7.9%) had local mucosal swelling, but the swelling resolved in all the cases. Other allergen-induced symptoms such as nasal symptoms (29 events, 14.0%), eye symptoms (14 events, 6.8%) and ear symptoms (20 events, 9.7%) were also recognized. All the AEs were minor, and discontinuation of SLIT was not necessitated in any of the patients because of AEs. There were 52 AEs (25.0%) in the up-dose phase and 61 AEs (29.3%) in the maintenance phase. However, only 4 of the 161 patients (2.5%) developed AEs during the pollen season. Most AEs developing during the maintenance phase occurred in the first few weeks. In 60% of the cases, the AEs disappeared within 2 weeks, and in 6.0% (5 events), they persisted for longer than 2 months. There were no age-or sex-related differences in the prevalence of cedar pollen-specific IgE, or in the adherence to the treatment. AEs in SLIT were shown in many patients, however, the severity of AEs was mild and no events interfered SLIT.

  19. Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome

    Science.gov (United States)

    Dougall, Dominic; Johnson, Anthony; Goldsmith, Kimberley; Sharpe, Michael; Angus, Brian; Chalder, Trudie; White, Peter

    2014-01-01

    Objective Adverse events (AEs) are health related events, reported by participants in clinical trials. We describe AEs in the PACE trial of treatments for chronic fatigue syndrome (CFS) and baseline characteristics associated with them. Methods AEs were recorded on three occasions over one year in 641 participants. We compared the numbers and nature of AEs between treatment arms of specialist medical care (SMC) alone, or SMC supplemented by adaptive pacing therapy (APT), cognitive behaviour therapy (CBT) or graded exercise therapy (GET). We examined associations with baseline measures by binary logistic regression analyses, and compared the proportions of participants who deteriorated by clinically important amounts. Results Serious adverse events and reactions were infrequent. Non-serious adverse events were common; the median (quartiles) number was 4 (2, 8) per participant, with no significant differences between treatments (P = .47). A greater number of NSAEs were associated with recruitment centre, and baseline physical symptom count, body mass index, and depressive disorder. Physical function deteriorated in 39 (25%) participants after APT, 15 (9%) after CBT, 18 (11%) after GET, and 28 (18%) after SMC (P < .001), with no significant differences in worsening fatigue. Conclusions The numbers of adverse events did not differ significantly between trial treatments, but physical deterioration occurred most often after APT. The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments. Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data. PMID:24913337

  20. Are measurements of patient safety culture and adverse events valid and reliable? Results from a cross sectional study.

    Science.gov (United States)

    Farup, Per G

    2015-05-02

    The association between measurements of the patient safety culture and the "true" patient safety has been insufficiently documented, and the validity of the tools used for the measurements has been questioned. This study explored associations between the patient safety culture and adverse events, and evaluated the validity of the tools. In 2008/2009, a survey on patient safety culture was performed with Hospital Survey on Patient Safety Culture (HSOPSC) in two medical departments in two geographically separated hospitals of Innlandet Hospital Trust. Later, a retrospective analysis of adverse events during the same period was performed with the Global Trigger Tool (GTT). The safety culture and adverse events were compared between the departments. 185 employees participated in the study, and 272 patient records were analysed. The HSOPSC scores were lower and adverse events less prevalent in department 1 than in department 2. In departments 1 and 2 the mean HSOPSC scores (SD) were at the unit level 3.62 (0.42) and 3.90 (0.37) (p events were 10/135 (7%) and 28/137 (20%) (p = 0.003) respectively. There was an inverse association between the patient safety culture and adverse events. Until the criterion validity of the tools for measuring patient safety culture and tracking of adverse events have been further evaluated, measurement of patient safety culture could not be used as a proxy for the "true" safety.

  1. Prenatal Tdap immunization and risk of maternal and newborn adverse events.

    Science.gov (United States)

    Layton, J Bradley; Butler, Anne M; Li, Dongmei; Boggess, Kim A; Weber, David J; McGrath, Leah J; Becker-Dreps, Sylvia

    2017-07-24

    Many countries recommend combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis immunization (Tdap) during pregnancy to stimulate transplacental transmission of pertussis antibodies to newborns. The immune system can be altered during pregnancy, potentially resulting in differing immunization risks in pregnant women. The safety of widespread Tdap immunization during pregnancy needs to be established. Our objective was to assess whether prenatal Tdap immunization was associated with adverse birth outcomes, and to evaluate the effect of timing of Tdap administration on these outcomes. We identified pregnancies at delivery in a large insurance claims database (2010-2014). Tdap immunization was categorized as optimal prenatal (27+weeks), early prenatal (Guillian-Barre syndrome [GBS]), adverse birth outcomes (e.g. preeclampsia/eclampsia, premature rupture or membranes, chorioamnionitis) and newborn outcomes (e.g. respiratory distress, pulmonary hypertension, neonatal jaundice). Women with optimal or early prenatal Tdap were compared to those not immunized in pregnancy, using propensity score-weighted log-binomial regression and Cox proportional hazards models to estimate risk ratios (RR) and hazard ratios (HR). We identified 1,079,034 deliveries and 677,075 linked newborns; 11.5% were immunized optimally and 2.3% immunized early. There were 1 case of post-immunization anaphylaxis, and 12 cases of maternal encephalopathy (all post- delivery); there were no cases of GBS. Optimally-timed immunization was associated with small increased relative risks of: chorioamnionitis [RR=1.11, (95% CI: 1.07-1.15), overall risk=2.8%], and postpartum hemorrhage [RR=1.23 (95% DI: 1.18-1.28), overall risk=2.4%]; however, these relative increases corresponded to low absolute risk increases. Tdap was not associated with increased risk of any adverse newborn outcome. Overall, prenatal Tdap immunization was not associated with newborn adverse events, but potential

  2. Sulfites--a food and drug administration review of recalls and reported adverse events.

    Science.gov (United States)

    Timbo, Babgaleh; Koehler, Kathleen M; Wolyniak, Cecilia; Klontz, Karl C

    2004-08-01

    Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested > or = 10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

  3. Toxicogenomics of nevirapine-associated cutaneous and hepatic adverse events among populations of African, Asian, and European descent

    NARCIS (Netherlands)

    Yuan, Jing; Guo, Sheng; Hall, David; Cammett, Anna M.; Jayadev, Supriya; Distel, Manuel; Storfer, Stephen; Huang, Zimei; Mootsikapun, Piroon; Ruxrungtham, Kiat; Podzamczer, Daniel; Haas, David W.; Benetucci, Jorge; Ortega, Gerardo; Cahn, Pedro; Cesar, Carina; Cassetti, Isabel; Bissio, Emiliano; Lupo, Sergio; Chuah, John; Workman, Cassy; Rees, Vanessa; Cooper, David A.; Hickey, Rebecca; Anderson, Jonathan; Moore, Richard; Hoy, Jennifer; Downs, Cath; Finlayson, Robert; Bodsworth, Neil; Eu, Beng; Lau, Helen; Montaner, Julio; Harris, Marianne; Walmsley, Sharon; d'Aquila, Adrianna; Conway, Brian; Tossonian, Harout; Morlat, Philippe; Louis, Isabelle; Yazdanpanah, Yazdan; Ajana, Faiza; Bollens, Diane; Girard, Pierre-Marie; May, Thierry; Pialoux, Gilles; Slama, Laurence; Lyavanc, Thomas; Piketty, Christophe; Pluot, Christel; Cotte, Laurent; Miailhes, Patrick; Reliquet, Veronique; Raffi, François; Phung, Bao; Yeni, Patrick; Simon, Anne; Bonmarchand, Manuela; Ponscarme, Diane; Rozenbaum, Willy; Alvarez, Muriel; Marchou, Bruno; Plettenberg, Andreas; Stoehr, Albrecht; Rockstroh, Jürgen; Schwarze-Zander, Carolynne; Brockmeyer, Norbert H.; Klinker, Hartwig; Heinz, Werner; Hoffmann, Christian; Bergmann, Frank; Schuermann, Dirk; Lutz, Thomas; Gute, Peter; Arastéh, Keikawus; Hartikainen, Jukka; Rittweger, Michael; Kern, Peter; Härter, Georg; Reuter, Stefan; Jensen, Björn; Esser, Stefan; Jablonka, Robert; Morbach, Karin; Jaegel-Guedes, Eva; Reiss, Peter; van den Berk, Guido; Branger, Judith; Brinkman, Kees; Puig, Jordi; Negredo, Eugènia; Viciana, Pompeyo; Lopez-Cortes, Luis; de Los Santos, Ignacio; Sanz, Jesús; Mallolas, Josep; Laguno, Montserrat; Ribera, Esteban; Villar del Saz, Sara; Vergas, Jorge; Téllez, M. Jesús; López, Juan Carlos; Sanchez-Conde, Matilde; Domingo, Pere; Casado, José L.; Pumares, María; Lin, Hsi-Hsun; Liu, Yung-Ching; Wang, Yung-Hsing; Tsai, Hung-Chin; Wang, Jen-Hsien; Wong, Wing Wai; Hu, Bor-Shen; Hsieh, Szu-Min; Sheng, Wang-Huei; Lin, Yu-Hui; Lu, Po-Liang; Chen, Tun-Chieh; Avihingsanon, Anchalee; Anekthananon, Thanomsak; Ratanasuwan, Winai; Tawana, Cheryl; Limb, Simon; Vilar, Francisco Javier; Clowes, Yvonne; Barrett, Sarah; Taylor, Stephen; Allan, Sris; Barnes, Justine; Fisher, Martin; Perry, Nicky; Pozniak, Anton L.; Boffito, Marta; Sadiq, Tariq; Adebiyi, Ade; Davis, Charles; Redfield, Robert R.; Kozal, Michael J.; Andrews, Laurie; Miller, Mark; Johnston, Barbara; Savage, Karen; Saag, Michael; Grossman, Howard A.; Cohen, Daniel E.; Overton, Edgar Turner; Snell, Mariea B.; Burman, William; Britt, Dale; Martorell, Claudia; Rivera, Jacqueline; Eron, Joseph J.; Menezes, Prema

    2011-01-01

    Nevirapine is widely prescribed for HIV-1 infection. We characterized relationships between nevirapine-associated cutaneous and hepatic adverse events and genetic variants among HIV-infected adults. We retrospectively identified cases and controls. Cases experienced symptomatic nevirapine-associated

  4. Association of nutritional status-related indices and chemotherapy-induced adverse events in gastric cancer patients.

    Science.gov (United States)

    Seo, Seung Hee; Kim, Sung-Eun; Kang, Yoon-Koo; Ryoo, Baek-Yeol; Ryu, Min-Hee; Jeong, Jae Ho; Kang, Shin Sook; Yang, Mihi; Lee, Jung Eun; Sung, Mi-Kyung

    2016-11-18

    Malnutrition in gastrectomized patients receiving chemotherapy is associated with the susceptibility to chemotherapy-related adverse events. This study evaluated pre-operative nutritional status-related indices associated with adverse events in post-operation gastric cancer patients receiving chemotherapy. Medical records of 234 gastrectomized patients under adjuvant tegafur/gimeracil/oteracil chemotherapy with extended lymph node dissection were analyzed. Nutritional status assessment included Patient-Generated Subjective Global Assessment (PG-SGA), body weight, body mass index, serum albumin concentration, and Nutrition Risk Index (NRI). Chemotherapy-originated adverse events were determined using Common Terminology Criteria for Adverse Events. PG-SGA indicated 59% of the patients were malnourished, and 27.8% of the patients revealed serious malnutrition with PG-SGA score of ≥9. Fifteen % of patients lost ≥10% of the initial body weight, 14.5% of the patients had hypoalbuminemia (cancer patients.

  5. The Effect of Real-time Clinical Monitoring and a "Closed Loop" Medication System on Adverse Drug Event Detection

    National Research Council Canada - National Science Library

    Mendelowitz, Paul C

    2008-01-01

    ...; as well as beside bar code scanning of patient, staff and medications. The implementation of this comprehensive redesign has allowed us to conduct research to determine whether decision support will foster a reduction in adverse drug events...

  6. Eventos adversos de la vacuna cubana antimeningocóccica Adverse events of antimeningococcal Cuban vaccine

    Directory of Open Access Journals (Sweden)

    Georgina Cruz Martínez

    2011-06-01

    . No existieron eventos adversos graves que requirieran de hospitalización, ni hubo secuelas.Introduction: in our country there is a surveillance exhaustive system offering statistical information on the severe, less severe and slight adverse events related to vaccines. This surveillance system is carried out by the Basic Health Staff; however, in many occasions, if these events have a poor defined and of less severity symptomatology they could remain without diagnosis and without research. Objective: using the design of retrospective and descriptive study, it was possible to analyze the 381 infants aged 3 and 5 months received the programmed VAMNGOC-BC® vaccine according the national scheme in 2006. The tool used for collection of information from medical records was the Epidemiological Survey of Adverse Events of Vaccination, established by the National Immunization Program. Results: from the 381 infants received vaccine that year, there were 17 with adverse events. The great percentage was after administration of the first dose (3,01 %. The more frequent local manifestations was pain in the injection site with 50,00 % after the first dose and induration (66,67 % after the second one. The more frequent systemic adverse effects in the first dose were fiver (54,55 % and irritability (27,27 %. The incidence of infants with adverse events was higher at the first 72 h (3,41 % and in the first dose (2,46 %. However, most of manifestation disappeared during the first 72 h (3,41 by each 100 vaccinated infants, that is, that recovery was fast. Conclusions: the local and systemic adverse events were discrete with predominance of the second ones for both doses of vaccine and the fever was the more frequent event after applied the two doses. There was neither severe adverse event requiring admission nor sequelae.

  7. Polytraumatization and Trauma Symptoms in Adolescent Boys and Girls: Interpersonal and Noninterpersonal Events and Moderating Effects of Adverse Family Circumstances

    Science.gov (United States)

    Nilsson, Doris Kristina; Gustafsson, Per E.; Svedin, Carl Goran

    2012-01-01

    The objective of this study was to investigate the cumulative effect of interpersonal and noninterpersonal traumatic life events (IPEs and nIPEs, respectively) on the mental health of adolescents and to determine if the adverse impacts of trauma were moderated by adverse family circumstances (AFC). Adolescents (mean age 16.7 years) from the…

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

    Science.gov (United States)

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

    2017-11-01

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

  9. Status and Problems of Adverse Event Reporting Systems in Korean Hospitals

    Science.gov (United States)

    Kim, Sukwha; Jung, Yoenyi; Kim, Eun-Kyung

    2010-01-01

    Objectives This study identifies the current status and problems of adverse event reporting system in Korean hospitals. The data obtained from this study will be used to raise international awareness and enable collaborative researches on patient safety. Methods We distributed the questionnaire developed by the Agency for Healthcare Research and Quality (AHRQ), USA to the 265 risk managers of hospitals by e-mail. Seventy-two percent of the risk managers responded to the inquiry. Results Eighty-five percent of the hospitals responded that they collect information regarding the event where harm has occurred or might have occurred to a patient. Seventy-five percent of the hospitals did not allow individuals to report occurrences without identifying themselves. Only 54% of the hospitals had an organized patient safety program that manages or coordinates all of the hospital's patient safety activities. The most frequent reason why errors were not reported was the fear of individuals being involved in the investigation and potential disadvantage resulting from it. Eighty-five percent of the hospitals produced reports of their adverse event data, but 68% of the hospitals did not distribute occurrence reports within the hospital. Conclusions Lack of standardized reporting system, available information, procedures for protecting the reporting individuals, and mindlessness/indifference of the hospital employees are identified as the major problems. Therefore, it is crucial to address these problems to develop appropriate solutions, enable proactive involvement from the healthcare community, and change the overall patient safety culture, specifically protecting privacy, to increase the quality of service in the healthcare industry. PMID:21818436

  10. Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes

    Science.gov (United States)

    Jia, Xiaoyu; Heller, Glenn; Barz, Allison; Sit, Laura; Fruscione, Michael; Appawu, Mark; Iasonos, Alexia; Atkinson, Thomas; Goldfarb, Shari; Culkin, Ann; Kris, Mark G.; Schrag, Deborah

    2009-01-01

    Background In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use of items from the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional data source, but the implications of such a shift are not understood. Methods Patients with lung cancer receiving chemotherapy and their clinicians independently reported six CTCAE symptoms and Karnofsky Performance Status longitudinally at sequential office visits. To compare how patient's vs clinician's reports relate to sentinel clinical events, a time-dependent Cox regression model was used to measure associations between reaching particular CTCAE grade severity thresholds with the risk of death and emergency room visits. To measure concordance of CTCAE reports with indices of daily health status, Kendall tau rank correlation coefficients were calculated for each symptom with EuroQoL EQ-5D questionnaire and global question scores. Statistical tests were two-sided. Results A total of 163 patients were enrolled for an average of 12 months (range = 1–28 months), with a mean of 11 visits and 67 (41%) deaths. CTCAE reports were submitted by clinicians at 95% of visits and by patients at 80% of visits. Patients generally reported symptoms earlier and more frequently than clinicians. Statistically significant associations with death and emergency room admissions were seen for clinician reports of fatigue (P < .001), nausea (P = .01), constipation (P = .038), and Karnofsky Performance Status (P < .001) but not for patient reports of these items. Higher concordance with EuroQoL EQ-5D questionnaire and global question scores was observed for patient-reported symptoms than for clinician-reported symptoms. Conclusions Longitudinally collected clinician CTCAE assessments better predict unfavorable clinical events, whereas patient reports better reflect daily health status. These perspectives are

  11. Epicardial adipose tissue thickness can be used to predict major adverse cardiac events.

    Science.gov (United States)

    Tanindi, Asli; Erkan, Aycan F; Ekici, Berkay

    2015-12-01

    Increase in epicardial adipose tissue (EAT) thickness is associated with subclinical and manifest coronary artery disease. In addition, it is associated with the severity and extent of coronary atherosclerosis. We aimed to investigate whether increased EAT thickness is associated with adverse cardiovascular outcomes. Two hundred consecutive patients who were admitted with stable angina pectoris, unstable angina pectoris or acute myocardial infarction (MI), and had undergone coronary angiography were included and followed for revascularization, nonfatal MI, hospitalization for heart failure and cardiovascular death for 26 (5-30) months. There were significantly more revascularizations, nonfatal MI and cardiovascular death in patients with an initial EAT thickness more than 7 mm (PEAT thickness more than 7 mm [hazard ratio (HR) 1.9, 95% confidence interval (CI) 0.4-8.3, P=0.039] and diabetes (HR 3.42, 95% CI 0.7-17.5, P=0.014) in the multivariate Cox regression analysis. Event-free survival for cardiovascular death in the EAT up to 7 mm group was 97.9%, whereas it was 90.7% in the EAT more than 7 mm group (P=0.021). In addition, significant predictors of MI were identified as an EAT thickness more than 7 mm (HR 2.4, 95% CI 0.6-10.0, P=0.021) and diabetes (HR 3.4, 95% CI 1.0-11.2, P=0.04). Event-free survival for MI in the EAT up to 7 mm group was 96.4%, whereas it was 68.2% in the EAT more than 7 mm group (P=0.001). Increase in EAT thickness independently predicts adverse cardiac events including MI and cardiovascular death.

  12. General surgical adverse events in a UK district general hospital-lessons to learn.

    Science.gov (United States)

    Gurjar, S V; Roshanzamir, S; Patel, Sandeep; Harinath, G

    2011-01-01

    An adverse event (AE) is defined as an unintended injury or complication caused by healthcare management rather than the disease process that may prolong admission and lead to disability or death. This study retrospectively assessed all reported general surgery-related AEs in a district general hospital in the south-east of England. All general surgical AEs arising from adult inpatient admissions between 2002 and 2007, that had been reported to the risk management team, following completion of the standard 'Adverse Incident Report Form', were retrospectively reviewed. There were 24,185 general surgical admissions over the period of the study; 461 AEs were reported (1.9% mean annual incident rate; 95% CI, 1.3%-2.5%). The majority (85%) were near miss or no injury events (category I and II) while serious/serious near-miss incidents accounted for just 2% of events. Communicative or administrative problems were implicated in 54% of cases while 12% arose from theatre/surgery-related failure. Of 58 medico-legal claims (0.24% of admissions) that were made, 16 (27.5%) progressed to the law courts for formal settlement. The reported annual AE incident rate of approximately 2% is well below the national average: this may be due to pre-selection of general surgery-related AEs or represent under-reporting of incidents. The vast majority of AEs were related to administrative and communicative error. These areas must be addressed if patient safety and outcome is to be significantly improved. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

  13. Computerized surveillance of opioid-related adverse drug events in perioperative care: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Gattis Katherine G

    2009-08-01

    Full Text Available Abstract Background Given the complexity of surgical care, perioperative patients are at high risk of opioid-related adverse drug events. Existing methods of detection, such as trigger tools and manual chart review, are time-intensive which makes sustainability challenging. Using strategic rule design, computerized surveillance may be an efficient, pharmacist-driven model for event detection that leverages existing staff resources. Methods Computerized adverse drug event surveillance uses a logic-based rules engine to identify potential adverse drug events or evolving unsafe clinical conditions. We extended an inpatient rule (administration of naloxone to detect opioid-related oversedation and respiratory depression to perioperative care at a large academic medical center. Our primary endpoint was the adverse drug event rate. For all patients with a naloxone alert, manual chart review was performed by a perioperative clinical pharmacist to assess patient harm. In patients with confirmed oversedation, other patient safety event databases were queried to determine if they could detect duplicate, prior, or subsequent opioid-related events. Results We identified 419 cases of perioperative naloxone administration. Of these, 101 were given postoperatively and 69 were confirmed as adverse drug events after chart review yielding a rate of 1.89 adverse drug events/1000 surgical encounters across both the inpatient and ambulatory settings. Our ability to detect inpatient opioid adverse drug events increased 22.7% by expanding surveillance into perioperative care. Analysis of historical surveillance data as well as a voluntary reporting database revealed that 11 of our perioperative patients had prior or subsequent harmful oversedation. Nine of these cases received intraoperative naloxone, and 2 had received naloxone in the post-anesthesia care unit. Pharmacist effort was approximately 3 hours per week to evaluate naloxone alerts and confirm adverse drug

  14. The economic burden of nurse-sensitive adverse events in 22 medical-surgical units: retrospective and matching analysis.

    Science.gov (United States)

    Tchouaket, Eric; Dubois, Carl-Ardy; D'Amour, Danielle

    2017-07-01

    The aim of this study was to assess the economic burden of nurse-sensitive adverse events in 22 acute-care units in Quebec by estimating excess hospital-related costs and calculating resulting additional hospital days. Recent changes in the worldwide economic and financial contexts have made the cost of patient safety a topical issue. Yet, our knowledge about the economic burden of safety of nursing care is quite limited in Canada in general and Quebec in particular. Retrospective analysis of charts of 2699 patients hospitalized between July 2008 - August 2009 for at least 2 days of 30-day periods in 22 medical-surgical units in 11 hospitals in Quebec. Data were collected from September 2009 to August 2010. Nurse-sensitive adverse events analysed were pressure ulcers, falls, medication administration errors, pneumonia and urinary tract infections. Descriptive statistics identified numbers of cases for each nurse-sensitive adverse event. A literature analysis was used to estimate excess median hospital-related costs of treatments with these nurse-sensitive adverse events. Costs were calculated in 2014 Canadian dollars. Additional hospital days were estimated by comparing lengths of stay of patients with nurse-sensitive adverse events with those of similar patients without nurse-sensitive adverse events. This study found that five adverse events considered nurse-sensitive caused nearly 1300 additional hospital days for 166 patients and generated more than Canadian dollars 600,000 in excess treatment costs. The results present the financial consequences of the nurse-sensitive adverse events. Government should invest in prevention and in improvements to care quality and patient safety. Managers need to strengthen safety processes in their facilities and nurses should take greater precautions. © 2017 John Wiley & Sons Ltd.

  15. Risk of cerebrovascular adverse events in older adults using antipsychotic agents: a propensity-matched retrospective cohort study.

    Science.gov (United States)

    Mehta, Sandhya; Johnson, Michael L; Chen, Hua; Aparasu, Rajender R

    2010-06-01

    To compare the risk of cerebrovascular adverse events with second-generation antipsychotic users versus those taking first-generation antipsychotics in community-dwelling older adults. A population-based retrospective cohort study matched on propensity score was used to examine the risk of cerebrovascular adverse events in second-generation antipsychotic users compared to first-generation antipsychotic users. IMS LifeLink Health Plan Claims Database was used to identify older adults (> or = 50 years) taking second-generation or first-generation antipsychotic agents from July 1, 2000, to December 31, 2007. Cox proportional hazards regression model stratified on matched pairs was used to examine the risk of hospitalization or emergency visits due to cerebrovascular adverse events within 1 year of follow-up (primary outcome measure). The covariates adjusted for include duration of therapy and exposure to other medication increasing risk of cerebrovascular adverse events. A total of 11,160 older adults (5,580 second-generation and 5,580 first-generation antipsychotic users) matched on propensity score was obtained. Regression analysis revealed that no statistically significant difference exists between second-generation and first-generation antipsychotic users with respect to risk of cerebrovascular adverse events (hazard ratio [HR], 0.858; 95% CI, 0.689-1.446). However, duration of therapy between 30-90 days (HR, 1.707; 95% CI, 1.174-2.481) and more than 90 days (HR, 1.570; 95% CI, 1.132-2.176) was associated with increased risk of cerebrovascular adverse events compared to duration of therapy less than 30 days. The use of second-generation antipsychotic agents was found not to be associated with increased risk of cerebrovascular adverse events compared to first-generation agents in older adults. However, long-term use of second- and first-generation antipsychotic agents is associated with increased risk of cerebrovascular adverse events. 2010 Physicians Postgraduate

  16. 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.

    Science.gov (United States)

    Schumm, Walter R

    2006-11-10

    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. 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. 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. 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

  17. Neurologic adverse events associated with smallpox vaccination in the United States – response and comment on reporting of headaches as adverse events after smallpox vaccination among military and civilian personnel

    Directory of Open Access Journals (Sweden)

    Schumm Walter R

    2006-11-01

    Full Text Available Abstract Background Accurate reporting of adverse events occurring after vaccination is an important component of determining risk-benefit ratios for vaccinations. Controversy has developed over alleged underreporting of adverse events within U.S. military samples. This report examines the accuracy of adverse event rates recently published for headaches, and examines the issue of underreporting of headaches as a function of civilian or military sources and as a function of passive versus active surveillance. Methods A report by Sejvar et al was examined closely for accuracy with respect to the reporting of neurologic adverse events associated with smallpox vaccination in the United States. Rates for headaches were reported by several scholarly sources, in addition to Sejvar et al, permitting a comparison of reporting rates as a function of source and type of surveillance. Results Several major errors or omissions were identified in Sejvar et al. The count of civilian subjects vaccinated and the totals of both civilians and military personnel vaccinated were reported incorrectly by Sejvar et al. Counts of headaches reported in VAERS were lower (n = 95 for Sejvar et al than for Casey et al (n = 111 even though the former allegedly used 665,000 subjects while the latter used fewer than 40,000 subjects, with both using approximately the same civilian sources. Consequently, rates of nearly 20 neurologic adverse events reported by Sejvar et al were also incorrectly calculated. Underreporting of headaches after smallpox vaccination appears to increase for military samples and for passive adverse event reporting systems. Conclusion Until revised or corrected, the rates of neurologic adverse events after smallpox vaccinated reported by Sejvar et al must be deemed invalid. The concept of determining overall rates of adverse events by combining small civilian samples with large military samples appears to be invalid. Reports of headaches as adverse events

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

    Directory of Open Access Journals (Sweden)

    Sakaeda Toshiyuki

    2011-10-01

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

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

    Science.gov (United States)

    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.

  20. Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study.

    Science.gov (United States)

    Daneman, Nick; Lu, Hong; Redelmeier, Donald A

    2015-11-18

    Fluoroquinolone-associated tendon ruptures are a recognised complication, but other severe collagen-associated adverse events may also be possible. Our objectives were to confirm the association of fluoroquinolones and tendon rupture, to clarify the potential association of fluoroquinolones and retinal detachment, and to test for a potentially lethal association between fluoroquinolones and aortic aneurysms. Population-based longitudinal cohort study in Ontario, Canada. Older adults turning 65 years between April 1 1997 and March 31 2012 were followed until primary outcome, death, or end of follow-up (March 31 2014). Fluoroquinolone prescriptions were measured as a time-varying covariate, with patients considered at risk during and for 30 days following a treatment course. Severe collagen-associated adverse events defined as tendon ruptures, retinal detachments and aortic aneurysms diagnosed in hospital and emergency departments. Among the 1,744,360 eligible patients, 657,950 (38%) received at least one fluoroquinolone during follow-up, amounting to 22,380,515 days of treatment. The patients experienced 37,338 (2.1%) tendon ruptures, 3246 (0.2%) retinal detachments, and 18,391 (1.1%) aortic aneurysms. Severe collagen-associated adverse events were more common during fluoroquinolone treatment than control periods, including tendon ruptures (0.82 vs 0.26/100-person years, pfluoroquinolones were associated with an increased hazard of tendon rupture (HR 3.13, 95% CI 2.98 to 3.28; adjusted HR 2.40, 95% CI 2.24 to 2.57) and an increased hazard of aortic aneurysms (HR 2.72, 95% CI 2.53 to 2.93; adjusted HR2.24, 95% CI 2.02 to 2.49) that were substantially greater in magnitude than the association of these outcomes with amoxicillin. The hazard of retinal detachment was marginal (HR 1.28, 95% CI 0.99 to 1.65; adjusted HR 1.47, 95% CI 1.08 to 2.00) and not greater in magnitude than that observed with amoxicillin. Fluoroquinolones are associated with subsequent tendon

  1. Analysis of incidence and risk factors for ERCP-related adverse events in patients with primary sclerosing cholangitis

    Directory of Open Access Journals (Sweden)

    BI Rongxin

    2015-02-01

    Full Text Available ObjectiveTo investigate the incidence and risk factors for endoscopic retrograde cholangiopancreatography (ERCP-related adverse events in patients with primary sclerosing cholangitis (PSC. MethodsThis study included 72 patients who were diagnosed with PSC by magnetic resonance cholangiopancreatography and underwent ERCP in the Third Hospital of Xingtai City from December 2009 to December 2013. The incidence of postoperative adverse events within 30 d after ERCP was monitored and recorded. Univariate and multivariate logistic regression analyses were used to analyze the risk factors for ERCP-related adverse events in PSC patients. ResultsThe success rate of ERCP was 94.4% (68/72. Among all adverse events, the incidence of pancreatitis and biliary tract infection were highest (6.94% and 4.17%, while the incidence of perforation was lowest (1.38%. Univariate logistic regression analysis showed that the risk of adverse events was significantly higher in patients who underwent cholangiopancreatography and sphincterotomy than in those not undergoing these procedures (OR=13.642, P=0.017; OR=7.381, P=0.000; guide wire insertion and cholangiopancreatography also increased the incidence of adverse reactions (OR=8.042, P=0.000; OR=2.651, P=0.032. Multivariate logistic regression analysis showed that guide wire insertion (OR = 4.547, 95%CI: 1.076-12.543 and biliary sphincterotomy (OR=5.023, 95%CI: 2.643-18.321 are associated with the incidence of ERCP-related adverse events. ConclusionSphincterotomy and guide wire insertion can increase the risk of adverse events in PSC patients after ERCP.

  2. Behavioral control blunts reactions to contemporaneous and future adverse events: Medial prefrontal cortex plasticity and a corticostriatal network

    Directory of Open Access Journals (Sweden)

    Steven F. Maier

    2015-01-01

    Full Text Available It has been known for many years that the ability to exert behavioral control over an adverse event blunts the behavioral and neurochemical impact of the event. More recently, it has become clear that the experience of behavioral control over adverse events also produces enduring changes that reduce the effects of subsequent negative events, even if they are uncontrollable and quite different from the original event controlled. This review focuses on the mechanism by which control both limits the impact of the stressor being experienced and produces enduring, trans-situational “immunization”. The evidence will suggest that control is detected by a corticostriatal circuit involving the ventral medial prefrontal cortex (mPFC and the posterior dorsomedial striatum (DMS. Once control is detected, other mPFC neurons that project to stress-responsive brainstem (dorsal raphe nucleus, DRN and limbic (amygdala structures exert top–down inhibitory control over the activation of these structures that is produced by the adverse event. These structures, such as the DRN and amygdala, in turn regulate the proximate mediators of the behavioral and physiological responses produced by adverse events, and so control blunts these responses. Importantly, the joint occurrence of control and adverse events seems to produce enduring plastic changes in the top–down inhibitory mPFC system such that this system is now activated by later adverse events even if they are uncontrollable, thereby reducing the impact of these events. Other issues are discussed that include a whether other processes such as safety signals and exercise, that lead to resistance/resilience, also use the mPFC circuitry or do so in other ways; b whether control has similar effects and neural mediation in humans, and c the relationship of this work to clinical phenomena.

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

    National Research Council Canada - National Science Library

    Wells, Timothy S

    2005-01-01

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

  4. New High Dose Pulsed Hyaluronidase Protocol for Hyaluronic Acid Filler Vascular Adverse Events.

    Science.gov (United States)

    DeLorenzi, Claudio

    2017-07-01

    adverse events are very treatable with an excellent prognosis, with a few exceptions. This new protocol offers excellent results, but requires further research to determine optimal parameters for various HA fillers. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  5. Detecting associations between behavioral addictions and dopamine agonists in the Food & Drug Administration's Adverse Event database.

    Science.gov (United States)

    Gendreau, Katherine E; Potenza, Marc N

    2014-03-01

    Studies have reported higher prevalences of four behavioral addictions (binge eating, compulsive shopping, hypersexuality, and pathological gambling) in dopamine agonist-treated Parkinson's disease relative to non-dopamine agonist-treated Parkinson's. However, recent case-control and epidemiological studies suggest that prevalences of behavioral addictions in dopamine agonist-treated Parkinson's may be similar to background population rates. This study tests that hypothesis by examining the FDA Adverse Event Reporting System (FAERS) for evidence of these associations, taking into account the potential impact of publicity on reporting rates. FAERS reports in 2004 (pre-publicity for all but pathological gambling) and 2007 (post-publicity for all four behaviors) were analyzed. A threshold consisting of ≥3 cases, proportional reporting ratio ≥2, and χ (2) with Yates' correction ≥4 was used to detect signals (drug-associated adverse reactions) involving any of five dopamine agonists and any of four behavioral addictions. No reports containing compulsive shopping and no signal for binge eating and dopamine agonists were found in either year. A weak signal was found for hypersexuality in 2004, with a stronger signal in 2007. A robust signal was found for pathological gambling in 2004, with a more robust signal in 2007. These results suggest that publicity may increase reporting rates in the FAERS. Findings for binge eating, compulsive shopping, and hypersexuality suggest that prevalences of these behaviors among those treated with dopamine agonists may be similar to background population rates and thus may not reflect an adverse safety signal. Further investigation of the relationship between dopamine agonists and behavioral addictions is warranted.

  6. Beta-blocker subtype and risks of perioperative adverse events following non-cardiac surgery

    DEFF Research Database (Denmark)

    Jørgensen, Mads E.; Sanders, Robert D.; Køber, Lars

    2017-01-01

    performed a Danish Nationwide cohort study, 2005-2011, of patients treated chronically with beta blocker (atenolol, bisoprolol, carvedilol, metoprolol, propranolol, or other) prior to non-cardiac surgery. Risks of 30-day all-cause mortality (ACM) and 30-day major adverse cardiovascular events (MACE) were...... estimated using adjusted logistic regression models and odds ratios with 95% confidence intervals. We identified 61 660 patients, most frequently treated with metoprolol (67% of patients, mean age 69 years, 49% males), atenolol (10% of patients, mean age 68 years, 36% males), or carvedilol (9% of patients......, mean age 68 years, 60% males). The crude incidences of ACM and MACE were 4.1 and 3.5% in patients with metoprolol, 3.0 and 2.3% with atenolol, and 4.8 and 4.6% with carvedilol. In adjusted models, risks were not significantly different with atenolol (ACM; 1.10 [0.92-1.32], MACE; 1.08 [0...

  7. High-Performance Signal Detection for Adverse Drug Events using MapReduce Paradigm.

    Science.gov (United States)

    Fan, Kai; Sun, Xingzhi; Tao, Ying; Xu, Linhao; Wang, Chen; Mao, Xianling; Peng, Bo; Pan, Yue

    2010-11-13

    Post-marketing pharmacovigilance is important for public health, as many Adverse Drug Events (ADEs) are unknown when those drugs were approved for marketing. However, due to the large number of reported drugs and drug combinations, detecting ADE signals by mining these reports is becoming a challenging task in terms of computational complexity. Recently, a parallel programming model, MapReduce has been introduced by Google to support large-scale data intensive applications. In this study, we proposed a MapReduce-based algorithm, for common ADE detection approach, Proportional Reporting Ratio (PRR), and tested it in mining spontaneous ADE reports from FDA. The purpose is to investigate the possibility of using MapReduce principle to speed up biomedical data mining tasks using this pharmacovigilance case as one specific example. The results demonstrated that MapReduce programming model could improve the performance of common signal detection algorithm for pharmacovigilance in a distributed computation environment at approximately liner speedup rates.

  8. Understanding the organisational context for adverse events in the health services: the role of cultural censorship.

    Science.gov (United States)

    Hart, E; Hazelgrove, J

    2001-12-01

    This paper responds to the current emphasis on organisational learning in the NHS as a means of improving healthcare systems and making hospitals safer places for patients. Conspiracies of silence have been identified as obstacles to organisational learning, covering error and hampering communication. In this paper we question the usefulness of the term and suggest that "cultural censorship", a concept developed by the anthropologist Robin Sherriff, provides a much needed insight into cultures of silence within the NHS. Drawing on a number of illustrations, but in particular the Ritchie inquiry into the disgraced gynaecologist Rodney Ledward, we show how the defining characteristics of cultural censorship can help us to understand how adverse events get pushed underground, only to flourish in the underside of organisational life.

  9. Evidence Report: Risk of Crew Adverse Health Event Due to Altered Immune Response

    Science.gov (United States)

    Crucian, Brian; Sams, Clarence F.

    2013-01-01

    The Risk of Crew Adverse Health Event Due to Altered Immune Response is identified by the National Aeronautics and Space Administration (NASA) Human Research Program (HRP) as a recognized risk to human health and performance in space. The HRP Program Requirements Document (PRD) defines these risks. This Evidence Report provides a summary of the evidence that has been used to identify and characterize this risk. It is known that human immune function is altered in- and post-flight, but it is unclear at present if such alterations lead to increased susceptibility to disease. Reactivation of latent viruses has been documented in crewmembers, although this reactivation has not been directly correlated with immune changes or with observed diseases. As described in this report, further research is required to better characterize the relationships between altered immune response and susceptibility to disease during and after spaceflight. This is particularly important for future deep-space exploration missions.

  10. Data-driven Markov models and their application in the evaluation of adverse events in radiotherapy

    CERN Document Server

    Abler, Daniel; Davies, Jim; Dosanjh, Manjit; Jena, Raj; Kirkby, Norman; Peach, Ken

    2013-01-01

    Decision-making processes in medicine rely increasingly on modelling and simulation techniques; they are especially useful when combining evidence from multiple sources. Markov models are frequently used to synthesize the available evidence for such simulation studies, by describing disease and treatment progress, as well as associated factors such as the treatment's effects on a patient's life and the costs to society. When the same decision problem is investigated by multiple stakeholders, differing modelling assumptions are often applied, making synthesis and interpretation of the results difficult. This paper proposes a standardized approach towards the creation of Markov models. It introduces the notion of ‘general Markov models’, providing a common definition of the Markov models that underlie many similar decision problems, and develops a language for their specification. We demonstrate the application of this language by developing a general Markov model for adverse event analysis in radiotherapy ...

  11. Risk prediction models for major adverse cardiac event (MACE) following percutaneous coronary intervention (PCI): A review

    Science.gov (United States)

    Manan, Norhafizah A.; Abidin, Basir

    2015-02-01

    Five percent of patients who went through Percutaneous Coronary Intervention (PCI) experienced Major Adverse Cardiac Events (MACE) after PCI procedure. Risk prediction of MACE following a PCI procedure therefore is helpful. This work describes a review of such prediction models currently in use. Literature search was done on PubMed and SCOPUS database. Thirty literatures were found but only 4 studies were chosen based on the data used, design, and outcome of the study. Particular emphasis was given and commented on the study design, population, sample size, modeling method, predictors, outcomes, discrimination and calibration of the model. All the models had acceptable discrimination ability (C-statistics >0.7) and good calibration (Hosmer-Lameshow P-value >0.05). Most common model used was multivariate logistic regression and most popular predictor was age.

  12. Auditing an Online Self-reported Interventional Radiology Adverse Event Database for Compliance and Accuracy.

    Science.gov (United States)

    Burch, Ezra A; Shyn, Paul B; Chick, Jeffrey F; Chauhan, Nikunj R

    2017-04-01

    The purpose of this study was to determine whether auditing an online self-reported interventional radiology quality assurance database improves compliance with record entry or improves the accuracy of adverse event (AE) reporting and grading. Physicians were trained in using the database before the study began. An audit of all database entries for the first 3 months, or the first quarter, was performed, at which point physicians were informed of the audit process; entries for the subsequent 3 months, or the second quarter, were again audited. Results between quarters were compared. Compliance with record entry improved from the first to second quarter, but reminders were necessary to ensure 100% compliance with record entry. Knowledge of the audit process did not significantly improve self-reporting of AE or accuracy of AE grading. However, auditing significantly changed the final AE reporting rates and grades. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  13. Adverse Events During Immunotherapy Against Grass Pollen-Induced Allergic Rhinitis

    DEFF Research Database (Denmark)

    Aasbjerg, Kristian; Dalhoff, Kim Peder; Backer, Vibeke

    2015-01-01

    Allergic rhinitis (AR) triggered by grass pollen is a common disease, affecting millions of people worldwide. Treatment consists of symptom-alleviating drugs, such as topical corticosteroids or antihistamines. Another option is potentially curative immunotherapy, currently available as sublingual...... and subcutaneous treatment. We investigated the potential differences in the prevalence and severity of adverse events related to subcutaneous and sublingual immunotherapy (SLIT) against grass pollen-induced AR. A thorough literature search was performed with PubMed and EMBASE. The findings were compared...... no systematically collected safety data. No sufficiently powered randomized trials comparing sublingual and subcutaneous immunotherapy (SCIT) were available, but general safety assessments indicate that sublingual tablet treatment is safer than subcutaneous treatment. Not all commonly used immunotherapy drugs...

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

    Science.gov (United States)

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

    2017-04-25

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

  15. Adverse events following immunization: is this time for the use of WHO causality assessment?

    Science.gov (United States)

    Tafuri, Silvio; Gallone, Maria Serena; Calabrese, Giulia; Germinario, Cinzia

    2015-05-01

    In recent years, public health authorities in industrialized countries have noted an increase in the numbers of parents choosing not to have their children vaccinated and in the activities of 'antivaccination' movements. Doubts about vaccine safety and lack of surveillance of adverse events following immunization (AEFI) are the most frequent themes proposed by antivaccination movements. This editorial aims to critically analyze the use of AEFI assessment procedures among national health authorities and public health researchers. In fact, the WHO recommended and published a systematic and standardized causality assessment process for serious AEFI, providing a method for individual causality assessment to be used by staff of national immunization programs, regulatory authorities and pharmacovigilance or surveillance departments. The last update was published in March 2013 but to date, an Internet search reveals no information or reports on AEFI surveillance that uses the WHO AEFI causality assessment.

  16. Two Cases of Nivolumab Re-Administration after Pneumonitis as Immune-Related Adverse Events

    Directory of Open Access Journals (Sweden)

    Keisuke Imafuku

    2017-04-01

    Full Text Available Nivolumab is a recently approved medication for the treatment of unresectable malignant melanoma. Many immune-related adverse events (irAEs associated with nivolumab have been reported, such as pneumonitis, hepatitis, dermatitis, and thyroiditis. Prednisolone can effectively treat irAEs. However, it is unclear how or if nivolumab should be administered to patients after they have experienced an irAE. Herein, we show 2 patients who underwent pneumonitis as irAE. Case 1 demonstrated a cryptogenic organizing pneumonia pattern in the CT scan and case 2 had a diffuse alveolar damage (DAD pattern. Oral corticosteroids improved chest shadow of CT scan in both cases. However, when nivolumab was re-administrated, case 1 demonstrated no symptoms, but case 2 demonstrated pneumonia again. From our cases, it is difficult to re-administrate nivolumab for the patients with pneumonitis which shows a DAD pattern in CT, even if oral corticosteroids improve their symptoms.

  17. Text mining for adverse drug events: the promise, challenges, and state of the art.

    Science.gov (United States)

    Harpaz, Rave; Callahan, Alison; Tamang, Suzanne; Low, Yen; Odgers, David; Finlayson, Sam; Jung, Kenneth; LePendu, Paea; Shah, Nigam H

    2014-10-01

    Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. It is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event (ADE) detection and assessment. This article provides an overview of recent advances in pharmacovigilance driven by the application of text mining, and discusses several data sources-such as biomedical literature, clinical narratives, product labeling, social media, and Web search logs-that are amenable to text mining for pharmacovigilance. Given the state of the art, it appears text mining can be applied to extract useful ADE-related information from multiple textual sources. Nonetheless, further research is required to address remaining technical challenges associated with the text mining methodologies, and to conclusively determine the relative contribution of each textual source to improving pharmacovigilance.

  18. Adverse events associated with opioid-containing cough and cold medications in children.

    Science.gov (United States)

    Paul, Ian M; Reynolds, Kate M; Green, Jody L

    2018-04-10

    Until recently most of the scrutiny of opioid-containing cough and cold medications (CCMs) by the US Food and Drug Administration (FDA) was focused on codeine, only recently shifting equal focus to those containing hydrocodone. We characterized adverse events (AEs) in children Dictionary for Regulatory Activities with preferred terms reported. One hundred and fourteen of the 7035 (2%) cases reviewed involved an opioid-containing product. Ninety-eight cases involved an AE at least potentially related to the opioid ingredient (38 (39%) codeine; 60 (61%) hydrocodone). All three fatality cases involved hydrocodone with an antihistamine. Among non-fatalities, somnolence, lethargy, and/or respiratory depression were more commonly reported among hydrocodone cases than codeine cases (86% vs. 61%; p = .005). These safety surveillance data support the FDA's expanded label changes limiting opioid CCMs for children.

  19. Prior chronic clopidogrel therapy is associated with increased adverse events and early stent thrombosis.

    Science.gov (United States)

    Asher, Elad; Fefer, Paul; Sabbag, Avi; Herscovici, Romana; Regev, Ehud; Mazin, Israel; Shlomo, Nir; Zahger, Doron; Atar, Shaul; Hammerman, Haim; Polak, Arthur; Beigel, Roy; Matetzky, Shlomi

    2016-01-01

    Despite the growing use of clopidogrel, limited data exist regarding the prognostic significance of chronic clopidogrel therapy in patients sustaining acute coronary syndrome (ACS). Our aim was to determine whether patients sustaining ACS while on chronic clopidogrel therapy have a worse prognosis than clopidogrel-naïve patients. A total of 5,386 consecutive ACS patients were prospectively characterised and followed-up for 30 days. Of them, 680 (13%) were treated with clopidogrel prior to the index ACS. Major adverse cardiovascular events (MACE) were defined as death, recurrent ACS, stroke and/or stent thrombosis. Compared with clopidogrel-naïve, chronic clopidogrel-treated patients were older (66 ± 12 vs 63 ± 13, respectively; pthrombosis (2.2% vs 1.0%, respectively; p=0.007). MACE at 30 days was also higher among chronic clopidogrel-treated compared with clopidogrel-naïve patients [12.3% vs 9.4%, respectively; pthrombosis [OR=2.6 (95%CI 1.2-5.6), p=0.001]. Patients sustaining ACS while on chronic clopidogrel treatment are at higher risk for in-hospital and 30-day adverse outcomes, including stent thrombosis.

  20. Building a time-saving and adaptable tool to report adverse drug events.

    Science.gov (United States)

    Parès, Yves; Declerck, Gunnar; Hussain, Sajjad; Ng, Romain; Jaulent, Marie-Christine

    2013-01-01

    The difficult task of detecting adverse drug events (ADEs) and the tedious process of building manual reports of ADE occurrences out of patient profiles result in a majority of adverse reactions not being reported to health regulatory authorities. The SALUS individual case safety report (ICSR) reporting tool, a component currently developed within the SALUS project, aims to support semi-automatic reporting of ADEs to regulatory authorities. In this paper, we present an initial design and current state of of our ICSR reporting tool that features: (i) automatic pre-population of reporting forms through extraction of the patient data contained in an Electronic Health Record (EHR); (ii) generation and electronic submission of the completed ICSRs by the physician to regulatory authorities; and (iii) integration of the reporting process into the physician's work-flow to limit the disturbance. The objective is to increase the rates of ADE reporting and the quality of the reported data. The SALUS interoperability platform supports patient data extraction independently of the EHR data model in use and allows generation of reports using the format expected by regulatory authorities.

  1. The incidence and management of cutaneous adverse events of the epidermal growth factor receptor inhibitors

    Directory of Open Access Journals (Sweden)

    Witold Owczarek

    2017-10-01

    Full Text Available Overexpression of the epidermal growth factor receptor (EGFR is found in many cancers, including those of the head and neck area, non-small-cell lung cancer, and colorectal, cervical, prostate, breast, ovary, stomach, and pancreatic cancer. The EGFR inhibitors are used at present in the treatment of such cancers. Skin lesions that develop during and after cancer treatment may be due to specific cytostatics, molecular-targeted drugs, radiation therapy, complementary therapy, or the cancer itself, and hence knowledge is essential to distinguish between them. The mechanism through which skin toxicity arises during treatment with EGFR inhibitors is not well known, but seems to be due to the modification of the RAS/RAF/MEK/ERK signal path associated with its activation, which results in the similarity between the adverse effects of EGFR inhibitors and the treatment of melanoma with BRAF and MEK inhibitors. The most common side effects are pruritus, xerosis, papulopustular rash, hand-foot skin reaction, alopecia and dystrophy of the hair, and paronychia. This work presents options for prevention and suggestions for managing these adverse events, which are of importance in the care of patients undergoing oncological treatment.

  2. Annual report on adverse events related with vaccines use in Calabria (Italy): 2012

    Science.gov (United States)

    Staltari, Orietta; Cilurzo, Felisa; Caroleo, Benedetto; Greco, Alexia; Corasaniti, Francesco; Genovesi, Maria Antonietta; Gallelli, Luca

    2013-01-01

    Vaccines are administered to large population of healthy individuals, particularly to millions of infants every year, through national immunization programs. Although vaccines represent a good defense against some infectious diseases, their administration may be related with the development of adverse vaccine events (AVEs); therefore their use is continually monitored to detect these side effects. In the presents work, we reported the suspected AVEs recorded in 2012 in Calabria, Italy. We performed a retrospective study on report forms of patients that developed AVEs in Calabria from January 1, 2012 to December 31, 2012. Naranjo score was used to evaluate the association between AVEs and vaccines and only suspected AVEs definable as certain, probable, or possible were included in this analysis. During the study period, we evaluated 461 records of adverse drug reactions (ADRs) and 18 (3.9%) were probably induced by vaccination. AVEs were common in females (almost 77.7%) and in children aged 0-3 years. The largest number of non-serious AVEs involved “skin and subcutaneous tissue disorders” and “general disorders and administration site conditions.” In conclusion, we documented that in Calabria the total number of AVEs is very low and it may be useful to increase the pharmacovigilance culture in order to evaluate the safety of these products in large populations. PMID:24347985

  3. Childhood adverse life events, disordered eating, and body mass index in US Military service members.

    Science.gov (United States)

    Bakalar, Jennifer L; Barmine, Marissa; Druskin, Lindsay; Olsen, Cara H; Quinlan, Jeffrey; Sbrocco, Tracy; Tanofsky-Kraff, Marian

    2018-03-02

    US service members appear to be at high-risk for disordered eating. Further, the military is experiencing unprecedented prevalence of overweight and obesity. US service members also report a high prevalence of childhood adverse life event (ALE) exposure. Despite consistent links between early adversity with eating disorders and obesity, there is a dearth of research examining the association between ALE exposure and disordered eating and weight in military personnel. An online survey study was conducted in active duty personnel to examine childhood ALE history using the Life Stressor Checklist - Revised, disordered eating using the Eating Disorder Examination - Questionnaire total score, and self-reported body mass index (BMI, kg/m 2 ). Among 179 respondents, multiple indices of childhood ALE were positively associated with disordered eating. Traumatic childhood ALE and subjective impact of childhood ALE were associated with higher BMI and these associations were mediated by disordered eating. Findings support evaluating childhood ALE exposure among service members with disordered eating and weight concerns. Moreover, findings support the need for prospective research to elucidate these relationships. © 2018 Wiley Periodicals, Inc.

  4. Treatment compliance and severe adverse events limit the use of tyrosine kinase inhibitors in refractory thyroid cancer

    Directory of Open Access Journals (Sweden)

    Chrisoulidou A

    2015-09-01

    Full Text Available Alexandra Chrisoulidou, Stylianos Mandanas, Efterpi Margaritidou, Lemonia Mathiopoulou, Maria Boudina, Konstantinos Georgopoulos, Kalliopi Pazaitou-PanayiotouDepartment of Endocrinology, Theagenio Cancer Hospital, Thessaloniki, GreeceObjective: The aim of the present study was to assess patient compliance with tyrosine kinase inhibitor (TKI treatment used for refractory and progressive thyroid cancer, in addition to the efficacy and serious adverse events associated with these agents.Methods: We retrospectively analyzed data from adult patients with metastatic differentiated or medullary thyroid cancer unresponsive to conventional treatment and treated with TKIs. Patients received treatment until disease progression or onset of serious adverse events, or until they expressed an intention to stop treatment.Results: Twenty-four patients received TKIs. The median duration of treatment was four (range: 1–19 cycles. The most frequent adverse events were fatigue, nausea, diarrhea, hypertension, and stomatitis, and the most severe were nasal bleeding, diarrhea, heart failure, rhabdomyolysis, renal failure, QT prolongation, neutropenia, and severe fatigue. Dose reduction was required in eight patients, while five decided to terminate TKI therapy because adverse events impaired their everyday activities. During therapy, two patients showed a partial response and three showed stable disease. The lungs were the metastatic sites favoring a response to treatment.Conclusion: Patient selection and meticulous pretreatment education are necessary in order to ensure adherence with TKI therapy. If adverse events appear, dose reduction or temporary treatment interruption may be offered because some adverse events resolve with continuation of treatment. In the event of serious adverse events, treatment discontinuation is necessary. Keywords: medullary thyroid carcinoma, differentiated thyroid cancer, TKIs, sorafenib, sunitinib, vandetanib

  5. A systematic review of adverse events of rifapentine and isoniazid compared to other treatments for latent tuberculosis infection.

    Science.gov (United States)

    Pease, Christopher; Hutton, Brian; Yazdi, Fatemeh; Wolfe, Dianna; Hamel, Candyce; Barbeau, Pauline; Skidmore, Becky; Alvarez, Gonzalo G

    2018-03-23

    Tuberculosis (TB) remains a common cause of death globally. A regimen of 12 doses of isoniazid (INH) and rifapentine given once weekly (INH/RPT-3) has recently been recommended by the World Health Organization for the treatment of latent TB infection (LTBI). We aimed to determine whether the INH/RPT-3 regimen had similar or lesser rates of adverse events compared to other LTBI regimens, namely INH for 9 months, INH for 6 months, rifampin for 3 to 4 months, and rifampin plus INH for 3 to 4 months. We searched MEDLINE, Embase, CENTRAL, PubMed, ICTRP, clinicaltrials.gov, and Canadian Agency for Drugs and Technologies in Health's Gray Matters Light for randomized, postmarketing, and comparative nonrandomized studies of patients with confirmed LTBI that reported the frequency of at least 1 adverse event of relevance for a regimen of interest. The search included studies published until March 2017. The frequencies of adverse events were extracted and are presented descriptively. Data from 23 randomized and 55 nonrandomized studies were included. Although inconsistent event reporting and high heterogeneity limited comparisons, the adverse event profile of INH/RPT-3 appeared generally favorable. Flu-like reactions were reported with an increased frequency and hepatotoxicity with a lower frequency than standard treatment. While INH/RPT-3 had an overall low frequency of adverse events compared to INH monotherapy, reporting of adverse events for many regimens was limited meaning results should be interpreted cautiously. Future studies of LTBI treatment would benefit from more complete collection and reporting of adverse events and more consistent definitions of hepatotoxicity. Copyright © 2018 John Wiley & Sons, Ltd.

  6. [Description of contributing factors in adverse events related to patient safety and their preventability].

    Science.gov (United States)

    Guerra-García, María Mercedes; Campos-Rivas, Beatriz; Sanmarful-Schwarz, Alexandra; Vírseda-Sacristán, Alicia; Dorrego-López, M Aránzazu; Charle-Crespo, Ángeles

    2017-11-25

    To assess the extent of healthcare related adverse events (AEs), their effect on patients, and their seriousness. To analyse the factors leading to the development of AEs, their relationship with the damage caused, and their degree of preventability. Retrospective descriptive study. Porriño, Pontevedra, Spain, Primary Care Service, from January-2014 to April-2016. Reported AEs were entered into the Patient Safety Reporting and Learning System (SiNASP). The variables measured were: Near Incident (NI) an occurrence with no effect or harm on the patient; Adverse Event (AE) an occurrence that affects or harms a patient. The level of harm is classified as minimal, minor, moderate, critical, and catastrophic. Preventability was classified as little evidence of being preventable, 50% preventable, and sound evidence of being preventable. percentages and Chi-squared test for qualitative variables; P<.05 with SPSS.15. SiNASP. Ethical considerations: approved by the Research Ethics Committee (2016/344). There were 166 recorded AEs (50.6% in males, and 46.4% in women. The mean age was 60.80years). Almost two-thirds 62.7% of AEs affected the patient, with 45.8% causing minimal damage, while 2.4% caused critical damages. Healthcare professionals were a contributing factor in 71.7% of the AEs, with the trend showing that poor communication and lack of protocols were related to the damage caused. Degree of preventability: 96.4%. Most AEs affected the patient, and were related to medication, diagnostic tests, and laboratory errors. The level of harm was related to communication problems, lack of, or deficient, protocols and a poor safety culture. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  7. Gastric outlet obstruction: An unusual adverse event of percutaneous endoscopic gastrostomy.

    Science.gov (United States)

    Barosa, Rita; Santos, Carla; Fonseca, Jorge

    2016-01-01

    Dear Editor, A 75-year-old woman living in a nursing home presented with a 24-hour history of abdominal cramping and vomiting. Medical history was remarkable for dementia and a percutaneous endoscopic gastrostomy (PEG) was performed 3 years earlier. The day before the admission the feeding tube was accidentally pulled out and a Foley catheter was placed in order to avoid stoma closure. On physical examination, there was extravasation of the gastric content through the stoma. The base of the "Y" of the Foley catheter was introduced in the gastric stoma and a pulling sensation was felt when it was mobilized. The remainder abdominal examination was unremarkable. On esophagogastroduodenoscopy the Foley catheter was identified passing the pylorus and pulling duodenal bulb towards the antrum (Figure 1). Advancing the scope through the duodenum, the Foley balloon impacted in the duodenal apex was identified. There was no mucosal injury so the balloon was deflated and the catheter removed. A 14 Fr. Bard PEG tube was latter placed to allow a reduction in the calibre of the stoma. Gastric outlet obstruction is an unusual adverse event of PEG tubes. In adults it is usually related to Foley catheters use as peristalsis can pull the balloon into the duodenum in the absence of an external bumper. A clinical picture of abdominal cramping, vomiting and resistance to the attempt of percutaneous reposition should raise the suspicion of gastrostomy tube migration through the pylorus. Foley catheters are easily available and some may use it to prevent gastrostomy closure after accidentally PEG tube extraction. We have performed more than 800 PEG and assisted several cases of gastric outlet obstruction and even stoma damage in this setting. This case emphasises the importance of receiving an early PEG tube with external bumper replacement to prevent this adverse event.

  8. [Adverse respiratory events after general anesthesia in patients at high risk of obstructive sleep apnea syndrome].

    Science.gov (United States)

    Xará, Daniela; Mendonça, Júlia; Pereira, Helder; Santos, Alice; Abelha, Fernando José

    2015-01-01

    Patients with STOP-BANG score >3 have a high risk of Obstructive sleep apnea. The aim of this study was to evaluate early postoperative respiratory complications in adults with STOP-BANG score >3 after general anesthesia. This is a prospective double cohort study matching 59 pairs of adult patients with STOP-BANG score >3 (high risk of obstructive sleep apnea) and patients with STOP-BANG score <3 (low risk of obstructive sleep apnea), similar with respect to gender, age and type of surgery, admitted after elective surgery in the Post-Anaesthesia Care Unit in May 2011. Primary outcome was the development of adverse respiratory events. Demographics data, perioperative variables, and postoperative length of stay in the Post-Anesthesia Care Unit and in hospital were recorded. The Mann-Whitney test, the chi-square test and the Fisher exact test were used for comparisons. Subjects in both pairs of study subjects had a median age of 56 years, including 25% males, and 59% were submitted to intra-abdominal surgery. High risk of obstructive sleep apnea patients had a higher median body mass index (31 versus 24kg/m(2), p<0.001) and had more frequently co-morbidities, including hypertension (58% versus 24%, p<0.001), dyslipidemia (46% versus 17%, p<0.001) and insulin-treated diabetes mellitus (17% versus 2%, p=0.004). These patients were submitted more frequently to bariatric surgery (20% versus 2%, p=0.002). Patients with high risk of obstructive sleep apnea had more frequently adverse respiratory events (39% versus 10%, p<0.001), mild to moderate desaturation (15% versus 0%, p=0.001) and inability to breathe deeply (34% versus 9%, p=0.001). After general anesthesia high risk of obstructive sleep apnea patients had an increased incidence of postoperative respiratory complications. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  9. Adverse respiratory events after general anesthesia in patients at high risk of obstructive sleep apnea syndrome.

    Science.gov (United States)

    Xará, Daniela; Mendonça, Júlia; Pereira, Helder; Santos, Alice; Abelha, Fernando José

    2015-01-01

    Patients with STOP-BANG score >3 have a high risk of Obstructive sleep apnea. The aim of this study was to evaluate early postoperative respiratory complications in adults with STOP-BANG score >3 after general anesthesia. This is a prospective double cohort study matching 59 pairs of adult patients with STOP-BANG score >3 (high risk of obstructive sleep apnea) and patients with STOP-BANG score <3 (low risk of obstructive sleep apnea), similar with respect to gender, age and type of surgery, admitted after elective surgery in the Post-Anaesthesia Care Unit in May 2011. Primary outcome was the development of adverse respiratory events. Demographics data, perioperative variables, and postoperative length of stay in the Post-Anesthesia Care Unit and in hospital were recorded. The Mann-Whitney test, the chi-square test and the Fisher exact test were used for comparisons. Subjects in both pairs of study subjects had a median age of 56 years, including 25% males, and 59% were submitted to intra-abdominal surgery. High risk of obstructive sleep apnea patients had a higher median body mass index (31 versus 24kg/m(2), p<0.001) and had more frequently co-morbidities, including hypertension (58% versus 24%, p<0.001), dyslipidemia (46% versus 17%, p<0.001) and insulin-treated diabetes mellitus (17% versus 2%, p=0.004). These patients were submitted more frequently to bariatric surgery (20% versus 2%, p=0.002). Patients with high risk of obstructive sleep apnea had more frequently adverse respiratory events (39% versus 10%, p<0.001), mild to moderate desaturation (15% versus 0%, p=0.001) and inability to breathe deeply (34% versus 9%, p=0.001). After general anesthesia high risk of obstructive sleep apnea patients had an increased incidence of postoperative respiratory complications. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  10. Adverse events and treatment completion for latent tuberculosis in jail inmates and homeless persons.

    Science.gov (United States)

    Lobato, Mark N; Reves, Randall R; Jasmer, Robert M; Grabau, John C; Bock, Naomi N; Shang, Nong

    2005-04-01

    Recently, a short-course treatment using 60 daily doses of rifampin and pyrazinamide was recommended for latent tuberculosis (TB) infection (LTBI). To determine the acceptability, tolerability, and completion of treatment. Observational cohort study. Five county jails and TB outreach clinics for homeless populations in three cities. Study staff enrolled 1,211 patients (844 inmates and 367 homeless persons). Sites used 60 daily doses of rifampin and pyrazinamide, an approved treatment regimen for LTBI. Types and frequency of drug-related adverse events and outcomes of treatment. Prior to treatment, 25 of 1,178 patients (2.1%) had a serum aminotransferase measurement at least 2.5 times the upper limit of normal. Patients who reported excess alcohol use in the past 12 months were more likely than other patients to have an elevated pretreatment serum aminotransferase level (odds ratio, 2.1; 95% confidence interval, 1.1 to 6.1; p = 0.03). Treatment was stopped in 66 of 162 patients (13.4%) who had a drug-related adverse event. Among 715 patients who had serum aminotransferase measured during treatment, 43 patients (6.0%) had an elevation > 5 times the upper limits of normal, including one patient who died of liver failure attributed to treatment. In multivariate analyses, increasing age, an abnormal baseline aspartate aminotransferase level, and unemployment within the past 24 months were independent risk factors for hepatotoxicity. Completion rates were similar in jail inmates (47.5%) and homeless persons (43.6%). This study detected the first treatment-associated fatality with the rifampin and pyrazinamide regimen, prompting surveillance that detected unacceptable levels of hepatotoxicity and retraction of recommendations for its routine use. Completion rates for LTBI treatment using a short-course regimen exceeds historical rates using isoniazid. Efforts to identify an effective short-course treatment for LTBI should be given a high priority.

  11. Prioritizing strategies for preventing medication errors and adverse drug events in pediatric inpatients.

    Science.gov (United States)

    Fortescue, Elizabeth B; Kaushal, Rainu; Landrigan, Christopher P; McKenna, Kathryn J; Clapp, Margaret D; Federico, Frank; Goldmann, Donald A; Bates, David W

    2003-04-01

    Medication errors in pediatric inpatients occur at similar rates as in adults but have 3 times the potential to cause harm. Error prevention strategies in this setting remain largely untested. The objective of this study was to classify the major types of medication errors in pediatric inpatients and to determine which strategies might most effectively prevent them. A prospective cohort study was conducted of 1020 patients who were admitted to 2 academic medical centers during a 6-week period in April and May 1999. Medication errors were characterized by subtype. Physician raters evaluated error prevention strategies and identified those that might be most effective in preventing errors. Of 10 778 medication orders reviewed, 616 contained errors. Of these, 120 (19.5%) were classified as potentially harmful, including 115 potential adverse drug events (18.7%) and 5 preventable adverse drug events (0.8%). Most errors occurred at the ordering stage (74%) and involved errors in dosing (28%), route (18%), or frequency (9%). Three interventions might have prevented most potentially harmful errors: 1) computerized physician order entry with clinical decision support systems (76%); 2) ward-based clinical pharmacists (81%); and 3) improved communication among physicians, nurses, and pharmacists (86%). Interrater reliability of error prevention strategy assignment was good (agreement: 0.92; kappa: 0.82). Of the assessed interventions, computerized physician order entry with clinical decision support systems; ward-based clinical pharmacists; and improved communication among physicians, nurses, and pharmacists had the greatest potential to reduce medication errors in pediatric inpatients. Development, implementation, and assessment of such interventions in the pediatric inpatient setting are needed.

  12. A tool to determine financial impact of adverse events in health care: healthcare quality calculator.

    Science.gov (United States)

    Yarbrough, Wendell G; Sewell, Andrew; Tickle, Erin; Rhinehardt, Eric; Harkleroad, Rod; Bennett, Marc; Johnson, Deborah; Wen, Li; Pfeiffer, Matthew; Benegas, Manny; Morath, Julie

    2014-12-01

    Hospital leaders lack tools to determine the financial impact of poor patient outcomes and adverse events. To provide health-care leaders with decision support for investments to improve care, we created a tool, the Healthcare Quality Calculator (HQCal), which uses institution-specific financial data to calculate impact of poor patient outcomes or quality improvement on present and future margin. Excel and Web-based versions of the HQCal were based on a cohort study framework and created with modular components including major drivers of cost and reimbursement. The Healthcare Quality Calculator (HQCal) compares payment, cost, and profit/loss for patients with and without poor outcomes or quality issues. Cost and payment information for groups with and without quality issues are used by the HQCal to calculate profit or loss. Importantly, institution-specific payment and cost data are used to calculate financial impact and attributable cost associated with poor patient outcomes, adverse events, or quality issues. Because future cost and reimbursement changes can be forecast, the HQCal incorporates a forward-looking component. The flexibility of the HQCal was demonstrated using surgical site infections after abdominal surgery and postoperative surgical airway complications. The Healthcare Quality Calculator determines financial impact of poor patient outcomes and the benefit of initiatives to improve quality. The calculator can identify quality issues that would provide the largest financial benefit if improved; however, it cannot identify specific interventions. The calculator provides a tool to improve transparency regarding both short- and long-term financial consequences of funding, or failing to fund, initiatives to close gaps in quality or improve patient outcomes.

  13. Rebound effect of modern drugs: serious adverse event unknown by health professionals.

    Science.gov (United States)

    Teixeira, Marcus Zulian

    2013-01-01

    Supported in the Hippocratic aphorism primum non nocere, the bioethical principle of non-maleficence pray that the medical act cause the least damage or injury to the health of the patient, leaving it to the doctor to assess the risks of a particular therapy through knowledge of possible adverse events of drugs. Among these, the rebound effect represents a common side effect to numerous classes of modern drugs, may cause serious and fatal disorders in patients. This review aims to clarify the health professionals on clinical and epidemiological aspects of rebound phenomenon. A qualitative, exploratory and bibliographic review was held in the PubMed database using the keywords 'rebound', 'withdrawal', 'paradoxical', 'acetylsalicylic acid', 'anti-inflammatory', 'bronchodilator', 'antidepressant', 'statin', 'proton pump inhibitor' and 'bisphosphonate'. The rebound effect occurs after discontinuation of numerous classes of drugs that act contrary to the disease disorders, exacerbating them at levels above those prior to treatment. Regardless of the disease, the drug and duration of treatment, the phenomenon manifests itself in a small proportion of susceptible individuals. However, it may cause serious and fatal adverse events should be considered a public health problem in view of the enormous consumption of drugs by population. Bringing together a growing and unquestionable body of evidence, the physician needs to have knowledge of the consequences of the rebound effect and how to minimize it, increasing safety in the management of modern drugs. On the other hand, this rebound can be used in a curative way, broadening the spectrum of the modern therapeutics. Copyright © 2012 Elsevier Editora Ltda. All rights reserved.

  14. Ceftriaxone-Associated Biliary and Cardiopulmonary Adverse Events in Neonates: A Systematic Review of the Literature.

    Science.gov (United States)

    Donnelly, Patrick C; Sutich, Rebecca M; Easton, Ryan; Adejumo, Oluwatunmise A; Lee, Todd A; Logan, Latania K

    2017-02-01

    Ceftriaxone is a third-generation cephalosporin with broad-spectrum activity against both Gram-positive and Gram-negative bacteria. Despite its effectiveness, its use for the treatment of infections in neonatal patients has been limited because of concern about its potential toxicity. Our aim was to review the literature for an association between ceftriaxone and cardiopulmonary events, hyperbilirubinemia, and pseudolithiasis among neonates. We searched PubMed and EMBASE and included studies that evaluated ceftriaxone safety in neonates. Study bias was evaluated in the following domains: exposure measurement, outcome measurement, attrition, generalizability, confounding, statistical analysis, and reporting. We included nine studies regarding ceftriaxone side effects, primarily spontaneous reports, published case reports, and small case series. Reports of bilirubin displacement attributed to ceftriaxone included increases in serum bilirubin necessitating antibiotic change in a subset of infants after administration of ceftriaxone. One study described self-resolving biliary sludge after ceftriaxone administration in six of 80 infants. Cardiopulmonary adverse events included a report of eight cardiopulmonary events related to concomitant ceftriaxone-calcium infusion, including seven infant deaths. Additional cardiopulmonary events reported included perinatal asphyxia, pulmonary hypertension, and thrombocytosis. However, the available literature had small sample sizes, poor external validity, and inconsistent outcome ascertainment methods, which made it impossible to estimate the magnitude of risk. Concomitant administration of intravenous ceftriaxone and calcium-containing solutions should be avoided in neonates. However, further controlled studies are needed to assess whether bilirubin displacement associated with the use of ceftriaxone is clinically relevant, particularly in healthy term and near-term neonates with mild hyperbilirubinemia.

  15. Multicenter Study of Adverse Events After Intravenous Tissue-Type Plasminogen Activator Treatment of Acute Ischemic Stroke.

    Science.gov (United States)

    Fernandez-Gotico, Hannah; Lightfoot, Tiffany; Meighan, Melissa

    2017-02-01

    The approved treatment by the Food and Drug Administration for acute ischemic stroke is intravenous tissue-type plasminogen activator (IV tPA). After IV tPA administration, patients are monitored for adverse events using an American Heart Association/American Stroke Association guideline instituted in 1996. There is limited evidence describing the safest and most efficient method to monitor patients during the first 24 hours after tPA administration. Although the overall rates of adverse events have been reported, the time when patients may be at most risk for an event has not been studied. The purpose of this study was to identify the time of adverse event occurrences in the first 24 hours after IV tPA administration. This was a descriptive, retrospective chart review study of patients admitted to an integrated health system and treated with IV tPA for acute stroke between July 2010 and July 2012. Charts were reviewed for adverse events using the Institute for Healthcare Improvement's Global Trigger Tool for Measuring Adverse Events. Possible chart indicators of adverse events or "triggers" included neurological decline, vital signs elevated above specified parameters, and emergent imaging. Adverse events included episodes of neurological decline, angioedema, allergic reactions, bleeding, and intracerebral hemorrhage (ICH). The timing of each detected event was determined, and descriptive statistics were used for data analysis. Fourteen adverse events (2.8%) were detected in a population of 498 patients. Reactions consisted of allergic reaction (n = 1), angioedema (n = 1), neurological decline without ICH (n = 1), gastrointestinal bleeding (n = 1), bleeding gums (n = 1), and high-risk ICH (n = 9). Thirteen of the 14 adverse events (92.9%) occurred within the first 12 hours after IV tPA administration. Close monitoring during the first 12 hours after IV tPA treatment may be essential. However, close monitoring after 12 hours may not contribute significantly to

  16. The Prevalence of Childhood Adversity among Healthcare Workers and Its Relationship to Adult Life Events, Distress and Impairment

    Science.gov (United States)

    Maunder, Robert G.; Peladeau, Nathalie; Savage, Diane; Lancee, William J.

    2010-01-01

    Objective: We investigated the prevalence of childhood adversity among healthcare workers and if such experiences affect responses to adult life stress. Methods: A secondary analysis was conducted of a 2003 study of 176 hospital-based healthcare workers, which surveyed lifetime traumatic events, recent life events, psychological distress, coping,…

  17. Complications in endoscopic retrograde cholangiopancreatography (ERCP and endoscopic ultrasound (EUS: analysis of 7-year physician-reported adverse events

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    Niv Y

    2011-06-01

    Full Text Available Yaron Niv1, Yael Gershtansky2, Ron S Kenett3, Yossi Tal2, Shlomo Birkenfeld41Department of Gastroenterology, Rabin Medical Center, Petach Tikva, Israel; 2Medical Risk Management, The Madanes Group, Tel Aviv, Israel; 3The KPA Group, University of Torino, Turin, Italy; 4Clalit Health Services, Tel Aviv, IsraelIntroduction: The number of malpractice claims against physicians and health institutes is increasing continuously in Israel as in the rest of the Western world, and has become a serious financial burden.Aim: In this study we analyzed the reports of gastroenterologists on endoscopic retrograde cholangiopancreatography (ERCP and endoscopic ultrasound (EUS adverse events to the risk management authority between January 1, 2000 and December 31, 2006.Methods: All the reported adverse events associated with ERCP and EUS of health institutes and covered by Madanes Insurance Agency were summarized and analyzed. Clinical and epidemiological details about the patients, procedures, and adverse events were coded into an Excel worksheet, discussed, and evaluated.Results: Forty-two cases of ERCP and EUS adverse events were reported. There were nine cases of men (21.4% and the average age was 69.3 ± 14.3 years. During this period, 10,647 procedures were performed by the institutes concerned and the number of adverse events was 20.2 to 67.8 per year for 10,000 procedures. Perforation occurred in one out of 367 procedures, bleeding in one out of 5323 procedures, teeth trauma in one out of 5323 procedures, and respiratory complications in one out of 10,647 procedures.Conclusion: This is the first study in Israel about physicians' reports of ERCP and EUS adverse events. Physicians reported only about severe adverse events with high rate of mortality and morbidity.Keywords: ERCP, EUS, defensive medicine, perforation, bleeding, sedation, risk management, patient safety

  18. The impact of adverse events on health care costs for older adults undergoing nonelective abdominal surgery.

    Science.gov (United States)

    Bailey, Jonathan G; Davis, Philip J B; Levy, Adrian R; Molinari, Michele; Johnson, Paul M

    2016-06-01

    Postoperative complications have been identified as an important and potentially preventable cause of increased hospital costs. While older adults are at increased risk of experiencing complications and other adverse events, very little research has specifically examined how these events impact inpatient costs. We sought to examine the association between postoperative complications, hospital mortality and loss of independence and direct inpatient health care costs in patients 70 years or older who underwent nonelective abdominal surgery. We prospectively enrolled consecutive patients 70 years or older who underwent nonelective abdominal surgery between July 1, 2011, and Sept. 30, 2012. Detailed patient-level data were collected regarding demographics, diagnosis, treatment and outcomes. Patient-level resource tracking was used to calculate direct hospital costs (2012 $CDN). We examined the association between complications, hospital mortality and loss of independence cost using multiple linear regression. During the study period 212 patients underwent surgery. Overall, 51.9% of patients experienced a nonfatal complication (32.5% minor and 19.4% major), 6.6% died in hospital and 22.6% experienced a loss of independence. On multivariate analysis nonfatal complications (p abdominal surgery in older adults and accounted for 44% of overall costs. This represents a substantial opportunity for better patient outcomes and cost savings with quality improvement strategies tailored to the needs of this high-risk surgical population.

  19. Death within 48 h--adverse events after general surgical procedures.

    Science.gov (United States)

    Mullen, Russell; Scollay, John M; Hecht, Garry; McPhillips, Gillian; Thompson, Alastair M

    2012-02-01

    Comorbidity and emergency intervention are established risk factors for post-operative mortality. This study sought to identify adverse events associated with death within 48 h of general surgical procedures. All general surgical patients who died within 48 h of operative intervention from 2002-2006 in Scotland underwent retrospective peer review using established Scottish Audit of Surgical Mortality (SASM) methodologies (www.SASM.org). During the 5 years, 1299 patients died within 48 h of surgery, 1134 (87.3%) admitted as an emergency, with a mean age of 71 years; 898 patients (69.1%) were ASA grade 3, 4 or 5; 727 (56.0%) patients had cardiovascular, 398 (30.6%) respiratory and 191 (14.7%) renal comorbidity. Over time exploratory laparotomy (443, 34.1%) was carried out less often (p = 0.004) prior to death due to cardiovascular disease (435, 33.5%), mesenteric ischaemia (264, 20.3%) or multi-organ failure (255, 19.6%). The decision to operate by consultant surgeons rose significantly (p surgery are usually elderly, emergency admissions with significant comorbidities who die of cardiovascular events. Timely, appropriate surgery and high quality peri-operative care delivered by consultant staff may prevent early post-operative mortality. Copyright © 2011 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

  20. Nursing workload and occurrence of adverse events in intensive care: a systematic review

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    Andrea Carvalho de Oliveira

    Full Text Available Abstract OBJECTIVE To identifyevidences of the influence of nursing workload on the occurrence of adverse events (AE in adult patients admitted to the intensive care unit (ICU. METHOD A systematic literature review was conducted in the databases MEDLINE, CINAHL, LILACS, SciELO, BDENF, and Cochrane from studies in English, Portuguese, or Spanish, published by 2015. The analyzed AE were infection, pressure ulcer (PU, patient falls, and medication errors. RESULTS Of 594 potential studies, eight comprised the final sample of the review. TheNursing Activities Score (NAS; 37.5% and the Therapeutic Intervention Scoring System(TISS; 37.5% were the instruments most frequently used for assessing nursing workload. Six studies (75.0% identified the influence of work overload in events of infection, PU, and medicationerrors. An investigation found that the NAS was a protective factor for PU. CONCLUSION The nursing workload required by patients in the ICU influenced the occurrence of AE, and nurses must monitor this variable daily to ensure proper sizing of staff and safety of care.

  1. Patients with single ventricle physiology undergoing noncardiac surgery are at high risk for adverse events.

    Science.gov (United States)

    Brown, Morgan L; DiNardo, James A; Odegard, Kirsten C

    2015-08-01

    intraoperative adverse events (9.8%) including: arrhythmias requiring treatment (n = 4), conversion from sedation to a general anesthetic (n = 2), difficult airway (n = 1), inadvertent extubation with desaturation and bradycardia (n = 1), hypotension and desaturation (n = 1), and cardiac arrest (n = 1). Postoperative events (surgery in a high-risk subgroup of palliated cardiac patients with single ventricle physiology. However, 11.8% of patients had an adverse event associated with their anesthetic. © 2015 John Wiley & Sons Ltd.

  2. Parental perspectives of vaccine safety and experience of adverse events following immunisation.

    Science.gov (United States)

    Parrella, Adriana; Gold, Michael; Marshall, Helen; Braunack-Mayer, Annette; Baghurst, Peter

    2013-04-12

    We aimed to determine demographic predictors of parental vaccine safety and risk perceptions, and assess the relationship between the occurrence of children's perceived adverse events following immunisation (AEFI) on parents' opinions. Computer-assisted telephone interviews (CATI) were conducted in 2011 with a cross-sectional, random general population sample of rural and metropolitan residents in South Australia. Multivariate ordinal logistic regression analyses examined associations between parental vaccine safety attitudes and socio-demographic factors, adjusting for whether children had ever experienced a previous suspected AEFI. Of 469 parents interviewed, 95% were confident in vaccine safety in general, but almost half expressed concern for pre-licensure testing of vaccines. Of all parents, 41% responded that at least one of their children had experienced an AEFI. Almost one third of the AEFI parent group indicated they reported their children's symptoms to either a healthcare professional or the Department of Health. Parental acceptability of the risks of febrile convulsion and anaphylaxis were 73% and 76% respectively. Ordinal logistic regression analyses showed parents of children who had experienced a suspected AEFI were associated with greater concern for vaccine safety (OR:0.53, p≤0.01) and more were likely to expect either a mild or a serious AEFI. After adjusting for demographics, parental confidence in vaccine safety was significantly associated with higher levels of education (OR:2.58, p=0.01) and being born in Australia OR:2.30, p=0.004. Mothers, when compared with fathers, were less accepting of the two vaccine risks presented: febrile convulsion (OR:0.57, p=0.04) and anaphylaxis, (OR:0.55, p=0.04). Parents commonly perceive and report that their child has experienced an AEFI. In this group of parents the subsequent expectation of an AEFI and vaccine safety concerns may be heightened. Further research should investigate parental understandings

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Emma C Davies

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

  5. Left atrial enlargement increases the risk of major adverse cardiac events independent of coronary vasodilator capacity

    Energy Technology Data Exchange (ETDEWEB)

    Koh, Angela S. [Brigham and Women' s Hospital, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Boston, MA (United States); National Heart Centre Singapore, Singapore (Singapore); Murthy, Venkatesh L.; Sitek, Arkadiusz; Gayed, Peter; Bruyere, John; Di Carli, Marcelo F. [Brigham and Women' s Hospital, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Boston, MA (United States); Wu, Justina [Brigham and Women' s Hospital, Division of Cardiology, Department of Medicine, and the Noninvasive Cardiovascular Imaging Program, Departments of Medicine (Cardiology) and Radiology, Boston, MA (United States); Dorbala, Sharmila [Brigham and Women' s Hospital, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Boston, MA (United States); Brigham and Women' s Hospital, Department of Radiology and the Division of Cardiology, Noninvasive Cardiovascular Imaging Section, Boston, MA (United States)

    2015-09-15

    Longstanding uncontrolled atherogenic risk factors may contribute to left atrial (LA) hypertension, LA enlargement (LAE) and coronary vascular dysfunction. Together they may better identify risk of major adverse cardiac events (MACE). The aim of this study was to test the hypothesis that chronic LA hypertension as assessed by LAE modifies the relationship between coronary vascular function and MACE. In 508 unselected subjects with a normal clinical {sup 82}Rb PET/CT, ejection fraction ≥40 %, no prior coronary artery disease, valve disease or atrial fibrillation, LAE was determined based on LA volumes estimated from the hybrid perfusion and CT transmission scan images and indexed to body surface area. Absolute myocardial blood flow and global coronary flow reserve (CFR) were calculated. Subjects were systematically followed-up for the primary end-point - MACE - a composite of all-cause death, myocardial infarction, hospitalization for heart failure, stroke, coronary artery disease progression or revascularization. During a median follow-up of 862 days, 65 of the subjects experienced a composite event. Compared with subjects with normal LA size, subjects with LAE showed significantly lower CFR (2.25 ± 0.83 vs. 1.95 ± 0.80, p = 0.01). LAE independently and incrementally predicted MACE even after accounting for clinical risk factors, medication use, stress left ventricular ejection fraction, stress left ventricular end-diastolic volume index and CFR (chi-squared statistic increased from 30.9 to 48.3; p = 0.001). Among subjects with normal CFR, those with LAE had significantly worse event-free survival (risk adjusted HR 5.4, 95 % CI 2.3 - 12.8, p < 0.0001). LAE and reduced CFR are related but distinct cardiovascular adaptations to atherogenic risk factors. LAE is a risk marker for MACE independent of clinical factors and left ventricular volumes; individuals with LAE may be at risk of MACE despite normal coronary vascular function. (orig.)

  6. Adverse Events Following Gastrointestinal Endoscopy in Children: Classifications, Characterizations, and Implications.

    Science.gov (United States)

    Kramer, Robert E; Narkewicz, Michael R

    2016-06-01

    To conduct a comprehensive study of postendoscopic adverse events (AEs) in children, categorizing them by the level of intervention required. Previous studies of endoscopic AE in children have focused on intraprocedural and short-term outcomes, such as bleeding, perforation, and infection, and may underestimate the incidence of AEs. Prospective observational study tracking AEs in pediatric patients within 72 hours of an endoscopic procedure. Single-center study performed at an academic, tertiary care, free-standing children's hospital over a 48-month period, from July 2010 through June 2014. Of 9577 pediatric endoscopic procedures, cases identified as having an AE during or following endoscopy were subject to additional chart review for abstraction of relevant data. Type, severity, and subsequent interventions of AEs were the primary outcome measures. Events were categorized by severity grade, with grade 1, no intervention; grade 2, outpatient evaluation; grade 3, hospitalization or repeat endoscopy; grade 4, surgery or intensive care unit admission; and grade 5, death. In total, 249 endoscopic AEs were recognized of 9577 procedures performed, yielding a rate of 2.6%. Of these, 160 were identified to result in medical evaluation and costs (≥grade 2) for a rate of 1.7%. Rates of endoscopic AE after advanced or interventional endoscopic procedures were higher, with 65 of 1167 events, resulting in a total AE rate of 5.6% and a rate of 4.4% for AE ≥ grade 2. There were 10 cases of significant bleeding (0.1%), 9 cases of infection (0.09%), and 12 cases of perforation (0.13%), primarily occurring with advanced/interventional procedures. Single-center study, lack of standardized criteria for ED referral. AEs presenting within 72 hours of endoscopy and resulting in medical intervention, occur more commonly than previously recognized in children. Standardized postendoscopy surveillance systems and definitions of AEs are needed.

  7. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  8. [Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database].

    Science.gov (United States)

    Sakai, Takamasa; Ohtsu, Fumiko; Sekiya, Yasuaki; Mori, Chiyo; Sakata, Hiroshi; Goto, Nobuyuki

    2016-01-01

    Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values differed between all reports in the JADER database and those on pregnant women, affecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals [PRR, 159.7; ROR, 669.9; 95% confidence interval (CI), 282.4-1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95%CI, 0.3-15.4). These findings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95%CI, 1.4-3.3). These findings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women.

  9. How many published cases of serious adverse events after yellow fever vaccination meet Brighton Collaboration diagnostic criteria?

    Science.gov (United States)

    Thomas, Roger E; Spragins, Wendy; Lorenzetti, Diane L

    2013-12-16

    To perform a systematic review of all serious adverse events (SAEs) after yellow fever vaccination and to assess them according to Brighton Collaboration criteria. Nine electronic databases were searched with the terms "yellow fever vaccine" and "adverse events" to 10 July 2013 (no language/date limits). Two reviewers independently assessed studies, entered data, and assessed cases with Brighton Collaboration criteria. One hundred and thirty-one cases met Brighton Collaboration criteria: 32 anaphylaxis, 41 neurologic (one death), 56 viscerotropic (24 deaths), and 2 both neurologic and viscerotropic criteria. All SAEs occurred following first yellow fever (YF) vaccination. Two additional cases which met Brighton Collaboration criteria were proven due to wild virus. An additional 345 cases were presented with insufficient detail to meet Brighton Collaboration criteria:173 neurological, 68 viscerotropic (24 deaths), 67 anaphylaxis, and 34 cases from a UK database and 3 from a Swiss database described as "serious adverse events" but not further classified into neurologic or viscerotropic. A further 253 cases were excluded as presenting insufficient data to be regarded as yellow fever vaccine (YFV) related SAEs. One hundred and thirty-one cases met Brighton Collaboration criteria for serious adverse events after yellow fever vaccination. Another 345 cases did not meet Brighton criteria and 253 were excluded as presenting insufficient data to be regarded as serious adverse events after YFV. There are likely to be cases in areas that are remote or with insufficient diagnostic resources that are neither correctly assessed nor not published. Copyright © 2013 Elsevier Ltd. All rights reserved.

  10. Lack of adverse events after medialization laryngoplasty With the montgomery thyroplasty implant in patients with unilateral laryngeal nerve paralysis.

    Science.gov (United States)

    Laccourreye, Ollivier; Benkhatar, Hakim; Ménard, Madeleine

    2012-11-01

    We sought to document the incidence of and risk factors for adverse events after medialization laryngoplasty with Montgomery implant insertion in patients with unilateral laryngeal nerve paralysis. We studied a retrospective series of 191 patients consecutively managed at a university teaching hospital. No adverse events were noted in 79.8% of the patients. Intraoperative, immediate, and late postoperative adverse events were noted in 8.3%, 8.9%, and 4.1% of the patients, respectively. The various adverse events noted were failure to insert the implant (3.6%), difficulties in stabilizing the implant (4.8%), misplacement of the implant (2.1%), dyspnea (2.7%), hematoma (4.8%), extrusion (1.6%), persistent morphological laryngeal alterations (1.6%), and keloid scars (1.1%). Tracheotomy, procedure-related death, and infection at the insertion site were not encountered. No significant statistical relationship was noted between the various adverse events encountered and the variables under analysis. Our data demonstrate that medialization laryngoplasty with Montgomery implant insertion in patients with unilateral laryngeal nerve paralysis from various causes is a relatively safe, reliable, and reproducible procedure with a short learning curve.

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

    Energy Technology Data Exchange (ETDEWEB)

    Connor, Michael J. [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California (United States); Marshall, Deborah C.; Moiseenko, Vitali; Moore, Kevin; Cervino, Laura; Atwood, Todd; Sanghvi, Parag; Mundt, Arno J.; Pawlicki, Todd [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona A., E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States)

    2017-01-01

    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). 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

  12. HOSPITALIZATIONS DUE TO ADVERSE DRUG EVENTS IN THE ELDERLY – A RETROSPECTIVE REGISTER STUDY

    Directory of Open Access Journals (Sweden)

    Outi Laatikainen

    2016-10-01

    Full Text Available Adverse drug events (ADEs are more likely to affect geriatric patients due to physiological changes occurring with aging. Even though this is an internationally recognized problem, similar research data in Finland is still lacking. The aim of this study was to determine the number of geriatric medication-related hospitalizations in the Finnish patient population and to discover the potential means of recognizing patients particularly at risk of ADEs. The study was conducted retrospectively from the 2014 emergency department patient records in Oulu University Hospital. A total number of 290 admissions were screened for ADEs, adverse drug reactions (ADRs and drug-drug interactions (DDIs by a multi-disciplinary research team. Customized Naranjo scale was used as a control method. All admissions were categorized into ‘probable’, ‘possible’, or ‘doubtful’ by both assessment methods. In total, 23.1% of admissions were categorized as ‘probably’ or ‘possibly’ medication-related. Vertigo, falling, and fractures formed the largest group of ADEs. The most common ADEs were related to medicines from N class of the ATC-code system. Age, sex, residence, or specialty did not increase the risk for medication-related admission significantly (min p= 0.077. Polypharmacy was, however, found to increase the risk (OR 3,3; 95% CI, 1.5-6.9 p = 0.01. In conclusion, screening patients for specific demographics or symptoms would not significantly improve the recognition of ADEs. In addition, as ADE detection today is largely based on voluntary reporting systems and retrospective manual tracking of errors, it is evident that more effective methods for ADE detection are needed in the future.

  13. Implant survival, adverse events, and bone remodeling of osseointegrated percutaneous implants for transhumeral amputees.

    Science.gov (United States)

    Tsikandylakis, Georgios; Berlin, Örjan; Brånemark, Rickard

    2014-10-01

    Osseointegrated percutaneous implants provide direct anchorage of the limb prosthesis to the residual limb. These implants have been used for the rehabilitation of transhumeral amputees in Sweden since 1995 using a two-stage surgical approach with a 6-month interval between the stages, but results on implant survival, adverse events, and radiologic signs of osseointegration and adaptive bone remodeling in transhumeral amputees treated with this method are still lacking. This study reports on 2- and 5-year implant survival, adverse events, and radiologic signs of osseointegration and bone remodeling in transhumeral amputees treated with osseointegrated prostheses. Between 1995 and 2010, we performed 18 primary osseointegrated percutaneous implants and two implant revisions in 18 transhumeral amputees; of those, 16 patients were available for followup at a minimum of 2 years (median, 8 years; range, 2-19 years). These include all transhumeral amputees who have received osseointegrated prostheses and represented approximately 20% of the all transhumeral amputees we evaluated for potential osseointegration during that time; general indications for this approach included transhumeral amputation resulting from trauma or tumor, inability to wear or severe problems wearing a conventional socket prosthesis, eg, very short residual limb, and compliant patients. Medical charts and plain radiographs were retrospectively evaluated. The 2- and 5-year implant survival rates were 83% and 80%, respectively. Two primary and one revised implant failed and were removed because of early loosening. A fourth implant was partially removed because of ipsilateral shoulder osteoarthritis and subsequent arthrodesis. The most common adverse event was superficial infection of the skin penetration site (15 infections in five patients) followed by skin reactions of the skin penetration site (eight), incomplete fracture at the first surgery (eight), defective bony canal at the second surgery

  14. Adverse events associated with fluoroscopically guided lumbosacral transforaminal epidural steroid injections.

    Science.gov (United States)

    Plastaras, Christopher; McCormick, Zachary L; Garvan, Cynthia; Macron, Donald; Joshi, Anand; Chimes, Gary; Smeal, Wesley; Rittenberg, Joshua; Kennedy, David J

    2015-10-01

    Although the types and incidence of adverse events (AEs) associated with transforaminal epidural steroid injection (TFESI) have been described, no study has used a systematic standardized questionnaire to solicit AEs from patients to capture an accurate range and incidence of complications. The aim was to systematically identify the types and incidence of AEs associated with TFESI. Additionally, this study evaluated demographic and clinical factors that may predict a higher risk of an AE. This was a retrospective cohort study from a multiphysician academic PM&R clinic. Patients, aged 19 to 89, who underwent a fluoroscopically guided TFESI for lumbosacral radicular pain between 2004 and 2007 were included. The relationship of AEs with gender, age, trainee presence, steroid type, preprocedure visual analog scale (VAS) pain score, systolic blood pressure, fluoroscopy time, and corticosteroid injectate volume was analyzed. Adverse event data were collected using a survey both immediately and at 24 to 72 hours after TFESI. Statistical analysis was performed using the chi-square, Fisher exact, or Wilcoxon rank sum two-sided tests. Logistic regression analysis was also performed. C.P. is the owner of Rehabilitation Institute of Chicago Physiatric Log & Analysis System computer software. In 1,295 consecutive patients undergoing 2,025 TFESI procedures, immediate AEs and delayed AEs occurred after 182 (9.2%) and 305 (20.0%) injections, respectively. The most common immediate AEs were: vasovagal reaction (4.2%) and interrupted procedure from intravascular flow (1.7%). Common delayed AEs included: pain exacerbation (5.0%), injection site soreness (3.9%), headache (3.9%), facial flushing/sweating (1.8%), and insomnia (1.6%). Significant associations were identified between AEs and gender, age, preprocedure VAS, steroid type, and fluoroscopy time. Trainee involvement in the procedure did not impact the complication rate. Fluoroscopically guided lumbosacral TFESI is associated

  15. A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes.

    Science.gov (United States)

    Hoffman, Keith B; Dimbil, Mo; Kyle, Robert F; Tatonetti, Nicholas P; Erdman, Colin B; Demakas, Andrea; Chen, Dingguo; Overstreet, Brian M

    2015-12-01

    Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real-world populations. To develop a drug safety statistic that estimates downstream medical costs associated with serious adverse events (AEs) and unfavorable patient outcomes associated with the use of 706 FDA-approved drugs. All primary suspect case reports for each drug were collected from the FDA's Adverse Event Reporting System database (FAERS) from 2010-2014. The Medical Dictionary for Regulatory Activities (MedDRA) was used to code serious AEs and outcomes, which were tallied for each case report. Medical costs associated with AEs and poor patient outcomes were derived from Agency for Healthcare Research and Quality (AHRQ) survey data, and their corresponding ICD-9-CM codes were mapped to MedDRA terms. Nonserious AEs and outcomes were not included. For each case report, either the highest AE cost or, if no eligible AE was listed, the highest outcome cost was used. All costed cases were aggregated for each drug and divided by the number of patients exposed to obtain a downstream estimated direct medical cost burden per exposure. Each drug was assigned a corresponding 1-100 point total. The 706 drugs showed an exponential distribution of downstream costs, and the data were transformed using the natural log to approximate a normal distribution. The minimum score was 8.29, and the maximum score was 99.25, with a mean of 44.32. Drugs with the highest individual scores tended to be kinase inhibitors, thalidomide analogs, and endothelin receptor antagonists. When scores were analyzed across Established Pharmacologic Class (EPC), the kinase inhibitor and endothelin receptor antagonist classes had the highest total. However

  16. Application of information retrieval approaches to case classification in the vaccine adverse event reporting system.

    Science.gov (United States)

    Botsis, Taxiarchis; Woo, Emily Jane; Ball, Robert

    2013-07-01

    Automating the classification of adverse event reports is an important step to improve the efficiency of vaccine safety surveillance. Previously we showed it was possible to classify reports using features extracted from the text of the reports. The aim of this study was to use the information encoded in the Medical Dictionary for Regulatory Activities (MedDRA(®)) in the US Vaccine Adverse Event Reporting System (VAERS) to support and evaluate two classification approaches: a multiple information retrieval strategy and a rule-based approach. To evaluate the performance of these approaches, we selected the conditions of anaphylaxis and Guillain-Barré syndrome (GBS). We used MedDRA(®) Preferred Terms stored in the VAERS, and two standardized medical terminologies: the Brighton Collaboration (BC) case definitions and Standardized MedDRA(®) Queries (SMQ) to classify two sets of reports for GBS and anaphylaxis. Two approaches were used: (i) the rule-based instruments that are available by the two terminologies (the Automatic Brighton Classification [ABC] tool and the SMQ algorithms); and (ii) the vector space model. We found that the rule-based instruments, particularly the SMQ algorithms, achieved a high degree of specificity; however, there was a cost in terms of sensitivity in all but the narrow GBS SMQ algorithm that outperformed the remaining approaches (sensitivity in the testing set was equal to 99.06 % for this algorithm vs. 93.40 % for the vector space model). In the case of anaphylaxis, the vector space model achieved higher sensitivity compared with the best values of both the ABC tool and the SMQ algorithms in the testing set (86.44 % vs. 64.11 % and 52.54 %, respectively). Our results showed the superiority of the vector space model over the existing rule-based approaches irrespective of the standardized medical knowledge represented by either the SMQ or the BC case definition. The vector space model might make automation of case definitions for

  17. Adverse events in cardiac surgery, a mixed methods retrospective study in an Italian teaching hospital.

    Science.gov (United States)

    Bellandi, Tommaso; Tartaglia, Riccardo; Forni, Silvia; D'Arienzo, Sara; Tulli, Giorgio

    2017-08-01

    Adverse events (AEs) are a major concern in surgery, but the evidence in cardiac surgery is limited, especially on the contributory factors. According to the data of the National Outcomes Program, a unit was selected to conduct a mixed methods investigation into the incidence, type, and cause of AE, given its mortality rate that was double the national average on coronary artery bypass grafting, valve reparation, and replacement. A retrospective investigation on the performance of a cardiac surgery, combining the routinely collected data on process and outcome measures with a 2-stage structured review of 280 medical records performed by 3 expert clinicians, with the support of a methodologist. At least one risk had been verified in 137 of 280 cases (48.9%, 95% CI, 43.1-54.8). The total number of AE was 42, with an incidence of 15% (95% CI, 10.8-20.2) and a preventability of 80.9% (95% CI, 69.1-92.8). In 11.9% of AE, the consequence is death, disability in 40.5%, and extended hospital stay in 69% of the cases. Adverse events are associated with problems in care management at the ward (89/137, 64.9%, 95% CI, 56.9-72.9), followed by surgical complications (46/137, 33.6%, 95% CI, 25.7-41.5) and infection/sepsis (32/137, 23.4%, 95% CI, 16.3-30.4). An active error was made by the health care workers in 31 of 42 cases with AE, either during the decision making or during the execution of an action. A total of 36 AEs were due to deficiencies attributed to organizational factors and 31 were linked to poor teamwork. The mixed methods approach demonstrated how a deep understanding of AE and poor performance may emerge thanks to the combination of routinely available data and experts' evaluations. The main limitation of this study is its focus on the cardiac surgery rather than on the entire process of care. The evaluation could have been integrated with on-site observations and the analysis of reported incidents. © 2017 John Wiley & Sons, Ltd.

  18. Association of Selected Antipsychotic Agents With Major Adverse Cardiovascular Events and Noncardiovascular Mortality in Elderly Persons.

    Science.gov (United States)

    Sahlberg, Marie; Holm, Ellen; Gislason, Gunnar H; Køber, Lars; Torp-Pedersen, Christian; Andersson, Charlotte

    2015-09-01

    Data from observational studies have raised concerns about the safety of treatment with antipsychotic agents (APs) in elderly patients with dementia, but this area has been insufficiently investigated. We performed a head-to-head comparison of the risk of major adverse cardiovascular events and noncardiovascular mortality associated with individual APs (ziprasidone, olanzapine, risperidone, quetiapine, levomepromazine, chlorprothixen, flupentixol, and haloperidol) in Danish treatment-naïve patients aged ≥70 years. We followed all treatment-naïve Danish citizens aged ≥70 years that initiated treatment with APs for the first time between 1997 and 2011 (n=91 774, mean age 82±7 years, 35 474 [39%] were men). Incidence rate ratios associated with use of different APs were assessed by multivariable time-dependent Poisson regression models. For the first 30 days of treatment, compared with risperidone, incidence rate ratios of major adverse cardiovascular events were higher with use of levomepromazine (3.80, 95% CI 3.43 to 4.21) and haloperidol (1.85, 95% CI 1.67 to 2.05) and lower for treatment with flupentixol (0.54, 95% CI 0.45 to 0.66), ziprasidone (0.31, 95% CI 0.10 to 0.97), chlorprothixen (0.76, 95% CI 0.61 to 0.95), and quetiapine (0.68, 95% CI 0.58 to 0.80). Relationships were generally similar for long-term treatment. The majority of agents were associated with higher risks among patients with cardiovascular disease compared with patients without cardiovascular disease (P for interaction <0.0001). Similar results were observed for noncardiovascular mortality, although differences in associations between patients with and without cardiovascular disease were small. Our study suggested some diversity in risks associated with individual APs but no systematic difference between first- and second-generation APs. Randomized placebo-controlled studies are warranted to confirm our findings and to identify the safest agents. © 2015 The Authors. Published on behalf

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

    Science.gov (United States)

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

    2013-01-01

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

  20. Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998.

    Science.gov (United States)

    DuVernoy, T S; Braun, M M

    2000-10-01

    A hypotonic-hyporesponsive episode (HHE) is the sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis that occurs within 48 hours after childhood immunizations. This syndrome has been primarily associated with pertussis-containing vaccines administered to children vaccinations. Previous studies of HHE were limited by small numbers of cases and, sometimes, by limited details of the event. To characterize a large number of HHE cases reported to the Vaccine Adverse Event Reporting System (VAERS), to assist clinicians in identifying HHE, and to assist researchers in investigating the risk factors, cause, and pathogenesis of this syndrome. More than 40,000 VAERS reports received between 1996 and 1998 were screened for HHE by a computer algorithm and reviewed, and a telephone follow-up questionnaire was administered to the witness of HHE. There were 215 HHE cases, all nonfatal. The median age of onset of HHE was 4.0 months (range: 1.1-107 months). Over half of the reports (53%) concerned females. The median birth weight was 3. 36 kg (range: 1.27-4.96 kg); 4.7% had a birth weight vaccination and HHE was 210 minutes (range: 1 minute-2 days). Among children with HHE who were 24 months of age. There were no relevant findings regarding family medical history or the mothers' gestational history. Nearly all of the children (98.6%) returned to their prevaccination state according to the telephone questionnaire; median time to return was 6 hours (range: 1 minute- 4 months). The 3 children reported as not returning to their prevaccination state all had VAERS reports submitted after they developed conditions (autism, complex partial epilepsy, and developmental delays with infantile spasms) that are not known to be causally associated with immunization. The vast majority of children (93%) with HHE received a pertussis-containing vaccine, either diphtheria-tetanus-acellular pertussis (DTaP, 28%), DTwP (11%), or diphtheria-tetanus-pertussis-Haemophilus influenzae type

  1. Concomitant use of clopidogrel and statins and risk of major adverse cardiovascular events following coronary stent implantation

    DEFF Research Database (Denmark)

    Schmidt, Morten Hvid; Johansen, Martin B; Maeng, Michael

    2012-01-01

    quantification of the interaction effect. WHAT THIS STUDY ADDS • Clopidogrel and CYP3A4-metabolizing statin use were each associated with a substantially reduced rate of major adverse cardiovascular events within 12 months after coronary stent implantation. • Although we observed an interaction between use...... of clopidogrel and statins, statin use vs. non-use was not associated with an increased rate of major adverse cardiovascular events in patients using clopidogrel after coronary stent implantation. AIMS To examine whether CYP3A4-metabolizing statin use modified the association between clopidogrel use and major...... adverse cardiovascular events (MACE) after coronary stent implantation, using time-varying drug exposure ascertainment. METHODS We conducted this population-based cohort study in Western Denmark (population: 3 million) using medical databases. We identified all 13 001 patients with coronary stent...

  2. Corticosteroid-related adverse events in patients with giant cell arteritis: A claims-based analysis.

    Science.gov (United States)

    Broder, Michael S; Sarsour, Khaled; Chang, Eunice; Collinson, Neil; Tuckwell, Katie; Napalkov, Pavel; Klearman, Micki

    2016-10-01

    Corticosteroids (CS) are standard treatment for giant cell arteritis (GCA), but concerns persist over toxicities associated with long-term use. In this retrospective study of medical claims data, we estimated risks for adverse events (AEs) in CS-treated GCA patients. Cox regression analyses with CS use as a time-dependent variable were conducted on data from the 2003 to 2012 Truven Health Analytics MarketScan Database. Patients 50 years of age and older who had ≥2 claims of newly diagnosed GCA, ≥1 filled oral CS prescription, and no AEs before GCA diagnosis were included. The primary outcome was presence of a new CS-related AE. In total, 2497 patients were included. Their mean age was 71.0 years, and 71% were women. Follow-up was 9680 patient-years (PY). CS treatment continued for a mean (SD) of 1.196 (729.2) days; mean (SD) prescribed cumulative CS dose was 6983.3mg (6519.9). The overall AE rate was 0.43 events/PY; the most frequent AEs were cataract and bone disease. For each 1000-mg increase in CS exposure, the hazard ratio (HR) increased by 3% (HR = 1.03; 95% CI: 1.02-1.05; P < 0.001). Additionally, statistically significant individual associations between increased CS exposure and AE risk were observed for bone-related AEs (P < 0.001), cataract (P < 0.001), glaucoma (P = 0.005), pneumonia (P = 0.003), and diabetes mellitus (P < 0.001 in a subset of patients with no previous history of diabetes). CS exposure significantly increased risk for potentially serious AEs, emphasizing a need for new treatment options for GCA patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Cardioversion and Risk of Adverse Events with Dabigatran versus Warfarin-A Nationwide Cohort Study.

    Directory of Open Access Journals (Sweden)

    Jannik Langtved Pallisgaard

    Full Text Available Cardioversion can rapidly and effectively restore sinus rhythm in patients with persistent atrial fibrillation. Since 2011 dabigatran has been available as an alternative to warfarin to prevent thromboembolic events in patients with non-valvular atrial fibrillation undergoing cardioversion. We studied time to cardioversion, risk of adverse events, and risk of readmission with atrial fibrillation after cardioversion according to anticoagulation therapy.Through the nationwide Danish registries we included 1,230 oral anticoagulation naïve patients with first time non-valvular atrial fibrillation and first time cardioversion from 2011 to 2012; 37% in the dabigatran group (n = 456, and 63% in the warfarin group (n = 774. Median time to cardioversion was 4.0 (interquartile range [IQR] 2.9 to 6.5 and 6.9 (IQR 3.9 to 12.1 weeks in the dabigatran and warfarin groups respectively, and the adjusted odds ratio of cardioversion within the first 4 weeks was 2.3 (95% confidence interval [CI] 1.7 to 3.1 in favor of dabigatran. The cumulative incidence of composite endpoint of stroke, bleeding or death were 2.0% and 1.0% at 30 weeks in the warfarin and dabigatran groups respectively, with an adjusted hazard ratio of 1.33 (95% CI 0.33 to 5.42. Cumulative incidence of readmission with atrial fibrillation after 30 weeks were 9% and 11% in the warfarin and dabigatran groups, respectively, and an adjusted hazard ratio of 0.66 (95% CI 0.41 to 1.08.Anticoagulation treatment with dabigatran allows shorter time to cardioversion for atrial fibrillation than warfarin, and appears to be an effective and safe alternative treatment strategy to warfarin.

  4. A method for systematic discovery of adverse drug events from clinical notes.

    Science.gov (United States)

    Wang, Guan; Jung, Kenneth; Winnenburg, Rainer; Shah, Nigam H

    2015-11-01

    Adverse drug events (ADEs) are undesired harmful effects resulting from use of a medication, and occur in 30% of hospitalized patients. The authors have developed a data-mining method for systematic, automated detection of ADEs from electronic medical records. This method uses the text from 9.5 million clinical notes, along with prior knowledge of drug usages and known ADEs, as inputs. These inputs are further processed into statistics used by a discriminative classifier which outputs the probability that a given drug-disorder pair represents a valid ADE association. Putative ADEs identified by the classifier are further filtered for positive support in 2 independent, complementary data sources. The authors evaluate this method by assessing support for the predictions in other curated data sources, including a manually curated, time-indexed reference standard of label change events. This method uses a classifier that achieves an area under the curve of 0.94 on a held out test set. The classifier is used on 2,362,950 possible drug-disorder pairs comprised of 1602 unique drugs and 1475 unique disorders for which we had data, resulting in 240 high-confidence, well-supported drug-AE associations. Eighty-seven of them (36%) are supported in at least one of the resources that have information that was not available to the classifier. This method demonstrates the feasibility of systematic post-marketing surveillance for ADEs using electronic medical records, a key component of the learning healthcare system. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  5. Adaptation options for wheat in Europe will be limited by increased adverse weather events under climate change.

    Science.gov (United States)

    Trnka, Miroslav; Hlavinka, Petr; Semenov, Mikhail A

    2015-11-06

    Ways of increasing the production of wheat, the most widely grown cereal crop, will need to be found to meet the increasing demand