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Sample records for adverse consequences including

  1. Adverse consequences of immunostimulation.

    PubMed

    Ponce, Rafael

    2008-01-01

    The therapeutic uses of immunostimulatory agents are generally in the treatments of infections or cancer. The traditional example of vaccination is one form of immunostimulation used in the prevention of pathogenic infections or cancer (e.g., human papillomavirus vaccine). Recombinant cytokines are increasingly used to stimulate immune system function. For example, interferon-alpha (IFNalpha) and interleukin (IL)-2 have been used to treat chronic hepatitis C virus infection and metastatic melanoma, respectively. In contrast, monoclonal antibodies are used to target malignant cells for elimination via antibody-dependent cytotoxicity mechanisms or apoptosis, including the anti-CD20 monoclonal antibody rituximab and the anti-CD56 monoclonal antibody alemtuzumab used in the treatment of B-cell malignancies, and the anti-erb2 receptor antibody trastuzumab used in the treatment of breast cancer. Finally, immunostimulation may develop via modulation of pathways involved in immune system regulation. For example, the anti-CD28 monoclonal antibody TGN1412 was developed as an agonist of regulatory T-cells for treatment of T-cell-mediated chronic inflammatory diseases or leukemias. A panel was convened to discuss potential toxicities associated with immunostimulation. At the Immunotoxicology IV meeting in 2006, a panel, moderated by Dr. Robert House (Dynport Vaccine Co., Frederick, MD), included Drs. Gary Burleson (Burleson Research Technologies, Inc., Raleigh, NC), Kenneth Hastings (US FDA, Center for Drug Evaluation and Research [CDER], Rockville, MD), Barbara Mounho (Amgen, Thousand Oaks, CA), Rafael Ponce (ZymoGenetics, Inc., Seattle, WA), Mark Wing (Huntington Life Sciences, Cambridgeshire, United Kingdom), Lauren Black (Navigators Consulting, Sparks, NV) and Anne Pilaro (US FDA, CDER, Rockville, MD). This paper reviews the major identified toxicities associated with immunostimulation, including the acute phase response, cell and tissue abnormalities/injury, cytokine

  2. Adverse health consequences of the Iraq War.

    PubMed

    Levy, Barry S; Sidel, Victor W

    2013-03-16

    The adverse health consequences of the Iraq War (2003-11) were profound. We conclude that at least 116,903 Iraqi non-combatants and more than 4800 coalition military personnel died over the 8-year course. Many Iraqi civilians were injured or became ill because of damage to the health-supporting infrastructure of the country, and about 5 million were displaced. More than 31,000 US military personnel were injured and a substantial percentage of those deployed suffered post-traumatic stress disorder, traumatic brain injury, and other neuropsychological disorders and their concomitant psychosocial problems. Many family members of military personnel had psychological problems. Further review of the adverse health consequences of this war could help to minimise the adverse health consequences of, and help to prevent, future wars.

  3. Adverse health consequences of the Vietnam War.

    PubMed

    Levy, Barry S; Sidel, Victor W

    2015-01-01

    The 40th anniversary of the end of the Vietnam War is a useful time to review the adverse health consequences of that war and to identify and address serious problems related to armed conflict, such as the protection of noncombatant civilians. More than 58,000 U.S. servicemembers died during the war and more than 150,000 were wounded. Many suffered from posttraumatic stress disorders and other mental disorders and from the long-term consequences of physical injuries. However, morbidity and mortality, although difficult to determine precisely, was substantially higher among the Vietnamese people, with at least two million of them dying during the course of the war. In addition, more than one million Vietnamese were forced to migrate during the war and its aftermath, including many "boat people" who died at sea during attempts to flee. Wars continue to kill and injure large numbers of noncombatant civilians and continue to damage the health-supporting infrastructure of society, expose civilians to toxic chemicals, forcibly displace many people, and divert resources away from services to benefit noncombatant civilians. Health professionals can play important roles in promoting the protection of noncombatant civilians during war and helping to prevent war and create a culture of peace.

  4. Workplace Bullying: A Tale of Adverse Consequences

    PubMed Central

    Sansone, Lori A.

    2015-01-01

    Workplace bullying is defined as the repetitive and systematic engagement of interpersonally abusive behaviors that negatively affect both the targeted individual and the work organization. According to the findings of 12 studies, being bullied in the workplace affects approximately 11 percent of workers. Victims are frequently blue-collar and unskilled workers. However, there also appear to be gender and milieu/management factors. Emotional/psychological consequences of workplace bullying may include increased mental distress, sleep disturbances, fatigue in women and lack of vigor in men, depression and anxiety, adjustment disorders, and even work-related suicide. Medical consequences of workplace bullying may include an increase in health complaints such as neck pain, musculoskeletal complaints, acute pain, fibromyalgia, and cardiovascular symptoms. Finally, socioeconomic consequences of workplace bullying may include absenteeism due to sick days and unemployment. Clinicians in both mental health and primary care settings need to be alert to the associations between bullying in the workplace and these potential negative consequences, as patients may not disclose workplace maltreatment due to embarrassment or fears of retribution. PMID:25852978

  5. New Unintended Adverse Consequences of Electronic Health Records.

    PubMed

    Sittig, D F; Wright, A; Ash, J; Singh, H

    2016-11-10

    Although the health information technology industry has made considerable progress in the design, development, implementation, and use of electronic health records (EHRs), the lofty expectations of the early pioneers have not been met. In 2006, the Provider Order Entry Team at Oregon Health & Science University described a set of unintended adverse consequences (UACs), or unpredictable, emergent problems associated with computer-based provider order entry implementation, use, and maintenance. Many of these originally identified UACs have not been completely addressed or alleviated, some have evolved over time, and some new ones have emerged as EHRs became more widely available. The rapid increase in the adoption of EHRs, coupled with the changes in the types and attitudes of clinical users, has led to several new UACs, specifically: complete clinical information unavailable at the point of care; lack of innovations to improve system usability leading to frustrating user experiences; inadvertent disclosure of large amounts of patient-specific information; increased focus on computer-based quality measurement negatively affecting clinical workflows and patient-provider interactions; information overload from marginally useful computer-generated data; and a decline in the development and use of internally-developed EHRs. While each of these new UACs poses significant challenges to EHR developers and users alike, they also offer many opportunities. The challenge for clinical informatics researchers is to continue to refine our current systems while exploring new methods of overcoming these challenges and developing innovations to improve EHR interoperability, usability, security, functionality, clinical quality measurement, and information summarization and display.

  6. Early life adversity: Lasting consequences for emotional learning.

    PubMed

    Krugers, Harm J; Arp, J Marit; Xiong, Hui; Kanatsou, Sofia; Lesuis, Sylvie L; Korosi, Aniko; Joels, Marian; Lucassen, Paul J

    2017-02-01

    The early postnatal period is a highly sensitive time period for the developing brain, both in humans and rodents. During this time window, exposure to adverse experiences can lastingly impact cognitive and emotional development. In this review, we briefly discuss human and rodent studies investigating how exposure to adverse early life conditions - mainly related to quality of parental care - affects brain activity, brain structure, cognition and emotional responses later in life. We discuss the evidence that early life adversity hampers later hippocampal and prefrontal cortex functions, while increasing amygdala activity, and the sensitivity to stressors and emotional behavior later in life. Exposure to early life stress may thus on the one hand promote behavioral adaptation to potentially threatening conditions later in life -at the cost of contextual memory formation in less threatening situations- but may on the other hand also increase the sensitivity to develop stress-related and anxiety disorders in vulnerable individuals.

  7. Long Term Physical Health Consequences of Adverse Childhood Experiences

    PubMed Central

    Monnat, Shannon M.; Chandler, Raeven Faye

    2015-01-01

    This study examined associations between adverse childhood family experiences and adult physical health using data from 52,250 US adults aged 18–64 from the 2009–2012 Behavioral Risk Factor Surveillance System (BRFSS). We found that experiencing childhood physical, verbal, or sexual abuse, witnessing parental domestic violence, experiencing parental divorce, and living with someone who was depressed, abused drugs or alcohol, or who had been incarcerated were associated with one or more of the following health outcomes: self-rated health, functional limitations, diabetes, and heart attack. Adult socioeconomic status and poor mental health and health behaviors significantly mediated several of these associations. The results of this study highlight the importance of family-based adverse childhood experiences on adult health outcomes and suggest that adult SES and stress-related coping behaviors may be crucial links between trauma in the childhood home and adult health. PMID:26500379

  8. Hypogonadism secondary to hyperprolactinaemia: successful treatment but adverse consequences.

    PubMed

    Narayanan, R P; Bujawansa, S; Qureshi, Z; Rimmer, M; Heald, A

    2012-05-01

    It is accepted that care must be taken in initiating testosterone replacement in hypogonadal individuals with historically low androgen levels. However less is reported about the influence of restoration of normal endogenous testosterone production on behaviour.Here we report how the adverse sequelae of successful treatment of hypogonadism secondary to hyperprolactinaemia, manifesting as irritability and low threshold to aggression, were managed through a joint approach between psychiatrist and physician.

  9. Amphotericin B nephrotoxicity: the adverse consequences of altered membrane properties.

    PubMed

    Sawaya, B P; Briggs, J P; Schnermann, J

    1995-08-01

    Amphotericin B (AmB) has been in clinical use for more than 30 yr but has remained the most effective drug for treatment of serious fungal infections. Its use has increased in recent years, as the result of increases in aggressive intensive care support and increased numbers of immunocompromised patients. Nephrotoxic manifestations are common, and this is the major factor limiting the clinical use of the drug. A number of recent studies have contributed to a better understanding of the mechanism by which AmB exerts its nephrotoxic effect. AmB alters cell membrane permeability and probably as a consequence alters tubular and vascular smooth muscle cell function, leading to various tubular transport defects and vasoconstriction. Decreased RBF appears to play a major role in AmB-induced reduction GFR, and recurrent ischemia may be the basis of permanent structural nephrotoxic effects. Salt loading is the only measure proven by controlled prospective study to ameliorate AmB nephrotoxicity in humans. Liposomal AmB and the formulation of an emulsion of AmB in lipid may provide a protective effect based on altering the affinity of AmB for mammalian cell membranes, while preserving high efficacy against fungal cells. However, further studies are needed to evaluate the efficacy and safety of these new AmB formulations.

  10. Adverse consequences of student drinking: the role of sex, social anxiety, drinking motives.

    PubMed

    Norberg, Melissa M; Olivier, Jake; Alperstein, Dion M; Zvolensky, Michael J; Norton, Alice R

    2011-08-01

    This study examined whether biological sex, social anxiety, and drinking motives relate differently to distinct types of alcohol-related consequences using Poisson regression. One hundred eighteen college students completed self-report measures assessing drinking motives and social anxiety and an interview assessing alcohol consumption and consequences. Highly socially anxious women were particularly apt to experience adverse role functioning consequences, while men were particularly apt to experience physical consequences. Although highly socially anxious women reported more personal consequences than did women with low to moderate social anxiety, men with low to moderate social anxiety reported experiencing more social and personal consequences than did women with low to moderate social anxiety. When taking into consideration the above associations, coping motives were statistically associated with social consequences and marginally related to personal consequences, while enhancement motives were significantly associated with physical consequences. Targeting these factors may lead to effective interventions for individuals with co-occurring social anxiety and drinking problems.

  11. Increases in Wheelchair Breakdowns, Repairs, and Adverse Consequences for People with Traumatic Spinal Cord Injury

    PubMed Central

    Worobey, Lynn; Oyster, Michelle; Nemunaitis, Gregory; Cooper, Rory; Boninger, Michael L.

    2016-01-01

    Objective The aims of this study were to report the current incidence of wheelchair breakdowns, repairs, and consequences and to compare current data with historical data. Design A convenience sample survey of 723 participants with spinal cord injury who use a wheelchair for more than 40 hrs/wk treated at a Spinal Cord Injury Model Systems center was conducted. Results Significant increases were found in the number of participants reporting repairs (7.8%) and adverse consequences (23.5%) in a 6-mo period (2006Y2011) compared with historical data (2004Y2006) (P G 0.001). When examining current data, minorities experienced a greater frequency and higher number of reported consequences (P = 0.03). Power wheelchair users reported a higher number of repairs and consequences than did manual wheelchair users (P G 0.001). Wheelchairs equipped with seat functions were associated with a greater frequency of adverse consequences (P = 0.01). Repairs did not vary across funding source, but individuals with wheelchairs provided by Medicare and Medicaid reported a higher frequency of consequences than did the combined group of the Department of Vocational Rehabilitation, Worker’s Compensation, and the Veterans Administration (P = 0.034 and P = 0.013, respectively). Conclusions The incidence and consequences of repairs are increasing from what was already a very high statistic in this United States population. Further investigation into causality is required, and intervention is needed to reverse this potential trend. PMID:22549473

  12. Overdependence on technology: an unintended adverse consequence of computerized provider order entry.

    PubMed

    Campbell, Emily M; Sittig, Dean F; Guappone, Kenneth P; Dykstra, Richard H; Ash, Joan S

    2007-10-11

    Computerized provider order entry (CPOE) and other clinical information systems can help reduce medical errors, promote practice standardization, and improve the quality of patient care. However, implementing these systems can result in unintended adverse consequences. Our multidisciplinary team used qualitative methods to gather and analyze data describing unintended adverse consequences related to CPOE adoption and use. Overdependence on technology emerged as one of nine major types we identified. Careful analysis of these data revealed three themes: 1) system downtime can create chaos when there are insufficient backup systems in place, 2) users have false expectations regarding data accuracy and processing, and 3) some clinicians cannot work efficiently without computerized systems. We provide recommendations for mitigating these important issues.

  13. Overdependence on Technology: An Unintended Adverse Consequence of Computerized Provider Order Entry

    PubMed Central

    Campbell, Emily M.; Sittig, Dean F.; Guappone, Kenneth P.; Dykstra, Richard H.; Ash, Joan S.

    Computerized provider order entry(CPOE) and other clinical information systems can help reduce medical errors, promote practice standardization, and improve the quality of patient care. However, implementing these systems can result in unintended adverse consequences. Our multidisciplinary team used qualitative methods to gather and analyze data describing unintended adverse consequences related to CPOE adoption and use. Overdependence on technology emerged as one of nine major types we identified. Careful analysis of these data revealed three themes: 1) system downtime can create chaos when there are insufficient backup systems in place, 2) users have false expectations regarding data accuracy and processing, and 3) some clinicians cannot work efficiently without computerized systems. We provide recommendations for mitigating these important issues. PMID:18693805

  14. The Consequences of Including Seductive Details during Lecture

    ERIC Educational Resources Information Center

    Harp, Shannon F.; Maslich, Amy A.

    2005-01-01

    When text passages include seductive details (i.e., interesting, tangentially related adjuncts that are irrelevant to the lesson), students perform worse on recall (Garner, Gillingham, & White, 1989) and problem-solving tests (Harp & Mayer, 1997, 1998) than students reading the same material without seductive details. To determine whether…

  15. Phentermine/topiramate for weight reduction and treatment of adverse metabolic consequences in obesity.

    PubMed

    Bays, H E; Gadde, K M

    2011-12-01

    Phentermine hydrochloride is a noradrenergic sympathetic amine approved for decades by the U.S. Food and Drug Administration (FDA) at doses as high as 37.5 mg/day for the short-term treatment of obesity. Topiramate is a sulfamate-substituted monosaccharide marketed since 1996, and approved by the FDA for seizure disorders at doses up to 400 mg/day and for the prevention of migraine headaches at doses up to 100 mg/day. Clinical trial data suggest topiramate promotes weight loss. The prescribing information of neither agent describes adverse drug interactions with the other. The controlled-release formulation of phentermine and topiramate at low, medium and full doses (with full dose containing 15 mg of phentermine hydrochloride and 92 mg of topiramate) promotes weight reduction, with clinical trial data supporting improvement in adiposopathic consequences leading to metabolic diseases. Reported adverse events with this combination agent are as expected, based upon knowledge of the individual components.

  16. Effects of Alcohol-Induced Working Memory Decline on Alcohol Consumption and Adverse Consequences of Use

    PubMed Central

    Lechner, William V.; Day, Anne M.; Metrik, Jane; Leventhal, Adam M.; Kahler, Christopher W.

    2015-01-01

    Rationale Alcohol use appears to decrease executive function acutely in a dose dependent manner, and lower baseline executive function appears to contribute to problematic alcohol use. However, no studies, to our knowledge, have examined the relationship between individual differences in working memory (a subcomponent of executive function) after alcohol consumption and drinking behaviors and consequences. Objectives The current study assessed the relationship between drinking behavior, alcohol-related consequences, and alcohol-induced changes in working memory (as assessed by Trails Making Test-B). Method Participants recruited from the community (n = 41), 57.3% male, mean age 39.2, took part in a three-session, within-subjects, repeated-measures design. Participants were administered a placebo, 0.4 g/kg, or 0.8 g/kg dose of alcohol. Working memory, past 30 day alcohol consumption, and consequences of alcohol use were measured at baseline; working memory was measured again after each beverage administration. Results Poorer working memory after alcohol administration (controlling for baseline working memory) was significantly associated with a greater number of drinks consumed per drinking day. Additionally, we observed a significant indirect relationship between the degree of alcohol-induced working memory decline and adverse consequences of alcohol use, which was mediated through greater average drinks per drinking day. Conclusions It is possible that greater individual susceptibility to alcohol-induced working memory decline may limit one’s ability to moderate alcohol consumption as evidenced by greater drinks per drinking day, and that this results in more adverse consequences of alcohol use. PMID:26407604

  17. Adverse Health Consequences of Performance-Enhancing Drugs: An Endocrine Society Scientific Statement

    PubMed Central

    Pope, Harrison G.; Wood, Ruth I.; Rogol, Alan; Nyberg, Fred; Bowers, Larry

    2014-01-01

    Despite the high prevalence of performance-enhancing drug (PED) use, media attention has focused almost entirely on PED use by elite athletes to illicitly gain a competitive advantage in sports, and not on the health risks of PEDs. There is a widespread misperception that PED use is safe or that adverse effects are manageable. In reality, the vast majority of PED users are not athletes but rather nonathlete weightlifters, and the adverse health effects of PED use are greatly underappreciated. This scientific statement synthesizes available information on the medical consequences of PED use, identifies gaps in knowledge, and aims to focus the attention of the medical community and policymakers on PED use as an important public health problem. PED users frequently consume highly supraphysiologic doses of PEDs, combine them with other PEDs and/or other classical drugs of abuse, and display additional associated risk factors. PED use has been linked to an increased risk of death and a wide variety of cardiovascular, psychiatric, metabolic, endocrine, neurologic, infectious, hepatic, renal, and musculoskeletal disorders. Because randomized trials cannot ethically duplicate the large doses of PEDs and the many factors associated with PED use, we need observational studies to collect valid outcome data on the health risks associated with PEDs. In addition, we need studies regarding the prevalence of PED use, the mechanisms by which PEDs exert their adverse health effects, and the interactive effects of PEDs with sports injuries and other high-risk behaviors. We also need randomized trials to assess therapeutic interventions for treating the adverse effects of PEDs, such as the anabolic-androgen steroid withdrawal syndrome. Finally, we need to raise public awareness of the serious health consequences of PEDs. PMID:24423981

  18. Obesity and pregnancy: mechanisms of short term and long term adverse consequences for mother and child.

    PubMed

    Catalano, Patrick M; Shankar, Kartik

    2017-02-08

    Obesity is the most common medical condition in women of reproductive age. Obesity during pregnancy has short term and long term adverse consequences for both mother and child. Obesity causes problems with infertility, and in early gestation it causes spontaneous pregnancy loss and congenital anomalies. Metabolically, obese women have increased insulin resistance in early pregnancy, which becomes manifest clinically in late gestation as glucose intolerance and fetal overgrowth. At term, the risk of cesarean delivery and wound complications is increased. Postpartum, obese women have an increased risk of venous thromboembolism, depression, and difficulty with breast feeding. Because 50-60% of overweight or obese women gain more than recommended by Institute of Medicine gestational weight guidelines, postpartum weight retention increases future cardiometabolic risks and prepregnancy obesity in subsequent pregnancies. Neonates of obese women have increased body fat at birth, which increases the risk of childhood obesity. Although there is no unifying mechanism responsible for the adverse perinatal outcomes associated with maternal obesity, on the basis of the available data, increased prepregnancy maternal insulin resistance and accompanying hyperinsulinemia, inflammation, and oxidative stress seem to contribute to early placental and fetal dysfunction. We will review the pathophysiology underlying these data and try to shed light on the specific underlying mechanisms.

  19. The consequences of early-life adversity: neurobiological, behavioural and epigenetic adaptations.

    PubMed

    Maccari, S; Krugers, H J; Morley-Fletcher, S; Szyf, M; Brunton, P J

    2014-10-01

    During the perinatal period, the brain is particularly sensitive to remodelling by environmental factors. Adverse early-life experiences, such as stress exposure or suboptimal maternal care, can have long-lasting detrimental consequences for an individual. This phenomenon is often referred to as 'early-life programming' and is associated with an increased risk of disease. Typically, rodents exposed to prenatal stress or postnatal maternal deprivation display enhanced neuroendocrine responses to stress, increased levels of anxiety and depressive-like behaviours, and cognitive impairments. Some of the phenotypes observed in these models of early-life adversity are likely to share common neurobiological mechanisms. For example, there is evidence for impaired glucocorticoid negative-feedback control of the hypothalamic-pituitary-adrenal axis, altered glutamate neurotransmission and reduced hippocampal neurogenesis in both prenatally stressed rats and rats that experienced deficient maternal care. The possible mechanisms through which maternal stress during pregnancy may be transmitted to the offspring are reviewed, with special consideration given to altered maternal behaviour postpartum. We also discuss what is known about the neurobiological and epigenetic mechanisms that underpin early-life programming of the neonatal brain in the first generation and subsequent generations, with a view to abrogating programming effects and potentially identifying new therapeutic targets for the treatment of stress-related disorders and cognitive impairment.

  20. Investigating epigenetic consequences of early-life adversity: some methodological considerations

    PubMed Central

    Fiori, Laura M.; Turecki, Gustavo

    2016-01-01

    Stressful and traumatic events occurring during early childhood have been consistently associated with the development of psychiatric disorders later in life. This relationship may be mediated in part by epigenetic mechanisms, such as DNA methylation, which are influenced by the early-life environment. Epigenetic patterns can have lifelong effects on gene expression and on the functioning of biological processes relevant to stress reactivity and psychopathology. Optimization of epigenetic research activity necessitates a discussion surrounding the methodologies used for DNA methylation analysis, selection of tissue sources, and timing of psychological and biological assessments. Recent studies related to early-life adversity and methylation, including both candidate gene and epigenome-wide association studies, have drawn from the variety of available techniques to generate interesting data in the field. Further discussion is warranted to address the limitations inherent to this field of research, along with future directions for epigenetic studies of adversity-related psychopathology. Highlights of the article We identified issues regarding sample characteristics in epigenetic studies of early life adversity. We compared methods and technologies used for candidate gene analysis and whole epigenome studies. We discussed future perspectives, including combining multiple forms of large-scale data and newer technologies. PMID:27837582

  1. Adverse consequences of unintended pregnancy for maternal and child health in Nepal.

    PubMed

    Singh, Abhishek; Singh, Ashish; Thapa, Shyam

    2015-03-01

    In Nepal, 26%-38% of recent births are estimated to be from unintended pregnancies, but little is known whether these pregnancies have adverse consequences for the health of the mother and child. Data from the 2011 Nepal Demographic and Health Survey are used to examine the hypothesis that unintended pregnancies are associated with negative health outcomes for both mothers and children. When the pregnancy was unintended (compared with when it was intended) mothers were more likely to receive inadequate prenatal care (odds ratio OR = 1.50; 95% confidence interval [CI] = 1.28-1.77). They were also more likely to opt for home births (OR = 1.30; 95% CI = 1.11-1.52). Likewise, the resultant newborns of unintended pregnancies were more likely to receive inadequate immunization (OR = 1.18; 95% CI = 1.00-1.40) and to remain stunted (OR = 1.25; 95% CI = 1.00-1.56). Findings suggest significant associations between unintended pregnancy and negative health outcomes for both mothers and children in Nepal.

  2. 20 CFR 1002.194 - Can the application of the escalator principle result in adverse consequences when the employee...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., DEPARTMENT OF LABOR REGULATIONS UNDER THE UNIFORMED SERVICES EMPLOYMENT AND REEMPLOYMENT RIGHTS ACT OF 1994... lawful adverse job consequences that result from the employee's restoration on the seniority ladder... or lower position, laid off, or even terminated. For example, if an employee's seniority or...

  3. 20 CFR 1002.194 - Can the application of the escalator principle result in adverse consequences when the employee...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., DEPARTMENT OF LABOR REGULATIONS UNDER THE UNIFORMED SERVICES EMPLOYMENT AND REEMPLOYMENT RIGHTS ACT OF 1994... lawful adverse job consequences that result from the employee's restoration on the seniority ladder... or lower position, laid off, or even terminated. For example, if an employee's seniority or...

  4. Consequences of early adverse rearing experience (EARE) on development: insights from non-human primate studies

    PubMed Central

    Zhang, Bo

    2017-01-01

    Early rearing experiences are important in one's whole life, whereas early adverse rearing experience (EARE) is usually related to various physical and mental disorders in later life. Although there were many studies on human and animals, regarding the effect of EARE on brain development, neuroendocrine systems, as well as the consequential mental disorders and behavioral abnormalities, the underlying mechanisms remain unclear. Due to the close genetic relationship and similarity in social organizations with humans, non-human primate (NHP) studies were performed for over 60 years. Various EARE models were developed to disrupt the early normal interactions between infants and mothers or peers. Those studies provided important insights of EARE induced effects on the physiological and behavioral systems of NHPs across life span, such as social behaviors (including disturbance behavior, social deficiency, sexual behavior, etc), learning and memory ability, brain structural and functional developments (including influences on neurons and glia cells, neuroendocrine systems, e.g., hypothalamic-pituitary-adrenal (HPA) axis, etc). In this review, the effects of EARE and the underlying epigenetic mechanisms were comprehensively summarized and the possibility of rehabilitation was discussed. PMID:28271667

  5. [Mental health of children, adolescents and young adults--part 1: prevalence, illness persistence, adversities, service use, treatment delay and consequences].

    PubMed

    Lambert, M; Bock, T; Naber, D; Löwe, B; Schulte-Markwort, M; Schäfer, I; Gumz, A; Degkwitz, P; Schulte, B; König, H H; Konnopka, A; Bauer, M; Bechdolf, A; Correll, C; Juckel, G; Klosterkötter, J; Leopold, K; Pfennig, A; Karow, A

    2013-11-01

    Numerous birth-control studies, epidemiological studies, and observational studies have investigated mental health and health care in childhood, adolescence and early adulthood, including prevalence, age at onset, adversities, illness persistence, service use, treatment delay and course of illness. Moreover, the impact of the burden of illness, of deficits of present health care systems, and the efficacy and effectiveness of early intervention services on mental health were evaluated. According to these data, most mental disorders start during childhood, adolescence and early adulthood. Many children, adolescents and young adults are exposed to single or multiple adversities, which increase the risk for (early) manifestations of mental diseases as well as for their chronicity. Early-onset mental disorders often persist into adulthood. Service use by children, adolescents and young adults is low, even lower than for adult patients. Moreover, there is often a long delay between onset of illness and first adequate treatment with a variety of linked consequences for a poorer psychosocial prognosis. This leads to a large burden of illness with respect to disability and costs. As a consequence several countries have implemented so-called "early intervention services" at the interface of child and adolescent and adult psychiatry. Emerging studies show that these health-care structures are effective and efficient. Part 1 of the present review summarises the current state of mental health in childhood, adolescence and early adulthood, including prevalence, age at onset, adversities, illness persistence, service use, and treatment delay with consequences.

  6. Adverse Childhood Experiences of Referred Children Exposed to Intimate Partner Violence: Consequences for their Wellbeing

    ERIC Educational Resources Information Center

    Lamers-Winkelman, Francien; Willemen, Agnes M.; Visser, Margreet

    2012-01-01

    Objective: This study investigated the relationships among Adverse Childhood Experiences (ACEs) in a high risk clinical sample of Dutch children whose mothers were abused by an intimate partner, and the severity of behavioral and emotional problems and trauma symptoms. Methods: The study population comprised 208 children (M = 7.81 years, SD =…

  7. Theoretical Framework to Extend Adverse Outcome Pathways to Include Pharmacokinetic Considerations

    EPA Science Inventory

    Adverse Outcome Pathways (AOPs) have generated intense interest for their utility in linking known population outcomes to a molecular initiating event (MIE) that can be quantified using in vitro methods. While there are tens of thousands of chemicals in commercial use, biology h...

  8. Capitalizing on Advances in Science to Reduce the Health Consequences of Early Childhood Adversity.

    PubMed

    Shonkoff, Jack P

    2016-10-01

    Advances in biology are providing deeper insights into how early experiences are built into the body with lasting effects on learning, behavior, and health. Numerous evaluations of interventions for young children facing adversity have demonstrated multiple, positive effects but they have been highly variable and difficult to sustain or scale. New research on plasticity and critical periods in development, increasing understanding of how gene-environment interaction affects variation in stress susceptibility and resilience, and the emerging availability of measures of toxic stress effects that are sensitive to intervention provide much-needed fuel for science-informed innovation in the early childhood arena. This growing knowledge base suggests 4 shifts in thinking about policy and practice: (1) early experiences affect lifelong health, not just learning; (2) healthy brain development requires protection from toxic stress, not just enrichment; (3) achieving breakthrough outcomes for young children facing adversity requires supporting the adults who care for them to transform their own lives; and (4) more effective interventions are needed in the prenatal period and first 3 years after birth for the most disadvantaged children and families. The time has come to leverage 21st-century science to catalyze the design, testing, and scaling of more powerful approaches for reducing lifelong disease by mitigating the effects of early adversity.

  9. Apoptosis May Explain the Pharmacological Mode of Action and Adverse Effects of Isotretinoin, Including Teratogenicity.

    PubMed

    Melnik, Bodo C

    2017-02-08

    Isotretinoin (13-cis retinoic acid) is the most effective sebum-suppressive drug for the treatment of severe acne. Its effect depends on sebocyte apoptosis, which results from isotretinoin-induced expression of the apoptotic protein tumour necrosis factor-related apoptosis-inducing ligand, insulin-like growth factor-binding protein-3 and neutrophil gelatinase-associated lipocalin. This review proposes that the pharmacological mode of action of isotretinoin in the treatment of severe acne, acute promyelocytic leukaemia, and neuroblastoma results from apoptosis. Furthermore, apoptosis may be the underlying and unifying mechanism of the adverse effects of isotretinoin on neural crest cells (teratogenicity), hippocampal neurones (depression), epidermal keratinocytes and mucosa cells (mucocutaneous side-effects), hair follicle cells (telogen effluvium), intestinal epithelial cells (inflammatory bowel disease), skeletal muscle cells (myalgia and release of creatine kinase), and hepatocytes (release of transaminases and very low-density lipoproteins). Genetic variants of components of the apoptotic signalling cascade, such as RARA polymorphisms, might explain variations in the magnitude of isotretinoin-induced apoptotic signalling and apparently identify subgroups of patients who experience either stronger adverse effects with isotretinoin therapy or resistance to treatment.

  10. Presence of Atrazine in the Biological Samples of Cattle and Its Consequence Adversity in Human Health

    PubMed Central

    Peighambarzadeh, SZ; Safi, S; Shahtaheri, SJ; Javanbakht, M; Rahimi Forushani, A

    2011-01-01

    Background Cattle can be considered as an important source for herbicides through nutrition. Therefore, herbicide residue in animal products is a potential human exposure to herbicides causing public health problems in human life. Triazines are a group of herbicides primarily used to control broadleaf weeds in corn and other feed ingredients and are considered as possible human carcinogens. To evaluate trace residue of these pollutants molecular imprinted solid phase extraction (MISPE) method has been developed, using biological samples. Methods: Blood samples were taken from the jugular vein of 45 Holstein cows in 3 commercial dairy farms in Khuzestan Province, Iran. Urine samples were also taken from the cows. Results: The mean ± SD concentrations of atrazine in serum and urine samples of the study group (0.739 ± 0.567 ppm and 1.389 ± 0.633 ppm, respectively) were higher (P < 0.05) than the concentrations in serum and urine samples of the control group (0.002 ± 0.005 ppm and 0.012 ± 0.026 ppm, respectively). Conclusion: Atrazine in the feed ingredients ingested by cattle could be transferred into the biological samples and consequently can be considered as a potential hazard for the public health. PMID:23113110

  11. Unintended Pregnancy and Its Adverse Social and Economic Consequences on Health System: A Narrative Review Article

    PubMed Central

    YAZDKHASTI, Mansureh; POURREZA, Abolghasem; PIRAK, Arezoo; ABDI, Fatemeh

    2015-01-01

    Abstract Unintended pregnancy is among the most troubling public health problems and a major reproductive health issue worldwide imposing appreciable socioeconomic burden on individuals and society. Governments generally plan to control growth of births (especially wanted births as well as orphans and illegitimate births) imposing extra burden on public funding of the governments which inevitably affects economic efficiency and leads to economic slowdown, too. The present narrative review focuses on socioeconomic impacts of unintended pregnancy from the health system perspective. Follow of Computerized searches of Academic, 53 scientific journals were found in various databases including PubMed, EMBASE, ISI, Iranian databases, IPPE, UNFPA (1985-2013). Original articles, review articles, published books about the purpose of the paper were used. During this search, 20 studies were found which met the inclusion criteria. Unintended pregnancy is one of the most critical challenges facing the public health system that imposes substantial financial and social costs on society. On the other hand, affecting fertility indicators, it causes reduced quality of life and workforce efficiency. Therefore lowering the incidence of intended pregnancies correlates with elevating economic growth, socio-economic development and promoting public health. Regarding recent policy changes in Iran on family planning programs and adopting a new approach in increasing population may place the country at a higher risk of increasing the rate of unintended pregnancy. Hence, all governmental plans and initiatives of public policy must be regulated intelligently and logically aiming to make saving in public spending and reduce healthcare cost inflation. PMID:26060771

  12. Unintended adverse consequences of electronic health record introduction to a mature universal HIV screening program.

    PubMed

    Medford-Davis, Laura N; Yang, Katharine; Pasalar, Siavash; Pillow, M Tyson; Miertschin, Nancy P; Peacock, William F; Giordano, Thomas P; Hoxhaj, Shkelzen

    2016-01-01

    Early HIV detection and treatment decreases morbidity and mortality and reduces high-risk behaviors. Many Emergency Departments (EDs) have HIV screening programs as recommended by the Centers for Disease Control and Prevention. Recent federal legislation includes incentives for electronic health record (EHR) adoption. Our objective was to analyze the impact of conversion to EHR on a mature ED-based HIV screening program. A retrospective pre- and post-EHR implementation cohort study was conducted in a large urban, academic ED. Medical records were reviewed for HIV screening rates from August 2008 through October 2013. On 1 November 2010, a comprehensive EHR system was implemented throughout the hospital. Before EHR implementation, labs were requested by providers by paper orders with HIV-1/2 automatically pre-selected on every form. This universal ordering protocol was not duplicated in the new EHR; rather it required a provider to manually enter the order. Using a chi-squared test, we compared HIV testing in the 6 months before and after EHR implementation; 55,054 patients presented before, and 50,576 after EHR implementation. Age, sex, race, acuity of presenting condition, and HIV seropositivity rates were similar pre- and post-EHR, and there were no major patient or provider changes during this period. Average HIV testing rate was 37.7% of all ED patients pre-, and 22.3% post-EHR, a 41% decline (p < 0.0001), leading to 167 missed new diagnoses after EHR. The rate of HIV screening in the ED decreased after EHR implementation, and could have been improved with more thoughtful inclusion of existing human processes in its design.

  13. Ginger for Prevention of Antituberculosis-induced Gastrointestinal Adverse Reactions Including Hepatotoxicity: A Randomized Pilot Clinical Trial.

    PubMed

    Emrani, Zahra; Shojaei, Esphandiar; Khalili, Hossein

    2016-06-01

    In this study, the potential benefits of ginger in preventing antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity have been evaluated in patients with tuberculosis. Patients in the ginger and placebo groups (30 patients in each group) received either 500 mg ginger (Zintoma)(®) or placebo one-half hour before each daily dose of antituberculosis drugs for 4 weeks. Patients' gastrointestinal complaints (nausea, vomiting, dyspepsia, and abdominal pain) and antituberculosis drug-induced hepatotoxicity were recorded during the study period. In this cohort, nausea was the most common antituberculosis drug-induced gastrointestinal adverse reactions. Forty eight (80%) patients experienced nausea. Nausea was more common in the placebo than the ginger group [27 (90%) vs 21 (70%), respectively, p = 0.05]. During the study period, 16 (26.7%) patients experienced antituberculosis drug-induced hepatotoxicity. Patients in the ginger group experienced less, but not statistically significant, antituberculosis drug-induced hepatotoxicity than the placebo group (16.7% vs 36.7%, respectively, p = 0.07). In conclusion, ginger may be a potential option for prevention of antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity. Copyright © 2016 John Wiley & Sons, Ltd.

  14. For neonates undergoing cardiac surgery does thymectomy as opposed to thymic preservation have any adverse immunological consequences?

    PubMed

    Afifi, Ahmed; Raja, Shahzad G; Pennington, Daniel J; Tsang, Victor T

    2010-09-01

    A best evidence topic in congenital cardiac surgery was written according to a structured protocol. The question addressed was whether neonatal thymectomy in patients undergoing cardiac surgery has any adverse immunological consequences. Altogether 164 papers were found using the reported search, of which nine papers represented the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated. The thymus is the major production site of T cells, whose stocks are built-up during foetal and early postnatal life. However, its function diminishes after the first years of life, and although thymic output is maintained into adulthood, the thymus mostly degenerates into fatty tissue in elderly adults. To date, there has been no general consensus with regard to the importance of this organ during childhood and adulthood. As a consequence, during cardiac surgery in neonates, partial or total thymectomy is routinely performed to enable better access to the heart and great vessels to correct congenital heart defects, suggesting that it may be dispensable during childhood and adulthood. Interestingly, current best available evidence from nine case-control studies suggests that neonatal thymectomy affects peripheral T-cell populations both in the short- as well as long-term and results in premature immunosenescence. However, the impact of these changes on the risk of infectious diseases or malignancy has not been thoroughly evaluated by any of these studies. Maintenance of a registry of patients undergoing neonatal thymectomy and further studies to assess the functional or clinical consequences of this practice would be valuable.

  15. Including public perception data in the evaluation of the consequences of sewerage derived urban flooding.

    PubMed

    Arthur, Scott; Crow, Helen; Karikas, Naoum

    2009-01-01

    This text reports research which was undertaken to assess the failure consequences associated with sewerage systems. In an effort to move away from considering only flood volume, depth or extent, the text will focus on how a survey of public opinion was used to inform the development of a consequence scoring methodology. The failure consequences considered range from internal flooding of properties, to road closure, environmental damage and odour problems. The text reports the extent to which experience of flooding influences perceptions of failure consequence and sewerage system management. It is also outlined how this data was used, along with other data sources, to construct an objective scoring process that can be used to evaluate failure consequence and readily prioritise sewerage maintenance.

  16. 10 CFR 709.14 - Consequences of a refusal to complete a CI evaluation including a polygraph examination.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Consequences of a refusal to complete a CI evaluation including a polygraph examination. 709.14 Section 709.14 Energy DEPARTMENT OF ENERGY COUNTERINTELLIGENCE EVALUATION PROGRAM CI Evaluation Protocols and Protection of National Security § 709.14 Consequences of...

  17. 10 CFR 709.14 - Consequences of a refusal to complete a CI evaluation including a polygraph examination.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Consequences of a refusal to complete a CI evaluation including a polygraph examination. 709.14 Section 709.14 Energy DEPARTMENT OF ENERGY COUNTERINTELLIGENCE EVALUATION PROGRAM CI Evaluation Protocols and Protection of National Security § 709.14 Consequences of...

  18. The health and social consequences of adverse childhood experiences (ACE) across the lifespan: an introduction to prevention and intervention in the community.

    PubMed

    Larkin, Heather; Shields, Joseph J; Anda, Robert F

    2012-01-01

    This introduction to the themed issue overviews of the Adverse Childhood Experiences (ACE) Study and discusses prevention and intervention with ACE and their consequences in communities. A commentary by Dr. Robert Anda, an ACE Study Co-Principal Investigator, is incorporated within this introduction. Implications of articles within the issue are addressed, and next steps are explored.

  19. Use of the adverse outcome pathway framework to represent cross-species consequences of specific pathway perturbations

    EPA Science Inventory

    The adverse outcome pathway (AOP) framework has been developed as a means for assembling scientifically defensible descriptions of how particular molecular perturbations, termed molecular initiating events (MIEs), can evoke a set of predictable responses at different levels of bi...

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

    PubMed

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

    2012-05-01

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

  1. Better Adherence to the Mediterranean Diet Could Mitigate the Adverse Consequences of Obesity on Cardiovascular Disease: The SUN Prospective Cohort

    PubMed Central

    Eguaras, Sonia; Toledo, Estefanía; Hernández-Hernández, Aitor; Cervantes, Sebastián; Martínez-González, Miguel A.

    2015-01-01

    Strong observational evidence supports the association between obesity and cardiovascular events. In elderly high-risk subjects, the Mediterranean diet (MedDiet) was reported to counteract the adverse cardiovascular effects of adiposity. Whether this same attenuation is also present in younger subjects is not known. We prospectively examined the association between obesity and cardiovascular clinical events (myocardial infarction, stroke or cardiovascular death) after 10.9 years follow-up in 19,065 middle-aged men and women (average age 38 year) according to their adherence to the MedDiet (<6 points or ≥6 points in the Trichopoulou’s Mediterranean Diet Score). We observed 152 incident cases of cardiovascular disease (CVD). An increased risk of CVD across categories of body mass index (BMI) was apparent if adherence to the MedDiet was low, with multivariable-adjusted hazard ratios (HRs): 1.44 (95% confidence interval: 0.93–2.25) for ≥25 – <30 kg/m2 of BMI and 2.00 (1.04–3.83) for ≥30 kg/m2 of BMI, compared to a BMI < 25 kg/m2. In contrast, these estimates were 0.77 (0.35–1.67) and 1.15 (0.39–3.43) with good adherence to MedDiet. Better adherence to the MedDiet was associated with reduced CVD events (p for trend = 0.029). Our results suggest that the MedDiet could mitigate the harmful cardiovascular effect of overweight/obesity. PMID:26556370

  2. Adverse effects of isolation: a prospective matched cohort study including 90 direct interviews of hospitalized patients in a French University Hospital.

    PubMed

    Guilley-Lerondeau, B; Bourigault, C; Guille des Buttes, A-C; Birgand, G; Lepelletier, D

    2017-01-01

    Isolation precautions in patients with multi-drug resistant bacteria or other communicable infectious agents can be associated with adverse effects. The aim of this study was to assess satisfaction and psychological impact of patients hospitalized with isolation precautions in comparison with controls. An observational prospective cohort study was performed in five different medical and surgical departments in a 3,000-bed university hospital in Western France between March and July 2012. Different scales were used to assess patient satisfaction (qualitative scale) and anxiety (Spielberger scale), including 30 patients with isolation precautions and 60 matched patients without isolation precautions over 45-hour interviews. Cases were significantly less satisfied than controls for healthcare workers (HCW) assistance in activities of daily life (p < 0.001), availability and relationships (17 % vs 5 %, p = 0.05 and 10 % vs 0%, p = 0.02, respectively). Sixty-seven percent of patients with isolation precautions were not satisfied about the quality of the information related to their infectious status control measures. The median score [range] of anxiety significantly was higher in patients with isolation precautions (52 [20-56] vs 31 [23-73], p <0.001). Isolation precautions may have negative psychological effects, leading to anxiety, and may compromise patient satisfaction according to the availability and relationship with HCW. Professionals should be aware of adverse effects of isolation and inform patients more actively with regard to their infectious status and precautions.

  3. Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring

    PubMed Central

    2011-01-01

    Background In spite of enhanced control efforts, malaria remains a major public health problem causing close to a million deaths annually. With support from several donors, large amounts of artemisinin-based combination therapy (ACT) are being deployed in endemic countries raising safety concerns as little is known about the use of ACT in several of the settings where they are deployed. This project was undertaken to profile the provenance of the pharmacovigilance reporting of all anti-malarials, including ACT to the WHO adverse drug reaction (ADR) database (Vigibase™) over the past 40 years. Methods The WHO Programme for International Drug Monitoring, the Uppsala Monitoring Centre (UMC) provided anonymized extracts of Vigibase™ covering the period 1968-2008. All countries in the programme were clustered according to their malaria control phase and income status. The number of individual case safety reports (ICSRs) of anti-malarials was analyzed according to those clusters. Results From 1968 to 2008, 21,312 ICSRs suspecting anti-malarials were received from 64 countries. Low-income countries, that are also malaria-endemic (categorized as priority 1 countries) submitted only 1.2% of the ICSRs. Only 60 out of 21,312 ICSRs were related to ACT, 51 of which were coming from four sub-Saharan African countries. Although very few ICSRs involved artemisinin-based compounds, many of the adverse events reported were potentially serious. Conclusions This paper illustrates the low reporting of ADRs to anti-malarials in general and ACT in particular. Most reports were submitted by non-endemic and/or high-income countries. Given the current mix of large donor funding, the insufficient information on safety of these drugs, increasing availability of ACT and artemisinin-based monotherapies in public and private sector channels, associated potential for inappropriate use and finally a pipeline of more than 10 new novel anti-malarials in various stages of development, the

  4. OAE: The Ontology of Adverse Events

    PubMed Central

    2014-01-01

    Background A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. For example, using the data extracted from the Vaccine Adverse Event Reporting System (VAERS), OAE was used to analyse vaccine adverse events associated with the administrations of different types of influenza vaccines. OAE has also been used to represent and classify the vaccine adverse events cited in package inserts of FDA-licensed human vaccines in the USA. Conclusion OAE is a biomedical ontology that logically defines and classifies various adverse events occurring after medical interventions. OAE has successfully been applied in several adverse event studies. The OAE ontological framework provides a platform for systematic representation and analysis of

  5. [Allergies and adverse events associated with fluoroquinolones].

    PubMed

    Muller, Y; Andrey, D; Emonet, S; Harr, T; Spoerl, D

    2015-04-08

    The prescription ot fluoroquinolones has been constantly increasing over the past decade. consequently, an increasing number of hyper-sensitivity reactions and adverse events have been reported. The aim of the review is to discuss the incidence of hypersensitivity reactions either IgE (immediate) or T cells mediated (delayed). We will make an overview ofthe diagnostic tools available to detect such hypersensitivity reactions. Finally, the specific adverse events associated with fluoroquinolones, including tendinopathy, chondrotoxicity, peripheral neuropathy or retinal detachment will be discussed.

  6. From ultrasocial to antisocial: a role for oxytocin in the acute reinforcing effects and long-term adverse consequences of drug use?

    PubMed

    McGregor, I S; Callaghan, P D; Hunt, G E

    2008-05-01

    Addictive drugs can profoundly affect social behaviour both acutely and in the long-term. Effects range from the artificial sociability imbued by various intoxicating agents to the depressed and socially withdrawn state frequently observed in chronic drug users. Understanding such effects is of great potential significance in addiction neurobiology. In this review we focus on the 'social neuropeptide' oxytocin and its possible role in acute and long-term effects of commonly used drugs. Oxytocin regulates social affiliation and social recognition in many species and modulates anxiety, mood and aggression. Recent evidence suggests that popular party drugs such as MDMA and gamma-hydroxybutyrate (GHB) may preferentially activate brain oxytocin systems to produce their characteristic prosocial and prosexual effects. Oxytocin interacts with the mesolimbic dopamine system to facilitate sexual and social behaviour, and this oxytocin-dopamine interaction may also influence the acquisition and expression of drug-seeking behaviour. An increasing body of evidence from animal models suggests that even brief exposure to drugs such as MDMA, cannabinoids, methamphetamine and phencyclidine can cause long lasting deficits in social behaviour. We discuss preliminary evidence that these adverse effects may reflect long-term neuroadaptations in brain oxytocin systems. Laboratory studies and preliminary clinical studies also indicate that raising brain oxytocin levels may ameliorate acute drug withdrawal symptoms. It is concluded that oxytocin may play an important, yet largely unexplored, role in drug addiction. Greater understanding of this role may ultimately lead to novel therapeutics for addiction that can improve mood and facilitate the recovery of persons with drug use disorders.

  7. Association of Antenatal Depression with Adverse Consequences for the Mother and Newborn in Rural Ghana: Findings from the DON Population-Based Cohort Study

    PubMed Central

    Weobong, Benedict; ten Asbroek, Augustinus H. A.; Soremekun, Seyi; Manu, Alexander A.; Owusu-Agyei, Seth; Prince, Martin; Kirkwood, Betty R.

    2014-01-01

    Background Whilst there is compelling evidence of an almost 2-fold increased risk of still births, and suggestive evidence of increased mortality among offspring of mothers with psychotic disorders, only three studies have addressed the role of antenatal depression (AND) on survival of the baby. We examined these associations in a large cohort of pregnant women in Ghana. Methods A Cohort study nested within 4-weekly surveillance of all women of reproductive age to identify pregnancies and collect data on births and deaths in the Kintampo Health Research Centre study area of Ghana. Women were screened for AND using the Patient Health Questionnaire (PHQ-9) to ascertain DSM-IV major or minor depression. Outcomes were adverse birth outcomes, maternal/infant morbidity, and uptake of key newborn care practices, examined using logistic regression; effect sizes reported as relative risks with 95% confidence intervals. Results 20679 (89.6%) pregnant women completed the PHQ-9. The prevalence of AND was 9.9% (n = 2032) (95% confidence interval 9.4%–10.2%). AND was associated with: prolonged labour (RR 1.25, 95% CI 1.02–1.53); peripartum complications (RR 1.11, 95% CI 1.07–1.15);postpartum complications (RR 1.27, 96% CI 1.21–1.34); non-vaginal delivery (RR 1.19, 95% CI 1.02–1.40); newborn illness (RR 1.52, 95% CI 1.16–1.99); and bed net use during pregnancy (RR 0.93, 95% CI 0.89–0.98), but not neonatal deaths, still births, low birth weight, immediate breast feeding initiation, or exclusive breastfeeding. AND was marginally associated with preterm births (RR 1.32, 95% CI 0.98–1.76). Conclusion This paper has contributed important evidence on the role of antenatal depression as a potential contributor to maternal and infant morbidity. Non-pharmacological treatments anchored on primary care delivery structures are recommended as an immediate step. We further recommend that trials are designed to assess if treating antenatal depression in conjunction with

  8. Magnitude of arsenic toxicity in tube-well drinking water in Bangladesh and its adverse effects on human health including cancer: evidence from a review of the literature.

    PubMed

    Khan, M M H; Sakauchi, Fumio; Sonoda, Tomoko; Washio, Masakazu; Mori, Mitsuru

    2003-01-01

    Only after a decade from 1993, arsenic contamination of groundwater in Bangladesh has been reported as the biggest arsenic catastrophe in the world. It is a burning public health issue in this country. More than 50 percent of the total population is estimated at risk of contamination. Already thousands of people have been affected by the disease arsenicosis. Many more may be on the way to manifest lesions in future. We conducted a review of previous studies and published articles including MEDLINE database on this issue. We found that 59 districts out of 64 have been already affected by arsenic in underground drinking water, where this particular source of drinking water is the main source for 97 percent of the rural people. The water is unfortunately now a great threat for the human being due to high level of arsenic. Continuous arsenic exposure can lead people to develop arsenicosis, which in turn elevates the risk of cancer. Skin lesions are the most common manifestations in arsenicosis patients. Relatively poor rural people and other socio-economically disadvantaged groups are more affected by this exposure. Until now cancer patients have been relatively limited in Bangladesh. One of the reasons may be that several years are needed to show cancer manifestations from the beginning of arsenic exposure. But it is suspected that after some years a large number of patients will appear with cancer in different sites for arsenic exposure in drinking water. Various studies have been conducted in arsenic affected countries - notably in Argentina, Chile, China, Japan, and Taiwan -to find the potential of arsenic exposure to cause development of cancer. Among the arsenic related cancers, liver, lung, skin, bladder and kidney cancers are reported to be prevalent in these countries. Unfortunately no scientific study has been yet conducted in Bangladesh to find the relationship between arsenic exposure and cancers in different sites of the body. So our aim is to conduct an

  9. Stochastic dynamic simulation modeling including multitrait genetics to estimate genetic, technical, and financial consequences of dairy farm reproduction and selection strategies.

    PubMed

    Kaniyamattam, K; Elzo, M A; Cole, J B; De Vries, A

    2016-10-01

    The objective of this study was to develop a daily stochastic dynamic dairy simulation model that included multitrait genetics and to evaluate the effects of reduced genetic models and various reproduction and selection strategies on the genetic, technical, and financial performance of a dairy herd. The 12 correlated genetic traits included in the 2014 lifetime net merit (NM$) index were modeled for each animal. For each animal, a true breeding value (TBV) for each trait was calculated as the average of the sire's and dam's TBV, plus a fraction of the inbreeding and Mendelian sampling variability. Similarly, an environmental component for each trait was calculated and was partitioned into a permanent and a daily (temporary) effect. The combined TBV and environmental effects were converted into the phenotypic performance of each animal. Hence, genetics and phenotypic performances were associated. Estimated breeding values (EBV) were also simulated. Genetic trends for each trait for the service sire were based on expected trends in US Holsteins. Surplus heifers were culled based on various ranking criteria to maintain a herd size of 1,000 milking cows. In the first 8 scenarios, culling of surplus heifers was either random or based on the EBV of NM$. Four different genetic models, depending on the presence or absence of genetic trends or genetic and environmental correlations, or both, were evaluated to measure the effect of excluding multitrait genetics on animal performance. In the last 5 scenarios, the full genetic model was used and culling of surplus heifers was either random or based on the EBV of NM$ or the EBV of milk. Sexed semen use and reliability of the EBV were also varied. Each scenario was simulated for 15yr into the future. Results showed that genetic models without all 12 genetic trends and genetic and environmental correlations provided biased estimates of the genetic, technical, and financial performance of the dairy herd. Average TBV of NM$ of all

  10. Implications of Public Reporting of Risk-Adjusted Mortality Following Percutaneous Coronary Intervention: Misperceptions and Potential Consequences for High-Risk Patients Including Nonsurgical Patients.

    PubMed

    Gupta, Anuj; Yeh, Robert W; Tamis-Holland, Jacqueline E; Patel, Shalin H; Guyton, Robert A; Klein, Lloyd W; Rab, Tanveer; Kirtane, Ajay J

    2016-10-24

    Assessment of clinical outcomes such as 30-day mortality following coronary revascularization procedures has historically been used to spur quality improvement programs. Public reporting of risk-adjusted outcomes is already mandated in several states, and proposals to further expand public reporting have been put forward as a means of increasing transparency and potentially incentivizing high quality care. However, for public reporting of outcomes to be considered a useful surrogate of procedural quality of care, several prerequisites must be met. First, the reporting measure must be truly representative of the quality of the procedure itself, rather than be dominated by other underlying factors, such as the overall level of illness of a patient. Second, to foster comparisons among physicians and institutions, the metric requires accurate ascertainment of and adjustment for differences in patient risk profiles. This is particularly relevant for high-risk clinical patient scenarios. Finally, the potential deleterious consequences of public reporting of a quality metric should be considered prior to expanding the use of public reporting more broadly. In this viewpoint, the authors review in particular the characterization of high-risk patients currently treated by percutaneous coronary interventional procedures, assessing the adequacy of clinical risk models used in this population. They then expand upon the limitations of 30-day mortality as a quality metric for percutaneous coronary intervention, addressing the strengths and limitations of this metric, as well as offering suggestions to enhance its future use in public reporting.

  11. Stochastic dynamic simulation modeling including multitrait genetics to estimate genetic, technical, and financial consequences of dairy farm reproduction and selection strategies

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The objective of this study was to develop a daily stochastic dynamic dairy simulation model which included multi-trait genetics, and to evaluate the effects of various reproduction and selection strategies on the genetic, technical and financial performance of a dairy herd. The 12 correlated geneti...

  12. Enduring psychobiological effects of childhood adversity.

    PubMed

    Ehlert, Ulrike

    2013-09-01

    This mini-review refers to recent findings on psychobiological long-term consequences of childhood trauma and adverse living conditions. The continuum of trauma-provoked aftermath reaches from healthy adaptation with high resilience, to severe maladjustment with co-occurring psychiatric and physical pathologies in children, adolescents and adults. There is increasing evidence of a strong interconnectivity between genetic dispositions, epigenetic processes, stress-related hormonal systems and immune parameters in all forms of (mal)-adjustment to adverse living conditions. Unfavorable constellations of these dispositions and systems, such as low cortisol levels and elevated markers of inflammation in maltreated children, seem to promote the (co)-occurrence of psychiatric and physical pathologies such as posttraumatic stress disorder, obesity, or diabetes. Although findings from prospective study designs support a deepened understanding of causal relations between adverse living conditions, including traumatic experiences, during childhood and its psychobiological effects, so far, little is known about the temporal coincidence of stress-sensitive developmental stages during childhood and adolescence and trauma consequences. Taken together, childhood adversity is a severe risk factor for the onset of psychobiological (mal)-adjustment, which has to be explained under consideration of diverse physiological systems and developmental stages of childhood and adolescence.

  13. The Complement System and Adverse Pregnancy Outcomes

    PubMed Central

    Regal, Jean F.; Gilbert, Jeffrey S.; Burwick, Richard M.

    2015-01-01

    Adverse pregnancy outcomes significantly contribute to morbidity and mortality for mother and child, with lifelong health consequences for both. The innate and adaptive immune system must be regulated to insure survival of the feta allograft, and the complement system is no exception. An intact complement system optimizes placental development and function and is essential to maintain host defense and fetal survival. Complement regulation is apparent at the placental interface from early pregnancy with some degree of complement activation occurring normally throughout gestation. However, a number of pregnancy complications including early pregnancy loss, fetal growth restriction, hypertensive disorders of pregnancy and preterm birth are associated with excessive or misdirected complement activation, and are more frequent in women with inherited or acquired complement system disorders or complement gene mutations. Clinical studies employing complement biomarkers in plasma and urine implicate dysregulated complement activation in components of each of the adverse pregnancy outcomes. In addition, mechanistic studies in rat and mouse models of adverse pregnancy outcomes address the complement pathways or activation products of importance and allow critical analysis of the pathophysiology. Targeted complement therapeutics are already in use to control adverse pregnancy outcomes in select situations. A clearer understanding of the role of the complement system in both normal pregnancy and complicated or failed pregnancy will allow a rational approach to future therapeutic strategies for manipulating complement with the goal of mitigating adverse pregnancy outcomes, preserving host defense, and improving long term outcomes for both mother and child. PMID:25802092

  14. Swedish children with celiac disease comply well with a gluten-free diet, and most include oats without reporting any adverse effects: a long-term follow-up study.

    PubMed

    Tapsas, Dimitrios; Fälth-Magnusson, Karin; Högberg, Lotta; Hammersjö, Jan-Åke; Hollén, Elisabet

    2014-05-01

    The only known treatment for celiac disease is a gluten-free diet (GFD), which initially meant abstention from wheat, rye, barley, and oats. Recently, oats free from contamination with wheat have been accepted in the GFD. Yet, reports indicate that all celiac disease patients may not tolerate oats. We hypothesized that celiac children comply well with a GFD and that most have included oats in their diet. A food questionnaire was used to check our patients; 316 questionnaires were returned. Mean time on the GFD was 6.9 years, and 96.8% of the children reported that they were trying to keep a strict GFD. However, accidental transgressions occurred in 263 children (83.2%). In 2 of 3 cases, mistakes took place when the patients were not at home. Symptoms after incidental gluten intake were experienced by 162 (61.6%) patients, mostly (87.5%) from the gastrointestinal tract. Small amounts of gluten (<4 g) caused symptoms in 38% of the cases, and 68% reported symptoms during the first 3 hours after gluten consumption. Oats were included in the diet of 89.4% of the children for a mean of 3.4 years. Most (81.9%) ate purified oats, and 45.3% consumed oats less than once a week. Among those who did not consume oats, only 5.9% refrained because of symptoms. General compliance with the GFD was good. Only the duration of the GFD appeared to influence adherence to the diet. Most patients did not report adverse effects after long-term consumption of oats.

  15. Cardiovascular consequences of metabolic syndrome.

    PubMed

    Tune, Johnathan D; Goodwill, Adam G; Sassoon, Daniel J; Mather, Kieren J

    2017-01-09

    The metabolic syndrome (MetS) is defined as the concurrence of obesity-associated cardiovascular risk factors including abdominal obesity, impaired glucose tolerance, hypertriglyceridemia, decreased HDL cholesterol, and/or hypertension. Earlier conceptualizations of the MetS focused on insulin resistance as a core feature, and it is clearly coincident with the above list of features. Each component of the MetS is an independent risk factor for cardiovascular disease and the combination of these risk factors elevates rates and severity of cardiovascular disease, related to a spectrum of cardiovascular conditions including microvascular dysfunction, coronary atherosclerosis and calcification, cardiac dysfunction, myocardial infarction, and heart failure. While advances in understanding the etiology and consequences of this complex disorder have been made, the underlying pathophysiological mechanisms remain incompletely understood, and it is unclear how these concurrent risk factors conspire to produce the variety of obesity-associated adverse cardiovascular diseases. In this review, we highlight current knowledge regarding the pathophysiological consequences of obesity and the MetS on cardiovascular function and disease, including considerations of potential physiological and molecular mechanisms that may contribute to these adverse outcomes.

  16. Cutaneous adverse reactions to lenalidomide.

    PubMed

    Imbesi, S; Allegra, A; Calapai, G; Musolino, C; Gangemi, S

    2015-01-01

    Lenalidomide is an immunomodulatory drug (IMiD) used principally in the treatment of multiple myeloma (MM), myelodysplastic syndromes (MS) and amyloidosis. Adverse reactions related to lenalidomide include myelosuppression (mainly neutropenia but also thrombocytopenia), gastrointestinal problems, skin eruption, atrial fibrillation and asthenia, decreased peripheral blood stem cell yield during stem cell collection, venous thromboembolism, and secondary malignances. In this review we focused our attention on the cutaneous adverse reactions to lenalidomide.

  17. Vaccine Adverse Events

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Vaccines, Blood & Biologics Home Vaccines, Blood & Biologics Safety & Availability ( ... Center for Biologics Evaluation & Research Vaccine Adverse Events Vaccine Adverse Events Share Tweet Linkedin Pin it More ...

  18. Adverse reactions to vaccines.

    PubMed

    Martin, Bryan L; Nelson, Michael R; Hershey, Joyce N; Engler, Renata J M

    2003-06-01

    (The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.) Immunization healthcare is becoming increasingly complex as the number and types of vaccines have continued to expand. Like all prescription drugs, vaccines may be associated with adverse events. The majority of these reactions are self-limited and not associated with prolonged disability. The media, Internet and public advocacy groups have focused on potentially serious vaccine-associated adverse events with questions raised about causal linkages to increasing frequencies of diseases such as autism and asthma. Despite a lack of evidence of a causal relationship to a variety of vaccine safety concerns, including extensive reviews by the Institute of Medicine, questions regarding vaccine safety continue to threaten the success of immunization programs. Risk communication arid individual risk assessment is further challenged by the public health success of vaccine programs creating the perception that certain vaccines are no longer necessary or justified because of the rare reaction risk. There is a need for improved understanding of true vaccine contraindications and precautions as well as host factors and disease threat in order to develop a patient specific balanced risk communication intervention. When they occur, vaccine related adverse events must be treated, documented and reported through the VAERS system. The increasing complexity of vaccination health care has led the Center of Disease Control and Prevention (CDC) to identify Vaccine Safety Assessment and Evaluation as a potential new specialty.

  19. Adverse effects of cannabis.

    PubMed

    2011-01-01

    establish a causal relationship in either direction, because of these methodological limitations. In Australia, the marked increase in cannabis use has not been accompanied by an increased incidence of schizophrenia. On the basis of the available data, we cannot reach firm conclusions on whether or not cannabis use causes psychosis. It seems prudent to inform apparently vulnerable individuals that cannabis may cause acute psychotic decompensation, especially at high doses. Users can feel dependent on cannabis, but this dependence is usually psychological. Withdrawal symptoms tend to occur within 48 hours following cessation of regular cannabis use, and include increased irritability, anxiety, nervousness, restlessness, sleep difficulties and aggression. Symptoms subside within 2 to 12 weeks. Driving under the influence of cannabis doubles the risk of causing a fatal road accident. Alcohol consumption plays an even greater role. A few studies and a number of isolated reports suggest that cannabis has a role in the occurrence of cardiovascular adverse effects, especially in patients with coronary heart disease. Numerous case-control studies have investigated the role of cannabis in the incidence of some types of cancer. Its role has not been ruled out, but it is not possible to determine whether the risk is distinct from that of the tobacco with which it is often smoked. Studies that have examined the influence of cannabis use on the clinical course of hepatitis C are inconclusive. Alcohol remains the main toxic agent that hepatitis C patients should avoid. In practice, the adverse effects of low-level, recreational cannabis use are generally minor, although they can apparently be serious in vulnerable individuals. The adverse effects of cannabis appear overall to be less serious than those of alcohol, in terms of neuropsychological and somatic effects, accidents and violence.

  20. [Cutaneous adverse drug reactions].

    PubMed

    Lebrun-Vignes, B; Valeyrie-Allanore, L

    2015-04-01

    Cutaneous adverse drug reactions (CADR) represent a heterogeneous field including various clinical patterns without specific features suggesting drug causality. Exanthematous eruptions, urticaria and vasculitis are the most common forms of CADR. Fixed eruption is uncommon in western countries. Serious reactions (fatal outcome, sequelae) represent 2% of CADR: bullous reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), DRESS (drug reaction with eosinophilia and systemic symptoms or drug-induced hypersensitivity syndrome) and acute generalized exanthematous pustulosis (AGEP). These forms must be quickly diagnosed to guide their management. The main risk factors are immunosuppression, autoimmunity and some HLA alleles in bullous reactions and DRESS. Most systemic drugs may induce cutaneous adverse reactions, especially antibiotics, anticonvulsivants, antineoplastic drugs, non-steroidal anti-inflammatory drugs, allopurinol and contrast media. Pathogenesis includes immediate or delayed immunologic mechanism, usually not related to dose, and pharmacologic/toxic mechanism, commonly dose-dependent or time-dependent. In case of immunologic mechanism, allergologic exploration is possible to clarify drug causality, with a variable sensitivity according to the drug and to the CADR type. It includes epicutaneous patch testing, prick test and intradermal test. However, no in vivo or in vitro test can confirm the drug causality. To determine the cause of the eruption, a logical approach based on clinical characteristics, chronologic factors and elimination of differential diagnosis is required, completed with a literature search. A reporting to pharmacovigilance network is essential in case of a serious CADR whatever the suspected drug and in any case if the involved drug is a newly marketed one or unusually related to cutaneous reactions.

  1. Human-Computer Interactions: Are There Adverse Health Consequences?

    ERIC Educational Resources Information Center

    Emurian, Henry H.

    1989-01-01

    Discusses the hypothesis that similarities may exist between laboratory research paradigms evoking elevated blood pressure during task performance by normal subjects and video display terminal (VDT) work done by data clerks and college students. Type A behavior and the development of coronary heart disease are discussed, and further research needs…

  2. PUTATIVE ADVERSE OUTCOME PATHWAY FOR INHIBITON ...

    EPA Pesticide Factsheets

    The adverse outcome pathway (AOP) provides a framework for organizing knowledge to define links between a molecular initiating event (MIE) and an adverse outcome (AO) occurring at a higher level of biological organization, such as the individual or population. The AOP framework proceeds from a general (e.g., not chemical specific) molecular mode of action, designated as a MIE, through stepwise changes in biological status, defined as key events (KEs), to a final AO that can be used in risk assessment. Because aromatase-inhibiting pharmaceuticals are widely used to treat breast cancer patients, we explored the unintended consequences that might occur in fish exposed to these chemicals through wastewater discharge into the aquatic environment. Unlike mammals, fish have two isoforms of aromatase, one that predominates in the ovary (cyp19a1a) and a second (cyp19a1b) that prevails in the brain. Aromatase activity in fish brain can be 100 to 1000 times that in mammals and is associated with reproduction. We have developed a putative AOP for inhibition of brain aromatase in fish leading to reproductive dysfunction based on review of relevant literature and reproductive experiments with the marine fish cunner (Tautogolabrus adspersus) exposed to aromatase-inhibiting pharmaceuticals in the laboratory. The first KE in this AOP is a decrease in brain aromatase activity due to exposure to an aromatase inhibitor. KEs then progress through subsequent steps including decreas

  3. The Public Health Burden of Early Adversity

    ERIC Educational Resources Information Center

    Schlueter, Lisa J.; Watamura, Sarah Enos

    2017-01-01

    Severe and chronic stress in early childhood has enormous physical and mental health costs across an individual's lifespan. Unfortunately, exposure to early life adversity is common, and costs accrue to individuals and society. This article highlights several promising approaches to buffer children from the negative health consequences associated…

  4. Mechanisms and Clinical Consequences of Vascular Calcification

    PubMed Central

    Zhu, Dongxing; Mackenzie, Neil C. W.; Farquharson, Colin; MacRae, Vicky E.

    2012-01-01

    Vascular calcification has severe clinical consequences and is considered an accurate predictor of future adverse cardiovascular events, including myocardial infarction and stroke. Previously vascular calcification was thought to be a passive process which involved the deposition of calcium and phosphate in arteries and cardiac valves. However, recent studies have shown that vascular calcification is a highly regulated, cell-mediated process similar to bone formation. In this article, we outline the current understanding of key mechanisms governing vascular calcification and highlight the clinical consequences. By understanding better the molecular pathways and genetic circuitry responsible for the pathological mineralization process novel drug targets may be identified and exploited to combat and reduce the detrimental effects of vascular calcification on human health. PMID:22888324

  5. Sexually transmitted diseases: magnitude, determinants and consequences.

    PubMed

    Aral, S O

    2001-04-01

    Sexually transmitted diseases (STDs) including human immuno-deficiency virus (HIV) infections constitute a major reproductive health burden for sexually-active individuals. The short-term and long-term consequences of STD have been well documented and include genital and other cancers, pelvic inflammatory disease, ectopic pregnancy, infertility, and adverse outcomes of pregnancy including pre-term delivery and low birth weight. The burden of sexually transmitted infections falls disproportionately on the young, the poor, minorities and women. At the societal level, there is a continuing need to educate people, particularly adolescents, about their risk for STDs and their sequelae and to increase the use of barrier methods including condoms. Policy decisions that facilitate more open discussion of sexuality and STDs, and that expand the accessibility and acceptability of sexual risk assessment, STD screening and treatment services would help decrease STD rates in the United States to levels similar to those observed in other industrialized countries.

  6. Neurodevelopment in children with intrauterine growth restriction: adverse effects and interventions.

    PubMed

    Wang, Yan; Fu, Wei; Liu, Jing

    2016-01-01

    Intrauterine growth restriction (IUGR) is associated with higher rates of fetal, perinatal, and neonatal morbidity and mortality. The consequences of IUGR include short-term metabolic, hematological and thermal disturbances that lead to metabolic syndrome in children and adults. Additionally, IUGR severely affects short- and long-term fetal brain development and brain function (including motor, cognitive and executive function) and neurobehavior, especially neuropsychology. This review details the adverse effects of IUGR on fetal brain development and discusses intervention strategies.

  7. Adverse drug reactions: part II.

    PubMed

    Wooten, James M

    2010-11-01

    Pharmacovigilance is the process of identifying, monitoring, and effectively reducing adverse drug reactions. Adverse drug reactions (ADRs) are an important consideration when assessing a patient's health. The proliferation of new pharmaceuticals means that the incidence of ADRs is increasing. The goal for all health care providers must be to minimize the risk of ADRs as much as possible. Steps to achieve this include understanding the pharmacology for all drugs prescribed and proactively assessing and monitoring those patients at greatest risk for developing an ADR. Groups at greatest risk for developing ADRs include the elderly, children, and pregnant patients, as well as others. Pharmacovigilance must be effectively practiced by all health care providers in order to avoid ADRs.

  8. Adverse drug reactions: Part I.

    PubMed

    Wooten, James M

    2010-10-01

    Pharmacovigilance is the process of identifying, monitoring, and effectively reducing adverse drug reactions. Adverse drug reactions (ADRs) are an important consideration when assessing a patient's health. The proliferation of new pharmaceuticals means that the incidence of ADRs is increasing. The goal for all health care providers must be to minimize the risk of ADRs as much as possible. Steps to achieve this include understanding the pharmacology for all drugs prescribed and proactively assessing and monitoring those patients at greatest risk for developing an ADR. Groups at greatest risk for developing ADRs include the elderly, children, and pregnant patients, as well as others. Pharmacovigilance must effectively be practiced by all health providers in order to avoid ADRs.

  9. Scientists Trace Adversity's Toll

    ERIC Educational Resources Information Center

    Sparks, Sarah D.

    2012-01-01

    The stress of a spelling bee or a challenging science project can enhance a student's focus and promote learning. But the stress of a dysfunctional or unstable home life can poison a child's cognitive ability for a lifetime, according to new research. Those studies show that stress forms the link between childhood adversity and poor academic…

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

    PubMed Central

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

    Purpose: 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. Methods: 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 < 0.01) were identified and presented as well. Results: We found that each cluster of patients typically had a most distinguishing adverse event. Examination of the co-occurrences of adverse events in patients led to the identification of potentially interesting adverse event correlations that may be further investigated as well as provide further patient stratification opportunities. Conclusions: We have demonstrated the feasibility of a novel approach in pharmacovigilance to stratify patients based on fine-grained adverse event profiles, which also makes it possible to identify adverse event correlations. Used on larger data sets, this data-driven method has the potential to reveal unknown patterns concerning adverse event occurrences. PMID:25249979

  11. RACIAL RESIDENTIAL SEGREGATION AND ADVERSE BIRTH OUTCOMES

    EPA Science Inventory

    INTRODUCTION. The disparity between black and white women's adverse birth outcomes has been subject to much investigation, yet the factors underlying its persistence remain elusive, which has encouraged research on neighborhood-level influences, including racial residential segr...

  12. Baby on board: do responses to stress in the maternal brain mediate adverse pregnancy outcome?

    PubMed

    Douglas, Alison J

    2010-07-01

    Stress and adverse environmental surroundings result in suboptimal conditions in a pregnant mother such that she may experience poor pregnancy outcome including complete pregnancy failure and preterm labor. Furthermore her developing baby is at risk of adverse programming, which confers susceptibility to long term ill health. While some mechanisms at the feto-maternal interface underlying these conditions are understood, the underlying cause for their adverse adaptation is often not clear. Progesterone plays a key role at many levels, including control of neuroendocrine responses to stress, procuring the required immune balance and controlling placental and decidual function, and lack of progesterone can explain many of the unwanted consequences of stress. How stress that is perceived by the mother inhibits progesterone secretion and action is beginning to be investigated. This overview of maternal neuroendocrine responses to stress throughout pregnancy analyses how they interact to compromise progesterone secretion and precipitate undesirable effects in mother and offspring.

  13. Adverse effects of psychological therapy: An exploratory study of practitioners' experiences from child and adolescent psychiatry.

    PubMed

    Jonsson, Ulf; Johanson, Josefin; Nilsson, Elin; Lindblad, Frank

    2016-07-01

    The scientific knowledge about adverse effects of psychological therapies and how such effects should be detected is limited. It is possible that children and adolescents are particularly vulnerable and need specific support in order to express adverse effects. In this exploratory study, we used a qualitative approach to explore practitioners' experiences of this phenomenon. Fourteen practitioners providing psychological therapy within the Child and Adolescent Psychiatric Service were interviewed. Qualitative content analysis was applied to the data. Four overarching categories brought up by the practitioners were identified: vagueness of the concept (reflecting that the concept was novel and hard to define), psychotherapist-client interaction (encompassing aspects of the interaction possibly related to adverse effects), consequences for the young person (including a range of emotional, behavioural and social consequences) and family effects (e.g. professional complications and decreased autonomy for the parent). Professional discussions on these issues could improve psychological therapy for children and adolescents. Based on our findings and previous research, we propose three basic aspects to consider when adverse effects are detected and managed in this context: typology (form, severity and duration), aetiology (hypothesis about the causes) and perspective (adverse effects seen from the points of view of different interested parties).

  14. Childhood adversity and frequent medical consultations.

    PubMed

    Fiddler, Maggie; Jackson, Judy; Kapur, Navneet; Wells, Adrian; Creed, Francis

    2004-01-01

    We assessed possible psychological mediators of the relationship between childhood adversity and frequent medical consultations among new outpatients at neurology, cardiology, and gastroenterology clinics. We assessed whether these differed in patients with and without organic disease that explained their symptoms. At first clinic visit we recorded Hospital Anxiety and Depression scale (HADS--anxiety and depression subscale scores), Illness Perception Questionnaire (IPQ--four subscales: consequences, cure, identity, timeline), Health Anxiety Questionnaire (total score), and Symptom Amplification Scale (total score). Subjects were divided into two groups according to whether they had experienced any type of childhood adversity using the Childhood Experience of Care and Abuse Schedule. Outcome was the (log) number of medical consultations for 12 months before and 6 months after the index clinic visits. Multiple regression analysis was used to determine mediators; this was performed separately for patients with symptoms explained and not explained by organic disease. One-hundred and twenty-nine patients (61% response) were interviewed. Fifty-two (40.3%) had experienced childhood adversity; they made a median of 16 doctor visits compared with 10 for those without adversity (adjusted P=.026). IPQ identity score (number of symptoms attributed to the illness) and HAD depression scores were significantly associated with both childhood adversity and number of medical consultations and these variables acted as mediators between childhood adversity and frequency of consultation in the multiple regression analyses. This association was limited to patients with medically unexplained symptoms and was mediated by IPQ Identity Score (number of symptoms attributed to the patient's illness) and HAD depression score. Sexual abuse and overt neglect were the adversities most closely associated with frequent consultations. In patients with medically unexplained symptoms the association

  15. Thiocolchicoside: review of adverse effects.

    PubMed

    2016-02-01

    Thiocolchicoside has long been used as a muscle relaxant, despite a lack of proven efficacy beyond the placebo effect. Its chemical structure consists of colchicine, a sugar (ose) and a sulphur-containing radical (thio), and its adverse effects are therefore likely to be similar to those of colchicine. Using the standard Prescrire methodology, we reviewed the available data on the adverse effects of thiocolchicoside. Liver injury, pancreatitis, seizures, blood cell disorders, severe cutaneous disorders, rhabdomyolysis and reproductive disorders have all been recorded in the French and European pharmacovigilance databases and in the periodic updates that the companies concerned submit to regulatory agencies. These data do not specify the frequency of the disorders nor do they identify the most susceptible patient populations. Thiocolchicoside is teratogenic in experimental animals and also damages chromosomes. Human data are limited to a follow-up of about 30 pregnant women (no major malformations) and reports of altered spermatogenesis, including cases of azoospermia. In practice, there is no justification for exposing patients to the adverse effects of thiocolchicoside. It is better to use an effective, well-known analgesic for patients complaining of muscle pain, starting with paracetamol.

  16. Early Adverse Experiences and the Developing Brain

    PubMed Central

    Bick, Johanna; Nelson, Charles A

    2016-01-01

    Children exposed to various forms of adversity early in life are at increased risk for a broad range of developmental difficulties, affecting both cognitive and emotional adjustment. We review a growing body of evidence suggesting that exposure to adverse circumstances affects the developing brain in ways that increase risk for a myriad of problems. We focus on two forms of adversity, one in which children are exposed to childhood maltreatment in family environments, and another in which children are exposed to extreme psychosocial deprivation in contexts of institutional rearing. We discuss ways in which each of these experiences represent violations of species-expected caregiving conditions, thereby imposing challenges to the developing brain. We also review emerging data pointing to the effectiveness of early intervention in remediating neurodevelopmental consequences associated with maltreatment or institutional rearing. We conclude by discussing implications of this work for public health efforts and highlight important directions for the field. PMID:26334107

  17. Adverse drug reactions.

    PubMed

    O'Reilly-Foley, Georgina

    2017-04-05

    What was the nature of the CPD activity, practice-related feedback and/or event and/or experience in your practice? The CPD article defined the different types of adverse drug reactions (ADRs) and explored when they can occur. It emphasised the importance of being knowledgeable about medications, considering patient safety when patients are taking medications, being alert to the possibility of ADRs, and recognising and responding to suspected ADRs.

  18. Adverse events to monoclonal antibodies used for cancer therapy

    PubMed Central

    Baldo, Brian A

    2013-01-01

    Fifteen monoclonal antibodies (mAbs) are currently registered and approved for the treatment of a range of different cancers. These mAbs are specific for a limited number of targets (9 in all). Four of these molecules are indeed directed against the B-lymphocyte antigen CD20; 3 against human epidermal growth factor receptor 2 (HER2 or ErbB2), 2 against the epidermal growth factor receptor (EGFR), and 1 each against epithelial cell adhesion molecule (EpCAM), CD30, CD52, vascular endothelial growth factor (VEGF), tumor necrosis factor (ligand) superfamily, member 11 (TNFSF11, best known as RANKL), and cytotoxic T lymphocyte-associated protein 4 (CTLA4). Collectively, the mAbs provoke a wide variety of systemic and cutaneous adverse events including the full range of true hypersensitivities: Type I immediate reactions (anaphylaxis, urticaria); Type II reactions (immune thrombocytopenia, neutopenia, hemolytic anemia); Type III responses (vasculitis, serum sickness; some pulmonary adverse events); and Type IV delayed mucocutaneous reactions as well as infusion reactions/cytokine release syndrome (IRs/CRS), tumor lysis syndrome (TLS), progressive multifocal leukoencephalopathy (PML) and cardiac events. Although the term “hypersensitivity” is widely used, no common definition has been adopted within and between disciplines and the requirement of an immunological basis for a true hypersensitivity reaction is sometimes overlooked. Consequently, some drug-induced adverse events are sometimes incorrectly described as “hypersensitivities” while others that should be described are not. PMID:24251081

  19. Analysis of 415 adverse events in dental practice in Spain from 2000 to 2010

    PubMed Central

    Perea-Pérez, Bernardo; Labajo-González, Elena; Santiago-Sáez, Andrés; Albarrán-Juan, Elena; Villa-Vigil, Alfonso

    2014-01-01

    Introduction: The effort to increase patient safety has become one of the main focal points of all health care professions, despite the fact that, in the field of dentistry, initiatives have come late and been less ambitious. The main objective of patient safety is to avoid preventable adverse events to the greatest extent possible and to limit the negative consequences of those which are unpreventable. Therefore, it is essential to ascertain what adverse events occur in each dental care activity in order to study them in-depth and propose measures for prevention. Objectives: To ascertain the characteristics of the adverse events which originate from dental care, to classify them in accordance with type and origin, to determine their causes and consequences, and to detect the factors which facilitated their occurrence. Material and Methods: This study includes the general data from the series of adverse dental vents of the Spanish Observatory for Dental Patient Safety (OESPO) after the study and analysis of 4,149 legal claims (both in and out of court) based on dental malpractice from the years of 2000 to 2010 in Spain. Results: Implant treatments, endodontics and oral surgery display the highest frequencies of adverse events in this series (25.5%, 20.7% and 20.4% respectively). Likewise, according to the results, up to 44.3% of the adverse events which took place were due to predictable and preventable errors and complications. Conclusions: A very significant percentage were due to foreseeable and preventable errors and complications that should not have occurred. Key words:Patient safety, adverse event, medical care risk, dentistry. PMID:24880444

  20. [Cardiovascular pharmacotherapy. Risks and adverse effects].

    PubMed

    Voigt, N; Heijman, J; Dobrev, D

    2014-03-01

    Adverse side effects of drugs are a significantly underestimated problem in modern medicine. In this review article, we summarize common adverse side effects of cardiovascular drugs. In particular, we highlight the factors promoting these adverse side effects in patients, including reduced hepatic or renal clearance in elderly patients that often requires dosage adjustment. Pharmacodynamic and pharmacokinetic interactions between drugs (e.g. through the cytochrome P450 system or P-glycoproteins) can modify the plasma concentration of many compounds, thereby also increasing the likelihood of unwanted side effects. The most prominent cardiac side effects include arrhythmias, e.g. atrioventricular (AV) block, drug-induced long-QT syndrome and torsade de pointes and altered inotropy. Non-cardiac side effects are subsequently discussed grouped by drug class. A better understanding of the risks and side effects of cardiovascular drugs is expected to reduce the mortality and morbidity associated with adverse side effects.

  1. Childhood adversities and psychosis: evidence, challenges, implications

    PubMed Central

    Morgan, Craig; Gayer‐Anderson, Charlotte

    2016-01-01

    There is a substantial body of research reporting evidence of associations between various forms of childhood adversity and psychosis, across the spectrum from experiences to disorder. This has been extended, more recently, to include studies of cumulative effects, of interactions with other factors, of specific effects, and of putative biological and psychological mechanisms. In this paper we evaluate this research and highlight the remaining methodological issues and gaps that temper, but do not dismiss, conclusions about the causal role of childhood adversity. We also consider the emerging work on cumulative, synergistic, and specific effects and on mechanisms; and discuss the broader implications of this line of research for our understanding of psychosis. We conclude that the current balance of evidence is that childhood adversities – particularly exposure to multiple adversities involving hostility and threat – do, in some people, contribute to the onset of psychotic experiences and psychotic disorders. PMID:27265690

  2. Childhood adversity: a review of measurement instruments.

    PubMed

    Burgermeister, Diane

    2007-01-01

    Measurement instruments are needed to stimulate research on the long-term outcomes of childhood adversity. Therefore, the purpose of this review was to locate, describe, and assess instruments to measure retrospective perceptions of childhood adversity. An electronic search of instruments was conducted using a combination of keywords that included child maltreatment, child trauma, and childhood stressful events. Nine instruments were located and described according to format, definition of childhood adversity as measured by the instrument, characteristics of the sample used in development and testing, reliability and validity evidence, and feasibility for use. Six out of the nine instruments were suitable for investigators who require a comprehensive measure of childhood adversity. Corroboration with independent sources and use of randomized samples are needed to improve upon reports of validity.

  3. Future Directions in Childhood Adversity and Youth Psychopathology.

    PubMed

    McLaughlin, Katie A

    2016-01-01

    Despite long-standing interest in the influence of adverse early experiences on mental health, systematic scientific inquiry into childhood adversity and developmental outcomes has emerged only recently. Existing research has amply demonstrated that exposure to childhood adversity is associated with elevated risk for multiple forms of youth psychopathology. In contrast, knowledge of developmental mechanisms linking childhood adversity to the onset of psychopathology-and whether those mechanisms are general or specific to particular kinds of adversity-remains cursory. Greater understanding of these pathways and identification of protective factors that buffer children from developmental disruptions following exposure to adversity is essential to guide the development of interventions to prevent the onset of psychopathology following adverse childhood experiences. This article provides recommendations for future research in this area. In particular, use of a consistent definition of childhood adversity, integration of studies of typical development with those focused on childhood adversity, and identification of distinct dimensions of environmental experience that differentially influence development are required to uncover mechanisms that explain how childhood adversity is associated with numerous psychopathology outcomes (i.e., multifinality) and identify moderators that shape divergent trajectories following adverse childhood experiences. A transdiagnostic model that highlights disruptions in emotional processing and poor executive functioning as key mechanisms linking childhood adversity with multiple forms of psychopathology is presented as a starting point in this endeavour. Distinguishing between general and specific mechanisms linking childhood adversity with psychopathology is needed to generate empirically informed interventions to prevent the long-term consequences of adverse early environments on children's development.

  4. Behavioral and physiological consequences of sleep restriction.

    PubMed

    Banks, Siobhan; Dinges, David F

    2007-08-15

    Adequate sleep is essential for general healthy functioning. This paper reviews recent research on the effects of chronic sleep restriction on neurobehavioral and physiological functioning and discusses implications for health and lifestyle. Restricting sleep below an individual's optimal time in bed (TIB) can cause a range of neurobehavioral deficits, including lapses of attention, slowed working memory, reduced cognitive throughput, depressed mood, and perseveration of thought. Neurobehavioral deficits accumulate across days of partial sleep loss to levels equivalent to those found after 1 to 3 nights of total sleep loss. Recent experiments reveal that following days of chronic restriction of sleep duration below 7 hours per night, significant daytime cognitive dysfunction accumulates to levels comparable to that found after severe acute total sleep deprivation. Additionally, individual variability in neurobehavioral responses to sleep restriction appears to be stable, suggesting a trait-like (possibly genetic) differential vulnerability or compensatory changes in the neurobiological systems involved in cognition. A causal role for reduced sleep duration in adverse health outcomes remains unclear, but laboratory studies of healthy adults subjected to sleep restriction have found adverse effects on endocrine functions, metabolic and inflammatory responses, suggesting that sleep restriction produces physiological consequences that may be unhealthy.

  5. Strong Medicine and Unintended Consequences.

    ERIC Educational Resources Information Center

    Barkdoll, Gerald L.

    1992-01-01

    Anecdotal evidence from interviews with some program managers gives evidence that unintended negative consequences of evaluations are more than a theoretical concern; they are a real problem deserving an evaluator's attention and energy. Negative consequences usually include: (1) wasted resources; (2) demotivation; and (3) program destruction and…

  6. Adverse drug reactions in hospitalized Colombian children

    PubMed Central

    Díaz-Agudelo, Daniela; Burgos-Flórez, Francisco Javier; Vaca, Claudia; Serrano-Meriño, Dolores Vanessa

    2016-01-01

    Introduction: The occurrence of adverse drug reactions is an important issue due to the lack of drug safety data in children. Objective: To describe the Adverse Drug Reactions in inpatient children under 6 years of age in two general pediatrics wards located in Barranquilla, Colombia. Methods: A prospective cohort study based on intensive pharmacovigilance was conducted during six months in order to monitor the emergence of Adverse Drug Reactions in inpatients children under 6 years of age with at least one medication prescribed. The study was conducted in two pediatric wards of two hospitals located in Barranquilla, Colombia. Naranjo´s Algorithm was used to evaluate imputability, the modified Hartwig and Siegel assessment scale to establish severity and the Schumock and Thornton criteria to determine preventability. Results: Of a total of 772 monitored patients, 156 Adverse Drug Reactions were detected on 147 children. The cumulative incidence of Adverse Drug Reactions was 19.0% (147/772); the incidence density was 37.6 Adverse Drug Reactions per 1,000 patients-days (147/3,913). The frequency was higher in children under 2 years of age (12.7%). Emergence of Adverse Drug Reactions was higher in male patients (RR= 1.66; 95% CI= 1.22-2.22, p= 0.001) and in those who used systemic antibiotics (RR= 1.82; 95% CI= 1.17-2.82, p= 0.005). Conclusions: Adverse Drug Reactions are common among hospitalized children and represent an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics. PMID:27821893

  7. Future Directions in Childhood Adversity and Youth Psychopathology

    PubMed Central

    McLaughlin, Katie A.

    2016-01-01

    Despite long-standing interest in the influence of adverse early experiences on mental health, systematic scientific inquiry into childhood adversity and developmental outcomes has emerged only recently. Existing research has amply demonstrated that exposure to childhood adversity is associated with elevated risk for multiple forms of youth psychopathology. In contrast, knowledge of developmental mechanisms linking childhood adversity to the onset of psychopathology—and whether those mechanisms are general or specific to particular kinds of adversity—remains cursory. Greater understanding of these pathways and identification of protective factors that buffer children from developmental disruptions following exposure to adversity is essential to guide the development of interventions to prevent the onset of psychopathology following adverse childhood experiences. This article provides recommendations for future research in this area. In particular, use of a consistent definition of childhood adversity, integration of studies of typical development with those focused on childhood adversity, and identification of distinct dimensions of environmental experience that differentially influence development are required to uncover mechanisms that explain how childhood adversity is associated with numerous psychopathology outcomes (i.e., multifinality) and identify moderators that shape divergent trajectories following adverse childhood experiences. A transdiagnostic model that highlights disruptions in emotional processing and poor executive functioning as key mechanisms linking childhood adversity with multiple forms of psychopathology is presented as a starting point in this endeavour. Distinguishing between general and specific mechanisms linking childhood adversity with psychopathology is needed to generate empirically informed interventions to prevent the long-term consequences of adverse early environments on children’s development. PMID:26849071

  8. Consequences of use of anabolic androgenic steroids.

    PubMed

    Casavant, Marcel J; Blake, Kathleen; Griffith, Jill; Yates, Andrew; Copley, LaRae M

    2007-08-01

    Whether providing anticipatory guidance to the young adolescent patient, conducting a preparticipation examination on a young athlete, or treating a sick user of anabolic androgenic steroids (AASs), the primary care physician must be familiar with the adverse consequences of the use of these compounds. This article reviews the endocrine, cardiovascular, neuropsychiatric, musculoskeletal, hematologic, hepatic, and miscellaneous effects of AASs, highlighting effects reported in children and adolescents, and relying on consequences in adults when pediatric data is unavailable.

  9. Adverse cutaneous drug reaction.

    PubMed

    Nayak, Surajit; Acharjya, Basanti

    2008-01-01

    In everyday clinical practice, almost all physicians come across many instances of suspected adverse cutaneous drug reactions (ACDR) in different forms. Although such cutaneous reactions are common, comprehensive information regarding their incidence, severity and ultimate health effects are often not available as many cases go unreported. It is also a fact that in the present world, almost everyday a new drug enters market; therefore, a chance of a new drug reaction manifesting somewhere in some form in any corner of world is unknown or unreported. Although many a times, presentation is too trivial and benign, the early identification of the condition and identifying the culprit drug and omit it at earliest holds the keystone in management and prevention of a more severe drug rash. Therefore, not only the dermatologists, but all practicing physicians should be familiar with these conditions to diagnose them early and to be prepared to handle them adequately. However, we all know it is most challenging and practically difficult when patient is on multiple medicines because of myriad clinical symptoms, poorly understood multiple mechanisms of drug-host interaction, relative paucity of laboratory testing that is available for any definitive and confirmatory drug-specific testing. Therefore, in practice, the diagnosis of ACDR is purely based on clinical judgment. In this discussion, we will be primarily focusing on pathomechanism and approach to reach a diagnosis, which is the vital pillar to manage any case of ACDR.

  10. Adverse reactions to drug additives.

    PubMed

    Simon, R A

    1984-10-01

    There is a long list of additives used by the pharmaceutical industry. Most of the agents used have not been implicated in hypersensitivity reactions. Among those that have, only reactions to parabens and sulfites have been well established. Parabens have been shown to be responsible for rare immunoglobulin E-mediated reactions that occur after the use of local anesthetics. Sulfites, which are present in many drugs, including agents commonly used to treat asthma, have been shown to provoke severe asthmatic attacks in sensitive individuals. Recent studies indicate that additives do not play a significant role in "hyperactivity." The role of additives in urticaria is not well established and therefore the incidence of adverse reactions in this patient population is simply not known. In double-blind, placebo-controlled studies, reactions to tartrazine or additives other than sulfites, if they occur at all, are indeed quite rare for the asthmatic population, even for the aspirin-sensitive subpopulation.

  11. Telithromycin: review of adverse effects.

    PubMed

    2014-11-01

    Telithromycin is a macrolide antibiotic that has been marketed since the early 2000s. It has not been shown to be more effective against any bacteria than other macrolide antibiotics. Its antibacterial activity is in no way remarkable. In early 2014, we reviewed its adverse effect profile using data from periodic safety update reports, drug regulatory agencies, and detailed published case reports. In addition to the adverse effect profile telithromycin shares with the other macrolides, it provokes several specific adverse effects: visual disturbances due to impaired accommodation; taste and smell disorders; severe liver damage; worsening of myasthenia gravis; rhabdomyolysis; and loss of consciousness. Prolongation of the QT interval with standard oral doses is a worrisome adverse effect. In practice, it is better not to use telithromycin as it exposes patients to disproportionate, serious adverse effects. When treatment with a macrolide antibiotic appears necessary, it is prudent to choose a different macrolide, such as spiramycin or azithromycin, which have fewer adverse effects.

  12. Long-Term Consequences of Neonatal Injury

    PubMed Central

    Beggs, Simon

    2015-01-01

    The maturation of the central nervous system’s (CNS’s) sensory connectivity is driven by modality-specific sensory input in early life. For the somatosensory system, this input is the physical, tactile interaction with the environment. Nociceptive circuitry is functioning at the time of birth; however, there is still considerable organization and refinement of this circuitry that occurs postnatally, before full discrimination of tactile and noxious input is possible. This fine-tuning involves separation of tactile and nociceptive afferent input to the spinal cord’s dorsal horn and the maturation of local and descending inhibitory circuitry. Disruption of that input in early postnatal life (for example, by tissue injury or other noxious stimulus), can have a profound influence on subsequent development, and consequently the mature functioning of pain systems. In this review, the impact of neonatal surgical incision on nociceptive circuitry is discussed in terms of the underlying developmental neurobiology. The changes are complex, occurring at multiple anatomical sites within the CNS, and including both neuronal and glial cell populations. The altered sensory input from neonatal injury selectively modulates neuronal excitability within the spinal cord, disrupts inhibitory control, and primes the immune system, all of which contribute to the adverse long-term consequences of early pain exposure. PMID:26174217

  13. Psychological consequences of childhood obesity: psychiatric comorbidity and prevention.

    PubMed

    Rankin, Jean; Matthews, Lynsay; Cobley, Stephen; Han, Ahreum; Sanders, Ross; Wiltshire, Huw D; Baker, Julien S

    2016-01-01

    Childhood obesity is one of the most serious public health challenges of the 21st century with far-reaching and enduring adverse consequences for health outcomes. Over 42 million children <5 years worldwide are estimated to be overweight (OW) or obese (OB), and if current trends continue, then an estimated 70 million children will be OW or OB by 2025. The purpose of this review was to focus on psychiatric, psychological, and psychosocial consequences of childhood obesity (OBy) to include a broad range of international studies. The aim was to establish what has recently changed in relation to the common psychological consequences associated with childhood OBy. A systematic search was conducted in MEDLINE, Web of Science, and the Cochrane Library for articles presenting information on the identification or prevention of psychiatric morbidity in childhood obesity. Relevant data were extracted and narratively reviewed. Findings established childhood OW/OBy was negatively associated with psychological comorbidities, such as depression, poorer perceived lower scores on health-related quality of life, emotional and behavioral disorders, and self-esteem during childhood. Evidence related to the association between attention-deficit/hyperactivity disorder (ADHD) and OBy remains unconvincing because of various findings from studies. OW children were more likely to experience multiple associated psychosocial problems than their healthy-weight peers, which may be adversely influenced by OBy stigma, teasing, and bullying. OBy stigma, teasing, and bullying are pervasive and can have serious consequences for emotional and physical health and performance. It remains unclear as to whether psychiatric disorders and psychological problems are a cause or a consequence of childhood obesity or whether common factors promote both obesity and psychiatric disturbances in susceptible children and adolescents. A cohesive and strategic approach to tackle this current obesity epidemic is

  14. Psychological consequences of childhood obesity: psychiatric comorbidity and prevention

    PubMed Central

    Rankin, Jean; Matthews, Lynsay; Cobley, Stephen; Han, Ahreum; Sanders, Ross; Wiltshire, Huw D; Baker, Julien S

    2016-01-01

    Childhood obesity is one of the most serious public health challenges of the 21st century with far-reaching and enduring adverse consequences for health outcomes. Over 42 million children <5 years worldwide are estimated to be overweight (OW) or obese (OB), and if current trends continue, then an estimated 70 million children will be OW or OB by 2025. The purpose of this review was to focus on psychiatric, psychological, and psychosocial consequences of childhood obesity (OBy) to include a broad range of international studies. The aim was to establish what has recently changed in relation to the common psychological consequences associated with childhood OBy. A systematic search was conducted in MEDLINE, Web of Science, and the Cochrane Library for articles presenting information on the identification or prevention of psychiatric morbidity in childhood obesity. Relevant data were extracted and narratively reviewed. Findings established childhood OW/OBy was negatively associated with psychological comorbidities, such as depression, poorer perceived lower scores on health-related quality of life, emotional and behavioral disorders, and self-esteem during childhood. Evidence related to the association between attention-deficit/hyperactivity disorder (ADHD) and OBy remains unconvincing because of various findings from studies. OW children were more likely to experience multiple associated psychosocial problems than their healthy-weight peers, which may be adversely influenced by OBy stigma, teasing, and bullying. OBy stigma, teasing, and bullying are pervasive and can have serious consequences for emotional and physical health and performance. It remains unclear as to whether psychiatric disorders and psychological problems are a cause or a consequence of childhood obesity or whether common factors promote both obesity and psychiatric disturbances in susceptible children and adolescents. A cohesive and strategic approach to tackle this current obesity epidemic is

  15. Adverse drug reactions in special populations – the elderly

    PubMed Central

    Davies, E A; O’Mahony, M S

    2015-01-01

    The International Conference on Harmonization considers older people a ‘special population’, as they differ from younger adults in terms of comorbidity, polypharmacy, pharmacokinetics and greater vulnerability to adverse drug reactions (ADRs). Medical practice is often based on single disease guidelines derived from clinical trials that have not included frail older people or those with multiple morbidities. This presents a challenge caring for older people, as drug doses in trials may not be achievable in real world patients and risks of ADRs are underestimated in clinical trial populations. The majority of ADRs in older people are Type A, potentially avoidable and associated with commonly prescribed medications. Several ADRs are particularly associated with major adverse consequences in the elderly and their reduction is therefore a clinical priority. Falls are strongly associated with benzodiazepines, neuroleptics, antidepressants and antihypertensives. There is good evidence for medication review as part of a multifactorial intervention to reduce falls risk in community dwelling elderly. Multiple medications also contribute to delirium, another multifactorial syndrome resulting in excess mortality particularly in frail older people. Clostridium difficile associated with use of broad spectrum antibiotics mainly affects frail older people and results in prolonged hospital stay with substantial morbidity and mortality. Antipsychotics increase the risk of stroke by more than three-fold in patients with dementia. Inappropriate prescribing can be reduced by adherence to prescribing guidelines, suitable monitoring and regular medication review. Given the heterogeneity within the older population, providing individualized care is pivotal to preventing ADRs. PMID:25619317

  16. Depot risperidone-induced adverse metabolic alterations in female rats.

    PubMed

    Horska, Katerina; Ruda-Kucerova, Jana; Karpisek, Michal; Suchy, Pavel; Opatrilova, Radka; Kotolova, Hana

    2017-04-01

    Atypical antipsychotics are associated with adverse metabolic effects including weight gain, increased adiposity, dyslipidaemia, alterations in glucose metabolism and insulin resistance. Increasing evidence suggests that metabolic dysregulation precedes weight gain development. The aim of this study was to evaluate alterations in adipokines, hormones and basic serum biochemical parameters induced by chronic treatment with depot risperidone at two doses (20 and 40 mg/kg) in female Sprague-Dawley rats. Dose-dependent metabolic alterations induced by risperidone after 6 weeks of treatment were revealed. Concomitant to weight gain and increased liver weight, an adverse lipid profile with an elevated triglyceride level was observed in the high exposure group, administered a 40 mg/kg dose repeatedly, while the low dose exposure group, administered a 20 mg/kg dose, developed weight gain without alterations in the lipid profile and adipokine levels. An initial peak in leptin serum level after the higher dose was observed in the absence of weight gain. This finding may indicate that the metabolic alterations observed in this study are not consequent to body weight gain. Taken together, these data may support the primary effects of atypical antipsychotics on peripheral tissues.

  17. [Adverse reactions and risks associated with non compliance].

    PubMed

    Russmann, Stefan; Curkovic, Ivanka; Huber, Martin

    2010-06-01

    Non compliance is a frequent and underestimated problem in clinical practice, that is associated with considerable risks, adverse reactions and costs. Next to omitting one or several doses with consequent lack of efficacy, other forms of non compliance can be described. These include administration of a wrong dose or at a wrong time, early termination of therapy or also its unwarranted continuation, and self-administered comedication without consideration of potential interactions. A number of risks and adverse effects can be derived from these different forms of non compliance, for which we present several examples from clinical practice and the literature. Anticipation, recognition and appropriate countermeasures are important elements for the prevention of non compliance, which may target the pharmacotherapy itself, the patient, or the health system providing the therapeutic framework. Furthermore, a climate of trust and good communication between the patient and the health care provider is the cornerstone for all strategies that aim to improve compliance. Computerized physician order entry and clinical decision support systems may have an additional important role for the prevention of non compliance in the future.

  18. [Laser trabeculoplasty: therapeutic options and adverse effects].

    PubMed

    Wacker, T; Eckert, S

    2010-01-01

    Laser trabeculoplasty is a simple method for treating glaucoma and ocular hypertension and has few adverse effects. There are different laser systems for reducing the intraocular pressure of patients with glaucoma and ocular hypertension. Complications include transient intraocular pressure elevation, iritis, and anterior synechiae.

  19. Adverse Reactions to Hallucinogenic Drugs.

    ERIC Educational Resources Information Center

    Meyer, Roger E. , Ed.

    This reports a conference of psychologists, psychiatrists, geneticists and others concerned with the biological and psychological effects of lysergic acid diethylamide and other hallucinogenic drugs. Clinical data are presented on adverse drug reactions. The difficulty of determining the causes of adverse reactions is discussed, as are different…

  20. Adverse events temporally associated with meningococcal vaccines.

    PubMed Central

    Yergeau, A; Alain, L; Pless, R; Robert, Y

    1996-01-01

    OBJECTIVE: To determine the incidence of severe adverse events temporally associated with meningococcal vaccines administered as part of a mass vaccination program. DESIGN: Retrospective descriptive study of events reported to a passive provincial surveillance system. SETTING: The province of Quebec. PARTICIPANTS: The 1,198,751 individuals aged 6 months to 20 years who were vaccinated against meningococcal disease between Dec. 27, 1992, and Mar. 31, 1993. OUTCOME MEASURES: Total numbers and rates of severe adverse events, including allergic reactions, anaphylactic reactions, neurological events (other than abnormal crying and screaming) and other serious or unusual events. RESULTS: A total of 118 reports of severe adverse events were selected from the surveillance system. The most frequent were allergic reactions (9.2 per 100,000 doses). Few anaphylactic or neurologic reactions were reported (0.1 and 0.5 per 100,000 doses respectively). There were no reports of sequelae or of encephalopathy, meningitis or encephalitis. CONCLUSION: Meningococcal vaccines seem to be associated with fewer adverse events than have previously been reported. Existing surveillance programs are useful for determining the incidence of adverse events temporally associated with vaccines. PMID:8630839

  1. Putative adverse outcome pathways relevant to neurotoxicity

    PubMed Central

    Bal-Price, Anna; Crofton, Kevin M.; Sachana, Magdalini; Shafer, Timothy J.; Behl, Mamta; Forsby, Anna; Hargreaves, Alan; Landesmann, Brigitte; Lein, Pamela J.; Louisse, Jochem; Monnet-Tschudi, Florianne; Paini, Alicia; Rolaki, Alexandra; Schrattenholz, André; Suñol, Cristina; van Thriel, Christoph; Whelan, Maurice; Fritsche, Ellen

    2016-01-01

    The Adverse Outcome Pathway (AOP) framework provides a template that facilitates understanding of complex biological systems and the pathways of toxicity that result in adverse outcomes (AOs). The AOP starts with an molecular initiating event (MIE) in which a chemical interacts with a biological target(s), followed by a sequential series of KEs, which are cellular, anatomical, and/or functional changes in biological processes, that ultimately result in an AO manifest in individual organisms and populations. It has been developed as a tool for a knowledge-based safety assessment that relies on understanding mechanisms of toxicity, rather than simply observing its adverse outcome. A large number of cellular and molecular processes are known to be crucial to proper development and function of the central (CNS) and peripheral nervous systems (PNS). However, there are relatively few examples of well-documented pathways that include causally linked MIEs and KEs that result in adverse outcomes in the CNS or PNS. As a first step in applying the AOP framework to adverse health outcomes associated with exposure to exogenous neurotoxic substances, the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) organized a workshop (March 2013, Ispra, Italy) to identify potential AOPs relevant to neurotoxic and developmental neurotoxic outcomes. Although the AOPs outlined during the workshop are not fully described, they could serve as a basis for further, more detailed AOP development and evaluation that could be useful to support human health risk assessment in a variety of ways. PMID:25605028

  2. Adverse perinatal events associated with ART.

    PubMed

    Skora, Daniel; Frankfurter, David

    2012-04-01

    Since the advent of ART, much research has focused on the potential adverse for resultant harm. Prematurity, low birth-weight, PIH, congenital malformations, and CP are closely tied to multiple gestation. With the increase in elective single embryo transfer, there will be a reduction in adversity related to multiple birth. It is understood that underlying causes of infertility, including advanced maternal age, PCOS, thyroid disease, and uterine fibroids, predispose to adverse outcomes. However, imprinting abnormalities do not appear to stem from multiple births, and thus the need to consider the association between fertility treatment and methylation disorders remains essential. These, as well as risks of multi-fetal gestation, must be discussed with patients when considering using assisted reproduction.

  3. The role of models in estimating consequences as part of the risk assessment process.

    PubMed

    Forde-Folle, K; Mitchell, D; Zepeda, C

    2011-08-01

    The degree of disease risk represented by the introduction, spread, or establishment of one or several diseases through the importation of animals and animal products is assessed by importing countries through an analysis of risk. The components of a risk analysis include hazard identification, risk assessment, risk management, and risk communication. A risk assessment starts with identification of the hazard(s) and then continues with four interrelated steps: release assessment, exposure assessment, consequence assessment, and risk estimation. Risk assessments may be either qualitative or quantitative. This paper describes how, through the integration of epidemiological and economic models, the potential adverse biological and economic consequences of exposure can be quantified.

  4. [Photodegradation of chlorpromazine, a drug-related adverse event].

    PubMed

    Chabi, Yossounon; Brahim, Kheira; Da Costa, Maryline; Caffin, Anne-Gaëlle; Camus, Gisèle; Paillet, Michel; Bohand, Xavier

    2016-04-01

    The photodegradation of an active substance during treatment is a rare drug-related adverse event which can sometimes have serious consequences. Health professionals must be aware of the specific storage and administration instructions with regard to chlorpromazine and ensure that they are respected.

  5. [Analysis of Spontaneously Reported Adverse Events].

    PubMed

    Nakamura, Mitsuhiro

    2016-01-01

    Observational study is necessary for the evaluation of drug effectiveness in clinical practice. In recent years, the use of spontaneous reporting systems (SRS) for adverse drug reactions has increased and they have become an important resource for regulatory science. SRS, being the largest and most well-known databases worldwide, are one of the primary tools used for postmarketing surveillance and pharmacovigilance. To analyze SRS, the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report Database (JADER) are reviewed. Authorized pharmacovigilance algorithms were used for signal detection, including the reporting odds ratio. An SRS is a passive reporting database and is therefore subject to numerous sources of selection bias, including overreporting, underreporting, and a lack of a denominator. Despite the inherent limitations of spontaneous reporting, SRS databases are a rich resource and data mining index that provide powerful means of identifying potential associations between drugs and their adverse effects. Our results, which are based on the evaluation of SRS databases, provide essential knowledge that could improve our understanding of clinical issues.

  6. Early life adversity and/or posttraumatic stress disorder severity are associated with poor diet quality, including consumption of trans fatty acids, and fewer hours of resting or sleeping in a US middle-aged population: A cross-sectional and prospective study

    PubMed Central

    Gavrieli, Anna; Farr, Olivia M; Davis, Cynthia R; Crowell, Judith A; Mantzoros, Christos S.

    2015-01-01

    Background Early life adversity (ELA) and post-traumatic stress disorder (PTSD) are associated with poorer psychological and physical health. Potential underlying mechanisms and mediators remain to be elucidated, and the lifestyle habits and characteristics of individuals with ELA and/or PTSD have not been fully explored. We investigated whether the presence of ELA and/or PTSD are associated with nutrition, physical activity, resting and sleeping and smoking. Methods A cross-sectional sample of 151 males and females (age: 45.6±3.5 y, BMI: 30.0±7.1kg/m2) underwent anthropometric measurements, as well as detailed questionnaires for dietary assessment, physical activity, resting and sleeping, smoking habits and psychosocial assessments. A prospective follow-up visit of 49 individuals was performed 2.5 years later and the same outcomes were assessed. ELA and PTSD were evaluated as predictors, in addition to a variable assessing the combined presence/severity of ELA–PTSD. Data were analyzed using analysis of covariance after adjusting for several socioeconomic, psychosocial and anthropometric characteristics. Results Individuals with higher ELA or PTSD severity were found to have a poorer diet quality (DASH score: p=0.006 and p=0.003, respectively; aHEI-2010 score: ELA p=0.009), including further consumption of trans fatty acids (ELA p=0.003); the differences were significantly attenuated null after adjusting mainly for education or income and/or race. Further, individuals with higher ELA severity reported less hours of resting and sleeping (p=0.043) compared to those with zero/lower ELA severity, and the difference remained significant in the fully adjusted model indicating independence from potential confounders. When ELA and PTSD were combined, an additive effect was observed on resting and sleeping (p=0.001); results remained significant in the fully adjusted model. They also consumed more energy from trans fatty acids (p=0.017) tended to smoke more (p=0

  7. Biometrical issues in the analysis of adverse events within the benefit assessment of drugs.

    PubMed

    Bender, Ralf; Beckmann, Lars; Lange, Stefan

    2016-07-01

    The analysis of adverse events plays an important role in the benefit assessment of drugs. Consequently, results on adverse events are an integral part of reimbursement dossiers submitted by pharmaceutical companies to health policy decision-makers. Methods applied in the analysis of adverse events commonly include simple standard methods for contingency tables. However, the results produced may be misleading if observations are censored at the time of discontinuation due to treatment switching or noncompliance, resulting in unequal follow-up periods. In this paper, we present examples to show that the application of inadequate methods for the analysis of adverse events in the reimbursement dossier can lead to a downgrading of the evidence on a drug's benefit in the subsequent assessment, as greater harm from the drug cannot be excluded with sufficient certainty. Legal regulations on the benefit assessment of drugs in Germany are presented, in particular, with regard to the analysis of adverse events. Differences in safety considerations between the drug approval process and the benefit assessment are discussed. We show that the naive application of simple proportions in reimbursement dossiers frequently leads to uninterpretable results if observations are censored and the average follow-up periods differ between treatment groups. Likewise, the application of incidence rates may be misleading in the case of recurrent events and unequal follow-up periods. To allow for an appropriate benefit assessment of drugs, adequate survival time methods accounting for time dependencies and duration of follow-up are required, not only for time-to-event efficacy endpoints but also for adverse events. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd.

  8. Early-life Social Adversity and Developmental Processes in Nonhuman Primates

    PubMed Central

    French, Jeffrey A; Carp, Sarah B

    2015-01-01

    Most primate species produce offspring that are altricial and highly dependent upon caregivers. As a consequence, a host of developmental trajectories can be dramatically altered by variation in early experiences. We review the impact of early social experiences (in both experimental models and natural contexts) on developmental profiles in three species of nonhuman primates: marmosets, squirrel monkeys, and macaques. Graded exposure to early-life social adversity (ELSA) produces short- to long-term effects on multiple developmental outcomes, including affect, social behavior, cognitive and attentional processes, and in the neural substrates that underlie these sociobehavioral traits. PMID:26858971

  9. Consequence Prioritization Process for Potential High Consequence Events (HCE)

    SciTech Connect

    Freeman, Sarah G.

    2016-10-31

    This document describes the process for Consequence Prioritization, the first phase of the Consequence-Driven Cyber-Informed Engineering (CCE) framework. The primary goal of Consequence Prioritization is to identify potential disruptive events that would significantly inhibit an organization’s ability to provide the critical services and functions deemed fundamental to their business mission. These disruptive events, defined as High Consequence Events (HCE), include both events that have occurred or could be realized through an attack of critical infrastructure owner assets. While other efforts have been initiated to identify and mitigate disruptive events at the national security level, such as Presidential Policy Directive 41 (PPD-41), this process is intended to be used by individual organizations to evaluate events that fall below the threshold for a national security. Described another way, Consequence Prioritization considers threats greater than those addressable by standard cyber-hygiene and includes the consideration of events that go beyond a traditional continuity of operations (COOP) perspective. Finally, Consequence Prioritization is most successful when organizations adopt a multi-disciplinary approach, engaging both cyber security and engineering expertise, as in-depth engineering perspectives are required to recognize and characterize and mitigate HCEs. Figure 1 provides a high-level overview of the prioritization process.

  10. Adverse effects of the antimalaria drug, mefloquine: due to primary liver damage with secondary thyroid involvement?

    PubMed Central

    Croft, Ashley M; Herxheimer, Andrew

    2002-01-01

    Background Mefloquine is a clinically important antimalaria drug, which is often not well tolerated. We critically reviewed 516 published case reports of mefloquine adverse effects, to clarify the phenomenology of the harms associated with mefloquine, and to make recommendations for safer prescribing. Presentation We postulate that many of the adverse effects of mefloquine are a post-hepatic syndrome caused by primary liver damage. In some users we believe that symptomatic thyroid disturbance occurs, either independently or as a secondary consequence of the hepatocellular injury. The mefloquine syndrome presents in a variety of ways including headache, gastrointestinal disturbances, nervousness, fatigue, disorders of sleep, mood, memory and concentration, and occasionally frank psychosis. Previous liver or thyroid disease, and concurrent insults to the liver (such as from alcohol, dehydration, an oral contraceptive pill, recreational drugs, and other liver-damaging drugs) may be related to the development of severe or prolonged adverse reactions to mefloquine. Implications We believe that people with active liver or thyroid disease should not take mefloquine, whereas those with fully resolved neuropsychiatric illness may do so safely. Mefloquine users should avoid alcohol, recreational drugs, hormonal contraception and co-medications known to cause liver damage or thyroid damage. With these caveats, we believe that mefloquine may be safely prescribed in pregnancy, and also to occupational groups who carry out safety-critical tasks. Testing Mefloquine's adverse effects need to be investigated through a multicentre cohort study, with small controlled studies testing specific elements of the hypothesis. PMID:11914150

  11. Reverse Engineering Adverse Outcome Pathways

    SciTech Connect

    Perkins, Edward; Chipman, J.K.; Edwards, Stephen; Habib, Tanwir; Falciani, Francesco; Taylor, Ronald C.; Van Aggelen, Graham; Vulpe, Chris; Antczak, Philipp; Loguinov, Alexandre

    2011-01-30

    The toxicological effects of many stressors are mediated through unknown, or poorly characterized, mechanisms of action. We describe the application of reverse engineering complex interaction networks from high dimensional omics data (gene, protein, metabolic, signaling) to characterize adverse outcome pathways (AOPs) for chemicals that disrupt the hypothalamus-pituitary-gonadal endocrine axis in fathead minnows. Gene expression changes in fathead minnow ovaries in response to 7 different chemicals, over different times, doses, and in vivo versus in vitro conditions were captured in a large data set of 868 arrays. We examined potential AOPs of the antiandrogen flutamide using two mutual information theory methods, ARACNE and CLR to infer gene regulatory networks and potential adverse outcome pathways. Representative networks from these studies were used to predict a network path from stressor to adverse outcome as a candidate AOP. The relationship of individual chemicals to an adverse outcome can be determined by following perturbations through the network in response to chemical treatment leading to the nodes associated with the adverse outcome. Identification of candidate pathways allows for formation of testable hypotheses about key biologic processes, biomarkers or alternative endpoints, which could be used to monitor an adverse outcome pathway. Finally, we identify the unique challenges facing the application of this approach in ecotoxicology, and attempt to provide a road map for the utilization of these tools. Key Words: mechanism of action, toxicology, microarray, network inference

  12. The adverse health effects of chronic cannabis use.

    PubMed

    Hall, Wayne; Degenhardt, Louisa

    2014-01-01

    This paper summarizes the most probable of the adverse health effects of regular cannabis use sustained over years, as indicated by epidemiological studies that have established an association between cannabis use and adverse outcomes; ruled out reverse causation; and controlled for plausible alternative explanations. We have also focused on adverse outcomes for which there is good evidence of biological plausibility. The focus is on those adverse health effects of greatest potential public health significance--those that are most likely to occur and to affect a substantial proportion of regular cannabis users. These most probable adverse effects of regular use include a dependence syndrome, impaired respiratory function, cardiovascular disease, adverse effects on adolescent psychosocial development and mental health, and residual cognitive impairment.

  13. Introduction: consequences of terrorism.

    PubMed

    Noji, Eric K

    2003-01-01

    Recent acts of terrorism have ranged from the dissemination of anthrax spores to intentional contamination of food to the release of chemical weapons to suicide attacks using explosives. The prediction of such events is difficult, if not impossible. The recent attacks that have generated massive numbers of injured and dead may signal the crossing of a new threshold from multi-casualty events to the use of weapons of mass destruction. Consequently, the medical and healthcare infrastructure must be able to prevent and treat illness and injury resulting from such events. Thus, a first step in improving the preparation for and responses to such events must include a sustained commitment to training physicians, nurses, identification specialists, pathologists, and other first responders. The rapid spread of SARS gives reason to believe that the distribution of such agents has potential advantages over the use of other weapons. Investments in the public health and healthcare systems provide the best defense against terrorism.

  14. Adverse effects of glucocorticoids: coagulopathy.

    PubMed

    Coelho, Maria Caroline Alves; Santos, Camila Vicente; Vieira Neto, Leonardo; Gadelha, Mônica R

    2015-10-01

    Hypercortisolism is associated with various systemic manifestations, including central obesity, arterial hypertension, glucose intolerance/diabetes mellitus, dyslipidemia, nephrolithiasis, osteoporosis, gonadal dysfunction, susceptibility to infections, psychiatric disorders, and hypercoagulability. The activation of the hemostatic system contributes to the development of atherosclerosis and subsequent cardiovascular morbidity and mortality. Previous studies have identified an increased risk of both unprovoked and postoperative thromboembolic events in patients with endogenous and exogenous Cushing's syndrome (CS). The risk for postoperative venous thromboembolism in endogenous CS is comparable to the risk after total hip or knee replacement under short-term prophylaxis. The mechanisms that are involved in the thromboembolic complications in hypercortisolism include endothelial dysfunction, hypercoagulability, and stasis (Virchow's triad). It seems that at least two factors from Virchow's triad must be present for the occurrence of a thrombotic event in these patients. Most studies have demonstrated that this hypercoagulable state is explained by increased levels of procoagulant factors, mainly factors VIII, IX, and von Willebrand factor, and also by an impaired fibrinolytic capacity, which mainly results from an elevation in plasminogen activator inhibitor 1. Consequently, there is a shortening of activated partial thromboplastin time and increased thrombin generation. For these reasons, anticoagulant prophylaxis might be considered in patients with CS whenever they have concomitant prothrombotic risk factors. However, multicenter studies are needed to determine which patients will benefit from anticoagulant therapy and the dose and time of anticoagulation.

  15. Hyperinsulinemia adversely affects lung structure and function.

    PubMed

    Singh, Suchita; Bodas, Manish; Bhatraju, Naveen K; Pattnaik, Bijay; Gheware, Atish; Parameswaran, Praveen Kolumam; Thompson, Michael; Freeman, Michelle; Mabalirajan, Ulaganathan; Gosens, Reinoud; Ghosh, Balaram; Pabelick, Christina; Linneberg, Allan; Prakash, Y S; Agrawal, Anurag

    2016-05-01

    There is limited knowledge regarding the consequences of hyperinsulinemia on the lung. Given the increasing prevalence of obesity, insulin resistance, and epidemiological associations with asthma, this is a critical lacuna, more so with inhaled insulin on the horizon. Here, we demonstrate that insulin can adversely affect respiratory health. Insulin treatment (1 μg/ml) significantly (P < 0.05) increased the proliferation of primary human airway smooth muscle (ASM) cells and induced collagen release. Additionally, ASM cells showed a significant increase in calcium response and mitochondrial respiration upon insulin exposure. Mice administered intranasal insulin showed increased collagen deposition in the lungs as well as a significant increase in airway hyperresponsiveness. PI3K/Akt mediated activation of β-catenin, a positive regulator of epithelial-mesenchymal transition and fibrosis, was observed in the lungs of insulin-treated mice and lung cells. Our data suggests that hyperinsulinemia may have adverse effects on airway structure and function. Insulin-induced activation of β-catenin in lung tissue and the contractile effects on ASM cells may be causally related to the development of asthma-like phenotype.

  16. Physical and psychological consequences of weight gain.

    PubMed

    Kawachi, I

    1999-01-01

    Obesity and overweight are clearly associated with many serious conditions, including type II diabetes mellitus, hypertension, and coronary heart disease. Excess weight also increases the risk of death. Recent evidence suggests that weight gain itself, even if persons remain within the "normal" weight range, also increases the risk of medical illnesses and premature death. Persons who gain 5.0 to 7.9 kg (11 to 17.3 lb) as adults are 1.9 times more likely to develop type II diabetes mellitus and 1.25 times more likely to develop coronary heart disease than those who lose weight or maintain a stable weight after age 18 years. Gaining 11 to 20 kg (24.2 to 44 lb) or more in adulthood increases the risk of ischemic stroke 1.69 to 2.52 times. The relationship between weight gain and breast cancer has been difficult to study, primarily because postmenopausal hormone replacement therapy can mask the effect of weight gain on cancer risk. Accordingly, weight gain in adulthood has been associated with an increased risk of breast cancer only among women who have never used hormone replacement therapy. In addition to its adverse effects on disease outcomes, weight gain also impairs physical functioning, reduces quality of life, and is associated with poor mental health. These psychological and mental health consequences of weight gain can become an added burden for patients with schizophrenia and other mental disorders.

  17. Maternal adverse effects of different antenatal magnesium sulphate regimens for improving maternal and infant outcomes: a systematic review

    PubMed Central

    2013-01-01

    Background Antenatal magnesium sulphate, widely used in obstetrics to improve maternal and infant outcomes, may be associated with adverse effects for the mother sufficient for treatment cessation. This systematic review aimed to quantify maternal adverse effects attributed to treatment, assess how adverse effects vary according to different regimens, and explore women’s experiences with this treatment. Methods Bibliographic databases were searched from their inceptions to July 2012 for studies of any design that reported on maternal adverse effects associated with antenatal magnesium sulphate given to improve maternal or infant outcomes. Primary outcomes were life-threatening adverse effects of treatment (death, cardiac arrest, respiratory arrest). For randomised controlled trials, data were meta-analysed, and risk ratios (RR) pooled using fixed-effects or random-effects models. For non-randomised studies, data were tabulated by design, and presented as RR, odds ratios or percentages, and summarised narratively. Results A total of 143 publications were included (21 randomised trials, 15 non-randomised comparative studies, 32 case series and 75 reports of individual cases), of mixed methodological quality. Compared with placebo or no treatment, magnesium sulphate was not associated with an increased risk of maternal death, cardiac arrest or respiratory arrest. Magnesium sulphate significantly increased the risk of 'any adverse effects’ overall (RR 4.62, 95% CI 2.42-8.83; 4 trials, 13,322 women), and treatment cessation due to adverse effects (RR 2.77; 95% CI 2.32-3.30; 5 trials, 13,666 women). Few subgroup differences were observed (between indications for use and treatment regimens). In one trial, a lower dose regimen (2 g/3 hours) compared with a higher dose regimen (5 g/4 hours) significantly reduced treatment cessation (RR 0.05; 95% CI 0.01-0.39, 126 women). Adverse effect estimates from studies of other designs largely supported data from randomised

  18. Metabolic and adverse effects of diuretics.

    PubMed

    Wilcox, C S

    1999-11-01

    Diuretics are among the most frequently prescribed drugs. They enjoy a very high clinical reputation for safety and efficacy. However, more than 3 decades of clinical investigation have disclosed a number of abnormalities in fluid electrolyte handling, metabolism, and other adverse effects that can complicate therapy with diuretic drugs. Some of these complications are a direct extension of the wanted action of the drug. These include extracellular fluid volume depletion, associated orthostatic hypotension, and prerenal azotemia. Others are not a direct action of the diuretic, but can be explained as an intranephronal compensation to the diuretic action. These include hypokalemia, in part to increased potassium secretion secondary to the enhanced tubular fluid flow and aldosterone secretion induced by diuretic administration. Metabolic abnormalities are usually mild. Hyperglycemia and carbohydrate intolerance have been related to diuretic-induced hypokalemia, which inhibits insulin secretion by the beta cells, and reductions in extracellular fluid volume and cardiac output. This is compounded by increases in catecholamines from sympathetic nerve activity which decrease peripheral glucose utilization. A mild increase in serum cholesterol concentration is seen frequently during initiation of diuretic therapy, but during steady state therapy after 6 to 12 months, values usually return to baseline. Knowledge of the more common adverse effects induced by diuretics helps the physician in predicting patients at risk and taking effective steps to anticipate or treat adverse responses.

  19. Adverse events in 50 cats with allergic dermatitis receiving ciclosporin.

    PubMed

    Heinrich, Nicole A; McKeever, Patrick J; Eisenschenk, Melissa C

    2011-12-01

    Ciclosporin is an immunosuppressive drug that has been used to treat allergies and other immune-mediated diseases in cats, dogs and humans. Information about the adverse effects of ciclosporin in cats has been limited to smaller studies and case reports. Adverse effects in dogs are mainly gastrointestinal in nature, but humans can also experience hypertension and altered renal function. The aim of this retrospective case series study was to document the occurrence and clinical appearance of adverse events in cats receiving ciclosporin to treat allergic skin disease. The medical records of 50 cats with allergic dermatitis treated with oral ciclosporin (1.9-7.3 mg/kg/day) were reviewed. Adverse events occurred in 66% (33 cats). Adverse events likely to be associated with ciclosporin included the following: vomiting or diarrhoea within 1-8 weeks of receiving ciclosporin (24%), weight loss (16%), anorexia and subsequent hepatic lipidosis (2%) and gingival hyperplasia (2%). Other adverse events less likely to be associated with ciclosporin therapy included the following: weight gain (14%), dental tartar and gingivitis (10%), otitis (4%), chronic diarrhoea (4%), inflammatory bowel disease with indolent gastrointestinal lymphoma (2%), urinary tract infection (2%), cataract (2%), elevated liver enzymes (2%), hyperthyroidism and renal failure (2%) and transient inappropriate urination (2%). Some cats experienced multiple adverse events. Case-control studies are needed to prove cause and effect of ciclosporin with regard to these adverse events.

  20. Recurrent adverse pregnancy outcome and antiphospholipid antibodies.

    PubMed

    Reece, E A; Gabrielli, S; Cullen, M T; Zheng, X Z; Hobbins, J C; Harris, E N

    1990-07-01

    Antiphospholipid antibodies, which include lupus-like anticoagulant and anticardiolipin antibody, have been linked to a number of adverse pregnancy outcomes, although their exact pathogenic mechanisms remain poorly defined. The relative risk of complications such as intrauterine growth retardation, spontaneous abortions, and stillbirth in patients with antiphospholipid antibodies also remains undetermined. Heightened attention has been focused on the association, leading to investigations into the pathogenesis. Uncontrolled studies have also explored therapeutic regimens such as aspirin, steroids, and heparin, and clinical trials have used various treatment protocols. Although knowledge into the association of antiphospholipid antibodies and recurrent adverse pregnancy outcome is limited and continues to evolve, this association provides new insights into the disease and offers promise for pharmacologic prophylaxis. In this article, current concepts on pathogenesis, diagnosis, and therapy are reviewed and recommendations are made for clinical care of these patients.

  1. Humanitarian Consequences of Land Mines.

    ERIC Educational Resources Information Center

    Rutherford, Ken

    1997-01-01

    Investigates the human and economic consequences of the continuing use and abandonment of land mines. Discusses the reasons for the worldwide proliferation (over 85 million uncleared mines in at least 62 countries) and the legal complexities in curtailing their use. Includes a brief account by a land-mine victim. (MJP)

  2. Adverse Childhood Experiences and Hallucinations

    ERIC Educational Resources Information Center

    Whitfield, C.L.; Dube, S.R.; Felitti, V.J.; Anda, R.F.

    2005-01-01

    Objective:: Little information is available about the contribution of multiple adverse childhood experiences (ACEs) to the likelihood of reporting hallucinations. We used data from the ACE study to assess this relationship. Methods:: We conducted a survey about childhood abuse and household dysfunction while growing up, with questions about health…

  3. Adverse ocular reactions to drugs.

    PubMed Central

    Spiteri, M. A.; James, D. G.

    1983-01-01

    Drugs acting on various parts of the body may also affect the eye insidiously. Increased awareness of such drug toxicity by the prescribing doctor should encourage him to consider effects on the cornea, lens, retina, optic nerve and elsewhere when checking the patient's progress. The following review concerns adverse ocular effects of systemic drug administration. PMID:6356101

  4. Urbanicity, social adversity and psychosis

    PubMed Central

    Heinz, Andreas; Deserno, Lorenz; Reininghaus, Ulrich

    2013-01-01

    In recent years, there has been increasing interest in research on geographical variation in the incidence of schizophrenia and other psychoses. In this paper, we review the evidence on variation in incidence of schizophrenia and other psychoses in terms of place, as well as the individual- and area-level factors that account for this variation. We further review findings on potential mechanisms that link adverse urban environment and psychosis. There is evidence from earlier and more recent studies that urbanicity is associated with an increased incidence of schizophrenia and non-affective psychosis. In addition, considerable variation in incidence across neighbourhoods has been observed for these disorders. Findings suggest it is unlikely that social drift alone can fully account for geographical variation in incidence. Evidence further suggests that the impact of adverse social contexts – indexed by area-level exposures such as population density, social fragmentation and deprivation – on risk of psychosis is explained (confounding) or modified (interaction) by environmental exposures at the individual level (i.e., cannabis use, social adversity, exclusion and discrimination). On a neurobiological level, several studies suggest a close link between social adversity, isolation and stress on the one hand, and monoamine dysfunction on the other, which resembles findings in schizophrenia patients. However, studies directly assessing correlations between urban stress or discrimination and neurobiological alterations in schizophrenia are lacking to date. PMID:24096775

  5. Reverse engineering adverse outcome pathways.

    PubMed

    Perkins, Edward J; Chipman, J Kevin; Edwards, Stephen; Habib, Tanwir; Falciani, Francesco; Taylor, Ronald; Van Aggelen, Graham; Vulpe, Chris; Antczak, Philipp; Loguinov, Alexandre

    2011-01-01

    The toxicological effects of many stressors are mediated through unknown, or incompletely characterized, mechanisms of action. The application of reverse engineering complex interaction networks from high dimensional omics data (gene, protein, metabolic, signaling) can be used to overcome these limitations. This approach was used to characterize adverse outcome pathways (AOPs) for chemicals that disrupt the hypothalamus-pituitary-gonadal endocrine axis in fathead minnows (FHM, Pimephales promelas). Gene expression changes in FHM ovaries in response to seven different chemicals, over different times, doses, and in vivo versus in vitro conditions, were captured in a large data set of 868 arrays. Potential AOPs of the antiandrogen flutamide were examined using two mutual information-based methods to infer gene regulatory networks and potential AOPs. Representative networks from these studies were used to predict network paths from stressor to adverse outcome as candidate AOPs. The relationship of individual chemicals to an adverse outcome can be determined by following perturbations through the network in response to chemical treatment, thus leading to the nodes associated with the adverse outcome. Identification of candidate pathways allows for formation of testable hypotheses about key biological processes, biomarkers, or alternative endpoints that can be used to monitor an AOP. Finally, the unique challenges facing the application of this approach in ecotoxicology were identified and a road map for the utilization of these tools presented.

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

    PubMed

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

    2016-09-01

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

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

    PubMed Central

    2016-01-01

    We conducted pharmacovigilance data mining for a β-lactam antibiotics, amoxicillin, and compare the adverse events (AEs) with the drug labels of 9 countries including Korea, USA, UK, Japan, Germany, Swiss, Italy, France, and Laos. We used the Korea Adverse Event Reporting System (KAERS) database, a nationwide database of AE reports, between December 1988 and June 2014. Frequentist and Bayesian methods were used to calculate disproportionality distribution of drug-AE pairs. The AE which was detected by all the three indices of proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was defined as a signal. The KAERS database contained a total of 807,582 AE reports, among which 1,722 reports were attributed to amoxicillin. Among the 192,510 antibiotics-AE pairs, the number of amoxicillin-AE pairs was 2,913. Among 241 AEs, 52 adverse events were detected as amoxicillin signals. Comparing the drug labels of 9 countries, 12 adverse events including ineffective medicine, bronchitis, rhinitis, sinusitis, dry mouth, gastroesophageal reflux, hypercholesterolemia, gastric carcinoma, abnormal crying, induration, pulmonary carcinoma, and influenza-like symptoms were not listed on any of the labels of nine countries. In conclusion, we detected 12 new signals of amoxicillin which were not listed on the labels of 9 countries. Therefore, it should be followed by signal evaluation including causal association, clinical significance, and preventability. PMID:27510377

  8. Systematic Review: Adverse Events of Fecal Microbiota Transplantation

    PubMed Central

    Wang, Weiqiang; Cao, Xiaocang; Piao, Meiyu; Khan, Samiullah; Yan, Fang; Cao, Hailong; Wang, Bangmao

    2016-01-01

    Background Fecal microbiota transplantation (FMT) is a microbiota-based therapy that shows therapeutic potential in recurrent or refractory Clostridium difficile infections and other intestinal or extra-intestinal disorders. Nonetheless, adverse events (AEs) remain a major challenge in the application of FMT. Aim To review the AEs of FMT and to address the concerns of safety during the procedure. Methods Publications were retrieved in the databases of Medline, Embase and Cochrane Library. AEs were classified according to their causality with FMT or their severity. Results A total of 7562 original articles about FMT were identified in this study, 50 of them fulfilled the inclusion criteria. Totally 78 kinds of AEs were revealed enrolled in these 50 selected publications. The total incidence rate of AEs was 28.5%. Among the 42 publications, 5 kinds were definitely and 38 kinds were probably related to FMT. The commonest FMT-attributable AE was abdominal discomfort, which was reported in 19 publications. For upper gastrointestinal routes of FMT, 43.6% (89/204) patients were compromised by FMT-attributable AE, while the incidence dropped to 17.7% (76/430) for lower gastrointestinal routes. In contrast, the incidences of serious adverse events (SAEs) were 2.0% (4/196) and 6.1% (40/659) for upper and lower gastrointestinal routes, respectively. A total of 44 kinds of SAEs occurred in 9.2% patients, including death (3.5%, 38/1089), infection (2.5%, 27/1089), relapse of inflammatory bowel diseases (0.6%, 7/1089) and Clostridium difficile infection (0.9%, 10/1089). Conclusion Consequently, both AEs and SAEs are not rare and should be carefully monitored throughout FMT. However, high quality randomized controlled trials are still needed for the more definite incidence of AEs of FMT. PMID:27529553

  9. Adverse outcome pathway (AOP) development II: Best practices

    EPA Science Inventory

    Organization of existing and emerging toxicological knowledge into adverse outcome pathway (AOP) descriptions can facilitate greater application of mechanistic data, including high throughput in vitro, high content omics and imaging, and biomarkers, in risk-based decision-making....

  10. [Adverse drug effects in the community pharmacy].

    PubMed

    Arnet, Isabelle; Seidling, Hanna M; Hersberger, Kurt E

    2015-12-01

    Community pharmacists represent an important pillar for the identification and the reporting of adverse drug effects (ADE}. Thanks to their broad view on the pharmacotherapy, over-the-counter medication included, they contribute greatly to the improvement of drug safety. In principle, the community pharmacy will face three groups of ADE which require specific attention. This article deals with these specific ADE groups and presents some illustrative examples from daily practice. Furthermore, we suggest some solutions to identify potential relevant interactions - including herbal-drug interactions - and give tips for daily practice, along with some often overseen cutaneous ADE.

  11. Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions

    PubMed Central

    Suh, JinUk; Yang, MyungSuk; Kang, WonKu; Kim, EunYoung

    2015-01-01

    Objective We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions. Methods Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary’s teaching hospital, Daejeon, Korea) from 2010–2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton’s preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed. Results Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization–Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001). Conclusions We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse

  12. Adverse health effects of non-medical cannabis use.

    PubMed

    Hall, Wayne; Degenhardt, Louisa

    2009-10-17

    For over two decades, cannabis, commonly known as marijuana, has been the most widely used illicit drug by young people in high-income countries, and has recently become popular on a global scale. Epidemiological research during the past 10 years suggests that regular use of cannabis during adolescence and into adulthood can have adverse effects. Epidemiological, clinical, and laboratory studies have established an association between cannabis use and adverse outcomes. We focus on adverse health effects of greatest potential public health interest-that is, those that are most likely to occur and to affect a large number of cannabis users. The most probable adverse effects include a dependence syndrome, increased risk of motor vehicle crashes, impaired respiratory function, cardiovascular disease, and adverse effects of regular use on adolescent psychosocial development and mental health.

  13. Seismic Consequence Abstraction

    SciTech Connect

    M. Gross

    2004-10-25

    The primary purpose of this model report is to develop abstractions for the response of engineered barrier system (EBS) components to seismic hazards at a geologic repository at Yucca Mountain, Nevada, and to define the methodology for using these abstractions in a seismic scenario class for the Total System Performance Assessment - License Application (TSPA-LA). A secondary purpose of this model report is to provide information for criticality studies related to seismic hazards. The seismic hazards addressed herein are vibratory ground motion, fault displacement, and rockfall due to ground motion. The EBS components are the drip shield, the waste package, and the fuel cladding. The requirements for development of the abstractions and the associated algorithms for the seismic scenario class are defined in ''Technical Work Plan For: Regulatory Integration Modeling of Drift Degradation, Waste Package and Drip Shield Vibratory Motion and Seismic Consequences'' (BSC 2004 [DIRS 171520]). The development of these abstractions will provide a more complete representation of flow into and transport from the EBS under disruptive events. The results from this development will also address portions of integrated subissue ENG2, Mechanical Disruption of Engineered Barriers, including the acceptance criteria for this subissue defined in Section 2.2.1.3.2.3 of the ''Yucca Mountain Review Plan, Final Report'' (NRC 2003 [DIRS 163274]).

  14. The Role of Adverse Childhood Experiences in Cardiovascular Disease Risk: a Review with Emphasis on Plausible Mechanisms

    PubMed Central

    Su, Shaoyong; Jimenez, Marcia P.; Roberts, Cole T. F.; Loucks, Eric B.

    2016-01-01

    Childhood adversity, characterized by abuse, neglect, and household dysfunction, is a problem that exerts a significant impact on individuals, families, and society. Growing evidence suggests that adverse childhood experiences (ACEs) are associated with health decline in adulthood, including cardiovascular disease (CVD). In the current review, we first provide an overview of the association between ACEs and CVD risk, with updates on the latest epidemiological evidence. Second, we briefly review plausible pathways by which ACEs could influence CVD risk, including traditional risk factors and novel mechanisms. Finally, we highlight the potential implications of ACEs in clinical and public health. Information gleaned from this review should help physicians and researchers in better understanding potential long-term consequences of ACEs and considering adapting current strategies in treatment or intervention for patients with ACEs. PMID:26289252

  15. 25 CFR 170.110 - How can State and local governments prevent discrimination or adverse impacts?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and adverse effects on tribes and Native American populations. (b) Examples of adverse effects include... excessive access to culturally or religiously sensitive areas; (3) Negatively affecting natural resources, trust resources, tribal businesses, religious, and cultural sites; (4) Harming indigenous plants...

  16. Serious Adverse Events After Cataract Surgery

    PubMed Central

    Stein, Joshua D.

    2013-01-01

    Purpose Over the past several decades there have been many advances in the equipment, instrumentation and techniques of performing cataract surgery. This review will address the impact of these advances on the safety profile of cataract surgery. Recent Findings Recent studies have demonstrated a decline in the risk of serious postoperative adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) following cataract surgery. Factors that increase the risk of serious complications from cataract surgery include patient-related factors (male sex, concomitant diabetic retinopathy, same day cataract surgery combined with another intraocular surgery, tamsulosin use) and surgeon-related factors (low surgical volume, limited experience, operating on patients who are most prone to adverse events). Summary Cataract surgery continues to be a very safe surgical procedure with few patients experiencing serious sight-threatening adverse events. Studies in the literature have helped surgeons identify patients who are at high risk for surgical complications and to develop strategies to limit surgical complications when operating on these patients. As multifocal intraocular lenses, femtosecond laser technology, and other surgical innovations continue to gain popularity, it will be interesting in the coming years to determine whether there will be a continued reduction in complications of cataract surgery. PMID:22450221

  17. Statin-Associated Muscle Adverse Events

    PubMed Central

    Al-Mohaissen, Maha A.; Ignaszewski, Martha J.; Frohlich, Jiri; Ignaszewski, Andrew P.

    2016-01-01

    Statins are potent medications which reduce low-density lipoprotein cholesterol (LDL-C) levels. Their efficacy in cardiovascular risk reduction is well established and indications for their use are expanding. While statins are generally well tolerated and safe, adverse events are relatively common, particularly statin-associated muscle adverse events (SaMAEs), which are the most frequently encountered type of adverse event. Recent guidelines and guideline updates on SaMAEs and statin intolerance have included revised definitions of SaMAEs, incorporating new evidence on their pathogenesis and management. As SaMAEs emerge as a therapeutic challenge, it is important for physicians to be aware of updates on management strategies to ensure better patient outcomes. The majority of patients who are considered statin-intolerant can nevertheless tolerate some forms of statin therapy and successfully achieve optimal LDL-C levels. This review article discusses the recent classification of SaMAEs with emphasis on pathogenesis and management strategies. PMID:28003885

  18. Neuropsychiatric Adverse Effects of Amphetamine and Methamphetamine.

    PubMed

    Harro, Jaanus

    2015-01-01

    Administration of amphetamine and methamphetamine can elicit psychiatric adverse effects at acute administration, binge use, withdrawal, and chronic use. Most troublesome of these are psychotic states and aggressive behavior, but a large variety of undesirable changes in cognition and affect can be induced. Adverse effects occur more frequently with higher dosages and long-term use. They can subside over time but some persist long-term. Multiple alterations in the gray and white matter of the brain assessed as changes in tissue volume or metabolism, or at molecular level, have been associated with amphetamine and methamphetamine use and the psychiatric adverse effects, but further studies are required to clarify their causal role, specificity, and relationship with preceding states and traits and comorbidities. The latter include other substance use disorders, mood and anxiety disorders, attention deficit hyperactivity disorder, and antisocial personality disorder. Amphetamine- and methamphetamine-related psychosis is similar to schizophrenia in terms of symptomatology and pathogenesis, and these two disorders share predisposing genetic factors.

  19. [Finasteride adverse effects: An update].

    PubMed

    Carreño-Orellana, Néstor; Moll-Manzur, Catherina; Carrasco-Zuber, Juan Eduardo; Álvarez-Véliz, Sergio; Berroeta-Mauriziano, Daniela; Porras-Kusmanic, Ninoska

    2016-12-01

    Finasteride is a 5-α reductase inhibitor that is widely used in the management of benign prostate hyperplasia and male pattern hair loss. It is well known that these agents improve the quality of life in men suffering from these conditions. However, they are associated with some transient and even permanent adverse effects. The aim of this article is to clarify the controversies about the safety of finasteride by analyzing the evidence available in the literature.

  20. [Pain as adverse drug reaction].

    PubMed

    Böhmdorfer, Birgit; Schaffarzick, Daniel; Nagano, Marietta; Janowitz, Susanne Melitta; Schweitzer, Ekkehard

    2012-09-01

    We present a multidisciplinary (anaesthesiology--clinical pharmacy--bioinformatics) analysis of pain as possible adverse drug reaction taking different manifestations of pain, indication groups, relevance to the Austrian drug market and possible mechanistic influence of drugs on development and apprehension of pain into consideration.We designed an overview that shows how transmitters that play a part in nociception and antinociception can be influenced by drugs. This allows conclusions to the dolorigene potential of therapeutics.

  1. Adverse food-drug interactions.

    PubMed

    de Boer, Alie; van Hunsel, Florence; Bast, Aalt

    2015-12-01

    Food supplements and herbal products are increasingly popular amongst consumers. This leads to increased risks of interactions between prescribed drugs and these products containing bioactive ingredients. From 1991 up to 2014, 55 cases of suspected adverse drug reactions due to concomitant intake of health-enhancing products and drugs were reported to Lareb, the Netherlands Pharmacovigilance Centre. An overview of these suspected interactions is presented and their potential mechanisms of action are described. Mainly during the metabolism of xenobiotics and due to the pharmacodynamics effects interactions seem to occur, which may result in adverse drug reactions. Where legislation is seen to distinct food and medicine, legislation concerning these different bioactive products is less clear-cut. This can only be resolved by increasing the molecular knowledge on bioactive substances and their potential interactions. Thereby potential interactions can be better understood and prevented on an individual level. By considering the dietary pattern and use of bioactive substances with prescribed medication, both health professionals and consumers will be increasingly aware of interactions and these interactive adverse effects can be prevented.

  2. Childhood Adversity Among Institutionalized Male Juvenile Offenders and Other High-Risk Groups Without Offense Records in Portugal.

    PubMed

    Pinto, Ricardo José; Fernandes, Ana Isabel; Mesquita, Cristina; Maia, Ângela Costa

    2015-01-01

    The literature has shown that delinquent adolescents report high rates of childhood adversity and family dysfunction. However, it is important to know both the degree of adversity among delinquent adolescents in comparison with other high-risk samples and the contribution of each single form of adversity to this comparison. The purpose of this study was to evaluate childhood adversity, psychopathology, and risk behaviors among 4 high-risk groups, including incarcerated delinquent youths. The participants were 120 male youths between 13 and 19 years old (M = 16.18, SD = 1.26), including 30 youths who were arrested and held in detention centers as a consequence of violent crimes; 30 youths who were identified by Child Protective Services (CPS) and remained with their families; 30 youths who were identified by CPS, removed from their homes, and placed in child and youth residential care; and 30 youths who were randomly selected from schools. The incarcerated youths reported significantly more adversity, global psychopathology, and global index of risk behaviors. When considering each risk behavior, the incarcerated youths reported higher percentages of alcohol abuse, drug use, early smoking initiation, physical assault, carrying weapons, early initiation of sexual intercourse, sexual intercourse under the influence of drugs, and sexual intercourse without condom use. The logistic regression analyses showed that only emotional neglect was significantly associated with delinquency. This study suggests that delinquent youths are exposed to a great magnitude of adversities in childhood, with emotional neglect as an independent risk factor for delinquency. In addition, these youths have higher rates of psychopathology and risk behaviors compared to other high-risk samples.

  3. Stochastic Consequence Analysis for Waste Leaks

    SciTech Connect

    HEY, B.E.

    2000-05-31

    This analysis evaluates the radiological consequences of potential Hanford Tank Farm waste transfer leaks. These include ex-tank leaks into structures, underneath the soil, and exposed to the atmosphere. It also includes potential misroutes, tank overflow

  4. Health consequences of shift work and implications for structural design.

    PubMed

    Figueiro, M G; White, R D

    2013-04-01

    The objective of the study was to perform a literature review on the health consequences of working rotating shifts and implications for structural design. A literature search was performed in June 2012 and a selection of the most relevant peer-review articles was included in the present review. Shift workers are more likely to suffer from a circadian sleep disorder characterized by sleepiness and insomnia. Shift work is associated with decreased productivity, impaired safety, diminished quality of life and adverse effects on health. Circadian disruption resulting from rotating shift work has also been associated with increased risk for metabolic syndrome, diabetes, cardiovascular disease and cancer. This article summarizes the known health effects of shift work and discusses how light can be used as a countermeasure to minimize circadian disruption at night while maintaining alertness. In the context of the lighted environment, implications for the design of newborn intensive care units are also discussed.

  5. "Diabetes Has Instant Consequences..."

    MedlinePlus

    ... turn Javascript on. Feature: Diabetes Stories "Diabetes has instant consequences…" Past Issues / Fall 2009 Table of Contents ... want to chuck it all. But Diabetes has instant consequences. You learn to be responsible pretty quickly, ...

  6. Rare and very rare adverse effects of clozapine

    PubMed Central

    De Fazio, Pasquale; Gaetano, Raffaele; Caroleo, Mariarita; Cerminara, Gregorio; Maida, Francesca; Bruno, Antonio; Muscatello, Maria Rosaria; Moreno, Maria Jose Jaén; Russo, Emilio; Segura-García, Cristina

    2015-01-01

    Clozapine (CLZ) is the drug of choice for the treatment of resistant schizophrenia; however, its suitable use is limited by the complex adverse effects’ profile. The best-described adverse effects in the literature are represented by agranulocytosis, myocarditis, sedation, weight gain, hypotension, and drooling; nevertheless, there are other known adverse effects that psychiatrists should readily recognize and manage. This review covers the “rare” and “very rare” known adverse effects of CLZ, which have been accurately described in literature. An extensive search on the basis of predefined criteria was made using CLZ and its combination with adverse effects as keywords in electronic databases. Data show the association between the use of CLZ and uncommon adverse effects, including ischemic colitis, paralytic ileus, hematemesis, gastroesophageal reflux disease, priapism, urinary incontinence, pityriasis rosea, intertriginous erythema, pulmonary thromboembolism, pseudo-pheochromocytoma, periorbital edema, and parotitis, which are influenced by other variables including age, early diagnosis, and previous/current pharmacological therapies. Some of these adverse effects, although unpredictable, are often manageable if promptly recognized and treated. Others are serious and potentially life-threatening. However, an adequate knowledge of the drug, clinical vigilance, and rapid intervention can drastically reduce the morbidity and mortality related to CLZ treatment. PMID:26273202

  7. Statin safety: an appraisal from the adverse event reporting system.

    PubMed

    Davidson, Michael H; Clark, John A; Glass, Lucas M; Kanumalla, Anju

    2006-04-17

    The adverse event (AE) profiles of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) agents are of great interest, in particular the most recently approved statin, rosuvastatin. The forwarding of reports of AEs has been shown to be influenced by several reporting biases, including secular trend, the new drug reporting effect, product withdrawals, and publicity. Comparative assessments that use AE reporting rates are difficult to interpret under these circumstances, because such effects can themselves lead to marked increases in AE reporting. Consequently, many comparative reporting rate analyses are best carried out in conjunction with other metrics that put reporting burden into context, such as report proportion. All-AE reporting rates showed a temporal profile that resembled those of other statins when marketing cycle and secular trend were taken into account. A before-and-after cerivastatin withdrawal comparison showed a substantial increase in the reporting of AEs of interest for the statin class overall. Report proportion analyses indicated that the burden of rosuvastatin-associated AEs was similar to that for other statin agents. Analyses of monthly reporting rates showed that the reporting of rosuvastatin-associated rhabdomyolysis and renal failure have increased following AE-specific mass media publicity. Postrosuvastatin AE reporting patterns were comparable to those seen with other statins and did not resemble cerivastatin.

  8. Duration of Internet use and adverse psychosocial effects among European adolescents.

    PubMed

    Secades-Villa, Roberto; Calafat, Amador; Fernández-Hermida, José Ramón; Juan, Montse; Duch, Mariangels; Skärstrand, Eva; Becoña, Elisardo; Talic, Sanela

    2014-01-01

    Despite the significant contributions from previous studies about the prevalence of problematic Internet use (PIU) among adolescents in Europe, important questions remain regarding adverse consequences of PIU. This study aims to assess the relation between duration of Internet use and adverse psychosocial effects among adolescents from six European countries. The final sample included 7,351 adolescents (50.8% male and 49.2% female; mean age: 14.6±1.90) recruited from randomly selected schools within the six study sites. Results showed that 12.9% of adolescents used Internet more than 20 hours per week. There was a significant relationship between duration of Internet use and frequency of alcohol, tobacco, cannabis and other illegal drug use. Duration of Internet use is also significantly associated with school problems, with use of slot machines and with other psychosocial problems. These findings highlight the need to strengthen preventive efforts for reducing PIU and related consequences among adolescents. Key Words: Internet, adolescents, psychosocial problems.

  9. Understanding adverse events: human factors.

    PubMed Central

    Reason, J

    1995-01-01

    (1) Human rather than technical failures now represent the greatest threat to complex and potentially hazardous systems. This includes healthcare systems. (2) Managing the human risks will never be 100% effective. Human fallibility can be moderated, but it cannot be eliminated. (3) Different error types have different underlying mechanisms, occur in different parts of the organisation, and require different methods of risk management. The basic distinctions are between: Slips, lapses, trips, and fumbles (execution failures) and mistakes (planning or problem solving failures). Mistakes are divided into rule based mistakes and knowledge based mistakes. Errors (information-handling problems) and violations (motivational problems) Active versus latent failures. Active failures are committed by those in direct contact with the patient, latent failures arise in organisational and managerial spheres and their adverse effects may take a long time to become evident. (4) Safety significant errors occur at all levels of the system, not just at the sharp end. Decisions made in the upper echelons of the organisation create the conditions in the workplace that subsequently promote individual errors and violations. Latent failures are present long before an accident and are hence prime candidates for principled risk management. (5) Measures that involve sanctions and exhortations (that is, moralistic measures directed to those at the sharp end) have only very limited effectiveness, especially so in the case of highly trained professionals. (6) Human factors problems are a product of a chain of causes in which the individual psychological factors (that is, momentary inattention, forgetting, etc) are the last and least manageable links. Attentional "capture" (preoccupation or distraction) is a necessary condition for the commission of slips and lapses. Yet, its occurrence is almost impossible to predict or control effectively. The same is true of the factors associated with

  10. Association Patterns in Open Data to Explore Ciprofloxacin Adverse Events

    PubMed Central

    2015-01-01

    Summary Background Ciprofloxacin is one of the main drugs to treat bacterial infections. Bacterial infections can lead to high morbidity, mortality, and costs of treatment in the world. In this study, an analysis was conducted using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database on the adverse events of ciprofloxacin. Objectives The aim of this study was to explore unknown associations among the adverse events of ciprofloxacin, patient demographics and adverse event outcomes. Methods A search of FDA AERS reports was performed and some statistics was highlighted. The most frequent adverse events and event outcomes of ciprofloxacin were listed, age and gender specific distribution of adverse events are reported, then the apriori algorithm was applied to the dataset to obtain some association rules and objective measures were used to select interesting ones. Furthermore, the results were compared against classical data mining algorithms and discussed. Results The search resulted in 6 531 reports. The reports included within the dataset consist of 3 585 (55.8%) female and 2 884 (44.1%) male patients. The mean age of patients is 54.59 years. Preschool child, middle aged and aged groups have most adverse events reports in all groups. Pyrexia has the highest frequency with ciprofloxacin, followed by pain, diarrhoea, and anxiety in this order and the most frequent adverse event outcome is hospitalization. Age and gender based differences in the events in patients were found. In addition, some of the interesting associations obtained from the Apriori algorithm include not only psychiatric disorders but specifically their manifestation in specific gender groups. Conclusions The FDA AERS offers an important data resource to identify new or unknown adverse events of drugs in the biomedical domain. The results that were obtained in this study can provide valuable information for medical researchers and decision makers at the

  11. [Statin-induced adverse effects -- facts and genes].

    PubMed

    Harangi, Mariann; Zsíros, Noémi; Juhász, Lilla; Paragh, György

    2013-01-20

    Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients.

  12. Adverse responses to local anaesthetics.

    PubMed

    Fisher, M M; Graham, R

    1984-11-01

    Progressive challenge was used to investigate twenty-seven patients with a history of an adverse response to local anaesthesia. True allergy was detected in only one patient. The method does not exclude reactions to additives and preservatives in local anaesthetics. If preservative-free local anaesthetics are used for subsequent exposure in patients with no response to progressive challenge, subsequent exposure is safe. The possibility that some of these patients may be reacting to preservatives in the solutions cannot be excluded by such testing. Where possible preservative-free local anaesthetic preparations should be used for subsequent anaesthesia.

  13. Adverse Outcomes in Group Psychotherapy

    PubMed Central

    Roback, Howard B.

    2000-01-01

    Group forms of therapy have been growing at a rapid rate, in part because of their documented effectiveness and economic considerations such as managed care. It is therefore becoming increasingly important to assess the psychological risks of these interventions. The author provides an overview of the published literature and conference presentations on negative effects in adult outpatient groups. Although much of the literature on adverse outcomes in group therapy focuses on single risk factors (e.g., negative leader, group process, or patient characteristics), the author argues that an interactional model should be encouraged. Means of reducing casualties are also discussed, as well as methodological issues and research directions. PMID:10896735

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

    PubMed Central

    Vural, Fisun; Ciftci, Seval; Vural, Birol

    2015-01-01

    OBJECTIVE: With the use of any drug comes the possibility of unintended consequences which when harmful are referred to as adverse drug reactions (ADRs). The development of national pharmacovigilance systems is the responsibility of all health workers. The aim of this study was to investigate the knowledge of nurses about pharmacovigilance and attitudes about ADR and adverse event reporting. METHODS: This descriptive-cross sectional study was performed in 112 nurses working in a public hospital. The questionnaire was applied about pharmacovigilance and adverse drug reactions. The knowledge, attitudes and practices about adverse drug reactions were asked. RESULTS: The 74.1% of the nurses definition of “severe adverse effect” of drug therapy. The ratio of participants who knew that ADRs are reported to contact person responsible from pharmacovigilance was 34.9%. Although 70.5% of nurses knew the necessity of ADR reporting, the 8% of the nurses knew Turkish Pharmacovigilance Center (TÜFAM). Only 8% of nurses reported ADRs in their professionality. CONCLUSION: Although most of the participants knew the importance of ADR event reporting, event reporting was low. Thiese results showed that there is a lack of knowledge about pharmacovigilance. Futher studies with different settings and healthcare staff are needed to improve awareness about pharmacovigilance. PMID:28058321

  15. Adverse Events of Auricular Therapy: A Systematic Review

    PubMed Central

    Molassiotis, Alexander; Wang, Tao; Suen, Lorna K. P.

    2014-01-01

    The aim of this study was to systematically evaluate the literature on adverse events associated with auricular therapy (AT). Case reports, case series, surveys, and all types of clinical trials reporting adverse events of AT were included. Relevant articles were mainly retrieved from 13 electronic databases and seven Chinese journals on complementary medicine. AT-related adverse events were reported in 32 randomized controlled trials, five uncontrolled clinical trials, four case reports, and two controlled clinical trials. For auricular acupuncture, the most frequently reported adverse events were tenderness or pain at insertion, dizziness, local discomfort, minor bleeding and nausea, and so forth. For auricular acupressure, local skin irritation and discomfort, mild tenderness or pain, and dizziness were commonly reported. Skin irritation, local discomfort, and pain were detected in auricular electroacupuncture, and minor infection was identified in auricular bloodletting therapy. Most of these events were transient, mild, and tolerable, and no serious adverse events were identified. Our findings provide preliminary evidence that AT is a relatively safe approach. Considering the patient's safety, prospective or retrospective surveys are needed in future research to gather practitioner-reported and patient-reported adverse events on AT, and the quality of adverse events reporting in future AT trials should be improved. PMID:25435890

  16. The Consequences of Feminization in Breeding Groups of Wild Fish

    PubMed Central

    Harris, Catherine A.; Hamilton, Patrick B.; Runnalls, Tamsin J.; Vinciotti, Veronica; Henshaw, Alan; Hodgson, Dave; Coe, Tobias S.; Jobling, Susan; Tyler, Charles R.; Sumpter, John P.

    2011-01-01

    Background The feminization of nature by endocrine-disrupting chemicals (EDCs) is a key environmental issue affecting both terrestrial and aquatic wildlife. A crucial and as yet unanswered question is whether EDCs have adverse impacts on the sustainability of wildlife populations. There is widespread concern that intersex fish are reproductively compromised, with potential population-level consequences. However, to date, only in vitro sperm quality data are available in support of this hypothesis. Objective The aim of this study was to examine whether wild endocrine-disrupted fish can compete successfully in a realistic breeding scenario. Methods In two competitive breeding experiments using wild roach (Rutilus rutilus), we used DNA microsatellites to assign parentage and thus determine reproductive success of the adults. Results In both studies, the majority of intersex fish were able to breed, albeit with varying degrees of success. In the first study, where most intersex fish were only mildly feminized, body length was the only factor correlated with reproductive success. In the second study, which included a higher number of more severely intersex fish, reproductive performance was negatively correlated with severity of intersex. The intersex condition reduced reproductive performance by up to 76% for the most feminized individuals in this study, demonstrating a significant adverse effect of intersex on reproductive performance. Conclusion Feminization of male fish is likely to be an important determinant of reproductive performance in rivers where there is a high prevalence of moderately to severely feminized males. PMID:21362587

  17. Adverse outcome pathway development II: best practices.

    PubMed

    Villeneuve, Daniel L; Crump, Doug; Garcia-Reyero, Natàlia; Hecker, Markus; Hutchinson, Thomas H; LaLone, Carlie A; Landesmann, Brigitte; Lettieri, Teresa; Munn, Sharon; Nepelska, Malgorzata; Ottinger, Mary Ann; Vergauwen, Lucia; Whelan, Maurice

    2014-12-01

    Organization of existing and emerging toxicological knowledge into adverse outcome pathway (AOP) descriptions can facilitate greater application of mechanistic data, including those derived through high-throughput in vitro, high content omics and imaging, and biomarker approaches, in risk-based decision making. The previously ad hoc process of AOP development is being formalized through development of internationally harmonized guidance and principles. The goal of this article was to outline the information content desired for formal AOP description and some rules of thumb and best practices intended to facilitate reuse and connectivity of elements of an AOP description in a knowledgebase and network context. For example, key events (KEs) are measurements of change in biological state that are indicative of progression of a perturbation toward a specified adverse outcome. Best practices for KE description suggest that each KE should be defined as an independent measurement made at a particular level of biological organization. The concept of "functional equivalence" can help guide both decisions about how many KEs to include in an AOP and the specificity with which they are defined. Likewise, in describing both KEs and evidence that supports a causal linkage or statistical association between them (ie, a key event relationship; KER), best practice is to build from and contribute to existing KE or KER descriptions in the AOP knowledgebase rather than creating redundant descriptions. The best practices proposed address many of the challenges and uncertainties related to AOP development and help promote a consistent and reliable, yet flexible approach.

  18. [Adverse events of immune checkpoint inhibitors].

    PubMed

    Foller, S; Oppel-Heuchel, H; Fetter, I; Winkler, Y; Grimm, M-O

    2017-04-01

    After immune checkpoint inhibitor therapy was approved for renal cell carcinoma last year, this new immune therapy has spread to urology. Further approvals (atezolizumab, nivolumab, pembrolizumab) are expected in 2017 for metastatic urothelial carcinoma that has progressed following treatment with platinum-based chemotherapy. With expanding use of immune checkpoint inhibitors, experience in diagnosing and managing immune-mediated adverse events increases. Although of low incidence, grade 3/4 toxicities play a central role. Organs most common for immune-mediated adverse events are skin, liver (hepatitis), kidneys (nephritis), gastrointestinal tract (diarrhea and colitis), lungs (pneumonitis), and endocrine organs (hyper-, hypothyroidism and hypophysitis). Diagnostic workup includes routine laboratory tests (including liver function tests) and may be supplemented with hormone values. In cases of pneumonitis or hypophysitis, imaging (high-resolution CT, MRI) can confirm diagnoses. Immune-mediated toxicities are treated with therapy interruption and administration of corticosteroids (and in individual cases additional immunosuppression). Dose modification is not intended!

  19. "Adversative Conjunction": The Poetics of Linguistic Opposition.

    ERIC Educational Resources Information Center

    Wallerstein, Nicholas

    1992-01-01

    The general use of adversative conjunction in (primarily) English and U.S. poetry is outlined. The contention is that the adversative is not merely a grammatical convenience but sometimes a highly functional tool of rhetorical strategy. (36 references) (LB)

  20. The international serious adverse events consortium.

    PubMed

    Holden, Arthur L; Contreras, Jorge L; John, Sally; Nelson, Matthew R

    2014-11-01

    The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.

  1. Systems Toxicology of Male Reproductive Development: Profiling 774 Chemicals for Molecular Targets and Adverse Outcomes

    PubMed Central

    Leung, Maxwell C.K.; Phuong, Jimmy; Baker, Nancy C.; Sipes, Nisha S.; Klinefelter, Gary R.; Martin, Matthew T.; McLaurin, Keith W.; Setzer, R. Woodrow; Darney, Sally Perreault; Judson, Richard S.; Knudsen, Thomas B.

    2015-01-01

    Background: Trends in male reproductive health have been reported for increased rates of testicular germ cell tumors, low semen quality, cryptorchidism, and hypospadias, which have been associated with prenatal environmental chemical exposure based on human and animal studies. Objective: In the present study we aimed to identify significant correlations between environmental chemicals, molecular targets, and adverse outcomes across a broad chemical landscape with emphasis on developmental toxicity of the male reproductive system. Methods: We used U.S. EPA’s animal study database (ToxRefDB) and a comprehensive literature analysis to identify 774 chemicals that have been evaluated for adverse effects on male reproductive parameters, and then used U.S. EPA’s in vitro high-throughput screening (HTS) database (ToxCastDB) to profile their bioactivity across approximately 800 molecular and cellular features. Results: A phenotypic hierarchy of testicular atrophy, sperm effects, tumors, and malformations, a composite resembling the human testicular dysgenesis syndrome (TDS) hypothesis, was observed in 281 chemicals. A subset of 54 chemicals with male developmental consequences had in vitro bioactivity on molecular targets that could be condensed into 156 gene annotations in a bipartite network. Conclusion: Computational modeling of available in vivo and in vitro data for chemicals that produce adverse effects on male reproductive end points revealed a phenotypic hierarchy across animal studies consistent with the human TDS hypothesis. We confirmed the known role of estrogen and androgen signaling pathways in rodent TDS, and importantly, broadened the list of molecular targets to include retinoic acid signaling, vascular remodeling proteins, G-protein coupled receptors (GPCRs), and cytochrome P450s. Citation: Leung MC, Phuong J, Baker NC, Sipes NS, Klinefelter GR, Martin MT, McLaurin KW, Setzer RW, Darney SP, Judson RS, Knudsen TB. 2016. Systems toxicology of male

  2. Adverse effects of statins - myths and reality.

    PubMed

    Šimić, Iveta; Reiner, Željko

    2015-01-01

    Statins reduce cardiovascular mortality and morbidity as well as cardiovascular events in patients with a very high risk of cardiovascular disease (CVD) and also in subjects with high or moderate risk by reducing the levels of low-density lipoprotein cholesterol (LDL-C). Although they are considered to be drugs with a very good safety profile, because of their wide use there are many concerns that their adverse effects might compromise their proven beneficial effects. Therefore this article reviews all the data and provides an evidence- based insight what are the proven adverse effects of statins and what are the "myths" about them. The most important side effects include myopathy and rhabdomyolysis. Another side effect is increased activity of liver tests which occurs occasionally and is reversible. However, recent studies even suggest that statin therapy can improve hepatic steatosis. It is beyond any doubt that statins do slightly increase the incidence of type 2 diabetes mellitus in people with two or more components of metabolic syndrome but the cardiovascular benefits of such a treatment by far exceed this risk. Statin therapy has also been associated with some adverse renal effects, eg. acute renal failure, but recent data suggest even a possible protective effect of these drugs on renal dysfunction. Concerns that statins might increase cancer have not been proven. On the contrary, several studies have indicated a possible benefit of these drugs in patients with different types of cancer. Early concerns about cognitive dysfunction and memory loss associated with statins use could not be proven and most recent data even suggest a possible beneficial effect of statins in the prevention of dementia. Systematic reviews and clinical guidelines suggest that the cardiovascular benefits of statins by far out-weight non-cardiovascular harms in patients with cardiovascular risk.

  3. The neurobiological Correlates of Childhood Adversity and Implications for Treatment

    PubMed Central

    Tyrka, Audrey R.; Burgers, Darcy E.; Philip, Noah S.; Price, Lawrence H.; Carpenter, Linda L.

    2013-01-01

    Objective This paper provides an overview of research on the neurobiological correlates of childhood adversity and a selective review of treatment implications. Method Findings from a broad array of human and animal studies of early adversity were reviewed. Results Topics reviewed include neuroendocrine, neurotrophic, neuroimaging, and cognitive effects of adversity, as well as genetic and epigenetic influences. Effects of early life stress on treatment outcome are considered, and development of treatments designed to address the neurobiological abnormalities is discussed. Conclusion Early adversity is associated with abnormalities of several neurobiological systems that are implicated in the development of psychopathology and other medical conditions. Early life stress negatively impacts treatment outcome and individuals may require treatments that are specific to this condition. PMID:23662634

  4. Adverse effects of isolation in hospitalised patients: a systematic review.

    PubMed

    Abad, C; Fearday, A; Safdar, N

    2010-10-01

    The use of transmission precautions such as contact isolation in patients known to be colonised or infected with multidrug-resistant organisms is recommended in healthcare institutions. Although essential for infection control, contact isolation has recently been associated with adverse effects in patients. We undertook a systematic review to determine whether contact isolation leads to psychological or physical problems for patients. Studies were included if (1) hospitalised patients were placed under isolation precautions for an underlying medical indication, and (2) any adverse events related to the isolation were evaluated. We found 16 studies that reported data regarding the impact of isolation on patient mental well-being, patient satisfaction, patient safety or time spent by healthcare workers in direct patient care. The majority showed a negative impact on patient mental well-being and behaviour, including higher scores for depression, anxiety and anger among isolated patients. A few studies also found that healthcare workers spent less time with patients in isolation. Patient satisfaction was adversely affected by isolation if patients were kept uninformed of their healthcare. Patient safety was also negatively affected, leading to an eight-fold increase in adverse events related to supportive care failures. We found that contact isolation may negatively impact several dimensions of patient care. Well-validated tools are necessary to investigate these results further. Large studies examining a number of safety indicators to assess the adverse effects of isolation are needed. Patient education may be an important step to mitigate the adverse psychological effects of isolation and is recommended.

  5. [Health consequence of stalking victimization].

    PubMed

    Will, R; Hintz, E; Blättner, B

    2012-05-01

    Life time prevalence of stalking is about 12-20%, while females are more often affected than male. Stalking is a statutory offense. However, it is not an assault of victims' law. For the purpose of health consequences for stalking victims, research in following database were conducted: EMBASE, CINAHL, MEDLINE, PsycINFO and Social Science Index. English and German published studies of the years 2002-2010 were included. 17 primary studies and 2 meta-analyses were identified. Direct physiological consequences are relatively rare; however stalking victims report a poorer physiological health status. Almost every second stalking victim shows impairments on his/her psychical well-being. Impairments of social well-being are common, too. As a result, there is still a lot of research, especially in long-term studies, required. Socio-legal reassessment of stalking will probably benefit only a few of the affected people.

  6. Systematic review of methods used in meta-analyses where a primary outcome is an adverse or unintended event

    PubMed Central

    2012-01-01

    Background Adverse consequences of medical interventions are a source of concern, but clinical trials may lack power to detect elevated rates of such events, while observational studies have inherent limitations. Meta-analysis allows the combination of individual studies, which can increase power and provide stronger evidence relating to adverse events. However, meta-analysis of adverse events has associated methodological challenges. The aim of this study was to systematically identify and review the methodology used in meta-analyses where a primary outcome is an adverse or unintended event, following a therapeutic intervention. Methods Using a collection of reviews identified previously, 166 references including a meta-analysis were selected for review. At least one of the primary outcomes in each review was an adverse or unintended event. The nature of the intervention, source of funding, number of individual meta-analyses performed, number of primary studies included in the review, and use of meta-analytic methods were all recorded. Specific areas of interest relating to the methods used included the choice of outcome metric, methods of dealing with sparse events, heterogeneity, publication bias and use of individual patient data. Results The 166 included reviews were published between 1994 and 2006. Interventions included drugs and surgery among other interventions. Many of the references being reviewed included multiple meta-analyses with 44.6% (74/166) including more than ten. Randomised trials only were included in 42.2% of meta-analyses (70/166), observational studies only in 33.7% (56/166) and a mix of observational studies and trials in 15.7% (26/166). Sparse data, in the form of zero events in one or both arms where the outcome was a count of events, was found in 64 reviews of two-arm studies, of which 41 (64.1%) had zero events in both arms. Conclusions Meta-analyses of adverse events data are common and useful in terms of increasing the power to

  7. Development of a Pediatric Adverse Events Terminology

    PubMed Central

    Gipson, Debbie S.; Kirkendall, Eric S.; Gumbs-Petty, Brenda; Quinn, Theresa; Steen, A.; Hicks, Amanda; McMahon, Ann; Nicholas, Savian; Zhao-Wong, Anna; Taylor-Zapata, Perdita; Turner, Mark; Herreshoff, Emily; Jones, Charlotte; Davis, Jonathan M.; Haber, Margaret; Hirschfeld, Steven

    2017-01-01

    In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute’s Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute’s Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization. PMID:28028203

  8. Development of a Pediatric Adverse Events Terminology.

    PubMed

    Gipson, Debbie S; Kirkendall, Eric S; Gumbs-Petty, Brenda; Quinn, Theresa; Steen, A; Hicks, Amanda; McMahon, Ann; Nicholas, Savian; Zhao-Wong, Anna; Taylor-Zapata, Perdita; Turner, Mark; Herreshoff, Emily; Jones, Charlotte; Davis, Jonathan M; Haber, Margaret; Hirschfeld, Steven

    2017-01-01

    In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute's Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute's Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization.

  9. Consumer reporting of adverse events following immunization

    PubMed Central

    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

  10. Accelerating Adverse Outcome Pathway (AOP) development ...

    EPA Pesticide Factsheets

    The Adverse Outcome Pathway (AOP) framework is increasingly being adopted as a tool for organizing and summarizing the mechanistic information connecting molecular perturbations by environmental stressors with adverse outcomes relevant for ecological and human health outcomes. However, the conventional process for assembly of these AOPs is time and resource intensive, and has been a rate limiting step for AOP use and development. Therefore computational approaches to accelerate the process need to be developed. We previously developed a method for generating computationally predicted AOPs (cpAOPs) by association mining and integration of data from publicly available databases. In this work, a cpAOP network of ~21,000 associations was established between 105 phenotypes from TG-GATEs rat liver data from different time points (including microarray, pathological effects and clinical chemistry data), 994 REACTOME pathways, 688 High-throughput assays from ToxCast and 194 chemicals. A second network of 128,536 associations was generated by connecting 255 biological target genes from ToxCast to 4,980 diseases from CTD using either HT screening activity from ToxCast for 286 chemicals or CTD gene expression changes in response to 2,330 chemicals. Both networks were separately evaluated through manual extraction of disease-specific cpAOPs and comparison with expert curation of the relevant literature. By employing data integration strategies that involve the weighting of n

  11. Risk, mercury levels, and birds: relating adverse laboratory effects to field biomonitoring.

    PubMed

    Burger, J; Gochfeld, M

    1997-11-01

    There is an abundance of field data on levels of mercury in a variety of organisms and there are a number of studies that demonstrate the adverse effects of mercury on laboratory animals, but few studies examine the relationship between the two. Thus it is often difficult to determine the ecological relevance of mercury concentrations found in nature, or to predict the ecosystem consequences of current levels. In this paper we review the levels in tissues that are associated with adverse effects in birds from laboratory studies and compare these with levels found in wild bird populations in the New York Bight to provide a basis for interpreting values in avian populations. We use feathers from fledgling birds which would have been fed on locally obtained food to eliminate the problem of where toxic burdens were acquired by more mobile adult birds. Laboratory studies indicate that in some species mercury levels of 1.5 ppm in eggs and/or 5 to 40 ppm in the feathers of birds are associated with adverse effects, including impaired reproduction. We report egg levels in birds that range as high as 3.8 ppm and feather levels that range as high as 10.3 ppm, although means are much lower. The levels in eggs of some wild birds in the New York Bight are within the range known to lower hatchability, embryo and chick survival, and chick weight, all variables that reduce reproductive success. Species with high egg levels include Forster's tern (Sterna forsteri) and black skimmer (Rynchops niger). Levels in feathers of some young wild birds from the New York Bight are within the range associated with reduced hatchability of eggs, behavioral abnormalities of adults, and infertility. Species with dangerously elevated mercury levels in feathers include great egret (Ardea [=Egretta] alba), snowy egret [Egretta thula), and black skimmers.

  12. Intuitions, principles and consequences

    PubMed Central

    Shaw, A

    2001-01-01

    Some approaches to the assessment of moral intuitions are discussed. The controlled ethical trial isolates a moral issue from confounding factors and thereby clarifies what a person's intuition actually is. Casuistic reasoning from situations, where intuitions are clear, suggests or modifies principles, which can then help to make decisions in situations where intuitions are unclear. When intuitions are defended by a supporting principle, that principle can be tested by finding extreme cases, in which it is counterintuitive to follow the principle. An approach to the resolution of conflict between valid moral principles, specifically the utilitarian and justice principles, is considered. It is argued that even those who justify intuitions by a priori principles are often obliged to modify or support their principles by resort to the consideration of consequences. Key Words: Intuitions • principles • consequences • utilitarianism PMID:11233371

  13. RMP Guidance for Offsite Consequence Analysis - Appendices

    EPA Pesticide Factsheets

    Assists owners/operators of processes covered by Chemical Accident Prevention Program rule in analysis of offsite consequences for toxic or flammable substances. Includes methods and tables for calculating worst-case/alternative scenarios and endpoints.

  14. Adverse events in healthcare: learning from mistakes.

    PubMed

    Rafter, N; Hickey, A; Condell, S; Conroy, R; O'Connor, P; Vaughan, D; Williams, D

    2015-04-01

    Large national reviews of patient charts estimate that approximately 10% of hospital admissions are associated with an adverse event (defined as an injury resulting in prolonged hospitalization, disability or death, caused by healthcare management). Apart from having a significant impact on patient morbidity and mortality, adverse events also result in increased healthcare costs due to longer hospital stays. Furthermore, a substantial proportion of adverse events are preventable. Through identifying the nature and rate of adverse events, initiatives to improve care can be developed. A variety of methods exist to gather adverse event data both retrospectively and prospectively but these do not necessarily capture the same events and there is variability in the definition of an adverse event. For example, hospital incident reporting collects only a very small fraction of the adverse events found in retrospective chart reviews. Until there are systematic methods to identify adverse events, progress in patient safety cannot be reliably measured. This review aims to discuss the need for a safety culture that can learn from adverse events, describe ways to measure adverse events, and comment on why current adverse event monitoring is unable to demonstrate trends in patient safety.

  15. Adverse Food Reaction and Functional Gastrointestinal Disorders: Role of the Dietetic Approach.

    PubMed

    Pasqui, Francesca; Poli, Carolina; Colecchia, Antonio; Marasco, Giovanni; Festi, Davide

    2015-09-01

    Bloating, abdominal discomfort or pain, disturbed bowel habits are very common symptoms, frequently reported by the patients soon after food ingestion. These symptoms may occur in different clinical conditions, such as functional bowel disorders, food adverse reactions, gluten-related syndromes, which frequently are interrelated. Consequently, in clinical practice, it is necessary to perform a correct diagnosis in order to identify, for the single patient, the most appropriate therapeutic strategy, which may include not only specific drugs, but also, and mainly, life style changes (healthy nutritional behavior and constant physical activity). The aim of this review is to provide to the general physician, according to the available evidence, the most appropriate diagnostic work-ups for recognizing the different clinical scenarios (i.e. food allergy and intolerance, functional bowel diseases, gluten-related syndromes), to identify their clinical interrelationships and to suggest the most appropriate management. In fact, as far as food intolerances are concerned, it is well known that the number of patients who believe that their symptoms are related to food intolerance is increasing and consequently they restrict their diet, possibly causing nutritional deficiencies. Furthermore, there is an increasing use of unconventional diagnostic tests for food intolerance which lack accurate scientific evidence; the application of their results may induce misdiagnosis and unhealthy therapeutic choices. Consequently the recognition of food intolerance has to be performed on the basis of reliable tests within an agreed diagnostic workup.

  16. Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors

    PubMed Central

    Schmitz, Astrid; Albers, Bernhard; Schrappe, Matthias

    2010-01-01

    Objectives To perform a systematic review of the frequency of (preventable) adverse events (AE/PAE) and to analyse contributing factors, such as sample size, settings, type of events, terminology, methods of collecting data and characteristics of study populations. Review methods Search of Medline and Embase from 1995 to 2007. Included were original papers with data on the frequency of AE or PAE, explicit definition of study population and information about methods of assessment. Results were included with percentages of patients having one or more AE/PAE. Extracted data enclosed contributing factors. Data were abstracted and analysed by two researchers independently. Results 156 studies in 152 publications met our inclusion criteria. 144/156 studies reported AE, 55 PAE (43 both). Sample sizes ranged from 60 to 8 493 876 patients (median: 1361 patients). The reported results for AE varied from 0.1% to 65.4%, and for PAE from 0.1% to 33.9%. Variation clearly decreased with increasing sample size. Estimates did not differ according to setting, type of event or terminology. In studies with fewer than 1000 patients, chart review prevailed, whereas surveys with more than 100 000 patients were based mainly on administrative data. No effect of patient characteristics was found. Conclusions The funnel-shaped distribution of AE and PAE rates with sample size is a probable consequence of variation and can be taken as an indirect indicator of study validity. A contributing factor may be the method of data assessment. Further research is needed to explain the results when analysing data by types of event or terminology. PMID:20679137

  17. Risk of Adverse Cognitive or Behavioral Conditions and Psychiatric Disorders

    NASA Technical Reports Server (NTRS)

    Slack, Kelley J.; Schneiderman, Jason S.; Leveton, Lauren B.; Whitmire, Alexandra M.; Picano, James J.

    2015-01-01

    The NASA commitment to human space flight includes continuing to fly astronauts on the ISS until it is decommissioned as well as possibly returning astronauts to the moon or having astronauts venture to an asteroid or Mars. As missions leave low Earth orbit and explore deeper space, BHP supports and conducts research to enable a risk posture that considers the risk of adverse cognitive or behavioral conditions and psychiatric disorders “acceptable given mitigations,” for pre-, in, and post-flight.The Human System Risk Board (HSRB) determines the risk of various mission scenarios using a likelihood (per person per year) by consequences matrix examining those risks across two categories—long term health and operational (within mission). Colors from a stoplight signal are used by HSRB and quickly provide a means of assessing overall perceived risk for a particular mission scenario. Risk associated with the current six month missions on the ISS are classified as “accepted with monitoring” while planetary missions, such as a mission to Mars, are recognized to be a “red” risk that requires mitigation to ensure mission success.Currently, the HSRB deems that the risk of adverse cognitive or behavioral conditions and psychiatric outcomes requires mitigation for planetary missions owing to long duration isolation and radiation exposure (see Table 1). While limited research evidence exists from spaceflight, it is well known anecdotally that the shift from the two week shuttle missions to the six month ISS missions renders the psychological stressors of space as more salient over longer duration missions. Shuttle astronauts were expected just to tolerate any stressors that arose during their mission and were successful at doing so (Whitmire et al, 2013). While it is possible to deal with stressors such as social isolation and to live with incompatible crewmembers for two weeks on shuttle, “ignoring it” is much less likely to be a successful coping mechanism

  18. Adverse consequences of altering the Farnsworth-Munsell 100-Hue test.

    PubMed

    Applegate, R A; Trick, L R

    1985-04-01

    Modifications of the Farnsworth-Munsell 100-Hue test (e.g., selection of new fixed-reference caps from within the test) have been proposed, with little or no theoretical justification or experimental verification. Predictions based on theoretical considerations of the underlying nature of the test and verified by experimental measurements on subjects with known color defects demonstrate that (1) modification can destroy the very nature of the test; (2) modification can alter axis determination and therefore, potentially, the diagnosis; (3) the resulting test scores cannot be compared reliably to established norms; and (4) accurate predictions of test performance can be made from theoretical considerations.

  19. Pathophysiology of Coronary Thrombus Formation and Adverse Consequences of Thrombus During PCI

    PubMed Central

    Srikanth, Sundararajan; Ambrose, John A

    2012-01-01

    Atherosclerosis is a systemic vascular pathology that is preceded by endothelial dysfunction. Vascular inflammation “fuels” atherosclerosis and creates the milieu for episodes of intravascular thromboses. Thrombotic events in the coronary vasculature may lead to asymptomatic progression of atherosclerosis or could manifest as acute coronary syndromes or even sudden cardiac death. Thrombus encountered in the setting of acute coronary syndromes has been correlated with acute complications during percutaneous coronary interventions such as no-reflow, acute coronary occlusion and long term complications such as stent thrombus. This article reviews the pathophysiology of coronary thrombogenesis and explores the complications associated with thrombus during coronary interventions. PMID:22920487

  20. Adverse Consequences of School Mobility for Children in Foster Care: A Prospective Longitudinal Study

    ERIC Educational Resources Information Center

    Pears, Katherine C.; Kim, Hyoun K.; Buchanan, Rohanna; Fisher, Philip A.

    2015-01-01

    Few prospective studies have examined school mobility in children in foster care. This study described the school moves of 86 such children and 55 community comparison children (primarily Caucasian), living in a medium-sized metropolitan area in the Pacific Northwest who were approximately 3 to 6 years old at the study start. Additionally, the…

  1. Reducing the adverse consequences of workplace aggression and violence: the buffering effects of organizational support.

    PubMed

    Schat, Aaron C H; Kelloway, E Kevin

    2003-04-01

    This study examined the buffering effects of 2 types of organizational support--instrumental and informational--on the relationships between workplace violence/aggression and both personal and organizational outcomes. Based on data from 225 employees in a health care setting, a series of moderated multiple regression analyses demonstrated that organizational support moderated the effects of physical violence, vicariously experienced violence, and psychological aggression on emotional well-being, somatic health, and job-related affect, but not on fear of future workplace violence and job neglect. These findings have implications for both research and intervention related to workplace violence.

  2. Belatacept and Sirolimus Prolong Nonhuman Primate Islet Allograft Survival: adverse consequences of concomitant alefacept therapy

    PubMed Central

    Lowe, MC; Badell, IR; Turner, AP; Thompson, PW; Leopardi, FV; Strobert, EA; Larsen, CP; Kirk, AD

    2012-01-01

    Calcineurin inhibitors (CNI) and steroids are known to promote insulin resistance, and their avoidance after islet transplantation is preferred from a metabolic standpoint. Belatacept, a B7-specific mediator of costimulation blockade (CoB), is clinically indicated as a CNI alternative in renal transplantation, and we have endeavored to develop a clinically translatable, belatacept-based regimen that could obviate the need for both CNIs and steroids. Based on the known synergy between CoB and mTOR inhibition, we studied rhesus monkeys undergoing MHC-mismatched islet allotransplants treated with belatacept and the mTOR inhibitor, sirolimus. To extend prior work on CoB-resistant rejection, some animals also received CD2 blockade with alefacept (LFA3-Ig). Nine rhesus macaques were rendered diabetic with streptozotocin and underwent islet allotransplantation. All received belatacept and sirolimus; six also received alefacept. Belatacept and sirolimus significantly prolonged rejection-free graft survival (median 225 days compared to 8 days in controls receiving basiliximab and sirolimus; p=0.022). The addition of alefacept provided no additional survival benefit, but was associated with Cytomegalovirus reactivation in 4/6 animals. No recipients produced donor-specific alloantibodies. The combination of belatacept and sirolimus successfully prevents islet allograft survival in rhesus monkeys, but induction with alefacept provides no survival benefit and increases the risk of viral reactivation. PMID:23279640

  3. Adverse Consequences of School Mobility for Children in Foster Care: A Prospective Longitudinal Study

    PubMed Central

    Pears, Katherine C.; Kim, Hyoun K.; Buchanan, Rohanna; Fisher, Philip A.

    2015-01-01

    Few prospective studies have examined school mobility in children in foster care. This study described the school moves of 86 such children and 55 community comparison children (primarily Caucasian), living in a medium-sized metropolitan area in the Pacific Northwest who were approximately 3-6-years-old at the study start. Additionally, the effects of moves from kindergarten through Grade 2 on academic and social emotional competence in Grades 3 through 5 were examined. A greater number of early school moves was associated with poorer later social emotional competence and partially mediated the effects of maltreatment and out-of-home placement on social emotional competence. This was only the case for children with poorer early learning skills in kindergarten. Implications for preventive intervention are discussed. PMID:25906815

  4. Consequences of the Allee effect and intraspecific competition on population persistence under adverse environmental conditions.

    PubMed

    Petrovskii, Sergei; Blackshaw, Rod; Li, Bai-Lian

    2008-02-01

    The impact of intraspecific interactions on ecological stability and population persistence in terms of steady state(s) existence is considered theoretically based on a general competition model. We compare persistence of a structured population consisting of a few interacting (competitive) subpopulations, or groups, to persistence of the corresponding unstructured population. For a general case, we show that if the intra-group competition is stronger than the inter-group competition, then the structured population is less prone to extinction, i.e. it can persist in a parameter range where the unstructured population goes extinct. For a more specific case of a population with hierarchical competition, we show that relative viability of structured and unstructured populations depend on the type of density dependence in the population growth. Namely, while in the case of logistic growth, structured and unstructured populations exhibit equivalent persistence; in the case of Allee dynamics, the persistence of a hierarchically structured population is shown to be higher. We then apply these results to the case of behaviourally structured populations and demonstrate that an extreme form of individual aggression can be beneficial at the population level and enhance population persistence.

  5. Adverse metabolic consequences in humans of prolonged sleep restriction combined with circadian disruption.

    PubMed

    Buxton, Orfeu M; Cain, Sean W; O'Connor, Shawn P; Porter, James H; Duffy, Jeanne F; Wang, Wei; Czeisler, Charles A; Shea, Steven A

    2012-04-11

    Epidemiological studies link short sleep duration and circadian disruption with higher risk of metabolic syndrome and diabetes. We tested the hypotheses that prolonged sleep restriction with concurrent circadian disruption, as can occur in people performing shift work, impairs glucose regulation and metabolism. Healthy adults spent >5 weeks under controlled laboratory conditions in which they experienced an initial baseline segment of optimal sleep, 3 weeks of sleep restriction (5.6 hours of sleep per 24 hours) combined with circadian disruption (recurring 28-hour "days"), followed by 9 days of recovery sleep with circadian re-entrainment. Exposure to prolonged sleep restriction with concurrent circadian disruption, with measurements taken at the same circadian phase, decreased the participants' resting metabolic rate and increased plasma glucose concentrations after a meal, an effect resulting from inadequate pancreatic insulin secretion. These parameters normalized during the 9 days of recovery sleep and stable circadian re-entrainment. Thus, in humans, prolonged sleep restriction with concurrent circadian disruption alters metabolism and could increase the risk of obesity and diabetes.

  6. Adverse events after hepatitis A B combination vaccine.

    PubMed

    Woo, Emily Jane; Miller, Nancy B; Ball, Robert

    2006-03-24

    In May 2001, the U.S. Food and Drug Administration (FDA) approved Hepatitis A Inactivated and Hepatitis B Recombinant Vaccine (HEPAB) for immunization of adults. From May 2001 to September 2003, the Vaccine Adverse Event Reporting System (VAERS) received 305 reports of adverse events after HEPAB. Many events were similar to those reported after the monovalent hepatitis A and B vaccines. Non-serious events included constitutional symptoms and local reactions. Serious events included neurologic, hepatobiliary, and dermatologic conditions, and detailed medical and epidemiological review did not suggest a clear pattern of evidence supporting a causal relationship with the vaccine, except for injection site reactions and some allergic reactions.

  7. Adverse effects of antihypertensive drugs.

    PubMed

    Husserl, F E; Messerli, F H

    1981-09-01

    Early essential hypertension is asymptomatic and should remain so throughout treatment. In view of the increasing number of available antihypertensive agents, clinicians need to become familiar with the potential side effects of these drugs. By placing more emphasis on non-pharmacological treatment (sodium restriction, weight loss, exercise) and thoroughly evaluating each case in particular, the pharmacological regimen can be optimally tailored to the patient's needs. Potential side effects should be predicted and can often be avoided; if they become clinically significant they should be rapidly recognised and corrected. These side effects can be easily remembered in most instances, as they fall into 3 broad categories: (a) those caused by an exaggerated therapeutic effect; (b) those due to a non-therapeutic pharmacological effect; and (c) those caused by a non-therapeutic, non-pharmacological effect probably representing idiosyncratic reactions. This review focuses mainly on adverse effects of the second and third kind. Each group of drugs in general shares the common side effects of the first two categories, while each individual drug has its own idiosyncratic side effects.

  8. Rethinking the Measurement of Adversity.

    PubMed

    Mersky, Joshua P; Janczewski, Colleen E; Topitzes, James

    2017-02-01

    Research on adverse childhood experiences (ACEs) has unified the study of interrelated risks and generated insights into the origins of disorder and disease. Ten indicators of child maltreatment and household dysfunction are widely accepted as ACEs, but further progress requires a more systematic approach to conceptualizing and measuring ACEs. Using data from a diverse, low-income sample of women who received home visiting services in Wisconsin ( N = 1,241), this study assessed the prevalence of and interrelations among 10 conventional ACEs and 7 potential ACEs: family financial problems, food insecurity, homelessness, parental absence, parent/sibling death, bullying, and violent crime. Associations between ACEs and two outcomes, perceived stress and smoking, were examined. The factor structure and test-retest reliability of ACEs was also explored. As expected, prevalence rates were high compared to studies of more representative samples. Except for parent/sibling death, all ACEs were intercorrelated and associated at the bivariate level with perceived stress and smoking. Exploratory factor analysis confirmed that conventional ACEs loaded on two factors, child maltreatment and household dysfunction, though a more complex four-factor solution emerged once new ACEs were introduced. All ACEs demonstrated acceptable test-retest reliability. Implications and future directions toward a second generation of ACE research are discussed.

  9. Energy Drink Consumption: Beneficial and Adverse Health Effects

    PubMed Central

    Alsunni, Ahmed Abdulrahman

    2015-01-01

    Consumption of energy drinks has been increasing dramatically in the last two decades, particularly amongst adolescents and young adults. Energy drinks are aggressively marketed with the claim that these products give an energy boost to improve physical and cognitive performance. However, studies supporting these claims are limited. In fact, several adverse health effects have been related to energy drink; this has raised the question of whether these beverages are safe. This review was carried out to identify and discuss the published articles that examined the beneficial and adverse health effects related to energy drink. It is concluded that although energy drink may have beneficial effects on physical performance, these products also have possible detrimental health consequences. Marketing of energy drinks should be limited or forbidden until independent research confirms their safety, particularly among adolescents. PMID:26715927

  10. Energy Drink Consumption: Beneficial and Adverse Health Effects.

    PubMed

    Alsunni, Ahmed Abdulrahman

    2015-10-01

    Consumption of energy drinks has been increasing dramatically in the last two decades, particularly amongst adolescents and young adults. Energy drinks are aggressively marketed with the claim that these products give an energy boost to improve physical and cognitive performance. However, studies supporting these claims are limited. In fact, several adverse health effects have been related to energy drink; this has raised the question of whether these beverages are safe. This review was carried out to identify and discuss the published articles that examined the beneficial and adverse health effects related to energy drink. It is concluded that although energy drink may have beneficial effects on physical performance, these products also have possible detrimental health consequences. Marketing of energy drinks should be limited or forbidden until independent research confirms their safety, particularly among adolescents.

  11. The NAS Perchlorate Review: Adverse Effects?

    SciTech Connect

    Johnston, Richard B.; Corley, Richard; Cowan, Linda; Utiger, Robert D.

    2005-11-01

    ), a dose of 9.2 mg/kg per day for 4 weeks had no effect on thyroid function. In occupational studies, doses as high as 0.5 mg/kg per day were not associated with adverse effects on thyroid function in workers. In epidemiologic studies, there were no abnormalities in growth or thyroid function in children exposed life-long to 100 to 120 mg of perchlorate per liter of drinking water, or in pregnant women and newborn infants similarly exposed. Given the choice of a non-adverse effect (inhibition of iodide uptake by the thyroid) as the point of departure and the multiple studies in which doses of perchlorate much larger than 0.007 mg/kg per day had no effect on any aspect of thyroid function, the committee did not apply a database uncertainty factor. Finally, Ginsberg and Rice argue that inhibition of thyroid iodide uptake is adverse. That conclusion assumes that any acute inhibition would be sustained, so that thyroid hormone production would fall. That is not the case. There is remarkable compensation for even substantial reductions in thyroid iodide uptake – and thyroid hormone production. As noted above, subjects given 0.04 mg/kg per day for 6 months and 9.2 mg/kg per day for 4 weeks-doses that certainly would inhibit thyroid iodide uptake for a few weeks-had no fall in serum thyroid hormone or rise in serum thyrotropin concentrations (the hallmark of even minor systemic thyroid deficiency). Short-term inhibition of thyroid iodide uptake is not an adverse effect; it has no adverse consequences, because there is rapid compensation mediated by several independent processes. One is upregulation of the thyroid sodium-iodide transport system, as a result of intrathyroidal iodide deficiency. The second, should there be even a very small fall in thyroid hormone production, is an increase in thyrotropin secretion, resulting in overall stimulation of the thyroid gland.

  12. Adverse Risks Associated With Proton Pump Inhibitors

    PubMed Central

    2009-01-01

    Proton pump inhibitors (PPIs) are among the most commonly utilized agents for treatment of symptomatic disorders of the upper gastrointestinal tract, accounting for a significant proportion of sales of both over-the-counter and prescription formulations. A systematic review of the literature was conducted via MEDLINE to evaluate the most rigorous studies linking the potential risk of PPI therapy with adverse events. Emerging data illustrate the potential risks associated with both short-and long-term PPI therapy, including Clostridium difficile–associated diarrhea, community-acquired pneumonia, osteoporotic fracture, vitamin B12 deficiency, and inhibition of antiplatelet therapy. Due to these associations, it is recommended that clinicians assess the continuing need for PPI therapy and use the lowest possible dose to achieve the desired therapeutic goals.

  13. Adverse events in medical management--vigabatrin as a paradigm of forensic responsibility with novel therapy.

    PubMed

    Beran, R G

    2001-01-01

    The ethics of medical management are not always straightforward. There are many contributing factors: the condition treated; its effects on the patient; the required treatment; the effects of that treatment; and a cost/benefit ratio. Treatment of epilepsy with vigabatrin (VGB) exemplifies these problems. VGB has recently been reported to cause constricted visual fields. Formal testing of visual fields of patients attending an outpatient epilepsy service showed constriction with tunnel vision, even in patients who are asymptomatic. The ethical questions include: Should all reports of adverse events be subjected to tests of validity and subsequent quality assurance? Should treatment with VGB be stopped, risking recurrence of seizures? What are the legal consequences of continuing VGB? Does informed consent protect the doctor? After stopping VGB can the patient drive?

  14. Social consequences of infected haemophilia cases in the Islamic Republic of Iran.

    PubMed

    Cheraghali, A M; Eshghi, P; Abolghasemi, H

    2011-06-01

    The unintentional contamination of haemophilia patients with HIV in the early 1980s raised serious questions about the safety of blood product supplies worldwide. The events initiated a cascade of consequences for both infected patients and the national health systems of many countries, including the Islamic Republic of Iran. Lawsuits have been filed in the courts mostly in developed countries, leading to the establishment of some kind of reimbursement programme for haemophilia patients who acquired viral infections. In the late 1990s the courts ordered the Iranian Ministry of Health, in addition to providing free care with the latest treatments to pay compensation to the haemophilia patients. The adverse consequences of these events on the equitable distribution of resources in the Iranian health care system are discussed in this paper.

  15. The consequences of bilharziasis

    PubMed Central

    Forsyth, D. M.; Bradley, D. J.

    1966-01-01

    A survey of the prevalence of bilharsiasis and its consequences in north-west Tanzania showed that, although Schistosoma mansoni infections were light and had little effect on public health, S. haematobium, rampant in the area, was giving rise to hydronephrosis, ureteric lesions or non-functioning kidneys in more than 20% of the child population and in over 10% of the adults. These figures, from an unselected community sample, were higher than had been expected; in addition, evidence of a significant mortality of young men from this cause was obtained. S. haematobium in Tanzania is therefore of considerable public health importance. PMID:5296234

  16. Adverse cardiac events to monoclonal antibodies used for cancer therapy

    PubMed Central

    Kounis, Nicholas G; Soufras, George D; Tsigkas, Grigorios; Hahalis, George

    2014-01-01

    Monoclonal antibodies are currently used in the treatment of neoplastic, hematological, or inflammatory diseases, a practice that is occasionally associated with a variety of systemic and cutaneous adverse events. Cardiac adverse events include cardiomyopathy, ventricular dysfunction, arrhythmias, arrests, and acute coronary syndromes, such as acute myocardial infarction and vasospastic angina pectoris. These events generally follow hypersensitivity reactions including cutaneous erythema, pruritus chills, and precordial pain. Recently, IgE specific for therapeutic monoclonal antibodies have been detected, pointing to the existence of hypersensitivity and Kounis hypersensitivity-associated syndrome. Therefore, the careful monitoring of cardiovascular events is of paramount importance in the course of monoclonal antibody-based therapies. Moreover, further studies are needed to elucidate the pathophysiology of cardiovascular adverse events elicited by monoclonal antibodies and to identify preventive, protective, and therapeutic measures. PMID:25340003

  17. Hospital deaths and adverse events in Brazil

    PubMed Central

    2011-01-01

    Background Adverse events are considered a major international problem related to the performance of health systems. Evaluating the occurrence of adverse events involves, as any other outcome measure, determining the extent to which the observed differences can be attributed to the patient's risk factors or to variations in the treatment process, and this in turn highlights the importance of measuring differences in the severity of the cases. The current study aims to evaluate the association between deaths and adverse events, adjusted according to patient risk factors. Methods The study is based on a random sample of 1103 patient charts from hospitalizations in the year 2003 in 3 teaching hospitals in the state of Rio de Janeiro, Brazil. The methodology involved a retrospective review of patient charts in two stages - screening phase and evaluation phase. Logistic regression was used to evaluate the relationship between hospital deaths and adverse events. Results The overall mortality rate was 8.5%, while the rate related to the occurrence of an adverse event was 2.9% (32/1103) and that related to preventable adverse events was 2.3% (25/1103). Among the 94 deaths analyzed, 34% were related to cases involving adverse events, and 26.6% of deaths occurred in cases whose adverse events were considered preventable. The models tested showed good discriminatory capacity. The unadjusted odds ratio (OR 11.43) and the odds ratio adjusted for patient risk factors (OR 8.23) between death and preventable adverse event were high. Conclusions Despite discussions in the literature regarding the limitations of evaluating preventable adverse events based on peer review, the results presented here emphasize that adverse events are not only prevalent, but are associated with serious harm and even death. These results also highlight the importance of risk adjustment and multivariate models in the study of adverse events. PMID:21929810

  18. Serenoa repens (saw palmetto): a systematic review of adverse events.

    PubMed

    Agbabiaka, Taofikat B; Pittler, Max H; Wider, Barbara; Ernst, Edzard

    2009-01-01

    Serenoa repens (W. Bartram) Small, also known as saw palmetto, is one of the most widely used herbal preparations for the treatment of lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Although a number of randomized controlled trials (RCTs) and systematic reviews of the efficacy of S. repens for the treatment of LUTS and BPH have been published, no systematic review on its drug interactions or adverse events currently exists. This review assesses all available human safety data of S. repens monopreparations. Systematic literature searches were conducted from date of inception to February 2008 in five electronic databases; reference lists and our departmental files were checked for further relevant publications. Information was requested from spontaneous reporting schemes of the WHO and national safety bodies. Twenty-four manufacturers/distributors of S. repens preparations and four herbalist organizations were contacted for additional information. No language restrictions were imposed. Only reports of adverse events in humans from monopreparations of S. repens were included. Data from all articles, regardless of study design, reporting adverse events or interactions were independently extracted by the first author and validated by the second. Forty articles (26 randomized controlled trials, 4 non-randomized controlled trials, 6 uncontrolled trials and 4 case reports/series) were included. They suggest that adverse events associated with the use of S. repens are mild and similar to those with placebo. The most frequently reported adverse events are abdominal pain, diarrhoea, nausea, fatigue, headache, decreased libido and rhinitis. More serious adverse events such as death and cerebral haemorrhage are reported in isolated case reports and data from spontaneous reporting schemes, but causality is questionable. No drug interactions were reported. Currently available data suggest that S. repens is well tolerated by most users and is not

  19. Minimizing AED adverse effects: improving quality of life in the interictal state in epilepsy care.

    PubMed

    St Louis, Erik K; Louis, Erik K

    2009-06-01

    The goals of epilepsy therapy are to achieve seizure freedom while minimizing adverse effects of treatment. However, producing seizure-freedom is often overemphasized, at the expense of inducing adverse effects of treatment. All antiepileptic drugs (AEDs) have the potential to cause dose-related, "neurotoxic" adverse effects (i.e., drowsiness, fatigue, dizziness, blurry vision, and incoordination). Such adverse effects are common, especially when initiating AED therapy and with polytherapy. Dose-related adverse effects may be obviated in most patients by dose reduction of monotherapy, reduction or elimination of polytherapy, or substituting for a better tolerated AED. Additionally, all older and several newer AEDs have idiosyncratic adverse effects which usually require withdrawal in an affected patient, including serious rash (i.e., Stevens-Johnson Syndrome, toxic epidermal necrolysis), hematologic dyscrasias, hepatotoxicity, teratogenesis in women of child bearing potential, bone density loss, neuropathy, and severe gingival hyperplasia. Unfortunately, occurrence of idiosyncratic AED adverse effects cannot be predicted or, in most cases, prevented in susceptible patients. This article reviews a practical approach for the definition and identification of adverse effects of epilepsy therapies, and reviews the literature demonstrating that adverse effects result in detrimental quality of life in epilepsy patients. Strategies for minimizing AED adverse effects by reduction or elimination of AED polytherapy, appropriately employing drug-sparing therapies, and optimally administering AEDs are outlined, including tenets of AED selection, titration, therapeutic AED laboratory monitoring, and avoidance of chronic idiosyncratic adverse effects.

  20. An examination of the consequences in high consequence operations

    SciTech Connect

    Spray, S.D.; Cooper, J.A.

    1996-06-01

    Traditional definitions of risk partition concern into the probability of occurrence and the consequence of the event. Most safety analyses focus on probabilistic assessment of an occurrence and the amount of some measurable result of the event, but the real meaning of the ``consequence`` partition is usually afforded less attention. In particular, acceptable social consequence (consequence accepted by the public) frequently differs significantly from the metrics commonly proposed by risk analysts. This paper addresses some of the important system development issues associated with consequences, focusing on ``high consequence operations safety.``

  1. Characterizing "Adversity" of Pathology Findings in ...

    EPA Pesticide Factsheets

    The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment in the toxicologic pathology community regarding how nonclinical adversity is determined and characterized. The European Society of Toxicologic Pathology (ESTP) therefore coordinated a workshop in June 2015 to review available definitions of adversity, weigh determining and qualifying factors of adversity based on case examples, and recommend a practical approach to define and characterize adversity in toxicology reports. The international group of expert pathologists and toxicologists emphasized that a holistic, weight-of-evidence, case-specific approach should be followed for each adversity assessment. It was recommended that nonclinical adversity should typically be determined at a morphological level (most often the organ) in the pathology report and should refer specifically to the test species. Final adversity calls, integration of target pharmacology/pathway information, and consideration of human translation should generally be made in toxicology overview reports. Differences in interpretation and implications of adversity calls between (agro)chemical and pharmaceutical industries and among world regions were highlighted. The results of this workshop should serve a valuable prerequisite for future organ- or lesion-specific workshops planned by the ESTP. This

  2. Symptoms of Common Mental Disorders and Adverse Health Behaviours in Male Professional Soccer Players.

    PubMed

    Gouttebarge, Vincent; Aoki, Haruhito; Kerkhoffs, Gino

    2015-12-22

    To present time, scientific knowledge about symptoms of common mental disorders and adverse health behaviours among professional soccer players is lacking. Consequently, the aim of the study was to determine the prevalence of symptoms of common mental disorders (distress, anxiety/depression, sleep disturbance) and adverse health behaviours (adverse alcohol behaviour, smoking, adverse nutrition behaviour) among professional soccer players, and to explore their associations with potential stressors (severe injury, surgery, life events and career dissatisfaction). Cross-sectional analyses were conducted on baseline questionnaires from an ongoing prospective cohort study among male professional players. Using validated questionnaires to assess symptoms of common mental disorders and adverse health behaviours as well as stressors, an electronic questionnaire was set up and distributed by players' unions in 11 countries from three continents. Prevalence of symptoms of common mental disorders and adverse health behaviours among professional soccer players ranged from 4% for smoking and 9% for adverse alcohol behaviour to 38% for anxiety/depression and 58% for adverse nutrition behaviour. Significant associations were found for a higher number of severe injuries with distress, anxiety/depression, sleeping disturbance and adverse alcohol behaviour, an increased number of life events with distress, sleeping disturbance, adverse alcohol behaviour and smoking, as well as an elevated level of career dissatisfaction with distress, anxiety/depression and adverse nutrition behaviour. Statistically significant correlations (p<0.01) were found for severe injuries and career dissatisfaction with most symptoms of common mental disorders. High prevalence of symptoms of common mental disorders and adverse health behaviours was found among professional players, confirming a previous pilot-study in a similar study population.

  3. Symptoms of Common Mental Disorders and Adverse Health Behaviours in Male Professional Soccer Players

    PubMed Central

    Gouttebarge, Vincent; Aoki, Haruhito; Kerkhoffs, Gino

    2015-01-01

    To present time, scientific knowledge about symptoms of common mental disorders and adverse health behaviours among professional soccer players is lacking. Consequently, the aim of the study was to determine the prevalence of symptoms of common mental disorders (distress, anxiety/depression, sleep disturbance) and adverse health behaviours (adverse alcohol behaviour, smoking, adverse nutrition behaviour) among professional soccer players, and to explore their associations with potential stressors (severe injury, surgery, life events and career dissatisfaction). Cross-sectional analyses were conducted on baseline questionnaires from an ongoing prospective cohort study among male professional players. Using validated questionnaires to assess symptoms of common mental disorders and adverse health behaviours as well as stressors, an electronic questionnaire was set up and distributed by players’ unions in 11 countries from three continents. Prevalence of symptoms of common mental disorders and adverse health behaviours among professional soccer players ranged from 4% for smoking and 9% for adverse alcohol behaviour to 38% for anxiety/depression and 58% for adverse nutrition behaviour. Significant associations were found for a higher number of severe injuries with distress, anxiety/depression, sleeping disturbance and adverse alcohol behaviour, an increased number of life events with distress, sleeping disturbance, adverse alcohol behaviour and smoking, as well as an elevated level of career dissatisfaction with distress, anxiety/depression and adverse nutrition behaviour. Statistically significant correlations (p<0.01) were found for severe injuries and career dissatisfaction with most symptoms of common mental disorders. High prevalence of symptoms of common mental disorders and adverse health behaviours was found among professional players, confirming a previous pilot-study in a similar study population. PMID:26925182

  4. High Consequence System Surety process description

    SciTech Connect

    Randall, G.T.

    1995-09-01

    This report documents work-in-progress accomplished prior to programmatic changes that negated bringing this effort to conclusion as originally intended. The High Consequence System Surety (HCS{sup 2}) project pulls together a multi-disciplinary team to integrate the elements of surety safety, security, control, reliability and quality--into a new, encompassing process. The benefit of using this process is enhanced surety in the design of a high consequence system through an up-front, designed-in approach. This report describes the integrated, high consequence surety process and includes a hypothetical example to illustrate the process.

  5. Adverse effects of oral antiviral therapy in chronic hepatitis B

    PubMed Central

    Kayaaslan, Bircan; Guner, Rahmet

    2017-01-01

    Oral nucleoside/nucleotide analogues (NAs) are currently the backbone of chronic hepatitis B (CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of patients have been treated with NAs. Safety data has accumulated over the years. The aim of this article is to review and update the adverse effects of oral NAs. NAs can cause class adverse effects (i.e., myopathy, neuropathy, lactic acidosis) and dissimilar adverse effects. All NAs carry a “Black Box” warning because of the potential risk for mitochondrial dysfunction. However, these adverse effects are rarely reported. The majority of cases are associated with lamivudine and telbivudine. Adefovir can lead to dose- and time-dependent nephrotoxicity, even at low doses. Tenofovir has significant renal and bone toxicity in patients with human immunodeficiency virus (HIV) infection. However, bone and renal toxicity in patients with CHB are not as prominent as in HIV infection. Entecavir and lamivudine are not generally associated with renal adverse events. Entecavir has been claimed to increase the risk of lactic acidosis in decompensated liver disease and high Model for End-Stage Liver Disease scores. However, current studies reported that entecavir could be safely used in decompensated cirrhosis. An increase in fetal adverse events has not been reported with lamivudine, telbivudine and tenofovir use in pregnant women, while there is no adequate data regarding entecavir and adefovir. Further long-term experience is required to highlight the adverse effects of NAs, especially in special patient populations, including pregnant women, elderly and patients with renal impairment. PMID:28261380

  6. Quality of whey powders stored under adverse conditions

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Whey protein concentrate powder (WPC) is exported by the U.S. and is included in emergency aid foods, but the bags sent overseas are usually stored without refrigeration and under elevated temperature and relative humidity (RH). The shelf life of WPC under adverse conditions must be known to preven...

  7. Adverse effects of orthodontic treatment: A clinical perspective

    PubMed Central

    Talic, Nabeel F.

    2011-01-01

    Orthodontic treatment is associated with a number of adverse effects, such as root resorption, pain, pulpal changes, periodontal disease, and temporomandibular dysfunction (TMD). Orthodontists should be aware of these effects and associated risk factors. Risk factors linked to root resorption include the duration of treatment, length, and shape of the root, trauma history, habits, and genetic predisposition. PMID:24151415

  8. 15 CFR 971.602 - Significant adverse environmental effects.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR COMMERCIAL RECOVERY PERMITS... significant adverse environmental effect or impact (for the purposes of sections 103(a)(2)(D), 105(a)(4), 106.... Determinations will be based upon the best information available, including relevant environmental...

  9. 15 CFR 971.602 - Significant adverse environmental effects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR COMMERCIAL RECOVERY PERMITS... significant adverse environmental effect or impact (for the purposes of sections 103(a)(2)(D), 105(a)(4), 106.... Determinations will be based upon the best information available, including relevant environmental...

  10. 15 CFR 971.602 - Significant adverse environmental effects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR COMMERCIAL RECOVERY PERMITS... significant adverse environmental effect or impact (for the purposes of sections 103(a)(2)(D), 105(a)(4), 106.... Determinations will be based upon the best information available, including relevant environmental...

  11. 15 CFR 971.602 - Significant adverse environmental effects.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... REGULATIONS OF THE ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR COMMERCIAL RECOVERY PERMITS... significant adverse environmental effect or impact (for the purposes of sections 103(a)(2)(D), 105(a)(4), 106.... Determinations will be based upon the best information available, including relevant environmental...

  12. Skin-lightening cosmetics: frequent, potentially severe adverse effects.

    PubMed

    2011-09-01

    Skin-lightening cosmetics are used by many women and men around the world. The products contain a variety of substances, which are often unknown to the users. Most of these products include topical corticosteroids, hydroquinone and mercury salts. Many other substances may be added. Several surveys and cohort studies, including several thousand individuals, have shown that regular application of skin-lightening cosmetics to large surface areas can have irreversible cutaneous adverse effects, such as patchy hyper- or hypopigmentation, skin atrophy, stretch marks and delayed wound healing, and can also mask or, on the contrary, promote or reactivate skin infections. Cases of skin cancer have been attributed to skin-lightening cosmetics. A Senegalese cohort study of 147 women showed a statistically significant increase in the risk of hypertension and diabetes linked to the use of skin-lightening agents. Other systemic adverse effects attributed to skin-lightening cosmetics include Cushing's syndrome, adrenal insufficiency, nephrotic syndrome, neurological disorders, and ocular disorders. Hypersensitivity reactions, including anaphylaxis, have also been attributed to these products. Many skin-lightening cosmetics contain substances that can harm the unborn child. For example, tretinoin is teratogenic while salicylic acid is feto-toxic. In practice, users are often unaware of the risk of severe adverse effects associated with skin-lightening cosmetics. Users should be informed of these adverse effects and encouraged to stop using these products, especially when skin disorders appear.

  13. Metabolic consequences of peritoneal dialysis.

    PubMed

    Burkart, John

    2004-01-01

    Optimization of the peritoneal dialysis (PD) prescription includes attempts to normalize the patient's blood pressure and extracellular volume. To do so, one must utilize crystalloid or colloid osmotic agents to achieve ultrafiltration. These osmotic agents are systemically absorbed and thus have both potential benefits and adverse effects. With glucose-based dialysate solutions, the average patient absorbs 300-450 kcal of glucose per day on either continuous ambulatory peritoneal dialysis (CAPD) or the cycler. The amount of glucose absorbed varies based on peritoneal transport characteristics, prescription, and tonicity of fluids used. Alternative osmotic agents such as amino acids and macromolecular solutions, including polypeptides and polyglucose (icodextrin) solutions, have a different rate of systemic absorption and thus a different caloric load profile. In addition, there are protein losses that average about 10 g/day with glucose-based solutions and glucose losses with either amino acid or icodextrin dialysate solutions. There are also potential advantages of these alternative solutions with regard to ultrafiltration. Glucose-based solutions require the development of significant crystalloid osmotic forces, which are dissipated as glucose is absorbed systemically. In contrast, macromolecular solutions achieve ultrafiltration via differences in colloid osmotic pressure, and the absorption of these agents is of a lesser magnitude than glucose-based solutions. Further research is needed to determine other potential risks and benefits of these alternative dialysate solutions.

  14. Systematic review of NSAID-induced adverse reactions in patients with rheumatoid arthritis in Japan.

    PubMed

    Tomita, Tetsuya; Ochi, Takahiro; Sugano, Kentaro; Uemura, Shinichi; Makuch, Robert W

    2003-06-01

    Abstract A systematic review of randomized controlled clinical trials of nonsteroidal antiinflammatory drugs (NSAIDs) in rheumatoid arthritis (RA) patients was conducted to evaluate the risk of NSAID-induced adverse reactions. Double-blind, randomized, controlled trials with 6-week treatments for RA patients were included in the study. The endpoints for the analysis included any adverse reactions, digestive adverse reactions, and upper gastrointestinal (GI) adverse reactions. A fixed-effect model was used for estimation of the risk. Time-to-event analysis of the incidence of adverse reactions was also conducted. A total of 28 trials was included for the analysis, and a total of 30 NSAIDs were used in the trials. The proportion of patients who experienced any adverse reaction was as follows: piroxicam 18.9% (3 trials), diclofenac 18.8% (4 trials), indomethacin 22.1% (14 trials), and aspirin 25.0% (4 trials). The proportion of patients who experienced digestive adverse reactions was as follows: piroxicam 10.2%, diclofenac 10.6%, indomethacin 13.1%, and aspirin 14.1%. Most withdrawals due to adverse reaction occurred during the first 3 weeks after administration of the NSAID. Although the risk of NSAID-induced adverse reaction was different from drug to drug, the risk of adverse reaction was clinically significant.

  15. Strategic approaches to adverse outcome pathway development

    EPA Science Inventory

    Adverse outcome pathways (AOPs) are conceptual frameworks for organizing biological and toxicological knowledge in a manner that supports extrapolation of data pertaining to the initiation or early progression of toxicity to an apical adverse outcome that occurs at a level of org...

  16. Vitamin D Deficiency Increases the Risk of Adverse Neonatal Outcomes in Gestational Diabetes

    PubMed Central

    Weinert, Letícia Schwerz; Reichelt, Angela Jacob; Schmitt, Leonardo Rauber; Boff, Roberta; Oppermann, Maria Lucia Rocha; Camargo, Joiza Lins; Silveiro, Sandra Pinho

    2016-01-01

    Background Gestational diabetes mellitus (GDM) and vitamin D deficiency have been associated with increased risk of adverse perinatal outcomes but the consequences of both conditions simultaneously present in pregnancy have not yet been evaluated. Our objective was to study the influence of vitamin D deficiency in neonatal outcomes of pregnancies with GDM. Methods 184 pregnant women with GDM referred to specialized prenatal monitoring were included in this cohort and had blood sampled for 25-hydroxyvitamin D measurement. Vitamin D was measured by chemiluminescence and deficiency was defined as < 20 ng/mL. Participants were followed until puerperium and adverse neonatal outcomes were evaluated. Results Newborns of women with vitamin D deficiency had higher incidences of hospitalization in intensive care units (ICU) (32 vs 19%, P = 0.048), of hypoglycemia (any, 17.3 vs 7.1%, P = 0.039requiring ICU, 15.3 vs 3.6%, P = 0.008), and were more frequently small for gestational age (SGA) (17.3 vs 5.9%, P = 0.017). After adjustment, relative risk (RR) for hypoglycemia requiring ICU was 3.63 (95%CI 1.09–12.11) and for SGA was 4.32 (95%CI 1.75–10.66). The incidence of prematurity, jaundice and shoulder dystocia was no statistically different between groups. Conclusions In this cohort of pregnant women with GDM, vitamin D deficiency was associated with a major increase in the incidence of adverse neonatal outcomes such as SGA newborns and neonatal hypoglycemia. PMID:27764194

  17. Drug adverse events and drop-out risk: a clinical case.

    PubMed

    Scoyni, R M; Aiello, L; Trani, I; Felli, B; Masin, A M R; Camponi, V; Dignazio, L; Cortese, M; Pacitti, M T; Carratelli, D; Morocutti, C

    2007-01-01

    We report a brief discussion on a clinical case of a female patient, 85 years old, affected by severe cognitive impairment and chronic obstructive pulmonary disease (COPD). The patient was not taking drugs at home (apart from promazine: 10 drops when necessary to control her behavioral diseases). A previous neuropsychological evaluation had shown a severe cognitive impairment MMSE=16/30; ADL=3/6; IADL=0/8) due to multiple brain ischemic areas (confirmed in 2003 by MRI neuroimaging). When the patient was admitted to our center she was able to perform some basic activities of daily living such as eating and walking and was not too confused. She was included in cognitive rehabilitation groups. Since she showed signs of Parkinsonism, a therapy based on omeprazol 20mg, acetylsalicylic acid, donepezil 10mg, pramipexol 0.18 mg, nimodipine 10 drops, levodopa+carbidopa 100/25mg was started. A few days later she became sleepy during daytime and, once, she lost her balance and fell. She was not self-sufficient any more. At first this was attributed to a lung infection that the patient had, but her state continue after the infection was completely cured with appropriate antibiotics therapy. At that point an adverse drug reaction was suspected and therapy with pramipexol 0.18 mg was interrupted. In a few days the patient regained her previous level of consciousness and self-sufficiency. We consider this a typical case of complex management in a patient with dementia and comorbidity in which adverse drug reactions can play an important role in lowering the level of cognitive functions. In this case the relationship with the family of the patient was made difficult by the attitude of the patient's daughter who decided, after the onset of the adverse drug reaction, to interrupt her mother's stay in our center even at risk of the worst consequences.

  18. 'Skating on thin ice?' Consultant surgeon's contemporary experience of adverse surgical events.

    PubMed

    Skevington, Suzanne M; Langdon, Joanne E; Giddins, Grey

    2012-01-01

    Concerns about patient safety have prompted studies of adverse surgical events (ASEs), but descriptive classification of errors and malpractice claims have overshadowed qualitative investigations into the processes that lead to expert errors and their solutions. We studied consultant surgeon's perspectives on how and why events occurred through semi-structured interviews about general and specific events. The sample contained heterogeneous cross-section of ages, gender and specialists, with >2 years consultant status and working within a 25-mile radius. Overarching findings included (1) pressures to work harder, faster and beyond capability within a blaming culture; (2) optimism bias from over-confidence and complacency; and (3) multiple pressures to 'finish' an operation or list, resulting in completion bias. Seven high order themes were identified on the healthcare system, adverse event types, contributing factors, emotions, cognitive processes, error detection, and strategies, solutions and barriers. The process of classifying event types guided solution selection, and the decision about whether to formally report it. How serious consequences were for patients and their temporal effects, defined an adversity continuum. Minor events arose routinely i.e. technical discrepancies, side-effects. More problematic were sub-optimal outcomes and avoidable events. Despite their expertise, consultants were vulnerable to unavoidable, uncontrollable events which were major concerns. Most serious were near-misses, errors and mistakes. However, major errors did not inevitably lead to a catastrophe and minor errors could be extremely serious. A 'cascade' of minor events exacerbated by negative emotions can precipitate major events, and interception methods need investigation. Consultants felt powerless and helpless to change environmental, organisational and systemic problems; new communication and action channels are desirable. Confidence building in team leadership would

  19. The psychological impact of chronic environmental adversity: Responding to prolonged drought.

    PubMed

    Stain, Helen J; Kelly, Brian; Carr, Vaughan J; Lewin, Terry J; Fitzgerald, Michael; Fragar, Lyn

    2011-12-01

    The health effects of chronic environmental adversity have received insufficient attention, particularly those associated with the psychological impact of drought. Resilience or adaptive response to drought has received even less attention than vulnerability factors. This research examined factors associated with drought impact in rural and remote Australian communities. In 2008 postal surveys were completed by 302 adults (mean age 53 years; 57% female, 77% married) living in rural areas of prolonged drought exposure. Outcome measures were: (i) psychological distress (Kessler 10) and (ii) an index of concern or worry about drought. A range of predictor variables were assessed: adaptability (hopefulness, neuroticism), other adverse events, personal support and community connectedness, and sense of place, as a measure of connection to the local environment. Predictors of drought related worry differed from those associated with psychological distress levels. The former included socio-economic factors (living on a farm [Odds Ratio, OR 3.09], current employment [OR 3.64]), personal psychological characteristics (neuroticism [OR 1.29]), and greater connection with the environment (sense of place [OR 1.05]). On the other hand, psychological distress was associated chiefly with personal factors, such as higher neuroticism [OR 1.92], lower levels of hopefulness [OR 0.28], and lower perceived social support and community connectedness [OR 0.39]. Practical financial, employment and family factors were identified as important elements of drought impact, as to a lesser extent was sense of place, reflecting a confrontation with the consequences of chronic environmental degradation, while personal hopefulness may help mitigate the psychological impact of such adversity.

  20. Adverse effects of thyroid hormone preparations and antithyroid drugs.

    PubMed

    Bartalena, L; Bogazzi, F; Martino, E

    1996-07-01

    Thyroid hormone preparations, especially thyroxine, are widely used either at replacement doses to correct hypothyroidism or at suppressive doses to abolish thyrotropin (thyroid-stimulating hormone) secretion in patients with differentiated thyroid carcinoma after total thyroidectomy or with diffuse/ nodular nontoxic goitre. In order to suppress thyrotropin secretion, it is necessary to administer slightly supraphysiological doses of thyroxine. Possible adverse effects of this therapy include cardiovascular changes (shortening of systolic time intervals, increased frequency of atrial premature beats and, possibly, left ventricular hypertrophy) and bone changes (reduced bone density and bone mass), but the risk of these adverse effects can be minimised by carefully monitoring serum free thyroxine and free liothyronine (triiodothyronine) measurements and adjusting the dosage accordingly. Thionamides [thiamazole (methimazole), carbimazole, propylthiouracil] are the most widely used antithyroid drugs. They are given for long periods of time and cause adverse effects in 3 to 5% of patients. In most cases, adverse effects are minor and transient (e.g. skin rash, itching, mild leucopenia). The most dangerous effect is agranulocytosis, which occurs in 0.1 to 0.5% of patients. This life-threatening condition can now be effectively treated by granulocyte colony-stimulating factor administration. Other major adverse effects (aplastic anaemia, thrombocytopenia, lupus erythematosus-like syndrome, vasculitis) are exceedingly rare.

  1. Patient knowledge on reporting adverse drug reactions in Poland

    PubMed Central

    Staniszewska, Anna; Dąbrowska-Bender, Marta; Olejniczak, Dominik; Duda-Zalewska, Aneta; Bujalska-Zadrożny, Magdalena

    2017-01-01

    Aim The aim of the study was to assess patient knowledge on reporting of adverse drug reactions. Materials and methods A prospective study was conducted among 200 patients. The study was based on an original survey composed of 15 single- and multiple-choice questions. The study involved individuals who have experienced adverse reactions as well as individuals who have never experienced any adverse reactions; people over the age of 18; literate; residing in Mazowieckie Voivodeship, who have not been diagnosed with any disease that could compromise their logical thinking skills. Results The respondents who lived in the city had a greater knowledge compared to the respondents who lived in the countryside (Pearson’s χ2=47.70, P=0.0013). The respondents who lived in the city were also more statistically likely to provide a correct answer to the question about the type of adverse reactions to be reported (Pearson’s χ2=50.66, P=0.012). Statistically significant associations were found between the place of residence of the respondents and the correct answer to the question about the data that must be included in the report on adverse reactions (Pearson’s χ2=11.7, P<0.0001). PMID:28096661

  2. Probable Nootropicinduced Psychiatric Adverse Effects: A Series of Four Cases

    PubMed Central

    Ajaltouni, Jean

    2015-01-01

    The misuse of nootropics—any substance that may alter, improve, or augment cognitive performance, mainly through the stimulation or inhibition of certain neurotransmitters—may potentially be dangerous and deleterious to the human brain, and certain individuals with a history of mental or substance use disorders might be particularly vulnerable to their adverse effects. We describe four cases of probable nootropic-induced psychiatric adverse effects to illustrate this theory. To the best of our knowledge this has not been previously reported in the formal medical literature. We briefly describe the most common classes of nootropics, including their postulated or proven methods of actions, their desired effects, and their adverse side effects, and provide a brief discussion of the cases. Our objective is to raise awareness among physicians in general and psychiatrists and addiction specialists in particular of the potentially dangerous phenomenon of unsupervised nootropic use among young adults who may be especially vulnerable to nootropics’ negative effects. PMID:27222762

  3. Contribution of patient and hospital characteristics to adverse patient incidents.

    PubMed Central

    Elnicki, R A; Schmitt, J P

    1980-01-01

    The 1974 medical malpractice "crisis" brought about extensive legislation and insurance regulation in the United States. Hospitals in many states are now required to support risk management programs that include investigation and systematic analyses of adverse patient incidents. However, no research supports the hypothesis that systematic analysis of adverse patient incidents can identify contributory factors. In this study, a simple prediction model was used to estimate relationships between adverse incidents and selected patient and environmental characteristics in a large hospital. While some of the incident-characteristic relationships were significant, none of the estimated equations yielded results that could be logically translated into policy recommendations for the hospital. These results point to the need for further research. The benefits that positive research results would have for patients, hospitals, an the bill-paying public are obvious. Additional negative results would suggest that many legislative bodies and regulatory agencies were presumptions in requiring hospitals to conduct analyses of incidents. PMID:7461973

  4. Adverse effects of anabolic steroids in athletes. A constant threat.

    PubMed

    Maravelias, C; Dona, A; Stefanidou, M; Spiliopoulou, C

    2005-09-15

    Anabolic-androgenic steroids (AAS) are used as ergogenic aids by athletes and non-athletes to enhance performance by augmenting muscular development and strength. AAS administration is often associated with various adverse effects that are generally dose related. High and multi-doses of AAS used for athletic enhancement can lead to serious and irreversible organ damage. Among the most common adverse effects of AAS are some degree of reduced fertility and gynecomastia in males and masculinization in women and children. Other adverse effects include hypertension and atherosclerosis, blood clotting, jaundice, hepatic neoplasms and carcinoma, tendon damage, psychiatric and behavioral disorders. More specifically, this article reviews the reproductive, hepatic, cardiovascular, hematological, cerebrovascular, musculoskeletal, endocrine, renal, immunologic and psychologic effects. Drug-prevention counseling to athletes is highlighted and the use of anabolic steroids is must be avoided, emphasizing that sports goals may be met within the framework of honest competition, free of doping substances.

  5. [Rodenticide resistance and consequences].

    PubMed

    Esther, A; Endepols, S; Freise, J; Klemann, N; Runge, M; Pelz, H-J

    2014-05-01

    Resistance to anticoagulant rodenticides, such as warfarin was first described in 1958. Polymorphisms in the vitamin K epoxide reductase complex subunit 1 (VKORC1) gene and respective substitutions of amino acids in the VKOR enzyme are the major cause for rodenticide resistance. Resistant Norway rats in Germany are characterized by the Tyr139Cys genotype, which is spread throughout the northwest of the country. Resistant house mice with the VKOR variants Tyr139Cys, Leu128Ser and Arg12Trp/Ala26Ser/Ala48Thr/Arg61Leu (spretus type) are distributed over a number of locations in Germany. Resistance can reduce management attempts with consequences for stored product protection, hygiene and animal health. Anticoagulants of the first generation (warfarin, chlorophacinone, coumatetralyl) as well as bromadiolone and difenacoum are not an option for the control of resistant Norway rats. The same applies for house mice whereby the tolerance to compounds can be different between local incidences. Due to the higher toxicity and tendency to persist, the most potent anticoagulant rodenticides brodifacoum, flocoumafen and difethialone should be applied but only where resistance is known. In other cases less toxic anticoagulants should be preferred for rodent management in order to mitigate environmental risks. Resistance effects of further VKOR polymorphisms and their combinations, the spread of resistant rats and conditions supporting and reducing resistance should be investigated in order to improve resistance management strategies.

  6. Mechanisms Underlying the Association Between Early-Life Adversity and Physical Health: Charting a Course for the Future.

    PubMed

    Bush, Nicole R; Lane, Richard D; McLaughlin, Katie A

    Early-life adversities (ELA) are associated with subsequent pervasive alterations across a wide range of neurobiological systems and psychosocial factors that contribute to accelerated onset of health problems and diseases. In this article, we provide an integrated perspective on recent developments in research on ELA, based on the articles published in this Special Issue of Psychosomatic Medicine. We focus on the following: 1) the distinction between specific versus general aspects of ELA with regard to the nature of exposure (e.g., physical and sexual abuse, emotional abuse or neglect, relative socioeconomic deprivation), biological and behavioral correlates of ELA, and differences across diseases; 2) the importance of timing in the critical phases of exposure to ELA; and 3) adaptive versus dysfunctional responses to ELA and their consequences for biological and behavioral risk factors for adverse health outcomes. This article concludes with outlining important new targets for research in this area, including the neurobiology of affect as a mechanism linking ELA to adverse health outcomes, and the need for large-scale longitudinal investigations of multisystem processes relevant to ELA in diverse samples, starting prenatally, continuing to late adolescence, and with long-term follow-up assessments that enable evaluation of incident disease outcomes.

  7. Gastroschisis: Antenatal Sonographic Predictors of Adverse Neonatal Outcome

    PubMed Central

    Ferraro, Zachary Michael; Moretti, Felipe; Fung Kee Fung, Karen

    2014-01-01

    Objectives. The aim of this review was to identify clinically significant ultrasound predictors of adverse neonatal outcome in fetal gastroschisis. Methods. A quasi-systematic review was conducted in PubMed and Ovid using the key terms “gastroschisis,” “predictors,” “outcome,” and “ultrasound.” Results. A total of 18 papers were included. The most common sonographic predictors were intra-abdominal bowel dilatation (IABD), intrauterine growth restriction (IUGR), and bowel dilatation not otherwise specified (NOS). Three ultrasound markers were consistently found to be statistically insignificant with respect to predicting adverse outcome including abdominal circumference, stomach herniation and dilatation, and extra-abdominal bowel dilatation (EABD). Conclusions. Gastroschisis is associated with several comorbidities, yet there is much discrepancy in the literature regarding which specific ultrasound markers best predict adverse neonatal outcomes. Future research should include prospective trials with larger sample sizes and use well-defined and consistent definitions of the adverse outcomes investigated with consideration given to IABD. PMID:25587450

  8. Risk factors associated with adverse reactions to antituberculosis drugs.

    PubMed

    Resende, Laíse Soares Oliveira; Santos-Neto, Edson Theodoro Dos

    2015-01-01

    This review sought to identify the available scientific evidence on risk factors associated with adverse reactions to antituberculosis drugs. We performed a systematic review of studies published in the 1965-2012 period and indexed in the MEDLINE and LILACS databases. A total of 1,389 articles were initially selected. After reading their abstracts, we selected 85 studies. Of those 85 studies, 16 were included in the review. Risk factors for adverse reactions to antituberculosis drugs included age > 60 years, treatment regimens, alcoholism, anemia, and HIV co-infection, as well as sodium, iron, and albumin deficiency. Protective factors against hepatic adverse effects of antituberculosis drugs included being male (combined OR = 0.38; 95% CI: 0.20-0.72) and showing a rapid/intermediate N-acetyltransferase 2 acetylator phenotype (combined OR = 0.41; 95% CI: 0.18-0.90). There is evidence to support the need for management of adverse reactions to antituberculosis drugs at public health care facilities.

  9. Risk factors associated with adverse reactions to antituberculosis drugs*

    PubMed Central

    Resende, Laíse Soares Oliveira; dos Santos-Neto, Edson Theodoro

    2015-01-01

    This review sought to identify the available scientific evidence on risk factors associated with adverse reactions to antituberculosis drugs. We performed a systematic review of studies published in the 1965-2012 period and indexed in the MEDLINE and LILACS databases. A total of 1,389 articles were initially selected. After reading their abstracts, we selected 85 studies. Of those 85 studies, 16 were included in the review. Risk factors for adverse reactions to antituberculosis drugs included age > 60 years, treatment regimens, alcoholism, anemia, and HIV co-infection, as well as sodium, iron, and albumin deficiency. Protective factors against hepatic adverse effects of antituberculosis drugs included being male (combined OR = 0.38; 95% CI: 0.20-0.72) and showing a rapid/intermediate N-acetyltransferase 2 acetylator phenotype (combined OR = 0.41; 95% CI: 0.18-0.90). There is evidence to support the need for management of adverse reactions to antituberculosis drugs at public health care facilities. PMID:25750677

  10. Mechanisms of adverse drug reactions to biologics.

    PubMed

    Clarke, Janet B

    2010-01-01

    Biologics encompass a broad range of therapeutics that include proteins and other products derived from living systems. Although the multiplicity of target organs often seen with new chemical entities is generally not seen with biologics, they can produce significant adverse reactions. Examples include IL-12 and an anti-CD28 antibody that resulted in patient deaths and/or long stays in intensive care units. Mechanisms of toxicities can be categorized as pharmacological or nonpharmacological, with most, excepting hypersensitivity reactions, associated with the interaction of the agent with its planned target. Unexpected toxicities generally arise as a result of previously unknown biology. Manufacturing quality is a significant issue relative to the toxicity of biologics. The development of recombinant technology represented the single biggest advance leading to humanized products with minimal or no contaminants in comparison to products purified from animal tissues. Nevertheless, the type of manufacturing process including choice of cell type, culture medium, and purification method can result in changes to the protein. For example, a change to the closure system for erythropoietin led to an increase in aplastic anemia as a result of changing the immunogenicity characteristics of the protein. Monoclonal antibodies represent a major class of successful biologics. Toxicities associated with these agents include those associated with the binding of the complementary determining region (CDR) with the target. First dose reactions or infusion reactions are generally thought to be mediated via the Fc region of the antibody activating cytokine release, and have been observed with several antibodies. Usually, these effects (flu-like symptoms, etc.) are transient with subsequent dosing. Although biologics can have nonpharmacologic toxicities, these are less common than with small molecule drugs.

  11. NEO Impact Consequences and Hazards

    NASA Astrophysics Data System (ADS)

    Fulchignoni, Marcello; Barucci, M. Antonietta

    2005-04-01

    A short overview of main characteristics of the impactor population from which major terrestrial impacts originated is given. This population includes the objects that may hit the Earth in the future (potentially hazardous asteroids, PHAs). An impact frequency (a way of measuring the probability of a given collision) versus impact energy (an index of the impact consequences) relationship is described on the basis of this analysis. The current state of actions started planetwide by the most developed countries to face the threat represented by an asteroid collision with the Earth is summarized. The 'Torino scale', which assesses the risks connected with a discovery of a PHA in a simple and clear way is finally described. To cite this article: M. Fulchignoni, M.A. Barucci, C. R. Physique 6 (2005).

  12. Neurobiological Consequences of Sleep Deprivation

    PubMed Central

    Alkadhi, Karim; Zagaar, Munder; Alhaider, Ibrahim; Salim, Samina; Aleisa, Abdulaziz

    2013-01-01

    Although the physiological function of sleep is not completely understood, it is well documented that it contributes significantly to the process of learning and memory. Ample evidence suggests that adequate sleep is essential for fostering connections among neuronal networks for memory consolidation in the hippocampus. Sleep deprivation studies are extremely valuable in understanding why we sleep and what are the consequences of sleep loss. Experimental sleep deprivation in animals allows us to gain insight into the mechanism of sleep at levels not possible to study in human subjects. Many useful approaches have been utilized to evaluate the effect of sleep loss on cognitive function, each with relative advantages and disadvantages. In this review we discuss sleep and the detrimental effects of sleep deprivation mostly in experimental animals. The negative effects of sleep deprivation on various aspects of brain function including learning and memory, synaptic plasticity and the state of cognition-related signaling molecules are discussed. PMID:24179461

  13. Pump apparatus including deconsolidator

    DOEpatents

    Sonwane, Chandrashekhar; Saunders, Timothy; Fitzsimmons, Mark Andrew

    2014-10-07

    A pump apparatus includes a particulate pump that defines a passage that extends from an inlet to an outlet. A duct is in flow communication with the outlet. The duct includes a deconsolidator configured to fragment particle agglomerates received from the passage.

  14. Synergistic childhood adversities and complex adult psychopathology.

    PubMed

    Putnam, Karen T; Harris, William W; Putnam, Frank W

    2013-08-01

    Numerous studies find a cumulative effect of different types of childhood adversities on increasing risk for serious adult mental and medical outcomes. This study uses the National Comorbidity Survey-Replication sample to investigate the cumulative impact of 8 childhood adversities on complex adult psychopathology as indexed by (a) number of lifetime diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed., DSM-IV; American Psychiatric Association, 1994); (b) number of 4 DSM-IV disorder categories (mood, anxiety, impulse control, and substance abuse disorders); and (c) coexistence of internalizing and externalizing disorders. Seven of the 8 childhood adversities were significantly associated with complex adult psychopathology. Individuals with 4 or more childhood adversities had an odds ratio of 7.3, 95% confidence interval [4.7, 11.7] for 4 disorder categories. Additive and multiplicative synergistic effects increasing adult psychopathology were found for specific pairwise combinations of childhood adversities. Synergistic patterns differed by gender suggesting that women are more impacted by sexual abuse and men by economic hardship. The absence of childhood adversities was protective, in that it significantly decreased an individual's risk for subsequent adult mental illness. The results support the clinical impression that increased childhood adversity is associated with more complex adult psychopathology.

  15. Adverse events in cardiovascular-related training programs in people with spinal cord injury: A systematic review

    PubMed Central

    Warms, Catherine A.; Backus, Deborah; Rajan, Suparna; Bombardier, Charles H.; Schomer, Katherine G.; Burns, Stephen P.

    2014-01-01

    Context There are anecdotal reports of adverse events (AEs) associated with exercise in people with spinal cord injury (SCI) and consequent concern by people with SCI and their providers about potential risks of exercise. Enumeration of specific events has never been performed and the extent of risk of exercise to people with SCI is not understood. Objective To systematically review published evidence to identify and enumerate reports of adverse events or AEs associated with training in persons with SCI. Methods Review was limited to peer-reviewed studies published in English from 1970 to 2011: (1) in adults with SCI, (2) evaluating training protocols consisting of repeated sessions over at least 4 weeks to maintain or improve cardiovascular health, (3) including volitional exercise modalities and functional electrical stimulation (FES)-enhanced exercise modalities, and (4) including a specific statement about AEs. Trained reviewers initially identified a total of 145 studies. After further screening, 38 studies were included in the review. Quality of evidence was evaluated using established procedures. Results There were no serious AEs reported. There were no common AEs reported across most types of interventions, except for musculoskeletal AEs related to FES walking. There were few AEs in volitional exercise studies. Conclusion There is no evidence to suggest that cardiovascular exercise done according to guidelines and established safety precautions is harmful. To improve the strength of these conclusions, future publications should include definition of AEs, information about pre-intervention screening, and statements of the nature and extent of AEs. PMID:24090603

  16. The Consequences of Hunger and Food Insecurity for Children: Evidence from Recent Scientific Studies.

    ERIC Educational Resources Information Center

    Brandeis Univ., Waltham, MA. Center on Hunger and Poverty.

    Asserting that 13 million U.S. children live in households with limited or uncertain access to sufficient food, this report highlights recent findings showing the adverse consequences of hunger and food insecurity for children. The findings are grouped into three broad areas: health consequences, psychosocial and behavioral impacts, and learning…

  17. Adverse outcome pathway and risks of anticoagulant rodenticides to predatory wildlife.

    PubMed

    Rattner, Barnett A; Lazarus, Rebecca S; Elliott, John E; Shore, Richard F; van den Brink, Nico

    2014-01-01

    Despite a long history of successful use, routine application of some anticoagulant rodenticides (ARs) may be at a crossroad due to new regulatory guidelines intended to mitigate risk. An adverse outcome pathway for ARs was developed to identify information gaps and end points to assess the effectiveness of regulations. This framework describes chemical properties of ARs, established macromolecular interactions by inhibition of vitamin K epoxide reductase, cellular responses including altered clotting factor processing and coagulopathy, organ level effects such as hemorrhage, organism responses with linkages to reduced fitness and mortality, and potential consequences to predator populations. Risk assessments have led to restrictions affecting use of some second-generation ARs (SGARs) in North America. While the European regulatory community highlighted significant or unacceptable risk of ARs to nontarget wildlife, use of SGARs in most EU member states remains authorized due to public health concerns and the absence of safe alternatives. For purposes of conservation and restoration of island habitats, SGARs remain a mainstay for eradication of invasive species. There are significant data gaps related to exposure pathways, comparative species sensitivity, consequences of sublethal effects, potential hazards of greater AR residues in genetically resistant prey, effects of low-level exposure to multiple rodenticides, and quantitative data on the magnitude of nontarget wildlife mortality.

  18. Adverse outcome pathway and risks of anticoagulant rodenticides to predatory wildlife

    USGS Publications Warehouse

    Rattner, Barnett A.; Lazarus, Rebecca; Elliott, John E.; Shore, Richard F.; van den Brink, Nico

    2014-01-01

    Despite a long history of successful use, routine application of some anticoagulant rodenticides (ARs) may be at a crossroad due to new regulatory guidelines intended to mitigate risk. An adverse outcome pathway for ARs was developed to identify information gaps and end points to assess the effectiveness of regulations. This framework describes chemical properties of ARs, established macromolecular interactions by inhibition of vitamin K epoxide reductase, cellular responses including altered clotting factor processing and coagulopathy, organ level effects such as hemorrhage, organism responses with linkages to reduced fitness and mortality, and potential consequences to predator populations. Risk assessments have led to restrictions affecting use of some second-generation ARs (SGARs) in North America. While the European regulatory community highlighted significant or unacceptable risk of ARs to nontarget wildlife, use of SGARs in most EU member states remains authorized due to public health concerns and the absence of safe alternatives. For purposes of conservation and restoration of island habitats, SGARs remain a mainstay for eradication of invasive species. There are significant data gaps related to exposure pathways, comparative species sensitivity, consequences of sublethal effects, potential hazards of greater AR residues in genetically resistant prey, effects of low-level exposure to multiple rodenticides, and quantitative data on the magnitude of nontarget wildlife mortality.

  19. Optical modulator including grapene

    DOEpatents

    Liu, Ming; Yin, Xiaobo; Zhang, Xiang

    2016-06-07

    The present invention provides for a one or more layer graphene optical modulator. In a first exemplary embodiment the optical modulator includes an optical waveguide, a nanoscale oxide spacer adjacent to a working region of the waveguide, and a monolayer graphene sheet adjacent to the spacer. In a second exemplary embodiment, the optical modulator includes at least one pair of active media, where the pair includes an oxide spacer, a first monolayer graphene sheet adjacent to a first side of the spacer, and a second monolayer graphene sheet adjacent to a second side of the spacer, and at least one optical waveguide adjacent to the pair.

  20. The Role of ADHD in Academic Adversity: Disentangling ADHD Effects from Other Personal and Contextual Factors

    ERIC Educational Resources Information Center

    Martin, Andrew J.

    2014-01-01

    Students with attention-deficit/hyperactivity disorder (ADHD) experience significant academic difficulties that can lead to numerous negative academic consequences. With a focus on adverse academic outcomes, this study seeks to disentangle variance attributable to ADHD from variance attributable to salient personal and contextual covariates.…

  1. Fetal and perinatal consequences of maternal obesity.

    PubMed

    Vasudevan, Chakrapani; Renfrew, Mary; McGuire, William

    2011-09-01

    In many industrialised countries, one in five women booking for antenatal care is obese. As well as affecting maternal health, maternal obesity may have important adverse consequences for fetal, neonatal and long-term health and well-being. Maternal obesity is associated with a higher risk of stillbirth, elective preterm birth and perinatal mortality. The incidence of severe birth defects, particularly neural tube and structural cardiac defects, appears to be higher in infants of obese mothers. Fetal macrosomia associated with maternal obesity and gestational diabetes predisposes infants to birth injuries, perinatal asphyxia and transitional problems such as neonatal respiratory distress and metabolic instability. Maternal obesity may also result in long-term health problems for offspring secondary to perinatal problems and to intrauterine and postnatal programming effects. Currently, the available interventions to prevent and treat maternal obesity are of limited proven utility and further research is needed to define the effects of maternal weight management interventions on fetal and neonatal outcomes.

  2. Guidelines for submitting adverse event reports for publication.

    PubMed

    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 adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation and reporting of suspected drug or other medical product adverse events.

  3. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William N; Arellano, Felix M; Barnes, Joanne; Bergman, Ulf; Edwards, I Ralph; Fernandez, Alina M; Freedman, Stephen B; Goldsmith, David I; Huang, Kui; Jones, Judith K; McLeay, Rachel; Moore, Nicholas; Stather, Rosie H; Trenque, Thierry; Troutman, William G; van Puijenbroek, Eugene; Williams, Frank; Wise, Robert P

    2007-05-01

    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 adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

  4. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William N; Arellano, Felix M; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph I; Fernandez, Alina M; Freedman, Stephen B; Goldsmith, David I; Huang, Kui A; Jones, Judith K; McLeay, Rachel; Moore, Nicholas; Stather, Rosie H; Trenque, Thierry; Troutman, William G; van Puijenbroek, Eugene; Williams, Frank; Wise, Robert P

    2007-01-01

    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 adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

  5. Idiosyncratic Adverse Drug Reactions: Current Concepts

    PubMed Central

    Naisbitt, Dean J.

    2013-01-01

    Idiosyncratic drug reactions are a significant cause of morbidity and mortality for patients; they also markedly increase the uncertainty of drug development. The major targets are skin, liver, and bone marrow. Clinical characteristics suggest that IDRs are immune mediated, and there is substantive evidence that most, but not all, IDRs are caused by chemically reactive species. However, rigorous mechanistic studies are very difficult to perform, especially in the absence of valid animal models. Models to explain how drugs or reactive metabolites interact with the MHC/T-cell receptor complex include the hapten and P-I models, and most recently it was found that abacavir can interact reversibly with MHC to alter the endogenous peptides that are presented to T cells. The discovery of HLA molecules as important risk factors for some IDRs has also significantly contributed to our understanding of these adverse reactions, but it is not yet clear what fraction of IDRs have a strong HLA dependence. In addition, with the exception of abacavir, most patients who have the HLA that confers a higher IDR risk with a specific drug will not have an IDR when treated with that drug. Interindividual differences in T-cell receptors and other factors also presumably play a role in determining which patients will have an IDR. The immune response represents a delicate balance, and immune tolerance may be the dominant response to a drug that can cause IDRs. PMID:23476052

  6. Consequences of excess iodine

    PubMed Central

    Leung, Angela M.; Braverman, Lewis E.

    2014-01-01

    Iodine is a micronutrient that is essential for the production of thyroid hormones. The primary source of iodine is the diet via consumption of foods that have been fortified with iodine, including salt, dairy products and bread, or that are naturally abundant in the micronutrient, such as seafood. Recommended daily iodine intake is 150 μg in adults who are not pregnant or lactating. Ingestion of iodine or exposure above this threshold is generally well-tolerated. However, in certain susceptible individuals, including those with pre-existing thyroid disease, the elderly, fetuses and neonates, or patients with other risk factors, the risk of developing iodine-induced thyroid dysfunction might be increased. Hypothyroidism or hyperthyroidism as a result of supraphysiologic iodine exposure might be either subclinical or overt, and the source of the excess iodine might not be readily apparent. PMID:24342882

  7. Adverse Outcome Pathways: From Definition to Application

    EPA Science Inventory

    A challenge for both human health and ecological toxicologists is the transparent application of mechanistic (e.g., molecular, biochemical, histological) data to risk assessments. The adverse outcome pathway (AOP) is a conceptual framework designed to meet this need. Specifical...

  8. Design of Adverse Drug Events-Scorecards.

    PubMed

    Marcilly, Romaric; Chazard, Emmanuel; Beuscart-Zéphir, Marie-Catherine; Hackl, Werner; Băceanu, Adrian; Kushniruk, Andre; Borycki, Elizabeth M

    2011-01-01

    This paper presents the design of Adverse Drug Event-Scorecards. The scorecards described are innovative and novel, not having previously been reported in the literature. The Scorecards provide organizations (e.g. hospitals) with summary information about Adverse Drug Events (ADEs) using a Web-based platform. The data used in the Scorecards are routinely updated and report on ADEs detected through data mining processes. The development of the ADE Scorecards is ongoing and they are currently undergoing clinical testing.

  9. The association of chronic adversity with psychiatric disorder and disorder severity in adolescents.

    PubMed

    Benjet, Corina; Borges, Guilherme; Méndez, Enrique; Fleiz, Clara; Medina-Mora, Maria Elena

    2011-09-01

    The purpose of this paper is to estimate the impact of chronic adversity on psychopathology in adolescents, taking into account the type of adversity, number of adversities experienced and type of psychiatric disorder, as well as to estimate the impact on severity of the disorder. A total of 3,005 male and female adolescents from the Mexican Adolescent Mental Health Survey aged 12-17 years were interviewed in a stratified multistage general population probability survey. Assessment of 20 DSM-IV disorders, disorder severity and 12 chronic childhood adversities were assessed with the adolescent version of the World Mental Health Composite International Diagnostic Interview (WMH-CIDI-A). Family dysfunction adversities including abuse presented the most consistent associations between chronic adversity and psychopathology and their impact was generally non-specific with regard to the type of disorder. Parental divorce, parental death and economic adversity were not individually associated with psychopathology. Among those with a psychiatric disorder, sexual abuse and family violence were associated with having a seriously impairing disorder. The odds of having a psychiatric disorder and a serious disorder increased with increasing numbers of adversities; however, each additional adversity increased the odds at a decreasing rate. While the study design does not allow for conclusions regarding causality, these findings suggest general pathways from family dysfunction to psychopathology rather than specific associations between particular adversities and particular disorders, and provide further evidence for the importance of family-focused intervention and prevention efforts.

  10. Severe Adverse Events Following Cataract Surgery Among Medicare Beneficiaries

    PubMed Central

    Stein, Joshua D.; Grossman, Daniel S.; Mundy, Kevin M.; Sugar, Alan; Sloan, Frank A.

    2012-01-01

    Purpose To determine rates and risk factors associated with severe post-operative complications following cataract surgery and whether they have been changing over the past decade. Design Retrospective longitudinal cohort study Participants 221,594 Medicare beneficiaries who underwent cataract surgery during 1994–2006. Methods Beneficiaries were stratified into 3 cohorts, those who underwent initial cataract surgery during 1994-5, 1999–2000, or 2005-6. One year rates of post-operative severe adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) were determined for each cohort. Cox regression analyses determined the hazard of developing severe adverse events for each cohort with adjustment for demographic factors, ocular and medical conditions, and surgeon case-mix. Main Outcome Measures Time period rates of development of severe post-operative adverse events. Results Among the 221,594 individuals who underwent cataract surgery, 0.5% (1,086) had at least one severe post-operative complication. After adjustment for confounders, individuals who underwent cataract surgery during 1994-5 had a 21% increased hazard of being diagnosed with a severe post-operative complication (Hazard Ratio (HR): 1.21; [95% Confidence Interval (CI): 1.05–1.41]) relative to individuals who underwent cataract surgery during 2005-6. Those who underwent cataract surgery during 1999–2000 had a 20% increased hazard of experiencing a severe complication (HR: 1.20 [95% CI: 1.04–1.39]) relative to the 2005-6 cohort. Risk factors associated with severe adverse events include a prior diagnosis of proliferative diabetic retinopathy (HR: 1.62 [95% CI: 1.07–2.45]) and cataract surgery combined with another intraocular surgical procedure on the same day (HR: 2.51 [95% CI: 2.07–3.04]). Individuals receiving surgery by surgeons with the case-mix least prone to developing a severe adverse event (HR: 0.52 [95% CI: 0.44–0.62]) had a 48% reduced hazard of a severe

  11. [The use of human immunoglobulins--adverse reactions].

    PubMed

    Pituch-Noworolska, Anna; Błaut-Szlósarczyk, Anita; Zwonarz, Katarzyna

    2010-09-01

    The primary immunodeficiency, mainly humoral immunity, secondary immunodeficiency and autoimmune diseases are the indications for immunoglobulins substitution. The prolonged substitution in primary immunodeficiency includes regular intravenous infusion of immunoglobulins in 0.4-0.6 g/kg of body weight every 21-28 days. The purpose of such substitution is decrease of frequency and diminishes the clinical course of infections. The high-dose use of immunoglobulins (1-2 g/kg body weight) is preferred in autoimmune diseases based on suppressive and anti-inflammatory activity of immunoglobulins. The subcutaneous administration of immunoglobulins is an alternative to intravenous way, but the singular dose (0.1 g/kg body weight) is too low for suppressive and anti-inflammatory activity of immunoglobulins, so this substitution is indicated in primary immunodeficiency only. The adverse events of immunoglobulins differentiate because of time of occurrence and clinical character. The rapid symptoms occurred just after beginning of infusion and often present the clinical features of anaphylactoid reaction. During the infusion the occurring adverse symptoms are mild and the life-threatening situations are very rare. The next periods of typical adverse reaction are 24-48 hrs after infusion, 72 hrs and later. The mechanisms leading to adverse reaction to immunoglobulins are based on presence of IgG dimmers, stimulating high production of pro-inflammatory cytokines by immunocompetent cells. High level of cytokines is associated with high fever, chills, flu-like symptoms, feeling malaise and sick. The reaction of anti-IgA antibodies present in patient serum with IgA in immunoglobulins preparation is responsible for moderate and severe adverse clinical symptoms. The late adverse events present the symptoms of aseptic meningo-encephalitis. In case of adverse events the stopping of infusion, additions saline/ glucose infusion, anti-histaminic drugs of I and II generation and steroids

  12. Recognizing and reporting adverse drug reactions.

    PubMed Central

    Lucas, L. M.; Colley, C. A.

    1992-01-01

    Although physicians in practice are most likely to see patients with adverse drug reactions, they may fail to recognize an adverse effect or to attribute it to a drug effect and, when recognized, they may fail to report serious reactions to the US Food and Drug Administration (FDA). To recognize and attribute an adverse event to a drug effect, physicians should review the patient's clinical course, looking at patient risk factors, the known adverse reactions to the suspected drug, and the likelihood of a causal relationship between the drug and the adverse event-based on the temporal relationship, response to stopping or restarting the drug, and whether other factors could explain the reaction. Once an adverse drug reaction has been identified, the patient should be informed and appropriate documentation made in the patient's medical record. Serious known reactions and all reactions to newly released drugs or those not previously known to occur (even if the certainty is low) should be reported to the FDA. PMID:1536067

  13. Smallpox vaccination and adverse reactions. Guidance for clinicians.

    PubMed

    Cono, Joanne; Casey, Christine G; Bell, David M

    2003-02-21

    The guidance in this report is for evaluation and treatment of patients with complications from smallpox vaccination in the preoutbreak setting. Information is also included related to reporting adverse events and seeking specialized consultation and therapies for these events. The frequencies of smallpox vaccine-associated adverse events were identified in studies of the 1960s. Because of the unknown prevalence of risk factors among today's population, precise predictions of adverse reaction rates after smallpox vaccination are unavailable. The majority of adverse events are minor, but the less-frequent serious adverse reactions require immediate evaluation for diagnosis and treatment. Agents for treatment of certain vaccine-associated severe adverse reactions are vaccinia immune globulin (VIG), the first-line therapy, and cidofovir, the second-line therapy. These agents will be available under Investigational New Drug (IND) protocols from CDC and the U.S. Department of Defense (DoD). Smallpox vaccination in the preoutbreak setting is contraindicated for persons who have the following conditions or have a close contact with the following conditions: 1) a history of atopic dermatitis (commonly referred to as eczema), irrespective of disease severity or activity; 2) active acute, chronic, or exfoliative skin conditions that disrupt the epidermis; 3) pregnant women or women who desire to become pregnant in the 28 days after vaccination; and 4) persons who are immunocompromised as a result of human immunodeficiency virus or acquired immunodeficiency syndrome, autoimmune conditions, cancer, radiation treatment, immunosuppressive medications, or other immunodeficiencies. Additional contraindications that apply only to vaccination candidates but do not include their close contacts are persons with smallpox vaccine-component allergies, women who are breastfeeding, those taking topical ocular steroid medications, those with moderate-to-severe intercurrent illness, and

  14. The interplay between structure and agency in shaping the mental health consequences of job loss

    PubMed Central

    2013-01-01

    Background Job loss is a discrete life event, with multiple adverse consequences for physical and mental health and implications for agency. Our research explores the consequences of job loss for retrenched workers’ mental health by examining the interplay between their agency and the structures shaping their job loss experiences. Methods We conducted two waves of in-depth, semi-structured interviews with a sample of 33 of the more than 1000 workers who lost their jobs at Mitsubishi Motors in South Australia during 2004 and 2005 as a result of industry restructuring. Interviews capturing the mental health consequences of job loss were recorded and transcribed verbatim. Thematic analysis was employed to determine the health consequences of the job loss and the impact of structural factors. Results Main themes that emerged from the qualitative exploration of the psychological distress of job loss included stress, changes to perceived control, loss of self-esteem, shame and loss of status, experiencing a grieving process, and financial strain. Drawing on two models of agency we identified the different ways workers employed their agency, and how their agency was enabled, but mainly constrained, when dealing with job loss consequences. Conclusions Respondents’ accounts support the literature on the moderating effects of economic resources such as redundancy packages. The results suggest the need for policies to put more focus on social, emotional and financial investment to mediate the structural constraints of job loss. Our study also suggests that human agency must be understood within an individual’s whole of life circumstances, including structural and material constraints, and the personal or interior factors that shape these circumstances. PMID:23384322

  15. Regular treatment with formoterol for chronic asthma: serious adverse events

    PubMed Central

    Cates, Christopher J; Cates, Matthew J

    2014-01-01

    Background Epidemiological evidence has suggested a link between beta2-agonists and increases in asthma mortality. There has been much debate about possible causal links for this association, and whether regular (daily) long-acting beta2-agonists are safe. Objectives The aim of this review is to assess the risk of fatal and non-fatal serious adverse events in trials that randomised patients with chronic asthma to regular formoterol versus placebo or regular short-acting beta2-agonists. Search methods We identified trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trial registers for unpublished trial data and Food and Drug Administration (FDA) submissions in relation to formoterol. The date of the most recent search was January 2012. Selection criteria We included controlled, parallel design clinical trials on patients of any age and severity of asthma if they randomised patients to treatment with regular formoterol and were of at least 12 weeks’ duration. Concomitant use of inhaled corticosteroids was allowed, as long as this was not part of the randomised treatment regimen. Data collection and analysis Two authors independently selected trials for inclusion in the review. One author extracted outcome data and the second author checked them. We sought unpublished data on mortality and serious adverse events. Main results The review includes 22 studies (8032 participants) comparing regular formoterol to placebo and salbutamol. Non-fatal serious adverse event data could be obtained for all participants from published studies comparing formoterol and placebo but only 80% of those comparing formoterol with salbutamol or terbutaline. Three deaths occurred on regular formoterol and none on placebo; this difference was not statistically significant. It was not possible to assess disease-specific mortality in view of the small number of deaths. Non-fatal serious adverse events were significantly increased when

  16. Utilizing the salutogenic paradigm to investigate well-being among adult survivors of childhood sexual abuse and other adversities.

    PubMed

    Dube, Shanta R; Rishi, Shobhana

    2017-02-26

    The long-term negative consequences of adverse childhood experiences are well documented. However, less is known about salutogenesis (well-being) among adult survivors of childhood adversity. The 2010 Behavioral Risk Factor Surveillance System data were analyzed to assess the contribution of four health promoting factors (physical activity, smoking abstinence, educational level, social-emotional support) with positive health-related quality of life (HRQoL), among adults who retrospectively reported childhood abuse or exposure to other childhood toxic stressors (n=12,032) and separately for adults who reported childhood sexual abuse (CSA). Outcomes examined included positive self-rated health (good/very good/excellent); mentally unhealthy days (MUDS) and physically unhealthy days (PUDS) in the past 30 days. After controlling for demographic characteristics and existing health conditions, physical activity (p<.05), smoking abstinence (p<.05), education of high school or greater (p<.05), and social-emotional support (p<.05) were associated with positive HRQoL outcomes among adult survivors of childhood adversity and adult survivors of CSA. Each unit increase of the health promoting factor score (0-4) resulted in adjusted odds ratio of 2.1 (95% CI: 1.3-2.4) for self-rated health and 1.6 (95%CI: 1.1-2.6) for <14 PUDs among male CSA survivors; among female survivors the adjusted odds ratios were 2.4 (95% CI: 1.8-3.2) for self-rated health, 2.3 (95% CI: 1.7-3.1) for <14 MUDs, and 2.2 (95% CI: 1.6-3.0) for <14 PUDs. The study validates that a large proportion of adults survive childhood adversities and underscores the importance of the salutogenic paradigm to identify strategies that may contribute to well-being.

  17. Potential Mechanisms of Hematological Adverse Drug Reactions in Patients Receiving Clozapine in Combination With Proton Pump Inhibitors.

    PubMed

    Wiciński, Michał; Węclewicz, Mateusz M; Miętkiewicz, Mateusz; Malinowski, Bartosz; Grześk, Elżbieta; Klonowska, Joanna

    2017-03-01

    Clozapine is a second-generation antipsychotic which has proven efficacy in treating the symptoms of schizophrenia. Although clozapine therapy is associated with a number of adverse drug reactions, it is frequently used. One of the most common adverse drug reactions is gastroesophageal reflux disease which is an indication for treatment with proton pump inhibitors (PPIs). Coadministration of clozapine and PPIs increases the risk of hematological adverse drug reactions, including neutropenia and agranulocytosis. The mechanism in idiosyncratic agranulocytosis is not dose related and involves either a direct toxic or an immune-allergic effect. It is suspected that the clozapine metabolites nitrenium ion and N-desmethylclozapine may cause apoptosis or impair growth of granulocytes. Formation of N-desmethylclozapine is correlated with activity of the cytochrome P450 enzymes 1A2 and 3A4 (CYP1A2 and CYP3A4). Nitrenium ion is produced by the flavin-containing monooxygenase system of leukocytes. A drug interaction between clozapine and a PPI is a consequence of the induction of common metabolic pathways either by the PPI or clozapine. Findings to date suggest that indirect induction of flavin-containing monooxygenase by omeprazole through the aryl hydrocarbon receptor increases the expression of the enzyme mRNA and in the long term may cause the increase in activity. Moreover, induction of CYP1A2, especially by omeprazole and lansoprazole, may increase the serum concentration of N-desmethylclozapine, which can accumulate in lymphocytes and may achieve toxic levels. Another hypothesis that may explain hematological adverse drug reactions is competitive inhibition of CYP2C19, which may contribute to increased serum concentrations of toxic metabolites.

  18. Drinking Water Consequences Tools. A Literature Review

    SciTech Connect

    Pasqualini, Donatella

    2016-05-12

    In support of the goals of Department of Homeland Security’s (DHS) National Protection and Programs Directorate and the Federal Emergency Management Agency, the DHS Office of Science and Technology is seeking to develop and/or modify consequence assessment tools to enable drinking water systems owner/operators to estimate the societal and economic consequences of drinking water disruption due to the threats and hazards. This work will expand the breadth of consequence estimation methods and tools using the best-available data describing water distribution infrastructure, owner/assetlevel economic losses, regional-scale economic activity, and health. In addition, this project will deploy the consequence methodology and capability within a Web-based platform. This report is intended to support DHS effort providing a review literature review of existing assessment tools of water and wastewater systems consequences to disruptions. The review includes tools that assess water systems resilience, vulnerability, and risk. This will help to understand gaps and limitations of these tools in order to plan for the development of the next-generation consequences tool for water and waste water systems disruption.

  19. Cardiovascular and Ventilatory Consequences of Laparoscopic Surgery.

    PubMed

    Atkinson, Tamara M; Giraud, George D; Togioka, Brandon M; Jones, Daniel B; Cigarroa, Joaquin E

    2017-02-14

    Although laparoscopic surgery accounts for >2 million surgical procedures every year, the current preoperative risk scores and guidelines do not adequately assess the risks of laparoscopy. In general, laparoscopic procedures have a lower risk of morbidity and mortality compared with operations requiring a midline laparotomy. During laparoscopic surgery, carbon dioxide insufflation may produce significant hemodynamic and ventilatory consequences such as increased intraabdominal pressure and hypercarbia. Hemodynamic insults secondary to increased intraabdominal pressure include increased afterload and preload and decreased cardiac output, whereas ventilatory consequences include increased airway pressures, hypercarbia, and decreased pulmonary compliance. Hemodynamic effects are accentuated in patients with cardiovascular disease such as congestive heart failure, ischemic heart disease, valvular heart disease, pulmonary hypertension, and congenital heart disease. Prevention of cardiovascular complications may be accomplished through a sound understanding of the hemodynamic and physiological consequences of laparoscopic surgery as well as a defined operative plan generated by a multidisciplinary team involving the preoperative consultant, anesthesiologist, and surgeon.

  20. Including Jews in Multiculturalism.

    ERIC Educational Resources Information Center

    Langman, Peter F.

    1995-01-01

    Discusses reasons for the lack of attention to Jews as an ethnic minority within multiculturalism both by Jews and non-Jews; why Jews and Jewish issues need to be included; and addresses some of the issues involved in the ethical treatment of Jewish clients. (Author)

  1. Recurrent miscarriage: psychological and relational consequences for couples.

    PubMed

    Serrano, Fátima; Lima, Maria Luisa

    2006-12-01

    Recurrent miscarriage is a rare condition that has been described as a traumatic event for couples. Although symptoms of depression, anxiety and lowered self-esteem have been related after recurrent miscarriage, little is known about its impact on couple sexuality and on gender differences in attitude and the grief that follow. The objectives of this study are to describe the consequences of recurrent pregnancy loss for the couple's relationship, and explore gender differences in attitudes and grief intensity toward this kind of reproductive failure. Each member of 30 couples with at least 3 recurrent miscarriages answered a set of questionnaires, including the Impact of Events Scale (Horowitz, Wilnwe, & Alvarez, 1979), the Perinatal Grief Scale (Toedter, Lasker, & Qlhadeff, 1988), the Partnership Questionnaire (Hahlweg, 1979) and the Intimate Relationship Scale (Hetherington & Soeken, 1990). Results showed that men do grieve, but less intensely than their partners. Although the couple's relationship seemed to not be adversely affected by recurrent miscarriage, couples described sexual changes after those events. Grief was related to the quality of communication in the couple for women, and to the quality of sex life for men.

  2. Circadian Rhythm and Sleep Disruption: Causes, Metabolic Consequences, and Countermeasures

    PubMed Central

    Skene, Debra J.; Arendt, Josephine; Cade, Janet E.; Grant, Peter J.; Hardie, Laura J.

    2016-01-01

    Circadian (∼24-hour) timing systems pervade all kingdoms of life and temporally optimize behavior and physiology in humans. Relatively recent changes to our environments, such as the introduction of artificial lighting, can disorganize the circadian system, from the level of the molecular clocks that regulate the timing of cellular activities to the level of synchronization between our daily cycles of behavior and the solar day. Sleep/wake cycles are intertwined with the circadian system, and global trends indicate that these, too, are increasingly subject to disruption. A large proportion of the world's population is at increased risk of environmentally driven circadian rhythm and sleep disruption, and a minority of individuals are also genetically predisposed to circadian misalignment and sleep disorders. The consequences of disruption to the circadian system and sleep are profound and include myriad metabolic ramifications, some of which may be compounded by adverse effects on dietary choices. If not addressed, the deleterious effects of such disruption will continue to cause widespread health problems; therefore, implementation of the numerous behavioral and pharmaceutical interventions that can help restore circadian system alignment and enhance sleep will be important. PMID:27763782

  3. Adverse event profile of tigecycline: data mining of the public version of the U.S. Food and Drug Administration adverse event reporting system.

    PubMed

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

    2012-01-01

    The recent emergence of multidrug-resistant pathogens and/or pharmacokinetics-pharmacodynamics considerations may result in off-label use of a certain class of antibacterials, including tigecycline. This study was performed to clarify the safety profile of tigecycline in the user-derived manner and to compare it with the prescribing information provided by the manufacturer. Numerous spontaneous adverse event reports (AERs) submitted to the U.S. Food and Drug Administration (FDA) were analyzed after a revision of arbitrary drug names and the deletion of duplicated submissions. 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. Based on 22017956 co-occurrences, i.e., drug-adverse event pairs, found in 1644220 AERs from 2004 to 2009, 248 adverse events were suggested as tigecycline-associated ones. Adverse events with a relatively high frequency included nausea, vomiting, pancreatitis, hepatic failure, hypoglycemia, and increase in levels of alanine aminotransferase, bilirubin, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyltransferase. It is noted that cholestasis, jaundice, an increase in International Normalized Ratio, and Stevens-Johnson syndrome were also, although they were infrequent. The adverse events suggested were in agreement with information provided by the manufacturer, suggesting that off-label use hardly results in unexpected adverse events, presumably due to usage with extreme caution.

  4. Pharmacokinetic consequences of spaceflight

    NASA Technical Reports Server (NTRS)

    Putcha, L.; Cintron, N. M.

    1991-01-01

    Spaceflight induces a wide range of physiological and biochemical changes, including disruption of gastrointestinal (GI) function, fluid and electrolyte balance, circulatory dynamics, and organ blood flow, as well as hormonal and metabolic perturbations. Any of these changes can influence the pharmacokinetics and pharmacodynamics of in-flight medication. That spaceflight may alter bioavailability was proposed when drugs prescribed to alleviate space motion sickness (SMS) had little therapeutic effect. Characterization of the pharmacokinetic and/or pharmacodynamic behavior of operationally critical medications is crucial for their effective use in flight; as a first step, we sought to determine whether drugs administered in space actually reach the site of action at concentrations sufficient to elicit the therapeutic response.

  5. The Consequence of Consequence: Motivation, Anxiety, and Test Performance.

    ERIC Educational Resources Information Center

    Wolf, Lisa F.; Smith, Jeffrey K.

    1995-01-01

    The relationships of test consequence, motivation, anxiety, and performance were studied with 158 undergraduates taking a child development course. Results indicated that test consequence (grade or no grade) had a strong influence on motivation and a modest influence on performance. Motivation and anxiety had opposite effects on performance. (SLD)

  6. 4 CFR 7.5 - Adverse actions: Suspensions for 14 days or less.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 4 Accounts 1 2012-01-01 2012-01-01 false Adverse actions: Suspensions for 14 days or less. 7.5... § 7.5 Adverse actions: Suspensions for 14 days or less. (a) Policy. A GAO employee may be suspended for 14 days or less for such cause as will promote the efficiency of GAO (including...

  7. 4 CFR 7.5 - Adverse actions: Suspensions for 14 days or less.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 4 Accounts 1 2014-01-01 2013-01-01 true Adverse actions: Suspensions for 14 days or less. 7.5... § 7.5 Adverse actions: Suspensions for 14 days or less. (a) Policy. A GAO employee may be suspended for 14 days or less for such cause as will promote the efficiency of GAO (including...

  8. 40 CFR 174.71 - Submission of information regarding adverse effects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... any information regarding adverse effects on human health or the environment alleged to have been... this part. This may include, for example, researchers performing field experiments, breeders making... information. (b) Adverse effects on human health or the environment for purposes of...

  9. 40 CFR 174.71 - Submission of information regarding adverse effects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... any information regarding adverse effects on human health or the environment alleged to have been... this part. This may include, for example, researchers performing field experiments, breeders making... information. (b) Adverse effects on human health or the environment for purposes of...

  10. 40 CFR 174.71 - Submission of information regarding adverse effects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... any information regarding adverse effects on human health or the environment alleged to have been... this part. This may include, for example, researchers performing field experiments, breeders making... information. (b) Adverse effects on human health or the environment for purposes of...

  11. 40 CFR 174.71 - Submission of information regarding adverse effects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... any information regarding adverse effects on human health or the environment alleged to have been... this part. This may include, for example, researchers performing field experiments, breeders making... information. (b) Adverse effects on human health or the environment for purposes of...

  12. 40 CFR 174.71 - Submission of information regarding adverse effects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... any information regarding adverse effects on human health or the environment alleged to have been... this part. This may include, for example, researchers performing field experiments, breeders making... information. (b) Adverse effects on human health or the environment for purposes of...

  13. Mixed-effects Poisson regression analysis of adverse event reports

    PubMed Central

    Gibbons, Robert D.; Segawa, Eisuke; Karabatsos, George; Amatya, Anup K.; Bhaumik, Dulal K.; Brown, C. Hendricks; Kapur, Kush; Marcus, Sue M.; Hur, Kwan; Mann, J. John

    2008-01-01

    SUMMARY A new statistical methodology is developed for the analysis of spontaneous adverse event (AE) reports from post-marketing drug surveillance data. The method involves both empirical Bayes (EB) and fully Bayes estimation of rate multipliers for each drug within a class of drugs, for a particular AE, based on a mixed-effects Poisson regression model. Both parametric and semiparametric models for the random-effect distribution are examined. The method is applied to data from Food and Drug Administration (FDA)’s Adverse Event Reporting System (AERS) on the relationship between antidepressants and suicide. We obtain point estimates and 95 per cent confidence (posterior) intervals for the rate multiplier for each drug (e.g. antidepressants), which can be used to determine whether a particular drug has an increased risk of association with a particular AE (e.g. suicide). Confidence (posterior) intervals that do not include 1.0 provide evidence for either significant protective or harmful associations of the drug and the adverse effect. We also examine EB, parametric Bayes, and semiparametric Bayes estimators of the rate multipliers and associated confidence (posterior) intervals. Results of our analysis of the FDA AERS data revealed that newer antidepressants are associated with lower rates of suicide adverse event reports compared with older antidepressants. We recommend improvements to the existing AERS system, which are likely to improve its public health value as an early warning system. PMID:18404622

  14. Prenatal programming: adverse cardiac programming by gestational testosterone excess

    PubMed Central

    Vyas, Arpita K.; Hoang, Vanessa; Padmanabhan, Vasantha; Gilbreath, Ebony; Mietelka, Kristy A.

    2016-01-01

    Adverse events during the prenatal and early postnatal period of life are associated with development of cardiovascular disease in adulthood. Prenatal exposure to excess testosterone (T) in sheep induces adverse reproductive and metabolic programming leading to polycystic ovarian syndrome, insulin resistance and hypertension in the female offspring. We hypothesized that prenatal T excess disrupts insulin signaling in the cardiac left ventricle leading to adverse cardiac programming. Left ventricular tissues were obtained from 2-year-old female sheep treated prenatally with T or oil (control) from days 30–90 of gestation. Molecular markers of insulin signaling and cardiac hypertrophy were analyzed. Prenatal T excess increased the gene expression of molecular markers involved in insulin signaling and those associated with cardiac hypertrophy and stress including insulin receptor substrate-1 (IRS-1), phosphatidyl inositol-3 kinase (PI3K), Mammalian target of rapamycin complex 1 (mTORC1), nuclear factor of activated T cells –c3 (NFATc3), and brain natriuretic peptide (BNP) compared to controls. Furthermore, prenatal T excess increased the phosphorylation of PI3K, AKT and mTOR. Myocardial disarray (multifocal) and increase in cardiomyocyte diameter was evident on histological investigation in T-treated females. These findings support adverse left ventricular remodeling by prenatal T excess. PMID:27328820

  15. Childhood Adversities and Adult Headache in Poland and Germany

    PubMed Central

    Reuchlein, Bettina; Henn, Lea; Brian, Tamara; Schier, Katarzyna; Hardt, Jochen

    2016-01-01

    Objective Various childhood adversities have been found to be associated with chronic pain in adulthood. However, associations were moderate in most studies, i.e. odds ratios (OR) were between one and two. Method An internet survey was performed in 508 Polish and 500 German subjects. A total of 19 childhood adversities were selected and their associations with headaches explored. Age, gender and country were included as potential confounders, as well as their two-way interaction with the risk factors. Results Two strong risk factors were identified. (1) A combined score for physical and emotional neglect showed an odds ratio (OR) of 2.78 (p < .002) to the frequency of headache in adulthood as a main effect. (2) Father having had chronic pain showed an OR of 4.36 (p < .001) with headache in adulthood for women, but not for men (OR = 0.86, p < .556). The majority of the examined childhood adversities were not associated with adult headache, neither when tested individually nor as a sum score. Conclusion This study confirms results from previous ones that childhood adversities may play a role in the development of adult headache, but it is a rather minor one. Contrary to other studies, neglect turned out to be one of the strongest predictors. PMID:26859500

  16. Effect of wettability on adverse mobility immiscible floods

    SciTech Connect

    Vives, M.T.; Chang, Y.C.; Mohanty, K.K.

    1995-12-31

    Many immiscible displacements in reservoirs occur at adverse mobility. Effect of wettability on these displacements is not well understood and often ignored in reservoir simulation. Recent macroscopic theories of viscous fingering treat adverse immiscible flows similar to miscible flows, the mixing in the fingered region being controlled by a Todd-Longstaff-type functional form. The wettability of the medium is taken into account only through the use of appropriate relative permeabilities. The goal of this paper is to understand the macroscopic bypassing in adverse mobility immiscible floods. Immiscible displacements are conducted in a quarter 5-spot model in both drainage and imbibition modes at similar effective mobility ratios and viscous-to-gravity numbers. The level of bypassing and gravity override is visualized and measured. Tertiary water-alternating-gas (WAG) displacements are also conducted at various WAG ratios and viscosity ratios. Fractional flow analysis and numerical simulation are used to understand these displacements. Experiments show that macroscopic viscous fingering is present in adverse viscosity immiscible displacements where no saturation shock is expected from 1-D fractional flow theory. Bypassing due to both fingering and gravity override is higher in the drainage mode than in the imbibition mode, with other key parameters being the same. Optimum WAG ratio in water-wet rock is a function of oil/solvent viscosity ratio. The macroscopic flow theory needs to include capillarity and viscous fingering to match these experimental findings.

  17. Early Institutionalization: Neurobiological Consequences and Genetic Modifiers

    PubMed Central

    Drury, Stacy; McLaughlin, Kate; Almas, Alisa

    2011-01-01

    Children raised in the profound deprivation associated with institutionalization are at elevated risk for negative outcomes across a host of social and cognitive domains. This risk appears to be mitigated by early foster care or adoption into a family setting. Although pervasive developmental problems have been noted in a substantial proportion of previously institutionalized children, marked variation exists in the nature and severity of these deficits. Increasing evidence suggests that institutional deprivation impacts the developing brain, potentially underlying the wide range of outcomes with which it is associated. In the current review we examine the neural consequences of institutionalization and genetic factors associated with differences in outcome in an effort to characterize the consequences of early deprivation at a neurobiological level. Although the effects of institutional deprivation have been studied for more than 50 years much remains unanswered regarding the pathways through which institutionalization impacts child development. Through a more complete and nuanced assessment of the neural correlates of exposure and recovery as well as a better understanding of the individual factors involved we will be better able to delineate the impact of early adversity in the setting of severe social deprivation. PMID:21042937

  18. Do Childhood Adversities Predict Suicidality? Findings from the General Population of the Metropolitan Area of São Paulo, Brazil

    PubMed Central

    Andrade, Laura Helena; Borges, Guilherme; Santana, Geilson Lima; Viana, Maria Carmen; Wang, Yuan-Pang

    2016-01-01

    Background Childhood adversities have been associated with a number of medical and psychiatric outcomes. However, the reported effects that specific childhood adversities have on suicidality vary across studies. Method This was a cross-sectional, stratified, multistage area probability investigation of a general population in Brazil, designated the São Paulo Megacity Mental Health Survey. The World Mental Health Composite International Diagnostic Interview was applied in 5037 individuals ≥ 18 years of age, in order to assess 12 different adversities occurring during childhood and/or adolescence, as well as to look for associations between those adversities and subsequent suicidality in different age strata. Results Over half of the respondents reported at least one childhood adversity. Only physical abuse was consistently associated with suicide attempts in all subsequent life stages (OR = 2.1). Among adults 20–29 years of age, the likelihood of a suicide attempt was correlated with parental divorce, whereas suicidal ideation was associated with prior sexual abuse. Among adults over 30 years of age, physical illness and economic adversity emerged as relevant childhood adversities associated with suicide attempts, whereas sexual abuse, family violence, and economic adversity were associated with suicidal ideation. Conclusion Childhood adversities, especially physical abuse, are likely associated with unfavorable consequences in subsequent years. For suicidality across a lifespan, the role of different childhood adversities must be examined independently. PMID:27192171

  19. College Drinking Games and Observed Consequences.

    ERIC Educational Resources Information Center

    Newman, Ian M.; Crawford, Janet K.

    A study was done to examine the role of college student drinking games, the consequences of playing drinking games, and the motivational nuances involved in playing these games. A typology of drinking games is presented; it includes five categories: (1) consumption games (who can consume the most alcohol during a given event); (2) skill games (the…

  20. Change and Its Consequences: A Case Study.

    ERIC Educational Resources Information Center

    Pierce, Susan Resneck

    2000-01-01

    The University of Puget Sound, Washington, represents a case study in institutional change (and its consequences) through innovative planning and bold initiatives. Over a decade of decisive actions that included ongoing conversation and communication, with all the fallout that entailed, has refashioned the institution into a stronger undergraduate…

  1. [Management of adverse effects with antituberculosis chemotherapy].

    PubMed

    Tsuyuguchi, Kazunari; Wada, Masako

    2011-02-01

    Tuberculosis has now become a curable disease with chemotherapy. So it is natural that the present issues in tuberculosis management are focused on how to complete standard chemotherapy. In this context, management of adverse effects constitutes an essential part of antituberculosis chemotherapy, as well as directly observed therapy. In this symposium, discussions were held about three major subjects on this issue. First, hepatotoxicity develops frequently and has sometimes fatal outcome, which makes it the most problematic adverse effect. "Management of hepatotoxicity during antituberculosis chemotherapy" was published by the Japanese Society for Tuberculosis (JST) in 2006. Dr. Shinsho Yoshiba evaluated this recommendation and pointed out that the criteria for discontinuation of drug based on AST, ALT and bilirubin levels is too sensitive and the concept of predicting fulminant hepatic failure (FHF) is lacking. He stressed the importance of monitoring serum prothrombin time for predicting FHF. Next, allergic drug reaction such as fever or skin rash often causes distress, although rarely fatal. As isoniazid (INH) and rifampicin (RFP) are key drugs for the cure, readministration of these drugs is often attempted by desensitization therapy. "Recommendation about desensitization therapy of antituberculosis drugs" was also published by JST in 1997. Dr. Yoshihiro Kobashi reported high success rates of 79 percent for INH and 75 percent for RFP according to this recommendation. He also reported correlated factor with the success, such as the longer period from the discontinuation to the desensitization therapy and lower doses of drugs at starting desensitization. Finally, we sometimes experience transient worsening of radiographical findings and general symptoms during antituberculosis chemotherapy. This is presumed to be due to allergic reaction to dead bacilli without requiring discontinuation of the drug. Differential diagnosis includes drug-induced pneumonia requring

  2. Is It Adverse, Nonadverse, Adaptive, or Artifact?

    PubMed

    Pandiri, Arun R; Kerlin, Roy L; Mann, Peter C; Everds, Nancy E; Sharma, Alok K; Myers, L Peyton; Steinbach, Thomas J

    2017-01-01

    One of the principal challenges facing a toxicologic pathologist is to determine and differentiate a true adverse effect from a nonadverse or an adaptive response. Recent publications from the Society of Toxicologic Pathology (STP) and the European STP provide guidance for determining and communicating adversity in nonclinical toxicology studies. In order to provide a forum to inform and engage in a discussion on this important topic, a continuing education (CE) course was held during the 2016 STP Annual meeting in San Diego, CA. The lectures at this course provided guidance on determining and communicating adversity using case studies involving both clinical pathology and anatomic pathology. In addition, one talk also focused on data quality, study design, and interpretation of artifacts that could hinder the determination of adversity. The CE course ended with a talk on understanding adversity in preclinical studies and engaging the regulatory agencies in the decision-making process. This manuscript is designed to provide brief summaries of all the talks in this well-received CE course.

  3. Environmental adversity and uncertainty favour cooperation

    PubMed Central

    Andras, Peter; Lazarus, John; Roberts, Gilbert

    2007-01-01

    Background A major cornerstone of evolutionary biology theory is the explanation of the emergence of cooperation in communities of selfish individuals. There is an unexplained tendency in the plant and animal world – with examples from alpine plants, worms, fish, mole-rats, monkeys and humans – for cooperation to flourish where the environment is more adverse (harsher) or more unpredictable. Results Using mathematical arguments and computer simulations we show that in more adverse environments individuals perceive their resources to be more unpredictable, and that this unpredictability favours cooperation. First we show analytically that in a more adverse environment the individual experiences greater perceived uncertainty. Second we show through a simulation study that more perceived uncertainty implies higher level of cooperation in communities of selfish individuals. Conclusion This study captures the essential features of the natural examples: the positive impact of resource adversity or uncertainty on cooperation. These newly discovered connections between environmental adversity, uncertainty and cooperation help to explain the emergence and evolution of cooperation in animal and human societies. PMID:18053138

  4. The Consequences of School Desegregation.

    ERIC Educational Resources Information Center

    Rossell, Christine H., Ed.; Hawley, Willis D., Ed.

    Materials on a variety of subjects related to school desegregation are collected in this book. Chapter 1 discusses assumptions about the overall consequences of desegregation. Chapters 2 to 5 synthesize the findings of existing research on the consequences of school desegregation for children and communities. Finally, Chapter 6 describes…

  5. Consequences of Diffusion of Innovations.

    ERIC Educational Resources Information Center

    Goss, Kevin F.

    1979-01-01

    The article traces evolution of diffusion theory; illustrates undesirable consequences in a cross-cultural setting, reviews criticisms of several scholars; considers distributional effects and unanticipated consequences for potential ameliorative impact on diffusion theory; and codifies these factors into a framework for research into consequences…

  6. Institutional Consequences of Quality Assessment

    ERIC Educational Resources Information Center

    Joao Rosa, Maria; Tavares, Diana; Amaral, Alberto

    2006-01-01

    This paper analyses the opinions of Portuguese university rectors and academics on the quality assessment system and its consequences at the institutional level. The results obtained show that university staff (rectors and academics, with more of the former than the latter) held optimistic views of the positive consequences of quality assessment…

  7. Drug-Related Adverse Events of Osteoporosis Therapy.

    PubMed

    Khan, Moin; Cheung, Angela M; Khan, Aliya A

    2017-03-01

    Postmenopausal osteoporosis is associated with microarchitectural deterioration and increased risk of fracture. Osteoporosis therapy effectively reduces the risk of vertebral, nonvertebral, and hip fracture and has been associated with increased survival. Currently approved treatments for osteoporosis include bisphosphonates, denosumab, selective estrogen receptor modulators, and teriparatide. This article reviews the adverse events of therapy associated with these medical interventions. Hormone replacement therapy is not included, because it is no longer indicated for the treatment of osteoporosis in all countries. Calcitonin and strontium ranelate are also not included, because their indication for osteoporosis has recently been limited or withdrawn.

  8. Nutritional therapies (including fosteum).

    PubMed

    Nieves, Jeri W

    2009-03-01

    Nutrition is important in promoting bone health and in managing an individual with low bone mass or osteoporosis. In adult women and men, known losses of bone mass and microarchitecture occur, and nutrition can help minimize these losses. In every patient, a healthy diet with adequate protein, fruits, vegetables, calcium, and vitamin D is required to maintain bone health. Recent reports on nutritional remedies for osteoporosis have highlighted the importance of calcium in youth and continued importance in conjunction with vitamin D as the population ages. It is likely that a calcium intake of 1200 mg/d is ideal, and there are some concerns about excessive calcium intakes. However, vitamin D intake needs to be increased in most populations. The ability of soy products, particularly genistein aglycone, to provide skeletal benefit has been recently studied, including some data that support a new medical food marketed as Fosteum (Primus Pharmaceuticals, Scottsdale, AZ).

  9. System Safety and the Unintended Consequence

    NASA Technical Reports Server (NTRS)

    Watson, Clifford

    2012-01-01

    The analysis and identification of risks often result in design changes or modification of operational steps. This paper identifies the potential of unintended consequences as an over-looked result of these changes. Examples of societal changes such as prohibition, regulatory changes including mandating lifeboats on passenger ships, and engineering proposals or design changes to automobiles and spaceflight hardware are used to demonstrate that the System Safety Engineer must be cognizant of the potential for unintended consequences as a result of an analysis. Conclusions of the report indicate the need for additional foresight and consideration of the potential effects of analysis-driven design, processing changes, and/or operational modifications.

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

    PubMed Central

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

    2013-01-01

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

  11. Adverse-event profile of Crataegus spp.: a systematic review.

    PubMed

    Daniele, Claudia; Mazzanti, Gabriela; Pittler, Max H; Ernst, Edzard

    2006-01-01

    Crataegus spp. (hawthorn) monopreparations are predominantly used for treating congestive heart failure. The effectiveness of hawthorn preparations (flowers with leaves; berries) is documented in a number of clinical studies, reviews and meta-analyses. The aim of this article is to assess the safety data of all available human studies on hawthorn monopreparations. Systematic searches were conducted on MEDLINE, EMBASE, AMED, The Cochrane Library, the UK National Research Register and the US ClinicalTrials.gov (up to January 2005). Data were requested from the spontaneous reporting scheme of the WHO. Hand searches were also conducted in a sample of relevant medical journals, conference proceedings, reference lists of identified articles and our own files. Eight manufacturers of hawthorn-containing preparations were contacted and asked to supply any information on adverse events or drug interactions. Data from all clinical studies and reports were assessed. Only human studies on monopreparations were included. Data from hawthorn-containing combination preparations and homeopathic preparations were excluded. All studies were read and evaluated by one reviewer and independently verified by at least one additional reviewer.Twenty-nine clinical studies were identified, of which 24 met our inclusion criteria. A total of 7311 patients were enrolled, and data from 5,577 patients were available for analysis. The daily dose and duration of treatment with hawthorn monopreparations ranged from 160 to 1,800 mg and from 3 to 24 weeks, respectively. The extracts most used in the clinical trials were WS 1,442 (extract of hawthorn standardised to 18.75% oligomeric procyanidins) and LI 132 (extract of hawthorn standardised to 2.25% flavonoids). Overall, 166 adverse events were reported. Most of these adverse events were, in general, mild to moderate; eight severe adverse events have been reported with the LI 132 extract. The most frequent adverse events were dizziness/vertigo (n = 15

  12. Standardizing drug adverse event reporting data.

    PubMed

    Wang, Liwei; Jiang, Guoqian; Li, Dingcheng; Liu, Hongfang

    2013-01-01

    Normalizing data in the Adverse Event Reporting System (AERS), an FDA database, would improve the mining capacity of AERS for drug safety signal detection. In this study, we aim to normalize AERS and build a publicly available normalized Adverse drug events (ADE) data source.he drug information in AERS is normalized to RxNorm, a standard terminology source for medication. Drug class information is then obtained from the National Drug File - Reference Terminology (NDF-RT). Adverse drug events (ADE) are aggregated through mapping with the PT (Preferred Term) and SOC (System Organ Class) codes of MedDRA. Our study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). The AERS-DM could provide more perspectives to mine AERS database for drug safety signal detection and could be used by research community in the data mining field.

  13. [Adverse reaction to not iodinated contrast].

    PubMed

    Palma-Gómez, Samuel; González-Díaz, Sandra Nora; Arias-Cruz, Alfredo; Macías-Weinmann, Alejandra; Amaro-Vivian, Laura Elizabeth; Pérez-Vanzzini, Rafael; Gutiérrez-Mujica, José Julio; Yong-Rodríguez, Adrián

    2014-01-01

    Adverse reactions to drugs are relatively frequent in clinical practice, and some of them can be life threatening. Reactions to contrast material (CM) represent an important percentage of these adverse reactions. It has been found that 70% of reactions to contrast material happen within the first five minutes of their administration. Despite the fact that hypersensitivity reactions are traditionally classified as non-allergic, in recent years investigators have reported positive skin prick tests in patients with immediate and late reactions to contrast material. This paper reports the case of a female patient with non-Hodgkin lymphoma that has presented on two distinct occasions adverse reactions to contrast material. We discuss on the type of reaction, severity, suggested prophylaxis, prognosis and recommendations, keeping in mind the underlying disease and the need to have further image studies performed.

  14. Adverse events related to blood transfusion.

    PubMed

    Sahu, Sandeep; Hemlata; Verma, Anupam

    2014-09-01

    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.

  15. Adverse Reactions in Allogeneic Blood Donors: A Tertiary Care Experience from a Developing Country

    PubMed Central

    Sultan, Sadia; Baig, Mohammad Amjad; Irfan, Syed Mohammed; Ahmed, Syed Ijlal; Hasan, Syeda Faiza

    2016-01-01

    Objectives Fragmented blood transfusion services along with an unmotivated blood donation culture often leads to blood shortage. Donor retention is crucial to meet the increasing blood demand, and adverse donor reactions have a negative impact on donor return. The aim of this study was to estimate adverse donor reactions and identify any demographic association.   Methods We conducted a prospective study between January 2011 and December 2013. A total of 41,759 healthy donors were enrolled. Professionally trained donor attendants drew blood and all donors were observed during and following donation for possible adverse events for 20 minutes. Blood donors were asked to report if they suffered from any delayed adverse consequences.   Results Out of 41,759 blood donors, 537 (1.3%) experienced adverse reactions. The incidence was one in every 78 donations. The mean age of donors who experienced adverse events was 26.0±6.8 years, and all were male. Out of 537 donors, 429 (80%) developed vasovagal reaction (VVR), 133 (25%) had nausea, 63 (12%) fainted, 35 (6%) developed hyperventilation, 9 (2%) had delayed syncope, and 9 (2%) developed hematoma. Arterial prick, nerve injury, cardiac arrest, and seizures were not observed. Donors aged less than < 30 years and weighing < 70 kg were significantly associated with VVR, hyperventilation, and nausea (p < 0.005). Undergraduates and Urdu speaking donors also had a significant association with fainting and nausea, respectively (p < 0.05).   Conclusion The prevalence of adverse events was low at our tertiary center. A VVR was the predominant adverse reaction and was associated with age and weight. Our study highlights the importance of these parameters in the donation process. A well-trained and experienced phlebotomist and pre-evaluation counseling of blood donors could further minimize the adverse reactions. PMID:27168923

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

    PubMed Central

    Golder, Su; Wright, Kath

    2016-01-01

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

  17. Adversity in childhood and depression: linked through SIRT1

    PubMed Central

    Lo Iacono, L; Visco-Comandini, F; Valzania, A; Viscomi, M T; Coviello, M; Giampà, A; Roscini, L; Bisicchia, E; Siracusano, A; Troisi, A; Puglisi-Allegra, S; Carola, V

    2015-01-01

    Experiencing an adverse childhood and parental neglect is a risk factor for depression in the adult population. Patients with a history of traumatic childhood develop a subtype of depression that is characterized by earlier onset, poor treatment response and more severe symptoms. The long-lasting molecular mechanisms that are engaged during early traumatic events and determine the risk for depression are poorly understood. In this study, we altered adult depression-like behavior in mice by applying juvenile isolation stress. We found that this behavioral phenotype was associated with a reduction in the levels of the deacetylase sirtuin1 (SIRT1) in the brain and in peripheral blood mononuclear cells. Notably, peripheral blood mRNA expression of SIRT1 predicted the extent of behavioral despair only when depression-like behavior was induced by juvenile—but not adult—stress, implicating SIRT1 in the regulation of adult behavior at early ages. Consistent with this hypothesis, pharmacological modulation of SIRT1 during juvenile age altered the depression-like behavior in naive mice. We also performed a pilot study in humans, in which the blood levels of SIRT1 correlated significantly with the severity of symptoms in major depression patients, especially in those who received less parental care during childhood. On the basis of these novel findings, we propose the involvement of SIRT1 in the long-term consequences of adverse childhood experiences. PMID:26327687

  18. Pharmacovigilance, risks and adverse effects of self-medication.

    PubMed

    Montastruc, Jean-Louis; Bondon-Guitton, Emmanuelle; Abadie, Delphine; Lacroix, Isabelle; Berreni, Aurélia; Pugnet, Grégory; Durrieu, Geneviève; Sailler, Laurent; Giroud, Jean-Paul; Damase-Michel, Christine; Montastruc, François

    2016-04-01

    Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used. Whilst the theoretical risks of self-medication have been abundantly discussed in the literature (adverse effects, interactions, product, dosage or treatment duration errors, difficulty in self-diagnosis, risk of addiction or abuse…), there is in fact very little detailed pharmacovigilance data concerning the characteristics and the consequences of this usage in real life. This study therefore describes the all too rare data that is available: patients, clinical characteristics, "seriousness" and drugs involved in the adverse effects of self-medication. It also discusses leads to be followed in order to minimize medication risks, which are obviously not well known and clearly not sufficiently notified.

  19. Refraction, including prisms.

    PubMed

    Hiatt, R L

    1991-02-01

    The literature in the past year on refraction is replete with several isolated but very important topics that have been of interest to strabismologists and refractionists for many decades. The refractive changes in scleral buckling procedures include an increase in axial length as well as an increase in myopia, as would be expected. Tinted lenses in dyslexia show little positive effect in the nonasthmatic patients in one study. The use of spectacles or bifocals as a way to control increase in myopia is refuted in another report. It has been shown that in accommodative esotropia not all patients will be able to escape the use of bifocals in the teenage years, even though surgery might be performed. The hope that disposable contact lenses would cut down on the instance of giant papillary conjunctivitis and keratitis has been given some credence, and the conventional theory that sclerosis alone is the cause of presbyopia is attacked. Also, gas permeable bifocal contact lenses are reviewed and the difficulties of correcting presbyopia by this method outlined. The practice of giving an aphakic less bifocal addition instead of a nonaphakic, based on the presumption of increased effective power, is challenged. In the review of prisms, the majority of articles concern prism adaption. The most significant report is that of the Prism Adaptation Study Research Group (Arch Ophthalmol 1990, 108:1248-1256), showing that acquired esotropia in particular has an increased incidence of stable and full corrections surgically in the prism adaptation group versus the control group.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. [Demographic trends in Thailand (1970-1981) and their consequences].

    PubMed

    Laine, J

    1985-01-01

    A review of demographic trends in Thailand between 1970 and 1981 and its consequences is presented. Separate consideration is given to urbanization and migration. The negative consequences of population growth discussed include the decrease in available arable land, poverty, and unemployment. Consideration is also given to the health status of the population, including public health, family planning, and malnutrition.

  1. Depicting adverse events in cardiac theatre: the preliminary conception of the RECORD model

    PubMed Central

    2013-01-01

    Human error is a byproduct of the human activity and may results in random unintended events; they may have major consequences when it comes to delivery of medicine. Furthermore the causes of error in surgical practice are multifaceted and complex. This article aims to raise awareness for safety measures in the cardiac surgical room and briefly “touch upon” the human factors that could lead to adverse outcomes. Finally, we describe a model that would enable us to depict and study adverse events in the operating theatre. PMID:23510398

  2. Transgenerational transmission of pregestational and prenatal experience: maternal adversity, enrichment, and underlying epigenetic and environmental mechanisms.

    PubMed

    Taouk, L; Schulkin, J

    2016-12-01

    Transgenerational transmission refers to positive and negative adaptations in brain function and behavior that affect following generations. In this paper, empirical findings regarding the transgenerational transmission of maternal adversity during three critical periods - childhood, pregestational adulthood and pregnancy - will be reviewed in terms of pregnancy outcomes, maternal care, offspring behavior and development, and physiological functioning. Research on the transgenerational transmission of enrichment and the implications for interventions to ameliorate the consequences of adversity will also be presented. In the final section, underlying epigenetic and environmental mechanisms that have been proposed to explain how experience is transferred across generations through transgenerational transmission will be reviewed. Directions for future research are suggested throughout.

  3. Mechanisms and assessment of statin-related muscular adverse effects.

    PubMed

    Moßhammer, Dirk; Schaeffeler, Elke; Schwab, Matthias; Mörike, Klaus

    2014-09-01

    Statin-associated muscular adverse effects cover a wide range of symptoms, including asymptomatic increase of creatine kinase serum activity and life-threatening rhabdomyolysis. Different underlying pathomechanisms have been proposed. However, a unifying concept of the pathogenesis of statin-related muscular adverse effects has not emerged so far. In this review, we attempt to categorize these mechanisms along three levels. Firstly, among pharmacokinetic factors, it has been shown for some statins that inhibition of cytochrome P450-mediated hepatic biotransformation and hepatic uptake by transporter proteins contribute to an increase of systemic statin concentrations. Secondly, at the myocyte membrane level, cell membrane uptake transporters affect intracellular statin concentrations. Thirdly, at the intracellular level, inhibition of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase results in decreased intracellular concentrations of downstream metabolites (e.g. selenoproteins, ubiquinone, cholesterol) and alteration of gene expression (e.g. ryanodine receptor 3, glycine amidinotransferase). We also review current recommendations for prescribers.

  4. Regular treatment with salmeterol for chronic asthma: serious adverse events

    PubMed Central

    Cates, Christopher J; Cates, Matthew J

    2014-01-01

    Background Epidemiological evidence has suggested a link between beta2-agonists and increases in asthma mortality. There has been much debate about possible causal links for this association, and whether regular (daily) long-acting beta2-agonists are safe. Objectives The aim of this review is to assess the risk of fatal and non-fatal serious adverse events in trials that randomised patients with chronic asthma to regular salmeterol versus placebo or regular short-acting beta2-agonists. Search methods We identified trials using the Cochrane Airways Group Specialised Register of trials. We checked websites of clinical trial registers for unpublished trial data and FDA submissions in relation to salmeterol. The date of the most recent search was August 2011. Selection criteria We included controlled parallel design clinical trials on patients of any age and severity of asthma if they randomised patients to treatment with regular salmeterol and were of at least 12 weeks’ duration. Concomitant use of inhaled corticosteroids was allowed, as long as this was not part of the randomised treatment regimen. Data collection and analysis Two authors independently selected trials for inclusion in the review. One author extracted outcome data and the second checked them. We sought unpublished data on mortality and serious adverse events. Main results The review includes 26 trials comparing salmeterol to placebo and eight trials comparing with salbutamol. These included 62,815 participants with asthma (including 2,599 children). In six trials (2,766 patients), no serious adverse event data could be obtained. All-cause mortality was higher with regular salmeterol than placebo but the increase was not significant (Peto odds ratio (OR) 1.33 (95% CI 0.85 to 2.08)). Non-fatal serious adverse events were significantly increased when regular salmeterol was compared with placebo (OR 1.15 95% CI 1.02 to 1.29). One extra serious adverse event occurred over 28 weeks for every 188 people

  5. Adverse Effects of Bisphosphonates: Implications for Osteoporosis Management

    PubMed Central

    Kennel, Kurt A.; Drake, Matthew T.

    2009-01-01

    Bisphosphonates are widely prescribed and highly effective at limiting the bone loss that occurs in many disorders characterized by increased osteoclast-mediated bone resorption, including senile osteoporosis in both men and women, glucocorticoid-associated osteoporosis, and malignancies metastatic to bone. Although they are generally well tolerated, potential adverse effects may limit bisphosphonate use in some patients. Optimal use of bisphosphonates for osteoporosis requires adequate calcium and vitamin D intake before and during therapy. The World Health Organization fracture risk assessment algorithm is currently available to determine absolute fracture risk in patients with low bone mass and is a useful tool for clinicians in identifying patients most likely to benefit from pharmacological intervention to limit fracture risk. This fracture risk estimate may facilitate shared decision making, especially when patients are wary of the rare but serious adverse effects that have recently been described for this class of drugs. PMID:19567717

  6. [Adverse cutaneous reactions induced by exposure to woods].

    PubMed

    Chomiczewska-Skóra, Dorota

    2013-01-01

    Various adverse cutaneous reactions may occur as a result of exposure to wood dust or solid woods. These include allergic contact dermatitis, irritant contact dermatitis and, more rarely, contact urticaria, photoallergic and phototoxic reactions. Also cases of erythema multiforme-like reactions have been reported. Contact dermatitis, both allergic and irritant, is most frequently provoked by exotic woods, e.g. wood of the Dalbergia spp., Machaerium scleroxylon or Tectona grandis. Cutaneous reactions are usually associated with manual or machine woodworking, in occupational setting or as a hobby. As a result of exposure to wood dust, airborne contact dermatitis is often diagnosed. Cases of allergic contact dermatitis due to solid woods of finished articles as jewelry or musical instruments have also been reported. The aim of the paper is to present various adverse skin reactions related to exposure to woods, their causal factors and sources of exposure, based on the review of literature.

  7. Early Adverse Care, Stress Neurobiology, and Prevention Science: Lessons Learned

    PubMed Central

    Bruce, Jacqueline; Gunnar, Megan R.; Pears, Katherine C.; Fisher, Philip A.

    2013-01-01

    There is growing evidence that some of the difficulties observed among children who have experienced early adverse care (e.g., children internationally adopted from institutional care and maltreated children in foster care) involve experience-induced alterations in stress-responsive neurobiological systems, including the hypothalamic-pituitary-adrenocortical (HPA) system. Thus, incorporating stress neurobiology into prevention research could aid in identifying the children most in need of preventive intervention services, elucidating the mechanisms of change in effective interventions, and providing insight into the differential responses of children to effective interventions. However, integrating stress neurobiology and prevention research is challenging. In this paper, the results of studies examining HPA system activity in children who have experienced early adverse care are reviewed, the implications of these results for prevention research are discussed, and critical steps for successfully incorporating stress neurobiology into prevention research are identified. PMID:23420476

  8. Reducing Adverse Impact: One City's Efforts.

    ERIC Educational Resources Information Center

    Prewitt, Jeff

    Following a workshop on "Innovations in Employment Testing that Improve Validity and Reduce Adverse Impact," the City of Louisville (Kentucky) implemented a strategy to develop a comprehensive testing and recruiting program for police recruits. To improve candidate expectations and preparation, the following activities were undertaken:…

  9. Educational Leadership: The Uses of Adversity

    ERIC Educational Resources Information Center

    Culbertson, Jack

    1976-01-01

    Skepticism about the power of education challenges the educational administrator to (1) attain a better understanding of the sources of dissatisfaction and their implications for change, (2) learn to cope with adversity and make constructive use of it, and (3) define the leadership requirements needed to address education's problems. (MB)

  10. The adverse outcome pathway knowledge base

    EPA Science Inventory

    The rapid advancement of the Adverse Outcome Pathway (AOP) framework has been paralleled by the development of tools to store, analyse, and explore AOPs. The AOP Knowledge Base (AOP-KB) project has brought three independently developed platforms (Effectopedia, AOP-Wiki, and AOP-X...

  11. Clinical spectrum of adverse reactions to tartrazine.

    PubMed

    Collins-Williams, C

    1985-01-01

    Tartrazine, a common additive in foods and drugs, often causes adverse reactions such as recurrent urticaria, angioedema, and asthma and is frequently implicated in hyperkinesis. This paper summarizes the recent literature on the subject and outlines a practical approach for the practicing physician to diagnose and treat these patients in an optimal manner.

  12. Adverse skin reactions following intravitreal bevacizumab injection

    PubMed Central

    Ameen, S; Entabi, M; Lee, N; Stavrakoglou, A

    2011-01-01

    The authors describe two separate cases of skin eruption following intravitreal bevacizumab injection with evidence to suggest that these were adverse drug reactions to bevacizumab. The authors also discuss how each case was treated and report on the final outcome. PMID:22715260

  13. Due Process in Adverse Personnel Action.

    ERIC Educational Resources Information Center

    Scriven, Michael

    1997-01-01

    A detailed checklist and timeline for ensuring due process are provided for adverse personnel actions, and the need to supplement this with expert, same-jurisdiction legal advice is stressed. This approach emphasizes the importance of treating due process as an ethical as well as a legal requirement. (SLD)

  14. Adverse outcome pathway (AOP) development and evaluation

    EPA Science Inventory

    The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be mea...

  15. Resilience in the Face of Adversity.

    ERIC Educational Resources Information Center

    Patterson, Jerry

    2001-01-01

    "Resilience" is the capacity for moving ahead under adverse circumstances. School superintendents are advised to stay upbeat and mindful of "both-and" opportunities; stay focused on what they care about; remain flexible and tolerant of ambiguity; be proactive, not reactive; and apply resilience-conserving strategies during…

  16. Parental drinking and adverse outcomes in children: A scoping review of cohort studies

    PubMed Central

    Felix, Lambert; Keating, Patrick; McCambridge, Jim

    2015-01-01

    Abstract Introduction and Aims There is a growing interest in measuring alcohol's harms to people other than the drinker themselves. ‘Children of alcoholics’ and foetal alcohol spectrum disorder have received widespread attention. Less is known about how children are affected by post‐natal exposure to parental drinking other than alcohol abuse/dependence. In this scoping review, we aim to assemble and map existing evidence from cohort studies on the consequences of parental alcohol use for children, and to identify limitations and gaps in this literature. Design and Methods Systematic review methods were used. Electronic databases were searched (1980 to October 2013) and a total of 3215 abstracts were screened, 326 full text papers examined and 99 eligible for inclusion according to selection criteria including separation of exposure and outcome measurement in time and report of a quantitative effect size. Results The main finding is the large literature available. Adolescent drinking behaviour was the most common outcome measure and outcomes other than substance use were rarely analysed. In almost two of every three published associations, parental drinking was found to be statistically significantly associated with a child harm outcome measure. Several limitations in the literature are noted regarding its potential to address a possible causal role of parental drinking in children's adverse outcomes. Discussion and Conclusions This study identifies targets for further study and provides a platform for more targeted analytic investigations which ascertain risk of bias, and which are capable of considering the appropriateness of causal inferences for the observed associations. [Rossow I, Felix L, Keating P, McCambridge J. Parental drinking and adverse outcomes in children: A scoping review of cohort studies. Drug Alcohol Rev 2016;35:397–405] PMID:26332090

  17. The prevalence of adverse cardiometabolic responses to exercise training with evidence-based practice is low

    PubMed Central

    Dalleck, Lance C; Van Guilder, Gary P; Richardson, Tara B; Vella, Chantal A

    2015-01-01

    Background The purpose of this study was to determine the prevalence of individuals who experienced exercise-induced adverse cardiometabolic response (ACR), following an evidence-based, individualized, community exercise program. Methods Prevalence of ACR was retrospectively analyzed in 332 adults (190 women, 142 men) before and after a 14-week supervised community exercise program. ACR included an exercise training-induced increase in systolic blood pressure of ≥10 mmHg, increase in plasma triglycerides (TG) of >37.0 mg/dL (≥0.42 mmol/L), or decrease in high-density lipoprotein cholesterol (HDL-C) of >4.0 mg/dL (0.12 mmol/L). A second category of ACR was also defined – this was ACR that resulted in a metabolic syndrome component (ACR-risk) as a consequence of the adverse response. Results According to the above criteria, prevalence of ACR between baseline and post-program was systolic blood pressure (6.0%), TG (3.6%), and HDL-C (5.1%). The prevalence of ACR-risk was elevated TG (3.2%), impaired fasting blood glucose (2.7%), low HDL-C (2.2%), elevated waist circumference (1.3%), and elevated blood pressure (0.6%). Conclusion Evidence-based practice exercise programming may attenuate the prevalence of exercise training-induced ACR. Our findings provide important preliminary evidence needed for the vision of exercise prescription as a personalized form of preventative medicine to become a reality. PMID:25678806

  18. DNA methylation of BDNF as a biomarker of early-life adversity

    PubMed Central

    Kundakovic, Marija; Gudsnuk, Kathryn; Herbstman, Julie B.; Tang, Deliang; Perera, Frederica P.; Champagne, Frances A.

    2015-01-01

    Early-life adversity increases the risk for psychopathology in later life. The underlying mechanism(s) is unknown, but epigenetic variation represents a plausible candidate. Early-life exposures can disrupt epigenetic programming in the brain, with lasting consequences for gene expression and behavior. This evidence is primarily derived from animal studies, with limited study in humans due to inaccessibility of the target brain tissue. In humans, although there is evidence for DNA methylation changes in the peripheral blood of psychiatric patients, a fundamental question remains as to whether epigenetic markers in the blood can predict epigenetic changes occurring in the brain. We used in utero bisphenol A (BPA) exposure as a model environmental exposure shown to disrupt neurodevelopment and exert long-term effects on behavior in animals and humans. We show that prenatal BPA induces lasting DNA methylation changes in the transcriptionally relevant region of the Bdnf gene in the hippocampus and blood of BALB/c mice and that these changes are consistent with BDNF changes in the cord blood of humans exposed to high maternal BPA levels in utero. Our data suggest that BDNF DNA methylation in the blood may be used as a predictor of brain BDNF DNA methylation and gene expression as well as behavioral vulnerability induced by early-life environmental exposure. Because BDNF expression and DNA methylation are altered in several psychiatric disorders that are associated with early-life adversity, including depression, schizophrenia, bipolar disorder, and autism, BDNF DNA methylation in the blood may represent a novel biomarker for the early detection of psychopathology. PMID:25385582

  19. Quality of life issues in hypertension: consequences of diagnosis and considerations in management.

    PubMed

    Wenger, N K

    1988-08-01

    Most patients with mild to moderate hypertension are asymptomatic. Any adverse response to nonpharmacologic or pharmacologic therapies can negatively influence some aspect of the patient's sense of well-being and life satisfaction; this will likely limit the compliance with and the resultant benefits of therapy. The diagnosis of hypertension itself is associated with psychological consequences, termed the "labeling effect," that impair life quality. A number of life-style modifications and a variety of highly effective and safe classes of antihypertensive agents can satisfactorily control blood pressure in most patients. Evaluation of the patient's response to an antihypertensive regimen should, in addition to measurement of the level of blood pressure and review of laboratory test values, include assessment of quality of life outcomes: impact of therapy on the patient's daily routine, fatigue or activity limitation, sexual dysfunction, impairment of memory, alertness, mood, or cognitive ability, sleep dysfunction, work performance and satisfaction, and satisfaction with family, social, and leisure time activities.

  20. Software Systems: Consequence versus Functionality

    SciTech Connect

    Berg, Ray; Winter, Victor L.

    1999-08-05

    The purpose of this panel is to present different perspectives and opinions regarding the issues surrounding why software should or shouldn't be entrusted with critical (high consequence) functionality.

  1. Adverse drug events: database construction and in silico prediction.

    PubMed

    Cheng, Feixiong; Li, Weihua; Wang, Xichuan; Zhou, Yadi; Wu, Zengrui; Shen, Jie; Tang, Yun

    2013-04-22

    Adverse drug events (ADEs) are the harms associated with uses of given medications at normal dosages, which are crucial for a drug to be approved in clinical use or continue to stay on the market. Many ADEs are not identified in trials until the drug is approved for clinical use, which results in adverse morbidity and mortality. To date, millions of ADEs have been reported around the world. Methods to avoid or reduce ADEs are an important issue for drug discovery and development. Here, we reported a comprehensive database of adverse drug events (namely MetaADEDB), which included more than 520,000 drug-ADE associations among 3059 unique compounds (including 1330 drugs) and 13,200 ADE items by data integration and text mining. All compounds and ADEs were annotated with the most commonly used concepts defined in Medical Subject Headings (MeSH). Meanwhile, a computational method, namely the phenotypic network inference model (PNIM), was developed for prediction of potential ADEs based on the database. The area under the receive operating characteristic curve (AUC) is more than 0.9 by 10-fold cross validation, while the AUC value was 0.912 for an external validation set extracted from the US-FDA Adverse Events Reporting System, which indicated that the prediction capability of the method was reliable. MetaADEDB is accessible free of charge at http://www.lmmd.org/online_services/metaadedb/. The database and the method provide us a useful tool to search for known side effects or predict potential side effects for a given drug or compound.

  2. Prolactin and schizophrenia: clinical consequences of hyperprolactinaemia.

    PubMed

    Meaney, Anna Maria; O'Keane, Veronica

    2002-07-19

    Prolactin is a polypeptide hormone that is synthesized and secreted from specialised cells of the anterior pituitary gland, known as lactotrophs. The hormone was given it's name because extracts from the bovine pituitary gland caused growth of the crop sac and stimulated the elaboration of crop milk in pigeons, and promoted lactation in rabbits. Although prolactin is best known for the multiple effects it exerts on the mammary gland, it has over 300 separate biological activities not represented by its name. It sub serves multiple roles in reproduction other than lactation and is an important modulator of homeostasis in the mammalian organism. Hence Bern and Nicoll suggested renaming it "omnipotin or versatilin". Schizophrenia is a severe psychiatric disorder that affects approximately one percent of the population worldwide. It is well established that traditional typical anti-psychotics elevate prolactin levels. It is also agreed that the serum prolactin concentration is not elevated in patients with schizophrenia who are not receiving anti-psychotic medication. Hyperprolactinaemia has direct effects on the brain and on other organs. Direct consequences include galactorrhoea. Indirect consequences of hyperprolactinaemia include oligomenorrhoea and amenorrhoea, erratic or absent ovulation, sexual dysfunction, reduced bone mineral density and cardiovascular disease. With the advent of prolactin sparing anti-psychotics, ample consideration needs to be given to the physiological consequences of hyperprolactinaemia in schizophrenic patients. In this paper we will examine molecular biology, secretion and physiology of prolactin. The consequences of hyperprolactinaemia in humans including effects on fertility, sexual dysfunction, bone mineral density, cardiovascular disease, changes in psychopathology and movement disorders will be reviewed. The literature on the association between schizophrenia, anti-psychotic medication and hyperprolactinaemia and more specifically

  3. Establishing Adverse Outcome Pathways of Thyroid Hormone Disruption in an Amphibian Model

    EPA Science Inventory

    The Adverse Outcome Pathway (AOP) provides a framework for understanding the relevance of toxicology data in ecotoxicological hazard assessments. The AOP concept can be applied to many toxicological pathways including thyroid hormone disruption. Thyroid hormones play a critical r...

  4. The Politics and Consequences of Including Stakeholders in International Development Evaluation

    ERIC Educational Resources Information Center

    Cullen, Anne E.; Coryn, Chris L. S.; Rugh, Jim

    2011-01-01

    Participatory evaluation approaches have a relatively long history of advocacy and application in the international development evaluation community. Despite widespread use and apparent resonance with practitioners and donors alike, very little empirical research exists on why and how participatory evaluation approaches are used in international…

  5. Health and environmental consequences of the world trade center disaster.

    PubMed Central

    Landrigan, Philip J; Lioy, Paul J; Thurston, George; Berkowitz, Gertrud; Chen, L C; Chillrud, Steven N; Gavett, Stephen H; Georgopoulos, Panos G; Geyh, Alison S; Levin, Stephen; Perera, Frederica; Rappaport, Stephen M; Small, Christopher

    2004-01-01

    The attack on the World Trade Center (WTC) created an acute environmental disaster of enormous magnitude. This study characterizes the environmental exposures resulting from destruction of the WTC and assesses their effects on health. Methods include ambient air sampling; analyses of outdoor and indoor settled dust; high-altitude imaging and modeling of the atmospheric plume; inhalation studies of WTC dust in mice; and clinical examinations, community surveys, and prospective epidemiologic studies of exposed populations. WTC dust was found to consist predominantly (95%) of coarse particles and contained pulverized cement, glass fibers, asbestos, lead, polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs), and polychlorinated furans and dioxins. Airborne particulate levels were highest immediately after the attack and declined thereafter. Particulate levels decreased sharply with distance from the WTC. Dust pH was highly alkaline (pH 9.0-11.0). Mice exposed to WTC dust showed only moderate pulmonary inflammation but marked bronchial hyperreactivity. Evaluation of 10,116 firefighters showed exposure-related increases in cough and bronchial hyperreactivity. Evaluation of 183 cleanup workers showed new-onset cough (33%), wheeze (18%), and phlegm production (24%). Increased frequency of new-onset cough, wheeze, and shortness of breath were also observed in community residents. Follow-up of 182 pregnant women who were either inside or near the WTC on 11 September showed a 2-fold increase in small-for-gestational-age (SGA) infants. In summary, environmental exposures after the WTC disaster were associated with significant adverse effects on health. The high alkalinity of WTC dust produced bronchial hyperreactivity, persistent cough, and increased risk of asthma. Plausible causes of the observed increase in SGA infants include maternal exposures to PAH and particulates. Future risk of mesothelioma may be increased, particularly among workers and

  6. Neighborhood adversity, child health, and the role for community development.

    PubMed

    Jutte, Douglas P; Miller, Jennifer L; Erickson, David J

    2015-03-01

    Despite medical advances, childhood health and well-being have not been broadly achieved due to rising chronic diseases and conditions related to child poverty. Family and neighborhood living conditions can have lasting consequences for health, with community adversity affecting health outcomes in significant part through stress response and increased allostatic load. Exposure to this "toxic stress" influences gene expression and brain development with direct and indirect negative consequences for health. Ensuring healthy child development requires improving conditions in distressed, high-poverty neighborhoods by reducing children's exposure to neighborhood stressors and supporting good family and caregiver functioning. The community development industry invests more than $200 billion annually in low-income neighborhoods, with the goal of improving living conditions for residents. The most impactful investments have transformed neighborhoods by integrating across sectors to address both the built environment and the social and service environment. By addressing many facets of the social determinants of health at once, these efforts suggest substantial results for children, but health outcomes generally have not been considered or evaluated. Increased partnership between the health sector and community development can bring health outcomes explicitly into focus for community development investments, help optimize intervention strategies for health, and provide natural experiments to build the evidence base for holistic interventions for disadvantaged children. The problems and potential solutions are beyond the scope of practicing pediatricians, but the community development sector stands ready to engage in shared efforts to improve the health and development of our most at-risk children.

  7. Negative affect predicts adults' ratings of the current, but not childhood, impact of adverse childhood events.

    PubMed

    LaNoue, Marianna; Graeber, David A; Helitzer, Deborah L; Fawcett, Jan

    2013-10-01

    Adverse childhood events (ACE's) have been empirically related to a wide range of negative health and mental health outcomes. However, not all individuals who experience ACE's follow a trajectory of poor outcomes, and not all individuals perceive the impact of ACE's as necessarily negative. The purpose of this study was to investigate positive and negative affect as predictors of adults' ratings of both the childhood and adult impact of their childhood adversity. Self-report data on ACE experiences, including number, severity, and 'impact' were collected from 158 community members recruited on the basis of having adverse childhood experiences. Results indicated that, regardless of event severity and number of different types of adverse events experienced, high levels of negative affect were the strongest predictor of whether the adult impact of the adverse childhood events was rated as negative. All individuals rated the childhood impact of events the same. Implications are discussed.

  8. Adverse event detection in drug development: recommendations and obligations beyond phase 3.

    PubMed

    Berlin, Jesse A; Glasser, Susan C; Ellenberg, Susan S

    2008-08-01

    Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems for assessment of postmarketing adverse events include spontaneous reports, computerized claims or medical record databases, and formal postmarketing studies. We briefly review the strengths and limitations of each. Postmarketing surveillance is essential for developing a full understanding of the balance between benefits and adverse effects. More work is needed in analysis of data from spontaneous reports of adverse effects and automated databases, design of ad hoc studies, and design of economically feasible large randomized studies.

  9. [Climate changes, floods, and health consequences].

    PubMed

    Michelozzi, Paola; de' Donato, Francesca

    2014-02-01

    In the European Region, floods are the most common natural disaster, causing extensive damage and disruption. In Italy, it has been estimated that over 68% of municipalities are at high hydrogeological risk and with the recent intense rainfall events local populations have been facing severe disruptions. The health consequences of floods are wide ranging and are dependent upon the vulnerability of the environment and the local population. Health effects can be a direct or indirect consequence of flooding. The immediate health impacts of floods include drowning, heart attacks, injuries and hypothermia. The indirect effects include, injuries and infections, water-borne infectious disease, mental health problems, respiratory disease and allergies in both the medium and long term after a flood. Future efforts should be addressed to integrate health preparedness and prevention measures into emergency flood plans and hydrological warning systems.

  10. Drinking water contaminants and adverse pregnancy outcomes: a review.

    PubMed Central

    Bove, Frank; Shim, Youn; Zeitz, Perri

    2002-01-01

    Concern for exposures to drinking water contaminants and their effects on adverse birth outcomes has prompted several studies evaluating chlorination disinfection by-products and chlorinated solvents. Some of these contaminants are found to be teratogenic in animal studies. This review evaluates 14 studies on chlorination disinfection by-products such as trihalomethanes (THMs) and five studies on chlorinated solvents such as trichloroethylene (TCE). The adverse birth outcomes discussed in this review include small for gestational age (SGA), low birth weight, preterm birth, birth defects, spontaneous abortions, and fetal deaths. Because of heterogeneities across the studies in the characterization of birth outcomes, the assessment and categorization of exposures, and the levels and mixtures of contaminants, a qualitative review was conducted. Generally, the chief bias in these studies was exposure misclassification that most likely underestimated the risk, as well as distorted exposure-response relationships. The general lack of confounding bias by risk factors resulted from these factors not being associated with drinking water exposures. The studies of THMs and adverse birth outcomes provide moderate evidence for associations with SGA, neural tube defects (NTDs), and spontaneous abortions. Because fewer studies have been conducted for the chlorinated solvents than for THMs, the evidence for associations is less clear. Nevertheless, the findings of excess NTDs, oral clefts, cardiac defects, and choanal atresia in studies that evaluated TCE-contaminated drinking water deserve follow-up. PMID:11834464

  11. Adverse childhood experiences and behavioral problems in middle childhood.

    PubMed

    Hunt, Tenah K A; Slack, Kristen S; Berger, Lawrence M

    2016-11-21

    Children who have been exposed to maltreatment and other adverse childhood experiences (ACEs) are at increased risk for various negative adult health outcomes, including cancer, liver disease, substance abuse, and depression. However, the proximal associations between ACEs and behavioral outcomes during the middle childhood years have been understudied. In addition, many of the ACE studies contain methodological limitations such as reliance on retrospective reports and limited generalizability to populations of lower socioeconomic advantage. The current study uses data from the Fragile Families and Child Wellbeing Study, a national urban birth cohort, to prospectively assess the adverse experiences and subsequent behavior problems of over 3000 children. Eight ACE categories to which a child was exposed by age 5 were investigated: childhood abuse (emotional and physical), neglect (emotional and physical), and parental domestic violence, anxiety or depression, substance abuse, or incarceration. Results from bivariate analyses indicated that Black children and children with mothers of low education were particularly likely to have been exposed to multiple ACE categories. Regression analyses showed that exposure to ACEs is strongly associated with externalizing and internalizing behaviors and likelihood of ADHD diagnosis in middle childhood. Variation in these associations by racial/ethnic, gender, and maternal education subgroups are examined. This study provides evidence that children as young as 9 begin to show behavioral problems after exposure to early childhood adversities.

  12. Adverse Family Experiences during Childhood and Adolescent Obesity

    PubMed Central

    Heerman, William J.; Krishnaswami, Shanthi; Barkin, Shari L.; McPheeters, Melissa

    2015-01-01

    Objective To evaluate the association between adverse family experiences (AFEs) during childhood and adolescent obesity and to determine populations at highest risk for adverse family experiences. Methods Cross sectional analysis of the 2011-2012 National Survey of Children’s Health, including children ages 10-17. Weighted estimates of 31,258,575 children were based on interviews with 42,239 caregivers. Caregiver-report of 9 psychosocial risk factors measured AFEs during childhood. Adolescent overweight and obesity were derived by caregiver-report of child height and weight. Results Nearly one-third (30.5%) of children had experienced ≥2 AFEs, with geographic variation by state. The prevalence of obesity among children experiencing ≥2 AFEs was 20.4%, compared with 12.5% among children with 0 AFEs. Adjusted survey regression models controlled for child, parent, household, and neighborhood characteristics. Children with ≥ 2 AFEs in childhood were more likely to be obese (AOR 1.8; 95% CI 1.47, 2.17; p<0.001) than those with no AFEs, with Non-Hispanic, White children most affected. Conclusions Adolescents in this national sample who were exposed to greater numbers of adverse family experiences in childhood also had higher rates of overweight and obesity. Geographic variation and differential associations based on race/ethnicity identify children at greatest risk. PMID:26853526

  13. Dietary aspects of adverse reactions to foods in adults.

    PubMed Central

    Parker, S L; Sussman, G L; Krondl, M

    1988-01-01

    Dietary considerations play an important role in the diagnosis, treatment and management of immunologic and nonimmunologic reactions to foods. Food diaries and trial elimination diets may prove helpful in identifying the responsible foods. Elimination diets must be monitored carefully for nutritional adequacy and should be used no longer than absolutely necessary; in some instances appropriate vitamin and mineral supplementation may be necessary. Ideally the identification of foods that provoke symptoms should be confirmed by means of double-blind challenge testing. Avoidance of some problem foods is unlikely to cause nutritional problems, but the practical and nutritional implications of allergies to staple foods such as cow's milk, eggs and wheat are far greater. Nonimmunologic adverse reactions that may mimic food allergic reactions include gastrointestinal disorders, sensitivity to food additives and psychologically based adverse reactions. There may be some degree of tolerance in metabolic disorders, which makes dietary management easier. Sensitivity to food additives necessitates careful scrutiny of food labels. In psychologic adverse reactions to foods, several foods are often involved, which increases the risk of nutritional problems. PMID:3048623

  14. Energy drink use and adverse effects among emergency department patients.

    PubMed

    Nordt, Sean Patrick; Vilke, Gary M; Clark, Richard F; Lee Cantrell, F; Chan, Theodore C; Galinato, Melissa; Nguyen, Vincent; Castillo, Edward M

    2012-10-01

    Energy drink usage is common and contains caffeine or other stimulants. We evaluated demographics, prevalence, reasons and adverse effects with consuming energy beverages. Cross-sectional study of a convenience sample of patients recruited from two San Diego Emergency Departments from January to December 2009. One-thousand-two-hundred-ninety-eight subjects participated of which 52.6% were male. Ethnicity: Caucasian 48.3%, African American 17%, Hispanic 18%, Other 16.7%. Age ranges: 18-29 years (38.4%), 30-54 years (49.6%) and greater than 55 years (12%). Reasons for use: 57% to "increase energy", 9.5% for studying/work projects, 2.4% while prolonged driving, improve sports performance 2%, with ethanol 6.3%, "other" reasons 22.1%. Adverse reactions reported by 33.5% (429) patients. Two-hundred-eighty report feeling "shaky/jittery", insomnia 136, palpitations 150, gastrointestinal upset 82, headache 68, chest pain 39, and seizures in 6. Eighty-five patients reported co-ingestion with illicit "stimulants" including cocaine and methamphetamine. We identified one-third of patients reported at least one adverse effect. Whilst most were not severe, a small number were serious e.g., seizures. In addition, some report purposely ingesting with illicit drugs.

  15. Adverse effects of extra-articular corticosteroid injections: a systematic review

    PubMed Central

    2010-01-01

    Background To estimate the occurrence and type of adverse effects after application of an extra-articular (soft tissue) corticosteroid injection. Methods A systematic review of the literature was made based on a PubMed and Embase search covering the period 1956 to January 2010. Case reports were included, as were prospective and retrospective studies that reported adverse events of corticosteroid injection. All clinical trials which used extra-articular corticosteroid injections were examined. We divided the reported adverse events into major (defined as those needing intervention or not disappearing) and minor ones (transient, not requiring intervention). Results The search yielded 87 relevant studies:44 case reports, 37 prospective studies and 6 retrospective studies. The major adverse events included osteomyelitis and protothecosis; one fatal necrotizing fasciitis; cellulitis and ecchymosis; tendon ruptures; atrophy of the plantar fat was described after injecting a neuroma; and local skin effects appeared as atrophy, hypopigmentation or as skin defect. The minor adverse events effects ranged from skin rash to flushing and disturbed menstrual pattern. Increased pain or steroid flare after injection was reported in 19 studies. After extra-articular injection, the incidence of major adverse events ranged from 0-5.8% and that of minor adverse events from 0-81%. It was not feasible to pool the risk for adverse effects due to heterogeneity of study populations and difference in interventions and variance in reporting. Conclusion In this literature review it was difficult to accurately quantify the incidence of adverse effects after extra-articular corticosteroid injection. The reported adverse events were relatively mild, although one fatal reaction was reported. PMID:20836867

  16. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  17. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  18. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  19. Holographic consequences of a no transmission principle

    NASA Astrophysics Data System (ADS)

    Engelhardt, Netta; Horowitz, Gary T.

    2016-01-01

    Two quantum field theories whose Hilbert spaces do not overlap cannot transmit a signal to one another. From this simple principle, we deduce some highly nontrivial consequences for holographic quantum gravity. These include: (i) certain cosmological bounces are forbidden, (ii) generic singularities inside black holes cannot be resolved, and (iii) traversable wormholes do not exist. At the classical level, this principle rules out certain types of naked singularities and suggests that new singularity theorems should exist.

  20. Frequency of Adverse Events after Vaccination with Different Vaccinia Strains

    PubMed Central

    Kretzschmar, Mirjam; Wallinga, Jacco; Teunis, Peter; Xing, Shuqin; Mikolajczyk, Rafael

    2006-01-01

    Background Large quantities of smallpox vaccine have been stockpiled to protect entire nations against a possible reintroduction of smallpox. Planning for an appropriate use of these stockpiled vaccines in response to a smallpox outbreak requires a rational assessment of the risks of vaccination-related adverse events, compared to the risk of contracting an infection. Although considerable effort has been made to understand the dynamics of smallpox transmission in modern societies, little attention has been paid to estimating the frequency of adverse events due to smallpox vaccination. Studies exploring the consequences of smallpox vaccination strategies have commonly used a frequency of approximately one death per million vaccinations, which is based on a study of vaccination with the New York City Board of Health (NYCBH) strain of vaccinia virus. However, a multitude of historical studies of smallpox vaccination with other vaccinia strains suggest that there are strain-related differences in the frequency of adverse events after vaccination. Because many countries have stockpiled vaccine based on the Lister strain of vaccinia virus, a quantitative evaluation of the adverse effects of such vaccines is essential for emergency response planning. We conducted a systematic review and statistical analysis of historical data concerning vaccination against smallpox with different strains of vaccinia virus. Methods and Findings We analyzed historical vaccination data extracted from the literature. We extracted data on the frequency of postvaccinal encephalitis and death with respect to vaccinia strain and age of vaccinees. Using a hierarchical Bayesian approach for meta-analysis, we estimated the expected frequencies of postvaccinal encephalitis and death with respect to age at vaccination for smallpox vaccines based on the NYCBH and Lister vaccinia strains. We found large heterogeneity between findings from different studies and a time-period effect that showed

  1. Broken or maladaptive? Altered trajectories in neuroinflammation and behavior after early life adversity

    PubMed Central

    Ganguly, Prabarna; Brenhouse, Heather C.

    2014-01-01

    Exposure to adversity and stress early in development yields vulnerability to mental illnesses throughout the lifespan. Growing evidence suggests that this vulnerability has mechanistic origins involving aberrant development of both neurocircuitry and neuro-immune activity. Here we review the current understanding of when and how stress exposure initiates neuroinflammatory events that interact with brain development. We first review how early life adversity has been associated with various psychopathologies, and how neuroinflammation plays a role in these pathologies. We then summarize data and resultant hypotheses describing how early life adversity may particularly alter neuro-immune development with psychiatric consequences. Finally, we review how sex differences contribute to individualistic vulnerabilities across the lifespan. We submit the importance of understanding how stress during early development might cause outright neural or glial damage, as well as experience-dependent plasticity that may insufficiently prepare an individual for sex-specific or life-stage specific challenges. PMID:25081071

  2. Race, Gender, and Chains of Disadvantage: Childhood Adversity, Social Relationships, and Health

    PubMed Central

    Umberson, Debra; Williams, Kristi; Thomas, Patricia A.; Liu, Hui; Thomeer, Mieke Beth

    2014-01-01

    We use a life course approach to guide an investigation of relationships and health at the nexus of race and gender. We consider childhood as a sensitive period in the life course, during which significant adversity may launch chains of disadvantage in relationships throughout the life course that then have cumulative effects on health over time. Data from a nationally representative panel study (Americans’ Changing Lives, N=3,477) reveal substantial disparities between black and white adults, especially pronounced among men, in the quality of close relationships and in the consequences of these relationships for health. Greater childhood adversity helps to explain why black men have worse health than white men, and some of this effect appears to operate through childhood adversity’s enduring influence on relationship strain in adulthood. Stress that occurs in adulthood plays a greater role than childhood adversity in explaining racial disparities in health among women. PMID:24578394

  3. Human factors in high consequence manufacturing systems

    SciTech Connect

    Forsythe, C.; Grose, E.

    1997-11-01

    A high consequence system is often defined as one in which the potential exists for severe or catastrophic accidents. Familiar examples include nuclear power plants, airline and other mass transportation, dams and reservoirs, and large-scale food processing. Many manufacturing systems also qualify as high consequence systems. Much of the authors` experience with high consequence systems derives from work associated with the surveillance and dismantlement of nuclear weapons for the US Department of Energy. With such operations, there exists a risk of high explosive detonation accompanied by radiological dispersal and, potentially, nuclear detonation. Analysis of major industrial accidents such as Three Mile Island, Chernobyl and Bhopal have revealed that these incidents were not attributable to a single event or direct cause, but were the result of multiple factors that combined to create a condition ripe for an accident. In each case, human error was a critical factor contributing to the accident. Consequently, many authors have emphasized the need for greater appreciation of systematic factors and in particular, human activities. This paper discusses approaches used in hazard analysis of US nuclear weapons operations to assess risk associated with human factors.

  4. An Ss Model with Adverse Selection.

    ERIC Educational Resources Information Center

    House, Christopher L.; Leahy, John V.

    2004-01-01

    We present a model of the market for a used durable in which agents face fixed costs of adjustment, the magnitude of which depends on the degree of adverse selection in the secondary market. We find that, unlike typical models, the sS bands in our model contract as the variance of the shock increases. We also analyze a dynamic version of the model…

  5. Childhood Adversities and Adult Cardiometabolic Health: Does the Quantity, Timing, and Type of Adversity Matter?

    PubMed Central

    Friedman, Esther M.; Montez, Jennifer Karas; Sheehan, Connor McDevitt; Guenewald, Tara L.; Seeman, Teresa E.

    2015-01-01

    Objective Adverse events in childhood can indelibly influence adult health. While evidence for this association has mounted, a fundamental set of questions about how to operationalize adverse events has been understudied. Method We used data from the National Survey of Midlife Development in the United States to examine how quantity, timing, and types of adverse events in childhood are associated with adult cardiometabolic health. Results The best-fitting specification of quantity of events was a linear measure reflecting a dose–response relationship. Timing of event mattered less than repeated exposure to events. Regarding the type of event, academic interruptions and sexual/physical abuse were most important. Adverse childhood events elevated the risk of diabetes and obesity similarly for men and women but had a greater impact on women’s risk of heart disease. Discussion Findings demonstrate the insights that can be gleaned about the early-life origins of adult health by examining operationalization of childhood exposures. PMID:25903978

  6. Positive consequences of false memories.

    PubMed

    Howe, Mark L; Garner, Sarah R; Patel, Megan

    2013-01-01

    Previous research is replete with examples of the negative consequences of false memories. In the current research, we provide a different perspective on false memories and their development and demonstrate that false memories can have positive consequences. Specifically, we examined the role false memories play in subsequent problem-solving tasks. Children and adults studied and recalled neutral or survival-relevant lists of associated words. They then solved age-normed compound remote associates, some of whose solutions had been primed by false memories created when studying the previous lists. The results showed that regardless of age: (a) survival-related words were not only better recollected but were also more susceptible than neutral words to false memory illusions; and (b) survival-related false memories were better than neutral false memories as primes for problem-solving. These findings are discussed in the context of recent speculation concerning the positive consequences of false memories, and the adaptive nature of reconstructive memory.

  7. Adverse Outcome Pathway (AOP) Network Development for ...

    EPA Pesticide Factsheets

    Adverse outcome pathways (AOPs) are descriptive biological sequences that start from a molecular initiating event (MIE) and end with an adverse health outcome. AOPs provide biological context for high throughput chemical testing and further prioritize environmental health risk research. According to the Organization for Economic Co-operation and Development guidelines, AOPs are pathways with one MIE anchored to an adverse outcome (AO) by key events (KEs) and key event relationships (KERs). However, this approach does not always capture the cumulative impacts of multiple MIEs on the AO. For example, hepatic lipid flux due to chemical-induced toxicity initiates from multiple ligand-activated receptors and signaling pathways that cascade across biology to converge upon a common fatty liver (FL, also known as steatosis) outcome. To capture this complexity, a top-down strategy was used to develop a FL AOP network (AOPnet). Literature was queried based on the terms steatosis, fatty liver, cirrhosis, and hepatocellular carcinoma. Search results were analyzed for physiological and pathophysiological organ level, cellular and molecular processes, as well as pathway intermediates, to identify potential KEs and MIEs that are key for hepatic lipid metabolism, maintenance, and dysregulation. The analysis identified four apical KE nodes (hepatic fatty acid uptake, de novo fatty acid and lipid synthesis, fatty acid oxidation, and lipid efflux) juxtaposed to the FL AO. The apic

  8. Combating adverse selection in secondary PC markets.

    PubMed

    Hickey, Stewart W; Fitzpatrick, Colin

    2008-04-15

    Adverse selection is a significant contributor to market failure in secondary personal computer (PC) markets. Signaling can act as a potential solution to adverse selection and facilitate superior remarketing of second-hand PCs. Signaling is a means whereby usage information can be utilized to enhance consumer perception of both value and utility of used PCs and, therefore, promote lifetime extension for these systems. This can help mitigate a large portion of the environmental impact associated with PC system manufacture. In this paper, the computer buying and selling behavior of consumers is characterized via a survey of 270 Irish residential users. Results confirm the existence of adverse selection in the Irish market with 76% of potential buyers being unwilling to purchase and 45% of potential vendors being unwilling to sell a used PC. The so-called "closet affect" is also apparent with 78% of users storing their PC after use has ceased. Results also indicate that consumers place a higher emphasis on specifications when considering a second-hand purchase. This contradicts their application needs which are predominantly Internet and word-processing/spreadsheet/presentation applications, 88% and 60% respectively. Finally, a market solution utilizing self monitoring and reporting technology (SMART) sensors for the purpose of real time usage monitoring is proposed, that can change consumer attitudes with regard to second-hand computer equipment.

  9. Consequences of Essential Fatty Acids

    PubMed Central

    Lands, Bill

    2012-01-01

    Essential fatty acids (EFA) are nutrients that form an amazingly large array of bioactive mediators that act on a large family of selective receptors. Nearly every cell and tissue in the human body expresses at least one of these receptors, allowing EFA-based signaling to influence nearly every aspect of human physiology. In this way, the health consequences of specific gene-environment interactions with these nutrients are more extensive than often recognized. The metabolic transformations have similar competitive dynamics for the n-3 and n-6 homologs when converting dietary EFA from the external environment of foods into the highly unsaturated fatty acid (HUFA) esters that accumulate in the internal environment of cells and tissues. In contrast, the formation and action of bioactive mediators during tissue responses to stimuli tend to selectively create more intense consequences for n-6 than n-3 homologs. Both n-3 and n-6 nutrients have beneficial actions, but many common health disorders are undesired consequences of excessive actions of tissue n-6 HUFA which are preventable. This review considers the possibility of preventing imbalances in dietary n-3 and n-6 nutrients with informed voluntary food choices. That action may prevent the unintended consequences that come from eating imbalanced diets which support excessive chronic actions of n-6 mediators that harm human health. The consequences from preventing n-3 and n-6 nutrient imbalances on a nationwide scale may be very large, and they need careful evaluation and implementation to avoid further harmful consequences for the national economy. PMID:23112921

  10. Consequences of bullying victimization in childhood and adolescence: A systematic review and meta-analysis

    PubMed Central

    Moore, Sophie E; Norman, Rosana E; Suetani, Shuichi; Thomas, Hannah J; Sly, Peter D; Scott, James G

    2017-01-01

    AIM To identify health and psychosocial problems associated with bullying victimization and conduct a meta-analysis summarizing the causal evidence. METHODS A systematic review was conducted using PubMed, EMBASE, ERIC and PsycINFO electronic databases up to 28 February 2015. The study included published longitudinal and cross-sectional articles that examined health and psychosocial consequences of bullying victimization. All meta-analyses were based on quality-effects models. Evidence for causality was assessed using Bradford Hill criteria and the grading system developed by the World Cancer Research Fund. RESULTS Out of 317 articles assessed for eligibility, 165 satisfied the predetermined inclusion criteria for meta-analysis. Statistically significant associations were observed between bullying victimization and a wide range of adverse health and psychosocial problems. The evidence was strongest for causal associations between bullying victimization and mental health problems such as depression, anxiety, poor general health and suicidal ideation and behaviours. Probable causal associations existed between bullying victimization and tobacco and illicit drug use. CONCLUSION Strong evidence exists for a causal relationship between bullying victimization, mental health problems and substance use. Evidence also exists for associations between bullying victimization and other adverse health and psychosocial problems, however, there is insufficient evidence to conclude causality. The strong evidence that bullying victimization is causative of mental illness highlights the need for schools to implement effective interventions to address bullying behaviours.

  11. Roll-up of vorticity in adverse-pressure-gradient boundary layers

    NASA Technical Reports Server (NTRS)

    Goldstein, M. E.; Durbin, P. A.; Leib, S. J.

    1987-01-01

    It is shown how the unsteady, nonlinear critical-layer equation determines the evolution of instability waves in a weak adverse-pressure-gradient boundary layer. Numerical solutions show that the nonlinearity halts the growth of these inviscidly unstable waves. The stabilizing effect of nonlinearity, in the present case, can be described as a consequence of either the increase (toward zero) of the phase jump across the critical layer or the roll-up of the critical-layer disturbance vorticity.

  12. Uncertainties in offsite consequence analysis

    SciTech Connect

    Young, M.L.; Harper, F.T.; Lui, C.H.

    1996-03-01

    The development of two new probabilistic accident consequence codes, MACCS and COSYMA, was completed in 1990. These codes estimate the consequences from the accidental releases of radiological material from hypothesized accidents at nuclear installations. In 1991, the U.S. Nuclear Regulatory Commission and the European Commission began co-sponsoring a joint uncertainty analysis of the two codes. The ultimate objective of this joint effort was to systematically develop credible and traceable uncertainty distributions for the respective code input variables using a formal expert judgment elicitation and evaluation process. This paper focuses on the methods used in and results of this on-going joint effort.

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

    PubMed

    Lai, Yi Chun; Yew, Yik Weng

    2015-07-01

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

  14. Sexually Dimorphic Responses to Early Adversity: Implications for Affective Problems and Autism Spectrum Disorder

    PubMed Central

    Davis, Elysia Poggi; Pfaff, Donald

    2014-01-01

    During gestation, development proceeds at a pace that is unmatched by any other stage of the lifecycle. For these reason the human fetus is particularly susceptible not only to organizing influences, but also to pathogenic disorganizing influences. Growing evidence suggests that exposure to prenatal adversity leads to neurological changes that underlie lifetime risks for mental illness. Beginning early in gestation, males and females show differential developmental trajectories and responses to stress. It is likely that sex-dependent organization of neural circuits during the fetal period influences differential vulnerability to mental health problems. We consider in this review evidence that sexually dimorphic responses to early life stress are linked to two developmental disorders: affective problems (greater female prevalence) and autism spectrum disorder (greater male prevalence). Recent prospective studies illustrating the neurodevelopmental consequences of fetal exposure to stress and stress hormones for males and females are considered here. Plausible biological mechanisms including the role of the sexually differentiated placenta are discussed. We consider in this review evidence that sexually dimorphic responses to early life stress are linked to two sets of developmental disorders: affective problems (greater female prevalence) and autism spectrum disorders (greater male prevalence). PMID:25038479

  15. Periodontal disease as a risk factor for adverse pregnancy outcomes: a systematic review and meta-analysis of case-control studies.

    PubMed

    Corbella, Stefano; Taschieri, Silvio; Francetti, Luca; De Siena, Francesca; Del Fabbro, Massimo

    2012-07-01

    Periodontal disease is a highly prevalent group of illnesses of microbial etiology, whose consequence is a severe breakdown of tooth-supporting structures. A link between periodontal infection and several systemic conditions, among which adverse pregnancy outcomes, has been suggested in the recent years. The aim of this review based on case-control studies was to evaluate if periodontal disease could be considered as a risk factor for preterm birth, low birth-weight and preterm low birth-weight. An electronic search (via Pubmed) was performed for case-control studies investigating the relationship between periodontal disease and adverse pregnancy outcomes. From the initially retrieved 417 articles, 17 case-control studies, accounting for a total of 10,148 patients, were included in the review and in the meta-analysis. The estimated odds ratio was 1.78 (CI 95%: 1.58, 2.01) for preterm birth, 1.82 (CI 95%: 1.51, 1.20) for low birth-weight and 3.00 (CI 95%: 1.93, 4.68) for preterm low birth-weight. Despite the results of the analysis of pooled data suggested a link between periodontal diseases and adverse pregnancy outcomes, the presence of important confounders, whose effect could not be addressed, prevents a validation of the meta-analysis outcomes. Further more accurate investigations based on individual data analysis could give a better insight into the topic of the present review.

  16. The lifelong effects of early childhood adversity and toxic stress.

    PubMed

    Boyce, W Thomas

    2014-01-01

    A rapidly expanding body of research indicates that early social environments characterized by adversity, subordination and stress, along with individual differences in susceptibility to such environments, create risks for lifelong chronic diseases, including declines in oral health. Emerging findings suggest that gene-environment interplay, resulting in epigenetically regulated differences in gene expression, underlie many such declines in health. The origins of these processes in early life reveal how many of the chronic morbidities of adulthood should be viewed as developmental disorders, with etiologic roots in childhood.

  17. Adverse experiences with nitric acid at the Savannah River Site

    SciTech Connect

    Durant, W.S.; Craig, D.K.; Vitacco, M.J.; McCormick, J.A.

    1991-06-01

    Nitric acid is used routinely at the Savannah River Site (SRS) in many processes. However, the site has experienced a number of adverse situations in handling nitric acid. These have ranged from minor injuries to personnel to significant explosions. This document compiles many of these events and includes discussions of process upsets, fires, injuries, and toxic effects of nitric acid and its decomposition products. The purpose of the publication is to apprise those using the acid that it is a potentially dangerous material and can react in many ways as demonstrated by SRS experience. 10 refs.

  18. Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors.

    PubMed

    Day, Daphne; Hansen, Aaron R

    2016-12-01

    Immune checkpoint inhibitors (ICIs), including antibodies targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed cell death protein-1 (PD-1), have shown durable treatment responses in multiple tumor types by enhancing antitumor immunity. However, removal of self-tolerance can induce autoimmunity and produce a unique immune-driven toxicity profile, termed immune-related adverse events (irAEs). As ICIs gain approval for a growing number of indications, it is imperative clinicians increase their knowledge of and ability to manage irAEs. This review examines the etiology, presentation, kinetics, and treatment of irAEs and aims to provide practical guidance for clinicians.

  19. Environmental chemicals impacting the thyroid: targets and consequences.

    PubMed

    Zoeller, R Thomas

    2007-09-01

    Thyroid hormone (TH) is essential for normal brain development, but the specific actions of TH differ across developmental time and brain region. These actions of TH are mediated largely by a combination of thyroid hormone receptor (TR) isoforms that exhibit specific temporal and spatial patterns of expression during animal and human brain development. In addition, TR action is influenced by different cofactors, proteins that directly link the TR protein to functional changes in gene expression. Considering the importance of TH signaling in development, it is important to consider environmental chemicals that may interfere with this signaling. Recent research indicates that environmental chemicals can interfere with thyroid function and with TH signaling. The key issues are to understand the mechanism by which these chemicals act and the dose at which they act, and whether adaptive responses intrinsic to the thyroid system can ameliorate potential adverse consequences (i.e., compensate). In addition, several recent studies show that TRs may be unintended targets of chemicals manufactured for industrial purposes to which humans and wildlife are routinely exposed. Polychlorinated biphenyls, polybrominated diphenyl ethers, bisphenol-A, and specific halogenated derivatives and metabolites of these compounds have been shown to bind to TRs and perhaps have selective effects on TR functions. A number of common chemicals, including polybrominated biphenyls and phthalates, may also exert such effects. When we consider the importance of TH in brain development, it will be important to pursue the possibilities that these chemicals-or interactions among chemical classes-are affecting children's health by influencing TH signaling in the developing brain.

  20. Acid Precipitation: Causes and Consequences.

    ERIC Educational Resources Information Center

    Babich, Harvey; And Others

    1980-01-01

    This article is the first of three articles in a series on the acid rain problem in recent years. Discussed are the causes of acid precipitation and its consequences for the abiotic and biotic components of the terrestrial and aquatic ecosystems, and for man-made materials. (Author/SA)

  1. Consequences of Growing Up Poor.

    ERIC Educational Resources Information Center

    Duncan, Greg J., Ed.; Brooks-Gunn, Jeanne, Ed.

    The consequences and correlates of growing up poor as well as the mechanisms through which poverty influences children are explored. This book is organized with a primary focus on research findings and a secondary concern with policy implications. The chapters are: (1) "Poor Families, Poor Outcomes: The Well-Being of Children and Youth" (Jeanne…

  2. Social Consequences of Teenage Childbearing.

    ERIC Educational Resources Information Center

    Presser, Harriet B.

    Most research on teenage parenthood is concerned with illegitimacy and its determinants such as attitudes toward sex, contraceptive knowledge and practice, family relationships, and cultural factors. Empirical studies on the consequences of illegitimacy are generally limited to problems of recidivism, school dropouts, and welfare dependency.…

  3. Literacy in Somali: Linguistic Consequences.

    ERIC Educational Resources Information Center

    Biber, Douglas; Hared, Mohamed

    1991-01-01

    Linguistic consequences of literacy in Somalia are examined in a review of the literature and through a study of five dimensions of variation among Somali registers and the expansion of linguistic variation in Somali resulting from the introduction of written registers. (36 references) (LB)

  4. Evidence-based interventions to reduce adverse events in hospitals: a systematic review of systematic reviews

    PubMed Central

    Zegers, Marieke; Hesselink, Gijs; Geense, Wytske; Vincent, Charles; Wollersheim, Hub

    2016-01-01

    Objective To provide an overview of effective interventions aimed at reducing rates of adverse events in hospitals. Design Systematic review of systematic reviews. Data sources PubMed, CINAHL, PsycINFO, the Cochrane Library and EMBASE were searched for systematic reviews published until October 2015. Study selection English-language systematic reviews of interventions aimed at reducing adverse events in hospitals, including studies with an experimental design and reporting adverse event rates, were included. Two reviewers independently assessed each study's quality and extracted data on the study population, study design, intervention characteristics and adverse patient outcomes. Results Sixty systematic reviews with moderate to high quality were included. Statistically significant pooled effect sizes were found for 14 types of interventions, including: (1) multicomponent interventions to prevent delirium; (2) rapid response teams to reduce cardiopulmonary arrest and mortality rates; (3) pharmacist interventions to reduce adverse drug events; (4) exercises and multicomponent interventions to prevent falls; and (5) care bundle interventions, checklists and reminders to reduce infections. Most (82%) of the significant effect sizes were based on 5 or fewer primary studies with an experimental study design. Conclusions The evidence for patient-safety interventions implemented in hospitals worldwide is weak. The findings address the need to invest in high-quality research standards in order to identify interventions that have a real impact on patient safety. Interventions to prevent delirium, cardiopulmonary arrest and mortality, adverse drug events, infections and falls are most effective and should therefore be prioritised by clinicians. PMID:27687901

  5. The professional consequences of whistleblowing by nurses.

    PubMed

    McDonald, S; Ahern, K

    2000-01-01

    When nurses encounter misconduct in the workplace, their ethical codes of conduct bind them to the role of patient advocacy and compel them to safeguard the patient from harm. However, reporting misconduct can be personally and professionally risky. The aim of the research was to examine the professional consequences of whistleblowing and nonwhistleblowing in nursing. A descriptive survey design was used to examine the professional effect of reporting misconduct (whistleblowing) and not reporting misconduct (nonwhistleblowing). Ninety-five respondents were included in the study; 70 were self-identified as whistleblowers and 25 were self-identified as nonwhistleblowers. Results indicated that there were severe professional reprisals if the nurse reported misconduct, but there were few professional consequences if the nurse remained silent. Official reprisals included demotion (4%), reprimand (11%), and referral to a psychiatrist (9%). Whistleblowers also reported that they received professional reprisals in the form of threats (16%), rejection by peers (14%), pressure to resign (7%), and being treated as a traitor (14%). Ten per cent reported that they felt their career had been halted. These findings suggest that when nurses identify and report misconduct in the workplace, they may experience serious professional consequences.

  6. Statin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System

    PubMed Central

    Sakaeda, Toshiyuki; Kadoyama, Kaori; Okuno, Yasushi

    2011-01-01

    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. PMID:22205938

  7. [Efforts to prevent adverse events in the United States--health care risk management and a fresh perspective on adverse events prevention].

    PubMed

    Ayuzawa, J

    2001-03-01

    Not causing adverse events is never-ceasing issue in the health care field. However, the advances and greater specialization of medical technologies and the increasing number of elderly people, are all factors in the occurrence of adverse events. At the same time, greater efficiency is now demanded in the health care field, and the problem of preventing adverse events has become tougher than ever before. Given the situation, a fresh perspective on attempts to prevent adverse events may be important. One hint for such a new perspective is the health care risk management that is widely practiced in the health care field in the United States. This was introduced in the mid-1970s to counter the disputes and lawsuits at the time, but over the years the focus has shifted to the importance of prevention, and is now recognized as a means to work toward the assurance of quality of health care. Hints are also found in the suggestions related to adverse events prevention. In "To Err Is Human," published in November 1999 in the United States, includes proposals to "respect human limits in process design" and "promote effective team functioning," which are just the approaches we should adopt for a new perspective. I would also like to draw attention to the idea that there should be investigations into "developing effective mechanisms for identifying and dealing with unsafe practitioners" and the importance of "protecting voluntary reporting systems" that is mentioned. Adopting American methods unchanged to the health care system in Japan may not be appropriate, but the way of thinking and know-how from health care risk management, as well as the suggestions for adverse events prevention will provide us new perspectives on adverse events prevention, from which we should work toward a system of more efficient, and high-quality adverse events prevention.

  8. Consequences of objective self-awareness during exercise

    PubMed Central

    Blascovich, Jim

    2015-01-01

    Although exercise is recommended by healthcare professionals for nearly everyone, adverse reactions can occur following exercising for some overweight individuals. The reported study investigated the cardiovascular consequences of exercise in a stressful environment. In all, 60 females completed two baseline and one biking (i.e. ergometer) periods while cardiovascular and self-report measures were recorded. Findings indicated that those who are more self-aware showed cardiovascular response patterns indicative of threat. Additionally, post-task exercise self-efficacy levels predicted intentions to exercise at a demanding level in the coming week. These findings suggest exercise may exacerbate health issues for some individuals for whom it is recommended. PMID:28070364

  9. Unintended consequences of immigration reform: discrimination and Hispanic employment.

    PubMed

    Lowell, B L; Teachman, J; Jing, Z

    1995-11-01

    The record-keeping requirements of the Immigration Reform and Control Act(IRCA), and fines for illegal employment, may induce employers to discriminate against foreign-appearing workers. The General Accounting Office (GAO) reported widespread IRCA-related discrimination but did not link reported discriminatory practices to discriminatory employment behavior. We analyze the GAO's random survey and, controlling for selectivity effects, demonstrate that employers who report discriminatory practices actually employ fewer Hispanics. Although the measured reduction of Hispanic employment due to IRCA is fairly small, this finding parallels research alerting us to adverse consequences of a law that so far has achieved few of its intended effects.

  10. Health consequences of sexual violence against women.

    PubMed

    Jina, Ruxana; Thomas, Leena S

    2013-02-01

    Sexual violence can lead to a multitude of health consequences, including physical, reproductive and psychological. Some may be fatal, whereas others, such as unhealthy behaviours, may occur indirectly as a result of the violence. In total, these result in a significant health burden and should be considered by service providers, government authorities and non-governmental agencies. For women who present early, immediate care should be provided with plans for follow up. Mental-health interventions are important, as women who are sexually assaulted have the highest burden of post-traumatic stress disorder. Cognitive- behavioural therapy has been found to be effective for preventing and treating post-traumatic stress disorder, but psychological debriefing for preventing post-traumatic stress disorder is not recommended. Implementing a routine screening and intervention programme in obstetrics and gynaecology departments may be valuable, as reproductive health consequences are common.

  11. Agricultural sources of contaminants of emerging concern and adverse health effects on freshwater fish

    USGS Publications Warehouse

    Tillitt, Donald E.; Buxton, Herbert T.

    2011-01-01

    Agricultural contaminants of emerging concern (CECs) are generally thought of as certain classes of chemicals associated with animal feeding and production facilities. Veterinary pharmaceuticals used in animal food production systems represent one of the largest groups of CECs. In our review, we discuss the extensive increase in use of antibiotics in animal feeding operations (AFOs) around the world. AFOs are a major consumer of antibiotics and other veterinary pharmaceuticals and over the past decade there has been growing information on the occurrence, release, and fate of CECs from animal food production operations, including the application of pharmaceutical-containing manure to agricultural fields and releases from waste lagoons. Concentrations of CECs in surface and ground water in proximity to AFOs correspond to their presence in the AFO wastes. In many cases, the environmental concentrations of agriculturally-derived CECs are below toxicity thresholds. Hormones and hormone replacement compounds are a notable exception, where chemical concentrations near AFOs can exceed concentrations known to cause adverse effects on endocrine-related functions in fish. In addition, some agricultural pesticides, once thought to be safe to non-target organisms, have demonstrated endocrine-related effects that may pose threats to fish populations in agricultural regions. That is, we have pesticides with emerging concerns, thus, the concern is emerging and not necessarily the chemical. In this light, one must consider certain agricultural pesticides to be included in the list of CECs. Even though agricultural pesticides are routinely evaluated in regulatory testing schemes which have been used for decades, the potential hazards of some pesticides have only recently been emerging. Emerging concerns of pesticides in fish include interference with hormone signaling pathways; additive (or more than additive) effects from pesticide mixtures; and adverse population-level effects at

  12. Determinants of Adverse Events in Vascular Surgery

    PubMed Central

    Hernandez-Boussard, Tina; McDonald, Kathryn; Morton, John; Dalman, Ron L; Bech, Fritz R

    2016-01-01

    Background Patient safety is a national priority. Patient Safety Indicators (PSIs) monitor potential adverse events during hospital stays. Surgical specialty PSI benchmarks do not exist, which are needed to account for differences in the range of procedures performed, reasons for the procedure, and differences in patient characteristics. A comprehensive profile of adverse events in vascular surgery was created. Study Design The Nationwide Inpatient Sample was queried for 8 vascular procedures using ICD-9-CM codes from 2005–2009. Factors associated with PSI development were evaluated in univariate and multivariate analyses. Results A total of 1,412,703 patients underwent a vascular procedure and 5.2% developed a PSI. PSIs were more frequent in female, non-white patients with public payers (p<.01). Patients at mid and low volume hospitals had greater odds of developing a PSI (Odds Ratio [OR], 1.17; 95% Confidence Interval [CI], 1.10–1.23 and OR, 1.69; CI, 1.53–1.87). Amputations had highest PSI risk-adjusted rate (RAR) and carotid endarterectomy and endovascular abdominal aortic aneurysm (AAA) repair had lower RAR (p<.0001). PSI RAR increased linearly by severity of patient indication: claudicants (OR, 0.40, CI, 0.35–0.46), rest pain patients (OR, 0.78, CI 0.69–0.90), ulcer (OR: 1.20, CI: 1.07–1.34) and gangrene patients (OR:1.85, CI: 1.66–2.06). Conclusions Patient safety events in vascular surgery were high and varied by procedure, with amputations and open AAA having substantially more potential adverse events. PSIs were associated with black race, public payer, and procedure indication. It is important to note the overall higher rates of PSIs occurring in vascular patients and appropriately adjust benchmarks for this surgical specialty. PMID:22425449

  13. Childhood Adversities and Traumata in Lebanon: A National Study

    PubMed Central

    Itani, Lynn; Haddad, Youmna C; Fayyad, John; Karam, Aimee; Karam, Elie

    2014-01-01

    Background: The goal of this paper is to map the total occurrence and evaluate the risk of co-occurrence of childhood adversities (CA) and a wide variety of childhood traumatic events (including war) in a national sample. Method: The nationally representative sample included 2,857 respondents and the instrument used was the Composite International Diagnostic Interview which screened for all CAs and traumatic events. Results: 27.9% experienced CAs; the most common were parental death and parental mental/substance use disorder. 70.6% experienced a war-related traumatic event during their lifetime, and around half of them (38.1%) experienced it below the age of 18 years. 51.3% of the subjects experienced a traumatic event not related to war during their lifetime, and 19.2% experienced it before the age of 18 years. Sexual abuse, being a refugee during war, and experiencing a natural disaster were associated with female gender. Having any CA was associated with active war exposure (OR: 4.2, CI: 2.0-8.6); war-related direct personal trauma (OR: 3.9, CI: 1.5-10.0); war-related trauma to others (OR: 2.4, CI: 1.3-4.4); non-war direct personal trauma (OR: 3.8, CI: 2.0-7.4); and any non-war childhood traumatic event (OR: 1.9, CI: 1.1-3.1). Conclusion:Childhood is awash with adversities and traumatic events that co-occur and should be measured simultaneously; otherwise, the effects of a subset of traumata or adversities could be wrongly thought to be the contributor to negative outcomes under study. PMID:25356085

  14. Cumulative adversity in early childhood is associated with increased BMI and behavioural problems.

    PubMed

    Crowell, Judith A

    2015-04-01

    Implications for practice and research: Mental health problems and obesity are significant outcomes for children experiencing adversity in early life. Behavioural outcomes and body mass index (BMI) are more consistently reported for children experiencing adversity in early life compared with blood pressure (BP). Incomplete data due to drop out over time and a reliance on parental reporting are challenges for large longitudinal studies; future research directions include balancing and testing such investigations with smaller in-depth studies.

  15. Agomelatine: a review of adverse effects.

    PubMed

    2013-03-01

    More pharmacovigilance data on agomelatine became available in 2012. The main sources of information were surveillance data from the French national monitoring system, EU periodic safety update reports (PSURs), and the European pharmacovigilance database. The principal adverse effects of agomelatine consist of hepatic, pancreatic, neuropsychiatric, muscular and cutaneous disorders. The harms associated with agomelatine, which has no proven efficacy in depression, clearly outweigh the benefits. Until regulatory agencies decide to withdraw agomelatine from the market, it is up to healthcare professionals to protect patients from this unnecessarily dangerous drug.

  16. Joint Commission suspends 'auto' adverse decision.

    PubMed

    2010-08-01

    The Joint Commission's revision of its policy on root cause analysis puts greater attention of something that, quite frankly, some ED managers might not have been aware of. The ED manager plays an important role when events occur in the department, such as: knowing who the main Joint Commission contact is in the hospital, and making them aware of a potential adverse or sentinel event that has occurred; participating in the root cause analysis to identify what ED processes might need improvement; making sure the remedial activities recommended can be measured, so The Joint Commission can see an active attempt is being made to improve.

  17. Environmental Perchlorate Exposure: Potential Adverse Thyroid Effects

    PubMed Central

    Leung, Angela M.; Pearce, Elizabeth N.; Braverman, Lewis E.

    2014-01-01

    Purpose of review This review will present a general overview of the sources, human studies, and proposed regulatory action regarding environmental perchlorate exposure. Recent findings Some recent studies have reported significant associations between urinary perchlorate concentrations, thyroid dysfunction, and decreased infant IQ in groups who would be particularly susceptible to perchlorate effects. An update regarding the recent proposed regulatory actions and potential costs surrounding amelioration of perchlorate contamination is provided. Summary The potential adverse thyroidal effects of environmental perchlorate exposure remain controversial, and further research is needed to further define its relationship to human health among pregnant and lactating women and their infants. PMID:25106002

  18. Mitigation of adverse environmental and unavoidable impacts

    SciTech Connect

    1995-10-01

    This portion of the Energy Vision 2020 draft report is a broad scope discussion of the mitigation of adverse environmental and unavoidable impacts. TVA will mitigate site specific environmental impacts from the construction and operation of new power facilities through a combination of planning, pollution prevention, and environmental controls. However, one of the most important mitigative measures associated with Energy Vision 2020 is the multi-attribute tradeoff method used for the evaluation. This method allowed proposed strategies to be reformated in order to reduce potential impacts.

  19. Adverse environments and children's creativity development: transforming the notion of "success in adversity" in China.

    PubMed

    Cheng, Li; Tan, Mei; Liu, Zhengkui

    2015-01-01

    China has been undergoing great social change due to its new focus on urbanization and globalization. Such change has had a tremendous adverse impact on the living conditions of millions of young children, simultaneously generating new interest in children's creativity development. The intersection of these two issues has important implications for China's future as it brings together one of China's core cultural values-"success in adversity"-the importance of creativity, and very real social and economic needs. "Success in adversity" reflects the strongly held belief that individuals who suffer adverse environments can rise to excellence and success through persistence, effort, and creativity. In this article, we briefly explore the historical sources of this belief and how it is closely related to the Chinese conception of creativity. We then present some studies on the creativity of some of China's migrant children. Findings show that while migrant children as a group may not generally exhibit higher creativity than their urban peers as hypothesized, indications of resilience and creative potential suggest that the notion of success in adversity may contribute to the positive development of China's migrant children more substantially when it is informed by research and augmented by research-supported policy.

  20. Adverse Effects of Psychotropic Medications: A Call to Action.

    PubMed

    Mago, Rajnish

    2016-09-01

    Adverse effects are common, bothersome, and a leading cause of discontinuation of treatment. The methodology for evaluating adverse effects of medications has been greatly neglected, however, especially in comparison to the methodology for assessment of efficacy of medications. Existing methods for assessment and reporting of adverse effects have important limitations leading to lack of much-needed data related to adverse effects. Lastly, there is little systematic research into management of most adverse effects. A series of recommendations are made in this article about how to improve identification, assessment, reporting, and management of adverse effects.

  1. Life adverse experiences in relation with obesity and binge eating disorder: A systematic review.

    PubMed

    Palmisano, Giovanni Luca; Innamorati, Marco; Vanderlinden, Johan

    2016-03-01

    Background and aims Several studies report a positive association between adverse life experiences and adult obesity. Despite the high comorbidity between binge eating disorder (BED) and obesity, few authors have studied the link between trauma and BED. In this review the association between exposure to adverse life experiences and a risk for the development of obesity and BED in adulthood is explored. Methods Based on a scientific literature review in Medline, PubMed and PsycInfo databases, the results of 70 studies (N = 306,583 participants) were evaluated including 53 studies on relationship between adverse life experiences and obesity, 7 studies on post-traumatic stress disorder (PTSD) symptoms in relation to obesity, and 10 studies on the association between adverse life experiences and BED. In addition, mediating factors between the association of adverse life experiences, obesity and BED were examined. Results The majority of studies (87%) report that adverse life experiences are a risk factor for developing obesity and BED. More precisely a positive association between traumatic experiences and obesity and PTSD and obesity were found, respectively, in 85% and 86% of studies. Finally, the great majority of studies (90%) between trauma and the development of BED in adulthood strongly support this association. Meanwhile, different factors mediating between the trauma and obesity link were identified. Discussion and conclusions Although research data show a strong association between life adverse experiences and the development of obesity and BED, more research is needed to explain this association.

  2. Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

    PubMed Central

    Brown, S L; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

    1998-01-01

    OBJECTIVES: To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants. METHODS: The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA. RESULTS: In 1988, adverse event reports related to SGBIs accounted for 2.4% of the 14,473 mandatory reports entered into the FDA database on medical devices. In 1992, SGBI-related reports accounted for 30.3% of the total 66,476 mandatory reports of adverse events. The most frequently reported adverse event in 1988, before the widespread publicity on breast implants, was implant burst or rupture. In contrast, in 1992 the most frequently reported event was reaction, a term used to describe a range of adverse effects. CONCLUSIONS: The numbers of mandatory and voluntary reports of SGBI-related adverse events increased exponentially, as did the complexity of the reports, following publicity over the lack of safety data on breast implants and a short voluntary moratorium on their sale. A significant proportion of reports lacked information on specific medical symptoms or diagnoses. PMID:9847926

  3. Life adverse experiences in relation with obesity and binge eating disorder: A systematic review

    PubMed Central

    Palmisano, Giovanni Luca; Innamorati, Marco; Vanderlinden, Johan

    2016-01-01

    Background and aims Several studies report a positive association between adverse life experiences and adult obesity. Despite the high comorbidity between binge eating disorder (BED) and obesity, few authors have studied the link between trauma and BED. In this review the association between exposure to adverse life experiences and a risk for the development of obesity and BED in adulthood is explored. Methods Based on a scientific literature review in Medline, PubMed and PsycInfo databases, the results of 70 studies (N = 306,583 participants) were evaluated including 53 studies on relationship between adverse life experiences and obesity, 7 studies on post-traumatic stress disorder (PTSD) symptoms in relation to obesity, and 10 studies on the association between adverse life experiences and BED. In addition, mediating factors between the association of adverse life experiences, obesity and BED were examined. Results The majority of studies (87%) report that adverse life experiences are a risk factor for developing obesity and BED. More precisely a positive association between traumatic experiences and obesity and PTSD and obesity were found, respectively, in 85% and 86% of studies. Finally, the great majority of studies (90%) between trauma and the development of BED in adulthood strongly support this association. Meanwhile, different factors mediating between the trauma and obesity link were identified. Discussion and conclusions Although research data show a strong association between life adverse experiences and the development of obesity and BED, more research is needed to explain this association. PMID:28092189

  4. Impact of early life adversity on EMG stress reactivity of the trapezius muscle

    PubMed Central

    Luijcks, Rosan; Vossen, Catherine J.; Roggeveen, Suzanne; van Os, Jim; Hermens, Hermie J.; Lousberg, Richel

    2016-01-01

    Abstract Human and animal research indicates that exposure to early life adversity increases stress sensitivity later in life. While behavioral markers of adversity-induced stress sensitivity have been suggested, physiological markers remain to be elucidated. It is known that trapezius muscle activity increases during stressful situations. The present study examined to what degree early life adverse events experienced during early childhood (0–11 years) and adolescence (12–17 years) moderate experimentally induced electromyographic (EMG) stress activity of the trapezius muscles, in an experimental setting. In a general population sample (n = 115), an anticipatory stress effect was generated by presenting a single unpredictable and uncontrollable electrical painful stimulus at t = 3 minutes. Subjects were unaware of the precise moment of stimulus delivery and its intensity level. Linear and nonlinear time courses in EMG activity were modeled using multilevel analysis. The study protocol included 2 experimental sessions (t = 0 and t = 6 months) allowing for examination of reliability. Results show that EMG stress reactivity during the stress paradigm was consistently stronger in people with higher levels of early life adverse events; early childhood adversity had a stronger moderating effect than adolescent adversity. The impact of early life adversity on EMG stress reactivity may represent a reliable facet that can be used in both clinical and nonclinical studies. PMID:27684800

  5. Insufficient sleep in adolescents: causes and consequences.

    PubMed

    Owens, Judith A; Weiss, Miriam R

    2017-02-17

    Insufficient sleep poses an important and complicated set of health risks in the adolescent population. Not only is deficient sleep (defined as both sleep duration inadequate to meet sleep needs and sleep timing misaligned with the body's circadian rhythms) at epidemic levels in this population, but the contributing factors are both complex and numerous and there are a myriad of negative physical and mental health, safety and performance consequences. Causes of inadequate sleep identified in this population include internal biological processes such as the normal shift (delay) in circadian rhythm that occurs in association with puberty and a developmentally-based slowing of the "sleep drive", and external factors including extracurricular activities, excessive homework load, evening use of electronic media, caffeine intake and early school start times. Consequences range from inattentiveness, reduction in executive functioning and poor academic performance to increased risk of obesity and cardio-metabolic dysfunction, mood disturbances which include increased suicidal ideation, a higher risk of engaging in health risk behaviors such as alcohol and substance use, and increased rates of car crashes, occupational injuries and sports-related injuries. In response to these concerns, a number of promising measures have been proposed to reduce the burden of adolescent sleep loss, including healthy sleep education for students and families, and later school start times to allow adolescents to obtain sufficient and appropriately-timed sleep.

  6. The economic consequences of immigration.

    PubMed

    Borjas, G J; Tienda, M

    1987-02-06

    Available research supports several major conclusions about the economic consequences of immigration. (i) The aggregate impacts of foreign workers on the earnings and employment of native workers are quite small, but differ for selected population subgroups and high ethnic density labor markets. (ii) Immigrants who arrived during the 1970s are less skilled than earlier arrivals, and their earnings will remain substantially below those of natives throughout their working lives. (iii) The evidence on immigrants' receipt of public assistance income is inconclusive.

  7. RMP Guidance for Chemical Distributors - Chapter 4: Offsite Consequence Analysis

    EPA Pesticide Factsheets

    How to perform the OCA for regulated substances, informing the government and the public about potential consequences of an accidental chemical release at your facility. Includes calculations for worst-case scenario, alternative scenarios, and endpoints.

  8. Adverse outcome pathway (AOP) development and evaluation ...

    EPA Pesticide Factsheets

    The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be measured in high throughput toxicity testing and the organism or population-level events that are commonly relevant in defining risk. Recognizing the importance of this emerging framework, the Organisation for Economic Co-operation and Development (OECD) launched a program to support the development, documentation and consideration of AOPs by the international community in 2012 (http://www.oecd.org/chemicalsafety/testing/adverse-outcome-pathways-molecular-screening-and-toxicogenomics.htm). In 2014, a handbook (https://aopkb.org/common/AOP_Handbook.pdf) was developed to guide users in the documentation and evaluation of AOPs and their entry into an official knowledgebase. The handbook draws on longstanding experience in consideration of mechanistic data (e.g., mode of action analysis) to inform risk assessment. To further assist users, a training program was developed by members of the OECD Extended Advisory Group to teach users the basic principles of AOP development and the best practices as outlined in the OECD AOP handbook. Training sessions began in early 2015, and this course will provide training for interested SOT scientists. Following this course, all participants will be familiar w

  9. Adverse effects of new antiepileptic drugs.

    PubMed

    Onat, Filiz; Ozkara, Cigdem

    2004-04-01

    Starting with phenobarbital in the 1900s, it took almost 70-80 years to introduce old-generation agents for the treatment of epilepsy. Then, in eleven years, nine more new antiepileptic drugs were added to the armamentarium. These drugs produce a nearly 40-50% decrease in seizure incidence in refractory patients, but few patients have been able to achieve complete freedom from seizures. So the search for more effective drugs with minimal adverse effect profiles will continue. Although the new antiepileptic drugs do not demonstrate a superior efficacy compared to the older ones, they do offer some advantages in terms of tolerability, fewer drug interactions and simpler pharmacokinetics. However, our knowledge concerning their safety profiles can not yet be considered adequate due to the relatively short time these drugs have been on the market and to the limited number of patients exposed to them. The fact that the serious side effects of felbamate and vigabatrine appeared late after marketing should be taken as an important lesson because it implies the potential for unknown side effects at any time during treatment. Antiepileptic drug treatment should begin with diagnosis of the seizure and epileptic syndrome, followed by selection of the drug most appropriate for treatment of the individual patient, and continued with monitoring of not only the seizures but the adverse effect profile as well.

  10. Immunomodulatory drugs: Oral and systemic adverse effects

    PubMed Central

    Mattila, Riikka; Gomez-Font, Rafael; Meurman, Jukka H.

    2014-01-01

    Objectives: The main objectives are to present the different adverses effects of the immunomodulatory drugs that can impair the quality of life of the immunosupressed patients and study the impact of immunomodualtion on oral diseases. Immunomodulatory drugs have changed the treatment protocols of many diseases where immune functions play a central role, such as rheumatic diseases. Their effect on oral health has not been systematically investigated, however. Study Design: We review current data on the new immunomodulatory drugs from the oral health perspective based on open literature search of the topic. Results: These target specific drugs appear to have less drug interactions than earlier immunomodulating medicines but have nevertheless potential side effects such as activating latent infections. There are some data showing that the new immunomodulatory drugs may also have a role in the treatment of certain oral diseases such as lichen planus or ameliorating symptoms in Sjögren´s syndrome, but the results have not been overly promising. Conclusions: In general, data are sparse of the effect of these new drugs vs. oral diseases and there are no properly powered randomized controlled trials published on this topic. Key words:Immunomodulatory drugs, oral diseases, adverse effects, therapeutic action. PMID:23986016

  11. Diagnosis of potential stressors adversely affecting benthic ...

    EPA Pesticide Factsheets

    Greenwich Bay is an urbanized embayment of Narragansett Bay potentially impacted by multiple stressors. The present study identified the important stressors affecting Greenwich Bay benthic fauna. First, existing data and information were used to confirm that the waterbody was impaired. Second, the presence of source, stressor, and effect were established. Then linkages between source, stressor, and effect were developed. This allows identification of probable stressors adversely affecting the waterbody. Three pollutant categories were assessed: chemicals, nutrients, and suspended sediments. This weight of evidence approach indicated that Greenwich Bay was primarily impacted by eutrophication-related stressors. The sediments of Greenwich Bay were carbon enriched and low dissolved oxygen concentrations were commonly seen, especially in the western portions of Greenwich Bay. The benthic community was depauperate, as would be expected under oxygen stress. Although our analysis indicated that contaminant loads in Greenwich Bay were at concentrations where adverse effects might be expected, no toxicity was observed, as a result of high levels of organic carbon in these sediments reducing contaminant bioavailability. Our analysis also indicated that suspended sediment impacts were likely nonexistent for much of the Bay. This analysis demonstrates that the diagnostic procedure was useful to organize and assess the potential stressors impacting the ecological well-being

  12. Maternal language and adverse birth outcomes in a statewide analysis.

    PubMed

    Sentell, Tetine; Chang, Ann; Ahn, Hyeong Jun; Miyamura, Jill

    2016-01-01

    Limited English proficiency is associated with disparities across diverse health outcomes. However, evidence regarding adverse birth outcomes across languages is limited, particularly among U.S. Asian and Pacific Islander populations. The study goal was to consider the relationship of maternal language to birth outcomes using statewide hospitalization data. Detailed discharge data from Hawaii childbirth hospitalizations from 2012 (n = 11,419) were compared by maternal language (English language or not) for adverse outcomes using descriptive and multivariable log-binomial regression models, controlling for race/ethnicity, age group, and payer. Ten percent of mothers spoke a language other than English; 93% of these spoke an Asian or Pacific Islander language. In multivariable models, compared to English speakers, non-English speakers had significantly higher risk (adjusted relative risk [ARR]: 2.02; 95% confidence interval [CI]: 1.34-3.04) of obstetric trauma in vaginal deliveries without instrumentation. Some significant variation was seen by language for other birth outcomes, including an increased rate of primary Caesarean sections and vaginal births after Caesarean, among non-English speakers. Non-English speakers had approximately two times higher risk of having an obstetric trauma during a vaginal birth when other factors, including race/ethnicity, were controlled. Non-English speakers also had higher rates of potentially high-risk deliveries.

  13. Maternal Language and Adverse Birth Outcomes in a Statewide Analysis

    PubMed Central

    Sentell, Tetine; Chang, Ann; Jun Ahn, Hyeong; Miyamura, Jill

    2016-01-01

    Background Limited English proficiency is associated with disparities across diverse health outcomes. However, evidence regarding adverse birth outcomes across languages is limited, particularly among US Asian and Pacific Islander populations. The study goal was to consider the relationship of maternal language to birth outcomes using statewide hospitalization data. Methods Detailed discharge data from Hawai‘i childbirth hospitalizations from 2012 (n=11,419) were compared by maternal language (English language or not) for adverse outcomes using descriptive and multivariable log-binomial regression models, controlling for race/ethnicity, age group, and payer. Results Ten percent of mothers spoke a language other than English; 93% of these spoke an Asian or Pacific Islander language. In multivariable models, compared to English speakers non-English speakers had significantly higher risk (adjusted relative risk [ARR]: 2.02; 95% Confidence Interval [CI]: 1.34–3.04) of obstetric trauma in vaginal deliveries without instrumentation. Some significant variation was seen by language for other birth outcomes, including an increased rate of primary Caesarean sections and vaginal births after Caesarean among non-English speakers. Conclusions Non-English speakers had approximately two times higher risk of having an obstetric trauma during a vaginal birth when other factors, including race/ethnicity, were controlled. Non-English speakers also had higher rates of potentially high-risk deliveries. PMID:26361937

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

    PubMed

    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.

  15. Consequences of gynecological cancer in patients and their partners from the sexual and psychological perspective

    PubMed Central

    Woźniak, Katarzyna; Iżycka, Natalia

    2016-01-01

    The diagnosis of gynecological cancer and the following consequences of the treatment radically change the lives of cancer patients and their partners. Women experience negative consequences in terms of sexual, psychological and social functioning. Surgical treatment may result in a decrease in sexual pleasure and pain during intercourse. Chemotherapy and radiotherapy can cause a loss of libido and negatively affect the capacity to experience pleasure or orgasm. Treatment-related changes may include the occurrence of body image disorders, decreased quality of life as well as depressive and anxiety disorders among patients. Furthermore, a negative influence on the relationship between the affected women and their partners, as well as an adverse effect on the social activity, can be observed. Cancer is not an individual experience. It also affects partners of the sick women in terms of psychological and sexual functioning. This article depicts possible problems encountered by cancer patients and their partners from the psychological and sexual perspective. The emphasis is put on understanding sexuality not only in the context of sexual performance, but also in a wider perspective. PMID:27582686

  16. Making Ends Meet: Some of the Consequences of Part-Time Work for College Students.

    ERIC Educational Resources Information Center

    Hammes, Judith F.; Haller, Emil J.

    1983-01-01

    Considered academic and nonacademic consequences of holding a part-time job while attending school, and the strategies used by students (N=300) to balance these responsibilities. Results indicated that employment has no adverse effect on students' academic performance and both costs and benefits seemed to be job-specific. (LLL)

  17. Organizational cynicism: bases and consequences.

    PubMed

    Abraham, R

    2000-08-01

    Organizational cynicism is the belief that an organization lacks integrity, which, when coupled with a powerful negative emotional reaction, leads to disparaging and critical behavior. In this article, the author attempts to theoretically clarify the process by which five forms of cynicism develop in the workplace and to empirically relate them to affective outcomes. Societal, employee, and organizational change cynicisms may be attributed to psychological contract violations; work cynicism may be related to burnout; and person-role conflict and personality cynicism may be related to innate hostility. Empirically, personality cynicism emerged as the strongest predictor of organizational cynicism, adversely affecting all of the criteria. Other forms of cynicism had more selective effects. Organizational change cynicism induced job dissatisfaction and alienation, and employee cynicism affected organizational commitment. Societal cynicism actually increased both job satisfaction and commitment. Both personality and work cynicisms were related to organizational citizenship indirectly, through alienation. Theoretical and practical implications are discussed.

  18. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  19. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  20. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  1. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  2. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  3. Adverse Outcome Pathways – Tailoring Development to Support Use

    EPA Science Inventory

    Adverse Outcome Pathways (AOPs) represent an ideal framework for connecting high-throughput screening (HTS) data and other toxicity testing results to adverse outcomes of regulatory importance. The AOP Knowledgebase (AOP-KB) captures AOP information to facilitate the development,...

  4. Adverse outcome pathway (AOP) development I: Strategies and principles

    EPA Science Inventory

    An adverse outcome pathway (AOP) is a conceptual framework that organizes existing knowledge concerning biologically plausible, and empirically-supported, links between molecular-level perturbation of a biological system and an adverse outcome at a level of biological organizatio...

  5. Adverse Outcome Pathway (AOP) Network Development for Fatty Liver

    EPA Science Inventory

    Adverse outcome pathways (AOPs) are descriptive biological sequences that start from a molecular initiating event (MIE) and end with an adverse health outcome. AOPs provide biological context for high throughput chemical testing and further prioritize environmental health risk re...

  6. Amniotic Fluid Infection, Cytokine Levels, and Mortality and Adverse Pulmonary, Intestinal, and Neurologic Outcomes in Infants at 32 Weeks' Gestation or Less

    PubMed Central

    2017-01-01

    To what extent the risks of neonatal morbidities are directly related to premature birth or to biological mechanisms of preterm birth remains uncertain. We aimed to examine the effect of exposure to amniotic fluid (AF) infection and elevated cytokine levels on the mortality and pulmonary, intestinal, and neurologic outcomes of preterm infants, and whether these associations persist after adjustment for gestational age at birth. This retrospective cohort study included 152 premature singleton infants who were born at ≤ 32 weeks. AF obtained by amniocentesis was cultured; and interleukin-6 (IL-6) and IL-8 levels in AF were determined. The primary outcome was adverse perinatal outcome defined as the presence of one or more of the followings: stillbirth, neonatal death, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage, and periventricular leukomalacia. Logistic regression analysis was adjusted for gestational age at birth and other potential confounders. In bivariate analyses, elevated AF IL-6 and IL-8 levels were significantly associated with adverse perinatal outcome. These results were not changed after adjusting for potential confounders, such as low Apgar scores, mechanical ventilation, and surfactant application. However, the independent effect of elevated cytokine levels in AF disappeared when additionally adjusted for low gestational age at birth; consequently, low gestational age remained strongly associated with the risk of adverse perinatal outcome. In conclusion, elevated levels of pro-inflammatory cytokines in AF are associated with increased risk of adverse perinatal outcomes, but this risk is not independent of low gestational age at birth. Culture-proven AF infection is not associated with this risk. PMID:28145652

  7. Severe Cutaneous Adverse Drug Reactions: A Clinicoepidemiological Study

    PubMed Central

    Sasidharanpillai, Sarita; Riyaz, Najeeba; Khader, Anza; Rajan, Uma; Binitha, Manikoth P; Sureshan, Deepthi N

    2015-01-01

    Background: Drug eruptions range from transient erythema to the life threatening severe cutaneous adverse reactions (SCAR) that encompass Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms complex (DRESS). Aims and Objectives: To study the clinical and epidemiological aspects of cutaneous adverse drug reactions (CADR). Materials and Methods: Ethical clearance was obtained from the institutional ethics committee. All patients admitted in the Dermatology ward of our tertiary care hospital with CADR (those who fit in the category of probable or possible drug reaction as per WHO casuality assessment) from first September 2011 to 31st August 2012 were included in this cross sectional study after obtaining written informed consent. The drug reaction patterns observed in the study population were determined and the common offending drugs were identified. Results: In the study, population of males outnumbered females and the majority were between 46 and 60 years of age. The commonest reaction pattern observed was SJS- TEN spectrum of illness and aromatic anticonvulsants were the common offending drugs. Prompt withdrawal of the culprit drug and administration of systemic steroids with or without I/V Ig reverted the adverse reaction in all except one. Conclusion: Severe drug reactions predominated as the study population was comprised of inpatients of a tertiary referral centre. Though; previous authors had reported a mortality rate of up to 20% in DRESS, all our patients with this reaction pattern, responded well to treatment. The mortality rate among TEN cases was much lower than the previous reports. Early diagnosis, prompt withdrawal of the suspected drug, careful monitoring for development of complications and immediate intervention can improve the prognosis of CADR. PMID:25657416

  8. An adverse event capture and management system for cancer studies

    PubMed Central

    2015-01-01

    Background Comprehensive capture of Adverse Events (AEs) is crucial for monitoring for side effects of a therapy while assessing efficacy. For cancer studies, the National Cancer Institute has developed the Common Terminology Criteria for Adverse Events (CTCAE) as a required standard for recording attributes and grading AEs. The AE assessments should be part of the Electronic Health Record (EHR) system; yet, due to patient-centric EHR design and implementation, many EHR's don't provide straightforward functions to assess ongoing AEs to indicate a resolution or a grade change for clinical trials. Methods At UAMS, we have implemented a standards-based Adverse Event Reporting System (AERS) that is integrated with the Epic EHR and other research systems to track new and existing AEs, including automated lab result grading in a regulatory compliant manner. Within a patient's chart, providers can launch AERS, which opens the patient's ongoing AEs as default and allows providers to assess (resolution/ongoing) existing AEs. In another tab, it allows providers to create a new AE. Also, we have separated symptoms from diagnoses in the CTCAE to minimize inaccurate designation of the clinical observations. Upon completion of assessments, a physician would submit the AEs to the EHR via a Health Level 7 (HL7) message and then to other systems utilizing a Representational State Transfer Web Service. Conclusions AERS currently supports CTCAE version 3 and 4 with more than 65 cancer studies and 350 patients on those studies. This type of standard integrated into the EHR aids in research and data sharing in a compliant, efficient, and safe manner. PMID:26424052

  9. Adverse drug reactions in therapeutic hypothermia after cardiac arrest

    PubMed Central

    Witcher, Robert; Dzierba, Amy L.; Kim, Catherine; Smithburger, Pamela L.; Kane-Gill, Sandra L.

    2016-01-01

    Background: Therapeutic hypothermia (TH) improves survival and neurologic function in comatose survivors of cardiac arrest. Many medications used to support TH have altered pharmacokinetics and pharmacodynamics during this treatment. It is unknown if or at what frequency the medications used during TH cause adverse drug reactions (ADRs). Methods: A retrospective chart review was conducted for patients admitted to an intensive care unit (ICU) after cardiac arrest and treated with TH from January 2009 to June 2012 at two urban, university-affiliated, tertiary-care medical centres. Medications commonly used during TH were screened for association with significant ADRs (grade 3 or greater per Common Terminology Criteria for Adverse Events) using three published ADR detection instruments. Results: A total of 229 patients were included, the majority being males with median age of 62 presenting with an out-of-hospital cardiac arrest in pulseless electrical activity or asystole. The most common comorbidities were hypertension, coronary artery disease, and diabetes mellitus. There were 670 possible ADRs and 69 probable ADRs identified. Of the 670 possible ADRs, propofol, fentanyl, and acetaminophen were the most common drugs associated with ADRs. Whereas fentanyl, insulin, and propofol were the most common drugs associated with a probable ADR. Patients were managed with TH for a median of 22 hours, with 38% of patients surviving to hospital discharge. Conclusions: Patients undergoing TH after cardiac arrest frequently experience possible adverse reactions associated with medications and the corresponding laboratory abnormalities are significant. There is a need for judicious use and close monitoring of drugs in the setting of TH until recommendations for dose adjustments are available to help prevent ADRs.

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

    PubMed

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

    2014-08-01

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

  11. Adverse weather impacts on arable cropping systems

    NASA Astrophysics Data System (ADS)

    Gobin, Anne

    2016-04-01

    Damages due to extreme or adverse weather strongly depend on crop type, crop stage, soil conditions and management. The impact is largest during the sensitive periods of the farming calendar, and requires a modelling approach to capture the interactions between the crop, its environment and the occurrence of the meteorological event. The hypothesis is that extreme and adverse weather events can be quantified and subsequently incorporated in current crop models. Since crop development is driven by thermal time and photoperiod, a regional crop model was used to examine the likely frequency, magnitude and impacts of frost, drought, heat stress and waterlogging in relation to the cropping season and crop sensitive stages. Risk profiles and associated return levels were obtained by fitting generalized extreme value distributions to block maxima for air humidity, water balance and temperature variables. The risk profiles were subsequently confronted with yields and yield losses for the major arable crops in Belgium, notably winter wheat, winter barley, winter oilseed rape, sugar beet, potato and maize at the field (farm records) to regional scale (statistics). The average daily vapour pressure deficit (VPD) and reference evapotranspiration (ET0) during the growing season is significantly lower (p < 0.001) and has a higher variability before 1988 than after 1988. Distribution patterns of VPD and ET0 have relevant impacts on crop yields. The response to rising temperatures depends on the crop's capability to condition its microenvironment. Crops short of water close their stomata, lose their evaporative cooling potential and ultimately become susceptible to heat stress. Effects of heat stress therefore have to be combined with moisture availability such as the precipitation deficit or the soil water balance. Risks of combined heat and moisture deficit stress appear during the summer. These risks are subsequently related to crop damage. The methodology of defining

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

    PubMed

    Umetsu, Ryogo; Abe, Junko; Ueda, Natsumi; Kato, Yamato; Nakayama, Yoko; Kinosada, Yasutomi; Nakamura, Mitsuhiro

    2015-01-01

    Over-the-counter (OTC) drugs play an important role in self-medication. To ensure patient safety, pharmacists should ask patients to pay attention to possible adverse events (AE) associated with OTC drugs and educate patients about the symptoms related to those AEs. The aims of the present study were as follows: (1) to assess the tendency of AEs to occur with OTC drug use in Japan; (2) to detect a safety signal for OTC drugs using the reporting odds ratio (ROR); and (3) to evaluate clustery features, which include suspected drugs and therapeutic classifications, and safety signal indices (number of reports and the ROR), using cluster analysis. The number of reports of AEs following use of combination cold remedy, antipyretic and analgesic remedy, and herbal medicine was 1007, 566, and 221, respectively. We set the cluster number at five; clustery features obtained were as follows: (1) high reporting rate for skin and subcutaneous tissue disorder AEs was the largest group related to combination cold remedy; (2) high reporting rate for nervous system disorder AEs including dizziness was the second largest group. The same medicinal ingredient may demonstrate similar tendencies of the occurrence of AEs and similar clustery features in the Japanese Adverse Drug Event Report database. Our analysis of AEs associated with OTC drugs may be useful for pharmacists and patients alike. Further studies are required to draw better-informed conclusions.

  13. [Histamine intolerance - are the criteria of an adverse reaction met?].

    PubMed

    Reese, Imke

    2016-06-01

    Searching the internet for an explaination of recurring symptoms, many people come across the so-called histamine intolerance disorder. Also many practitioners like to diagnose this disorder without making sure that reproducibility, a prerequisite for an adverse reaction, is present. Consequently, presumably affected persons are often advised to follow a low-histamine diet. Depending on the source of information, these diets often avoid a huge variety of foods containing more or less histamine, which has a considerable impact on patient quality of life. While most persons benefit from such a diet in the beginning - this might be due to the change in dietary habits or the expectation of symptom improvement by dieting - in the long run the expected loss of symptoms will not happen. Underlying a diminished capacity for histamine degradation, the lack of partial or complete symptom improvement might be due to the fact that endogenous histamine release is responsible for reactions. The role of ingested histamine is discussed controversially. However, it is more than obvious that the histamine content of a certain food alone is not enough to predict its tolerance.If histamine intolerance is suspected, an individual diagnostic and therapeutic procedure is mandatory in order to minimize avoidance and to preserve a high quality of life. Ideally this is done in a close cooperation between allergologists and nutritionists/dieticians.

  14. Antiepileptic drugs and adverse skin reactions: An update.

    PubMed

    Błaszczyk, Barbara; Lasoń, Władysław; Czuczwar, Stanisław Jerzy

    2015-06-01

    This paper summarizes current views on clinical manifestation, pathogenesis, prognosis and management of antiepileptic drug (AED)-induced adverse skin reactions. Cochrane Central Register of Controlled Trials, MEDLINE (PubMed) and ISI Web of Knowledge were searched. The recent classification, among drug-induced skin injuries, points to Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis and hypersensitivity syndrome (HSS), which may be also recognized as a drug reaction with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS). The use of aromatic AEDs, e.g. phenytoin, carbamazepine, oxcarbazepine, phenobarbital, primidone, zonisamide, and lamotrigine is more frequently associated with cutaneous eruption and other signs or symptoms of drug hypersensitivity. There is a high degree of cross-reactivity (40-80%) in patients with hypersensitivity or allergic reactions to AEDs. Pharmacogenetic variations in drug biotransformation may also play a role in inducing these undesired effects. It is suggested that avoidance of specific AEDs in populations at special risk, cautious dose titration and careful monitoring of clinical response and, if applicable, laboratory parameters can minimize the serious consequences of idiosyncratic reactions.

  15. Under the influence of Facebook? Excess use of social networking sites and drinking motives, consequences, and attitudes in college students.

    PubMed

    Hormes, Julia M

    2016-03-01

    Background and aims Excessive use of social networking sites (SNS) has recently been conceptualized as a behavioral addiction (i.e., "disordered SNS use") using key criteria for the diagnosis of substance dependence and shown to be associated with a variety of impairments in psychosocial functioning, including an increased risk of problem drinking. This study sought to characterize associations between "disordered SNS use" and attitudes towards alcohol, drinking motives, and adverse consequences resulting from alcohol use in young adults. Methods Undergraduate students (n = 537, 64.0% female, mean age = 19.63 years, SD = 4.24) reported on their use of SNSs and completed the Alcohol Use Disorders Identification Test, Temptation and Restraint Inventory, Approach and Avoidance of Alcohol and Drinking Motives Questionnaires, and Drinker Inventory of Consequences. Results Respondents meeting previously established criteria for "disordered SNS use" were significantly more likely to use alcohol to cope with negative affect and to conform to perceived social norms, reported significantly more conflicting (i.e., simultaneous positive and negative) attitudes towards alcohol, and had experienced significantly more, and more frequent adverse consequences from drinking in their inter- and intrapersonal, physical, and social functioning, compared to individuals without problems related to SNS use. Discussion and conclusions Findings add to an emerging body of literature suggesting a link between excess or maladaptive SNS use and problems related to alcohol in young adults and point to emotion dysregulation and coping motives as potential shared risk factors for substance and behavioral addictions in this demographic.

  16. Under the influence of Facebook? Excess use of social networking sites and drinking motives, consequences, and attitudes in college students

    PubMed Central

    Hormes, Julia M.

    2016-01-01

    Background and aims Excessive use of social networking sites (SNS) has recently been conceptualized as a behavioral addiction (i.e., “disordered SNS use”) using key criteria for the diagnosis of substance dependence and shown to be associated with a variety of impairments in psychosocial functioning, including an increased risk of problem drinking. This study sought to characterize associations between “disordered SNS use” and attitudes towards alcohol, drinking motives, and adverse consequences resulting from alcohol use in young adults. Methods Undergraduate students (n = 537, 64.0% female, mean age = 19.63 years, SD = 4.24) reported on their use of SNSs and completed the Alcohol Use Disorders Identification Test, Temptation and Restraint Inventory, Approach and Avoidance of Alcohol and Drinking Motives Questionnaires, and Drinker Inventory of Consequences. Results Respondents meeting previously established criteria for “disordered SNS use” were significantly more likely to use alcohol to cope with negative affect and to conform to perceived social norms, reported significantly more conflicting (i.e., simultaneous positive and negative) attitudes towards alcohol, and had experienced significantly more, and more frequent adverse consequences from drinking in their inter- and intrapersonal, physical, and social functioning, compared to individuals without problems related to SNS use. Discussion and conclusions Findings add to an emerging body of literature suggesting a link between excess or maladaptive SNS use and problems related to alcohol in young adults and point to emotion dysregulation and coping motives as potential shared risk factors for substance and behavioral addictions in this demographic. PMID:28092186

  17. Space Radiation and its Associated Health Consequences

    NASA Technical Reports Server (NTRS)

    Wu, Honglu

    2007-01-01

    During space travel, astronauts are exposed to energetic particles of a complex composition and energy distribution. For the same amount of absorbed dose, these particles can be much more effective than X- or gamma rays in the induction of biological effects, including cell inactivation, genetic mutations, cataracts, and cancer induction. Several of the biological consequences of space radiation exposure have already been observed in astronauts. This presentation will introduce the space radiation environment and discuss its associated health risks. Accurate assessment of the radiation risks and development of respective countermeasures are essential for the success of future exploration missions to the Moon and Mars.

  18. The Effect of Work Hours on Adverse Events and Errors in Health Care

    PubMed Central

    Olds, Danielle M.; Clarke, Sean P.

    2010-01-01

    Introduction We studied the relationship between registered nurses' extended work duration with adverse events and errors, including needlestick injuries, work-related injuries, patient falls with injury, nosocomial infections, and medication errors. Method Using bivariate and multivariate logistic regression, this secondary analysis of 11,516 registered nurses examined nurse characteristics, work hours, and adverse events and errors. Results All of the adverse event and error variables were significantly related to working more than 40 hours in the average week. Medication errors and needlestick injuries had the strongest and most consistent relationships with the work hour and voluntary overtime variables. Discussion This study confirms prior findings that increased work hours raise the likelihood of adverse events and errors in healthcare, and further found the same relationship with voluntary overtime. Impact on Industry Legislation has focused on mandatory overtime; however, this study demonstrated that voluntary overtime could also negatively impact nurse and patient safety. PMID:20497801

  19. Environmental consequences of energy production: Proceedings

    SciTech Connect

    none,

    1989-01-01

    The Seventeenth Annual Illinois Energy conference entitled Environmental consequences of Energy Production was held in Chicago, Illinois on October 19-20, 1989. The purpose of the meeting was to provide a forum for exchange of information on the technical, economic and institutional issues surrounding energy production and related environmental problems. The conference program was developed by a planning committee which included Illinois energy and environmental specialists from the major sectors including energy industries, environmental organizations, research universities, utility companies, federal, state and local government agencies, and public interest groups. The conference included presentations on four major topic areas. The issue areas were: urban pollution: where are we now and what needs to be done in the future; the acid rain problem: implications of proposed federal legislation on the Midwest; global warming: an update on the scientific debate; and strategies to minimize environmental damage. Separate abstracts have been prepared for the individual presentations. (FL)

  20. Prenatal alcohol and other early childhood adverse exposures: Direct and indirect pathways to adolescent drinking

    PubMed Central

    Cornelius, Marie D.; De Genna, Natacha M.; Goldschmidt, Lidush; Larkby, Cynthia; Day, Nancy L.

    2016-01-01

    We examined direct and indirect pathways between adverse environmental exposures during gestation and childhood and drinking in mid-adolescence. Mothers and their offspring (n = 917 mother/child dyads) were followed prospectively from second trimester to a 16-year follow-up assessment. Interim assessments occurred at delivery, 6, 10, and 14 years. Adverse environmental factors included gestational exposures to alcohol, tobacco, and marijuana, exposures to childhood maltreatment and violence, maternal psychological symptoms, parenting practices, economic and home environments, and demographic characteristics of the mother and child. Indirect effects of early child behavioral characteristics including externalizing, internalizing activity, attention, and impulsivity were also examined. Polytomous logistic regression analyses were used to evaluate direct effects of adverse environmental exposures with level of adolescent drinking. Structural equation modeling (SEM) was applied to simultaneously estimate the relation between early adversity variables, childhood characteristics, and drinking level at age 16 while controlling for significant covariates. Level of drinking among the adolescent offspring was directly predicted by prenatal exposure to alcohol, less parental strictness, and exposures to maltreatment and violence during childhood. Whites and offspring with older mothers were more likely to drink at higher levels. There was a significant indirect effect between childhood exposure to violence and adolescent drinking via childhood externalizing behavior problems. All other hypothesized indirect pathways were not significant. Thus most of the early adversity measures directly predicted adolescent drinking and did not operate via childhood behavioral dysregulation characteristics. These results highlight the importance of adverse environmental exposures on pathways to adolescent drinking. PMID:26994529

  1. Adverse event prediction in patients with left ventricular assist devices.

    PubMed

    Tsipouras, Markos G; Karvounis, Evaggelos C; Tzallas, Alexandros T; Katertsidis, Nikolaos S; Goletsis, Yorgos; Frigerio, Maria; Verde, Alessandro; Trivella, Maria G; Fotiadis, Dimitrios I

    2013-01-01

    This work presents the Treatment Tool, which is a component of the Specialist's Decision Support Framework (SDSS) of the SensorART platform. The SensorART platform focuses on the management of heart failure (HF) patients, which are treated with implantable, left ventricular assist devices (LVADs). SDSS supports the specialists on various decisions regarding patients with LVADs including decisions on the best treatment strategy, suggestion of the most appropriate candidates for LVAD weaning, configuration of the pump speed settings, while also provides data analysis tools for new knowledge extraction. The Treatment Tool is a web-based component and its functionality includes the calculation of several acknowledged risk scores along with the adverse events appearance prediction for treatment assessment.

  2. Managing adverse events in the use of bevacizumab and chemotherapy.

    PubMed

    Blowers, Elaine; Hall, Kate

    The anti-angiogenic agent bevacizumab (Avastin) has received regulatory approval for the treatment of metastatic breast cancer (MBC) in combination with the taxane chemotherapy agent paclitaxel. A range of side-effects associated with this agent have been identified across different tumour types; these are known to differ from those frequently reported with chemotherapy agents. This article is part one of a two-part literature review that was conducted to provide insight into the range, frequency and severity of adverse events that arise specifically in breast cancer when bevacizumab is combined with cytotoxic chemotherapy. PubMed and the websites of oncology conferences were searched to identify studies of bevacizumab plus chemotherapy in patients with MBC. Seventeen studies met the search criteria, including 3,836 bevacizumab-treated patients. Side-effects associated with bevacizumab included hypertension, proteinuria, thromboembolic events, bleeding and cardiac toxicity. Part two of the series will appear in the next issue of BJN.

  3. Forecasting Epidemiological Consequences of Maternal Immunization

    PubMed Central

    Bento, Ana I.; Rohani, Pejman

    2016-01-01

    Background. The increase in the incidence of whooping cough (pertussis) in many countries with high vaccination coverage is alarming. Maternal pertussis immunization has been proposed as an effective means of protecting newborns during the interval between birth and the first routine dose. However, there are concerns regarding potential interference between maternal antibodies and the immune response elicited by the routine schedule, with possible long-term population-level effects. Methods. We formulated a transmission model comprising both primary routine and maternal immunization. This model was examined to evaluate the long-term epidemiological effects of routine and maternal immunization, together with consequences of potential immune interference scenarios. Results. Overall, our model demonstrates that maternal immunization is an effective strategy in reducing the incidence of pertussis in neonates prior to the onset of the primary schedule. However, if maternal antibodies lead to blunting, incidence increases among older age groups. For instance, our model predicts that with 60% routine and maternal immunization coverage and 30% blunting, the incidence among neonates (0–2 months) is reduced by 43%. Under the same scenario, we observe a 20% increase in incidence among children aged 5–10 years. However, the downstream increase in the older age groups occurs with a delay of approximately a decade or more. Conclusions. Maternal immunization has clear positive effects on infant burden of disease, lowering mean infant incidence. However, if maternally derived antibodies adversely affect the immunogenicity of the routine schedule, we predict eventual population-level repercussions that may lead to an overall increase in incidence in older age groups. PMID:27838674

  4. CO(2)-concentrating: consequences in crassulacean acid metabolism.

    PubMed

    Lüttge, Ulrich

    2002-11-01

    The consequences of CO(2)-concentrating in leaf air-spaces of CAM plants during daytime organic acid decarboxylation in Phase III of CAM (crassulacean acid metabolism) are explored. There are mechanistic consequences of internal CO(2) partial pressures, p(i)(CO(2)). These are (i) effects on stomata, i.e. high p(i)(CO(2)) eliciting stomatal closure in Phase III, (ii) regulation of malic acid remobilization from the vacuole, malate decarboxylation and refixation of CO(2) via Rubisco (ribulose bisphosphate carboxylase/oxygenase), and (iii) internal signalling functions during the transitions between Phases II and III and III and IV, respectively, in the natural day/night cycle and in synchronizing the circadian clocks of individual leaf cells or leaf patches in the free-running endogenous rhythmicity of CAM. There are ecophysiological consequences. Obvious beneficial ecophysiological consequences are (i) CO(2)-acquisition, (ii) increased water-use- efficiency, (iii) suppressed photorespiration, and (iv) reduced oxidative stress by over-energization of the photosynthetic apparatus. However, the general potency of these beneficial effects may be questioned. There are also adverse ecophysiological consequences. These are (i) energetics, (ii) pH effects and (iii) Phase III oxidative stress. A major consequence of CO(2)-concentrating in Phase III is O(2)-concentrating, increased p(i)(CO(2)) is accompanied by increased p(i)(O(2)). Do reversible shifts of C(3)/CAM-intermediate plants between the C(3)-CAM-C(3) modes of photosynthesis indicate that C(3)-photosynthesis provides better protection from irradiance stress? There are many open questions and CAM remains a curiosity.

  5. Adversity and Resilience: A Synthesis of International Research

    ERIC Educational Resources Information Center

    Noltemeyer, Amity L.; Bush, Kevin R.

    2013-01-01

    Children and adolescents worldwide experience a variety of adversities that have the potential to disrupt typical development. However, some of these individuals exhibit resilience, evidencing normal development in the face of adversity. Here we review research on these constructs of risk, adversity, and resilience; synthesize international…

  6. 36 CFR 800.5 - Assessment of adverse effects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Assessment of adverse effects... PROTECTION OF HISTORIC PROPERTIES The section 106 Process § 800.5 Assessment of adverse effects. (a) Apply criteria of adverse effect. In consultation with the SHPO/THPO and any Indian tribe or Native...

  7. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. Link to an amendment published at 77 FR 18, Jan. 3, 2012. (a) Records shall be maintained of any reports of complaints of adverse reactions regarding each unit of blood or blood...

  8. 36 CFR 800.6 - Resolution of adverse effects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Resolution of adverse effects... PROTECTION OF HISTORIC PROPERTIES The section 106 Process § 800.6 Resolution of adverse effects. (a) Continue... the undertaking that could avoid, minimize, or mitigate adverse effects on historic properties....

  9. 7 CFR 1900.55 - Adverse action procedures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS... REGULATIONS GENERAL Adverse Decisions and Administrative Appeals § 1900.55 Adverse action procedures. (a) If an applicant, guaranteed lender, a holder, borrower or grantee is adversely affected by a...

  10. Adverse effects of differential parental attention1

    PubMed Central

    Sajwaj, Thomas E.; Pinkston, Susan; Cordua, Glenn; Jackson, Carolyn; Herbert, Emily W.; Pinkston, Elsie M.; Hayden, M. Loeman

    1973-01-01

    In two independent parent training projects (Kansas and Mississippi), mothers of deviant young children were observed to follow almost all child behaviors with attention. The mothers were then trained to use differential attention procedures to increase their child's appropriate behaviors and to decrease deviant behaviors. Contrary to expectations, the differential attention procedure produced substantial increases in deviant behavior for four of the children. This adverse effect was maintained over many sessions and was replicated in single organism, reversal designs. A fifth child showed no change. A sixth child showed some improvement. However, this effect was not recovered in a second application of differential attention, and the child became worse. The results underline the importance of subject generality in applied behavior analysis and strongly suggest that service programs using operant techniques must carefully evaluate their effects on behavior. PMID:16795386

  11. D-Dimer elevation and adverse outcomes.

    PubMed

    Halaby, Rim; Popma, Christopher J; Cohen, Ander; Chi, Gerald; Zacarkim, Marcelo Rodrigues; Romero, Gonzalo; Goldhaber, Samuel Z; Hull, Russell; Hernandez, Adrian; Mentz, Robert; Harrington, Robert; Lip, Gregory; Peacock, Frank; Welker, James; Martin-Loeches, Ignacio; Daaboul, Yazan; Korjian, Serge; Gibson, C Michael

    2015-01-01

    D-Dimer is a biomarker of fibrin formation and degradation. While a D-dimer within normal limits is used to rule out the diagnosis of deep venous thrombosis and pulmonary embolism among patients with a low clinical probability of venous thromboembolism (VTE), the prognostic association of an elevated D-dimer with adverse outcomes has received far less emphasis. An elevated D-dimer is independently associated with an increased risk for incident VTE, recurrent VTE, and mortality. An elevated D-dimer is an independent correlate of increased mortality and subsequent VTE across a broad variety of disease states. Therefore, medically ill subjects in whom the D-dimer is elevated constitute a high risk subgroup in which the prospective evaluation of the efficacy and safety of antithrombotic therapy is warranted.

  12. Adverse reactions to the sulphite additives

    PubMed Central

    Misso, Neil LA

    2012-01-01

    Sulphites are widely used as preservative and antioxidant additives in the food and pharmaceutical industries. Exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. Most studies report a prevalence of sulphite sensitivity of 3 to 10% among asthmatic subjects who ingest these additives. However, the severity of these reactions varies, and steroid-dependent asthmatics, those with marked airway hyperresponsiveness, and children with chronic asthma, appear to be at greater risk. Although a number of potential mechanisms have been proposed, the precise mechanisms underlying sulphite sensitivity remain unclear. PMID:24834193

  13. Vaccine adverse events: separating myth from reality.

    PubMed

    Kimmel, Sanford R

    2002-12-01

    Vaccines have turned many childhood diseases into distant memories in industrialized countries. However, questions have been raised about the safety of some vaccines because of rare but serious adverse effects that have been attributed to them. Pain, swelling, and redness at the injection site are common local reactions to vaccines. Fever and irritability may occur after some immunizations. Currently, no substantial evidence links measles-mumps-rubella vaccine to autism, or hepatitis B vaccine to multiple sclerosis. Thimerosal is being eliminated from routine childhood vaccines because of concerns that multiple immunizations with vaccines containing this preservative could exceed recommended mercury exposures. Family physicians should be knowledgeable about vaccines so that they can inform their patients of the benefits of immunization and any proven risks. If immunization rates fall, the incidence of vaccine-preventable illnesses may rise.

  14. Adverse Environments and Children's Creativity Development: Transforming the Notion of "Success in Adversity" in China

    ERIC Educational Resources Information Center

    Cheng, Li; Tan, Mei; Liu, Zhengkui

    2015-01-01

    China has been undergoing great social change due to its new focus on urbanization and globalization. Such change has had a tremendous adverse impact on the living conditions of millions of young children, simultaneously generating new interest in children's creativity development. The intersection of these two issues has important implications…

  15. Adverse Experiences in Early Childhood and Kindergarten Outcomes

    PubMed Central

    Wade, Roy; Lin, Yong; Morrow, Lesley M.; Reichman, Nancy E.

    2016-01-01

    OBJECTIVE: To examine associations between adverse childhood experiences (ACEs) in early childhood and teacher-reported academic and behavioral problems in kindergarten. METHODS: We conducted a secondary analysis of data from the Fragile Families and Child Wellbeing Study, a national urban birth cohort. Subjects with primary caregiver-reported information on ACE exposures ascertained at 5 years and teacher-reported outcomes at the end of the child’s kindergarten year were included. Outcomes included teacher ratings of academic skills, emergent literacy skills, and behavior. We included 8 ACE exposures on the basis of the original Centers for Disease Control and Prevention Kaiser study and created an ACE score by summing individual adversities. We examined the associations between teacher-reported academic and behavioral outcomes and ACE scores by using logistic regression. RESULTS: In the study sample, 1007 children were included. Fifty-five percent had experienced 1 ACE and 12% had experienced ≥ 3. Adjusting for potential confounders, experiencing ≥ 3 ACEs was associated with below-average language and literacy skills (adjusted odds ratio [AORs]: 1.8; 95% confidence interval [CI]: 1.1–2.9) and math skills (AOR: 1.8, 95% CI: 1.1–2.9), poor emergent literacy skills, attention problems (AOR: 3.5, 95% CI: 1.8–6.5), social problems (AOR: 2.7, 95% CI: 1.4–5.0), and aggression (AOR: 2.3, 95% CI: 1.2–4.6). CONCLUSIONS: In this study of urban children, experiencing ACEs in early childhood was associated with below-average, teacher-reported academic and literacy skills and behavior problems in kindergarten. These findings underscore the importance of integrated approaches that promote optimal development among vulnerable children. PMID:26768347

  16. Childhood Adversity as a Predictor of Non-Adherence to Statin Therapy in Adulthood

    PubMed Central

    Korhonen, Maarit Jaana; Halonen, Jaana I.; Brookhart, M. Alan; Kawachi, Ichiro; Pentti, Jaana; Karlsson, Hasse; Kivimäki, Mika; Vahtera, Jussi

    2015-01-01

    Purpose To investigate whether adverse experiences in childhood predict non-adherence to statin therapy in adulthood. Methods A cohort of 1378 women and 538 men who initiated statin therapy during 2008–2010 after responding to a survey on childhood adversities, was followed for non-adherence during the first treatment year. Log-binomial regression was used to estimate predictors of non-adherence, defined as the proportion of days covered by dispensed statin tablets <80%. In fully adjusted models including age, education, marital status, current smoking, heavy alcohol use, physical inactivity, obesity, presence of depression and cardiovascular comorbidity, the number of women ranged from 1172 to 1299 and that of men from 473 to 516, because of missing data on specific adversities and covariates. Results Two in three respondents reported at least one of the following six adversities in the family: divorce/separation of the parents, long-term financial difficulties, severe conflicts, frequent fear, severe illness, or alcohol problem of a family member. 51% of women and 44% of men were non-adherent. In men, the number of childhood adversities predicted an increased risk of non-adherence (risk ratio [RR] per adversity 1.11, 95% confidence interval [CI] 1.01–1.21], P for linear trend 0.013). Compared with those reporting no adversities, men reporting 3–6 adversities had a 1.44-fold risk of non-adherence (95% CI 1.12–1.85). Experiencing severe conflicts in the family (RR 1.27, 95% CI 1.03–1.57]) and frequent fear of a family member (RR 1.27, 95% CI 1.00–1.62]) in particular, predicted an increased risk of non-adherence. In women, neither the number of adversities nor any specific type of adversity predicted non-adherence. Conclusions Exposure to childhood adversity may predict non-adherence to preventive cardiovascular medication in men. Usefulness of information on childhood adversities in identification of adults at high risk of non-adherence deserves

  17. Vaccine-related adverse events in Cuban children, 1999-2008.

    PubMed

    Galindo, Belkys M; Concepción, Damarys; Galindo, Miguel A; Pérez, Antonio; Saiz, Jesús

    2012-01-01

    INTRODUCTION Cuba has implemented an effective National Immunization Program since 1962. The schedule, administered primarily to children, comprises 11 vaccines (8 domestically produced) protecting against 13 diseases. In 1999 Cuba launched a national vaccine adverse event surveillance system to monitor and assess the safety of the immunization program, its vaccination procedures and the products administered. OBJECTIVES Describe adverse events following vaccination reported in children aged <16 years in Cuba from 1999 through 2008. METHODS A retrospective descriptive study was conducted of adverse events following vaccination reported from January 1999 through December 2008. Variables used: year, number of adverse events, province, type of vaccine, type and severity of adverse events (common minor, rare, severe), vaccination program errors, number of deaths, and final results of investigations of severe events. Percentages and rates per dose administered were calculated. Adverse event rates were calculated per 100,000 doses administered and by percentages of individual effects among events reported. RESULTS A total of 45,237,532 vaccine doses were administered, and 26,159 vaccine-associated adverse events were reported (overall rate: 57.8 per 100,000 doses). The group aged 0-5 years reported the highest rate of vaccine-associated adverse events (82/100,000 doses). The DTwP vaccine exhibited the highest rate of adverse events. Common minor events were: fever (17,538), reactions at injection site (4470) and systemic side effects (2422). Rare events (by WHO definition) reported were: persistent crying (2666), hypotonic-hyporesponsive episodes (3), encephalopathy (2) and febrile seizures (112). Severe events included: anaphylaxis (2), respiratory distress (1), multiple organ failure (1), sudden death (1), vaccine-associated paralytic poliomyelitis (2), toxic shock syndrome (3), and sepsis (1). The 10 deaths and 3 cases of disability were investigated by an expert

  18. An “ADME Module” in the Adverse Outcome Pathway ...

    EPA Pesticide Factsheets

    The Adverse Outcome Pathway (AOP) framework has generated intense interest for its utility to organize knowledge on the toxicity mechanisms, starting from a molecular initiating event (MIE) to an adverse outcome across various levels of biological organization. While the AOP framework is designed to be chemical agnostic, it is widely recognized that considering chemicals’ absorption, distribution, metabolism, and excretion (ADME) behaviors is critical in applying the AOP framework in chemical-specific risk assessment. Currently, information being generated as part of the Organisation for Economic Co-operation and Development (OECD) AOP Development Programme is being consolidated into an AOP Knowledgebase (http://aopwiki.org). To enhance the use of this Knowledgebase in risk assessment, an ADME Module has been developed to contain the ADME information needed to connect MIEs and other key events in an AOP for specific chemicals. The conceptual structure of this module characterizes the potential of a chemical to reach the target MIE based on either its structure-based features or relative rates of ADME. The key features of this module include (1) a framework for connecting biology-based AOP to biochemical-based ADME and chemical/human activity-based exposure pathways; (2) links to qualitative tools (e.g., structure-based cheminformatic model) that screen for chemicals that could potentially reach the target MIE; (3) links to quantitative tools (e.g., dose-r

  19. Managing adverse birth outcomes: helping parents and families cope.

    PubMed

    Van Dinter, Maureen C; Graves, Lisa

    2012-05-01

    Unexpected adverse fetal and neonatal outcomes (e.g., stillbirth, birth trauma, congenital anomalies) present a crisis for the family and the medical care team. In cases of stillbirth, the family physician should be flexible in supporting the parents' choices, validate the loss, and work as a team with the nursing staff. Psychosocial support includes offering counseling services, assessing women for postpartum depression and anxiety, and considering the effect of the loss on the entire family. Although infants with birth asphyxia or major anomalies may require transfer to facilities with a neonatal intensive care unit, the physician will usually provide ongoing care for the mother in the postpartum period. A comprehensive assessment can determine the etiology of fetal demise in most cases, which may guide future preconception and maternity care. Women with a previous adverse pregnancy outcome may have increased psychological stress in a subsequent pregnancy. Knowledge of community resources will facilitate care for the mother and her partner or family. Physicians may need to seek peer support to cope with their own feelings of loss.

  20. Racial Discrimination and Adverse Birth Outcomes: An Integrative Review

    PubMed Central

    Alhusen, Jeanne L.; Bower, Kelly; Epstein, Elizabeth; Sharps, Phyllis

    2016-01-01

    Introduction This article presents an integrative review of the literature examining the relationship between racial discrimination and adverse birth outcomes. Methods Searches for research studies published from 2009 to 2015 were conducted using PubMed, CINAHL, Scopus, PsycINFO, Web of Science, and Embase. Articles were assessed for potential inclusion using the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) 2009 framework. Results Fifteen studies met criteria for review. The majority of the studies found a significant relationship between racial discrimination and low birth weight, preterm birth, and small for gestational age. Each of the studies that examined more proximal variables related to birth outcomes such as entry into prenatal care, employment opportunities, neighborhood characteristics, or inflammatory markers found significant associations between the specific variables examined and racial discrimination. Participants in qualitative studies discussed experiences of institutional racism with regard to several components of prenatal care including access and quality of care. Discussion Racial discrimination is a significant risk factor for adverse birth outcomes. To best understand the mechanisms by which racial discrimination impacts birth outcomes, and to inform the development of effective interventions that eliminate its harmful effects on health, longitudinal research that incorporates comprehensive measures of racial discrimination is needed. Health care providers must fully acknowledge and address the psychosocial factors that impact health outcomes in minority racial/ethnic women. PMID:27737504

  1. Adverse health effects of anabolic-androgenic steroids.

    PubMed

    van Amsterdam, Jan; Opperhuizen, Antoon; Hartgens, Fred

    2010-06-01

    Anabolic-androgenic steroids (AAS) are synthetic drugs derived from testosterone. Illegally, these drugs are regularly self-administered by body builders and power lifters to enhance their sportive performance. Adverse side effects of AAS include sexual dysfunction, alterations of the cardiovascular system, psyche and behavior, and liver toxicity. However, severe side effects appear only following prolonged use of AAS at high dose and their occurrence is limited. Occasionally, AAS abuse may be linked to certain social and psychological traits of the user, like low self-esteem, low self-confidence, suffered hostility, childhood conduct disorder, and tendency to high-risk behavior. The overwhelming stereotype about AAS is that these compounds cause aggressive behavior in males. However, the underlying personality traits of a specific subgroup of the AAS abusers, who show aggression and hostility, may be relevant, as well. Use of AAS in combination with alcohol largely increases the risk of violence and aggression. The dependence liability of AAS is very low, and withdrawal effects are relatively mild. Based on the scores for acute and chronic adverse health effects, the prevalence of use, social harm and criminality, AAS were ranked among 19 illicit drugs as a group of drugs with a relatively low harm.

  2. Subjective adverse reactions to metronidazole in patients with amebiasis.

    PubMed

    Ohnishi, Kenji; Sakamoto, Naoya; Kobayashi, Ken-Ichiro; Iwabuchi, Sentaro; Nakamura-Uchiyama, Fukumi; Ajisawa, Atsushi; Yamauchi, Yuko; Takeshita, Nozomi; Yamamoto, Yasuyuki; Tsunoda, Takafumi; Yoshimura, Yukihiro; Tachikawa, Natsuo; Uehira, Tomoko

    2014-10-01

    Subjective adverse reactions to metronidazole were analyzed in 111 patients with amebiasis. Metronidazole was administered to 36 patients at a daily dose of 2250 mg and 75 patients at daily doses lower than 2250 mg. The reactions reported included nausea without vomiting in 11 (9.9%) patients, nausea with vomiting in 2 (1.8%), dysgeusia in 2 (1.8%), diarrhea in 1 (0.9%), headache in 1 (0.9%), numbness in 1 (0.9%), dizziness in 1 (0.9%), urticaria in 1 (0.9%), exanthema in 1 (0.9%), and discomfort in 1 (0.9%). Nausea was reported by 28% (10/36) of the patients receiving metronidazole at a daily dose of 2250 mg and 4% (3/75) of the patients receiving lower daily doses. The duration of the metronidazole administration in days was not associated with the appearance of nausea. No life-threatening adverse reactions were identified, and good clinical therapeutic effects were observed in 96% (107/111) of the patients. While metronidazole appears to be a safe anti-protozoal agent for patients with amebiasis, our results indicate that a daily metronidazole dose of 2250 mg is excessive for amebiasis, as it often induces nausea.

  3. [The association between adverse events and nursing care: measurement problems].

    PubMed

    Palese, Alvisa

    2011-01-01

    The association between adverse events and nursing care: measurement problems. Staffing of RNs below target levels has been associated with increased adverse events, included mortality. Some events may be directly associated to lack of surveillance or care, others occur as a result of neglected care and cannot be associated to the shift with levels of nurses below the target. However, a close look to negative events, neglecting positive events provides an incomplete view. Such studies have been criticized because they have not shown a direct link between the level of staffing and individual patient experiences, often did not control for sill mix and did not explore in depth what nurses do and what are their priorities when there is an higher workload. Often these studies present data with mean values ignoring that nurse staffing is not the same across an entire hospital and nursing care is delivered in geographically-based units, with wide variation in staffing levels. A future challenge of research is to combine a descriptive-quantitative approach with the collection of more qualitative data and prospective designs.

  4. Innate immunity, coagulation and placenta-related adverse pregnancy outcomes.

    PubMed

    Li, Min; Huang, S Joseph

    2009-12-01

    Maternal immunity undergoes subtle adjustment in order to tolerate the semi-allogeneic embryo and maintain the host defense against potential pathogens. Concomitantly, coagulation systems change from an anti-coagulant state to a pro-coagulant state to meet the hemostatic challenge of placentation and delivery. Innate immunity and blood coagulation systems are the first line of defense to protect a host against exogenous challenges, including alloantigens and mechanical insults, and preserve the integrity of an organism. The interactions between coagulation and immune systems have been extensively studied. Immune cells play a pivotal role in the initiation of the coagulation cascade, whereas coagulation proteases display substantial immuno-modulatory effects. Upon exogenous challenges, the immune and coagulation systems are capable of potentiating each other leading to a vicious cycle. Natural killer (NK) cells, macrophages (Mphis) and dendritic cells (DCs) are three major innate immune cells that have been demonstrated to play essential roles in early pregnancy. However, immune maladaptation and hemostatic imbalance have been suggested to be responsible for adverse pregnant outcomes, such as preeclampsia (PE), miscarriage, recurrent spontaneous abortion (RSA) and intrauterine growth restriction (IUGR). In this review, we will summarize the mutual regulation between blood coagulation and innate immune systems as well as their roles in the maintenance of normal pregnancy and in the pathogenesis of adverse pregnancy outcomes.

  5. Antecedents and Consequences of Words

    PubMed Central

    Catania, A. Charles

    2006-01-01

    As instances of behavior, words interact with environments. But they also interact with each other and with other kinds of behavior. Because of the interlocking nature of the contingencies into which words enter, their behavioral properties may become increasingly removed from nonverbal contingencies, and their relationship to those contingencies may become distorted by the social contingencies that maintain verbal behavior. Verbal behavior is an exceedingly efficient way in which one organism can change the behavior of another. All other functions of verbal behavior derive from this most basic function, sometimes called verbal governance. Functional verbal antecedents in verbal governance may be extended across time and space when individuals replicate the verbal behavior of others or their own verbal behavior. Differential contact with different verbal antecedents may follow from differential attention to verbal stimuli correlated with consequential events. Once in place, verbal behavior can be shaped by (usually social) consequences. Because these four verbal processes (verbal governance, replication, differential attention, and verbal shaping) share common stimulus and response terms, they produce interlocking contingencies in which extensive classes of behavior come to be dominated by verbal antecedents. Very different consequences follow from verbal behavior depending on whether it is anchored to environmental events, as in scientific verbal practices, or becomes independent of it, as in religious fundamentalism. PMID:22477347

  6. Nutritional consequences of chronic diarrhoea.

    PubMed

    Gorospe, Emmanuel C; Oxentenko, Amy S

    2012-10-01

    There is an undeniable link between gastrointestinal disorders and malnutrition. Chronic diarrhoea is one of the most common gastrointestinal conditions that can impact a patient's nutritional status. The nutritional consequences will depend on the cause of the diarrhoea as well as the location and extent of gastrointestinal involvement. In general, malabsorption plays a central role in the interaction between malnutrition and chronic diarrhoea. Malabsorption can result in both nutritional deficits and diarrhoea. With severe malnutrition, chronic diarrhoea can persist due to impaired immune function and poor mucosal recovery. Food intolerance and an inappropriate diet in the setting of malabsorption may also contribute to chronic diarrhoea. Patients may attribute their gastrointestinal symptoms to specific dietary intake, which can lead to self-imposed indiscriminate dietary restrictions. Therefore, disease-specific treatment in conjunction with appropriate nutritional counselling and intervention is recommended in the prevention and treatment of malnutrition in patients with chronic diarrhoea. Specialized nutritional support through enteral or parenteral administration may be required to treat severe caloric and micronutrient deficiencies. In this review, we aim to summarize the mechanism, diagnosis, and treatment of the nutritional consequences of chronic diarrhoea.

  7. Determinants and Consequences of Obesity

    PubMed Central

    Hruby, Adela; Manson, JoAnn E.; Qi, Lu; Malik, Vasanti S.; Rimm, Eric B.; Sun, Qi; Willett, Walter C.

    2016-01-01

    Objectives. To review the contribution of the Nurses’ Health Studies (NHS and NHS II) in addressing hypotheses regarding risk factors for and consequences of obesity. Methods. Narrative review of the publications of the NHS and NHS II between 1976 and 2016. Results. Long-term NHS research has shown that weight gain and being overweight or obese are important risk factors for type 2 diabetes, cardiovascular diseases, certain types of cancers, and premature death. The cohorts have elucidated the role of dietary and lifestyle factors in obesity, especially sugar-sweetened beverages, poor diet quality, physical inactivity, prolonged screen time, short sleep duration or shift work, and built environment characteristics. Genome-wide association and gene–lifestyle interaction studies have shown that genetic factors predispose individuals to obesity but that such susceptibility can be attenuated by healthy lifestyle choices. This research has contributed to evolving clinical and public health guidelines on the importance of limiting weight gain through healthy dietary and lifestyle behaviors. Conclusions. The NHS cohorts have contributed to our understanding of the risk factors for and consequences of obesity and made a lasting impact on clinical and public health guidelines on obesity prevention. PMID:27459460

  8. Metabolic Consequences after Urinary Diversion

    PubMed Central

    Stein, Raimund; Rubenwolf, Peter

    2014-01-01

    Metabolic disturbances are well-known, but sometimes neglected immediate consequences or late sequelae following urinary diversion (UD) using bowel segments. Whereas subclinical disturbances appear to be quite common, clinically relevant metabolic complications, however, are rare. Exclusion of bowel segments for UD results in loss of absorptive surface for its physiological function. Previous studies demonstrated that at least some of the absorptive and secreting properties of the bowel are preserved when exposed to urine. For each bowel segment typical consequences and complications have been reported. The use of ileal and/or colonic segments may result in hyperchloremic metabolic acidosis, which can be prevented if prophylactic treatment with alkali supplementation is started early. The resection of ileal segments may be responsible for malabsorption of vitamin B12 and bile acids with subsequent neurological and hematological late sequelae as well as potential worsening of the patient’s bowel habits. Hence, careful patient and procedure selection, meticulous long-term follow-up, and prophylactic treatment of subclinical acidosis is of paramount importance in the prevention of true metabolic complications. PMID:24653981

  9. Are There Adverse Consequences to Being a Sibling of a Person with a Disability? A Propensity Score Analysis

    ERIC Educational Resources Information Center

    Neely-Barnes, Susan L.; Graff, J. Carolyn

    2011-01-01

    This study examined whether siblings of children with disabilities have increased mental health problems, behavioral difficulties, or greater mental health service use as compared to siblings of children without disabilities. Data come from the 2006 National Health Interview Survey. Propensity score matching was used to complete the analysis.…

  10. Adverse reactions triggered by dental local anesthetics: a clinical survey.

    PubMed Central

    Kaufman, E.; Goharian, S.; Katz, Y.

    2000-01-01

    One hundred and seventy-nine patients completed a questionnaire focusing on adverse reactions to dental local anesthetics as manifested by 16 signs and symptoms. Twenty-six percent of the participants reported having at least 1 adverse reaction. It was found that most of the adverse reactions occurred within the first 2 hours following the injection of local anesthetics. Pallor, palpitations, diaphoresis, and dizziness were the most common adverse reactions reported in the study. The results pointed to a significant relationship between anxiety, gender, injection technique, and procedure with a higher incidence of adverse reactions. PMID:11432179

  11. The consequences of tourism for sustainable water use on a tropical island: Zanzibar, Tanzania.

    PubMed

    Gössling, S

    2001-02-01

    Many developing countries in the tropics have focused on tourism to generate additional income sources and to diversity the economy. Coastlines in particular have been on the forefront of tourist infrastructure development. Here, the presence of a large number of tourists has often had negative consequences for the sustainable use of the available resources, which in turn has had an effect on the integrity of the ecosystems. In this paper, the situation is described for the use of freshwater resources on the east coast of Zanzibar, Tanzania. This region is water poor, relying on freshwater derived from seasonal rains and stored in less efficient aquifers, which consist of freshwater lenses floating on the underlying seawater. Tourism in the area has grown rapidly in recent years and is expected to further increase in the future. This development is expected to put additional pressure on the freshwater resources of the east coast, which show already signs of over-use. The consequences of overexploitation can include the lowering of the groundwater table, land subsidence, deteriorating groundwater quality, and saltwater intrusion. These, in turn, determine the living conditions in coastal areas and the effects will be felt both by the local populations and the tourist industry. An investigation is made into the causes and consequences of water abstraction by the tourist industry. The results show that present levels of withdrawal are not sustainable, and parts of the local populations are already experiencing water deficits on a daily basis. In the future, if the expected increase in tourist numbers occurs, the pressure on the aquifers will correspondingly increase. The results could be that the tourism in the area becomes unsustainable, which could have an adverse effect on the national economy and also on the local population and environment. Therefore, a precautionary water-management approach is suggested.

  12. The Effects of Consequence Manipulation during Functional Analysis of Problem Behavior Maintained by Negative Reinforcement

    ERIC Educational Resources Information Center

    Potoczak, Kathryn; Carr, James E.; Michael, Jack

    2007-01-01

    Two distinct analytic methods have been used to identify the function of problem behavior. The antecedent-behavior-consequence (ABC) method (Iwata, Dorsey, Slifer, Bauman, & Richman, 1982/1994) includes the delivery of consequences for problem behavior. The AB method (Carr & Durand, 1985) does not include consequence delivery, instead relying…

  13. Simulating Ocean Fertilization: Effectiveness and Unintended Consequences

    SciTech Connect

    Caldeira, K

    2002-11-03

    The primary objectives of this project are to assess, and improve our understanding of: (1) The effectiveness of various proposals to intentionally store carbon in the ocean through fertilization of the surface ocean with iron and/or macronutrients; and (2) Biologically relevant consequences of long-term and extensive ocean fertilization. The PISCES ocean biogeochemistry model, developed at the MPI in Hamburg, Germany, and IPSL in Saclay, France will be used in this study. This model considers Fe, N, P, O{sub 2}, Si, alkalinity, and carbon, in organic and inorganic, dissolved and particulate forms. The model represents diatoms, coccolithophorids, nitrogen fixers, and two classes of zooplankton. This model will be incorporated into the LLNL ocean GCM, which is already being applied to other problems in ocean carbon sequestration. After coupling the ocean biogeochemistry and circulation models, the reliability of this model will be evaluated by comparison to observations. These include observations of natural ecological and biogeochemical variation and observations of small-scale iron fertilization experiments (e.g. SOFeX, IRONEx). This strategy will produce a tested model with predictive capability that we will use to address the following important questions: What is the long-term effectiveness of ocean carbon sequestration via different ocean fertilization strategies? What are the long-term environmental consequences of prolonged or widespread ocean fertilization? What processes need to be included in the models, to better reproduce effects observed in iron fertilization experiments? What should the next experiment measure to better aid the models?

  14. Cumulative early life adversity predicts longevity in wild baboons

    PubMed Central

    Tung, Jenny; Archie, Elizabeth A.; Altmann, Jeanne; Alberts, Susan C.

    2016-01-01

    In humans and other animals, harsh circumstances in early life predict morbidity and mortality in adulthood. Multiple adverse conditions are thought to be especially toxic, but this hypothesis has rarely been tested in a prospective, longitudinal framework, especially in long-lived mammals. Here we use prospective data on 196 wild female baboons to show that cumulative early adversity predicts natural adult lifespan. Females who experience ≥3 sources of early adversity die a median of 10 years earlier than females who experience ≤1 adverse circumstances (median lifespan is 18.5 years). Females who experience the most adversity are also socially isolated in adulthood, suggesting that social processes partially explain the link between early adversity and adult survival. Our results provide powerful evidence for the developmental origins of health and disease and indicate that close ties between early adversity and survival arise even in the absence of health habit and health care-related explanations. PMID:27091302

  15. Cumulative early life adversity predicts longevity in wild baboons.

    PubMed

    Tung, Jenny; Archie, Elizabeth A; Altmann, Jeanne; Alberts, Susan C

    2016-04-19

    In humans and other animals, harsh circumstances in early life predict morbidity and mortality in adulthood. Multiple adverse conditions are thought to be especially toxic, but this hypothesis has rarely been tested in a prospective, longitudinal framework, especially in long-lived mammals. Here we use prospective data on 196 wild female baboons to show that cumulative early adversity predicts natural adult lifespan. Females who experience ≥3 sources of early adversity die a median of 10 years earlier than females who experience ≤1 adverse circumstances (median lifespan is 18.5 years). Females who experience the most adversity are also socially isolated in adulthood, suggesting that social processes partially explain the link between early adversity and adult survival. Our results provide powerful evidence for the developmental origins of health and disease and indicate that close ties between early adversity and survival arise even in the absence of health habit and health care-related explanations.

  16. Childhood Adversity and Neural Development: Deprivation and Threat as Distinct Dimensions of Early Experience

    PubMed Central

    McLaughlin, Katie A.; Sheridan, Margaret A.; Lambert, Hilary K.

    2014-01-01

    A growing body of research has examined the impact of childhood adversity on neural structure and function. Advances in our understanding of the neurodevelopmental consequences of adverse early environments require the identification of dimensions of environmental experience that influence neural development differently and mechanisms other than the frequently-invoked stress pathways. We propose a novel conceptual framework that differentiates between deprivation (absence of expected environmental inputs and complexity) and threat (presence of experiences that represent a threat to one’s physical integrity) and make predictions grounded in basic neuroscience principles about their distinct effects on neural development. We review animal research on fear learning and sensory deprivation as well as human research on childhood adversity and neural development to support these predictions. We argue that these previously undifferentiated dimensions of experience exert strong and distinct influences on neural development that cannot be fully explained by prevailing models focusing only on stress pathways. Our aim is not to exhaustively review existing evidence on childhood adversity and neural development, but to provide a novel framework to guide future research. PMID:25454359

  17. Classroom-level adversity: Associations with children's internalizing and externalizing behaviors across elementary school.

    PubMed

    Abry, Tashia; Bryce, Crystal I; Swanson, Jodi; Bradley, Robert H; Fabes, Richard A; Corwyn, Robert F

    2017-03-01

    Concerns regarding the social-behavioral maladjustment of U.S. youth have spurred efforts among educators and policymakers to identify and remedy educational contexts that exacerbate children's anxiety, depression, aggression, and misconduct. However, investigations of the influence of collective classroom student characteristics on individuals' social-behavioral functioning are few. The present study examined concurrent and longitudinal relations between adversity factors facing the collective classroom student group and levels of children's internalizing and externalizing behaviors across the elementary school years, and whether the pattern of relations differed for girls and boys. First-, third-, and fifth-grade teachers reported on the extent to which adversity-related factors (e.g., home/family life, academic readiness, social readiness, English proficiency, tardiness/absenteeism, student mobility, health) presented a challenge in their classrooms (i.e., classroom-level adversity [CLA]). Mothers reported on their child's internalizing and externalizing behavior at each grade. Autoregressive, lagged panel models controlled for prior levels of internalizing and externalizing behavior, mothers' education, family income-to-needs, and class size. For all children at each grade, CLA was concurrently and positively associated with externalizing behavior. For first-grade girls, but not boys, CLA was also concurrently and positively associated with internalizing behavior. Indirect effects suggested CLA influenced later internalizing and externalizing behavior through its influence on maladjustment in a given year. Discussion highlights possible methods of intervention to reduce CLA or the negative consequences associated with being in a higher-adversity classroom. (PsycINFO Database Record

  18. Macro- and micronutrient dyshomeostasis in the adverse structural remodelling of myocardium

    PubMed Central

    Weber, Karl T.; Weglicki, William B.; Simpson, Robert U.

    2009-01-01

    Hypertension and heart failure are worldwide health problems of ever-increasing proportions. A failure of the heart, during either systolic and/or diastolic phases of the cardiac cycle, has its origins rooted in an adverse structural, biochemical, and molecular remodelling of myocardium that involves its cellular constituents, extracellular matrix, and intramural coronary vasculature. Herein we focus on the pathogenic role of a dyshomeostasis of several macro- (i.e. Ca2+ and Mg2+) and micronutrients (i.e. Zn2+, Se2+, and vitamin D) in contributing to adverse remodelling of the myocardium and its failure as a pulsatile muscular pump. An improved understanding of how these macro- and micronutrients account for the causes and consequences of adverse myocardial remodelling carries with it the potential of identifying new biomarkers predictive of risk, onset and progression, and response to intervention(s), which could be monitored non-invasively and serially over time. Moreover, such incremental knowledge will serve as the underpinning to the development of novel strategies aimed at preventing and/or regressing the ongoing adverse remodelling of myocardium. The time is at hand to recognize the importance of macro- and micronutrient dyshomeostasis in the evaluation and management of hypertension and heart failure. PMID:18835843

  19. A replication of the study ‘Adverse effects of spinal manipulation: a systematic review’

    PubMed Central

    2012-01-01

    Objective To assess the significance of adverse events after spinal manipulation therapy (SMT) by replicating and critically reviewing a paper commonly cited when reviewing adverse events of SMT as reported by Ernst (J Roy Soc Med 100:330–338, 2007). Method Replication of a 2007 Ernst paper to compare the details recorded in this paper to the original source material. Specific items that were assessed included the time lapse between treatment and the adverse event, and the recording of other significant risk factors such as diabetes, hyperhomocysteinemia, use of oral contraceptive pill, any history of hypertension, atherosclerosis and migraine. Results The review of the 32 papers discussed by Ernst found numerous errors or inconsistencies from the original case reports and case series. These errors included alteration of the age or sex of the patient, and omission or misrepresentation of the long term response of the patient to the adverse event. Other errors included incorrectly assigning spinal manipulation therapy (SMT) as chiropractic treatment when it had been reported in the original paper as delivered by a non-chiropractic provider (e.g. Physician). The original case reports often omitted to record the time lapse between treatment and the adverse event, and other significant clinical or risk factors. The country of origin of the original paper was also overlooked, which is significant as chiropractic is not legislated in many countries. In 21 of the cases reported by Ernst to be chiropractic treatment, 11 were from countries where chiropractic is not legislated. Conclusion The number of errors or omissions in the 2007 Ernst paper, reduce the validity of the study and the reported conclusions. The omissions of potential risk factors and the timeline between the adverse event and SMT could be significant confounding factors. Greater care is also needed to distinguish between chiropractors and other health practitioners when reviewing the application of SMT

  20. Antipsychotics and hyperprolactinaemia: mechanisms, consequences and management.

    PubMed

    Holt, Richard I G; Peveler, Robert C

    2011-02-01

    Hyperprolactinaemia is a common side effect in people receiving antipsychotics. The propensity to cause hyperprolactinaemia differs markedly between antipsychotics as a result of differential dopamine D(2) receptor-binding affinity and ability to cross the blood-brain barrier. Sexual dysfunction is common and under-recognized in people with severe mental illness and is in part caused by hyperprolactinaemia. There are a number of long-term consequences of hyperprolactinaemia, including osteoporosis. Regular monitoring before and during treatment will help identify those developing antipsychotic-induced hyperprolactinaemia. The treatment includes dose reduction and change in antipsychotic. Where this is not possible because of the risk of relapse of the mental illness, sex steroid replacement may be helpful in improving symptoms secondary to hypogonadism and reducing the risk of osteoporosis. Tertiary prevention of complications should also be considered.

  1. [Psychic consequences of natural disasters].

    PubMed

    Stepień, Agnieszka; Malyszczak, Krzysztof

    2008-01-01

    The consequences of natural disasters were presented according to: development of the diagnosis of PTSD, variability of factors impacting on formation and sustenance (support) of distemper related to a cataclysm. The natural disaster causing emotional sufferings might be also the reason of psychic distempers that led to: 1. real or anticipate fear of death, 2. physical injuries, 3. economic loss, or 4. death of the relatives. Occurrence of PTSD relies on the pre-traumatic factors (like sex, coexistence of psychic disaster and/or risk of any other traumatic disturbances in the past, economical status, education), on the sort, intensity and duration of keeping the disorders initiated by the stressor and on the posttraumatic features such as social and psychological support.

  2. Hydrological consequences of global warming

    SciTech Connect

    Miller, Norman L.

    2009-06-01

    The 2007 Intergovernmental Panel for Climate Change indicates there is strong evidence that the atmospheric concentration of carbon dioxide far exceeds the natural range over the last 650,000 years, and this recent warming of the climate system is unequivocal, resulting in more frequent extreme precipitation events, earlier snowmelt runoff, increased winter flood likelihoods, increased and widespread melting of snow and ice, longer and more widespread droughts, and rising sea level. The effects of recent warming has been well documented and climate model projections indicate a range of hydrological impacts with likely to very likely probabilities (67 to 99 percent) of occurring with significant to severe consequences in response to a warmer lower atmosphere with an accelerating hydrologic cycle.

  3. [Cardiovascular consequences of aerobic maneuvers].

    PubMed

    Trivelloni, Pierandrea; Berrettini, Umberto

    2010-10-01

    Gravitational (G) stress during aerobatics flights, both military and civilian, can suddenly incapacitate pilots in agile and supermaneuverable aircrafts. High +Gz stress, up to +9Gz, has two different physiological consequences: the first is the drop in head-level blood pressure that is proportional to the G load; the other, slightly delayed, is the blood pooling in the lower part of the body and the abdomen. This blood shift results in a decreased return of venous blood to the heart, decreased cardiac output, and decreased blood pressure, leading to a likely loss of consciousness. The natural countermeasure against the effects of high G stress is the baroreceptor reflex. The human physiological tolerance to the gravito-inertial forces developed in flight operations can be increased by physiological and technological means.

  4. Antecedents and Consequences of Envy.

    PubMed

    Thompson, Geir; Glasø, Lars; Martinsen, Øyvind

    2016-01-01

    The aim of this study was to examine the relationship between individual attributes and envy, and to determine how envy may impact personal response variables in the workplace. To address these issues we apply Vecchio's theory on antecedents and consequences of envy (1995) as a theoretical framework. The present study relied on a cross-sectional measurement design. A total of 135 leaders and 772 followers employed in business organizations participated. SEM analysis shows that span of supervision serves as an important antecedent of envy, where span of supervision is significantly associated to envy via supportive leadership. Furthermore, envy seems to be indirectly and negatively related to self-esteem via distress and directly related to social loafing. The implications of these findings are discussed, and suggestions for future research are outlined.

  5. The Useage of Opioids and their Adverse Effects in Gastrointestinal Practice: A Review

    PubMed Central

    Khansari, MahmoudReza; Sohrabi, MasourReza; Zamani, Farhad

    2013-01-01

    Opium is one of the oldest herbal medicines currently used as an analgesic, sedative and antidiarrheal treatment. The effects of opium are principally mediated by the μ-, κ- and δ-opioid receptors. Opioid substances consist of all natural and synthetic alkaloids that are derived from opium. Most of their effects on gastrointestinal motility and secretion result from suppression of neural activity. Inhibition of gastric emptying, increase in sphincter tone, changes in motor patterns, and blockage of peristalsis result from opioid use. Common adverse effects of opioid administration include sedation, dizziness, nausea, vomiting, constipation, dependency and tolerance, and respiratory depression. The most common adverse effect of opioid use is constipation. Although stool softeners are frequently used to decrease opioid-induced bowel dysfunction, however they are not efficacious. Possibly, the use of specific opioid receptor antagonists is a more suitable approach. Opioid antagonists, both central and peripheral, could affect gastrointestinal function and visceromotor sensitivity, which suggests an important role for endogenous opioid peptides in the control of gastrointestinal physiology. Underlying diseases or medications known to influence the central nervous system (CNS) often accelerate the opioid’s adverse effects. However, changing the opioid and/or route of administration could also decrease their adverse effects. Appropriate patient selection, patient education and discussion regarding potential adverse effects may assist physicians in maximizing the effectiveness of opioids, while reducing the number and severity of adverse effects. PMID:24829664

  6. Childhood adverse life events and parental psychopathology as risk factors for bipolar disorder.

    PubMed

    Bergink, V; Larsen, J T; Hillegers, M H J; Dahl, S K; Stevens, H; Mortensen, P B; Petersen, L; Munk-Olsen, T

    2016-10-25

    Childhood adverse events are risk factors for later bipolar disorder. We quantified the risks for a later diagnosis of bipolar disorder after exposure to adverse life events in children with and without parental psychopathology. This register-based population cohort study included all persons born in Denmark from 1980 to 1998 (980 554 persons). Adversities before age 15 years were: familial disruption; parental somatic illness; any parental psychopathology; parental labour market exclusion; parental imprisonment; placement in out-of-home care; and parental natural and unnatural death. We calculated risk estimates of each of these eight life events as single exposure and risk estimates for exposure to multiple life events. Main outcome variable was a diagnosis of bipolar disorder after the age of 15 years, analysed with Cox proportional hazard regression. Single exposure to most of the investigated adversities were associated with increased risk for bipolar disorder, exceptions were parental somatic illness and parental natural death. By far the strongest risk factor for bipolar disorder in our study was any mental disorder in the parent (hazard ratio 3.53; 95% confidence interval 2.73-4.53) and the additional effects of life events on bipolar risk were limited. An effect of early adverse life events on bipolar risk later in life was mainly observed in children without parental psychopathology. Our findings do not exclude early-life events as possible risk factors, but challenge the concept of adversities as important independent determinants of bipolar disorder in genetically vulnerable individuals.

  7. Close Friends' Psychopathology as a Pathway From Early Adversity to Young Adulthood Depressive Symptoms.

    PubMed

    Raposa, Elizabeth B; Hammen, Constance L; Brennan, Patricia A

    2015-01-01

    Past research has highlighted the negative impact of early adverse experiences on childhood social functioning, including friendship selection, and later mental health. The current study explored the long-term effects of early adversity on young adults' close friends' psychological symptoms and the impact of these close friendships on later depressive symptoms. A prospective longitudinal design was used to examine 816 youth from a large community-based sample, who were followed from birth through age 25. Participants' mothers provided contemporaneous information about adversity exposure up to age 5, and participants completed questionnaires about their own depressive symptoms at age 20 and in their early 20s. Youth also nominated a best friend to complete questionnaires about his or her own psychopathology at age 20. Individuals who experienced more early adversity by age 5 had best friends with higher rates of psychopathology at age 20. Moreover, best friends' psychopathology predicted target youth depressive symptoms 2 to 5 years later. Results indicate that early adversity continues to affect social functioning throughout young adulthood and that best friendships marked by elevated psychopathology in turn negatively affect mental health. Findings have implications for clinical interventions designed to prevent the development of depressive symptoms in youth who have been exposed to early adversity.

  8. Childhood adverse life events and parental psychopathology as risk factors for bipolar disorder

    PubMed Central

    Bergink, V; Larsen, J T; Hillegers, M H J; Dahl, S K; Stevens, H; Mortensen, P B; Petersen, L; Munk-Olsen, T

    2016-01-01

    Childhood adverse events are risk factors for later bipolar disorder. We quantified the risks for a later diagnosis of bipolar disorder after exposure to adverse life events in children with and without parental psychopathology. This register-based population cohort study included all persons born in Denmark from 1980 to 1998 (980 554 persons). Adversities before age 15 years were: familial disruption; parental somatic illness; any parental psychopathology; parental labour market exclusion; parental imprisonment; placement in out-of-home care; and parental natural and unnatural death. We calculated risk estimates of each of these eight life events as single exposure and risk estimates for exposure to multiple life events. Main outcome variable was a diagnosis of bipolar disorder after the age of 15 years, analysed with Cox proportional hazard regression. Single exposure to most of the investigated adversities were associated with increased risk for bipolar disorder, exceptions were parental somatic illness and parental natural death. By far the strongest risk factor for bipolar disorder in our study was any mental disorder in the parent (hazard ratio 3.53; 95% confidence interval 2.73–4.53) and the additional effects of life events on bipolar risk were limited. An effect of early adverse life events on bipolar risk later in life was mainly observed in children without parental psychopathology. Our findings do not exclude early-life events as possible risk factors, but challenge the concept of adversities as important independent determinants of bipolar disorder in genetically vulnerable individuals. PMID:27779625

  9. Betel quid chewing and risk of adverse pregnancy outcomes among aborigines in southern Taiwan.

    PubMed

    Yang, M S; Chang, F T; Chen, S S; Lee, C H; Ko, Y C

    1999-07-01

    It is known that substance use is associated with increased risk of adverse pregnancy, outcomes. The aims of this study were to estimate the prevalence of alcohol, cigarette, betel quid and drug use during pregnancy and to assess the risk of adverse effects of betel quid chewing on pregnancy outcomes in aboriginal women in southern Taiwan. The study population included 62 women with adverse pregnancy outcomes and 124 age-matched women. Subjects were interviewed at their homes by trained interviewers using a structure questionnaire. Prevalences of various substance use in aborigines with adverse pregnancy outcomes were estimated as follows: alcohol, 43.6%; smoking, 14.5%; betel quid chewing, 43.6% and over-the-counter drug use, 8.1%; whereas in the comparison group it was alcohol, 38.7%; smoking, 8.1%; betel quid chewing, 28.2% and none used drugs. Univariate analysis revealed that adverse pregnancy outcomes were associated with maternal betel quid chewing, maternal illness during pregnancy, and the number of pregnancies (gravidity) experienced. After adjusting for maternal illness and number of previous pregnancies covariates, the prevalence of adverse pregnancy outcome was computed to be 2.8-fold higher among betel quid chewing women as compared to non-chewers (AOR=2.8, 95% CI=1.2-6.8). Among the aboriginal women, prenatal care is essential not only for routine care, but also to focus health education on the harmful effects of substance use, especially betel quid use during pregnancy.

  10. Adverse Childhood Experiences, Commitment Offense, and Race/Ethnicity: Are the Effects Crime-, Race-, and Ethnicity-Specific?

    PubMed Central

    DeLisi, Matt; Alcala, Justin; Kusow, Abdi; Hochstetler, Andy; Heirigs, Mark H.; Caudill, Jonathan W.; Trulson, Chad R.; Baglivio, Michael T.

    2017-01-01

    Adverse childhood experiences are associated with an array of health, psychiatric, and behavioral problems including antisocial behavior. Criminologists have recently utilized adverse childhood experiences as an organizing research framework and shown that adverse childhood experiences are associated with delinquency, violence, and more chronic/severe criminal careers. However, much less is known about adverse childhood experiences vis-à-vis specific forms of crime and whether the effects vary across race and ethnicity. Using a sample of 2520 male confined juvenile delinquents, the current study used epidemiological tables of odds (both unadjusted and adjusted for onset, total adjudications, and total out of home placements) to evaluate the significance of the number of adverse childhood experiences on commitment for homicide, sexual assault, and serious persons/property offending. The effects of adverse childhood experiences vary considerably across racial and ethnic groups and across offense types. Adverse childhood experiences are strongly and positively associated with sexual offending, but negatively associated with homicide and serious person/property offending. Differential effects of adverse childhood experiences were also seen among African Americans, Hispanics, and whites. Suggestions for future research to clarify the mechanisms by which adverse childhood experiences manifest in specific forms of criminal behavior are offered. PMID:28327508

  11. Adverse Childhood Experiences, Commitment Offense, and Race/Ethnicity: Are the Effects Crime-, Race-, and Ethnicity-Specific?

    PubMed

    DeLisi, Matt; Alcala, Justin; Kusow, Abdi; Hochstetler, Andy; Heirigs, Mark H; Caudill, Jonathan W; Trulson, Chad R; Baglivio, Michael T

    2017-03-22

    Adverse childhood experiences are associated with an array of health, psychiatric, and behavioral problems including antisocial behavior. Criminologists have recently utilized adverse childhood experiences as an organizing research framework and shown that adverse childhood experiences are associated with delinquency, violence, and more chronic/severe criminal careers. However, much less is known about adverse childhood experiences vis-à-vis specific forms of crime and whether the effects vary across race and ethnicity. Using a sample of 2520 male confined juvenile delinquents, the current study used epidemiological tables of odds (both unadjusted and adjusted for onset, total adjudications, and total out of home placements) to evaluate the significance of the number of adverse childhood experiences on commitment for homicide, sexual assault, and serious persons/property offending. The effects of adverse childhood experiences vary considerably across racial and ethnic groups and across offense types. Adverse childhood experiences are strongly and positively associated with sexual offending, but negatively associated with homicide and serious person/property offending. Differential effects of adverse childhood experiences were also seen among African Americans, Hispanics, and whites. Suggestions for future research to clarify the mechanisms by which adverse childhood experiences manifest in specific forms of criminal behavior are offered.

  12. VOLCANIC RISK ASSESSMENT - PROBABILITY AND CONSEQUENCES

    SciTech Connect

    G.A. Valentine; F.V. Perry; S. Dartevelle

    2005-08-26

    Risk is the product of the probability and consequences of an event. Both of these must be based upon sound science that integrates field data, experiments, and modeling, but must also be useful to decision makers who likely do not understand all aspects of the underlying science. We review a decision framework used in many fields such as performance assessment for hazardous and/or radioactive waste disposal sites that can serve to guide the volcanological community towards integrated risk assessment. In this framework the underlying scientific understanding of processes that affect probability and consequences drive the decision-level results, but in turn these results can drive focused research in areas that cause the greatest level of uncertainty at the decision level. We review two examples of the determination of volcanic event probability: (1) probability of a new volcano forming at the proposed Yucca Mountain radioactive waste repository, and (2) probability that a subsurface repository in Japan would be affected by the nearby formation of a new stratovolcano. We also provide examples of work on consequences of explosive eruptions, within the framework mentioned above. These include field-based studies aimed at providing data for ''closure'' of wall rock erosion terms in a conduit flow model, predictions of dynamic pressure and other variables related to damage by pyroclastic flow into underground structures, and vulnerability criteria for structures subjected to conditions of explosive eruption. Process models (e.g., multiphase flow) are important for testing the validity or relative importance of possible scenarios in a volcanic risk assessment. We show how time-dependent multiphase modeling of explosive ''eruption'' of basaltic magma into an open tunnel (drift) at the Yucca Mountain repository provides insight into proposed scenarios that include the development of secondary pathways to the Earth's surface. Addressing volcanic risk within a decision

  13. The adverse effects profile of levetiracetam in epilepsy: a more detailed look.

    PubMed

    Mbizvo, Gashirai K; Dixon, Pete; Hutton, Jane L; Marson, Anthony G

    2014-09-01

    The adverse effects profile of levetiracetam in epilepsy is still being fully described. We recently published a Cochrane Review evaluating the effectiveness of levetiracetam, added on to usual care, in treating drug-resistant focal epilepsy. The five most common adverse effects were reported and analysed with no scope for reporting any less common adverse effects than those. Here, we report and analyse the remaining adverse effects (including the five most common). These were (in decreasing order of frequency) somnolence; headache; asthenia; accidental injury; dizziness; infection; pharyngitis; pain; rhinitis; abdominal pain; flu syndrome; vomiting; diarrhoea; convulsion; nausea; increased cough; anorexia; upper respiratory tract infection; hostility; personality disorder; urinary tract infection; nervousness; depression; aggression; back pain; agitation; emotional liability; psychomotor hyperactivity; pyrexia; rash; ECG abnormalities; decreased appetite; nasal congestion; irritability; abnormal behaviour; epistaxis; insomnia; altered mood; anxiety; bloody urine; diplopia; dissociation; memory impairment; pruritis; increased appetite; acne; and stomach discomfort. Only somnolence and infection were significantly associated with levetiracetam. When adverse effects pertaining to infection were combined, these affected 19.7% and 15.1% of participants on levetiracetam and placebo (relative risk 1.16, CI 0.89-1.50, Chi(2) heterogeneity p = 0.13). Somnolence and infection further retained significance in adults while no single adverse effect was significant in children. This review updates the adverse effects profile data on levetiracetam use by empirically reporting its common and uncommon adverse effects and analysing their relative importance statistically using data from a group of trials that possess low Risk of Bias and high Quality of Evidence GRADE scores.

  14. Neurological, Metabolic, and Psychiatric Adverse Events in Children and Adolescents Treated With Aripiprazole.

    PubMed

    Jakobsen, Klaus Damgaard; Bruhn, Christina Hedegaard; Pagsberg, Anne-Katrine; Fink-Jensen, Anders; Nielsen, Jimmi

    2016-10-01

    Aripiprazole is a partial dopamine agonist with only minor neurological and psychiatric adverse effects, making it a potential first-line drug for the treatment of psychiatric disorders. However, the evidence of its use in children and adolescents is rather sparse. The aim of this case study is to discuss adverse drug reaction (ADR) reports concerning aripiprazole-associated neurological and psychiatric events in children and adolescents. The ADR report database at Danish Medicines Agency was searched for all ADRs involving children and adolescents (<18 years) reported by the search term [aripiprazole] AND all spontaneous reports since the introduction of aripiprazole in 2003 until December 31, 2015. Nineteen case reports were included in the study and included both patients with psychotic disorders (PS group) and nonpsychotic disorders (non-PS group). The PS group consisted of 5 patients with schizophrenia and psychoses, not otherwise specified; and the non-PS group consisted of fourteen cases including autism spectrum disorders, attention deficit and hyperactivity disorder, obsessive-compulsive disorder, and Tourette syndrome. The main reported adverse effects in the non-PS group were chronic insomnia, Parkinsonism, behavioral changes psychoses, and weight gain, whereas the adverse effects in the PS group was predominantly anxiety, convulsions, and neuroleptic malignant syndrome. Although aripiprazole is considered safe and well tolerated in children and adolescents, severe adverse events as neuroleptic malignant syndrome, extreme insomnia, and suicidal behavior has been reported to health authorities. Clinicians should pay attention to these possible hazards when prescribing aripiprazole to this vulnerable group of patients.

  15. Development and function of consequence classes in operant behavior

    PubMed Central

    Cuvo, Anthony J.

    2000-01-01

    The term class has been discussed extensively in the behavioral literature for groups of stimuli or responses that share a common function. In contrast, the concept of consequence class, including its definition, its formation, and other relevant characteristics, has not been the topic of much attention in the literature. Issues pertaining to consequence classes are discussed to provide a more thorough analysis of the units of operant and discriminated operant functional relations. The concept of class for consequences provides a means to integrate data and theory from the behavior-analytic literature. PMID:22478338

  16. Short-term medical benefits and adverse effects of weight loss.

    PubMed

    Pi-Sunyer, F X

    1993-10-01

    Weight loss reduces many of the health hazards associated with obesity including insulin resistance, diabetes mellitus, hypertension, dyslipidemia, sleep apnea, hypoxemia and hypercarbia, and osteoarthritis. Potential adverse effects of weight loss include a greater risk for gallstone formation and cholecystitis, excessive loss of lean body mass, water and electrolyte problems, mild liver dysfunction, and elevated uric acid levels. Less consequential problems such as diarrhea, constipation, hair loss, and cold intolerance may also occur. The short-term adverse effects are not severe enough to contraindicate weight loss, nor do they outweigh its short-term benefits.

  17. Consequences of contamination of the spacecraft environment: immunologic consequences.

    PubMed

    Shearer, W T

    2001-06-01

    Long-term space voyages pose numerous known and unknown health hazards, to the human immune system. Well-studied clinical examples of secondary immunodeficiencies created on Earth, lead one to predict that the conditions of prolonged space flight would weaken the human immune responses that normally hold infection and cancer in check. From evidence gathered from humans flown for prolonged periods in space and from human models of space flight studied on Earth it is reasonable to suspect that space travelers to the planet Mars would experience a weakening of immunity. Subtle defects of immune cell structure and function have been observed in astronauts, such as weakening of specific T-lymphocyte recall of specific antigens. Ground-based models also have demonstrated alterations of immune function, such as the elevation of neuroendocrine immune system messengers, interleukin-6, and soluble tumor necrosis factor-alpha receptor in sleep deprivation. Since severe immune compromise the clinical consequences of reactivation of latent virus infections and the development of cancer, has yet to be seen in space flight or in the Earth models, it is extremely important to begin to quantify early changes in immunity to predict the development of immune system collapse with poor clinical outcomes. This approach is designed to validate a number of surrogate markers that will predict trouble ahead. Inherent in this research is the development of countermeasures to reduce the risks of infection and cancer in the first humans going to Mars.

  18. Consequences of contamination of the spacecraft environment: immunologic consequences

    NASA Technical Reports Server (NTRS)

    Shearer, W. T.

    2001-01-01

    Long-term space voyages pose numerous known and unknown health hazards, to the human immune system. Well-studied clinical examples of secondary immunodeficiencies created on Earth, lead one to predict that the conditions of prolonged space flight would weaken the human immune responses that normally hold infection and cancer in check. From evidence gathered from humans flown for prolonged periods in space and from human models of space flight studied on Earth it is reasonable to suspect that space travelers to the planet Mars would experience a weakening of immunity. Subtle defects of immune cell structure and function have been observed in astronauts, such as weakening of specific T-lymphocyte recall of specific antigens. Ground-based models also have demonstrated alterations of immune function, such as the elevation of neuroendocrine immune system messengers, interleukin-6, and soluble tumor necrosis factor-alpha receptor in sleep deprivation. Since severe immune compromise the clinical consequences of reactivation of latent virus infections and the development of cancer, has yet to be seen in space flight or in the Earth models, it is extremely important to begin to quantify early changes in immunity to predict the development of immune system collapse with poor clinical outcomes. This approach is designed to validate a number of surrogate markers that will predict trouble ahead. Inherent in this research is the development of countermeasures to reduce the risks of infection and cancer in the first humans going to Mars.

  19. Peripartum cocaine use and adverse pregnancy outcome.

    PubMed

    Little, Bertis B.; Snell, Laura M.; Trimmer, Kenneth J.; Ramin, Susan M.; Ghali, Fred; Blakely, Craig A.; Garret, Andrea

    1999-09-01

    The objective of the study was to analyze possible adverse effects of peripartum cocaine use on maternal and fetal outcomes. Informed consent was given by 720 (97%) of 740 women who delivered consecutively at a large urban public hospital to test an umbilical cord blood sample for the presence of non-medically administered drugs of abuse and alcohol and to be interviewed for the study. Samples were tested for the presence of a cocaine metabolite (benzoylecgonine-BZE) by radioimmunoassay. The presence of other substances of abuse (alcohol, methamphetamine, opiates) resulted in exclusion from the sample of 143 subjects. Thus, in this cohort analysis, drug-free controls (N = 469) were compared to those positive for cocaine only (N = 108). Peripartum exposure to cocaine only, and no other substances of abuse, was associated with an increased frequency of abruptio placentae (1.9% vs 0% for control, P < 0.004), thick meconium stained amniotic fluid (3.9% vs 0.7% for controls, P < 0.006), premature rupture of membranes (P < 0.02), genitourinary anomalies (OR = 3.6, P < 0.05), abdominal wall defects (OR = 4.4, P < 0.01) and increased frequency of low birth weight (OR = 2.0, P < 0.02). These are important findings because previous studies have been complicated by the confounding effects of other substances of abuse. Am. J. Hum. Biol. 11:598-602, 1999. Copyright 1999 Wiley-Liss, Inc.

  20. Constructing Adverse Outcome Pathways: a Demonstration of ...

    EPA Pesticide Factsheets

    Adverse outcome pathway (AOP) provides a conceptual framework to evaluate and integrate chemical toxicity and its effects across the levels of biological organization. As such, it is essential to develop a resource-efficient and effective approach to extend molecular initiating events (MIEs) of chemicals to their downstream phenotypes of a greater regulatory relevance. A number of ongoing public phenomics (high throughput phenotyping) efforts have been generating abundant phenotypic data annotated with ontology terms. These phenotypes can be analyzed semantically and linked to MIEs of interest, all in the context of a knowledge base integrated from a variety of ontologies for various species and knowledge domains. In such analyses, two phenotypic profiles (PPs; anchored by genes or diseases) each characterized by multiple ontology terms are compared for their semantic similarities within a common ontology graph, but across boundaries of species and knowledge domains. Taking advantage of publicly available ontologies and software tool kits, we have implemented an OS-Mapping (Ontology-based Semantics Mapping) approach as a Java application, and constructed a network of 19383 PPs as nodes with edges weighed by their pairwise semantic similarity scores. Individual PPs were assembled from public phenomics data. Out of possible 1.87×108 pairwise connections among these nodes, about 71% of them have similarity scores between 0.2 and the maximum possible of 1.0.

  1. Adapting biomarker technologies to adverse outcome ...

    EPA Pesticide Factsheets

    Adverse outcome pathways (AOP) research is a relatively new concept in human systems biology for assessing the molecular level linkage from an initiating (chemical) event that could lead to a disease state. Although most implementations of AOPs are based on liquids analyses, there are now new technologies being considered derived from the broad field of breath research, especially in applications of gas-phase analysis and instrumentation. The ultimate goal is to discover disease progressions in human or animal systems, identify them at the molecular or cellular level, and then choose analytes that can distinctly define the presence of a particular path (Ankley et al. 2010, Villeneuve et al. 2014). Once such in vivo pathways are identified, then in vitro assays can be developed for streamlined testing of chemical effects without additional human or animal based studies (Pleil et al. 2012). Recent work has focused on discovery analysis in breath, or other biological media, wherein as many as possible compounds are cataloged and then linked to their biochemical source as exogenous (external), endogenous (internal) or from the microbiome (Pleil et al. 2013a, de Lacy Costello 2014, Pleil et al. 2013b, Trefz et al. 2013, Pleil et al. 2014). Such research lays the groundwork for identifying compounds from systems biology that might be relevant for developing AOPs for in vitro research. The National Exposure Research Laboratory’s (NERL’s) Human Exposure and Atm

  2. Adverse immunologic effects of antithyroid drugs.

    PubMed Central

    Wing, S S; Fantus, I G

    1987-01-01

    Propylthiouracil and methimazole are frequently used in the management of hyperthyroidism. Two patients in whom adverse immunologic effects other than isolated agranulocytosis developed during treatment with propylthiouracil are described. A review of the literature revealed 53 similar cases over a 35-year period. Rash, fever, arthralgias and granulocytopenia were the most common manifestations. Vasculitis, particularly with cutaneous manifestations, occurs and may be fatal. The clinical evidence suggests that an immunologic mechanism is involved. A number of different autoantibodies were reported, but antinuclear antibodies were infrequent, and none of the cases met the criteria for a diagnosis of systemic lupus erythematosus. Thus, the reactions do not represent a true drug-induced lupus syndrome. Current hypotheses and experimental data regarding the cause of the reactions are reviewed. No specific clinical subgroup at high risk can be identified, and manifestations may occur at any dosage and at any time during therapy. Cross-reactivity between the two antithyroid drugs can be expected. Except for minor symptoms (e.g., mild arthralgias or transient rash), such reactions are an indication for withdrawal of the drug and the use of alternative methods to control the hyperthyroidism. In rare cases of severe vasculitis a short course of high-dose glucocorticoid therapy may be helpful. PMID:3539299

  3. Analyzing risks of adverse pregnancy outcomes.

    PubMed

    Kramer, Michael S; Zhang, Xun; Platt, Robert W

    2014-02-01

    Approaches for analyzing the risks of adverse pregnancy outcomes have been the source of much debate and many publications. Much of the problem, in our view, is the conflation of time at risk with gestational age at birth (or birth weight, a proxy for gestational age). We consider the causal questions underlying such analyses with the help of a generic directed acyclic graph. We discuss competing risks and populations at risk in the context of appropriate numerators and denominators, respectively. We summarize 3 different approaches to quantifying risks with respect to gestational age, each of which addresses a distinct etiological or prognostic question (i.e., cumulative risk, prospective risk, or instantaneous risk (hazard)) and suggest the appropriate denominators for each. We show how the gestational age-specific risk of perinatal death (PND) can be decomposed as the product of the gestational age-specific risk of birth and the risk of PND conditional on birth at a given gestational age. Finally, we demonstrate how failure to consider the first of these 2 risks leads to selection bias. This selection bias creates the well-known crossover paradox, thus obviating the need to posit common causes of early birth and PND other than the study exposure.

  4. Reporting vaccine-associated adverse events.

    PubMed Central

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

    1997-01-01

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

  5. Adverse childhood experiences and trauma informed care: the future of health care.

    PubMed

    Oral, Resmiye; Ramirez, Marizen; Coohey, Carol; Nakada, Stephanie; Walz, Amy; Kuntz, Angela; Benoit, Jenna; Peek-Asa, Corinne

    2016-01-01

    Adverse childhood experiences (ACEs) are related to short- and long-term negative physical and mental health consequences among children and adults. Studies of the last three decades on ACEs and traumatic stress have emphasized their impact and the importance of preventing and addressing trauma across all service systems utilizing universal systemic approaches. Current developments on the implementation of trauma informed care (TIC) in a variety of service systems call for the surveillance of trauma, resiliency, functional capacity, and health impact of ACEs. Despite such efforts in adult medical care, early identification of childhood trauma in children still remains a significant public health need. This article reviews childhood adversity and traumatic toxic stress, presents epidemiologic data on the prevalence of ACEs and their physical and mental health impacts, and discusses intervention modalities for prevention.

  6. Management of egfr tki–induced dermatologic adverse events

    PubMed Central

    Melosky, B.; Leighl, N.B.; Rothenstein, J.; Sangha, R.; Stewart, D.; Papp, K.

    2015-01-01

    Targeting the epidermal growth factor receptor (egfr) pathway has become standard practice for the treatment of advanced non-small-cell lung cancer. Compared with chemotherapy, egfr tyrosine kinase inhibitors (tkis) have been associated with improved efficacy in patients with an EGFR mutation. Together with the increase in efficacy comes an adverse event (ae) profile different from that of chemotherapy. That profile includes three of the most commonly occurring dermatologic aes: acneiform rash, stomatitis, and paronychia. Currently, no randomized clinical trials have evaluated the treatments for the dermatologic aes that patients experience when taking egfr tkis. Based on the expert opinion of the authors, some basic strategies have been developed to manage those key dermatologic aes. Those strategies have the potential to improve patient quality of life and compliance and to prevent inappropriate dose reductions. PMID:25908911

  7. A time-indexed reference standard of adverse drug reactions.

    PubMed

    Harpaz, Rave; Odgers, David; Gaskin, Greg; DuMouchel, William; Winnenburg, Rainer; Bodenreider, Olivier; Ripple, Anna; Szarfman, Ana; Sorbello, Alfred; Horvitz, Eric; White, Ryen W; Shah, Nigam H

    2014-11-11

    Undetected adverse drug reactions (ADRs) pose a major burden on the health system. Data mining methodologies designed to identify signals of novel ADRs are of deep importance for drug safety surveillance. The development and evaluation of these methodologies requires proper reference benchmarks. While progress has recently been made in developing such benchmarks, our understanding of the performance characteristics of the data mining methodologies is limited because existing benchmarks do not support prospective performance evaluations. We address this shortcoming by providing a reference standard to support prospective performance evaluations. The reference standard was systematically curated from drug labeling revisions, such as new warnings, which were issued and communicated by the US Food and Drug Administration in 2013. The reference standard includes 62 positive test cases and 75 negative controls, and covers 44 drugs and 38 events. We provide usage guidance and empirical support for the reference standard by applying it to analyze two data sources commonly mined for drug safety surveillance.

  8. Genomic architecture of pharmacological efficacy and adverse events

    PubMed Central

    Chhibber, Aparna; Kroetz, Deanna L; Tantisira, Kelan G; McGeachie, Michael; Cheng, Cheng; Plenge, Robert; Stahl, Eli; Sadee, Wolfgang; Ritchie, Marylyn D; Pendergrass, Sarah A

    2015-01-01

    The pharmacokinetic and pharmacodynamic disciplines address pharmacological traits, including efficacy and adverse events. Pharmacogenomics studies have identified pervasive genetic effects on treatment outcomes, resulting in the development of genetic biomarkers for optimization of drug therapy. Pharmacogenomics-based tests are already being applied in clinical decision making. However, despite substantial progress in identifying the genetic etiology of pharmacological response, current biomarker panels still largely rely on single gene tests with a large portion of the genetic effects remaining to be discovered. Future research must account for the combined effects of multiple genetic variants, incorporate pathway-based approaches, explore gene-gene interactions and nonprotein coding functional genetic variants, extend studies across ancestral populations, and prioritize laboratory characterization of molecular mechanisms. Because genetic factors can play a key role in drug response, accurate biomarker tests capturing the main genetic factors determining treatment outcomes have substantial potential for improving individual clinical care. PMID:25521360

  9. Possible adverse effects of frying with vegetable oils.

    PubMed

    Dobarganes, Carmen; Márquez-Ruiz, Gloria

    2015-04-01

    The question of whether heated fats in the diet may be detrimental to health is nowadays of the upmost concern, but finding an answer is not easy and requires careful consideration of different aspects of lipid oxidation. This review is divided into two sections. The first part deals with the nature of the new compounds formed at high temperature in the frying process as well as their occurrence in the diet while the second part focuses on their possible nutritional and physiological effects. Oxidation products present in abused frying fats and oils are the compounds most suspected of impairing the nutritional properties of the oils or involving adverse physiological effects. The recent studies on their health implications include those related to their fate and those focused on their effects in metabolic pathways and the most prevalent diseases.

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

    PubMed Central

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

    2016-01-01

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

  11. Consequences of Predicted or Actual Asteroid Impacts

    NASA Astrophysics Data System (ADS)

    Chapman, C. R.

    2003-12-01

    Earth impact by an asteroid could have enormous physical and environmental consequences. Impactors larger than 2 km diameter could be so destructive as to threaten civilization. Since such events greatly exceed any other natural or man-made catastrophe, much extrapolation is necessary just to understand environmental implications (e.g. sudden global cooling, tsunami magnitude, toxic effects). Responses of vital elements of the ecosystem (e.g. agriculture) and of human society to such an impact are conjectural. For instance, response to the Blackout of 2003 was restrained, but response to 9/11 terrorism was arguably exaggerated and dysfunctional; would society be fragile or robust in the face of global catastrophe? Even small impacts, or predictions of impacts (accurate or faulty), could generate disproportionate responses, especially if news media reports are hyped or inaccurate or if responsible entities (e.g. military organizations in regions of conflict) are inadequately aware of the phenomenology of small impacts. Asteroid impact is the one geophysical hazard of high potential consequence with which we, fortunately, have essentially no historical experience. It is thus important that decision makers familiarize themselves with the hazard and that society (perhaps using a formal procedure, like a National Academy of Sciences study) evaluate the priority of addressing the hazard by (a) further telescopic searches for dangerous but still-undiscovered asteroids and (b) development of mitigation strategies (including deflection of an oncoming asteroid and on- Earth civil defense). I exemplify these issues by discussing several representative cases that span the range of parameters. Many of the specific physical consequences of impact involve effects like those of other geophysical disasters (flood, fire, earthquake, etc.), but the psychological and sociological aspects of predicted and actual impacts are distinctive. Standard economic cost/benefit analyses may not

  12. Emotional consequences of nuclear power plant disasters.

    PubMed

    Bromet, Evelyn J

    2014-02-01

    The emotional consequences of nuclear power plant disasters include depression, anxiety, post-traumatic stress disorder, and medically unexplained somatic symptoms. These effects are often long term and associated with fears about developing cancer. Research on disasters involving radiation, particularly evidence from Chernobyl, indicates that mothers of young children and cleanup workers are the highest risk groups. The emotional consequences occur independently of the actual exposure received. In contrast, studies of children raised in the shadows of the Three Mile Island (TMI) and Chernobyl accidents suggest that although their self-rated health is less satisfactory than that of their peers, their emotional, academic, and psychosocial development is comparable. The importance of the psychological impact is underscored by its chronicity and by several studies showing that poor mental health is associated with physical health conditions, early mortality, disability, and overuse of medical services. Given the established increase in mental health problems following TMI and Chernobyl, it is likely that the same pattern will occur in residents and evacuees affected by the Fukushima meltdowns. Preliminary data from Fukushima indeed suggest that workers and mothers of young children are at risk of depression, anxiety, psychosomatic, and post-traumatic symptoms both as a direct result of their fears about radiation exposure and an indirect result of societal stigma. Thus, it is important that non-mental health providers learn to recognize and manage psychological symptoms and that medical programs be designed to reduce stigma and alleviate psychological suffering by integrating psychiatric and medical treatment within the walls of their clinics.Introduction of Emotional Consequences of Nuclear Power Plant Disasters (Video 2:15, http://links.lww.com/HP/A34).

  13. Childhood adversity impacts on brain subcortical structures relevant to depression.

    PubMed

    Frodl, Thomas; Janowitz, Deborah; Schmaal, Lianne; Tozzi, Leonardo; Dobrowolny, Henrik; Stein, Dan J; Veltman, Dick J; Wittfeld, Katharina; van Erp, Theo G M; Jahanshad, Neda; Block, Andrea; Hegenscheid, Katrin; Völzke, Henry; Lagopoulos, Jim; Hatton, Sean N; Hickie, Ian B; Frey, Eva Maria; Carballedo, Angela; Brooks, Samantha J; Vuletic, Daniella; Uhlmann, Anne; Veer, Ilya M; Walter, Henrik; Schnell, Knut; Grotegerd, Dominik; Arolt, Volker; Kugel, Harald; Schramm, Elisabeth; Konrad, Carsten; Zurowski, Bartosz; Baune, Bernhard T; van der Wee, Nic J A; van Tol, Marie-Jose; Penninx, Brenda W J H; Thompson, Paul M; Hibar, Derrek P; Dannlowski, Udo; Grabe, Hans J

    2017-03-01

    Childhood adversity plays an important role for development of major depressive disorder (MDD). There are differences in subcortical brain structures between patients with MDD and healthy controls, but the specific impact of childhood adversity on such structures in MDD remains unclear. Thus, aim of the present study was to investigate whether childhood adversity is associated with subcortical volumes and how it interacts with a diagnosis of MDD and sex. Within the ENIGMA-MDD network, nine university partner sites, which assessed childhood adversity and magnetic resonance imaging in patients with MDD and controls, took part in the current joint mega-analysis. In this largest effort world-wide to identify subcortical brain structure differences related to childhood adversity, 3036 participants were analyzed for subcortical brain volumes using FreeSurfer. A significant interaction was evident between childhood adversity, MDD diagnosis, sex, and region. Increased exposure to childhood adversity was associated with smaller caudate volumes in females independent of MDD. All subcategories of childhood adversity were negatively associated with caudate volumes in females - in particular emotional neglect and physical neglect (independently from age, ICV, imaging site and MDD diagnosis). There was no interaction effect between childhood adversity and MDD diagnosis on subcortical brain volumes. Childhood adversity is one of the contributors to brain structural abnormalities. It is associated with subcortical brain abnormalities that are relevant to psychiatric disorders such as depression.

  14. Multidisciplinary Treatments, Patient Characteristics, Context of Care, and Adverse Incidents in Older, Hospitalized Adults

    PubMed Central

    Shever, Leah L.; Titler, Marita G.

    2012-01-01

    The purpose of this study was to examine factors that contribute to adverse incidents by creating a model that included patient characteristics, clinical conditions, nursing unit context of care variables, medical treatments, pharmaceutical treatments, and nursing treatments. Data were abstracted from electronic, administrative, and clinical data repositories. The sample included older adults hospitalized during a four-year period at one, academic medical facility in the Midwestern United States who were at risk for falling. Relational databases were built and a multistep, statistical model building analytic process was used. Total registered nurse (RN) hours per patient day (HPPD) and HPPDs dropping below the nursing unit average were significant explanatory variables for experiencing an adverse incident. The number of medical and pharmaceutical treatments that a patient received during hospitalization as well as many specific nursing treatments (e.g., restraint use, neurological monitoring) were also contributors to experiencing an adverse incident. PMID:22530112

  15. Diversity and intensity of adverse events in the treatment of hypertension with barnidipine.

    PubMed

    van der Velden, J W; Beudeker, H J; Nishi, M

    1998-01-01

    Calcium antagonists (CaAs) are divided into three structural classes, typically represented by verapamil, diltiazem and nifedipine. As a group, the principal (type I) adverse effects of these drugs relate to the pharmacological action of calcium channel blockade, namely vasodilation, and include dizziness, flushing, palpitations and peripheral oedema. The clinical safety of the new dihydropyridine CaA, barnidipine, has been assessed in more than 12 clinical trials, including 2041 patients who have been treated with one or more doses of barnidipine (dose of up to 50 mg). Adverse events with barnidipine are of mild to moderate intensity, most commonly of type I, occurring in the early phase of treatment. The incidence of serious adverse events and the rate of withdrawals are low. Hence, barnidipine is likely to be well tolerated in general clinical use.

  16. Early origins of inflammation: an examination of prenatal and childhood social adversity in a prospective cohort study

    PubMed Central

    Slopen, Natalie; Loucks, Eric B.; Appleton, Allison A.; Kawachi, Ichiro; Kubzansky, Laura D.; Non, Amy L.; Buka, Stephen; Gilman, Stephen E.

    2014-01-01

    Background Children exposed to social adversity carry a greater risk of poor physical and mental health into adulthood. This increased risk is thought to be due, in part, to inflammatory processes associated with early adversity that contribute to the etiology of many adult illnesses. The current study asks whether aspects of the prenatal social environment are associated with levels of inflammation in adulthood, and whether prenatal and childhood adversity both contribute to adult inflammation. Methods We examined associations of prenatal and childhood adversity assessed through direct interviews of participants in the Collaborative Perinatal Project between 1959–1974 with blood levels of C-reactive protein in 355 offspring interviewed in adulthood (mean age=42.2 years). Linear and quantile regression models were used to estimate the effects of prenatal adversity and childhood adversity on adult inflammation, adjusting for age, sex, and race and other potential confounders. Results In separate linear regression models, high levels of prenatal and childhood adversity were associated with higher CRP in adulthood. When prenatal and childhood adversity were analyzed together, our results support the presence of an effect of prenatal adversity on (log) CRP level in adulthood (β=0.73, 95% CI: 0.26, 1.20) that is independent of childhood adversity and potential confounding factors including maternal health conditions reported during pregnancy. Supplemental analyses revealed similar findings using quantile regression models and logistic regression models that used a clinically-relevant CRP threshold (>3 mg/L). In a fully-adjusted model that included childhood adversity, high prenatal adversity was associated with a 3-fold elevated odds (95% CI: 1.15, 8.02) of having a CRP level in adulthood that indicates high risk of cardiovascular disease. Conclusions Social adversity during the prenatal period is a risk factor for elevated inflammation in adulthood independent of

  17. Metabolic consequences of polycystic ovary syndrome.

    PubMed

    Churchill, S J; Wang, E T; Pisarska, M D

    2015-12-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women and the leading cause of anovulatory infertility. The prevalence of the syndrome ranges between 6 to 15% based on broader Rotterdam diagnostic criteria verses strict NIH diagnostic criteria.1 The condition is characterized by a combination of ovulatory dysfunction, hyperandrogenism and the presence of polycystic ovaries. PCOS has been associated with multiple metabolic alterations and consequences including impaired glucose tolerance, insulin resistance, hyperinsulinemia, type II diabetes, dyslipidemia, metabolic syndrome, obesity and subclinical cardiovascular disease. It remains unclear however if these associations lead to an increased risk of clinically significant long-term cardiovascular disease. Large prospective studies to date have not detected significant differences in overall cardiovascular morbidity and mortality in PCOS. The phenotypical variability in PCOS has made researching each of these associations challenging as different aspects of the syndrome may be contributing, opposing or confounding factors. The ability to detect significant differences in long-term cardiovascular outcomes may also be due to the variable nature of the syndrome. In this review, we attempt to describe a summary of the current literature concerning the metabolic alterations and cardiovascular consequences of polycystic ovary syndrome.

  18. The educational consequences of teen childbearing.

    PubMed

    Kane, Jennifer B; Philip Morgan, S; Harris, Kathleen Mullan; Guilkey, David K

    2013-12-01

    A huge literature shows that teen mothers face a variety of detriments across the life course, including truncated educational attainment. To what extent is this association causal? The estimated effects of teen motherhood on schooling vary widely, ranging from no discernible difference to 2.6 fewer years among teen mothers. The magnitude of educational consequences is therefore uncertain, despite voluminous policy and prevention efforts that rest on the assumption of a negative and presumably causal effect. This study adjudicates between two potential sources of inconsistency in the literature—methodological differences or cohort differences—by using a single, high-quality data source: namely, The National Longitudinal Study of Adolescent Health. We replicate analyses across four different statistical strategies: ordinary least squares regression; propensity score matching; and parametric and semiparametric maximum likelihood estimation. Results demonstrate educational consequences of teen childbearing, with estimated effects between 0.7 and 1.9 fewer years of schooling among teen mothers. We select our preferred estimate (0.7), derived from semiparametric maximum likelihood estimation, on the basis of weighing the strengths and limitations of each approach. Based on the range of estimated effects observed in our study, we speculate that variable statistical methods are the likely source of inconsistency in the past. We conclude by discussing implications for future research and policy, and recommend that future studies employ a similar multimethod approach to evaluate findings.

  19. Adverse effects of cow's milk in infants.

    PubMed

    Ziegler, Ekhard E

    2007-01-01

    The feeding of cow's milk has adverse effects on iron nutrition in infants and young children. Several different mechanisms have been identified that may act synergistically. Probably most important is the low iron content of cow's milk. It makes it difficult for the infant to obtain the amounts of iron needed for growth. A second mechanism is the occult intestinal blood loss, which occurs in about 40% of normal infants during feeding of cow's milk. Loss of iron in the form of blood diminishes with age and ceases after 1 year of age. A third factor is calcium and casein provided by cow's milk in high amounts. Calcium and casein both inhibit the absorption of dietary nonheme iron. Infants fed cow's milk receive much more protein and minerals than they need. The excess has to be excreted in the urine. The high renal solute load leads to higher urine concentration during the feeding of cow's milk than during the feeding of breast milk or formula. When fluid intakes are low and/or when extrarenal water losses are high, the renal concentrating ability of infants may be insufficient for maintaining water balance in the face of high water use for excretion of the high renal solute. The resulting negative water balance, if prolonged, can lead to serious dehydration. There is strong epidemiological evidence that the feeding of cow's milk or formulas with similarly high potential renal solute load places infants at an increased risk of serious dehydration. The feeding of cow's milk to infants is undesirable because of cow's milk's propensity to lead to iron deficiency and because it unduly increases the risk of severe dehydration.

  20. Observational Consequences of Galactic Oscillations

    NASA Technical Reports Server (NTRS)

    Miller, R. H.; Smith, Bruce F.; Cuzzi, Jeff C. (Technical Monitor)

    1996-01-01

    The normal mode oscillations of galaxies we reported recently are large enough to produce observational consequences. The two lowest order modes were both very strong and long lived: the fundamental is a "breathing" mode in which the entire galaxy expands and contracts homologously, while the second radial mode is spherically symmetrical and has one radial node. A sheet of neutral hydrogen in an oscillating galaxy partakes of the general oscillations, and the resulting velocity fields would normally be interpreted in terms of warps or oval distortions. More interestingly, the second radial mode might be a dynamical driver for bulges in early-type spiral galaxies. If bulges result from a dynamical process within the galaxy, there might be other observable properties driven by the same dynamical process. The hole often reported in neutral hydrogen in early type spiral galaxies is one such candidate. It has sometimes been reported to be about the same size as the bulge. We will discuss evidence from velocity fields concerning the fundamental mode and from the coincidence of bulge and HI hole sizes as evidence for the second mode.