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Sample records for adverse childhood events

  1. Adverse childhood event experiences, fertility difficulties, and menstrual cycle characteristics

    PubMed Central

    Jacobs, Marni B.; Boynton-Jarrett, Renee D.; Harville, Emily W.

    2016-01-01

    Introduction Increased childhood adversity may be affect adult fertility, however, the mechanism through which this occurs is unclear. Menstrual cycle abnormalities are predictive of fertility difficulties, and stress influences menstrual cycle characteristics. Here, we assesses whether adverse childhood experiences (ACEs) are associated with fertility difficulties and menstrual cycle dysregulation, offering a plausible mechanism for the link between lifetime stress and fertility. Methods From April 2012 – February 2014, 742 pregnant and non-pregnant women aged 18–45 years residing in southeastern Louisiana provided information on childhood adversity and reproductive history. Associations between ACEs and fertility difficulties and menstrual cycle patterns were evaluated. Results As the number of ACEs increased, risk of fertility difficulties and amenorrhea increased (RR = 1.09, 95% CI 1.05 – 1.13 and RR = 1.07, 95% CI 1.04 – 1.10, respectively), while fecundability decreased (FR = 0.97, 95% CI 0.95 – 1.00). Compared to women with no adversity, women in the high adversity group were more likely to experience both infertility and amenorrhea (RR = 2.75, 95% CI 1.45 – 5.21 and RR = 2.54, 95% CI 1.52 – 4.25, respectively), and reduced fecundability (FR = 0.75, 95% CI 0.56 – 1.00). Although similar patterns were seen for menstrual cycle irregularity, associations were diminished. Associations did not materially change following adjustment for age, BMI, race, education, smoking, and income. Results are constrained by the self-report nature of the study and the limited generalizability of the study population. Discussion To our knowledge, this is the first study to present evidence of a link between childhood stressors, menstrual cycle disruption, and fertility difficulties. The effect of childhood stress on fertility may be mediated through altered functioning of the HPA axis, acting to suppress fertility in response to less than optimal reproductive

  2. Childhood Adverse Events and Health Outcomes among Methamphetamine-Dependent Men and Women

    ERIC Educational Resources Information Center

    Messina, Nena P.; Marinelli-Casey, Patricia; Hillhouse, Maureen; Ang, Alfonso; Hunter, Jeremy; Rawson, Richard

    2008-01-01

    To describe the prevalence of childhood adverse events (CAEs) among methamphetamine-dependent men and women, and assess the relationship of cumulative CAEs to health problems. Data for 236 men and 351 women were analyzed assessing CAEs. Dependent variables included 14 self-reported health problems or psychiatric symptom domains. Mental health was…

  3. The Prevalence of Childhood Adversity among Healthcare Workers and Its Relationship to Adult Life Events, Distress and Impairment

    ERIC Educational Resources Information Center

    Maunder, Robert G.; Peladeau, Nathalie; Savage, Diane; Lancee, William J.

    2010-01-01

    Objective: We investigated the prevalence of childhood adversity among healthcare workers and if such experiences affect responses to adult life stress. Methods: A secondary analysis was conducted of a 2003 study of 176 hospital-based healthcare workers, which surveyed lifetime traumatic events, recent life events, psychological distress, coping,…

  4. Adverse events in childhood and chronic widespread pain in adult life: Results from the 1958 British Birth Cohort Study.

    PubMed

    Jones, Gareth T; Power, Chris; Macfarlane, Gary J

    2009-05-01

    Chronic widespread pain (CWP) is a common and frequently disabling condition. Several studies have shown that early life adversity is associated with CWP in later life; however, the majority are retrospective and suffer from potential recall bias. Using data from the 1958 British Birth Cohort Study, the aim of the current study was to examine, prospectively, the relationship between childhood physical and psychological adversity and CWP in adulthood. At 7 yrs data were collected, by parental report, on physically traumatic events (hospitalisation following a road traffic accident, or for surgery); and factors indicating poor social and psychological environment (periods in local authority care, death of a parent; or parental divorce, alcoholism, or financial hardship). CWP was assessed at 45 yrs using self-completion questionnaires. The relationship between childhood events and CWP was examined using Poisson regression. 7571 individuals provided pain data at 45 yrs (71.5%). There was no association between childhood surgery and CWP in adulthood (relative risk: 1.0; 95%CI: 0.9-1.1). However, children who had been hospitalised following a road traffic accident experienced a significant increase in the risk of future CWP (1.5; 1.05-2.1). Children who had resided in institutional care also experienced an increase in the risk of CWP (1.7; 1.3-2.4) as did those who experienced maternal death (2.0; 1.08-3.7) and familial financial hardship (1.6; 1.3-1.9). Further these associations were not explained by adult psychological distress or social class. To prevent long-term consequences of adverse childhood events, future research should study the mechanisms, in particular the biological mechanisms, underlying these relationships. PMID:19304391

  5. 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 ...

  6. Dose-Effect Relationships for Adverse Events After Cranial Radiation Therapy in Long-term Childhood Cancer Survivors

    SciTech Connect

    Dijk, Irma W.E.M. van; Cardous-Ubbink, Mathilde C.; Pal, Helena J.H. van der; Oldenburger, Foppe; Os, Rob M. van; Ronckers, Cécile M.; Schouten–van Meeteren, Antoinette Y.N.; Kremer, Leontien C.M.

    2013-03-01

    Purpose: To evaluate the prevalence and severity of clinical adverse events (AEs) and treatment-related risk factors in childhood cancer survivors treated with cranial radiation therapy (CRT), with the aim of assessing dose-effect relationships. Methods and Materials: The retrospective study cohort consisted of 1362 Dutch childhood cancer survivors, of whom 285 were treated with CRT delivered as brain irradiation (BI), as part of craniospinal irradiation (CSI), and as total body irradiation (TBI). Individual CRT doses were converted into the equivalent dose in 2-Gy fractions (EQD{sub 2}). Survivors had received their diagnoses between 1966 and 1996 and survived at least 5 years after diagnosis. A complete inventory of Common Terminology Criteria for Adverse Events grade 3.0 AEs was available from our hospital-based late-effect follow-up program. We used multivariable logistic and Cox regression analyses to examine the EQD{sub 2} in relation to the prevalence and severity of AEs, correcting for sex, age at diagnosis, follow-up time, and the treatment-related risk factors surgery and chemotherapy. Results: There was a high prevalence of AEs in the CRT group; over 80% of survivors had more than 1 AE, and almost half had at least 5 AEs, both representing significant increases in number of AEs compared with survivors not treated with CRT. Additionally, the proportion of severe, life-threatening, or disabling AEs was significantly higher in the CRT group. The most frequent AEs were alopecia and cognitive, endocrine, metabolic, and neurologic events. Using the EQD{sub 2}, we found significant dose-effect relationships for these and other AEs. Conclusion: Our results confirm that CRT increases the prevalence and severity of AEs in childhood cancer survivors. Furthermore, analyzing dose-effect relationships with the cumulative EQD{sub 2} instead of total physical dose connects the knowledge from radiation therapy and radiobiology with the clinical experience.

  7. Adverse Childhood Events and the Risk for New-Onset Depression and Post-Traumatic Stress Disorder Among U.S. National Guard Soldiers.

    PubMed

    Rudenstine, Sasha; Cohen, Greg; Prescott, Marta; Sampson, Laura; Liberzon, Israel; Tamburrino, Marijo; Calabrese, Joseph; Galea, Sandro

    2015-09-01

    This article examines the relationship between childhood adversity and postdeployment new-onset psychopathology among a sample of U.S. National Guard personnel deployed during Operation Iraqi Freedom and Operation Enduring Freedom with no history of post-traumatic stress disorder (PTSD) or depression. We recruited a sample of 991 Ohio Army National Guard soldiers and conducted structured interviews to assess traumatic event exposure, a history of childhood adversity, and postdeployment depression, and PTSD, consistent with the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition. We assessed childhood adversity by using questions from the Childhood Adverse Events Survey. In multivariable logistic models, a history of any childhood adversity was significantly associated with new-onset depression, but not PTSD, postdeployment. This finding suggests that a history of childhood adversity is predisposing for new-onset depression, among U.S. National Guard soldiers who were deployed with no prior history of PTSD or depression. This highlights the centrality of childhood experience for the production of mental health among soldiers. PMID:26327549

  8. 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…

  9. Screening for adverse events.

    PubMed

    Karson, A S; Bates, D W

    1999-02-01

    Adverse events (AEs) in medical patients are common, costly, and often preventable. Development of quality improvement programs to decrease the number and impact of AEs demands effective methods for screening for AEs on a routine basis. Here we describe the impact, types, and potential causes of AEs and review various techniques for identifying AEs. We evaluate the use of generic screening criteria in detail and describe a recent study of the sensitivity and specificity of individual generic screening criteria and combinations of these criteria. In general, the most sensitive screens were the least specific and no small sub-set of screens identified a large percentage of adverse events. Combinations of screens that were limited to administrative data were the least expensive, but none were particularly sensitive, although in practice they might be effective since routine screening is currently rarely done. As computer systems increase in sophistication sensitivity will improve. We also discuss recent studies that suggest that programs that screen for and identify AEs can be useful in reducing AE rates. While tools for identifying AEs have strengths and weaknesses, they can play an important role in organizations' quality improvement portfolios. PMID:10468381

  10. Posttraumatic Stress Disorder, Adverse Childhood Events, and Buccal Cell Telomere Length in Elderly Swiss Former Indentured Child Laborers

    PubMed Central

    Küffer, Andreas Lorenz; O’Donovan, Aoife; Burri, Andrea; Maercker, Andreas

    2016-01-01

    Posttraumatic stress disorder (PTSD) is associated with increased risk for age-related diseases and early mortality. Accelerated biological aging could contribute to this elevated risk. The aim of the present study was to assess buccal cell telomere length (BTL) – a proposed marker of biological age – in men and women with and without PTSD. The role of childhood trauma was assessed as a potential additional risk factor for shorter telomere length. The sample included 62 former indentured Swiss child laborers (age: M = 76.19, SD = 6.18) and 58 healthy controls (age: M = 71.85, SD = 5.97). Structured clinical interviews were conducted to screen for PTSD and other psychiatric disorders. The Childhood Trauma Questionnaire (CTQ) was used to assess childhood trauma exposure. Quantitative polymerase chain reaction was used to measure BTL. Covariates include age, sex, years of education, self-evaluated financial situation, depression, and mental and physical functioning. Forty-eight (77.42%) of the former indentured child laborers screened positive for childhood trauma, and 21 (33.87%) had partial or full-blown PTSD. Results did not support our hypotheses that PTSD and childhood trauma would be associated with shorter BTL. In fact, results revealed a trend toward longer BTL in participants with partial or full PTSD [F(2,109) = 3.27, p = 0.04, η2 = 0.06], and longer BTL was marginally associated with higher CTQ scores (age adjusted: β = 0.17 [95% CI: −0.01 to 0.35], t = 1.90, p = 0.06). Furthermore, within-group analyses indicated no significant association between BTL and CTQ scores. To the best of our knowledge, this is the first study exploring the association between childhood trauma and BTL in older individuals with and without PTSD. Contrary to predictions, there were no significant differences in BTL between participants with and without PTSD in our adjusted analyses, and childhood adversity was not associated with

  11. Adulthood personality correlates of childhood adversity

    PubMed Central

    Carver, Charles S.; Johnson, Sheri L.; McCullough, Michael E.; Forster, Daniel E.; Joormann, Jutta

    2014-01-01

    Objective: Childhood adversity has been linked to internalizing and externalizing disorders and personality disorders in adulthood. This study extends that research by examining several personality measures as correlates of childhood adversity. Method: In a college sample self-reports were collected of childhood adversity, several scales relating to personality, and current depression symptoms as a control variable. The personality-related scales were reduced to four latent variables, which we termed anger/aggression, extrinsic focus, agreeableness, and engagement. Results: Controlling for concurrent depressive symptoms and gender, higher levels of reported childhood adversity related to lower agreeableness and to higher anger/aggression and extrinsic focus. Conclusions: Findings suggest that early adversity is linked to personality variables relevant to the building of social connection. PMID:25484874

  12. Associations between childhood adversity, adult stressful life events, and past-year drug use disorders in the National Epidemiological Study of Alcohol and Related Conditions (NESARC)

    PubMed Central

    Myers, Bronwyn; McLaughlin, Katie A.; Wang, Shuai; Blanco, Carlos; Stein, Dan J.

    2014-01-01

    Stress sensitization, whereby CA lowers tolerance to later stressors, has been proposed as a potential mechanism explaining the association between exposure to childhood adversities (CA) and drug use disorders in adulthood. However this mechanism remains untested. This paper begins to address this gap through exploring associations between CA exposure and stressful events in adulthood for predicting drug use disorders. We used data drawn from Wave 2 of the U.S. National Epidemiological Survey of Alcohol and Related Conditions (n=34,653) to explore whether the association between past-year stressful life events and the 12-month prevalence of disordered cannabis, stimulant and opiate use varied by the number of types of CA that an individual was exposed to. Past-year stressful life events were associated with an increased risk of cannabis, stimulant and opiate use disorders among men and women. Exposure to CA was associated with increased risk for disordered cannabis use among men and women and opiate use among men only. Finally, we found significant associations between exposure to CA and past year stressful life events in predicting disordered drug use, but only for women in relation to disordered stimulant and opiate use. Findings are suggestive of possible stress sensitization effects in predicting disordered stimulant and opiate use among women. Implications of these findings for the prevention and treatment of drug use disorders and for future research are discussed. PMID:25134042

  13. Relationship between childhood adversity and clinical and cognitive features in schizophrenia.

    PubMed

    McCabe, Kathryn L; Maloney, Elizabeth A; Stain, Helen J; Loughland, Carmel M; Carr, Vaughan J

    2012-05-01

    Childhood adversity is associated with elevated risk for a wide range of adult psychiatric disorders, and has significant and sustained negative effects on adult behavioural and social functioning. Elevated rates of childhood adversity have been reported for people with a diagnosis of schizophrenia. The aim of the present study was to assess rates of retrospectively reported childhood adversity among adults with schizophrenia and to examine the relationship between childhood adversity and clinical and cognitive features. Data were available for 408 schizophrenia participants and 267 healthy control participants recruited through the Australian Schizophrenia Research Bank (ASRB). History of childhood adversity was obtained using the Childhood Adversity Questionnaire (CAQ). A five-factor solution was identified from the CAQ. Schizophrenia participants reported experiencing more childhood adversities than controls. In both groups, those reporting childhood adversity were more likely to be female and older. Among participants with schizophrenia, positive symptom severity and fewer years of education were associated with childhood adversity. Lower IQ scores and personality traits were associated with reporting a greater number of childhood adversities and with adversity sub-types of abusive, neglectful and dysfunctional parenting. The rate of childhood adversity reported in this sample was high which suggests greater exposure to adverse childhood events among participants with schizophrenia in comparison with healthy controls. We identified unique groups amongst CAQ items that provided a salient framework from which to investigate the connection between childhood adversity and clinical and cognitive features. PMID:22329951

  14. Adverse Childhood Experiences and Adult Smoking, Nebraska, 2011

    PubMed Central

    Safranek, Thomas; Buss, Bryan; Cadwell, Betsy L.; Mannino, David

    2013-01-01

    Introduction Smoking is a public health risk; the prevalence of smoking among adults in Nebraska is 18.4%. Studies indicate that maltreatment of children alters their brain development, possibly increasing risk for tobacco use. Previous studies have documented associations between childhood maltreatment and adult health behaviors, demonstrating the influence of adverse experiences on tobacco use. We examined prevalence and associations between adverse childhood experiences and smoking among Nebraskans. Methods We analyzed 2011 Nebraska Behavioral Risk Factor Surveillance System (Adverse Childhood Experience module) data, defining adverse childhood experience exposures as physical, sexual, and verbal abuse (ie, direct exposures), and household dysfunction associated with mental illness, substance abuse, divorce, domestic violence, and living with persons with incarceration histories (ie, environmental exposures). We estimated prevalence of exposures, taking into account the complex survey design. We used logistic regression with predicted margins to estimate adjusted relative risk for smoking by direct or environmental exposure. Results Approximately 51% of Nebraskans experienced 1 or more adverse childhood events; 7% experienced 5 or more. Prevalence of environmental exposures (42%) was significantly higher than that of direct exposures (31%). Prevalence of individual exposures ranged from 6% (incarceration of a household member) to 25% (verbal abuse). Adjusted relative risks of smoking for direct and environmental exposures were 1.5 and 1.8, respectively. Conclusion We present a new method of evaluating adverse childhood experience data. Prevalence of adverse childhood experiences is high among Nebraskans, and these exposures are associated with smoking. State-specific strategies to monitor adverse events among children and provide interventions might help to decrease the smoking rate in this population. PMID:24050529

  15. 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

  16. Adverse Childhood Experiences and Childhood Autobiographical Memory Disturbance

    ERIC Educational Resources Information Center

    Brown, David W.; Anda, Robert F.; Edwards, Valerie J.; Felitti, Vincent J.; Dube, Shanta R.; Giles, Wayne H.

    2007-01-01

    Objective: To examine relationships between childhood autobiographical memory disturbance (CAMD) and adverse childhood experiences (ACEs) which are defined as common forms of child maltreatment and related traumatic stressors. Methods: We use the ACE score (an integer count of eight different categories of ACEs) as a measure of cumulative exposure…

  17. [Adverse events of psychotropic drugs].

    PubMed

    Watanabe, Koichiro; Kikuchi, Toshiaki

    2014-01-01

    The authors discuss adverse events which are often missed but clinicians should pay attention to in order to preserve patients'quality of life(QOL). Among mood stabilizers, lithium may cause a urinary volume increase, hyperparathyroidism, and serum calcium elevation; sodium valproate possibly increases androgenic hormone levels and the risk of polycystic ovary syndrome (PCOS) as well as hypothyroidism. Moreover, in addition to teratogenesis, it has been reported that fetal exposure to a higher dose of valproate is associated with a lower intelligence quotient and higher incidence of autism spectrum disorders in children. Antidepressants with a higher affinity for serotonin transporters might induce gastrointestinal bleeding, and some antidepressants cause sexual dysfunction more frequently than others. Activation syndrome is still a key side effect which should be noted. Regarding the adverse events of antipsychotics, subjective side effects unpleasant to patients such as dysphoria and a lower subjective well-being should not be overlooked. We clinicians have to cope with adverse events worsening the QOL of patients with psychiatric disorders and, therefore, we need to adopt appropriate counter-measures. PMID:24864567

  18. 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. PMID:23850228

  19. Detecting Adverse Events Using Information Technology

    PubMed Central

    Bates, David W.; Evans, R. Scott; Murff, Harvey; Stetson, Peter D.; Pizziferri, Lisa; Hripcsak, George

    2003-01-01

    Context: Although patient safety is a major problem, most health care organizations rely on spontaneous reporting, which detects only a small minority of adverse events. As a result, problems with safety have remained hidden. Chart review can detect adverse events in research settings, but it is too expensive for routine use. Information technology techniques can detect some adverse events in a timely and cost-effective way, in some cases early enough to prevent patient harm. Objective: To review methodologies of detecting adverse events using information technology, reports of studies that used these techniques to detect adverse events, and study results for specific types of adverse events. Design: Structured review. Methodology: English-language studies that reported using information technology to detect adverse events were identified using standard techniques. Only studies that contained original data were included. Main Outcome Measures: Adverse events, with specific focus on nosocomial infections, adverse drug events, and injurious falls. Results: Tools such as event monitoring and natural language processing can inexpensively detect certain types of adverse events in clinical databases. These approaches already work well for some types of adverse events, including adverse drug events and nosocomial infections, and are in routine use in a few hospitals. In addition, it appears likely that these techniques will be adaptable in ways that allow detection of a broad array of adverse events, especially as more medical information becomes computerized. Conclusion: Computerized detection of adverse events will soon be practical on a widespread basis. PMID:12595401

  20. A revised inventory of Adverse Childhood Experiences.

    PubMed

    Finkelhor, David; Shattuck, Anne; Turner, Heather; Hamby, Sherry

    2015-10-01

    This study examines whether the items from the original Adverse Childhood Experiences (ACE) scale can be improved in their prediction of health outcomes by adding some additional widely recognized childhood adversities. The analyses come from the National Survey of Children's Exposure to Violence 2014, a telephone survey conducted from August 2013 through April 2014 with a nationally representative sample of 1,949 children and adolescents aged 10-17 and their caregivers who were asked about adversities, physical health conditions and mental health symptoms. The addition of measures of peer victimization, peer isolation/rejection, and community violence exposure added significantly to the prediction of mental health symptoms, and the addition of a measure of low socioeconomic status (SES) added significantly to the prediction of physical health problems. A revised version of the ACES scale is proposed. PMID:26259971

  1. Childhood Adversity, Recent Life Stressors and Suicidal Behavior in Chinese College Students

    PubMed Central

    You, Zhiqi; Chen, Mingxi; Yang, Sen; Zhou, Zongkui; Qin, Ping

    2014-01-01

    Background Although the independent effects of childhood adversities and of recent negative events on suicidality have been well-documented, the combinative role of childhood and recent adversities on risk for suicidality is still underexplored, especially in the context of Chinese culture and in consideration of specific types of negative events. Method 5989 students, randomly sampled from six universities in central China, completed the online survey for this study. Suicidal behavior, life adversity during childhood and stressful events in recent school life were assessed with designed questionnaires. Results Students experiencing recent stressful life events more often reported an experience of life adversity during childhood. While recent stressful life events and childhood life adversity both were associated with an increased risk for suicidal behavior, the two exposures presented conjunctively and acted interactively to increase the risk. There was noticeable variation of effects associated with specific childhood life adversities, and sexual abuse, poor parental relationship, divorce of parents and loss of a parent were among the adversities associated with the highest increased risk. Recent conflicts with classmates, poor school performance and rupture of romantic relationships were the recent school life stressors associated with the highest increased risk. Conclusions Childhood adversity and recent school life stressors had a combinative role in predicting suicidality of young people studying in Chinese colleges. Unhappy family life during childhood and recent interpersonal conflicts in school were the most important predictors of suicidality in this population. PMID:24681891

  2. 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. PMID:25078411

  3. 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

  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. Adversity in childhood and depression: linked through SIRT1.

    PubMed

    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

  6. 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

  7. Adverse childhood experiences and health anxiety in adulthood.

    PubMed

    Reiser, Sarah J; McMillan, Katherine A; Wright, Kristi D; Asmundson, Gordon J G

    2014-03-01

    Childhood experiences are thought to predispose a person to the development of health anxiety later in life. However, there is a lack of research investigating the influence of specific adverse experiences (e.g., childhood abuse, household dysfunction) on this condition. The current study examined the cumulative influence of multiple types of childhood adversities on health anxiety in adulthood. Adults 18-59 years of age (N=264) completed a battery of measures to assess adverse childhood experiences, health anxiety, and associated constructs (i.e., negative affect and trait anxiety). Significant associations were observed between adverse childhood experiences, health anxiety, and associated constructs. Hierarchical multiple regression analysis indicted that adverse childhood experiences were predictive of health anxiety in adulthood; however, the unique contribution of these experience were no longer significant following the inclusion of the other variables of interest. Subsequently, mediation analyses indicated that both negative affect and trait anxiety independently mediated the relationship between adverse childhood experiences and health anxiety in adulthood. Increased exposure to adverse childhood experiences is associated with higher levels of health anxiety in adulthood; this relationship is mediated through negative affect and trait anxiety. Findings support the long-term negative impact of cumulative adverse childhood experiences and emphasize the importance of addressing negative affect and trait anxiety in efforts to prevent and treat health anxiety. PMID:24011493

  8. Early Childhood Adversity and Pregnancy Outcomes

    PubMed Central

    Smith, Megan V.; Gotman, Nathan; Yonkers, Kimberly A.

    2016-01-01

    Objectives To examine the association between adverse childhood experiences (ACEs) and pregnancy outcomes; to explore mediators of this association including psychiatric illness and health habits. Methods Exposure to ACEs was determined by the Early Trauma Inventory Self Report Short Form; psychiatric diagnoses were generated by the Composite International Diagnostic Interview administered in a cohort of 2303 pregnant women. Linear regression and structural equation modeling bootstrapping approaches tested for multiple mediators. Results Each additional ACE decreased birth weight by 16.33 g and decreased gestational age by 0.063. Smoking was the strongest mediator of the effect on gestational age. Conclusions ACEs have an enduring effect on maternal reproductive health, as manifested by mothers’ delivery of offspring that were of reduced birth weight and shorter gestational age. PMID:26762511

  9. Early Childhood Adversity and Pregnancy Outcomes.

    PubMed

    Smith, Megan V; Gotman, Nathan; Yonkers, Kimberly A

    2016-04-01

    Objectives To examine the association between adverse childhood experiences (ACEs) and pregnancy outcomes; to explore mediators of this association including psychiatric illness and health habits. Methods Exposure to ACEs was determined by the Early Trauma Inventory Self Report Short Form; psychiatric diagnoses were generated by the Composite International Diagnostic Interview administered in a cohort of 2303 pregnant women. Linear regression and structural equation modeling bootstrapping approaches tested for multiple mediators. Results Each additional ACE decreased birth weight by 16.33 g and decreased gestational age by 0.063. Smoking was the strongest mediator of the effect on gestational age. Conclusions ACEs have an enduring effect on maternal reproductive health, as manifested by mothers' delivery of offspring that were of reduced birth weight and shorter gestational age. PMID:26762511

  10. Adverse childhood experiences and premature all-cause mortality.

    PubMed

    Kelly-Irving, Michelle; Lepage, Benoit; Dedieu, Dominique; Bartley, Mel; Blane, David; Grosclaude, Pascale; Lang, Thierry; Delpierre, Cyrille

    2013-09-01

    Events causing stress responses during sensitive periods of rapid neurological development in childhood may be early determinants of all-cause premature mortality. Using a British birth cohort study of individuals born in 1958, the relationship between adverse childhood experiences (ACE) and mortality≤50 year was examined for men (n=7,816) and women (n=7,405) separately. ACE were measured using prospectively collected reports from parents and the school: no adversities (70%); one adversity (22%), two or more adversities (8%). A Cox regression model was carried out controlling for early life variables and for characteristics at 23 years. In men the risk of death was 57% higher among those who had experienced 2+ ACE compared to those with none (HR 1.57, 95% CI 1.13, 2.18, p=0.007). In women, a graded relationship was observed between ACE and mortality, the risk increasing as ACE accumulated. Women with one ACE had a 66% increased risk of death (HR 1.66, 95% CI 1.19, 2.33, p=0.003) and those with ≥2 ACE had an 80% increased risk (HR 1.80, 95% CI 1.10, 2.95, p=0.020) versus those with no ACE. Given the small impact of adult life style factors on the association between ACE and premature mortality, biological embedding during sensitive periods in early development is a plausible explanatory mechanism. PMID:23887883

  11. Adverse event recording post hip fracture surgery.

    PubMed

    Doody, K; Mohamed, K M S; Butler, A; Street, J; Lenehan, B

    2013-01-01

    Accurate recording of adverse events post hip fracture surgery is vital for planning and allocating resources. The purpose of this study was to compare adverse events recorded prospectively at point of care with adverse recorded by the Hospital In-Patient Enquiry (HIPE) System. The study examined a two month period from August to September 2011 at University Hospital Limerick. Out of a sample size of 39, there were 7 males (17.9%) and 32 females (82.1%) with an age range of between 53 and 98 years. The mean age was 80.5 years. 55 adverse events were recorded, in contrast to the HIPE record of 13 (23.6%) adverse events. The most common complications included constipation 10 (18.2%), anaemia 8 (14.5%), urinary retention 8 (14.50%), pneumonia 5 (9.1%) and delirium 5 (9.1%). Of the female cohort, 24 (68.8%) suffered an adverse event, while only 4 (57%) males suffered an adverse event. PMID:24579408

  12. Translating Developmental Science to Address Childhood Adversity.

    PubMed

    Garner, Andrew S; Forkey, Heather; Szilagyi, Moira

    2015-01-01

    Demystifying child development is a defining element of pediatric care, and pediatricians have long appreciated the profound influences that families and communities have on both child development and life course trajectories. Dramatic advances in the basic sciences of development are beginning to reveal the biologic mechanisms underlying well-established associations between a spectrum of childhood adversities and less than optimal outcomes in health, education and economic productivity. Pediatricians are well positioned to translate this new knowledge into both practice and policy, but doing so will require unprecedented levels of collaboration with educators, social service providers, and policy makers. Pediatricians might recognize the negative impact of family-level adversities on child development, but developing an effective response will likely require the engagement of community partners. By developing collaborative, innovative ways to promote the safe, stable, and nurturing relationships that are biologic prerequisites for health, academic success, and economic productivity, family-centered pediatric medical homes will remain relevant in an era that increasingly values wellness and population health. PMID:26183002

  13. 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

  14. 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

  15. Childhood adversities and adolescent depression: a matter of both risk and resilience.

    PubMed

    Oldehinkel, Albertine J; Ormel, Johan; Verhulst, Frank C; Nederhof, Esther

    2014-11-01

    Childhood adversities have been proposed to modify later stress sensitivity and risk of depressive disorder in several ways: by stress sensitization, stress amplification, and stress inoculation. Combining these models, we hypothesized that childhood adversities would increase risk of early, but not later, onsets of depression (Hypothesis 1). In those without an early onset, childhood adversities were hypothesized to predict a relatively low risk of depression in high-stress conditions (Hypothesis 2a) and a relatively high risk of depression in low-stress conditions (Hypothesis 2b), compared to no childhood adversities. These hypotheses were tested in 1,584 participants of the Tracking Adolescents' Individual Lives Survey, a prospective cohort study of adolescents. Childhood adversities were assessed retrospectively at ages 11 and 13.5, using self-reports and parent reports. Lifetime DSM-IV major depressive episodes were assessed at age 19, by means of the Composite International Diagnostic Interview. Stressful life events during adolescence were established using interview-based contextual ratings of personal and network events. The results provided support for all hypotheses, regardless of the informant and timeframe used to assess childhood adversities and regardless of the nature (personal vs. network, dependent vs. independent) of recent stressful events. These findings suggest that age at first onset of depression may be an effective marker to distinguish between various types of reaction patterns. PMID:24933401

  16. 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. PMID:23920875

  17. Linking systemic arterial stiffness among adolescents to adverse childhood experiences.

    PubMed

    Klassen, Stephen A; Chirico, Daniele; O'Leary, Deborah D; Cairney, John; Wade, Terrance J

    2016-06-01

    Adverse childhood experiences (ACEs) have been linked with cardiovascular disease and early mortality among adults. Most research examines this relationship retrospectively. Examining the association between ACEs and children's cardiovascular health is required to understand the time course of this association. We examined the relationship between ACEs exposure and ECG-to-toe pulse wave velocity (PWV), a measure of systemic arterial stiffness that is strongly related to cardiovascular mortality among adults. PWV (distance/transit time; m/s) was calculated using transit times from the ECG R-wave to the pulse wave contour at the toe. Transit times were collected over 15 heartbeats and the distance from the sternal notch to the left middle toe was used. A total of 221 children (119 females) aged 10-14 years participated in data collection of PWV, hemodynamic and anthropometric variables. Parents of these children completed a modified inventory of ACEs taken from the Childhood Trust Events Survey. Multivariable regression assessed the relationship between ACEs group (<4 ACEs versus ≥4 ACEs) and PWV. Analyses yielded an ACEs group by sex interaction, with males who experienced four or more ACEs having higher PWV (p<0.01). This association was independent of hemodynamic, anthropometric and sociodemographic variables (R(2)=0.346; p<0.01). Four or more ACEs is associated with greater arterial stiffness in male children aged 10-14 years. Addressing stress and trauma exposure in childhood is an important target for public health interventions to reduce early cardiovascular risk. PMID:27107504

  18. Identifying Adverse Drug Events by Relational Learning

    PubMed Central

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

    2013-01-01

    The pharmaceutical industry, consumer protection groups, users of medications and government oversight agencies are all strongly interested in identifying adverse reactions to drugs. While a clinical trial of a drug may use only a thousand patients, once a drug is released on the market it may be taken by millions of patients. As a result, in many cases adverse drug events (ADEs) are observed in the broader population that were not identified during clinical trials. Therefore, there is a need for continued, post-marketing surveillance of drugs to identify previously-unanticipated ADEs. This paper casts this problem as a reverse machine learning task, related to relational subgroup discovery and provides an initial evaluation of this approach based on experiments with an actual EMR/EHR and known adverse drug events. PMID:24955289

  19. Adverse events related to blood transfusion

    PubMed Central

    Sahu, Sandeep; Hemlata; Verma, Anupam

    2014-01-01

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

  20. Adverse childhood experience and asthma onset: a systematic review.

    PubMed

    Exley, Daniel; Norman, Alyson; Hyland, Michael

    2015-06-01

    Adverse childhood experiences such as abuse and neglect are associated with subsequent immune dysregulation. Some studies show an association between adverse childhood experiences and asthma onset, although significant disparity in results exists in the published literature. We aimed to review available studies employing a prospective design that investigates associations between adverse childhood experience and asthma. A search protocol was developed and studies were drawn from four electronic journal databases. Studies were selected in accordance with pre-set inclusion criteria and relevant data were extracted. 12 studies, assessing data from a total of 31 524 individuals, were identified that investigate the impact of a range of adverse childhood experiences on the likelihood of developing asthma. Evidence suggests that chronic stress exposure and maternal distress in pregnancy operate synergistically with known triggers such as traffic-related air pollution to increase asthma risk. Chronic stress in early life is associated with an increased risk of asthma onset. There is evidence that adverse childhood experience increases the impact of traffic-related air pollution and inconsistent evidence that adverse childhood experience has an independent effect on asthma onset. PMID:26028641

  1. Childhood adversities and adult-onset asthma: a cohort study

    PubMed Central

    Korkeila, Jyrki; Lietzen, Raija; Sillanmäki, Lauri H; Rautava, Päivi; Korkeila, Katariina; Kivimäki, Mika; Koskenvuo, Markku; Vahtera, Jussi

    2012-01-01

    Objectives Childhood adversities may be important determinants of later illnesses and poor health behaviour. However, large-scale prospective studies on the associations between childhood adversities and the onset of asthma in adulthood are lacking. Design Prospective cohort study with 7-year follow-up. Setting Nationally representative study. Data were collected from the Health and Social Support (HeSSup) survey and national registers. Participants The participants represent the Finnish population from the following age groups: 20–24, 30–34, 40–44, and 50–54 years at baseline in 1998 (24 057 survey participants formed the final cohort of this study). The occurrence of childhood adversities was assessed at baseline with a six-item survey scale. The analyses were adjusted for sociodemographic characteristics, behavioural health risks and common mental disorders. Primary and secondary outcomes The survey data were linked to data from national health registers on incident asthma during a 7-year follow-up to define new-onset asthma cases with verified diagnoses. Results A total of 12 126 (59%) participants reported that they encountered a childhood adversity. Of them 3677 (18% of all) endured three to six adversities. During a follow-up of 7 years, 593 (2.9%) participants were diagnosed with incident asthma. Those who reported three or more childhood adversities had a 1.6-fold (95% CI 1.31 to 2.01) greater risk of asthma compared to those without childhood adversities. This hazard attenuated but remained statistically significant after adjustment for conventional risk factors (HR 1.33; 95% CI 1.06 to 1.67). Conclusions Adults who report having encountered adversities in childhood may have an increased risk of developing asthma. PMID:23069774

  2. [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. PMID:27040337

  3. 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

  4. 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

  5. Adverse Childhood Experiences and the Mental Health of Veterans.

    PubMed

    McGuinness, Teena M; Waldrop, Jessica R

    2015-06-01

    Many U.S. Veterans have experienced the burdens of mental illness and suicide. The current article focuses on Veterans who served from 2001-2015. Although combat exposure and suicidal ideation are linked, approximately one half of all suicides among Active Duty service members (who have served since 2001) occurred among those who never deployed. Researchers who sought additional risks for suicide found that Veterans have greater odds of adversities in childhood than the general population. Adverse childhood experiences are stressful and traumatic experiences, including abuse and neglect, as well as witnessing household dysfunction, or growing up with individuals with mental illness or substance abuse. Further, childhood physical abuse has been shown to be a significant predictor for posttraumatic stress disorder and suicide. Adverse childhood experiences confer additional risk for the mental health of service members. Psychiatric nursing implications include the importance of assessing early childhood adversity during psychosocial assessments. Providing trauma-informed strategies for treatment is an essential element of psychiatric nursing care. PMID:26091547

  6. Standardizing adverse drug event reporting data

    PubMed Central

    2014-01-01

    Background The Adverse Event Reporting System (AERS) is an FDA database providing rich information on voluntary reports of adverse drug events (ADEs). Normalizing data in the AERS would improve the mining capacity of the AERS for drug safety signal detection and promote semantic interoperability between the AERS and other data sources. In this study, we normalize the AERS and build a publicly available normalized ADE data source. The drug information in the AERS is normalized to RxNorm, a standard terminology source for medication, using a natural language processing medication extraction tool, MedEx. Drug class information is then obtained from the National Drug File-Reference Terminology (NDF-RT) using a greedy algorithm. Adverse events are aggregated through mapping with the Preferred Term (PT) and System Organ Class (SOC) codes of Medical Dictionary for Regulatory Activities (MedDRA). The performance of MedEx-based annotation was evaluated and case studies were performed to demonstrate the usefulness of our approaches. Results Our study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). In total, the AERS-DM contains 37,029,228 Drug-ADE records. Seventy-one percent (10,221/14,490) of normalized drug concepts in the AERS were classified to 9 classes in NDF-RT. The number of unique pairs is 4,639,613 between RxNorm concepts and MedDRA Preferred Term (PT) codes and 205,725 between RxNorm concepts and SOC codes after ADE aggregation. Conclusions We have built an open-source Drug-ADE knowledge resource with data being normalized and aggregated using standard biomedical ontologies. The data resource has the potential to assist the mining of ADE from AERS for the data mining research community. PMID:25157320

  7. Childhood adversity and adult health: Evaluating intervening mechanisms.

    PubMed

    Turner, R Jay; Thomas, Courtney S; Brown, Tyson H

    2016-05-01

    Substantial evidence has accumulated supporting a causal link between childhood adversity and risk for poor health years and even decades later. One interpretation of this evidence is that this linkage arises largely or exclusively from a process of biological embedding that is not modifiable by subsequent social context or experience - implying childhood as perhaps the only point at which intervention efforts are likely to be effective. This paper considers the extent to which this long-term association arises from intervening differences in social context and/or environmental experiences - a finding that would suggest that post-childhood prevention efforts may also be effective. Based on the argument that the selected research definition of adult health status may have implications for the early adversity-adult health linkage, we use a representative community sample of black and white adults (N = 1252) to evaluate this relationship across three health indices: doctor diagnosed illnesses, self-rated health, and allostatic load. Results generally indicate that observed relationships between childhood adversity and dimensions of adult health status were totally or almost totally accounted for by variations in adult socioeconomic position (SEP) and adult stress exposure. One exception is the childhood SEP-allostatic load association, for which a statistically significant relationship remained in the context of adult stress and SEP. This lone finding supports a conclusion that the impact of childhood adversity is not always redeemable by subsequent experience. However, in general, analyses suggest the likely utility of interventions beyond childhood aimed at reducing exposure to social stress and improving social and economic standing. Whatever the effects on adult health that derive from biological embedding, they appear to be primarily indirect effects through adult social context and exposure. PMID:27030896

  8. 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

  9. 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

  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. Managing Adverse Events With Immune Checkpoint Agents.

    PubMed

    Dadu, Ramona; Zobniw, Chrystia; Diab, Adi

    2016-01-01

    Immune checkpoint inhibitors (anti-cytotoxic T-lymphocyte antigen 4 and anti programmed cell death 1/programmed cell death 1 ligand antibodies) have shown impressive clinical activity in multiple cancer types. Despite achieving great clinical success, challenges and limitations of these drugs as monotherapy or various combinational strategies include the development of a unique set of immune-related adverse events (irAEs) that can be severe and even fatal. Therefore, identification of patients at risk, prevention, consistent communication between patients and medical team, rapid recognition, and treatment of irAEs are critical in optimizing treatment outcomes. This review focuses on the description of more common irAEs and provides a suggested approach for management of specific irAEs. PMID:27111908

  12. Additive Contributions of Childhood Adversity and Recent Stressors to Inflammation at Midlife: Findings from the MIDUS Study

    ERIC Educational Resources Information Center

    Hostinar, Camelia E.; Lachman, Margie E.; Mroczek, Daniel K.; Seeman, Teresa E.; Miller, Gregory E.

    2015-01-01

    We examined the joint contributions of self-reported adverse childhood experiences (ACEs) and recent life events (RLEs) to inflammation at midlife, by testing 3 competing theoretical models: stress generation, stress accumulation, and early life stress sensitization. We aimed to identify potential mediators between adversity and inflammation.…

  13. 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

  14. The Link Between Adverse Childhood Experiences and Diabetes.

    PubMed

    Huffhines, Lindsay; Noser, Amy; Patton, Susana R

    2016-06-01

    Exposure to adversity in childhood (adverse childhood experiences [ACEs]) is linked to a number of chronic diseases in adulthood, yet there is limited research examining the impact of ACEs on diabetes. The current review sought to examine the association between ACEs, other trauma exposure or posttraumatic stress disorder (PTSD) diagnosis, and risk for diabetes. Thirty-eight studies are reviewed. Unlike in other diseases, several studies in diabetes show a threshold-response versus a dose-response relation, while other studies show a relation between greater abuse severity and diabetes risk. There were mixed results for studies examining abuse type and frequency. Chronic or comorbid PTSD was also related to increased diabetes risk among veterans, but in community samples, only trauma exposure predicted diabetes risk. While the research is still limited, diabetes researchers and clinicians should consider screening for ACEs and examine severity and frequency across abuse type as a predictor of both diabetes and poor diabetes outcomes. PMID:27112958

  15. [Treatments with immunoglobulin and thrombotic adverse events].

    PubMed

    Darnige, L; Lillo-Le Louët, A

    2014-01-01

    Treatments with intravenous or subcutaneous immunoglobulin (Ig) are used in a broad variety of disorders. Tolerance of Ig is usually good but adverse events, including some serious ones, have been reported and may differ among different Ig preparations. Thrombotic complications occur in 0.6 to 13% of cases and can involve arterial or venous circulation, rarely both. Deep venous thrombosis with or without pulmonary embolism, stroke or myocardial infarction remained the most frequent thrombotic complications. Some risk factors have been identified, mainly old age, multiple cardiovascular risk factors, and past history of thrombo-embolic manifestations. Several mechanisms are suggested to explain this increased risk of thrombotic complications. Indeed, Ig treatments increase the plasma viscosity, increase and activate platelets, can trigger the coagulation cascade through the presence of activated factor XI in some Ig preparations, and release vasoactive molecules responsible for vasospasm. Patients have to be carefully monitored and risk factors to be identified as soon as possible. The role of antiplatelets or anticoagulation is not well determined but should probably be proposed to patients with high risk. PMID:24011913

  16. Severe Life Events and Chronic Adversities as Antecedents to Anxiety in Children: A Matched Control Study

    ERIC Educational Resources Information Center

    Allen, Jennifer L.; Rapee, Ronald M.; Sandberg, Seija

    2008-01-01

    The present study compared the number of severe life events and chronic adversities as reported retrospectively by mothers of children with an anxiety disorder (n = 39) prior to the onset of their most recent episode, with controls (n = 39) matched for age and sex. The parent version of the Psychosocial Assessment of Childhood Experiences (PACE)…

  17. The impact of childhood sexual abuse and other forms of childhood adversity on adulthood parenting.

    PubMed

    Barrett, Betty

    2009-09-01

    This study investigated the independent impact of child sexual abuse on five dimensions of adulthood parenting after controlling for other forms of childhood adversity in a predominantly African-American sample of mothers receiving public assistance (N = 483). An analysis of data previously collected as part of the Illinois Families Study Child Well-Being Supplement was conducted to address these questions. Data were analyzed using hierarchal multiple regression. Childhood sexual abuse survivors reported significantly lower rates of parental warmth, higher rates of psychological aggression, and more frequent use of corporal punishment than mothers who had not experienced childhood sexual abuse. These effects, however, were nonsignificant when sociodemographic factors and other forms of childhood adversity were considered. Implications for future research are provided. PMID:20183414

  18. An approach to death as an adverse event following immunization.

    PubMed

    Gold, Michael S; Balakrishnan, Madhava Ram; Amarasinghe, Ananda; MacDonald, Noni E

    2016-01-01

    Co-incidental death occurring proximate to vaccination may be reported as an adverse event following immunization. Such events are particularly concerning because they may raise community and health provider concerns about the safety of the specific vaccine and often the immunization programme in general. Coincidental events need to be differentiated from vaccine reactions, such as anaphylaxis, which may very rarely result in death. In 2013, the World Health Organization (WHO) released an updated manual for the Causality Assessment of an AEFI. The purpose of this review is to apply the WHO causality methodology to death when this is reported as an AEFI. The causality assessment scheme recommends a four step process to enable classification of the AEFI and to differentiate events which are causally consistent from those that are inconsistent with immunization. However, for some events causality maybe indeterminate. Consistent causal reactions that may result in death are very rare and maybe related to the vaccine product (e.g. anaphylaxis, viscerotrophic disease), vaccine quality defect (e.g. an incompletely attenuated live vaccine agent) or an immunization error (e.g. vaccine vial contamination). Events that are inconsistent with immunizations are due to co-incidental conditions that may account for infant and childhood mortality. In countries with a high infant mortality rate the coincidental occurrence of death and immunization may occur not infrequently and a robust mechanism to obtain information from autopsy and perform an AEFI investigation and causality assessment is essential. Communication with the community and all stakeholders to maintain confidence in the immunization programme is critical. PMID:26608326

  19. Childhood adversity and adult depression among the incarcerated: differential exposure and vulnerability by race/ethnicity and gender.

    PubMed

    Roxburgh, Susan; MacArthur, Kelly Rhea

    2014-08-01

    The relationship between childhood adversity and adult depression is well-established but less is known about the association between childhood adversity and adult depression among the incarcerated. In this paper, we examine differential exposure and vulnerability to childhood adversity by race/ethnicity and gender on adult depression among the incarcerated in the United States. We address three research questions: does exposure to childhood adverse experiences vary by race/ethnicity and gender? Is there an association between these childhood adverse events and depression and does the strength of the association vary by the specific adverse experiences? And does vulnerability to childhood adversity vary by gender and race/ethnicity? Using the 2004 Survey of Inmates in State and Federal Correctional Facilities (SI-SFCF), we measure four key childhood adverse events - parental/caretaker substance abuse, physical assault, having been placed in foster care, and sexual assault. We use ordinary least squares regression and a series of interaction effect analyses to examine differential exposure and vulnerability to the four childhood adverse experiences by race/ethnicity and gender. Incarcerated women are more likely to report parental substance abuse, but all inmates/prisoners are similarly vulnerable to this experience. For the other three adverse experiences measured, we find that there are important racial/ethnic and gender differences in both exposure and vulnerability. African American men and women are more vulnerable to the effects of physical and sexual victimization than White and Hispanic men and women. Women are much more likely to be exposed to sexual victimization, but men who report this experience are significantly more depressed. Hispanic women and White men and women are more likely to report foster care, but all inmates/prisoners who report foster care experiences are significantly more depressed than other inmates/prisoners, with the exception of

  20. Experimentally Evoking Nonbelieved Memories for Childhood Events

    ERIC Educational Resources Information Center

    Otgaar, Henry; Scoboria, Alan; Smeets, Tom

    2013-01-01

    We report on the 1st experimental elicitation of nonbelieved memories for childhood events in adults (Study 1) and children (Study 2) using a modified false memory implantation paradigm. Participants received true (trip to a theme park) and false (hot air balloon ride) narratives and recalled these events during 2 interviews. After debriefing, 13%…

  1. Traumatic Childhood Events and Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Kerns, Connor Morrow; Newschaffer, Craig J.; Berkowitz, Steven J.

    2015-01-01

    Traumatic childhood events are associated with a wide range of negative physical, psychological and adaptive outcomes over the life course and are one of the few identifiable causes of psychiatric illness. Children with autism spectrum disorder (ASD) may be at increased risk for both encountering traumatic events and developing traumatic sequelae;…

  2. Impact of Adverse Childhood Experiences on Psychotic-Like Symptoms and Stress Reactivity in Daily Life in Nonclinical Young Adults

    PubMed Central

    Ballespí, Sergi; Mitjavila, Mercè; Myin-Germeys, Inez; Kwapil, Thomas R.; Barrantes-Vidal, Neus

    2016-01-01

    Background There is increasing interest in elucidating the association of different childhood adversities with psychosis-spectrum symptoms as well as the mechanistic processes involved. This study used experience sampling methodology to examine (i) associations of a range of childhood adversities with psychosis symptom domains in daily life; (ii) whether associations of abuse and neglect with symptoms are consistent across self-report and interview methods of trauma assessment; and (iii) the role of different adversities in moderating affective, psychotic-like, and paranoid reactivity to situational and social stressors. Method A total of 206 nonclinical young adults were administered self-report and interview measures to assess childhood abuse, neglect, bullying, losses, and general traumatic events. Participants received personal digital assistants that signaled them randomly eight times daily for one week to complete questionnaires about current experiences, including symptoms, affect, and stress. Results Self-reported and interview-based abuse and neglect were associated with psychotic-like and paranoid symptoms, whereas only self-reported neglect was associated with negative-like symptoms. Bullying was associated with psychotic-like symptoms. Losses and general traumatic events were not directly associated with any of the symptom domains. All the childhood adversities were associated with stress reactivity in daily life. Interpersonal adversities (abuse, neglect, bullying, and losses) moderated psychotic-like and/or paranoid reactivity to situational and social stressors, whereas general traumatic events moderated psychotic-like reactivity to situational stress. Also, different interpersonal adversities exacerbated psychotic-like and/or paranoid symptoms in response to distinct social stressors. Discussion The present study provides a unique examination of how childhood adversities impact the expression of spectrum symptoms in the real world and lends support

  3. Setting the stage for chronic health problems: cumulative childhood adversity among homeless adults with mental illness in Vancouver, British Columbia

    PubMed Central

    2014-01-01

    Background It is well documented that childhood abuse, neglect and household dysfunction are disproportionately present in the backgrounds of homeless adults, and that these experiences adversely impact child development and a wide range of adult outcomes. However, few studies have examined the cumulative impact of adverse childhood experiences on homeless adults with mental illness. This study examines adverse events in childhood as predictors of duration of homelessness, psychiatric and substance use disorders, and physical health in a sample of homeless adults with mental illness. Methods This study was conducted using baseline data from a randomized controlled trial in Vancouver, British Columbia for participants who completed the Adverse Childhood Experiences (ACE) scale at 18 months follow-up (n = 364). Primary outcomes included current mental disorders; substance use including type, frequency and severity; physical health; duration of homelessness; and vocational functioning. Results In multivariable regression models, ACE total score independently predicted a range of mental health, physical health, and substance use problems, and marginally predicted duration of homelessness. Conclusions Adverse childhood experiences are overrepresented among homeless adults with complex comorbidities and chronic homelessness. Our findings are consistent with a growing body of literature indicating that childhood traumas are potent risk factors for a number of adult health and psychiatric problems, particularly substance use problems. Results are discussed in the context of cumulative adversity and self-trauma theory. Trials registration This trial has been registered with the International Standard Randomized Control Trial Number Register and assigned ISRCTN42520374. PMID:24726046

  4. Adverse childhood experiences in the lives of female sex offenders.

    PubMed

    Levenson, Jill S; Willis, Gwenda M; Prescott, David S

    2015-06-01

    This study explored the prevalence of early trauma in a sample of U.S. female sexual offenders (N = 47) using the Adverse Childhood Experiences (ACE) scale. Compared with females in the general population, sex offenders had more than three times the odds of child sexual abuse, four times the odds of verbal abuse, and more than three times the odds of emotional neglect and having an incarcerated family member. Half of the female sex offenders had been sexually abused as a child. Only 20% endorsed zero adverse childhood experiences (compared with 35% of the general female population) and 41% endorsed four or more (compared with 15% of the general female population). Higher ACE scores were associated with having younger victims. Multiple maltreatments often co-occurred in households with other types of dysfunction, suggesting that many female sex offenders were raised within a disordered social environment by adults with problems of their own who were ill-equipped to protect their daughters from harm. By enhancing our understanding of the frequency and correlates of early adverse experiences, we can better devise trauma-informed interventions that respond to the clinical needs of female sex offender clients. PMID:25210107

  5. Childhood adversities and risk for problematic alcohol use.

    PubMed

    Dragan, Małgorzata; Hardt, Jochen

    2016-08-01

    The findings from studies exploring the relationship between childhood adversities (CAs) and adolescent and adult drinking problems are inconclusive - some researchers have found strong effects, others virtually none. In this study, we sought to examine the associations between 23 types of retrospectively reported CAs and adult problematic alcohol use in two samples, one drawn from Germany, the other from Poland. A total sample of 1008 participants was recruited via the internet: 500 in Germany and 508 in Poland. They completed a set of questionnaires including questions regarding various types of CA, and also the CAGE tool for the identification of problem drinking. CAs were grouped into four categories: Negative Personal Experience, Family Adversities, Parental Disorders, Parent-Child Relationships; this last category included role reversal. Separate logistic regression analyses were performed, with age, gender and country as potential confounders. The probability of having an alcohol problem was higher in men, and higher in Poland than in Germany. Of the risk factors tested, three displayed a significant association with problematic alcohol use. The risk factors concerned were Regular Arguments Between the Parents, plus two types of adversities from the Parent-Child Relationships cluster: Maternal Control and Maternal Role Reversal. The results serve to underline the importance of examining links between childhood risk factors and problematic alcohol use, and also suggest that certain less visible symptoms of a disordered parent-child (particularly mother-child) relationship, such as parentification, may constitute important risk factors for the development of drinking problems in later life. PMID:27082746

  6. History of Childhood Adversity is Positively Associated with Ventral Striatal Dopamine Responses to Amphetamine

    PubMed Central

    Oswald, Lynn M.; Wand, Gary S.; Kuwabara, Hiroto; Wong, Dean F.; Zhu, Shijun; Brasic, James R.

    2014-01-01

    Childhood exposure to severe or chronic trauma is an important risk factor for the later development of adult mental health problems, such as substance abuse. Even in nonclinical samples of healthy adults, persons with a history of significant childhood adversity seem to experience greater psychological distress than those without this history. Evidence from rodent studies suggests that early life stress may impair dopamine function in ways that increase risks for drug abuse. However, the degree to which these findings translate to other species remains unclear. This study was conducted to examine associations between childhood adversity and dopamine and subjective responses to amphetamine in humans. Following intake assessment, 28 healthy male and female adults, ages 18–29 years, underwent two consecutive 90-minute positron emission tomography (PET) studies with high specific activity [11C]raclopride. The first scan was preceded by intravenous saline; the second by amphetamine (AMPH 0.3 mg/kg). Consistent with prior literature, findings showed positive associations between childhood trauma and current levels of perceived stress. Moreover, greater number of traumatic events and higher levels of perceived stress were each associated with higher ventral striatal dopamine responses to AMPH. Findings of mediation analyses further showed that a portion of the relationship between childhood trauma and dopamine release may be mediated by perceived stress. Overall, results are consistent with preclinical findings suggesting that early trauma may lead to enhanced sensitivity to psychostimulants and that this mechanism may underlie increased vulnerability for drug abuse. PMID:24448898

  7. The Impact of Childhood Sexual Abuse and Other Forms of Childhood Adversity on Adulthood Parenting

    ERIC Educational Resources Information Center

    Barrett, Betty

    2009-01-01

    This study investigated the independent impact of child sexual abuse on five dimensions of adulthood parenting after controlling for other forms of childhood adversity in a predominantly African-American sample of mothers receiving public assistance (N = 483). An analysis of data previously collected as part of the Illinois Families Study Child…

  8. Peri-operative adverse respiratory events in children.

    PubMed

    von Ungern-Sternberg, B S; Ramgolam, A; Hall, G L; Sly, P D; Habre, W

    2015-04-01

    Three quarters of all critical incidents and a third of all peri-operative cardiac arrests in paediatric anaesthesia are caused by adverse respiratory events. We screened for risk factors from children's and their families' histories, and assessed the usefulness of common markers of allergic sensitisation of the airway as surrogates for airway inflammation and increased risk for adverse respiratory events. One hundred children aged up to 16 years with two or more risk factors undergoing elective surgery were included in the study. Eosinophil counts, IgE level, specific IgE for D. pteronyssinus, cat epithelia and Gx2 (grass pollen) were measured for each child and adverse respiratory events (bronchospasm, laryngospasm, oxygen desaturation < 95%, severe persistent coughing, airway obstruction and postoperative stridor) were recorded. Twenty-one patients had an adverse respiratory event but allergic markers were poor predictors. Binary logistic regression showed a lack of predictive value of the eosinophil range and adverse respiratory events (p = 0.249). Receiver operating characteristic (ROC) curves for the presence of adverse respiratory events vs level of specific IgE antibody (to Gx2 (AUC 0.614), cat epithelia (0.564) and D. pteronyssinus (0.520)) demonstrated poor predictive values. However, the presence of risk factors was strongly associated with adverse respiratory events (p < 0.001) and a ROC-curve analysis indicated a fair capacity to predict adverse respiratory events (AUC 0.788). There was a significant difference (p = 0.001) between the presence of adverse respiratory events in patients with more than four (p = 0.006), compared with less than four (p = 0.001), risk factors. We conclude that while risk factors taken from the child's (or family) history proved good predictors of adverse respiratory events, immunological markers of allergic sensitisation demonstrated low predictive values. Pre-operative identification of children at high risk for an adverse

  9. Separate and Cumulative Effects of Adverse Childhood Experiences in Predicting Adult Health and Health Care Utilization

    ERIC Educational Resources Information Center

    Chartier, Mariette J.; Walker, John R.; Naimark, Barbara

    2010-01-01

    Objectives: Objectives of this population-based study were: (1) to examine the relative contribution of childhood abuse and other adverse childhood experiences to poor adult health and increased health care utilization and (2) to examine the cumulative effects of adverse childhood experiences on adult health and health care utilization. Methods:…

  10. Adverse Events of Monoclonal Antibodies Used for Cancer Therapy

    PubMed Central

    Guan, Mei; Zhou, Yan-Ping; Sun, Jin-Lu; Chen, Shu-Chang

    2015-01-01

    In 1997, the first monoclonal antibody (MoAb), the chimeric anti-CD20 molecule rituximab, was approved by the US Food and Drug administration for use in cancer patients. Since then, the panel of MoAbs that are approved by international regulatory agencies for the treatment of hematopoietic and solid malignancies has continued to expand, currently encompassing a stunning amount of 20 distinct molecules for 11 targets. We provide a brief scientific background on the use of MoAbs in cancer therapy, review all types of monoclonal antibodies-related adverse events (e.g., allergy, immune-related adverse events, cardiovascular adverse events, and pulmonary adverse events), and discuss the mechanism and treatment of adverse events. PMID:26075239

  11. Adverse events of monoclonal antibodies used for cancer therapy.

    PubMed

    Guan, Mei; Zhou, Yan-Ping; Sun, Jin-Lu; Chen, Shu-Chang

    2015-01-01

    In 1997, the first monoclonal antibody (MoAb), the chimeric anti-CD20 molecule rituximab, was approved by the US Food and Drug administration for use in cancer patients. Since then, the panel of MoAbs that are approved by international regulatory agencies for the treatment of hematopoietic and solid malignancies has continued to expand, currently encompassing a stunning amount of 20 distinct molecules for 11 targets. We provide a brief scientific background on the use of MoAbs in cancer therapy, review all types of monoclonal antibodies-related adverse events (e.g., allergy, immune-related adverse events, cardiovascular adverse events, and pulmonary adverse events), and discuss the mechanism and treatment of adverse events. PMID:26075239

  12. Extraction of potential adverse drug events from medical case reports

    PubMed Central

    2012-01-01

    The sheer amount of information about potential adverse drug events published in medical case reports pose major challenges for drug safety experts to perform timely monitoring. Efficient strategies for identification and extraction of information about potential adverse drug events from free‐text resources are needed to support pharmacovigilance research and pharmaceutical decision making. Therefore, this work focusses on the adaptation of a machine learning‐based system for the identification and extraction of potential adverse drug event relations from MEDLINE case reports. It relies on a high quality corpus that was manually annotated using an ontology‐driven methodology. Qualitative evaluation of the system showed robust results. An experiment with large scale relation extraction from MEDLINE delivered under‐identified potential adverse drug events not reported in drug monographs. Overall, this approach provides a scalable auto‐assistance platform for drug safety professionals to automatically collect potential adverse drug events communicated as free‐text data. PMID:23256479

  13. Commentary: Childhood Exposure to Environmental Adversity and the Well-Being of People with Intellectual Disabilities

    ERIC Educational Resources Information Center

    Emerson, E.

    2013-01-01

    People with intellectual disabilities have poorer health than their non-disabled peers. They are also more likely to be exposed to a wide range of environmental adversities in childhood. Research undertaken in the general population has demonstrated that exposure to environmental adversity in childhood can have an adverse impact on health and…

  14. 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

  15. 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. PMID:21545660

  16. Childhood adversities and adult psychopathology in the WHO World Mental Health Surveys

    PubMed Central

    Kessler, Ronald C.; McLaughlin, Katie A.; Green, Jennifer Greif; Gruber, Michael J.; Sampson, Nancy A.; Zaslavsky, Alan M.; Aguilar-Gaxiola, Sergio; Alhamzawi, Ali Obaid; Alonso, Jordi; Angermeyer, Matthias; Benjet, Corina; Bromet, Evelyn; Chatterji, Somnath; de Girolamo, Giovanni; Demyttenaere, Koen; Fayyad, John; Florescu, Silvia; Gal, Gilad; Gureje, Oye; Haro, Josep Maria; Hu, Chi-yi; Karam, Elie G.; Kawakami, Norito; Lee, Sing; Lépine, Jean-Pierre; Ormel, Johan; Posada-Villa, José; Sagar, Rajesh; Tsang, Adley; Üstün, T. Bedirhan; Vassilev, Svetlozar; Viana, Maria Carmen; Williams, David R.

    2010-01-01

    Background Although significant associations of childhood adversities with adult mental disorders are widely documented, most studies focus on single childhood adversities predicting single disorders. Aims To examine joint associations of 12 childhood adversities with first onset of 20 DSM–IV disorders in World Mental Health (WMH) Surveys in 21 countries. Method Nationally or regionally representative surveys of 51 945 adults assessed childhood adversities and lifetime DSM–IV disorders with the WHO Composite International Diagnostic Interview (CIDI). Results Childhood adversities were highly prevalent and interrelated. Childhood adversities associated with maladaptive family functioning (e.g. parental mental illness, child abuse, neglect) were the strongest predictors of disorders. Co-occurring childhood adversities associated with maladaptive family functioning had significant subadditive predictive associations and little specificity across disorders. Childhood adversities account for 29.8% of all disorders across countries. Conclusions Childhood adversities have strong associations with all classes of disorders at all life-course stages in all groups of WMH countries. Long-term associations imply the existence of as-yet undetermined mediators. PMID:21037215

  17. Data mining for signal detection of adverse event safety data.

    PubMed

    Chen, Hung-Chia; Tsong, Yi; Chen, James J

    2013-01-01

    The Adverse Event Reporting System (AERS) is the primary database designed to support the Food and Drug Administration (FDA) postmarketing safety surveillance program for all approved drugs and therapeutic biologic products. Most current disproportionality analysis focuses on the detection of potential adverse events (AE) involving a single drug and a single AE only. In this paper, we present a data mining biclustering technique based on the singular value decomposition to extract local regions of association for a safety study. The analysis consists of collection of biclusters, each representing an association between a set of drugs with the corresponding set of adverse events. Significance of each bicluster can be tested using disproportionality analysis. Individual drug-event combination can be further tested. A safety data set consisting of 193 drugs with 8453 adverse events is analyzed as an illustration. PMID:23331228

  18. Stress Sensitization and Adolescent Depressive Severity as a Function of Childhood Adversity: A Link to Anxiety Disorders

    ERIC Educational Resources Information Center

    Espejo, Emmanuel P.; Hammen, Constance L.; Connolly, Nicole P.; Brennan, Patricia A.; Najman, Jake M.; Bor, William

    2007-01-01

    The goal of the present study was to determine whether exposure to adversity in childhood contributes to a differential threshold at which stressful life events provoke depressive reactions in adolescence. In addition, to address empirical and conceptual questions about stress effects, the moderating effect of anxiety disorder history was also…

  19. Emotional suppression mediates the relation between adverse life events and adolescent suicide: implications for prevention.

    PubMed

    Kaplow, Julie B; Gipson, Polly Y; Horwitz, Adam G; Burch, Bianca N; King, Cheryl A

    2014-04-01

    Suicidal ideation substantially increases the odds of future suicide attempts, and suicide is the second leading cause of death among adolescents. A history of adverse life events has been linked with future suicidal ideation and attempts, although studies examining potential mediating variables have been scarce. One probable mediating mechanism is how the individual copes with adverse life events. For example, certain coping strategies appear to be more problematic than others in increasing future psychopathology, and emotional suppression in particular has been associated with poor mental health outcomes in adults and children. However, no studies to date have examined the potential mediating role of emotional suppression in the relation between adverse life events and suicidal thoughts/behavior in adolescence. The goal of the current study was to examine emotional suppression as a mediator in the relation between childhood adversity and future suicidal thoughts/behaviors in youth. A total of 625 participants, aged 14-19 years, seeking ER services were administered measures assessing adverse life events, coping strategies, suicidal ideation in the last 2 weeks, and suicide attempts in the last month. The results suggest that emotional suppression mediates the relation between adversity and both (1) suicidal thoughts and (2) suicide attempts above and beyond demographic variables and depressive symptoms. This study has important implications for interventions aimed at preventing suicidal thoughts and behavior in adolescents with histories of adversity. PMID:23412949

  20. Appetitive Aggression and Adverse Childhood Experiences Shape Violent Behavior in Females Formerly Associated with Combat.

    PubMed

    Augsburger, Mareike; Meyer-Parlapanis, Danie; Bambonye, Manassé; Elbert, Thomas; Crombach, Anselm

    2015-01-01

    This study investigated the impact of violent experiences during childhood, posttraumatic stress disorder (PTSD) and appetitive aggression on everyday violent behavior in Burundian females with varying participation in war. Moreover, group differences in trauma-related and aggression variables were expected. Appetitive aggression describes the perception of violence perpetration as fascinating and appealing and is a common phenomenon in former combatants. Semi-structured interviews were conducted with 158 females, either former combatants, supporters of armed forces or civilians during the civil war in Burundi. The PTSD Symptom Scale Interview was used to assess PTSD symptom severity, the Appetitive Aggression Scale to measure appetitive aggression and the Domestic and Community Violence Checklist to assess both childhood maltreatment and recent aggressive behavior. Former combatants had experienced more traumatic events, perpetrated more violence and reported higher levels of appetitive aggression than supporters and civilians. They also suffered more severely from PTSD symptoms than civilians but not than supporters. The groups did not differ regarding childhood maltreatment. Both appetitive aggression and childhood violence predicted ongoing aggressive behavior, whereas the latter outperformed PTSD symptom severity. These findings support current research showing that adverse childhood experiences and a positive attitude toward aggression serve as the basis for aggressive behavior and promote an ongoing cycle of violence in post-conflict regions. Female members of armed groups are in need of demobilization procedures including trauma-related care and interventions addressing appetitive aggression. PMID:26635666

  1. Appetitive Aggression and Adverse Childhood Experiences Shape Violent Behavior in Females Formerly Associated with Combat

    PubMed Central

    Augsburger, Mareike; Meyer-Parlapanis, Danie; Bambonye, Manassé; Elbert, Thomas; Crombach, Anselm

    2015-01-01

    This study investigated the impact of violent experiences during childhood, posttraumatic stress disorder (PTSD) and appetitive aggression on everyday violent behavior in Burundian females with varying participation in war. Moreover, group differences in trauma-related and aggression variables were expected. Appetitive aggression describes the perception of violence perpetration as fascinating and appealing and is a common phenomenon in former combatants. Semi-structured interviews were conducted with 158 females, either former combatants, supporters of armed forces or civilians during the civil war in Burundi. The PTSD Symptom Scale Interview was used to assess PTSD symptom severity, the Appetitive Aggression Scale to measure appetitive aggression and the Domestic and Community Violence Checklist to assess both childhood maltreatment and recent aggressive behavior. Former combatants had experienced more traumatic events, perpetrated more violence and reported higher levels of appetitive aggression than supporters and civilians. They also suffered more severely from PTSD symptoms than civilians but not than supporters. The groups did not differ regarding childhood maltreatment. Both appetitive aggression and childhood violence predicted ongoing aggressive behavior, whereas the latter outperformed PTSD symptom severity. These findings support current research showing that adverse childhood experiences and a positive attitude toward aggression serve as the basis for aggressive behavior and promote an ongoing cycle of violence in post-conflict regions. Female members of armed groups are in need of demobilization procedures including trauma-related care and interventions addressing appetitive aggression. PMID:26635666

  2. Traumatic Childhood Events and Autism Spectrum Disorder.

    PubMed

    Kerns, Connor Morrow; Newschaffer, Craig J; Berkowitz, Steven J

    2015-11-01

    Traumatic childhood events are associated with a wide range of negative physical, psychological and adaptive outcomes over the life course and are one of the few identifiable causes of psychiatric illness. Children with autism spectrum disorder (ASD) may be at increased risk for both encountering traumatic events and developing traumatic sequelae; however, this topic has been understudied. This review considers the rationale for examining traumatic events and related symptomology in individuals with ASD and summarizes the limited research on this topic. A conceptual framework for understanding the interplay of ASD, trauma and traumatic sequelae is proposed and recommendations for future research presented. PMID:25711547

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

    PubMed Central

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

    2014-01-01

    Background The Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) is a repository of spontaneously-reported adverse drug events (ADEs) for FDA-approved prescription drugs. FAERS reports include both structured reports and unstructured narratives. The narratives often include essential information for evaluation of the severity, causality, and description of ADEs that are not present in the structured data. The timely identification of unknown toxicities of prescription drugs is an important, unsolved problem. Objective The objective of this study was to develop an annotated corpus of FAERS narratives and biomedical named entity tagger to automatically identify ADE related information in the FAERS narratives. Methods We developed an annotation guideline and annotate medication information and adverse event related entities on 122 FAERS narratives comprising approximately 23,000 word tokens. A named entity tagger using supervised machine learning approaches was built for detecting medication information and adverse event entities using various categories of features. Results The annotated corpus had an agreement of over .9 Cohen’s kappa for medication and adverse event entities. The best performing tagger achieves an overall performance of 0.73 F1 score for detection of medication, adverse event and other named entities. Conclusions In this study, we developed an annotated corpus of FAERS narratives and machine learning based models for automatically extracting medication and adverse event information from the FAERS narratives. Our study is an important step towards enriching the FAERS data for postmarketing pharmacovigilance. PMID:25600332

  4. [Adverse events in patients from a pediatric hospital.

    PubMed

    Ornelas-Aguirre, José Manuel; Arriaga-Dávila, José de Jesús; Domínguez-Serrano, María Isabel; Guzmán-Bihouet, Beatriz Filomena; Navarrete-Navarro, Susana

    2013-01-01

    Background: detection of adverse events is part of the safety management in hospitalized patients. The objective of this study was to describe the incidence of adverse events that occurred in a pediatric hospital. Methods: cross-sectional study of the adverse events occurred in a pediatric hospital from 2007 to 2009. Factors associated with their developmental causes were identified. The statistical analysis was descriptive and bivariate, with contingency tables to estimate the relationship between those factors. A p value = 0.05 was considered significant. Results: a total of 177 adverse events were registered. When they began, human factor occurred in 23 cases (13 %, OR = 1.41, p = 0.001), organizational factor was present in 71 cases (40 %, OR = 1.91, p = 0.236) and technical factor in 46 cases (26 %, OR = 0.87, p = 0.01). Blows or bruises from falls as a result of adverse events occurred in 71 cases (40 %, 95 % CI = 64-78). Conclusions: we found 1.84 events per 100 hospital discharges during the study period. The fall of patients ranked first of the adverse events identified. PMID:24290022

  5. Childhood adversities as specific contributors to the co-occurrence of posttraumatic stress and alcohol use disorders.

    PubMed

    Müller, Mario; Vandeleur, Caroline; Rodgers, Stephanie; Rössler, Wulf; Castelao, Enrique; Preisig, Martin; Ajdacic-Gross, Vladeta

    2015-08-30

    There is much evidence that alcohol use disorders (AUD) often co-occur with posttraumatic stress disorders (PTSD), and that the comorbid condition is associated with a more severe clinical profile than that of PTSD without AUD. However, little is known about the role of childhood adversities as specific risk factors for the development of AUD in individuals presenting with PTSD. The aim of the study was to explore whether specific stressors from the spectrum of trauma and childhood adversities contribute to the development of AUD among subjects with PTSD. From a large community sample, of N=140 individuals with PTSD, N=24 (17.14%) received an additional diagnosis of AUD with an onset after the onset of PTSD. Those with comorbid PTSD/AUD and those with PTSD only were compared regarding type and features of their trauma, childhood adversities and psychiatric comorbidity. Compared to PTSD alone, PTSD/AUD was associated with higher levels of stress in terms of childhood adversities; in particular, sexual abuse below the age of 16, but also with having been brought up in a foster home. PTSD/AUD was also associated with an earlier age of adverse events. Treatment of AUD should include standardized assessments of trauma, especially of trauma experienced during childhood. PMID:26163721

  6. Adverse childhood experiences of persons at risk for Huntington's disease or BRCA1/2 hereditary breast/ovarian cancer.

    PubMed

    van der Meer, L B; van Duijn, E; Wolterbeek, R; Tibben, A

    2012-01-01

    Huntington's disease (HD) is known to have a negative impact on family life. Offspring of HD patients may be exposed to adversity in childhood because of the parent's disease and its psychological consequences. BRCA1/2 hereditary breast and ovarian cancer (BRCA1/2) increases the risk for offspring of being exposed to parental disease or loss. Childhood adversity is associated with psychopathology and various other problems in later life. Adverse childhood experiences (ACEs) before age 16 were assessed in adults at 50% risk for HD (n = 74) or BRCA1/2 (n = 82) and in controls (n = 101), using the Negative Life Events Scale. Mean number and occurrence of ACEs were compared between groups. The odds of having experienced adversity in childhood were higher in HD offspring and BRCA1/2 offspring than in controls. HD offspring reported a higher mean number of ACEs than controls or BRCA1/2 offspring. In HD offspring, the prevalence of parental disease and parental dysfunction experienced before age 16 was higher than in controls. In BRCA1/2 offspring, the prevalence of parental loss before age 16 was higher than in controls. This study indicates that 53% of HD offspring and 45% of BRCA1/2 offspring are exposed to adversity in childhood or adolescence. The relevance of these findings for counseling in predictive testing programs, reproductive decision-making, and child rearing matters is discussed. PMID:21895638

  7. Adverse reproductive events and electromagnetic radiation

    SciTech Connect

    Stewart, W.; Ouellet-Hellstrom, R.

    1991-07-31

    In 1989 approximately 42,000 questionnaires were mailed to female physical therapists to assess the risk of adverse reproductive effects among those exposed to electromagnetic radiation at radiofrequencies. From the resulting data, the risk of early recognized fetal loss was assessed using a nested case-control design. The cases (1753 miscarriages) were matched to controls (1753 other pregnancies except ectopics) on mothers age at conception and the number of years elapsed between conception and interview. The results of the study indicate that female physical therapists who work with microwave diathermy 6 months prior to the pregnancy and/or during the first trimester were at increased risk of experiencing a recognized early fetal loss, but female physical therapists who work with shortwave diathermy were not at an increased risk. This association was shown to hold even when the mother's age at conception, the number of years elapsed between conception and interview, the number of prior early fetal losses, mother's conditions ever diagnosed, and use of other modalities were controlled. The data also suggest a possible association between exposure to transcutaneous electrical nerve stimulation with an elevated risk of early recognized fetal loss.

  8. The science of evaluation of adverse events associated with vaccination.

    PubMed

    Halsey, Neal A

    2002-07-01

    All vaccines cause some adverse events; serious adverse events are rare. Causal associations between a vaccine and an adverse event rarely can be determined by specific tests such as identifying a vaccine agent in the affected tissue of patients. In the absence of such data, epidemiologic studies can be used to determine if the risk of the disorder is increased in vaccinated compared to unvaccinated individuals. Common mistakes include assuming a causal relationship based on a temporal association only or a series of affected patients. Careful studies have demonstrated that many hypothesized causal associations between vaccines and adverse events were not substantiated. False assumptions regarding causality are likely to occur for illnesses without a carefully defined etiology or pathogenesis. PMID:12199617

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

    PubMed

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

    2012-11-01

    Dermatologic adverse events to cancer therapies have become more prevalent and may to lead to dose modifications or discontinuation of life-saving or prolonging treatments. This has resulted in a new collaboration between oncologists and dermatologists, which requires accurate cataloging and grading of side effects. The Common Terminology Criteria for Adverse Events Version 4.0 is a descriptive terminology and grading system that can be used for uniform reporting of adverse events. A proper understanding of this standardized classification system is essential for dermatologists to properly communicate with all physicians caring for patients with cancer. PMID:22502948

  10. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada

    PubMed Central

    Baker, G. Ross; Norton, Peter G.; Flintoft, Virginia; Blais, Régis; Brown, Adalsteinn; Cox, Jafna; Etchells, Ed; Ghali, William A.; Hébert, Philip; Majumdar, Sumit R.; O'Beirne, Maeve; Palacios-Derflingher, Luz; Reid, Robert J.; Sheps, Sam; Tamblyn, Robyn

    2004-01-01

    Background Research into adverse events (AEs) has highlighted the need to improve patient safety. AEs are unintended injuries or complications resulting in death, disability or prolonged hospital stay that arise from health care management. We estimated the incidence of AEs among patients in Canadian acute care hospitals. Methods We randomly selected 1 teaching, 1 large community and 2 small community hospitals in each of 5 provinces (British Columbia, Alberta, Ontario, Quebec and Nova Scotia) and reviewed a random sample of charts for nonpsychiatric, nonobstetric adult patients in each hospital for the fiscal year 2000. Trained reviewers screened all eligible charts, and physicians reviewed the positively screened charts to identify AEs and determine their preventability. Results At least 1 screening criterion was identified in 1527 (40.8%) of 3745 charts. The physician reviewers identified AEs in 255 of the charts. After adjustment for the sampling strategy, the AE rate was 7.5 per 100 hospital admissions (95% confidence interval [CI] 5.7– 9.3). Among the patients with AEs, events judged to be preventable occurred in 36.9% (95% CI 32.0%–41.8%) and death in 20.8% (95% CI 7.8%–33.8%). Physician reviewers estimated that 1521 additional hospital days were associated with AEs. Although men and women experienced equal rates of AEs, patients who had AEs were significantly older than those who did not (mean age [and standard deviation] 64.9 [16.7] v. 62.0 [18.4] years; p = 0.016). Interpretation The overall incidence rate of AEs of 7.5% in our study suggests that, of the almost 2.5 million annual hospital admissions in Canada similar to the type studied, about 185 000 are associated with an AE and close to 70 000 of these are potentially preventable. PMID:15159366

  11. Therapeutic apheresis in Sweden: update of epidemiology and adverse events.

    PubMed

    Norda, Rut; Stegmayr, Bernd G

    2003-10-01

    The indications of apheresis have changed over time due to results from various studies as well as the innovation of new techniques and ideas. To get an overview of the indications used for apheresis by colleagues elsewhere, data from registries are valuable. In addition, registries can be used for detection of severe adverse events as well as extent of adverse events in various types of treatment. To have a basis for statistical calculations, apheresis units need to be very large or centralisation of data needs to be performed. Data from more than 20000 procedures show that in about 4.3% of occasions adverse events and other problems will develop. Interruption of the procedure was done in 1%, most frequently a plasma exchange. Technical problems can be expected more frequent when performing LDL apheresis and immunoadsorption. Severe adverse events needing medication or interruption of the treatment, such as hypotension and arrhythmia, will develop in about 1% of the procedures. Such an episode occurs more often in patients with TTP/HUS and Guillain-Barré syndrome than in hypercholesterolemia, hyperviscosity syndrome or septic shock/MODS. The non-severe adverse events have increased over time. The results will provide focus in analyses for the reduction of such adverse events. PMID:12941356

  12. A longitudinal perspective on childhood adversities and onset risk of various psychiatric disorders.

    PubMed

    Oldehinkel, Albertine J; Ormel, Johan

    2015-06-01

    It is well-known that childhood adversities can have long-term effects on mental health, but a lot remains to be learned about the risk they bring about for a first onset of various psychiatric disorders, and how this risk develops over time. In the present study, which was based on a Dutch longitudinal population survey of adolescents TRAILS (N = 1,584), we investigated whether and how childhood adversities, as assessed with three different measures, affected the risk of developing an incident depressive, anxiety, or disruptive behavior in childhood and adolescence. In addition, we tested gender differences in any of the effects under study. The results indicated that depressive, anxiety and disruptive behavior disorders each had their own, characteristic, pattern of associations with childhood adversities across childhood and adolescence, which was maintained after adjustment for comorbid disorders. For depressive disorders, the overall pattern suggested a high excess risk of incidence during childhood, which decreased during adolescence. Anxiety disorders were characterized by a moderately increased incident risk during childhood, which remained approximately stable over time. Disruptive behavior disorders took an intermediate position. Of the three childhood adversities tested, an overall rating of the stressfulness of the childhood appeared to predict onset of psychiatric disorders best. To conclude, the risk of developing a psychiatric disorder after exposure to adversities early in life depends on the nature of the adversities, the nature of the outcome, and the time that has passed since the adversities without disorder onset. PMID:24723042

  13. The Disease Burden of Childhood Adversities in Adults: A Population-Based Study

    ERIC Educational Resources Information Center

    Cuijpers, Pim; Smit, Filip; Unger, Froukje; Stikkelbroek, Yvonne; ten Have, Margreet; de Graaf, Ron

    2011-01-01

    Objectives: There is much evidence showing that childhood adversities have considerable effects on the mental and physical health of adults. It could be assumed therefore, that the disease burden of childhood adversities is high. It has not yet been examined, however, whether this is true. Method: We used data of a large representative sample (N =…

  14. Changing Medicine and Building Community: Maine’s Adverse Childhood Experiences Momentum

    PubMed Central

    Forstadt, Leslie; Cooper, Sally; Andrews, Sue Mackey

    2015-01-01

    Physicians are instrumental in community education, prevention, and intervention for adverse childhood experiences. In Maine, a statewide effort is focusing on education about adverse childhood experiences and ways that communities and physicians can approach childhood adversity. This article describes how education about adversity and resilience can positively change the practice of medicine and related fields. The Maine Resilience Building Network brings together ongoing programs, supports new ventures, and builds on existing resources to increase its impact. It exemplifies the collective impact model by increasing community knowledge, affecting medical practice, and improving lives. PMID:25902346

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

    PubMed Central

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

    2011-01-01

    Background The reporting of serious adverse events (SAEs) is a requirement when conducting a clinical trial involving human subjects, necessary for the protection of the participants. The reporting process is a multi-step procedure, involving a number of individuals from initiation to final review, and must be completed in a timely fashion. Purpose The purpose of this project was to automate the adverse event reporting process, replacing paper-based processes with computer-based processes, so that personnel effort and time required for serious adverse event reporting was reduced, and the monitoring of reporting performance and adverse event characteristics was facilitated. Methods Use case analysis was employed to understand the reporting workflow and generate software requirements. The automation of the workflow was then implemented, employing computer databases, web-based forms, electronic signatures, and email communication. Results In the initial year (2007) of full deployment, 588 SAE reports were processed by the automated system, eSAEy™. The median time from initiation to Principal Investigator electronic signature was less than 2 days (mean 7 ± 0.7 days). This was a significant reduction from the prior paper-based system, which had a median time for signature of 24 days (mean of 45 ± 5.7 days). With eSAEy™, reports on adverse event characteristics (type, grade, etc.) were easily obtained and had consistent values based on standard terminologies. Limitation The automated system described was designed specifically for the work flow at Thomas Jefferson University. While the methodology for system design, and the system requirements derived from common clinical trials adverse reporting procedures are applicable in general, specific work flow details may not relevant at other institutions. Conclusion The system facilitated analysis of individual investigator reporting performance, as well as the aggregation and analysis of the nature of reported adverse

  16. Adverse childhood experiences and risk of physical violence in adolescent dating relationships

    PubMed Central

    Miller, Elizabeth; Breslau, Joshua; Chung, W-J Joanie; Green, Jennifer Greif; McLaughlin, Katie A; Kessler, Ronald C

    2012-01-01

    Background This study evaluates associations of commonly co-occurring childhood adversities with physical violence in dating relationships to identify potential strategies for refining and targeting dating violence prevention programmes. Methods Data on 5130 adult respondents to a nationally representative survey with at least one dating relationship before the age of 21 years were analysed. Logistic regression models assessed associations between 12 childhood adversities and physical dating violence (PDV). Results Adjusting for the number of co-occurring adversities, 10 of the 12 childhood adversities were significantly associated with PDV perpetration or victimisation (OR 1.5–2.8). The population attributable risk proportion of PDV due to all 12 childhood adversities was 53.4%. Childhood adversities with the highest attributable risk proportions were sexual abuse (13.8%), interparental violence (11.6%) and parent mental illness (10.7%). Multivariate prediction equations ranked respondents by their childhood adversity risk profiles; 46.4% of PDV cases occurred in the top two risk deciles. Conclusions Assessment of a broad range of childhood exposures to familial adversities may help to identify adolescents at particularly high risk of PDV and to guide prevention efforts. PMID:21321063

  17. Polypectomy Techniques, Endoscopist Characteristics, and Serious Gastrointestinal Adverse Events

    PubMed Central

    CHUKMAITOV, ASKAR; BRADLEY, CATHY J.; DAHMAN, BASSAM; SIANGPHOE, UMAPORN; BOUHAIDAR, DOUMIT; WARREN, JOAN L.

    2016-01-01

    Background A use of polypectomy techniques by endoscopist specialty (primary care, surgery, and gastroenterology) and experience (volume), and associations with serious gastrointestinal adverse events, were examined. Methods A retrospective follow-up study with ambulatory surgery and hospital discharge datasets from Florida, 1999–2001, was used. Thirty-day hospitalizations due to colonic perforations and gastrointestinal bleeding were investigated for 323,585 patients. Results Primary care endoscopists and surgeons used hot biopsy forceps/ablation, while gastroenterologists provided snare polypectomy or complex colonoscopy. Low-volume endoscopists were more likely to use simpler rather than complex procedures. For hot forceps/ablation and snare polypectomy, low- and medium-volume endoscopists reported higher odds of adverse events. For complex colonoscopy, higher odds of adverse events were reported for primary care endoscopists (1.74 [95% CI, 1.18–2.56]) relative to gastroenterologists. Conclusions Endoscopists regardless of specialty and experience can safely use cold biopsy forceps. For hot biopsy and snare polypectomy, low volume, but not specialty, contributed to increased odds of adverse events. For complex colonoscopy, primary care specialty, but not low volume, added to the odds of adverse events. Comparable outcomes were reported for surgeons and gastroenterologists. Cross-training and continuing medical education of primary care endoscopists in high-volume endoscopy settings are recommended for complex colonoscopy procedures. PMID:24706376

  18. Care of the clinician after an adverse event.

    PubMed

    Pratt, S D; Jachna, B R

    2015-02-01

    The past two decades has seen a growing understanding that health care leads to harm in a large number of patients. With this insight has come an understanding that clinicians who care for patients who are harmed experience an understandable and predictable emotional response. After an adverse event, medical care givers may experience a wide range of symptoms including anger, guilt, shame, fear, loneliness, frustration and decreased job satisfaction. These may be accompanied by physical signs of fatigue, sleep disturbances, concentration difficulties, tachycardia and hypertension. These clinicians have been referred to as the "second victims." While many clinicians recover relatively quickly from an adverse event, for some this syndrome can last for weeks, months or indefinitely. Some have even contemplated or completed suicide. Being involved in an adverse event or error may also negatively impact the quality of care the clinician subsequently provides, either because of acute emotional distraction or chronic burnout. This can lead to additional errors and a vicious cycle of error, burnout and error. Health care systems have a moral responsibility to care for second victims. Care might be as simple as asking, "Are you OK?" and acknowledging the normal human emotional response to adverse events. Some centers have developed formal peer support programs in which clinicians are trained to act as peer supporter for emotional recovery after adverse events. Finally, more formal emotional support systems might be needed by some clinicians, including employee assistance programs, hospital clergy or psychological and psychiatric services. PMID:25499810

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

    PubMed

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

    2015-06-01

    CSIRO Adverse Drug Event Corpus (Cadec) is a new rich annotated corpus of medical forum posts on patient-reported Adverse Drug Events (ADEs). The corpus is sourced from posts on social media, and contains text that is largely written in colloquial language and often deviates from formal English grammar and punctuation rules. Annotations contain mentions of concepts such as drugs, adverse effects, symptoms, and diseases linked to their corresponding concepts in controlled vocabularies, i.e., SNOMED Clinical Terms and MedDRA. The quality of the annotations is ensured by annotation guidelines, multi-stage annotations, measuring inter-annotator agreement, and final review of the annotations by a clinical terminologist. This corpus is useful for studies in the area of information extraction, or more generally text mining, from social media to detect possible adverse drug reactions from direct patient reports. The corpus is publicly available at https://data.csiro.au.(1). PMID:25817970

  20. [Reporting adverse reactions and events in randomised clinical trials].

    PubMed

    Hemmingsen, Bianca; Støy, Lina; Wetterslev, Jørn; Tarnow, Lise; Friis, Karin Bach; Christensen, Louise Lundby; Sales, Nader; Gluud, Christian

    2010-08-30

    "Good clinical practice" (GCP) is an international guideline on how to conduct clinical trials on medical products involving human participants. Danish statute follows the EU trial directive (2001/20/EF) including the GCP guidelines. This article summarises the practical implementation of reporting adverse events and adverse reactions to the Danish Medicines Agency and the regional ethics committee based on the protocol of the ongoing Copenhagen Insulin and Metformin Therapy (CIMT) trial. PMID:20825743

  1. Prevalence of negative life events and chronic adversities in European pre- and primary-school children: results from the IDEFICS study

    PubMed Central

    2012-01-01

    Background Children are not always recognized as being susceptible to stress, although childhood stressors may originate from multiple events in their everyday surroundings with negative effects on children’s health. Methods As there is a lack of large-scale, European prevalence data on childhood adversities, this study presents the prevalence of (1) negative life events and (2) familial and social adversities in 4637 European pre- and primary-school children (4–11 years old), using a parentally-reported questionnaire embedded in the IDEFICS project (‘Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS’). Results The following findings were observed: (1) Certain adversities occur only rarely, while others are very regular (i.e. parental divorce); (2) A large percentage of children is shielded from stressors, while a small group of children is exposed to multiple, accumulating adversities; (3) The prevalence of childhood adversity is influenced by geographical location (e.g. north versus south), age group and sex; (4) Childhood adversities are associated and co-occur, resulting in potential cumulative childhood stress. Conclusions This study demonstrated the importance of not only studying traumatic events but also of focusing on the early familial and social environment in childhood stress research and indicated the importance of recording or monitoring childhood adversities. PMID:23173879

  2. Predicting adverse drug events from personal health messages.

    PubMed

    Chee, Brant W; Berlin, Richard; Schatz, Bruce

    2011-01-01

    Adverse drug events (ADEs) remain a large problem in the United States, being the fourth leading cause of death, despite post market drug surveillance. Much post consumer drug surveillance relies on self-reported "spontaneous" patient data. Previous work has performed datamining over the FDA's Adverse Event Reporting System (AERS) and other spontaneous reporting systems to identify drug interactions and drugs correlated with high rates of serious adverse events. However, safety problems have resulted from the lack of post marketing surveillance information about drugs, with underreporting rates of up to 98% within such systems. We explore the use of online health forums as a source of data to identify drugs for further FDA scrutiny. In this work we aggregate individuals' opinions and review of drugs similar to crowd intelligence3. We use natural language processing to group drugs discussed in similar ways and are able to successfully identify drugs withdrawn from the market based on messages discussing them before their removal. PMID:22195073

  3. Antimicrobial Postexposure Prophylaxis for Anthrax: Adverse Events and Adherence

    PubMed Central

    Soriano-Gabarro, Montse; Zell, Elizabeth R.; Hayslett, James; Lukacs, Susan; Goldstein, Susan; Factor, Stephanie; Jones, Joshua; Ridzon, Renee; Williams, Ian; Rosenstein, Nancy

    2002-01-01

    We collected data during postexposure antimicrobial prophylaxis campaigns and from a prophylaxis program evaluation 60 days after start of antimicrobial prophylaxis involving persons from six U.S. sites where Bacillus anthracis exposures occurred. Adverse events associated with antimicrobial prophylaxis to prevent anthrax were commonly reported, but hospitalizations and serious adverse events as defined by Food and Drug Administration criteria were rare. Overall adherence during 60 days of antimicrobial prophylaxis was poor (44%), ranging from 21% of persons exposed in the Morgan postal facility in New York City to 64% of persons exposed at the Brentwood postal facility in Washington, D.C. Adherence was highest among participants in an investigational new drug protocol to receive additional antibiotics with or without anthrax vaccine—a likely surrogate for anthrax risk perception. Adherence of <60 days was not consistently associated with adverse events. PMID:12396927

  4. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... 10.115). The guidance represents the Agency's current thinking on postmarketing adverse event... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Postmarketing Adverse Event... announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting...

  5. 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

  6. The Impact of Childhood Adversity on the Clinical Features of Schizophrenia.

    PubMed

    Rajkumar, Ravi Philip

    2015-01-01

    Introduction. Recent research has drawn attention to the link between childhood maltreatment and schizophrenia. Child abuse and neglect may have an impact on symptoms and physical health in these patients. This association has not been studied to date in India. Materials and Methods. Clinically stable patients with schizophrenia (n = 62) were assessed for childhood adversity using the Childhood Trauma Questionnaire. The association of specific forms of adversity with symptomatology and associated variables was examined. Results. Emotional abuse was reported by 56.5% patients and physical abuse by 33.9%; scores for childhood neglect were also high. Persecutory delusions were linked to physical abuse, while anxiety was linked to emotional neglect and depression to emotional abuse and childhood neglect. Physical abuse was linked to elevated systolic blood pressure, while emotional abuse and neglect in women were linked to being overweight. Conclusions. Childhood adversity is common in schizophrenia and appears to be associated with a specific symptom profile. Certain components of the metabolic syndrome also appear to be related to childhood adversity. These results are subject to certain limitations as they are derived from remitted patients, and no control group was used for measures of childhood adversity. PMID:26345291

  7. The Impact of Childhood Adversity on the Clinical Features of Schizophrenia

    PubMed Central

    Rajkumar, Ravi Philip

    2015-01-01

    Introduction. Recent research has drawn attention to the link between childhood maltreatment and schizophrenia. Child abuse and neglect may have an impact on symptoms and physical health in these patients. This association has not been studied to date in India. Materials and Methods. Clinically stable patients with schizophrenia (n = 62) were assessed for childhood adversity using the Childhood Trauma Questionnaire. The association of specific forms of adversity with symptomatology and associated variables was examined. Results. Emotional abuse was reported by 56.5% patients and physical abuse by 33.9%; scores for childhood neglect were also high. Persecutory delusions were linked to physical abuse, while anxiety was linked to emotional neglect and depression to emotional abuse and childhood neglect. Physical abuse was linked to elevated systolic blood pressure, while emotional abuse and neglect in women were linked to being overweight. Conclusions. Childhood adversity is common in schizophrenia and appears to be associated with a specific symptom profile. Certain components of the metabolic syndrome also appear to be related to childhood adversity. These results are subject to certain limitations as they are derived from remitted patients, and no control group was used for measures of childhood adversity. PMID:26345291

  8. Adverse Childhood Experiences and Adult Criminality: How Long Must We Live before We Possess Our Own Lives?

    PubMed Central

    Reavis, James A; Looman, Jan; Franco, Kristina A; Rojas, Briana

    2013-01-01

    Background: Empirical research associated with the Kaiser Permanente and Centers for Disease Control and Prevention Adverse Childhood Experiences (ACE) Study has demonstrated that ACE are associated with a range of negative outcomes in adulthood, including physical and mental health disorders and aggressive behavior. Methods: Subjects from 4 different offender groups (N = 151) who were referred for treatment at an outpatient clinic in San Diego, CA, subsequent to conviction in criminal court, completed the ACE Questionnaire. Groups (nonsexual child abusers, domestic violence offenders, sexual offenders, and stalkers) were compared on the incidence of ACE, and comparisons were made between the group offenders and a normative sample. Results: Results indicated that the offender group reported nearly four times as many adverse events in childhood than an adult male normative sample. Eight of ten events were found at significantly higher levels among the criminal population. In addition, convicted sexual offenders and child abusers were more likely to report experiencing sexual abuse in childhood than other offender types. Conclusions: On the basis of a review of the literature and current findings, criminal behavior can be added to the host of negative outcomes associated with scores on the ACE Questionnaire. Childhood adversity is associated with adult criminality. We suggest that to decrease criminal recidivism, treatment interventions must focus on the effects of early life experiences. PMID:23704843

  9. Root Cause Analysis: Learning from Adverse Safety Events.

    PubMed

    Brook, Olga R; Kruskal, Jonathan B; Eisenberg, Ronald L; Larson, David B

    2015-10-01

    Serious adverse events continue to occur in clinical practice, despite our best preventive efforts. It is essential that radiologists, both as individuals and as a part of organizations, learn from such events and make appropriate changes to decrease the likelihood that such events will recur. Root cause analysis (RCA) is a process to (a) identify factors that underlie variation in performance or that predispose an event toward undesired outcomes and (b) allow for development of effective strategies to decrease the likelihood of similar adverse events occurring in the future. An RCA process should be performed within the environment of a culture of safety, focusing on underlying system contributors and, in a confidential manner, taking into account the emotional effects on the staff involved. The Joint Commission now requires that a credible RCA be performed within 45 days for all sentinel or major adverse events, emphasizing the need for all radiologists to understand the processes with which an effective RCA can be performed. Several RCA-related tools that have been found to be useful in the radiology setting include the "five whys" approach to determine causation; cause-and-effect, or Ishikawa, diagrams; causal tree mapping; affinity diagrams; and Pareto charts. PMID:26466177

  10. 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

  11. Prenatal alcohol and other early childhood adverse exposures: Direct and indirect pathways to adolescent drinking.

    PubMed

    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 14years. 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

  12. 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. PMID:27510377

  13. 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

  14. Hematological Adverse Events in Clozapine-Treated Children and Adolescents

    ERIC Educational Resources Information Center

    Gerbino-Rosen, Ginny; Roofeh, David; Tompkins, D. Andrew; Feryo, Doug; Nusser, Laurie; Kranzler, Harvey; Napolitano, Barbara; Frederickson, Anne; Henderson, Inika; Rhinewine, Joe; Kumra, Sanjiv

    2005-01-01

    Objective: To retrospectively examine rates of hematological adverse events (HAEs) in psychiatrically ill, hospitalized children treated with clozapine. Method: Clozapine treatment was administered in an open-label fashion using a flexible titration schedule, and data from weekly complete blood counts was obtained. The rate of neutropenia and…

  15. Adverse Life Events and Mental Health in Middle Adolescence

    ERIC Educational Resources Information Center

    Flouri, Eirini; Kallis, Constantinos

    2011-01-01

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

  16. [Learning from errors after a care-related adverse event].

    PubMed

    Richard, Christian; Pibarot, Marie-Laure; Zantman, Françoise

    2016-04-01

    The mobilisation of all health professionals with regard to the detection and analysis of care-related adverse events is an essential element in the improvement of the safety of care. This approach is required by the authorities and justifiably expected by users. PMID:27085926

  17. [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. PMID:27085925

  18. [The management of an adverse event in a paediatric unit].

    PubMed

    Cruz, Emmanuelle; Dubrulle, Aurélie

    2016-04-01

    Adverse events remain a major issue in care services. The mission of hospital authorities is to analyse them in order to put in place corrective and preventive measures. The objective is to prevent them reoccurring and to ensure the sustainable improvement of the quality and safety of care. This article presents an example in paediatrics with parenteral nutrition. PMID:27085928

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

    PubMed

    Shonkoff, Jack P; Garner, Andrew S

    2012-01-01

    Advances in fields of inquiry as diverse as neuroscience, molecular biology, genomics, developmental psychology, epidemiology, sociology, and economics are catalyzing an important paradigm shift in our understanding of health and disease across the lifespan. This converging, multidisciplinary science of human development has profound implications for our ability to enhance the life prospects of children and to strengthen the social and economic fabric of society. Drawing on these multiple streams of investigation, this report presents an ecobiodevelopmental framework that illustrates how early experiences and environmental influences can leave a lasting signature on the genetic predispositions that affect emerging brain architecture and long-term health. The report also examines extensive evidence of the disruptive impacts of toxic stress, offering intriguing insights into causal mechanisms that link early adversity to later impairments in learning, behavior, and both physical and mental well-being. The implications of this framework for the practice of medicine, in general, and pediatrics, specifically, are potentially transformational. They suggest that many adult diseases should be viewed as developmental disorders that begin early in life and that persistent health disparities associated with poverty, discrimination, or maltreatment could be reduced by the alleviation of toxic stress in childhood. An ecobiodevelopmental framework also underscores the need for new thinking about the focus and boundaries of pediatric practice. It calls for pediatricians to serve as both front-line guardians of healthy child development and strategically positioned, community leaders to inform new science-based strategies that build strong foundations for educational achievement, economic productivity, responsible citizenship, and lifelong health. PMID:22201156

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

    PubMed

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

    2015-08-26

    The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. PMID:26209838

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

    PubMed Central

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

    2015-01-01

    The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) conduct post-licensure vaccine safety monitoring using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous (or passive) reporting system. This means that after a vaccine is approved, CDC and FDA continue to monitor safety while it is distributed in the marketplace for use by collecting and analyzing spontaneous reports of adverse events that occur in persons following vaccination. Various methods and statistical techniques are used to analyze VAERS data, which CDC and FDA use to guide further safety evaluations and inform decisions around vaccine recommendations and regulatory action. VAERS data must be interpreted with caution due to the inherent limitations of passive surveillance. VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination. CDC makes VAERS data available to the public and readily accessible online. We describe fundamental vaccine safety concepts, provide an overview of VAERS for healthcare professionals who provide vaccinations and might want to report or better understand a vaccine adverse event, and explain how CDC and FDA analyze VAERS data. We also describe strengths and limitations, and address common misconceptions about VAERS. Information in this review will be helpful for healthcare professionals counseling patients, parents, and others on vaccine safety and benefit-risk balance of vaccination. PMID:26209838

  2. Race, gender, and chains of disadvantage: childhood adversity, social relationships, and health.

    PubMed

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

    2014-03-01

    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. Social work and adverse childhood experiences research: implications for practice and health policy.

    PubMed

    Larkin, Heather; Felitti, Vincent J; Anda, Robert F

    2014-01-01

    Medical research on "adverse childhood experiences" (ACEs) reveals a compelling relationship between the extent of childhood adversity, adult health risk behaviors, and principal causes of death in the United States. This article provides a selective review of the ACE Study and related social science research to describe how effective social work practice that prevents ACEs and mobilizes resilience and recovery from childhood adversity could support the achievement of national health policy goals. This article applies a biopsychosocial perspective, with an emphasis on mind-body coping processes to demonstrate that social work responses to adverse childhood experiences may contribute to improvement in overall health. Consistent with this framework, the article sets forth prevention and intervention response strategies with individuals, families, communities, and the larger society. Economic research on human capital development is reviewed that suggests significant cost savings may result from effective implementation of these strategies. PMID:24188292

  4. 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

  5. Childhood Adversity Accelerates Intended Reproductive Timing in Adolescent Girls without Increasing Interest in Infants

    PubMed Central

    Clutterbuck, Stephanie; Adams, Jean; Nettle, Daniel

    2014-01-01

    Women experiencing greater childhood adversity exhibit faster reproductive trajectories. One possible psychological mechanism underlying this phenomenon is an increased interest in infants. Interest in infants is thought to be an adaptation important for successful rearing as it motivates the acquisition of caretaking skills. We investigated the relationships between childhood adversity, intended reproductive timing and interest in infants in a sample of English adolescent girls. Specifically we sought to investigate the relationship between 1) childhood adversity and intended reproductive timing; 2) childhood adversity and interest in infants; and 3) intended reproductive timing and interest in infants. Additionally we explored different methods of measuring interest in infants using self-reported fondness for babies, a forced choice adult versus infant paper-based preference task and a novel computer based attention task using adult and infant stimuli. In total 357 girls aged nine to 14 years participated in the study, which took place in schools. Participants completed the two interest in infants tasks before moving on to a childhood adversity questionnaire. Girls with more childhood adversity reported earlier ideal ages at parenthood. We found some evidence that, contrary to our predictions, girls with less childhood adversity were more interested in infants. There was no relationship between intended reproductive timing and interest in infants. The different measurements for interest in infants were only weakly related, if at all, highlighting the complexity of measuring this construct. Our findings suggest that rather than interest in infants being a mechanism for the effect of childhood adversity on early reproductive timing it might instead be an indicator of future reproductive strategies. PMID:24454778

  6. CHILDHOOD ADVERSITY AND PUBERTAL TIMING: UNDERSTANDING THE ORIGINS OF ADULTHOOD CARDIOVASCULAR RISK

    PubMed Central

    Bleil, Maria E.; Adler, Nancy E.; Appelhans, Bradley M.; Gregorich, Steven E.; Sternfeld, Barbara; Cedars, Marcelle I.

    2013-01-01

    Objective To determine whether greater childhood adversity relates to younger menarcheal age; whether younger menarcheal age relates to increased CVD risk; and whether greater childhood adversity relates to increased CVD risk, directly or indirectly (mediated by menarcheal age). Methods Among 650 pre-menopausal women (ages 25-45; M=34.9[5.6]), SEM was performed to estimate relations between childhood adversity, menarcheal age, and CVD risk. Results Results supported a covariate-adjusted model (RMSEA=0.035; CFI=0.983) in which greater childhood adversity was related to younger menarcheal age (β=−.13, p<.01) and younger menarcheal age was related to greater CVD risk (β=−.18, p<.05). Direct and indirect effects of childhood adversity on CVD risk were non-significant. Re-evaluation of the same model with additional covariate-adjustment for adulthood body composition showed the relation between menarcheal age and CVD risk attenuated (β=−.03, p=.376). Conclusions Cross-sectional evidence suggests family-related adversity experiences in childhood confer risk for earlier menarche which, in turn, relates to increased CVD risk in adulthood, possibly via post-pubertal body size. PMID:23428374

  7. Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

    PubMed Central

    Alshammari, Thamir M.; Al-Kathiri, Wa’ad H.; Louet, Hervé Le; Aljadhey, Hisham S.

    2015-01-01

    Objectives: To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications. Methods: A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS. The completeness was assessed by reviewing the components of the adverse drug reactions (ADRs) form, and how many fields were completed. Descriptive statistics are reported. Result: There were 14,783 reports during the study period. Eighty percent of these reports were spontaneous reports. Information related to the drug (99%) and adverse events (98%) of the reports were completed. While the patient’s demographic data were completed only in 38% of all reports, the least completed item in the ADRs form was the reporter information (15%). The most reported drug class was tumor necrosis factor inhibitors (7%), whereas events involving the respiratory organ system were the most frequently reported (4.5%). Conclusion: Although the SAERS is considered new, it has a high number of reports. More efforts are needed to improve the completeness of the SAERS to be a good source to assess the signals between events and suspected drugs, especially when there is a high number of reports. PMID:26108586

  8. 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

  9. Childhood adversities as risk factors for onset and persistence of suicidal behaviour

    PubMed Central

    Bruffaerts, Ronny; Demyttenaere, Koen; Borges, Guilherme; Haro, Josep Maria; Chiu, Wai Tat; Hwang, Irving; Karam, Elie G.; Kessler, Ronald C.; Sampson, Nancy; Alonso, Jordi; Andrade, Laura Helena; Angermeyer, Matthias; Benjet, Corina; Bromet, Evelyn; de Girolamo, Giovanni; de Graaf, Ron; Florescu, Silvia; Gureje, Oye; Horiguchi, Itsuko; Hu, Chiyi; Kovess, Viviane; Levinson, Daphna; Posada-Villa, Jose; Sagar, Rajesh; Scott, Kate; Tsang, Adley; Vassilev, Svetlozar M.; Williams, David R.; Nock, Matthew K.

    2010-01-01

    Background Suicide is a leading cause of death worldwide, but the precise effect of childhood adversities as risk factors for the onset and persistence of suicidal behaviour (suicide ideation, plans and attempts) are not well understood. Aims To examine the associations between childhood adversities as risk factors for the onset and persistence of suicidal behaviour across 21 countries worldwide. Method Respondents from nationally representative samples (n = 55 299) were interviewed regarding childhood adversities that occurred before the age of 18 years and lifetime suicidal behaviour. Results Childhood adversities were associated with an increased risk of suicide attempt and ideation in both bivariate and multivariate models (odds ratio range 1.2–5.7). The risk increased with the number of adversities experienced, but at a decreasing rate. Sexual and physical abuse were consistently the strongest risk factors for both the onset and persistence of suicidal behaviour, especially during adolescence. Associations remained similar after additional adjustment for respondents’ lifetime mental disorder status. Conclusions Childhood adversities (especially intrusive or aggressive adversities) are powerful predictors of the onset and persistence of suicidal behaviours. PMID:20592429

  10. Childhood adversity and social functioning in psychosis: Exploring clinical and cognitive mediators.

    PubMed

    Palmier-Claus, Jasper; Berry, Katherine; Darrell-Berry, Hannah; Emsley, Richard; Parker, Sophie; Drake, Richard; Bucci, Sandra

    2016-04-30

    Childhood adversity may increase risk of impaired social functioning across the continuum of psychosis. However, the pathways by which adversity dictates functional outcome remain underexplored. This study investigated the association between childhood adversity and social functioning, and the clinical and cognitive mediators of this relationship. Fifty-four clinical (20 chronic, 20 first episode, 14 at ultra-high risk) and 120 non-clinical participants completed standardised questionnaires, semi-structured interviews and tests of theory of mind ability. The authors used multiple group structural equation modelling to fit mediation models allowing for differential relationships between the clinical and non-clinical samples. When examining each pathway separately, depression, paranoia and anxious attachment mediated the effect of childhood adversity on social functioning. In a combined model, depression was the only significant mediating variable with greater adversity predicting lower mood across groups. Childhood adversity did not significantly predict theory of mind ability in any of the models. This is the first study to indicate that childhood adversity acts on social functioning by increasing levels of depression, suggesting a common mechanism across the spectrum of psychosis. Clinical interventions should target low mood in order to improve social functioning at all stages of psychotic disorder. PMID:27086207

  11. Perioperative Adverse Respiratory Events in Overweight/Obese Children: Systematic Review.

    PubMed

    Kiekkas, Panagiotis; Stefanopoulos, Nikolaos; Bakalis, Nick; Kefaliakos, Antonios; Konstantinou, Evangelos

    2016-02-01

    Childhood obesity is associated with numerous respiratory disorders, which may be aggravated when general anesthesia is administered. This systematic review aimed to investigate and synthesize the published literature on the associations between childhood obesity and perioperative adverse respiratory events (PAREs). By using key terms, observational studies published between 1990 and 2014 in English-language journals indexed by Cumulative Index for Nursing and Allied Health Literature, PubMed, Web of Science, Cochrane Database, and EMBASE were searched for reports of relevant associations. Nine articles were considered eligible for inclusion. In all studies, significant univariate and multivariate associations were reported between obesity and increased risk for PAREs in pediatric patients, mainly for hypoxemia, upper airway obstruction, and difficult mask ventilation. Appropriate strategies for preventing PAREs in obese children need to be followed by health care professionals. Multicenter studies are also recommended for ensuring high generalizability of reported associations and elucidating underlying mechanisms that link obesity to PAREs. PMID:26847776

  12. Gambling and Adverse Life Events Among Urban Adolescents

    PubMed Central

    Lee, Grace P.; Derevensky, Jeffrey L.; Ialongo, Nicholas S.; Martins, Silvia S.

    2011-01-01

    This study explored the cross sectional association between adverse life events and gambling in a sample of 515 urban adolescents (average age 17, 55% male, 88% African American). Approximately half of the sample had gambled in the past year (51%); 78% of the gamblers gambled monthly and 39% had a gambling-related problem. On the other hand, 88% of the sample had experienced at least one life event in the past year, and those experiencing events tended to live in more disadvantaged neighborhoods. The mere acknowledgement of experiencing a stressful life event in the past year (yes/no) was not associated with an increase in odds of being a gambler, with gambling more frequently, or with having a gambling problem. However, when the context of the event was considered, an association was found between directly experiencing threatening and deviant/violent types of events and frequent gambling (OR > 2). Additionally, the probability of being a gambler increased as the number of events experienced increased (aOR = 1.07, 95% CI = 1.01, 1.13, P = 0.013), but problems among gamblers were not associated with the number of events experienced (aOR = 1.01, 95% CI = 0.92, 1.11, P = 0.876). During adolescence, life events appear to be connected more with the frequency of gambling rather than with problems related to gambling. PMID:21614529

  13. Immune-Related Adverse Events From Immune Checkpoint Inhibitors.

    PubMed

    Marrone, K A; Ying, W; Naidoo, J

    2016-09-01

    Immunotherapy for cancer treatment has come of age, specifically with the use of immune checkpoint antibodies directed against molecules such as CTLA-4, PD-1, and PD-L1. Single-agent and combinatorial approaches utilizing these agents and other immunotherapies that may enhance antitumor effects are under investigation. With increasing clinical use of these agents, an appreciation for their toxicities comes to the fore. Adverse events that occur as a result of the immunologic effects of these therapies are termed "immune-related adverse events" (irAEs), and range in both frequency and severity in reported single-agent and combination studies. Improvements in our understanding of how and why irAEs develop and how to effectively manage them are needed. Herein we provide a state-of-the-art synopsis of the incidence, clinical features, mechanisms, and management of selected irAEs with immune checkpoint inhibitors currently in use. PMID:27170616

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

    PubMed

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

    2005-01-01

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

  15. Predicting Adverse Drug Events from Personal Health Messages

    PubMed Central

    Chee, Brant W.; Berlin, Richard; Schatz, Bruce

    2011-01-01

    Adverse drug events (ADEs) remain a large problem in the United States, being the fourth leading cause of death, despite post market drug surveillance. Much post consumer drug surveillance relies on self-reported “spontaneous” patient data. Previous work has performed datamining over the FDA’s Adverse Event Reporting System (AERS) and other spontaneous reporting systems to identify drug interactions and drugs correlated with high rates of serious adverse events. However, safety problems have resulted from the lack of post marketing surveillance information about drugs, with underreporting rates of up to 98% within such systems1,2. We explore the use of online health forums as a source of data to identify drugs for further FDA scrutiny. In this work we aggregate individuals’ opinions and review of drugs similar to crowd intelligence3. We use natural language processing to group drugs discussed in similar ways and are able to successfully identify drugs withdrawn from the market based on messages discussing them before their removal. PMID:22195073

  16. 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

  17. 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

  18. Childhood Adversity Is Associated with Adult Theory of Mind and Social Affiliation, but Not Face Processing.

    PubMed

    Germine, Laura; Dunn, Erin C; McLaughlin, Katie A; Smoller, Jordan W

    2015-01-01

    People vary substantially in their ability to acquire and maintain social ties. Here, we use a combined epidemiological and individual differences approach to understand the childhood roots of adult social cognitive functioning. We assessed exposure to 25 forms of traumatic childhood experiences in over 5000 adults, along with measures of face discrimination, face memory, theory of mind, social motivation, and social support. Retrospectively-reported experiences of parental maltreatment in childhood (particularly physical abuse) were the most broadly and robustly associated with adult variations in theory of mind, social motivation, and social support. Adult variations in face discrimination and face memory, on the other hand, were not significantly associated with exposure to childhood adversity. Our findings indicate domains of social cognition that may be particularly vulnerable to the effects of adverse childhood environments, and suggest mechanisms whereby environmental factors might influence the development of social abilities. PMID:26068107

  19. CLUSTERING OF DEPRESSION AND INFLAMMATION IN ADOLESCENTS PREVIOUSLY EXPOSED TO CHILDHOOD ADVERSITY

    PubMed Central

    Miller, Gregory E.; Cole, Steve W.

    2012-01-01

    Background There is mounting interest in the hypothesis that inflammation contributes to the pathogenesis of depression, and underlies depressed patients’ vulnerability to comorbid medical conditions. However, research on depression and inflammation has yielded conflicting findings, fostering speculation that these conditions associate only in certain subgroups, like patients exposed to childhood adversity. Methods We studied 147 adolescent females. All were in good health at baseline, but at high risk for depression by virtue of family history and/or cognitive vulnerability. Subjects were assessed every six months for 2.5 years, undergoing diagnostic interviews and venipuncture for measurement of two inflammatory biomarkers, C-reactive protein (CRP) and interleukin-6 (IL-6). Childhood adversity was indexed by parental separation, low socioeconomic status, and familial psychopathology. Results Multilevel models indicated that childhood adversity promotes clustering of depression and inflammation. Among subjects exposed to high childhood adversity, the transition to depression was accompanied by increases in both CRP and IL-6. The higher CRP remained evident six months later, even after depressive symptoms had abated. These lingering effects were bi-directional, such that among subjects with childhood adversity, high IL-6 forecasted depression six months later, even after concurrent inflammation was considered. This coupling of depression and inflammation was not apparent in subjects without childhood adversity. Conclusions These findings suggest that childhood adversity promotes the formation of a neuroimmune pipeline, wherein inflammatory signaling between the brain and periphery is amplified. Once established, this pipeline leads to a coupling of depression and inflammation, which may contribute to later affective difficulties and biomedical complications. PMID:22494534

  20. [Procedure adverse events: nursing care in central venous catheter fracture].

    PubMed

    Pérez-Juan, Eva; Maqueda-Palau, Mònica; Romero-Grilo, Cristina; Muñoz-Moles, Yolanda

    2014-01-01

    In a intensive care unit (ICU) there are many factors that can lead to the occurrence of adverse events. A high percentage of these events are associated with the administration of drugs. Diagnostic tests, such as computed tomography, is common in critically ill patients and technique can be performed with injection of contrast agent to enhance the visualization of soft tissue. The contrast is a medication and the nurse is responsible for its proper administration. The management of the critically ill patient is complex. ICU team and radiology shares responsibility for the care and safety of the patient safety during the transfer and performing tests with contrast. The World Health Organisation patient safety strategies, recommends analysing errors and learning from them. Therefore, it was decided to investigate the causes of the category E severity adverse events that occurred in a patient who was admitted to the ICU for septic shock of abdominal origin. An abdominal computed tomography was performed with contrast which was injected through a central venous catheter. The contrast did not appear in the image. What happened? Causal analysis helped to understand what triggered the event. A care plan and an algorithm were drafted to prevent it from happening again, with the following objectives: improving knowledge, skills and promoting positive attitudes towards patient safety, working at primary, secondary and tertiary care levels. PMID:24439203

  1. Assessment of surgical adverse events in Rio de Janeiro hospitals.

    PubMed

    Moura, Maria de Lourdes de Oliveira; Mendes, Walter

    2012-09-01

    A study on surgical adverse events (AE) is relevant because of the frequency of these events, because they are in part attributable to deficiencies in health care, because of their considerable impact on patient health and economic consequences on social and health expenditures, and because this study is an assessment tool for quality of care. We aimed to evaluate the incidence and the contributive factors of surgical AE in hospitals of Rio de Janeiro. This retrospective cohort study aimed to perform a descriptive analysis of secondary data obtained from the Adverse Events Computer Program, which was developed for collecting data for the assessment of AE in three teaching hospitals in the state of Rio de Janeiro. Incidence of patients with surgical AE was 3.5% (38 of 1,103 patients) (95% CI 2.4 - 4.4) and the proportion of patients submitted to surgery among patients with surgical AE was 5.9% (38 of 643) (95% CI 4.1 - 7.6). The proportion of avoidable surgical AE was 68.3% (28 of 41 events) and the proportion of patients with avoidable surgical AE was 65.8% (25 of 38 patients). One in five patients with surgical AE had a permanent disability or died. Over 60% of the cases were classified as not complex or of low complexity, and with low risk for care-related AE. PMID:23090300

  2. Adulthood Stressors, History of Childhood Adversity, and Risk of Perpetration of Intimate Partner Violence

    PubMed Central

    Roberts, Andrea L.; McLaughlin, Katie A.; Conron, Kerith J.; Koenen, Karestan C.

    2010-01-01

    Background Over half a million U.S. women and more than 100,000 men are treated for injuries from intimate partner violence (IPV) annually, making IPV perpetration a major public health problem. However, little is known about causes of perpetration across the life course. Purpose This paper examines the role of “stress sensitization,” whereby adult stressors increase risk for IPV perpetration most strongly in people with a history of childhood adversity. Methods The study investigated a possible interaction effect between adulthood stressors and childhood adversities in risk of IPV perpetration, specifically, whether the difference in risk of IPV perpetration associated with past-year stressors varied by history of exposure to childhood adversity. Analyses were conducted in 2010 using de-identified data from 34,653 U.S. adults from the 2004–2005 follow-up wave of the National Epidemiologic Survey on Alcohol and Related Conditions. Results There was a significant stress sensitization effect. For men with high-level childhood adversity, past-year stressors were associated with an 8.8% increased risk of perpetrating compared to a 2.3% increased risk among men with low-level adversity. Women with high-level childhood adversity had a 14.3% increased risk compared with a 2.5% increased risk in the low-level adversity group. Conclusions Individuals with recent stressors and histories of childhood adversity are at particularly elevated risk of IPV perpetration; therefore, prevention efforts should target this population. Treatment programs for IPV perpetrators, which have not been effective in reducing risk of perpetrating, may benefit from further investigating the role of stress and stress reactivity in perpetration. PMID:21238860

  3. Adverse childhood experiences, allostasis, allostatic load, and age-related disease.

    PubMed

    Danese, Andrea; McEwen, Bruce S

    2012-04-12

    How do adverse childhood experiences get 'under the skin' and influence health outcomes through the life-course? Research reviewed here suggests that adverse childhood experiences are associated with changes in biological systems responsible for maintaining physiological stability through environmental changes, or allostasis. Children exposed to maltreatment showed smaller volume of the prefrontal cortex, greater activation of the HPA axis, and elevation in inflammation levels compared to non-maltreated children. Adults with a history of childhood maltreatment showed smaller volume of the prefrontal cortex and hippocampus, greater activation of the HPA axis, and elevation in inflammation levels compared to non-maltreated individuals. Despite the clear limitations in making longitudinal claims from cross-sectional studies, work so far suggests that adverse childhood experiences are associated with enduring changes in the nervous, endocrine, and immune systems. These changes are already observable in childhood years and remain apparent in adult life. Adverse childhood experiences induce significant biological changes in children (biological embedding), modifying the maturation and the operating balance of allostatic systems. Their chronic activation can lead to progressive wear and tear, or allostatic load and overload, and, thus, can exert long-term effects on biological aging and health. PMID:21888923

  4. Childhood Adversity, Self-Esteem, and Diurnal Cortisol Profiles Across the Life Span.

    PubMed

    Zilioli, Samuele; Slatcher, Richard B; Chi, Peilian; Li, Xiaoming; Zhao, Junfeng; Zhao, Guoxiang

    2016-09-01

    Childhood adversity is associated with poor health outcomes in adulthood; the hypothalamic-pituitary-adrenal (HPA) axis has been proposed as a crucial biological intermediary of these long-term effects. Here, we tested whether childhood adversity was associated with diurnal cortisol parameters and whether this link was partially explained by self-esteem. In both adults and youths, childhood adversity was associated with lower levels of cortisol at awakening, and this association was partially driven by low self-esteem. Further, we found a significant indirect pathway through which greater adversity during childhood was linked to a flatter cortisol slope via self-esteem. Finally, youths who had a caregiver with high self-esteem experienced a steeper decline in cortisol throughout the day compared with youths whose caregiver reported low self-esteem. We conclude that self-esteem is a plausible psychological mechanism through which childhood adversity may get embedded in the activity of the HPA axis across the life span. PMID:27481911

  5. Childhood adversities increase the risk of psychosis: a meta-analysis of patient-control, prospective- and cross-sectional cohort studies.

    PubMed

    Varese, Filippo; Smeets, Feikje; Drukker, Marjan; Lieverse, Ritsaert; Lataster, Tineke; Viechtbauer, Wolfgang; Read, John; van Os, Jim; Bentall, Richard P

    2012-06-01

    Evidence suggests that adverse experiences in childhood are associated with psychosis. To examine the association between childhood adversity and trauma (sexual abuse, physical abuse, emotional/psychological abuse, neglect, parental death, and bullying) and psychosis outcome, MEDLINE, EMBASE, PsychINFO, and Web of Science were searched from January 1980 through November 2011. We included prospective cohort studies, large-scale cross-sectional studies investigating the association between childhood adversity and psychotic symptoms or illness, case-control studies comparing the prevalence of adverse events between psychotic patients and controls using dichotomous or continuous measures, and case-control studies comparing the prevalence of psychotic symptoms between exposed and nonexposed subjects using dichotomous or continuous measures of adversity and psychosis. The analysis included 18 case-control studies (n = 2048 psychotic patients and 1856 nonpsychiatric controls), 10 prospective and quasi-prospective studies (n = 41,803) and 8 population-based cross-sectional studies (n = 35,546). There were significant associations between adversity and psychosis across all research designs, with an overall effect of OR = 2.78 (95% CI = 2.34-3.31). The integration of the case-control studies indicated that patients with psychosis were 2.72 times more likely to have been exposed to childhood adversity than controls (95% CI = 1.90-3.88). The association between childhood adversity and psychosis was also significant in population-based cross-sectional studies (OR = 2.99 [95% CI = 2.12-4.20]) as well as in prospective and quasi-prospective studies (OR = 2.75 [95% CI = 2.17-3.47]). The estimated population attributable risk was 33% (16%-47%). These findings indicate that childhood adversity is strongly associated with increased risk for psychosis. PMID:22461484

  6. Childhood Adversities Increase the Risk of Psychosis: A Meta-analysis of Patient-Control, Prospective- and Cross-sectional Cohort Studies

    PubMed Central

    Varese, Filippo; Smeets, Feikje; Drukker, Marjan; Lieverse, Ritsaert; Lataster, Tineke; Viechtbauer, Wolfgang; Read, John; van Os, Jim; Bentall, Richard P.

    2012-01-01

    Evidence suggests that adverse experiences in childhood are associated with psychosis. To examine the association between childhood adversity and trauma (sexual abuse, physical abuse, emotional/psychological abuse, neglect, parental death, and bullying) and psychosis outcome, MEDLINE, EMBASE, PsychINFO, and Web of Science were searched from January 1980 through November 2011. We included prospective cohort studies, large-scale cross-sectional studies investigating the association between childhood adversity and psychotic symptoms or illness, case-control studies comparing the prevalence of adverse events between psychotic patients and controls using dichotomous or continuous measures, and case-control studies comparing the prevalence of psychotic symptoms between exposed and nonexposed subjects using dichotomous or continuous measures of adversity and psychosis. The analysis included 18 case-control studies (n = 2048 psychotic patients and 1856 nonpsychiatric controls), 10 prospective and quasi-prospective studies (n = 41 803) and 8 population-based cross-sectional studies (n = 35 546). There were significant associations between adversity and psychosis across all research designs, with an overall effect of OR = 2.78 (95% CI = 2.34–3.31). The integration of the case-control studies indicated that patients with psychosis were 2.72 times more likely to have been exposed to childhood adversity than controls (95% CI = 1.90–3.88). The association between childhood adversity and psychosis was also significant in population-based cross-sectional studies (OR = 2.99 [95% CI = 2.12–4.20]) as well as in prospective and quasi-prospective studies (OR = 2.75 [95% CI = 2.17–3.47]). The estimated population attributable risk was 33% (16%–47%). These findings indicate that childhood adversity is strongly associated with increased risk for psychosis. PMID:22461484

  7. 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

  8. Analysis of Adverse Events in Identifying GPS Human Factors Issues

    NASA Technical Reports Server (NTRS)

    Adams, Catherine A.; Hwoschinsky, Peter V.; Adams, Richard J.

    2004-01-01

    The purpose of this study was to analyze GPS related adverse events such as accidents and incidents (A/I), Aviation Safety Reporting System (ASRS) reports and Pilots Deviations (PDs) to create a framework for developing a human factors risk awareness program. Although the occurrence of directly related GPS accidents is small the frequency of PDs and ASRS reports indicated there is a growing problem with situational awareness in terminal airspace related to different types of GPs operational issues. This paper addresses the findings of the preliminary research and a brief discussion of some of the literature on related GPS and automation issues.

  9. [ Preventing adverse drug events using clinical decision support systems].

    PubMed

    Salili, Ali Reza; Hammann, Felix; Taegtmeyer, Anne B

    2015-12-01

    Adverse drug events pose a great risk to patients, are an everyday clinical problem and can have potential/ega/ consequences. Computerized physician order entry or computerized provider order entry (CPOE} in combination with clinical decision support systems {CDSS) are popular and aim to reduce prescribing errors as well as identifying potentially harmful drug drug interactions. The quantifiable benejit these systems bring to patients, has however, yet to be definitively proven. This article focusses on the current standpoint of CPOE-/CDSS, their risks and benefits, the potential for improvement and their perspectives for the future. PMID:26654813

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

    PubMed

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

    2011-01-01

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

  11. Cardiovascular adverse events associated with smoking-cessation pharmacotherapies.

    PubMed

    Sharma, Abhishek; Thakar, Saurabh; Lavie, Carl J; Garg, Jalaj; Krishnamoorthy, Parasuram; Sochor, Ondrej; Arbab-Zadeh, Armin; Lichstein, Edgar

    2015-01-01

    Smoking continues to be the leading cause of preventable deaths in the USA, accounting for one in every five deaths every year, and cardiovascular (CV) disease remains the leading cause of those deaths. Hence, there is increasing awareness to quit smoking among the public and counseling plays an important role in smoking cessation. There are different pharmacological methods to help quit smoking that includes nicotine replacement products available over the counter, including patch, gum, and lozenges, to prescription medications, such as bupropion and varenicline. There have been reports of both nonserious and serious adverse CV events associated with the use of these different pharmacological methods, especially varenicline, which has been gaining media attention recently. Therefore, we systematically reviewed the various pharmacotherapies used in smoking cessation and analyzed the evidence behind these CV events reported with these therapeutic agents. PMID:25410148

  12. Serious adverse events associated with yellow fever vaccine

    PubMed Central

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

    2015-01-01

    Yellow fever vaccine was considered one of the safest vaccines, but in recent years it was found that it could rarely cause invasive and disseminated disease in some otherwise healthy individuals, with high lethality. After extensive studies, although some risk factors have been identified, the real cause of causes of this serious adverse event are largely unknown, but findings point to individual host factors. Meningoencephalitis, once considered to happen only in children less than 6 months of age, has also been identified in older children and adults, but with good prognosis. Efforts are being made to develop a safer yellow fever vaccine, and an inactivated vaccine or a vaccine prepared with the vaccine virus envelope produced in plants are being tested. Even with serious and rare adverse events, yellow fever vaccine is the best way to avoid yellow fever, a disease of high lethality and should be used routinely in endemic areas, and on people from non-endemic areas that could be exposed, according to a careful risk-benefit analysis. PMID:26090855

  13. Predicting adverse drug events using pharmacological network models.

    PubMed

    Cami, Aurel; Arnold, Alana; Manzi, Shannon; Reis, Ben

    2011-12-21

    Early and accurate identification of adverse drug events (ADEs) is critically important for public health. We have developed a novel approach for predicting ADEs, called predictive pharmacosafety networks (PPNs). PPNs integrate the network structure formed by known drug-ADE relationships with information on specific drugs and adverse events to predict likely unknown ADEs. Rather than waiting for sufficient post-market evidence to accumulate for a given ADE, this predictive approach relies on leveraging existing, contextual drug safety information, thereby having the potential to identify certain ADEs earlier. We constructed a network representation of drug-ADE associations for 809 drugs and 852 ADEs on the basis of a snapshot of a widely used drug safety database from 2005 and supplemented these data with additional pharmacological information. We trained a logistic regression model to predict unknown drug-ADE associations that were not listed in the 2005 snapshot. We evaluated the model's performance by comparing these predictions with the new drug-ADE associations that appeared in a 2010 snapshot of the same drug safety database. The proposed model achieved an AUROC (area under the receiver operating characteristic curve) statistic of 0.87, with a sensitivity of 0.42 given a specificity of 0.95. These findings suggest that predictive network methods can be useful for predicting unknown ADEs. PMID:22190238

  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. PMID:24576654

  15. Antidepressants and cardiovascular adverse events: A narrative review

    PubMed Central

    Nezafati, Mohammad Hassan; Vojdanparast, Mohammad; Nezafati, Pouya

    2015-01-01

    BACKGROUND Major depression or deterioration of previous mood disorders is a common adverse consequence of coronary heart disease, heart failure, and cardiac revascularization procedures. Therefore, treatment of depression is expected to result in improvement of mood condition in these patients. Despite demonstrated effects of anti-depressive treatment in heart disease patients, the use of some antidepressants have shown to be associated with some adverse cardiac and non-cardiac events. In this narrative review, the authors aimed to first assess the findings of published studies on beneficial and also harmful effects of different types of antidepressants used in patients with heart diseases. Finally, a new categorization for selecting antidepressants according to their cardiovascular effects was described. METHODS Using PubMed, Web of Science, SCOPUS, Index Copernicus, CINAHL, and Cochrane Database, we identified studies designed to evaluate the effects of depression and also using antidepressants on cardiovascular outcome. A 40 studies were finally assessed systematically. Among those eligible studies, 14 were cohort or historical cohort studies, 15 were randomized clinical trial, 4 were retrospective were case-control studies, 3 were meta-analyses and 2 animal studies, and 2 case studies. RESULTS According to the current review, we recommend to divide antidepressants into three categories based on the severity of cardiovascular adverse consequences including (1) the safest drugs including those drugs with cardio-protective effects on ventricular function, as well as cardiac conductive system including selective serotonin reuptake inhibitors, (2) neutralized drugs with no evidenced effects on cardiovascular system including serotonin-norepinephrine reuptake inhibitors, and (3) harmful drugs with adverse effects on cardiac function, hemodynamic stability, and heart rate variability including tricyclic antidepressants, serotonin antagonist and reuptake inhibitors

  16. Psychological Defense Styles, Childhood Adversities and Psychopathology in Adulthood

    ERIC Educational Resources Information Center

    Nickel, R.; Egle, U. T.

    2006-01-01

    Objective: The present study explores the link between reported sexual and/or physical abuse and psychological defense styles, as well as the association of both with psychological distress in adulthood. In two patient samples that differ in psychological distress and somatization, we examine whether the adversities reported and immature defense…

  17. The enduring effects of abuse and related adverse experiences in childhood

    PubMed Central

    Anda, Robert F.; Felitti, Vincent J.; Bremner, J. Douglas; Walker, John D.; Whitfield, Charles; Perry, Bruce D.; Dube, Shanta R.; Giles, Wayne H.

    2011-01-01

    Background Childhood maltreatment has been linked to a variety of changes in brain structure and function and stress-responsive neurobiological systems. Epidemiological studies have documented the impact of childhood maltreatment on health and emotional well-being. Methods After a brief review of the neurobiology of childhood trauma, we use the Adverse Childhood Experiences (ACE) Study as an epidemiological “case example” of the convergence between epidemiologic and neurobiological evidence of the effects of childhood trauma. The ACE Study included 17,337 adult HMO members and assessed 8 adverse childhood experiences (ACEs) including abuse, witnessing domestic violence, and serious household dysfunction. We used the number of ACEs (ACE score) as a measure of cumulative childhood stress and hypothesized a “dose-response” relationship of the ACE score to 18 selected outcomes and to the total number of these outcomes (comorbidity). Results Based upon logistic regression analysis, the risk of every outcome in the affective, somatic, substance abuse, memory, sexual, and aggression-related domains increased in a graded fashion as the ACE score increased (P < 0.001). The mean number of comorbid outcomes tripled across the range of the ACE score. Conclusions The graded relationship of the ACE score to 18 different outcomes in multiple domains theoretically parallels the cumulative exposure of the developing brain to the stress response with resulting impairment in multiple brain structures and functions. PMID:16311898

  18. Impact of childhood adversities on the short-term course of illness in psychotic spectrum disorders.

    PubMed

    Schalinski, Inga; Fischer, Yolanda; Rockstroh, Brigitte

    2015-08-30

    Accumulating evidence indicates an impact of childhood adversities on the severity and course of mental disorders, whereas this impact on psychotic disorders remains to be specified. Effects of childhood adversities on comorbidity, on symptom severity of the Positive and Negative Syndrome Scale and global functioning across four months (upon admission, 1 and 4 months after initial assessment), as well as the course of illness (measured by the remission rate, number of re-hospitalizations and dropout rate) were evaluated in 62 inpatients with psychotic spectrum disorders. Adverse experiences (of at least 1 type) were reported by 73% of patients. Patients with higher overall level of childhood adversities (n=33) exhibited more co-morbid disorders, especially alcohol/substance abuse and dependency, and higher dropout rates than patients with a lower levels of adverse experiences (n=29), together with higher levels of positive symptoms and symptoms of excitement and disorganization. Emotional and physical neglect were particularly related to symptom severity. Results suggest that psychological stress in childhood affects the symptom severity and, additionally, a more unfavorable course of disorder in patients diagnosed with psychoses. This impact calls for its consideration in diagnostic assessment and psychiatric care. PMID:26099657

  19. Voluntary Electronic Reporting of Medical Errors and Adverse Events

    PubMed Central

    Milch, Catherine E; Salem, Deeb N; Pauker, Stephen G; Lundquist, Thomas G; Kumar, Sanjaya; Chen, Jack

    2006-01-01

    OBJECTIVE To describe the rate and types of events reported in acute care hospitals using an electronic error reporting system (e-ERS). DESIGN Descriptive study of reported events using the same e-ERS between January 1, 2001 and September 30, 2003. SETTING Twenty-six acute care nonfederal hospitals throughout the U.S. that voluntarily implemented a web-based e-ERS for at least 3 months. PARTICIPANTS Hospital employees and staff. INTERVENTION A secure, standardized, commercially available web-based reporting system. RESULTS Median duration of e-ERS use was 21 months (range 3 to 33 months). A total of 92,547 reports were obtained during 2,547,154 patient-days. Reporting rates varied widely across hospitals (9 to 95 reports per 1,000 inpatient-days; median=35). Registered nurses provided nearly half of the reports; physicians contributed less than 2%. Thirty-four percent of reports were classified as nonmedication-related clinical events, 33% as medication/infusion related, 13% were falls, 13% as administrative, and 6% other. Among 80% of reports that identified level of impact, 53% were events that reached a patient (“patient events”), 13% were near misses that did not reach the patient, and 14% were hospital environment problems. Among 49,341 patient events, 67% caused no harm, 32% temporary harm, 0.8% life threatening or permanent harm, and 0.4% contributed to patient deaths. CONCLUSIONS An e-ERS provides an accessible venue for reporting medical errors, adverse events, and near misses. The wide variation in reporting rates among hospitals, and very low reporting rates by physicians, requires investigation. PMID:16390502

  20. Childhood Adversity, Timing of Puberty and Adolescent Depressive Symptoms: A Longitudinal Study in Taiwan.

    PubMed

    Strong, Carol; Tsai, Meng-Che; Lin, Chung-Ying; Cheng, Chung-Ping

    2016-06-01

    Childhood adversity contributes to depressive symptoms in adolescence, but far less research has focused on an Asian context. This study aims to identify the long-term impact of childhood adversity on adolescents' depressive symptoms and whether this association is moderated by gender and early pubertal timing in Taiwan. Data in this study are from the Taiwan Education Panel Survey, a longitudinal study that surveyed and followed 4261 junior high school students in year 2001 (at age 13) and three more waves (at ages 15, 17, and 18). Conditional latent growth model results show that having adversity is positively associated with the intercept, but negatively associated with the linear trend of changes of depressive symptoms in adolescence (p < .01). Early pubertal timing is only positively associated with baseline levels for boys (p < .01). Both adversity and early pubertal timing contributes to depressive symptoms when adolescents start junior high school. PMID:26206735

  1. Altered Stress-Induced Regulation of Genes in Monocytes in Adults with a History of Childhood Adversity.

    PubMed

    Schwaiger, Marion; Grinberg, Marianna; Moser, Dirk; Zang, Johannes C S; Heinrichs, Markus; Hengstler, Jan G; Rahnenführer, Jörg; Cole, Steve; Kumsta, Robert

    2016-09-01

    Exposure to serious or traumatic events early in life can lead to persistent alterations in physiological stress response systems, including enhanced cross talk between the neuroendocrine and immune system. These programming effects may be mechanistically involved in mediating the effects of adverse childhood experience on disease risk in adulthood. We investigated hormonal and genome-wide mRNA expression responses in monocytes to acute stress exposure, in a sample of healthy adults (n=30) with a history of early childhood adversity, and a control group (n=30) without trauma experience. The early adversity group showed altered hypothalamus-pituitary-adrenal axis responses to stress, evidenced by lower ACTH and cortisol responses. Analyses of gene expression patterns showed that stress-responsive transcripts were enriched for genes involved in cytokine activity, cytokine-cytokine receptor interaction, chemokine activity, and G-protein coupled receptor binding. Differences between groups in stress-induced regulation of gene transcription were observed for genes involved in steroid binding, hormone activity, and G-protein coupled receptor binding. Transcription factor binding motif analysis showed an increased activity of pro-inflammatory upstream signaling in the early adversity group. We also identified transcripts that were differentially correlated with stress-induced cortisol increases between the groups, enriched for genes involved in cytokine-cytokine receptor interaction and glutamate receptor signaling. We suggest that childhood adversity leads to persistent alterations in transcriptional control of stress-responsive pathways, which-when chronically or repeatedly activated-might predispose individuals to stress-related psychopathology. PMID:27091381

  2. 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

  3. Childhood adversity increases vulnerability for behavioral symptoms and immune dysregulation in women with breast cancer

    PubMed Central

    Witek Janusek, Linda; Tell, Dina; Albuquerque, Kevin; Mathews, Herbert L.

    2012-01-01

    Women respond differentially to the stress-associated with breast cancer diagnosis and treatment, with some women experiencing more intense and/or sustained behavioral symptoms and immune dysregulation than others. Childhood adversity has been identified to produce long-term dysregulation of stress response systems, increasing reactivity to stressors encountered during adulthood. This study determined whether childhood adversity increased vulnerability for more intense and sustained behavioral symptoms (fatigue, perceived stress, and depressive symptoms), poorer quality of life, and greater immune dysregulation in women (N=40) with breast cancer. Evaluation was after breast surgery and through early survivorship. Hierarchical linear modeling was used to examine intra-individual and inter-individual differences with respect to initial status and to the pattern of change (i.e. trajectory) of outcomes. At initial assessment, women exposed to childhood emotional neglect/abuse had greater perceived stress, fatigue, depressive symptoms and poorer quality of life, as well as lower natural killer cell activity (NKCA). Although these outcomes improved over time, women with greater childhood emotional neglect/abuse exhibited worse outcomes through early survivorship. No effect was observed on the trajectory for these outcomes. In contrast, childhood physical neglect predicted sustained trajectories of greater perceived stress, worse quality of life, and elevated plasma IL-6; with no effect observed at initial assessment. Thus, childhood adversity leaves an enduring imprint, increasing vulnerability for behavioral symptoms, poor quality of life, and elevations in IL-6 in women with breast cancer. Further, childhood adversity predisposes to lower NKCA at a critical time when this immune-effector mechanism is most effective at halting nascent tumor seeding. PMID:22659062

  4. 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

  5. Adverse Childhood Experiences and Geriatric Depression: Results from the 2010 BRFSS

    PubMed Central

    Ege, Margaret A.; Messias, Erick; Thapa, Puru; Krain, Lewis P.

    2014-01-01

    Introduction Adverse childhood experiences (ACEs), including physical, sexual, and emotional abuse, have been shown to result in a variety of poor outcomes including depression. The majority of research has examined the impact of such events on adolescents and young adults leaving a dearth of information regarding how these events may affect depressive symptom point prevalence later in life. Methods Data from the CDC’s 2010 Behavioral Risk Factor Surveillance Survey (BRFSS) were used to estimate the point prevalence of depression in individuals sixty years of age and greater based on presence or absence of certain ACEs. Depressive symptoms were assessed using eight items from the Patient Health Questionnaire (PHQ). Subjects with a PHQ score of 10 or greater were categorized as depressed. Six different types of ACE were included in the study: parents being physically abusive to each other, being physically harmed by a parent, being sworn at by the parent, being touched sexually by an adult, being forced to sexually touch an adult, and being forced into a sexual encounter. ACEs were categorized as never, single if subject reported it occurring once, or repeated if subject reported multiple episodes. Results The study sample consisted of 8,051 adults aged 60 years and greater who responded to questions about adverse childhood experiences. The study sample was comprised of 53% females, 83% Caucasians, and had a mean age of 70.4 years. After controlling for age, gender, and race, depression was significantly correlated with repeated ACEs of all types (adjusted odds ratio [AOR] ranging from 2.41 to 9.78, all statistically significant). The only ACE where a single occurrence was significantly associated with late life depression was forced sexual intercourse (AOR 2.92, 95% C.I. 1.06-8.02). After controlling for all types of abuse in a single model, repeated physical abuse and repeated forced sexual intercourse remained significant (AOR 2.94, 95% C.I. 1.68-5.13, and AOR

  6. Evaluating imbalances of adverse events during biosimilar development.

    PubMed

    Vana, Alicia M; Freyman, Amy W; Reich, Steven D; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A; Zacharchuk, Charles M; Ewesuedo, Reginald

    2016-07-01

    Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

  7. Evaluating imbalances of adverse events during biosimilar development

    PubMed Central

    Vana, Alicia M.; Freyman, Amy W.; Reich, Steven D.; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A.; Zacharchuk, Charles M.; Ewesuedo, Reginald

    2016-01-01

    ABSTRACT Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

  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. 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

  10. Automatic adverse drug events detection using letters to the editor.

    PubMed

    Yang, Chao; Srinivasan, Padmini; Polgreen, Philip M

    2012-01-01

    We present and test the intuition that letters to the editor in journals carry early signals of adverse drug events (ADEs). Surprisingly these letters have not yet been exploited for automatic ADE detection unlike for example, clinical records and PubMed. Part of the challenge is that it is not easy to access the full-text of letters (for the most part these do not appear in PubMed). Also letters are likely underrated in comparison with full articles. Besides demonstrating that this intuition holds we contribute techniques for post market drug surveillance. Specifically, we test an automatic approach for ADE detection from letters using off-the-shelf machine learning tools. We also involve natural language processing for feature definitions. Overall we achieve high accuracy in our experiments and our method also works well on a second new test set. Our results encourage us to further pursue this line of research. PMID:23304379

  11. Genomic architecture of pharmacological efficacy and adverse events.

    PubMed

    Chhibber, Aparna; Kroetz, Deanna L; Tantisira, Kelan G; McGeachie, Michael; Cheng, Cheng; Plenge, Robert; Stahl, Eli; Sadee, Wolfgang; Ritchie, Marylyn D; Pendergrass, Sarah A

    2014-12-01

    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

  12. A review of adverse events caused by immune checkpoint inhibitors.

    PubMed

    Fukushima, Satoshi

    2016-01-01

      There has been no effective therapy in the unresectable melanoma for more than 40 years. Anti-PD-1 antibody and anti-CTLA-4 antibody have totally changed the situation. They have clearly shown the survival benefits of the patients with metastatic melanoma. However, immune checkpoint inhibitors sometimes induce various kinds of immune-related adverse events (irAEs). It is very important for the clinicians to know the reported cases of irAEs and to keep in mind the symptoms of irAEs for the early detection. This review describes the previously reported irAEs and adequate managements for irAEs induced by immune checkpoint inhibitors. PMID:27181232

  13. Automatic Adverse Drug Events Detection Using Letters to the Editor

    PubMed Central

    Yang, Chao; Srinivasan, Padmini; Polgreen, Philip M.

    2012-01-01

    We present and test the intuition that letters to the editor in journals carry early signals of adverse drug events (ADEs). Surprisingly these letters have not yet been exploited for automatic ADE detection unlike for example, clinical records and PubMed. Part of the challenge is that it is not easy to access the full-text of letters (for the most part these do not appear in PubMed). Also letters are likely underrated in comparison with full articles. Besides demonstrating that this intuition holds we contribute techniques for post market drug surveillance. Specifically, we test an automatic approach for ADE detection from letters using off-the-shelf machine learning tools. We also involve natural language processing for feature definitions. Overall we achieve high accuracy in our experiments and our method also works well on a second new test set. Our results encourage us to further pursue this line of research. PMID:23304379

  14. Mining for adverse drug events with formal concept analysis.

    PubMed

    Estacio-Moreno, Alexander; Toussaint, Yannick; Bousquet, Cédric

    2008-01-01

    The pharmacovigilance databases consist of several case reports involving drugs and adverse events (AEs). Some methods are applied consistently to highlight all signals, i.e. all statistically significant associations between a drug and an AE. These methods are appropriate for verification of more complex relationships involving one or several drug(s) and AE(s) (e.g; syndromes or interactions) but do not address the identification of them. We propose a method for the extraction of these relationships based on Formal Concept Analysis (FCA) associated with disproportionality measures. This method identifies all sets of drugs and AEs which are potential signals, syndromes or interactions. Compared to a previous experience of disproportionality analysis without FCA, the addition of FCA was more efficient for identifying false positives related to concomitant drugs. PMID:18487830

  15. Childhood Adversity and Epigenetic Modulation of the Leukocyte Glucocorticoid Receptor: Preliminary Findings in Healthy Adults

    PubMed Central

    Tyrka, Audrey R.; Price, Lawrence H.; Marsit, Carmen; Walters, Oakland C.; Carpenter, Linda L.

    2012-01-01

    Background A history of early adverse experiences is an important risk factor for adult psychopathology. Changes in stress sensitivity and functioning of the hypothalamic-pituitary-adrenal (HPA) axis may underlie the association between stress and risk for psychiatric disorders. Preclinical work in rodents has linked low levels of maternal care to increased methylation of the promoter region of the glucocorticoid receptor (GR) gene, as well as to exaggerated hormonal and behavioral responses to stress. Recent studies have begun to examine whether early-life stress leads to epigenetic modifications of the GR gene in humans. Methods We examined the degree of methylation of a region of the promoter of the human GR gene (NR3C1) in leukocyte DNA from 99 healthy adults. Participants reported on their childhood experiences of parental behavior, parental death or desertion, and childhood maltreatment. On a separate day, participants completed the dexamethasone/corticotropin-releasing hormone (Dex/CRH) test, a standardized neuroendocrine challenge test. Results Disruption or lack of adequate nurturing, as measured by parental loss, childhood maltreatment, and parental care, was associated with increased NR3C1 promoter methylation (p<.05). In addition, NR3C1 promoter methylation was linked to attenuated cortisol responses to the Dex/CRH test (p<.05). Conclusions These findings suggest that childhood maltreatment or adversity may lead to epigenetic modifications of the human GR gene. Alterations in methylation of this gene could underlie the associations between childhood adversity, alterations in stress reactivity, and risk for psychopathology. PMID:22295073

  16. Oral Sedation Postdischarge Adverse Events in Pediatric Dental Patients

    PubMed Central

    Huang, Annie; Tanbonliong, Thomas

    2015-01-01

    The study investigated patient discharge parameters and postdischarge adverse events after discharge among children who received oral conscious sedation for dental treatment. This prospective study involved 51 patients needing dental treatment under oral conscious sedation. Each patient received one of various regimens involving combinations of a narcotic (ie, morphine or meperidine), a sedative-hypnotic (ie, chloral hydrate), a benzodiazepine (ie, midazolam or diazepam), and/or an antihistamine (ie, hydroxyzine HCl). Nitrous oxide and local anesthesia were used in conjunction with all regimens. After written informed consent was obtained, each guardian was contacted by phone with specific questions in regard to adverse events following the dental appointment. Out of 51 sedation visits, 46 were utilized for analysis including 23 boys and 23 girls ranging from 2 years 2 months to 10 years old (mean 5.8 years). 60.1% of patients slept in the car on the way home, while 21.4% of that group was difficult to awaken upon reaching home. At home, 76.1% of patients slept; furthermore, 85.7% of patients who napped following the dental visit slept longer than usual. After the appointment, 19.6% exhibited nausea, 10.1% vomited, and 7.0% experienced a fever. A return to normal behavior was reported as follows: 17.4% in <2 hours, 39.1% in 2–6 hours, 28.3% in 6–10 hours, and 15.2% in >10 hours. Postdischarge excessive somnolence, nausea, and emesis were frequent complications. The time to normality ranged until the following morning demonstrating the importance of careful postdischarge adult supervision. PMID:26398124

  17. Oral Sedation Postdischarge Adverse Events in Pediatric Dental Patients.

    PubMed

    Huang, Annie; Tanbonliong, Thomas

    2015-01-01

    The study investigated patient discharge parameters and postdischarge adverse events after discharge among children who received oral conscious sedation for dental treatment. This prospective study involved 51 patients needing dental treatment under oral conscious sedation. Each patient received one of various regimens involving combinations of a narcotic (ie, morphine or meperidine), a sedative-hypnotic (ie, chloral hydrate), a benzodiazepine (ie, midazolam or diazepam), and/or an antihistamine (ie, hydroxyzine HCl). Nitrous oxide and local anesthesia were used in conjunction with all regimens. After written informed consent was obtained, each guardian was contacted by phone with specific questions in regard to adverse events following the dental appointment. Out of 51 sedation visits, 46 were utilized for analysis including 23 boys and 23 girls ranging from 2 years 2 months to 10 years old (mean 5.8 years). 60.1% of patients slept in the car on the way home, while 21.4% of that group was difficult to awaken upon reaching home. At home, 76.1% of patients slept; furthermore, 85.7% of patients who napped following the dental visit slept longer than usual. After the appointment, 19.6% exhibited nausea, 10.1% vomited, and 7.0% experienced a fever. A return to normal behavior was reported as follows: 17.4% in <2 hours, 39.1% in 2-6 hours, 28.3% in 6-10 hours, and 15.2% in >10 hours. Postdischarge excessive somnolence, nausea, and emesis were frequent complications. The time to normality ranged until the following morning demonstrating the importance of careful postdischarge adult supervision. PMID:26398124

  18. 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

  19. 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 =…

  20. Childhood Adversities and Delinquency in Early Adolescence: Analyses of Samples from the Former Germanies.

    ERIC Educational Resources Information Center

    Silbereisen, Rainer K.; And Others

    Risk factors for early adolescents' (700 between the ages of 10 to 13) delinquency were compared between groups of children high and low in childhood adversities. The samples represented young people from the two former Germanies (200 from former East and 500 from West Germany) who were interviewed in person. Additional information was gathered…

  1. Adverse Childhood Experiences (ACE) and Health-Risk Behaviors among Adults in a Developing Country Setting

    ERIC Educational Resources Information Center

    Ramiro, Laurie S.; Madrid, Bernadette J.; Brown, David W.

    2010-01-01

    Objective: This study aimed to examine the association among adverse childhood experiences, health-risk behaviors, and chronic disease conditions in adult life. Study population: One thousand and sixty-eight (1,068) males and females aged 35 years and older, and residing in selected urban communities in Metro Manila participated in the…

  2. Adverse Childhood Experiences and Suicide Attempts: The Mediating Influence of Personality Development and Problem Behaviors.

    PubMed

    Perez, Nicholas M; Jennings, Wesley G; Piquero, Alex R; Baglivio, Michael T

    2016-08-01

    Adverse childhood experiences, comprised of forms of maltreatment and certain dysfunctional household environments, can affect the development of a child in a variety of different ways. This multitude of developmental changes may subsequently produce compounding harmful effects on the child's life and increase acutely maladaptive outcomes, including adolescent suicidal behavior. This study uses data collected from 2007 to 2012 for 64,329 Florida Department of Juvenile Justice youth (21.67 % female, 42.88 % African American, and 15.37 % Hispanic) to examine the direct and indirect effects of adverse childhood experiences on suicide attempts. Using a generalized structural equation model, the effects of adverse childhood experience scores are estimated on suicidal behavior through pathways of certain aspects of a child's personality development (aggression and impulsivity), as well as adolescent problem behaviors (school difficulties and substance abuse). The results show that a large proportion of the relationship between childhood adversity and suicide is mediated by the aforementioned individual characteristics, specifically through the youth's maladaptive personality development. These results suggest that, if identified early enough, the developmental issues for these youth could potentially be addressed in order to thwart potential suicidal behavior. PMID:27289554

  3. The Impact of Adverse Childhood Experiences on an Urban Pediatric Population

    ERIC Educational Resources Information Center

    Burke, Nadine J.; Hellman, Julia L.; Scott, Brandon G.; Weems, Carl F.; Carrion, Victor G.

    2011-01-01

    Objective: The goal of this study was to investigate the adverse childhood experiences (ACEs) in youth in a low-income, urban community. Study design: Data from a retrospective chart review of 701 subjects from the Bayview Child Health Center in San Francisco are presented. Medical chart documentation of ACEs as defined in previous studies were…

  4. Validity of Adult Retrospective Reports of Adverse Childhood Experiences: Review of the Evidence

    ERIC Educational Resources Information Center

    Hardt, Jochen; Rutter, Michael

    2004-01-01

    Background: Influential studies have cast doubt on the validity of retrospective reports by adults of their own adverse experiences in childhood. Accordingly, many researchers view retrospective reports with scepticism. Method: A computer-based search, supplemented by hand searches, was used to identify studies reported between 1980 and 2001 in…

  5. Serious adverse event reporting in investigator-initiated clinical trials.

    PubMed

    Wallace, Sophie; Myles, Paul S; Zeps, Nikolajs; Zalcberg, John R

    2016-04-01

    Reporting adverse events (AEs) and serious AEs (SAEs) are practical steps to ensure safety for volunteers and patients in medical research involving medications, treatments and devices. However, the burden and cost of reporting should be proportionate with the public health benefit of this information. Unfortunately, in Australia there is clear evidence of ever-increasing requirements from sponsors and ethics committees to report AEs and SAEs unnecessarily, leading to a decrease in the uptake of research, particularly less well funded investigator-initiated trials. We believe that individual AE reports to ethics committees serve no useful purpose, because in most cases the study group identity (drug exposure) is not known in studies with blinded treatment arms and their value is limited. Pragmatic, investigator-initiated Phase IV clinical trials of post-marketed drugs or devices are needed to understand their role in everyday clinical practice. In this setting, the workload and costs of systematic, complete reporting of all AEs and SAEs (independent of whether these are treatment-related) is wasteful, and mostly unnecessary. A trial data safety and monitoring committee is in the unique position of being able to review safety information according to the blinded treatment arms of the study. This enables safety data to be analysed appropriately and a summary report provided to the trial steering committee, principal investigators and the relevant ethics committees in a meaningful way. Defined trial endpoints do not need to be reported as safety events (because they are being properly monitored and analysed). PMID:27031396

  6. Cognitive adaptations to stressful environments: When childhood adversity enhances adult executive function.

    PubMed

    Mittal, Chiraag; Griskevicius, Vladas; Simpson, Jeffry A; Sung, Sooyeon; Young, Ethan S

    2015-10-01

    Can growing up in a stressful childhood environment enhance certain cognitive functions? Drawing participants from higher-income and lower-income backgrounds, we tested how adults who grew up in harsh or unpredictable environments fared on 2 types of executive function tasks: inhibition and shifting. People who experienced unpredictable childhoods performed worse at inhibition (overriding dominant responses), but performed better at shifting (efficiently switching between different tasks). This finding is consistent with the notion that shifting, but not inhibition, is especially useful in unpredictable environments. Importantly, differences in executive function between people who experienced unpredictable versus predictable childhoods emerged only when they were tested in uncertain contexts. This catalyst suggests that some individual differences related to early life experience are manifested under conditions of uncertainty in adulthood. Viewed as a whole, these findings indicate that adverse childhood environments do not universally impair mental functioning, but can actually enhance specific types of cognitive performance in the face of uncertainty. PMID:26414842

  7. Using a sibling design to compare childhood adversities in female patients with BPD and their sisters.

    PubMed

    Laporte, Lise; Paris, Joel; Guttman, Herta; Russell, Jennifer; Correa, José A

    2012-11-01

    Abuse and neglect are well-established risk correlates of borderline personality disorder (BPD). The goal of this study was to examine whether BPD probands can be differentiated from their sisters with respect to a range of developmental adversity and maltreatment indicators, including retrospective self-reports of past experiences of childhood abuse and neglect, dysfunctional parent-child relationships and peer victimization and dysfunctional peer relationships. A total of 53 patients with BPD were compared to 53 sisters who were currently free of psychopathology on measures assessing childhood adversities. Both probands and sisters reported similar prevalence of intrafamilial abuse, although BPD patients reported more severe physical and emotional abuse. BPD patients reported higher prevalence of physical abuse by peers. These findings generally support the principle of multifinality, in which similar histories of adversities can be associated with a variety of outcomes, ranging from psychopathology to resilience. PMID:23076835

  8. Gender Differences in the Physical and Psychological Manifestation of Childhood Trauma and/or Adversity in People with Psychosis

    PubMed Central

    Sweeney, Shaun; Air, Tracy; Zannettino, Lana; Shah, Sonal S.; Galletly, Cherrie

    2015-01-01

    The link between childhood trauma and/or adversity and risk of psychosis is well known. Our aim was to determine the prevalence of childhood trauma and/or adversity in people who have psychotic disorders and to investigate the association between childhood trauma and/or adversity and a range of social and health measures. Participants (n = 391, 42% male) were specifically asked about any experience of childhood trauma and/or adversity. Respondents provided information about education, employment, physical health, and health service utilization. Univariate analyses revealed that childhood trauma and/or adversity was associated with poorer levels of self-reported physical health and social problems. This includes the experience of chronic pain, headaches, arthritis, asthma, and victimization/stigma in men. Participants with a childhood trauma and/or adversity history indicated higher rates of lifetime suicide attempts with women reporting more lifetime depressive symptoms. Multivariate analyses revealed differing profiles in relation to physical and psychological health variable between males and females. Males with the experience of childhood trauma and/or adversity were significantly more likely to report cardiovascular/stroke issues, migraines and anhedonia. Females with the experience of childhood trauma and/or adversity were more likely to report a lifetime history of elevated mood and to be married or in a de facto relationship. There has been very little research into the assessment and treatment of the effects of childhood trauma and/or adversity in adults with psychosis. Childhood trauma and/or adversity may contribute to higher rates of self-reported poor health in men and is associated with increased depression in women. Our findings suggest that interventions to address the effects of past trauma are urgently needed. PMID:26635676

  9. Tamoxifen in men: a review of adverse events.

    PubMed

    Wibowo, E; Pollock, P A; Hollis, N; Wassersug, R J

    2016-09-01

    Tamoxifen is an off-label option to treat men for breast cancer, infertility, and idiopathic gynecomastia. Lately, tamoxifen has been proposed as a treatment to prevent gynecomastia in prostate cancer patients receiving antiandrogen therapy. We reviewed the adverse events (AEs) reported in studies of men prescribed tamoxifen for these conditions to better understand its side-effect profile. We searched PubMed for randomized controlled trials (RCTs) that included safety data of tamoxifen treatment in men with prostate cancer, breast cancer, infertility, and idiopathic gynecomastia. Non-RCTs were also reviewed. The results demonstrate that the AE profile in tamoxifen-treated male populations varied. Excluding breast events, gastrointestinal, and cardiovascular problems were the most commonly reported AEs in prostate cancer patients, whereas more psychiatric disorders were reported in male breast cancer patients. Few AEs have been documented in men receiving tamoxifen for infertility and idiopathic gynecomastia. Less than 5% of men withdrew from tamoxifen therapy because of toxicity. This suggests that for most men, tamoxifen is well-tolerated. Of those who discontinued tamoxifen, the majority were male breast cancer patients, and cardiovascular events were the most common reason for stopping tamoxifen treatment. Unfortunately, in many cases, the reasons for withdrawing tamoxifen were unspecified. Based on the available evidence, tamoxifen's AE profile appears to vary depending upon which male population is treated. Also, the frequency at which AEs occur varies - less AEs in men with infertility and idiopathic gynecomastia compared to men with prostate cancer or breast cancer. Long-term studies that rigorously document the side-effect profile of tamoxifen in men are lacking. PMID:27152880

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

    PubMed

    Lu, Meng-jie; Liu, Yu-xiu

    2015-11-01

    Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed. PMID:26911031

  11. Adverse events reporting--the tip of an iceberg.

    PubMed

    Shamoo, A E

    2001-01-01

    NIH data indicate that annually seven million human subjects are enrolled in research sponsored by NIH alone. In addition, there are sixteen federal agencies and numerous departments outside NIH conducting experiments with human subjects. Moreover, the pharmaceutical industry spends $26 billion on research (compared to $16 billion for NIH), thus, the total number of human subjects enrolled in research for both the public and private sectors can be estimated as high as nineteen million. I present data on the potential magnitude of adverse events in the United States among human subjects enrolled in research that appear to be unreported and unaccounted for. We obtained data from the Office for Human Research Protections (OHRP) through the Freedom of Information Act for the years 1990 to August 2000 regarding all Institutional Incident Reports (IRPTs) and a list of Compliance Oversight Branch Investigations (COBIs) involving Multiple Project Assurances (MPAs). In the ten years of reporting for nearly seventy million human subjects, there were only 878 IRPTs and 41 investigations. From the incident reports to OHRP, 44% involved adverse events. Those projects investigated for Multiple Project Assurances violations (41 such investigations) showed that 51% were suspended or terminated. The number of deaths reported to OHRP in ten years for the seventy million human subjects is merely eight. The anticipated number of deaths among the general population in seventy million (assuming subject's duration in trials is one month) is 51,000. The number of suicides and attempted suicides alone among the seventy million expected research subjects can be anticipated to be about 5,000. Therefore, the number of expected deaths should have been between 5,000 and 51,000. These numbers and percentages represent minimal numbers since they are not a result of random audits or investigations, but a result of self-reporting or an exogenous complaint. Despite the fact that these are

  12. Maternal childhood adversity and child temperament: an association moderated by child 5-HTTLPR genotype.

    PubMed

    Bouvette-Turcot, Andrée-Anne; Fleming, A S; Wazana, A; Sokolowski, M B; Gaudreau, H; Gonzalez, A; Deslauriers, J; Kennedy, J L; Steiner, M; Meaney, M J

    2015-03-01

    We examined transgenerational effects of maternal childhood adversity on child temperament and a functional promoter polymorphism, 5-HTTLPR, in the serotonin-transporter gene (SLC6A4) as potential moderators of such maternal influences in 154 mother-child dyads, recruited into a longitudinal birth cohort study. We examined the interactive effects of maternal childhood experience using an integrated measure derived from Childhood Trauma Questionnaire (CTQ) and Parental Bonding Index (PBI). Triallelic genotyping of 5-HTTLPR was performed. A measure of 'negative emotionality/behavioural dysregulation' was derived from the Early Childhood Behaviour Questionnaire at 18 and 36 months. Negative emotionality/behavioural dysregulation was highly stable between 18 and 36 months and predicted psychosocial problems at 60 months. After controlling multiple demographics as well as both previous and concurrent maternal depression there was a significant interaction effect of maternal childhood adversity and offspring 5-HTTLPR genotype on child negative emotionality/behavioural dysregulation (β = 1.03, t(11,115) = 2.71, P < .01). The results suggest a transgenerational effect of maternal developmental history on emotional function in the offspring, describing a pathway that likely contributes to the familial transmission of vulnerability for psychopathology. PMID:25688466

  13. Childhood adversity and youth depression: influence of gender and pubertal status.

    PubMed

    Rudolph, Karen D; Flynn, Megan

    2007-01-01

    This research examined three possible models to explain how childhood social adversity and recent stress interact to predict depression in youth: stress sensitization, stress amplification, and stress inoculation. Drawing from a stress-sensitization theory of depression, we hypothesized that exposure to childhood adversity, in the form of disruptions in critical interpersonal relationships, would lower youths' threshold for depressive reactions to recent interpersonal stress. We expected that this pattern of stress sensitization would be most salient for girls negotiating the pubertal transition. These hypotheses were examined in two studies: a longitudinal, questionnaire-based investigation of 399 youth (M = 11.66 years) and a concurrent, interview-based investigation of 147 youth (M = 12.39 years). Findings supported the role of stress-sensitization processes in pubertal girls and prepubertal boys, and stress-amplification processes in prepubertal girls. Childhood social adversity specifically predicted sensitization to recent interpersonal, but not noninterpersonal, stress. These findings build on prior theory and research by suggesting that early adversity exerts context-specific effects that vary across gender and development. Future research will need to identify the specific mechanisms underlying this stress-sensitization process. PMID:17459181

  14. 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

  15. Childhood adversity and neural development: deprivation and threat as distinct dimensions of early experience.

    PubMed

    McLaughlin, Katie A; Sheridan, Margaret A; Lambert, Hilary K

    2014-11-01

    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

  16. Individual Differences among Undergraduate Women in Methods of Coping with Stressful Events: The Impact of Cumulative Childhood Stressors and Abuse

    ERIC Educational Resources Information Center

    Leitenberg, Harold; Gibson, Laura E.; Novy, Pamela L.

    2004-01-01

    Objective: The purpose of the current study was to determine if a history of greater exposure to different types of adverse and/or abusive experiences in childhood would influence coping strategies used by undergraduate women to deal with new stressful events in young adulthood. Method: A sample of 828 women undergraduates from a New England state…

  17. Preventable Adverse Events in Surgical Care in Sweden

    PubMed Central

    Nilsson, Lena; Risberg, Madeleine Borgstedt; Montgomery, Agneta; Sjödahl, Rune; Schildmeijer, Kristina; Rutberg, Hans

    2016-01-01

    Abstract Adverse events (AEs) occur in health care and may result in harm to patients especially in the field of surgery. Our objective was to analyze AEs in surgical patient care from a nationwide perspective and to analyze the frequency of AEs that may be preventable. In total 19,141 randomly selected admissions in 63 Swedish hospitals were reviewed each month during 2013 using a 2-stage record review method based on the identification of predefined triggers. The subgroup of 3301 surgical admissions was analyzed. All AEs were categorized according to site, type, level of severity, and degree of preventability. We reviewed 3301 patients’ records and 507 (15.4%) were associated with AEs. A total of 62.5% of the AEs were considered probably preventable, over half contributed to prolonged hospital care or readmission, and 4.7% to permanent harm or death. Healthcare acquired infections composed of more than one third of AEs. The majority of the most serious AEs composed of healthcare acquired infections and surgical or other invasive AEs. The incidence of AEs was 13% in patients 18 to 64 years old and 17% in ≥65 years. Pressure sores and drug-related AEs were more common in patients being ≥65 years. Urinary retention and pressure sores showed the highest degree of preventability. Patients with probably preventable AEs had in median 7.1 days longer hospital stay. We conclude that AEs are common in surgical care and the majority are probably preventable. PMID:26986126

  18. Life-threatening Dermatologic Adverse Events in Oncology

    PubMed Central

    Rosen, Alyx C.; Balagula, Yevgeniy; Raisch, Dennis.W.; Garg, Vishvas; Nardone, Beatrice; Larsen, Nicole; Sorrell, Jennifer; West, Dennis P.; Anadkat, Milan J.; Lacouture, Mario E.

    2013-01-01

    Background: The incidence of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. Methods: We searched the literature (Ovid:1950-June 2013 and PubMed:1948-June 2013) using terms for SJS/TEN and anticancer therapy. Primary case reports, case series, and clinical trials were included. Additionally, MedWatch, Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968-August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3) and empirical Bayes geometric mean (EBGM>2, N>3, lower 95% confidence interval (EBGM0.05 >2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. Results: There were 45 SJS and 37 TEN cases associated with 17 and 22 anticancer drugs in the literature, respectively. Among cases in FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine . Conclusion: Several drugs reported in published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to assist oncology practitioners in the recognition of possible, yet uncommon, serious and/or life-threatening skin reactions. PMID:24108082

  19. Life-threatening dermatologic adverse events in oncology.

    PubMed

    Rosen, Alyx C; Balagula, Yevgeniy; Raisch, Dennis W; Garg, Vishvas; Nardone, Beatrice; Larsen, Nicole; Sorrell, Jennifer; West, Dennis P; Anadkat, Milan J; Lacouture, Mario E

    2014-02-01

    The incidences of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. We searched the literature (Ovid: 1950 to June 2013 and PubMed: 1948 to June 2013) using terms for SJS/TEN and anticancer therapies. Primary case reports, case series, and clinical trials were included. In addition, MedWatch, the Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968 to August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3), empirical Bayes geometric mean (EBGM>2, N>3), and lower 95% confidence interval (EBGM0.05>2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. There were 46 SJS and 37 TEN cases associated with 18 and 22 anticancer drugs in the literature, respectively. Among cases in the FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine. Several drugs reported in the published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to aid oncology practitioners in the recognition of possible, yet uncommon, serious, and/or life-threatening skin reactions. PMID:24108082

  20. Elucidating Reasons for Resident Underutilization of Electronic Adverse Event Reporting.

    PubMed

    Hatoun, Jonathan; Suen, Winnie; Liu, Constance; Shea, Sandy; Patts, Gregory; Weinberg, Janice; Eng, Jessica

    2016-07-01

    Reasons for resident underutilization of adverse event (AE) reporting systems are unclear, particularly given frequent resident exposure to AEs and near misses (NMs). Residents at an academic medical center were surveyed about AEs/NMs, barriers to reporting, patient safety climate, and educational interventions. A total of 350 of 527 eligible residents (66%) completed the survey; 77% of respondents reported involvement in an AE/NM, though only 43% had used the reporting system. Top barriers to reporting were not knowing what or how to report. Surgeons reported more than other residents (surgery, 61%; medical, 38%; hospital-based, 15%; P < .01), yet more often felt that systems were unlikely to change after reporting (surgery, 49%; medical, 28%; hospital-based. 18%; P < .01). Residents preferred discussions with supervisors (52%) and department-led conferences (46%) to increased reporting. Efforts to increase resident reporting should address common barriers to reporting as well as department-specific differences in resident knowledge, perceptions of system effectiveness, and educational preferences. PMID:25753451

  1. Algorithm to assess causality after individual adverse events following immunizations.

    PubMed

    Halsey, Neal A; Edwards, Kathryn M; Dekker, Cornelia L; Klein, Nicola P; Baxter, Roger; Larussa, Philip; Marchant, Colin; Slade, Barbara; Vellozzi, Claudia

    2012-08-24

    Assessing individual reports of adverse events following immunizations (AEFI) can be challenging. Most published reviews are based on expert opinions, but the methods and logic used to arrive at these opinions are neither well described nor understood by many health care providers and scientists. We developed a standardized algorithm to assist in collecting and interpreting data, and to help assess causality after individual AEFI. Key questions that should be asked during the assessment of AEFI include: Is the diagnosis of the AEFI correct? Does clinical or laboratory evidence exist that supports possible causes for the AEFI other than the vaccine in the affected individual? Is there a known causal association between the AEFI and the vaccine? Is there strong evidence against a causal association? Is there a specific laboratory test implicating the vaccine in the pathogenesis? An algorithm can assist with addressing these questions in a standardized, transparent manner which can be tracked and reassessed if additional information becomes available. Examples in this document illustrate the process of using the algorithm to determine causality. As new epidemiologic and clinical data become available, the algorithm and guidelines will need to be modified. Feedback from users of the algorithm will be invaluable in this process. We hope that this algorithm approach can assist with educational efforts to improve the collection of key information on AEFI and provide a platform for teaching about causality assessment. PMID:22507656

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

    PubMed Central

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

    2013-01-01

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

  3. 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. PMID:16581327

  4. Adverse Events from a Randomized, Multi-Arm, Placebo-Controlled Trial of Mebendazole in Children 12-24 Months of Age.

    PubMed

    Joseph, Serene A; Montresor, Antonio; Casapía, Martín; Pezo, Lidsky; Gyorkos, Theresa W

    2016-07-01

    Large-scale deworming interventions, using anthelminthic drugs, are recommended in areas where the prevalence of soil-transmitted helminth infection is high. Anthelminthic safety has been established primarily in school-age children. Our objective was to provide evidence on adverse events from anthelminthic use in early childhood. A randomized multi-arm, placebo-controlled trial of mebendazole, administered at different times and frequencies, was conducted in children 12 months of age living in Iquitos, Peru. Children were followed up to 24 months of age. The association between mebendazole administration and the occurrence of a serious or minor adverse event was determined using logistic regression. There was a total of 1,686 administrations of mebendazole and 1,676 administrations of placebo to 1,760 children. Eighteen serious adverse events (i.e., 11 deaths and seven hospitalizations) and 31 minor adverse events were reported. There was no association between mebendazole and the occurrence of a serious adverse event (odds ratio [OR] = 1.21; 95% confidence interval [CI] = 0.47, 3.09) or a minor adverse event (OR = 0.84; 95% CI = 0.41, 1.72). Results from our trial support evidence of safety in administering mebendazole during early childhood. These results support World Health Organization deworming policy and the scaling up of interventions to reach children as of 12 months of age in endemic areas. PMID:27139441

  5. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting Systems

    PubMed Central

    Perrone, Valentina; Pozzi, Marco; Antoniazzi, Stefania; Clementi, Emilio; Radice, Sonia

    2013-01-01

    Objective To evaluate epidemiological features of post vaccine acute disseminated encephalomyelitis (ADEM) by considering data from different pharmacovigilance surveillance systems. Methods The Vaccine Adverse Event Reporting System (VAERS) database and the EudraVigilance post-authorisation module (EVPM) were searched to identify post vaccine ADEM cases. Epidemiological features including sex and related vaccines were analysed. Results We retrieved 205 and 236 ADEM cases from the EVPM and VAERS databases, respectively, of which 404 were considered for epidemiological analysis following verification and causality assessment. Half of the patients had less than 18 years and with a slight male predominance. The time interval from vaccination to ADEM onset was 2-30 days in 61% of the cases. Vaccine against seasonal flu and human papilloma virus vaccine were those most frequently associated with ADEM, accounting for almost 30% of the total cases. Mean number of reports per year between 2005 and 2012 in VAERS database was 40±21.7, decreasing after 2010 mainly because of a reduction of reports associated with human papilloma virus and Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B vaccines. Conclusions This study has a high epidemiological power as it is based on information on adverse events having occurred in over one billion people. It suffers from lack of rigorous case verification due to the weakness intrinsic to the surveillance databases used. At variance with previous reports on a prevalence of ADEM in childhood we demonstrate that it may occur at any age when post vaccination. This study also shows that the diminishing trend in post vaccine ADEM reporting related to Diphtheria, Pertussis, Tetanus, Polio and Haemophilus Influentiae type B and human papilloma virus vaccine groups is most likely due to a decline in vaccine coverage indicative of a reduced attention to this adverse drug reaction. PMID:24147076

  6. Adverse Childhood Experiences in the Lives of Male Sex Offenders: Implications for Trauma-Informed Care.

    PubMed

    Levenson, Jill S; Willis, Gwenda M; Prescott, David S

    2016-06-01

    This study explored the prevalence of childhood trauma in a sample of male sexual offenders (N = 679) using the Adverse Childhood Experience (ACE) scale. Compared with males in the general population, sex offenders had more than 3 times the odds of child sexual abuse (CSA), nearly twice the odds of physical abuse, 13 times the odds of verbal abuse, and more than 4 times the odds of emotional neglect and coming from a broken home. Less than 16% endorsed zero ACEs and nearly half endorsed four or more. Multiple maltreatments often co-occurred with other types of household dysfunction, suggesting that many sex offenders were raised within a disordered social environment. Higher ACE scores were associated with higher risk scores. By enhancing our understanding of the frequency and correlates of early adverse experiences, we can better devise trauma-informed interventions that respond to the clinical needs of sex offender clients. PMID:24872347

  7. Adolescent parents and their children: a multifaceted approach to prevention of adverse childhood experiences (ACE).

    PubMed

    Mayer, Lynn Milgram; Thursby, Ellen

    2012-01-01

    Childhood experiences can have long-term effects. Research shows that children who undergo adverse childhood experiences (ACE) often have negative health and mental health outcomes later in life. Children of adolescent parents with high ACE Scores are at greater risk of ACE. As such, an intergenerational approach to preventing ACE is proposed in this article, addressing the needs of both the adolescent parent and their children. A review of the literature indicates that a public health perspective can guide the development of a prevention model aimed at reducing the effects of ACE. The current article proposes a universal, multifaceted, and interdisciplinary prevention science model that has two targets: adolescent parents and their children. Schools and early childhood programs can be mobilized to offer community prevention strategies across realms to include the individual, community, provider, coalitions/networks, organizational practices, and policy/legislation. PMID:22970783

  8. Adverse Environmental Exposures During Gestation and Childhood: Predictors of Adolescent Drinking.

    PubMed

    Cornelius, Marie D; De Genna, Natacha; Goldschmidt, Lidush; Larkby, Cynthia; Day, Nancy

    2016-08-23

    Adverse conditions, including exposures to drugs and other environmental influences during early development, may affect behaviors later in life. This study examined the role of environmental influences from the gestation and childhood on adolescent drinking behavior. 917 mother/offspring dyads were followed prospectively from pregnancy to a 16-year follow-up assessment. Interim assessments occurred at delivery, 6, 10, and 14 years. Prenatal exposures to alcohol, tobacco, and marijuana were measured during gestation. Data were collected at each phase on childhood environment, including parenting practices, quality of the home environment, maternal depression and hostility, and lifetime exposure to child maltreatment and community violence. Alcohol outcomes were offspring age of drinking initiation and level of drinking at age 16 years. Cox Proportional Hazards ratios were used to model offspring age of drinking initiation. Logistic regression analyses were used to evaluate significant predictors of drinking level. Childhood environment, including less parental strictness, greater exposure to violence and childhood maltreatment, significantly predicted earlier age of alcohol initiation. Level of drinking among the adolescent offspring was significantly 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 initiate alcohol use early and drink at higher levels. Early and heavier alcohol use was associated with early exposures to adversity such as prenatal alcohol exposure, and child exposures to maltreatment and violence. These results highlight the importance of environmental adversity and less effective parenting practices on the development of adolescent drinking behavior. PMID:27220026

  9. Emergency Department Visits by Adults for Psychiatric Medication Adverse Events

    PubMed Central

    Hampton, Lee M.; Daubresse, Matthew; Chang, Hsien-Yen; Alexander, G. Caleb; Budnitz, Daniel S.

    2015-01-01

    IMPORTANCE In 2011, an estimated 26.8 million US adults used prescription medications for mental illness. OBJECTIVE To estimate the numbers and rates of adverse drug event (ADE) emergency department (ED) visits involving psychiatric medications among US adults between January 1, 2009, and December 31, 2011. DESIGN AND SETTING Descriptive analyses of active, nationally representative surveillance of ADE ED visits using the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance system and of drug prescribing during outpatient visits using the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. PARTICIPANTS Medical records from national probability samples of ED and outpatient visits by adults 19 years or older were reviewed and analyzed. EXPOSURES Antidepressants, antipsychotics, lithium salts, sedatives and anxiolytics, and stimulants. MAIN OUTCOMES AND MEASURES National estimates of ADE ED visits resulting from therapeutic psychiatric medication use and of psychiatric medication ADE ED visits per 10 000 outpatient visits at which psychiatric medications were prescribed. RESULTS From 2009 through 2011, there were an estimated 89 094 (95% CI, 68 641–109 548) psychiatric medication ADE ED visits annually, with 19.3% (95% CI, 16.3%–22.2%) resulting in hospitalization and 49.4% (95% CI, 46.5%–52.4%) involving patients aged 19 to 44 years. Sedatives and anxiolytics, antidepressants, antipsychotics, lithium salts, and stimulants were implicated in an estimated 30 707 (95% CI, 23 406–38 008), 25 377 (95% CI, 19 051–31 704), 21 578 (95% CI, 16 599–26 557), 3620 (95% CI, 2311–4928), and 2779 (95% CI, 1764–3794) respective ADE ED visits annually. Antipsychotics and lithium salts were implicated in 11.7 (95% CI, 10.1–13.2) and 16.4 (95% CI, 13.0–19.9) ADE ED visits per 10 000 outpatient prescription visits, respectively, compared with 3.6 (95% CI, 3.2–4.1) for sedatives

  10. Mix of methods is needed to identify adverse events in general practice: A prospective observational study

    PubMed Central

    Wetzels, Raymond; Wolters, René; van Weel, Chris; Wensing, Michel

    2008-01-01

    Background The validity and usefulness of incident reporting and other methods for identifying adverse events remains unclear. This study aimed to compare five methods in general practice. Methods In a prospective observational study, with five general practitioners, five methods were applied and compared. The five methods were physician reported adverse events, pharmacist reported adverse events, patients' experiences of adverse events, assessment of a random sample of medical records, and assessment of all deceased patients. Results A total of 68 events were identified using these methods. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number. No overlap between the methods was detected. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number. Conclusion A mix of methods is needed to identify adverse events in general practice. PMID:18554418

  11. Psychiatrists' Attitudes toward Metabolic Adverse Events in Patients with Schizophrenia

    PubMed Central

    Sugawara, Norio; Yasui-Furukori, Norio; Yamazaki, Manabu; Shimoda, Kazutaka; Mori, Takao; Sugai, Takuro; Suzuki, Yutaro; Someya, Toshiyuki

    2014-01-01

    Background There is growing concern about the metabolic abnormalities in patients with schizophrenia. Aims The aim of this study was to assess the attitudes of psychiatrists toward metabolic adverse events in patients with schizophrenia. Method A brief questionnaire was constructed to cover the following broad areas: the psychiatrists' recognition of the metabolic risk of antipsychotic therapy, pattern of monitoring patients for physical risks, practice pattern for physical risks, and knowledge of metabolic disturbance. In March 2012, the questionnaire was mailed to 8,482 psychiatrists who were working at hospitals belonging to the Japan Psychiatric Hospitals Association. Results The overall response rate was 2,583/8,482 (30.5%). Of the respondents, 85.2% (2,200/2,581) reported that they were concerned about prescribing antipsychotics that have a risk of elevating blood sugar; 47.6% (1,201/2,524) stated that their frequency of monitoring patients under antipsychotic treatment was based on their own experiences; and only 20.6% (5,22/2,534) of respondents answered that the frequency with which they monitored their patients was sufficient to reduce the metabolic risks. Conclusions Psychiatrists practicing in Japan were generally aware and concerned about the metabolic risks for patients being treated with antipsychotics. Although psychiatrists should monitor their patients for metabolic abnormalities to balance these risks, a limited number of psychiatrists answered that the frequency with which they monitored patients to reduce the metabolic risks was sufficient. Promotion of the best practices of pharmacotherapy and monitoring is needed for psychiatrists treating patients with schizophrenia. PMID:24466260

  12. Automated identification of adverse events related to central venous catheters.

    PubMed

    Penz, Janet F E; Wilcox, Adam B; Hurdle, John F

    2007-04-01

    Methods for surveillance of adverse events (AEs) in clinical settings are limited by cost, technology, and appropriate data availability. In this study, two methods for semi-automated review of text records within the Veterans Administration database are utilized to identify AEs related to the placement of central venous catheters (CVCs): a Natural Language Processing program and a phrase-matching algorithm. A sample of manually reviewed records were then compared to the results of both methods to assess sensitivity and specificity. The phrase-matching algorithm was found to be a sensitive but relatively non-specific method, whereas a natural language processing system was significantly more specific but less sensitive. Positive predictive values for each method estimated the CVC-associated AE rate at this institution to be 6.4 and 6.2%, respectively. Using both methods together results in acceptable sensitivity and specificity (72.0 and 80.1%, respectively). All methods including manual chart review are limited by incomplete or inaccurate clinician documentation. A secondary finding was related to the completeness of administrative data (ICD-9 and CPT codes) used to identify intensive care unit patients in whom a CVC was placed. Administrative data identified less than 11% of patients who had a CVC placed. This suggests that other methods, including automated methods such as phrase matching, may be more sensitive than administrative data in identifying patients with devices. Considerable potential exists for the use of such methods for the identification of patients at risk, AE surveillance, and prevention of AEs through decision support technologies. PMID:16901760

  13. Adverse Cardiovascular Events after a Venomous Snakebite in Korea

    PubMed Central

    Kim, Oh Hyun; Lee, Joon Woo; Kim, Hyung Il; Cha, KyoungChul; Kim, Hyun; Lee, Kang Hyun; Hwang, Sung Oh

    2016-01-01

    Purpose Although cardiac involvement is an infrequently recognized manifestation of venomous snakebites, little is known of the adverse cardiovascular events (ACVEs) arising as a result of snakebite in Korea. Accordingly, we studied the prevalence of ACVEs associated with venomous snakebites in Korea and compared the clinical features of patients with and without ACVEs. Materials and Methods A retrospective review was conducted on 65 consecutive venomous snakebite cases diagnosed and treated at the emergency department of Wonju Severance Christian Hospital between May 2011 and October 2014. ACVEs were defined as the occurrence of at least one of the following: 1) myocardial injury, 2) shock, 3) ventricular dysrhythmia, or 4) cardiac arrest. Results Nine (13.8%) of the 65 patients had ACVEs; myocardial injury (9 patients, 13.8%) included high sensitivity troponin I (hs-TnI) elevation (7 patients, 10.8%) or electrocardiogram (ECG) determined ischemic change (2 patients, 3.1%), and shock (2 patient, 3.1%). Neither ventricular dysrhythmia nor cardiac arrest was observed. The median of elevated hs-TnI levels observed in the present study were 0.063 ng/mL (maximum: 3.000 ng/mL) and there was no mortality in the ACVEs group. Underlying cardiac diseases were more common in the ACVEs group than in the non-ACVEs group (p=0.017). Regarding complications during hospitalization, 3 patients (5.4%) in the non-ACVEs group and 3 patients (33.3%) in the ACVEs group developed bleeding (p=0.031). Conclusion Significant proportion of the patients with venomous snakebite is associated with occurrence of ACVEs. Patients with ACVEs had more underlying cardiac disease and bleeding complication. PMID:26847308

  14. Monitoring adverse events in Norwegian hospitals from 2010 to 2013

    PubMed Central

    Deilkås, Ellen Tveter; Bukholm, Geir; Lindstrøm, Jonas Christoffer; Haugen, Marion

    2015-01-01

    Objectives To describe how adverse event (AE) rates were monitored and estimated nationally across all Norwegian hospitals from 2010 to 2013, and how they developed during the monitoring period. Monitoring was based on medical record review with Global Trigger Tool (GTT). Setting All publicly and privately owned hospitals were mandated to review randomly selected medical records to monitor AE rates. The initiative was part of the Norwegian patient safety campaign, launched by the Norwegian Ministry of Health and Care Services. It started in January 2011 and lasted until December 2013. 2010 was the baseline for the review. One of the main aims of the campaign was to reduce patient harm. Method To standardise the medical record reviews in all hospitals, GTT was chosen as a standard method. GTT teams from all hospitals reviewed 40 851 medical records randomly selected from 2 249 957 discharges from 2010 to 2013. Data were plotted in time series for local measurement and national AE rates were estimated, plotted and monitored. Results AE rates were estimated and published nationally from 2010 to 2013. Estimated AE rates in severity categories E-I decreased significantly from 16.1% in 2011 to 13.0% in 2013 (−3.1% (95% CI −5.2% to −1.1%)). Conclusions Monitoring estimated AE rates emerges as a potential element in national systems for patient safety. Estimated AE rates in the category of least severity decreased significantly during the first 2 years of the monitoring. PMID:26719311

  15. [The role of genotype in the intergenerational transmission of experiences of childhood adversity].

    PubMed

    Reichl, Corinna; Kaess, Michael; Resch, Franz; Brunner, Romuald

    2014-09-01

    The prevalence of childhood abuse and maltreatment is estimated to lie at about 15% in the overall German population. Previous research suggested that about one third of all individuals who had experienced childhood adversity subsequently maltreated their own children or responded insensitively to their children's needs. Empirical studies imply that interindividual differences in the responsiveness to childhood adversity can partially be explained by gene-environment interactions. This article discusses the potential interplay of genes and environment in the context of transmitting maltreating behavior and (in)sensitive parenting against the background of current challenges in genetic research. Selected studies on gene × environment interactions are presented and relevant gene polymorphisms are identified. Overall, previous studies reported interactions between polymorphisms of the serotonergic, dopaminergic, oxytocin-related, and arginine vasopressin-related systems and childhood experiences of care and abuse in the prediction of social behaviors during mother-child interactions. The results indicate a differential susceptibility toward both negative and positive environments which is dependent on genetic characteristics. Future research should thus investigate the effects of children's presumed risk gene variants toward negative as well as positive parenting. This could contribute to a deeper understanding of the underlying mechanisms of the intergenerational transmission of abusive and beneficial parenting behavior and help to avoid false stigmatizations. PMID:25163997

  16. Adverse Childhood Experiences and Arrest Patterns in a Sample of Sexual Offenders.

    PubMed

    Levenson, Jill S; Socia, Kelly M

    2016-06-01

    Developmental psychopathology theories suggest that childhood adversity can contribute to antisocial conduct and delinquent activities. The purpose of this study was to explore the influence of adverse childhood experiences (ACE) on arrest patterns in a sample of sexual offenders (N = 740). Higher ACE scores were associated with a variety of arrest outcomes, indicating that the accumulation of early trauma increased the likelihood of versatility and persistence of criminal behavior. Rapists of adults had higher ACE scores, lower levels of specialization, and higher levels of persistence than sex offenders with minor victims only. Child sexual abuse, emotional neglect, and domestic violence in the childhood home were significant predictors of a higher number of sex crime arrests. For measures of nonsexual arrests and criminal versatility, it was the household dysfunction factors-substance abuse, unmarried parents, and incarceration of a family member-that were predictive, suggesting that family dysfunction and a chaotic home environment contributed significantly to increased risk of general criminal behavior. Sex offenders inspire little sympathy in our society but may be among those most in need of trauma-informed models of treatment that recognize the influence of early adversity on maladaptive schema and self-regulation deficits related to criminal behavior. PMID:25711615

  17. Home visiting and the biology of toxic stress: opportunities to address early childhood adversity.

    PubMed

    Garner, Andrew S

    2013-11-01

    Home visiting is an important mechanism for minimizing the lifelong effects of early childhood adversity. To do so, it must be informed by the biology of early brain and child development. Advances in neuroscience, epigenetics, and the physiology of stress are revealing the biological mechanisms underlying well-established associations between early childhood adversity and suboptimal life-course trajectories. Left unchecked, mediators of physiologic stress become toxic, alter both genome and brain, and lead to a vicious cycle of chronic stress. This so-called "toxic stress" results a wide array of behavioral attempts to blunt the stress response, a process known as "behavioral allostasis." Although behaviors like smoking, overeating, promiscuity, and substance abuse decrease stress transiently, over time they become maladaptive and result in the unhealthy lifestyles and noncommunicable diseases that are the leading causes of morbidity and mortality. The biology of toxic stress and the concept of behavioral allostasis shed new light on the developmental origins of lifelong disease and highlight opportunities for early intervention and prevention. Future efforts to minimize the effects of childhood adversity should focus on expanding the capacity of caregivers and communities to promote (1) the safe, stable, and nurturing relationships that buffer toxic stress, and (2) the rudimentary but foundational social-emotional, language, and cognitive skills needed to develop healthy, adaptive coping skills. Building these critical caregiver and community capacities will require a public health approach with unprecedented levels of collaboration and coordination between the healthcare, childcare, early education, early intervention, and home visiting sectors. PMID:24187125

  18. Developmental Patterns of Adverse Childhood Experiences and Current Symptoms and Impairment in Youth Referred For Trauma-Specific Services.

    PubMed

    Grasso, Damion J; Dierkhising, Carly B; Branson, Christopher E; Ford, Julian D; Lee, Robert

    2016-07-01

    By the time children reach adolescence, most have experienced at least one type of severe adversity and many have been exposed to multiple types. However, whether patterns of adverse childhood experiences are consistent or change across developmental epochs in childhood is not known. Retrospective reports of adverse potentially traumatic childhood experiences in 3 distinct developmental epochs (early childhood, 0- to 5-years-old; middle childhood, 6- to 12-years-old; and adolescence, 13- to 18-years-old) were obtained from adolescents (N = 3485) referred to providers in the National Child Traumatic Stress Network (NCTSN) for trauma-focused assessment and treatment. Results from latent class analysis (LCA) revealed increasingly complex patterns of adverse/traumatic experiences in middle childhood and adolescence compared to early childhood. Depending upon the specific developmental epoch assessed, different patterns of adverse/traumatic experiences were associated with gender and with adolescent psychopathology (e.g., internalizing/externalizing behavior problems), and juvenile justice involvement. A multiply exposed subgroup that had severe problems in adolescence was evident in each of the 3 epochs, but their specific types of adverse/traumatic experiences differed depending upon the developmental epoch. Implications for research and clinical practice are identified. PMID:26438634

  19. Impact of Different Childhood Adversities on 1-Year Outcomes of Psychotic Disorder in the Genetics and Psychosis Study.

    PubMed

    Trotta, Antonella; Murray, Robin M; David, Anthony S; Kolliakou, Anna; O'Connor, Jennifer; Di Forti, Marta; Dazzan, Paola; Mondelli, Valeria; Morgan, Craig; Fisher, Helen L

    2016-03-01

    While the role of childhood adversity in increasing the risk of psychosis has been extensively investigated, it is not clear what the impact of early adverse experiences is on the outcomes of psychotic disorders. Therefore, we investigated associations between childhood adversity and 1-year outcomes in 285 first-presentation psychosis patients. Exposure to childhood adversity prior to 17 years of age was assessed using the Childhood Experience of Care and Abuse Questionnaire. Data on illness course, symptom remission, length of psychiatric hospitalization, compliance with medication, employment, and relationship status were extracted from clinical records for the year following first contact with mental health services for psychosis. Seventy-one percent of patients reported exposure to at least 1 type of childhood adversity (physical abuse, sexual abuse, parental separation, parental death, disrupted family arrangements, or being taken into care). No robust associations were found between childhood adversity and illness course or remission. However, childhood physical abuse was associated with almost 3-fold increased odds of not being in a relationship at 1-year follow-up compared to patients who did not report such adverse experiences. There was also evidence of a significant association between parental separation in childhood and longer admissions to psychiatric wards during 1-year follow-up and 2-fold increased odds of noncompliance with medication compared to those not separated from their parents. Therefore, our findings suggest that there may be some specificity in the impact of childhood adversity on service use and social functioning among psychosis patients over the first year following presentation to mental health services. PMID:26373540

  20. Impact of Different Childhood Adversities on 1-Year Outcomes of Psychotic Disorder in the Genetics and Psychosis Study

    PubMed Central

    Trotta, Antonella; Murray, Robin M.; David, Anthony S.; Kolliakou, Anna; O’Connor, Jennifer; Di Forti, Marta; Dazzan, Paola; Mondelli, Valeria; Morgan, Craig; Fisher, Helen L.

    2016-01-01

    While the role of childhood adversity in increasing the risk of psychosis has been extensively investigated, it is not clear what the impact of early adverse experiences is on the outcomes of psychotic disorders. Therefore, we investigated associations between childhood adversity and 1-year outcomes in 285 first-presentation psychosis patients. Exposure to childhood adversity prior to 17 years of age was assessed using the Childhood Experience of Care and Abuse Questionnaire. Data on illness course, symptom remission, length of psychiatric hospitalization, compliance with medication, employment, and relationship status were extracted from clinical records for the year following first contact with mental health services for psychosis. Seventy-one percent of patients reported exposure to at least 1 type of childhood adversity (physical abuse, sexual abuse, parental separation, parental death, disrupted family arrangements, or being taken into care). No robust associations were found between childhood adversity and illness course or remission. However, childhood physical abuse was associated with almost 3-fold increased odds of not being in a relationship at 1-year follow-up compared to patients who did not report such adverse experiences. There was also evidence of a significant association between parental separation in childhood and longer admissions to psychiatric wards during 1-year follow-up and 2-fold increased odds of noncompliance with medication compared to those not separated from their parents. Therefore, our findings suggest that there may be some specificity in the impact of childhood adversity on service use and social functioning among psychosis patients over the first year following presentation to mental health services. PMID:26373540

  1. Reporting of adverse events for marketed drugs: Need for strengthening safety database

    PubMed Central

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  2. Reporting of adverse events for marketed drugs: Need for strengthening safety database.

    PubMed

    Apte, Aditi Anand

    2016-01-01

    Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders. PMID:27453826

  3. The incidence of adverse events in Swedish hospitals: a retrospective medical record review study

    PubMed Central

    Soop, Michael; Fryksmark, Ulla; Köster, Max; Haglund, Bengt

    2009-01-01

    Objectives To estimate the incidence, nature and consequences of adverse events and preventable adverse events in Swedish hospitals. Design A three-stage structured retrospective medical record review based on the use of 18 screening criteria. Setting Twenty-eight Swedish hospitals. Population A representative sample (n = 1967) of the 1.2 million Swedish hospital admissions between October 2003 and September 2004. Main Outcome Measures Proportion of admissions with adverse events, the proportion of preventable adverse events and the types and consequences of adverse events. Results In total, 12.3% (n = 241) of the 1967 admissions had adverse events (95% CI, 10.8–13.7), of which 70% (n = 169) were preventable. Fifty-five percent of the preventable events led to impairment or disability, which was resolved during the admission or within 1 month from discharge, another 33% were resolved within 1 year, 9% of the preventable events led to permanent disability and 3% of the adverse events contributed to patient death. Preventable adverse events led to a mean increased length of stay of 6 days. Ten of the 18 screening criteria were sufficient to detect 90% of the preventable adverse events. When extrapolated to the 1.2 million annual admissions, the results correspond to 105 000 preventable adverse events (95% CI, 90 000–120 000) and 630 000 days of hospitalization (95% CI, 430 000–830 000). Conclusions This study confirms that preventable adverse events were common, and that they caused extensive human suffering and consumed a significant amount of the available hospital resources. PMID:19556405

  4. Interactive Effects of Childhood Maltreatment and Recent Stressful Life Events on Alcohol Consumption in Adulthood

    PubMed Central

    Young-Wolff, Kelly C.; Kendler, Kenneth S.; Prescott, Carol A.

    2012-01-01

    Objective: Childhood maltreatment is associated with early alcohol use initiation, alcohol-related problem behaviors, and alcohol use disorders in adulthood. Heavy drinking risk among individuals exposed to childhood maltreatment could be partly attributable to stress sensitization, whereby early adversity leads to psychobiological changes that heighten sensitivity to subsequent stressors and increase risk for stress-related drinking. We addressed this issue by examining whether the association between past-year stressful life events and past-year drinking density, a weighted quantity–frequency measure of alcohol consumption, was stronger among adults exposed to childhood maltreatment. Method: Drinking density, stressful life events, and childhood maltreatment were assessed using structured clinical interviews in a sample of 4,038 male and female participants ages 20–58 years from the Virginia Adult Twin Study of Psychiatric and Substance Use Disorders. Stress sensitization was examined using hierarchical multiple regression analyses to test whether stressful events moderated the association between maltreatment and drinking density. Analyses were stratified by sex and whether the impact was different for independent stressful events or dependent stressful events as related to a participant's actions. Results: Independent stressful events were associated with heavier drinking density among women exposed to maltreatment. In contrast, drinking density was roughly the same across independent stressful life events exposure among women not exposed to maltreatment. There was little evidence for Maltreatment × Independent Stressor interactions in men or Maltreatment × Dependent Stressor interactions in either gender. Conclusions: Early maltreatment may have direct effects on vulnerability to stress-related drinking among women, particularly in association with stressors that are out of one's control. PMID:22630794

  5. Application of a Temporal Reasoning Framework Tool in Analysis of Medical Device Adverse Events

    PubMed Central

    Clark, Kimberly K.; Sharma, Deepak K.; Chute, Christopher G.; Tao, Cui

    2011-01-01

    The Clinical Narrative Temporal Relation Ontology (CNTRO)1 project offers a semantic-web based reasoning framework, which represents temporal events and relationships within clinical narrative texts, and infer new knowledge over them. In this paper, the CNTRO reasoning framework is applied to temporal analysis of medical device adverse event files. One specific adverse event was used as a test case: late stent thrombosis. Adverse event narratives were obtained from the Food and Drug Administration’s (FDA) Manufacturing and User Facility Device Experience (MAUDE) database2. 15 adverse event files in which late stent thrombosis was confirmed were randomly selected across multiple drug eluting stent devices. From these files, 81 events and 72 temporal relations were annotated. 73 temporal questions were generated, of which 65 were correctly answered by the CNTRO system. This results in an overall accuracy of 89%. This system should be pursued further to continue assessing its potential benefits in temporal analysis of medical device adverse events. PMID:22195199

  6. Adverse childhood experiences, chronic diseases, and risky health behaviors in Saudi Arabian adults: a pilot study.

    PubMed

    Almuneef, Maha; Qayad, Mohammed; Aleissa, Majid; Albuhairan, Fadia

    2014-11-01

    Adverse childhood experiences (ACEs) have been linked with risky health behaviors and the development of chronic diseases in adulthood. This study examined associations between ACEs, chronic diseases, and risky behaviors in adults living in Riyadh, Saudi Arabia in 2012 using the ACE International Questionnaire (ACE-IQ). A cross-sectional design was used, and adults who were at least 18 years of age were eligible to participate. ACEs event scores were measured for neglect, household dysfunction, abuse (physical, sexual, and emotional), and peer and community violence. The ACE-IQ was supplemented with questions on risky health behaviors, chronic diseases, and mood. A total of 931 subjects completed the questionnaire (a completion rate of 88%); 57% of the sample was female, 90% was younger than 45 years, 86% had at least a college education, 80% were Saudi nationals, and 58% were married. One-third of the participants (32%) had been exposed to 4 or more ACEs, and 10%, 17%, and 23% had been exposed to 3, 2, or 1 ACEs respectively. Only 18% did not have an ACE. The prevalence of risky health behaviors ranged between 4% and 22%. The prevalence of self-reported chronic diseases ranged between 6% and 17%. Being exposed to 4 or more ACEs increased the risk of having chronic diseases by 2-11 fold, and increased risky health behaviors by 8-21 fold. The findings of this study will contribute to the planning and development of programs to prevent child maltreatment and to alleviate the burden of chronic diseases in adults. PMID:24974249

  7. Mental Health and Childhood Adversities: A Longitudinal Study in Kabul, Afghanistan

    PubMed Central

    Panter-Brick, Catherine; Goodman, Anna; Tol, Wietse; Eggerman, Mark

    2011-01-01

    Objective To identify prospective predictors of mental health in Kabul, Afghanistan. Method Using stratified random-sampling in schools, mental health and life events for 11-to 16-year-old students and their caregivers were assessed. In 2007, 1 year after baseline, the retention rate was 64% (n = 115 boys, 119 girls, 234 adults) with no evidence of selection bias. Self- and caregiver-rated child mental health (Strengths and Difficulties Questionnaire), depressive (Depression Self-Rating Scale), and posttraumatic stress (Child Revised Impact of Events Scale) symptoms and caregiver mental health (Self-Report Questionnaire) were assessed. Lifetime trauma and past-year traumatic, stressful, and protective experiences were assessed. Results With the exception of posttraumatic stress, one-year trajectories for all mental health outcomes showed significant improvement (p < .001). Family violence had a striking impact on the Strengths and Difficulties Questionnaire data, raising caregiver-rated scores by 3.14 points (confidence interval [CI] 2.21–4.08) or half a standard deviation, and self-rated scores by 1.26 points (CI 0.50–2.03); past-year traumatic beatings independently raised self-rated scores by 1.85 points (CI 0.03–3.66). A major family conflict raised depression scores by 2.75 points (CI 0.89–4.61), two thirds of a standard deviation, whereas improved family life had protective effects. Posttraumatic stress symptom scores, however, were solely contingent on lifetime trauma, with more than three events raising scores by 5.38 points (CI 1.76–9.00). Conclusions Family violence predicted changes in mental health problems other than posttraumatic stress symptoms in a cohort that showed resilience to substantial socioeconomic and war-related stressors. The importance of prospectively identifying impacts of specific types of childhood adversities on mental health outcomes is highlighted to strengthen evidence on key modifiable factors for intervention in war

  8. Childhood adversity and psychiatric disorder in young adulthood: An analysis of 107,704 Swedes.

    PubMed

    Björkenstam, Emma; Burström, Bo; Vinnerljung, Bo; Kosidou, Kyriaki

    2016-06-01

    Childhood adversity (CA) is associated with increased risks of psychiatric disorder in young adulthood, but details in this association are less known. We aimed to explore the association of a range of CA indicators with psychiatric disorder in young adulthood, and the impact of age at exposure, disorder type and accumulation of indicators. We capitalized on Sweden's extensive and high-quality registers and analyzed a cohort of all Swedes (N = 107,704) born in Stockholm County 1987-1991. Adversities included familial death, parental substance misuse and psychiatric disorder, parental criminality, parental separation, public assistance recipiency and residential instability. Age at exposure was categorized as: 0-6.9 years (infancy and early childhood), 7-11.9 years (middle childhood), and 12-14 years (early adolescence). Psychiatric disorders after age 15 were defined from ICD codes through registers. Risks were calculated as Hazard Ratios (HR) with 95% confidence intervals (CI). Results showed that exposure to at least one CA was associated with an increased risk of psychiatric disorder (HR 1.4, 95% CI: 1.3-1.4). Risks were increased for mood, anxiety, and psychotic disorders and ADHD but not for eating disorders. The risk varied with type of disorder but was similar for all exposure periods. Individuals with multiple (3+) CAs had a two-fold risk of psychiatric disorder (HR 2.0, 95% CI: 1.9-2.1). In conclusion, our findings support the long-term negative impact of CA on mental health, regardless of developmental period of exposure. Given that experience of CA is common, efforts should be put to alleviate the burden of childhood adversities for children, particularly among the most disadvantaged. PMID:26994339

  9. Statistical issues in the analysis of adverse events in time-to-event data.

    PubMed

    Allignol, Arthur; Beyersmann, Jan; Schmoor, Claudia

    2016-07-01

    The aim of this work is to shed some light on common issues in the statistical analysis of adverse events (AEs) in clinical trials, when the main outcome is a time-to-event endpoint. To begin, we show that AEs are always subject to competing risks. That is, the occurrence of a certain AE may be precluded by occurrence of the main time-to-event outcome or by occurrence of another (fatal) AE. This has raised concerns on 'informative' censoring. We show that, in general, neither simple proportions nor Kaplan-Meier estimates of AE occurrence should be used, but common survival techniques for hazards that censor the competing event are still valid, but incomplete analyses. They must be complemented by an analogous analysis of the competing event for inference on the cumulative AE probability. The commonly used incidence rate (or incidence density) is a valid estimator of the AE hazard assuming it to be time constant. An estimator of the cumulative AE probability can be derived if the incidence rate of AE is combined with an estimator of the competing hazard. We discuss less restrictive analyses using non-parametric and semi-parametric approaches. We first consider time-to-first-AE analyses and then briefly discuss how they can be extended to the analysis of recurrent AEs. We will give a practical presentation with illustration of the methods by a simple example. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26929180

  10. Adverse Childhood Experiences and Adult Risk Factors for Age-Related Disease

    PubMed Central

    Danese, Andrea; Moffitt, Terrie E.; Harrington, HonaLee; Milne, Barry J.; Polanczyk, Guilherme; Pariante, Carmine M.; Poulton, Richie; Caspi, Avshalom

    2013-01-01

    Objective To understand why children exposed to adverse psychosocial experiences are at elevated risk for age-related disease, such as cardiovascular disease, by testing whether adverse childhood experiences predict enduring abnormalities in stress-sensitive biological systems, namely, the nervous, immune, and endocrine/metabolic systems. Design A 32-year prospective longitudinal study of a representative birth cohort. Setting New Zealand. Participants A total of 1037 members of the Dunedin Multidisciplinary Health and Development Study. Main Exposures During their first decade of life, study members were assessed for exposure to 3 adverse psychosocial experiences: socioeconomic disadvantage, maltreatment, and social isolation. Main Outcome Measures At age 32 years, study members were assessed for the presence of 3 age-related-disease risks: major depression, high inflammation levels (high-sensitivity C-reactive protein level >3 mg/L), and the clustering of metabolic risk biomarkers (overweight, high blood pressure, high total cholesterol, low high-density lipoprotein cholesterol, high glycated hemoglobin, and low maximum oxygen consumption levels. Results Children exposed to adverse psychosocial experiences were at elevated risk of depression, high inflammation levels, and clustering of metabolic risk markers. Children who had experienced socioeconomic disadvantage (incidence rate ratio, 1.89; 95% confidence interval, 1.36–2.62), maltreatment (1.81; 1.38–2.38), or social isolation (1.87; 1.38–2.51) had elevated age-related-disease risks in adulthood. The effects of adverse childhood experiences on age-related-disease risks in adulthood were nonredundant, cumulative, and independent of the influence of established developmental and concurrent risk factors. Conclusions Children exposed to adverse psychosocial experiences have enduring emotional, immune, and metabolic abnormalities that contribute to explaining their elevated risk for age-related disease. The

  11. Moderating role of FKBP5 genotype in the impact of childhood adversity on cortisol stress response during adulthood.

    PubMed

    Buchmann, Arlette F; Holz, Nathalie; Boecker, Regina; Blomeyer, Dorothea; Rietschel, Marcella; Witt, Stephanie H; Schmidt, Martin H; Esser, Günter; Banaschewski, Tobias; Brandeis, Daniel; Zimmermann, Ulrich S; Laucht, Manfred

    2014-06-01

    Recent research suggests an important role of FKBP5, a glucocorticoid receptor regulating co-chaperone, in the development of stress-related diseases such as depression and anxiety disorders. The present study aimed to replicate and extend previous evidence indicating that FKBP5 polymorphisms moderate hypothalamus-pituitary-adrenal (HPA) function by examining whether FKBP5 rs1360780 genotype and different measures of childhood adversity interact to predict stress-induced cortisol secretion. At age 19 years, 195 young adults (90 males, 105 females) participating in an epidemiological cohort study completed the Trier Social Stress Test (TSST) to assess cortisol stress responsiveness and were genotyped for the FKBP5 rs1360780. Childhood adversity was assessed using the Childhood Trauma Questionnaire (CTQ) and by a standardized parent interview yielding an index of family adversity. A significant interaction between genotype and childhood adversity on cortisol response to stress was demonstrated for exposure to childhood maltreatment as assessed by retrospective self-report (CTQ), but not for prospectively ascertained objective family adversity. Severity of childhood maltreatment was significantly associated with attenuated cortisol levels among carriers of the rs1360780 CC genotype, while no such effect emerged in carriers of the T allele. These findings point towards the functional involvement of FKBP5 in long-term alterations of neuroendocrine stress regulation related to childhood maltreatment, which have been suggested to represent a premorbid risk or resilience factor in the context of stress-related disorders. PMID:24411633

  12. 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

  13. Probability of severe adverse events as a function of hospital occupancy.

    PubMed

    Boyle, Justin; Zeitz, Kathryn; Hoffman, Richard; Khanna, Sankalp; Beltrame, John

    2014-01-01

    A unique application of regression modeling is described to compare hospital bed occupancy with reported severe adverse events amongst inpatients. The probabilities of the occurrence of adverse events as a function of hospital occupancy are calculated using logistic and multinomial regression models. All models indicate that higher occupancy rates lead to an increase in adverse events. The analysis identified that at an occupancy level of 100%, there is a 22% chance of one severe event occurring and a 28% chance of at least one severe event occurring. This modeling contributes evidence toward the management of hospital occupancy to benefit patient outcomes. PMID:24403399

  14. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false How do I complete and submit an individual adverse event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING Generally Applicable Requirements for Individual Adverse Event Reports...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary......

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

    PubMed Central

    Varallo, Fabiana Rossi; Capucho, Helaine Carneiro; da Silva Planeta, Cleópatra; de Carvalho Mastroianni, Patrícia

    2014-01-01

    OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%), fatigue (12.3%), and chest pain (9.0%). Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases. PMID:24626940

  17. Effect of Two Different Methods of Initiating Atomoxetine on the Adverse Event Profile of Atomoxetine

    ERIC Educational Resources Information Center

    Greenhill, Laurence L.; Newcorn, Jeffrey H.; Gao, Haitao; Feldman, Peter D.

    2007-01-01

    Objective: To compare the effects of two different methods for initiating atomoxetine in terms of the incidence of early adverse events. Method: Data on atomoxetine treatment-emergent adverse events in youths, ages 6 to 18 years, were analyzed from five randomized, double-blind, placebo-controlled, acute-phase studies. Two studies involve…

  18. Incorporating adverse event relatedness into dose-finding clinical trial designs.

    PubMed

    Darssan, Darsy; Thompson, Mery H; Pettitt, Anthony N

    2014-03-30

    Dose-finding designs estimate the dose level of a drug based on observed adverse events. Relatedness of the adverse event to the drug has been generally ignored in all proposed design methodologies. These designs assume that the adverse events observed during a trial are definitely related to the drug, which can lead to flawed dose-level estimation. We incorporate adverse event relatedness into the so-called continual reassessment method. Adverse events that have 'doubtful' or 'possible' relationships to the drug are modelled using a two-parameter logistic model with an additive probability mass. Adverse events 'probably' or 'definitely' related to the drug are modelled using a cumulative logistic model. To search for the maximum tolerated dose, we use the maximum estimated toxicity probability of these two adverse event relatedness categories. We conduct a simulation study that illustrates the characteristics of the design under various scenarios. This article demonstrates that adverse event relatedness is important for improved dose estimation. It opens up further research pathways into continual reassessment design methodologies. PMID:24122859

  19. 5 CFR 1631.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1631.33 Section 1631.33 Administrative Personnel FEDERAL RETIREMENT THRIFT INVESTMENT BOARD... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  20. 10 CFR 1707.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1707.210 Section 1707.210 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD TESTIMONY BY DNFSB EMPLOYEES AND....210 Procedure in the event of an adverse ruling. If the court or other competent authority fails...

  1. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 4 2013-10-01 2013-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  2. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 19 Customs Duties 1 2012-04-01 2012-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  3. 22 CFR 504.13 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Procedure in the event of an adverse ruling. 504.13 Section 504.13 Foreign Relations BROADCASTING BOARD OF GOVERNORS TESTIMONY BY BBG EMPLOYEES... Requests for Testimony and Production of Documents § 504.13 Procedure in the event of an adverse ruling....

  4. 10 CFR 202.26 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 3 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 202.26 Section 202.26 Energy DEPARTMENT OF ENERGY OIL PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  5. 5 CFR 1305.4 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1305.4 Section 1305.4 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET ADMINISTRATIVE....4 Procedure in the event of an adverse ruling. If the court or other authority declines to stay...

  6. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 1 2011-04-01 2011-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  7. 10 CFR 1707.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 1707.210 Section 1707.210 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD TESTIMONY BY DNFSB EMPLOYEES AND....210 Procedure in the event of an adverse ruling. If the court or other competent authority fails...

  8. 12 CFR 1070.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 9 2014-01-01 2014-01-01 false Procedure in the event of an adverse ruling. 1070.36 Section 1070.36 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION DISCLOSURE OF RECORDS... Procedure in the event of an adverse ruling. If a stay or, or other relief from, the effect of a demand...

  9. 10 CFR 9.204 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 9.204 Section 9.204 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Production or Disclosure in Response to Subpoenas or Demands of Courts or Other Authorities § 9.204 Procedure in the event of an adverse ruling....

  10. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 4 2013-07-01 2013-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  11. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 4 2014-10-01 2014-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  12. 10 CFR 9.204 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 9.204 Section 9.204 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Production or Disclosure in Response to Subpoenas or Demands of Courts or Other Authorities § 9.204 Procedure in the event of an adverse ruling....

  13. 5 CFR 2502.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 2502.33 Section 2502.33 Administrative Personnel OFFICE OF ADMINISTRATION, EXECUTIVE OFFICE OF... Other Authorities § 2502.33 Procedure in the event of an adverse ruling. If the court or other...

  14. 29 CFR 2.24 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 1 2012-07-01 2012-07-01 false Procedure in the event of an adverse ruling. 2.24 Section 2.24 Labor Office of the Secretary of Labor GENERAL REGULATIONS Employees Served With Subpoenas § 2.24 Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  15. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 4 2010-07-01 2010-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  16. 29 CFR 2.24 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 1 2014-07-01 2013-07-01 true Procedure in the event of an adverse ruling. 2.24 Section 2.24 Labor Office of the Secretary of Labor GENERAL REGULATIONS Employees Served With Subpoenas § 2.24 Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  17. 12 CFR 404.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 404.33 Section 404.33 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES INFORMATION DISCLOSURE... § 404.33 Procedure in the event of an adverse ruling. If the court or other authority declines to...

  18. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 4 2010-10-01 2010-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  19. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 4 2011-07-01 2011-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  20. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  1. 22 CFR 504.13 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Procedure in the event of an adverse ruling. 504.13 Section 504.13 Foreign Relations BROADCASTING BOARD OF GOVERNORS TESTIMONY BY BBG EMPLOYEES... Requests for Testimony and Production of Documents § 504.13 Procedure in the event of an adverse ruling....

  2. 28 CFR 16.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Procedure in the event of an adverse ruling. 16.28 Section 16.28 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF... event of an adverse ruling. If the court or other authority declines to stay the effect of the demand...

  3. 28 CFR 16.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Procedure in the event of an adverse ruling. 16.28 Section 16.28 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF... event of an adverse ruling. If the court or other authority declines to stay the effect of the demand...

  4. 10 CFR 202.26 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 202.26 Section 202.26 Energy DEPARTMENT OF ENERGY OIL PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  5. 22 CFR 172.7 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure in the event of an adverse ruling. 172.7 Section 172.7 Foreign Relations DEPARTMENT OF STATE ACCESS TO INFORMATION SERVICE OF PROCESS... FEDERAL OR STATE LITIGATION; EXPERT TESTIMONY § 172.7 Procedure in the event of an adverse ruling. If...

  6. 28 CFR 16.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Procedure in the event of an adverse ruling. 16.28 Section 16.28 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION OR DISCLOSURE OF... event of an adverse ruling. If the court or other authority declines to stay the effect of the demand...

  7. 5 CFR 1216.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1216.210 Section 1216.210 Administrative Personnel MERIT SYSTEMS PROTECTION BOARD ORGANIZATION... Procedure in the event of an adverse ruling. If the court or other competent authority fails to stay...

  8. 22 CFR 172.7 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Procedure in the event of an adverse ruling. 172.7 Section 172.7 Foreign Relations DEPARTMENT OF STATE ACCESS TO INFORMATION SERVICE OF PROCESS... FEDERAL OR STATE LITIGATION; EXPERT TESTIMONY § 172.7 Procedure in the event of an adverse ruling. If...

  9. 29 CFR 1610.36 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 4 2012-07-01 2012-07-01 false Procedure in the event of an adverse ruling. 1610.36 Section 1610.36 Labor Regulations Relating to Labor (Continued) EQUAL EMPLOYMENT OPPORTUNITY COMMISSION... Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  10. 45 CFR 1201.8 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 4 2011-10-01 2011-10-01 false Procedure in the event of an adverse ruling. 1201.8 Section 1201.8 Public Welfare Regulations Relating to Public Welfare (Continued) CORPORATION FOR... OR STATE LITIGATION § 1201.8 Procedure in the event of an adverse ruling. If the court or...

  11. 12 CFR 404.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Procedure in the event of an adverse ruling. 404.33 Section 404.33 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES INFORMATION DISCLOSURE... § 404.33 Procedure in the event of an adverse ruling. If the court or other authority declines to...

  12. 19 CFR 103.25 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 19 Customs Duties 1 2013-04-01 2013-04-01 false Procedure in the event of an adverse ruling. 103.25 Section 103.25 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY... Foreign Proceedings § 103.25 Procedure in the event of an adverse ruling. If the court or other...

  13. 29 CFR 2.24 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 1 2011-07-01 2011-07-01 false Procedure in the event of an adverse ruling. 2.24 Section 2.24 Labor Office of the Secretary of Labor GENERAL REGULATIONS Employees Served With Subpoenas § 2.24 Procedure in the event of an adverse ruling. If the court or other authority declines to stay the effect...

  14. 10 CFR 1707.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 1707.210 Section 1707.210 Energy DEFENSE NUCLEAR FACILITIES SAFETY BOARD TESTIMONY BY DNFSB EMPLOYEES AND....210 Procedure in the event of an adverse ruling. If the court or other competent authority fails...

  15. 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

  16. The Adverse Events of Oxycodone in Cancer-Related Pain

    PubMed Central

    Ma, Hu; Liu, Yuan; Huang, Lang; Zeng, Xian-Tao; Jin, Su-Han; Yue, Guo-Jun; Tian, Xu; Zhou, Jian-Guo

    2016-01-01

    Abstract The adverse events (AEs) of oxycodone in cancer-related pain were controversial, so we conducted a meta-analysis to determine it. PubMed, Embase, CBM, CNKI, WanFang database, The Cochrane library, Web of Science, and the reference of included studies were searched to recognize pertinent studies. Relative risk (RR) with 95% confidence intervals (CIs) for all AEs were all extracted. The fixed-effects model was used to calculate pooled RRs and 95% CIs. Power calculation was performed using macro embedded in SAS software after all syntheses were completed. We identified 11 eligible trials involving 1211 patients: 604 patients included in oxycodone group and 607 patients involved in control group. Our quantitative analysis included 8 AEs, and the pooled analyses indicated that oxycodone compared with other opioids in cancer-related pain were not significantly decreased RRs of all AEs (dizziness RR = 0.94, 95% CI: 0.69–1.30, Z = 0.35, P = 0.72; nausea RR = 0.88, 95% CI: 0.72–1.07, Z = 1.26, P = 0.21; vomiting RR = 0.89, 95% CI: 0.70–1.15, Z = 0.9, P = 0.37; sleepiness RR = 0.86, 95% CI: 0.38–1.36, Z = 0.36, P = 0.72; constipation RR = 0.98, 95% CI: 0.81–1.19, Z = 0.21, P = 0.83; anorexia RR = 0.97, 95% CI = 0.58–1.62, Z = 0.11, P = 0.91; pruritus RR = 0.76, 95% CI: 0.44–1.30, Z = 1.01, P = 0.31; dysuria RR = 0.33, 95% CI: 0.07–1.62, Z = 1.36, P = 0.1)]. The subgroup analysis shown that Ox controlled-release (CR) had less sleepiness compared with MS-contin (Mc) CR (RR = 0.47, 95% CI: 0.25–0.90, P = 0.02). The power analysis suggests that all AEs have low statistical power. The present meta-analysis detected that no statistically significant difference were found among oxycodone and other opioids in all AEs, but Ox CR may had less sleepiness compared with Mc CR when subgroup analysis were conducted. PMID:27082588

  17. Narrative Perspectives in Psychosocial Intervention Following Adverse Life Events.

    ERIC Educational Resources Information Center

    Borden, William

    1992-01-01

    Demonstrates how narrative perspectives provide means of conceptualizing brief psychotherapy following negative life outcomes. Representative case studies illustrate three types of narrative construction following adverse experiences and show how narrative perspectives shift focus from disability and dysfunction to concern for client strengths,…

  18. Childhood adversities and adult use of potentially injurious physical discipline in Japan

    PubMed Central

    Umeda, Maki; Kawakami, Norito; Kessler, Ronald C.; Miller, Elizabeth

    2015-01-01

    Using data derived from the World Mental Health Japan Survey (n = 1,186), this study examined the intergenerational continuity of potentially injurious physical discipline of children in a community sample from Japan with a special focus on the confounding effects of 11 other types of childhood adversities (CAs) and the intervening effects of mental disorders and socioeconomic status. Bivariate analyses revealed that having experienced physical discipline as children and five other CAs was significantly associated with the use of physical discipline as parents in the Japanese community examined. However, childhood physical discipline was the only CA that remained significant after adjusting for the other CAs. The association of childhood physical discipline with adult perpetration was independent of the respondents’ mental disorders and household income. No significant gender differences were found in the associations between childhood physical discipline and adult perpetration. The current study on Japan provided empirical support consistent with results found in other countries regarding the intergenerational transmission of child physical abuse. PMID:26478655

  19. The FDA's proposal for public disclosure of adverse events in gene therapy trials.

    PubMed

    Barnbaum, D R

    2000-09-01

    In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials. PMID:15468489

  20. Adverse childhood experiences: Prevalence and related factors in adolescents of a Brazilian birth cohort☆

    PubMed Central

    Soares, Ana Luiza Gonçalves; Howe, Laura D.; Matijasevich, Alicia; Wehrmeister, Fernando C.; Menezes, Ana M.B.; Gonçalves, Helen

    2016-01-01

    Adverse childhood experiences (ACEs) can affect people's health and wellbeing not only at the time the ACE is experienced, but also later in life. The majority of studies on ACEs are carried out in high-income countries and little is known about its prevalence in low and middle-income countries. Thus, the aim of this study was to assess the prevalence of ACEs, associations between ACEs and sociodemographic factors, and the interrelationship between types of ACEs in adolescents of a Brazilian birth cohort. Data from 3,951 adolescents (78.4% of the original cohort) from the 1993 Pelotas Cohort were analyzed. Seven types of ACEs were assessed in those up to 18 years old: physical abuse, sexual abuse, physical neglect, emotional neglect, domestic violence, parental separation and parental death. The most common ACE was parental separation (42%), followed by emotional neglect (19.7%) and domestic violence (10.3%). Approximately 85% of the adolescents experienced at least one ACE, and females reported a higher number of adversities. Several socioeconomic, demographic and family-related characteristics were associated with the occurrence of ACEs, e.g. non-white skin color, low family income, low maternal schooling, absence of mother's partner, maternal smoking, and poor maternal mental health. A strong interrelationship was observed among the ACEs, indicating clustering of risk. These aspects should be considered by health and social care professionals in the prevention and identification of childhood adversities. PMID:26707919

  1. Adverse childhood experiences, gender, and HIV risk behaviors: Results from a population-based sample.

    PubMed

    Fang, Lin; Chuang, Deng-Min; Lee, Yookyong

    2016-12-01

    Recent HIV research suggested assessing adverse childhood experiences (ACEs) as contributing factors of HIV risk behaviors. However, studies often focused on a single type of adverse experience and very few utilized population-based data. This population study examined the associations between ACE (individual and cumulative ACE score) and HIV risk behaviors. We analyzed the 2012 Behavioral Risk Factor Surveillance Survey (BRFSS) from 5 states. The sample consisted of 39,434 adults. Eight types of ACEs that included different types of child abuse and household dysfunctions before the age of 18 were measured. A cumulative score of ACEs was also computed. Logistic regression estimated of the association between ACEs and HIV risk behaviors using odds ratio (OR) with 95% confidence intervals (CIs) for males and females separately. We found that ACEs were positively associated with HIV risk behaviors overall, but the associations differed between males and females in a few instances. While the cumulative ACE score was associated with HIV risk behaviors in a stepwise manner, the pattern varied by gender. For males, the odds of HIV risk increased at a significant level as long as they experienced one ACE, whereas for females, the odds did not increase until they experienced three or more ACEs. Future research should further investigate the gender-specific associations between ACEs and HIV risk behaviors. As childhood adversities are prevalent among general population, and such experiences are associated with increased risk behaviors for HIV transmission, service providers can benefit from the principles of trauma-informed practice. PMID:27413671

  2. Adverse childhood experiences: Prevalence and related factors in adolescents of a Brazilian birth cohort.

    PubMed

    Soares, Ana Luiza Gonçalves; Howe, Laura D; Matijasevich, Alicia; Wehrmeister, Fernando C; Menezes, Ana M B; Gonçalves, Helen

    2016-01-01

    Adverse childhood experiences (ACEs) can affect people's health and wellbeing not only at the time the ACE is experienced, but also later in life. The majority of studies on ACEs are carried out in high-income countries and little is known about its prevalence in low and middle-income countries. Thus, the aim of this study was to assess the prevalence of ACEs, associations between ACEs and sociodemographic factors, and the interrelationship between types of ACEs in adolescents of a Brazilian birth cohort. Data from 3,951 adolescents (78.4% of the original cohort) from the 1993 Pelotas Cohort were analyzed. Seven types of ACEs were assessed in those up to 18 years old: physical abuse, sexual abuse, physical neglect, emotional neglect, domestic violence, parental separation and parental death. The most common ACE was parental separation (42%), followed by emotional neglect (19.7%) and domestic violence (10.3%). Approximately 85% of the adolescents experienced at least one ACE, and females reported a higher number of adversities. Several socioeconomic, demographic and family-related characteristics were associated with the occurrence of ACEs, e.g. non-white skin color, low family income, low maternal schooling, absence of mother's partner, maternal smoking, and poor maternal mental health. A strong interrelationship was observed among the ACEs, indicating clustering of risk. These aspects should be considered by health and social care professionals in the prevention and identification of childhood adversities. PMID:26707919

  3. Adverse Childhood Experiences and the Health of University Students in Eight Provinces of Vietnam.

    PubMed

    Tran, Quynh Anh; Dunne, Michael P; Vo, Thang Van; Luu, Ngoc Hoat

    2015-11-01

    Recent systematic reviews have emphasized the need for more research into the health and social impacts of adverse childhood experiences (ACEs) in the Asia-Pacific region. This cross-sectional study was conducted with 2099 young adult students in 8 medical universities throughout Vietnam. An anonymous, self-report questionnaire included the World Health Organization ACE-International Questionnaire and standardized measures of mental and physical health. Three quarters (76%) of the students reported at least one exposure to ACEs; 21% had 4 or more ACEs. The most commonly reported adversities were emotional abuse, physical abuse, and witnessing a household member being treated violently (42.3%, 39.9%, and 34.6%, respectively). Co-occurrence of ACEs had dose-response relationships with poor mental health, suicidal ideation, and low physical health-related quality of life. This first multisite study of ACEs among Vietnamese university students provided evidence that childhood adversity is common and is significantly linked with impaired health and well-being into the early adult years. PMID:26047629

  4. The Ontology of Vaccine Adverse Events (OVAE) and its usage in representing and analyzing adverse events associated with US-licensed human vaccines

    PubMed Central

    2013-01-01

    Background Licensed human vaccines can induce various adverse events (AE) in vaccinated patients. Due to the involvement of the whole immune system and complex immunological reactions after vaccination, it is difficult to identify the relations among vaccines, adverse events, and human populations in different age groups. Many known vaccine adverse events (VAEs) have been recorded in the package inserts of US-licensed commercial vaccine products. To better represent and analyze VAEs, we developed the Ontology of Vaccine Adverse Events (OVAE) as an extension of the Ontology of Adverse Events (OAE) and the Vaccine Ontology (VO). Results Like OAE and VO, OVAE is aligned with the Basic Formal Ontology (BFO). The commercial vaccines and adverse events in OVAE are imported from VO and OAE, respectively. A new population term ‘human vaccinee population’ is generated and used to define VAE occurrence. An OVAE design pattern is developed to link vaccine, adverse event, vaccinee population, age range, and VAE occurrence. OVAE has been used to represent and classify the adverse events recorded in package insert documents of commercial vaccines licensed by the USA Food and Drug Administration (FDA). OVAE currently includes over 1,300 terms, including 87 distinct types of VAEs associated with 63 human vaccines licensed in the USA. For each vaccine, occurrence rates for every VAE in different age groups have been logically represented in OVAE. SPARQL scripts were developed to query and analyze the OVAE knowledge base data. To demonstrate the usage of OVAE, the top 10 vaccines accompanying with the highest numbers of VAEs and the top 10 VAEs most frequently observed among vaccines were identified and analyzed. Asserted and inferred ontology hierarchies classify VAEs in different levels of AE groups. Different VAE occurrences in different age groups were also analyzed. Conclusions The ontology-based data representation and integration using the FDA-approved information from

  5. Childhood Adversity and Cumulative Life Stress: Risk Factors for Cancer-Related Fatigue

    PubMed Central

    Bower, Julienne E.; Crosswell, Alexandra D.; Slavich, George M.

    2013-01-01

    Fatigue is a common symptom in healthy and clinical populations, including cancer survivors. However, risk factors for cancer-related fatigue have not been identified. On the basis of research linking stress with other fatigue-related disorders, we tested the hypothesis that stress exposure during childhood and throughout the life span would be associated with fatigue in breast cancer survivors. Stress exposure was assessed using the Stress and Adversity Inventory, a novel computer-based instrument that assesses for 96 types of acute and chronic stressors that may affect health. Results showed that breast cancer survivors with persistent fatigue reported significantly higher levels of cumulative lifetime stress exposure, including more stressful experiences in childhood and in adulthood, compared to a control group of nonfatigued survivors. These findings identify a novel risk factor for fatigue in the growing population of cancer survivors and suggest targets for treatment. PMID:24377083

  6. Adverse childhood experiences, posttraumatic stress disorder symptoms, and emotional intelligence in partner aggression.

    PubMed

    Swopes, Rachael M; Simonet, Daniel V; Jaffe, Anna E; Tett, Robert P; Davis, Joanne L

    2013-01-01

    Intimate partner violence (IPV) has been linked to childhood abuse, posttraumatic stress disorder (PTSD), and low emotional intelligence (EI). Relationships among adverse childhood experiences (ACE), PTSD symptoms, and partner aggression (i.e., generalized tendency to aggress toward one's partner) were assessed in 108 male IPV offenders. It was hypothesized that ACE is positively correlated with partner aggression, PTSD mediates the ACE-aggression relationship, and the ACE-PTSD-aggression mediation varies by selected EI facets. Results indicate that ACE has an indirect effect on partner aggression via PTSD and PTSD mediates the ACE-aggression link when emotional self-regulation is low and when intuition (vs. reason) is high. Trauma-exposed IPV offenders may benefit from comprehensive treatments focusing on PTSD symptoms, emotional control, and reasoning skills to reduce aggression. PMID:23862313

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

    PubMed Central

    2010-01-01

    Background The "Put Prevention into Practice" campaign of the US Public Health Service (USPHS) was launched with the dissemination of the Clinician's Handbook of Preventive Services that recommended standards of clinical care for various prevention activities, including preventive clinical strategies to reduce the risk of adverse drug events. We explored whether nonprescribing clinicians such as chiropractors may contribute to advancing drug safety initiatives by identifying potential adverse drug events in their chiropractic patients, and by bringing suspected adverse drug events to the attention of the prescribing clinicians. Methods Mail survey of US chiropractors about their detection of potential adverse drug events in their chiropractic patients. Results Over half of responding chiropractors (62%) reported having identified a suspected adverse drug event occurring in one of their chiropractic patients. The severity of suspected drug-related events detected ranged from mild to severe. Conclusions Chiropractors or other nonprescribing clinicians may be in a position to detect potential adverse drug events in the community. These detection and reporting mechanisms should be standardized and policies related to clinical case management of suspected adverse drug events occurring in their patients should be developed. PMID:21083911

  8. Adverse childhood experiences are associated with adult sleep disorders: a systematic review

    PubMed Central

    Kajeepeta, Sandhya; Gelaye, Bizu; Jackson, Chandra L.; Williams, Michelle A.

    2015-01-01

    Adverse childhood experiences (ACEs) represent substantial threats to public health and affect about 58% of youth in the US. In addition to their acute effects such as injury and physical trauma, ACEs are associated with an increased risk of several negative health outcomes throughout the life course. Emerging evidence suggests sleep disorders may be one such outcome, but existing studies have not been systematically reviewed and summarized. We conducted a systematic review to summarize the evidence concerning the relationship between ACEs and sleep disorders and disturbances, with a focus on adult women. Original publications were identified through searches of the electronic databases MEDLINE, Embase, and Web of Science using key words “childhood,” “adversity,” “abuse,” and “sleep” as well as searches of the reference lists of eligible studies. Studies evaluating ACEs that occurred before 18 years of age and sleep outcomes that were assessed at 18 years or older were adjudicated and included. A total of 30 publications were identified. Of the 30 studies, 28 were retrospective analyses and there was vast heterogeneity in types of ACEs and sleep outcomes measured. The majority of retrospective studies (N=25 of 28) documented statistically significant associations between sleep disorders including sleep apnea, narcolepsy, nightmare distress, sleep paralysis, and psychiatric sleep disorders with a history of childhood adversity. In many studies, the strengths of associations increased with the number and severity of adverse experiences. These associations were corroborated by the two prospective studies published to date. Notably, investigators have documented statistically significant associations between family conflict at 7-15 years of age and insomnia at 18 years of age (OR = 1.4; 95% CI = 1.2-1.7) and between childhood sexual abuse and sleep disturbances 10 years later in adult women (β = 0.24, p < 0.05). There is a growing scientific body of

  9. Adverse childhood experiences are associated with adult sleep disorders: a systematic review.

    PubMed

    Kajeepeta, Sandhya; Gelaye, Bizu; Jackson, Chandra L; Williams, Michelle A

    2015-03-01

    Adverse childhood experiences (ACEs) represent substantial threats to public health and affect about 58% of youth in the US. In addition to their acute effects such as injury and physical trauma, ACEs are associated with an increased risk of several negative health outcomes throughout the life course. Emerging evidence suggests that sleep disorders may be one such outcome, but existing studies have not been systematically reviewed and summarized. We conducted a systematic review to summarize the evidence concerning the relationship between ACEs and sleep disorders and disturbances, with a focus on adult women. Original publications were identified through searches of the electronic databases MEDLINE, Embase, and Web of Science using the keywords "childhood," "adversity," "abuse," and "sleep" as well as searches of the reference lists of eligible studies. Studies evaluating ACEs that occurred before 18 years of age and sleep outcomes that were assessed at 18 years or older were adjudicated and included. A total of 30 publications were identified. Of the 30 studies, 28 were retrospective analyses and there was vast heterogeneity in the types of ACEs and sleep outcomes measured. The majority of retrospective studies (N = 25 of 28) documented statistically significant associations between sleep disorders including sleep apnea, narcolepsy, nightmare distress, sleep paralysis, and psychiatric sleep disorders with a history of childhood adversity. In many studies, the strengths of associations increased with the number and severity of adverse experiences. These associations were corroborated by the two prospective studies published to date. Notably, investigators have documented statistically significant associations between family conflict at 7-15 years of age and insomnia at 18 years of age (odds ratio, OR = 1.4; 95% confidence interval, CI = 1.2-1.7) and between childhood sexual abuse and sleep disturbances 10 years later in adult women (β = 0.24, p

  10. Group attachment-based intervention: trauma-informed care for families with adverse childhood experiences.

    PubMed

    Murphy, Anne; Steele, Howard; Bate, Jordan; Nikitiades, Adella; Allman, Brooke; Bonuck, Karen; Meissner, Paul; Steele, Miriam

    2015-01-01

    This article outlines the main premises of an innovative trauma-informed intervention, group attachment-based intervention, specifically developed to target vulnerable families with infants and toddlers, living in one of the poorest urban counties in the nation. It also reports on the trauma-relevant characteristics of 60 families entering a clinical trial to study the effectiveness of Group Attachment-Based Intervention. Initial survey results revealed high levels of neglect, abuse, and household dysfunction in mothers' histories (77% reported ≥4 adverse childhood experiences, with more than 90% reporting 2 or more current toxic stressors, including poverty, obesity, domestic and community violence, and homelessness). PMID:26017004

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

    PubMed Central

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

    2014-01-01

    Background Haemovigilance hinges on a systematically structured reporting system, which unfortunately does not always exist in resource-limited settings. We determined the incidence and pattern of transfusion-related adverse events reported to the National Blood Service Zimbabwe. Materials and methods A retrospective review of the transfusion-event records of the National Blood Service Zimbabwe was conducted covering the period from 1 January 1999 to 31 December 2011. All transfusion-related event reports received during the period were analysed. Results A total of 308 transfusion adverse events (0.046%) were reported for 670,625 blood components distributed. The majority (61.6%) of the patients who experienced an adverse event were female. The median age was 36 years (range, 1–89 years). The majority (68.8%) of the adverse events were acute transfusion reactions consisting of febrile non-haemolytic transfusion reactions (58.5%), minor allergies (31.6%), haemolytic reactions (5.2%), severe allergic reactions (2.4%), anaphylaxis (1.4%) and hypotension (0.9%). Two-thirds (66.6%) of the adverse events occurred following administration of whole blood, although only 10.6% of the blood was distributed as whole blood. Packed cells, which accounted for 75% of blood components distributed, were associated with 20.1% of the events. Discussion The incidence of suspected transfusion adverse events was generally lower than the incidences reported globally in countries with well-established haemovigilance systems. The administration of whole blood was disproportionately associated with transfusion adverse events. The pattern of the transfusion adverse events reported here highlights the probable differences in practice between different settings. Under-reporting of transfusion events is rife in passive reporting systems. PMID:24887217

  12. Interactions between the apolipoprotein E ε4 allele status and adverse childhood experiences on depressive symptoms in older adults

    PubMed Central

    Park, Subin; Nam, Yoon-Young; Sim, Yoojin; Hong, Jin Pyo

    2015-01-01

    Background The influence of childhood adversity on depression is modulated by genetic vulnerability. The apolipoprotein E ε4 (APOE-ε4) allele is a strong genetic risk factor for Alzheimer's disease (AD). Because late-life depressive symptoms could be a part of the preclinical course of AD, the APOE-ε4 allele may contribute to depression in old age. Objective The aim of this study was to evaluate whether an APOE-ε4 carrier status was associated with depressive symptoms in older adults and to detect the gene–environment interaction between APOE-ε4 status and childhood adversity in relation to depressive symptoms in old age. Method The participants consisted of 137 older adults (age range 50–70) without any psychiatric history or clinically significant cognitive impairment. APOE genotypes and measures of childhood adversity and depressive symptoms were obtained. Results There was a significant positive association between adverse childhood experiences (ACE) scores and depressive symptoms (B=0.60; 95% CI=0.26, 0.93 for a 1 score increase in ACE scores; p=0.001). Although APOE-ε4 status per se was not associated with depressive symptoms, there was a significant interaction of the ACE scores with the APOE genotype in relation to depressive symptoms (B=0.78; 95% CI=0.02, 1.55; p=0.044). There was a significantly higher effect of childhood adversity on depressive symptoms in APOE-ε4 carriers than non-carriers (t=2.13, p=0.035). Conclusions Our results suggest that the APOE-ε4 may modulate the association between childhood adversity and depressive symptoms in older adults. However, more research in a larger sample is needed to gain a better understanding of the relationship between the APOE-ε4, childhood adversity, and depression. PMID:25630472

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

    PubMed

    Bohn, J; Kortepeter, C; Muñoz, M; Simms, K; Montenegro, S; Dal Pan, G

    2015-05-01

    Spontaneous adverse event reports constitute an important source of information on previously unknown adverse reactions to marketed medicines. However, the dynamics of such reporting following generic introduction are poorly understood. Using adverse event reports on five antiepileptic drugs from the US Food and Drug Administration's Adverse Event Reporting System, we describe temporal trends in adverse event reporting before and after generic introduction, and survey the quality of product-identifying information contained therein. The majority of reports were sent by innovator drug manufacturers while few were sent by generic manufacturers, even when generics accounted for >90% of dispensed prescriptions. We manually reviewed narratives from 2,500 reports and found that the suspect product type (brand or generic) could not be determined in 84% of reports, while generic products (16%) were identified more often than brand-name products (<1%). These results suggest that pharmacovigilance stakeholders should act to promote more detailed reporting practices. PMID:25670505

  14. Neighborhood Collective Efficacy Moderates the Association between Maternal Adverse Childhood Experiences and Marital Conflict.

    PubMed

    Madigan, Sheri; Wade, Mark; Plamondon, André; Jenkins, Jennifer M

    2016-06-01

    In a socio-demographically diverse sample of 501 caregivers participating in a longitudinal birth cohort study during the childbearing years, we examined whether neighborhood collective efficacy moderated the association between maternal adverse childhood experience (ACEs) and marital conflict. Maternal ACEs were assessed via retrospective reports. Neighborhood collective efficacy was measured via maternal and paternal reports at 2 months, and maternal reports of marital conflict were collected at infant age 2 and 18 months. Multiple linear regression analyses revealed that maternal ACEs were associated with increased marital conflict. Neighborhood collective efficacy moderated the association between early maternal ACEs and marital conflict, such that mothers experiencing ACEs had lower levels of marital conflict when exposed to high levels of neighborhood collective efficacy. Results suggest that extra-familial sources of social support and control, such as feelings of security, trust, order, and connectedness with others, may buffer the effects of early adversity on marital discord. PMID:27250904

  15. The impact of adverse life events and the serotonin transporter gene promoter polymorphism on the development of eating disorder symptoms.

    PubMed

    Akkermann, Kirsti; Kaasik, Kadri; Kiive, Evelyn; Nordquist, Niklas; Oreland, Lars; Harro, Jaanus

    2012-01-01

    Adverse life events have been shown to predict weight fluctuations and dietary restraint, as well as eating disorders during adolescence or early adulthood. Since the s-allele carriers of the 5-HTT gene-linked polymorphic region (5-HTTLPR) are biologically more reactive to stress related stimuli, we aimed to explore whether the eating disturbances are predicted by environmental stressors and moderated by the 5-HTTLPR genotype. The sample was based on the younger cohort of the Estonian Children Personality, Behaviour and Health Study and included those participating in its second and third wave. The history of stressful life events was self-reported at age 15. Data on eating behaviour and attitudes, anxiety, impulsivity and depressiveness were collected at age 18. The effect of the adverse life events on binge eating and on drive for thinness was found to be moderated by the 5-HTTLPR. Adolescent girls who at age 15 had reported a history of frequent adverse life events had elevated scores in EDI-2 Bulimia subscale at age 18 if they were carrying the s-allele. The effect of the s-allele on binge eating was even more pronounced when solely the experience of sexual abuse was considered. The interaction effect of the 5-HTTLPR and the past sexual abuse was also observed on drive for thinness. These data give further support to the idea that adverse life events in childhood may heighten susceptibility to serotonergic dysregulation following stress, and suggest that in individuals vulnerable to eating disorders this may result in disturbed eating behaviours. PMID:22018958

  16. Adverse Events Associated with Hormonal Therapy for Prostate Cancer

    PubMed Central

    Kumar, Ravi J; Barqawi, Al; Crawford, E. David

    2005-01-01

    With expanding indications for androgen deprivation therapy for the treatment of prostate cancer, it is imperative that health care providers be cognizant of the possible adverse effects of therapy, as well as their prevention and treatment. Neurologic and psychiatric effects include depression and declines in cognitive function. Musculoskeletal effects of hormonal therapy include osteoporosis, decrease in muscle mass, and fatigue. Gynecomastia, weight gain, and erectile dysfunction are also seen, as are hematologic effects. Further research is needed to evaluate alternative forms of therapy, such as intermittent hormonal deprivation and antiandrogen monotherapy. PMID:16985883

  17. A pipeline to extract drug-adverse event pairs from multiple data sources

    PubMed Central

    2014-01-01

    Background Pharmacovigilance aims to uncover and understand harmful side-effects of drugs, termed adverse events (AEs). Although the current process of pharmacovigilance is very systematic, the increasing amount of information available in specialized health-related websites as well as the exponential growth in medical literature presents a unique opportunity to supplement traditional adverse event gathering mechanisms with new-age ones. Method We present a semi-automated pipeline to extract associations between drugs and side effects from traditional structured adverse event databases, enhanced by potential drug-adverse event pairs mined from user-comments from health-related websites and MEDLINE abstracts. The pipeline was tested using a set of 12 drugs representative of two previous studies of adverse event extraction from health-related websites and MEDLINE abstracts. Results Testing the pipeline shows that mining non-traditional sources helps substantiate the adverse event databases. The non-traditional sources not only contain the known AEs, but also suggest some unreported AEs for drugs which can then be analyzed further. Conclusion A semi-automated pipeline to extract the AE pairs from adverse event databases as well as potential AE pairs from non-traditional sources such as text from MEDLINE abstracts and user-comments from health-related websites is presented. PMID:24559132

  18. Adverse events associated with vitamin K1: results of a worldwide postmarketing surveillance programme.

    PubMed

    Pereira, S P; Williams, R

    1998-05-01

    We compared adverse events associated with a conventional vitamin K(1) preparation, Konakion, with a new mixed micellar formulation, Konakion MM. Data were obtained worldwide from spontaneous reports, clinical trials and postmarketing surveillance. During the period 1974 to July 1995, an estimated 635 million adults and 728 million children were prescribed Konakion or Konakion MM. Of the 404 adverse events in 286 subjects reported, 387 (96%) were associated with Konakion. Konakion MM accounted for 4% (n=17) of the reported adverse events, and 5% of total sales figures. Thirteen of the 17 adverse events (76%) reported for Konakion MM were minor injection site reactions. Overall, 120 of the adverse events were serious, of which 117 (98%) were associated with Konakion. Eighty-five probable anaphylactoid reactions (of which six were fatal) were reported for conventional Konakion, compared with one non-fatal anaphylactoid reaction for Konakion MM. During the last 12 months of postmarketing surveillance, there were 14 serious adverse events reported in an estimated 21 million individuals treated with Konakion, but none in the 13 million who received Konakion MM. These results suggest that the Cremophor EL-solubilized preparations of vitamin K(1) have a higher profile of adverse events, including anaphylactoid reactions, than the newer mixed micellar preparation, Konakion MM. PMID:15073995

  19. Childhood adversity and behavioral health outcomes for youth: An investigation using state administrative data.

    PubMed

    Lucenko, Barbara A; Sharkova, Irina V; Huber, Alice; Jemelka, Ron; Mancuso, David

    2015-09-01

    This study aimed to measure the relative contribution of adverse experiences to adolescent behavioral health problems using administrative data. Specifically, we sought to understand the predictive value of adverse experiences on the presence of mental health and substance abuse problems for youth receiving publicly funded social and health services. Medicaid claims and other service records were analyzed for 125,123 youth age 12-17 and their biological parents. Measures from administrative records reflected presence of parental domestic violence, mental illness, substance abuse, criminal justice involvement, child abuse and/or neglect, homelessness, and death of a biological parent. Mental health and substance abuse status of adolescents were analyzed as functions of adverse experiences and other youth characteristics using logistic regression. In multivariate analyses, all predictors except parental domestic violence were statistically significant for substance abuse; parental death, parental mental illness, child abuse or neglect and homelessness were statistically significant for mental illness. Odds ratios for child abuse/neglect were particularly high in both models. The ability to identify risks during childhood using administrative data suggests the potential to target prevention and early intervention efforts for children with specific family risk factors who are at increased risk for developing behavioral health problems during adolescence. This study illustrates the utility of administrative data in understanding adverse experiences on children and the advantages and disadvantages of this approach. PMID:26234784

  20. Adverse events during intrahospital transport of critically ill patients: incidence and risk factors

    PubMed Central

    2013-01-01

    Background Transport of critically ill patients for diagnostic or therapeutic procedures is at risk of complications. Adverse events during transport are common and may have significant consequences for the patient. The objective of the study was to collect prospectively adverse events that occurred during intrahospital transports of critically ill patients and to determine their risk factors. Methods This prospective, observational study of intrahospital transport of consecutively admitted patients with mechanical ventilation was conducted in a 38-bed intensive care unit in a university hospital from May 2009 to March 2010. Results Of 262 transports observed (184 patients), 120 (45.8%) were associated with adverse events. Risk factors were ventilation with positive end-expiratory pressure >6 cmH2O, sedation before transport, and fluid loading for intrahospital transports. Within these intrahospital transports with adverse events, 68 (26% of all intrahospital transports) were associated with an adverse event affecting the patient. Identified risk factors were: positive end-expiratory pressure >6 cmH2O, and treatment modification before transport. In 44 cases (16.8% of all intrahospital transports), adverse event was considered serious for the patient. In our study, adverse events did not statistically increase ventilator-associated pneumonia, time spent on mechanical ventilation, or length of stay in the intensive care unit. Conclusions This study confirms that the intrahospital transports of critically ill patients leads to a significant number of adverse events. Although in our study adverse events have not had major consequences on the patient stay, efforts should be made to decrease their incidence. PMID:23587445

  1. Are nilotinib-associated vascular adverse events an under-estimated problem?

    PubMed

    Stève-Dumont, Marie; Baldin, Bernadette; Legros, Laurence; Thyss, Antoine; Re, Daniel; Rocher, Fanny; Ajmia, Florian; Spreux, Anne; Drici, Milou-Daniel

    2015-04-01

    Vascular adverse events have been reported with nilotinib, a tyrosine kinase inhibitor prescribed for chronic myeloid leukaemia. However, few data specify their incidence, or whether they occur in predisposed patients. Hence, we prospectively studied 30 consecutive patients to assess the frequency of such adverse reactions and determine whether the patients presenting with these adverse events bear predisposing factors. From 3 to 73 months after nilotinib initiation, 10 of the 30 patients experienced vascular events. Three patients of these 10 were devoid of any patent cardiovascular risk factor, except for age. This study points out an occurrence more frequent than expected of vascular adverse events associated with nilotinib (> 30% vs. < 1% in summary of product characteristics), and particularly of vascular events of late onset in patients with no pre-existing risk factors. PMID:25619238

  2. Possible adverse events in children treated by manual therapy: a review

    PubMed Central

    2010-01-01

    Background Pediatric manual therapy is controversial within the medical community particularly with respect to adverse events. Pediatric manual therapy (Ped MT) is commonly used by a number of professions such as chiropractors, osteopaths and naturopaths for a variety of treatments in children. Ped MT interventions range from advice, light touch, massage, through to mobilisation and high velocity spinal manipulation. However, current evidence related to adverse events associated with Ped MT is not well understood. Objective To update the clinical research literature from the 2007 report by Vohra, Johnston, Cramer and Humphreys on possible adverse events in children treated by spinal manipulation. Methods A review of the clinical research literature from June 2004 until January 2010 as reported in MEDLINE, PubMed and PubMed Central for adverse events specifically related to the treatment of pediatric cases by manual therapy. Results Only three new clinical studies, one systematic review with meta-analysis and one evidence report were identified. Two clinical studies reported on chiropractic care and one on osteopathic spinal manipulation in children. The systematic review investigated all studies of adverse events and manual therapy and was not specific for pediatric patients. The evidence review focused on effectiveness of spinal manipulation in a variety of musculoskeletal conditions. No serious or catastrophic adverse events were reported in the clinical studies or systematic review. However for adults, it has been estimated that between 0.003% and 0.13% of manual therapy treatments may result in a serious adverse event. Although mild to moderate adverse events are common in adults, an accurate estimate from high quality pediatric studies is currently not available. Conclusions There is currently insufficient research evidence related to adverse events and manual therapy. However, clinical studies and systematic reviews from adult patients undergoing manual

  3. Adverse events among nurse aides in long-term care facilities in Taiwan.

    PubMed

    Yu, Man-Ling; Perng, Shoa-Jen

    2014-01-01

    The study investigated the relationship between the incidence of adverse events and related factors among nurse aides in long-term settings in Taiwan. Of 213 nurse aides, 54.93% experienced an adverse event during the previous year. Four variables, including institution type, certification, years of work experience as a nurse aide, and job type, were found to be associated with the occurrence of adverse events. Findings suggested that health care managers provide training to nurse aides with a specific focus on maintaining quality care. PMID:24375108

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

    NASA Technical Reports Server (NTRS)

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

    2015-01-01

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

  5. The association of adverse childhood experiences and appetitive aggression with suicide attempts and violent crimes in male forensic psychiatry inpatients.

    PubMed

    Dudeck, Manuela; Sosic-Vasic, Zrinka; Otte, Stefanie; Rasche, Katharina; Leichauer, Katharina; Tippelt, Susanne; Shenar, Riad; Klingner, Solveig; Vasic, Nenad; Streb, Judith

    2016-06-30

    Although previous studies in inmates, forensic and psychiatric samples suggest the relation between childhood trauma and suicide behavior as well as between childhood trauma and violent delinquency, the understanding of possible underlying mechanisms is still fragmentary. In a naturalistic study design, we tested if suicidal attempts and violent crimes are differently associated with adverse childhood experiences and levels of appetitive aggression in male forensic psychiatry inpatients. Adverse childhood experiences and appetitive aggression styles were collected by means of self-report measures, suicide attempts were taken from the medical history and violent crimes were appraised by official court records. The data were analyzed by the means of generalized linear models. Results revealed that appetitive aggression and adverse childhood experiences were significant predictors of suicide attempts, whereas violent crimes were associated solely with appetitive aggression. Suicide attempts and violent delinquency in forensic patients seem to be both positively associated with high levels of appetitive aggression, whereas their etiological pathways might differ with regard to adverse childhood experiences. Considering these interrelations to a greater extent might improve both diagnostics and treatment of forensic patients. PMID:27138831

  6. Adverse Childhood Experiences and Intimate Partner Violence: Testing Psychosocial Mediational Pathways among Couples

    PubMed Central

    Mair, Christina; Cunradi, Carol B.; Todd, Michael

    2012-01-01

    Purpose Adverse childhood experiences (ACEs) are associated with an increased likelihood of intimate partner violence (IPV) in adulthood. This study tests whether psychosocial factors, such as depression, anxiety, and impulsivity, and problem drinking mediate associations between ACEs and IPV. Methods Couple data from a cross-sectional sample of married/cohabiting couples residing in 50 medium-to-large California cities (n=1,861 couples) were used. Hypothesized relationships among male and female ACE, male-to-female partner violence (MFPV) and female-to-male partner violence (FMPV), frequency of intoxication, depression, impulsivity, and anxiety were tested with structural equation path models, and the significance of both individual direct paths and indirect associations was determined. Results Male and female partners had positive direct associations between ACEs and depression, anxiety, and impulsivity. Males’ anxiety and impulsivity, and females’ depression, were positively related to MFPV. Males’ depression and frequency of intoxication, and females’ depression, were positively related to FMPV. Indirect associations between male ACEs and MPFV via depression; male ACEs and FMPV via anxiety and impulsivity; and female ACEs and MPFV and FMPV via depression were all positive and significant. Conclusions Adverse childhood experiences impact IPV partially through psychosocial characteristics. Interventions targeted at reducing ACEs and subsequent psychosocial outcomes may help reduce adult IPV. PMID:23084843

  7. Adverse Childhood Experiences and Adult Health Outcomes Among Veteran and Non-Veteran Women

    PubMed Central

    Blosnich, John R.; Dichter, Melissa E.

    2015-01-01

    Abstract Background: Women veterans represent a vulnerable population with unique health needs and disparities in access to care. One constellation of exposures related to subsequent poor health includes adverse childhood experiences (ACEs; e.g., physical and sexual child abuse), though research on impacts of ACEs among women veterans is limited. Methods: Data were drawn from the 2010 Behavioral Risk Factor Surveillance System for the 11 states that included the ACE module (n=36,485). Weighted chi-squared tests and multivariable logistic regression were used to assess the prevalence of ACEs among women veterans compared with women non-veterans and differences in the following outcomes, controlling for ACEs: social support, inadequate sleep, life satisfaction, mental distress, smoking, heavy alcohol use, obesity, diabetes, cardiovascular disease symptoms, asthma, and disability. Results: Women veterans (1.6% of the total sample) reported a higher prevalence of 7 out of 11 childhood adversities and higher mean ACE score than women non-veterans. Women veterans were more likely to be current smokers and report a disability, associations which were attenuated when controlling for ACE. Conclusions: Despite women veterans' higher prevalence of ACE, their health outcomes did not differ substantially from non-veterans. Further research is needed to understand the intersections of traumatic experiences and sources of resilience over the lifecourse among women veterans. PMID:26390379

  8. Prevalence and relationship between adverse childhood experiences and child behavior among young children.

    PubMed

    Clarkson Freeman, Pamela A

    2014-01-01

    Exposure to adverse childhood experiences (ACEs) such as child abuse and neglect impact a child's socioemotional development. Drawing from the methods employed in the Adverse Childhood Experiences (ACE; Felitti et al.,) Study, the present study utilized data from the National Survey of Child and Adolescent Well-Being to examine the prevalence of ACEs among children birth to 6 years, and the relationship of ACEs to emotional and behavioral outcomes 59 to 97 months after the close of investigation or assessment. Logistic regression also was used to examine the cumulative impact of ACEs on child behavior outcomes. By the age of 6, approximately 70% of children experienced three or more ACEs, and there were strong relationships between ACEs. Numerous ACEs were associated with long-term behavioral problems, and results supported a dose-response effect. Three or greater ACEs more than quadrupled the risk of experiencing internalizing problems, and almost quadrupled the risk of experiencing either externalizing or total problems at 59 to 97 months' postinvestigation. Based on these findings, it is crucial for both early screening/assessment and increased collaboration between child welfare and early intervention programs. PMID:25798504

  9. Subtypes of non-suicidal self-injury based on childhood adversity.

    PubMed

    Vaughn, Michael G; Salas-Wright, Christopher P; Underwood, Sarah; Gochez-Kerr, Tatiana

    2015-03-01

    The aim of this study was to examine the latent clusters in non-suicidal self-injury (NSSI) based on childhood adversity. Data were derived from Waves I (2001-2002) and II (2004-2005) of the National Epidemiologic Survey on Alcohol and Related Conditions, a nationally representative sample of U.S. adults. Individuals engaging in NSSI (N = 672) comprised the analytic sample. Latent class statistical analysis was undertaken to elucidate the latent structure of NSSI based on child experiences of physical and sexual abuse, neglect, and family violence. Four-classes of respondents were identified vis-à-vis childhood adversities. A low abuse/neglect class (35.7% of respondents, 91.1% male) demonstrated less mental health and substance use comorbidity and antisocial behavior. A sexual abuse class (43.1% of respondents, 98.6% female) evinced somewhat lower levels of antisocial behavior than the other classes but similarly high levels of mental health disorder and a non-sexual abuse/neglect class (8.3% of respondents, 91.5% male) characterized by varied and intensive forms of antisocial and externalizing behaviors. Finally, a severe high abuse/neglect/family violence class (12.95% of respondents, 100% female) demonstrated high levels of clinical psychiatric and personality disorders. The current project is a nationally representative study of NSSI latent clusters and extends and validates the existence of NSSI subtypes revealed by prior research. PMID:25124121

  10. Health care costs for prostate cancer patients receiving androgen deprivation therapy: treatment and adverse events

    PubMed Central

    Krahn, M.D.; Bremner, K.E.; Luo, J.; Alibhai, S.M.H.

    2014-01-01

    Background Serious adverse events have been associated with androgen deprivation therapy (adt) for prostate cancer (pca), but few studies address the costs of those events. Methods All pca patients (ICD-9-CM 185) in Ontario who started 90 days or more of adt or had orchiectomy at the age of 66 or older during 1995–2005 (n = 26,809) were identified using the Ontario Cancer Registry and drug and hospital data. Diagnosis dates of adverse events—myocardial infarction, acute coronary syndrome, congestive heart failure, stroke, deep vein thrombosis or pulmonary embolism, any diabetes, and fracture or osteoporosis—before and after adt initiation were determined from administrative data. We excluded patients with the same diagnosis before and after adt, and we allocated each patient’s time from adt initiation to death or December 31, 2007, into health states: adt (no adverse event), adt-ae (specified single adverse event), Multiple (>1 event), and Final (≤180 days before death). We used methods for Canadian health administrative data to estimate annual total health care costs during each state, and we examined monthly trends. Results Approximately 50% of 21,811 patients with no pre-adt adverse event developed 1 or more events after adt. The costliest adverse event state was stroke ($26,432/year). Multiple was the most frequent (n = 2,336) and the second most costly health state ($24,374/year). Costs were highest in the first month after diagnosis (from $1,714 for diabetes to $14,068 for myocardial infarction). Costs declined within 18 months, ranging from $784 per 30 days (diabetes) to $1,852 per 30 days (stroke). Adverse events increased the costs of adt by 100% to 265%. Conclusions The economic burden of adverse events is relevant to programs and policies from clinic to government, and that burden merits consideration in the risks and benefits of adt. PMID:24940106

  11. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  12. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  13. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  14. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  15. 24 CFR 2004.28 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Procedure in the event of an... Testimony and Production of Documents § 2004.28 Procedure in the event of an adverse ruling. (a) Opportunity... seek review of that decision pursuant to paragraph (c) of this section. (b) Procedure in the event...

  16. Childhood adversity moderates the effect of ADH1B on risk for alcohol-related phenotypes in Jewish Israeli drinkers.

    PubMed

    Meyers, Jacquelyn L; Shmulewitz, Dvora; Wall, Melanie M; Keyes, Katherine M; Aharonovich, Efrat; Spivak, Baruch; Weizman, Abraham; Frisch, Amos; Edenberg, Howard J; Gelernter, Joel; Grant, Bridget F; Hasin, Deborah

    2015-01-01

    Childhood adversity and genetic variant ADH1B-rs1229984 have each been shown to influence heavy alcohol consumption and disorders. However, little is known about how these factors jointly influence these outcomes. We assessed the main and additive interactive effects of childhood adversity (abuse, neglect and parental divorce) and the ADH1B-rs1229984 on the quantitative phenotypes 'maximum drinks in a day' (Maxdrinks) and DSM-Alcohol Use Disorder (AUD) severity, adjusting for demographic variables, in an Israeli sample of adult household residents (n = 1143) evaluated between 2007 and 2009. Childhood adversity and absence of the protective ADH1B-rs1229984 A allele were associated with greater mean Maxdrinks (mean differences: 1.50; 1.13, respectively) and AUD severity (mean ratios: 0.71; 0.27, respectively). In addition, childhood adversity moderated the ADH1B-rs1229984 effect on Maxdrinks (P < 0.01) and AUD severity (P < 0.05), in that there was a stronger effect of ADH1B-rs1229984 genotype on Maxdrinks and AUD severity among those who had experienced childhood adversity compared with those who had not. ADH1B-rs1229984 impacts alcohol metabolism. Therefore, among those at risk for greater consumption, e.g. those who experienced childhood adversity, ADH1B-rs1229984 appears to have a stronger effect on alcohol consumption and consequently on risk for AUD symptom severity. Evidence for the interaction of genetic vulnerability and early life adversity on alcohol-related phenotypes provides further insight into the complex relationships between genetic and environmental risk factors. PMID:24164917

  17. Childhood adversity moderates the effect of ADH1B on risk for alcohol-related phenotypes in Jewish Israeli drinkers

    PubMed Central

    Meyers, Jacquelyn L.; Shmulewitz, Dvora; Wall, Melanie M.; Keyes, Katherine M.; Aharonovich, Efrat; Spivak, Baruch; Weizman, Abraham; Frisch, Amos; Edenberg, Howard J.; Gelernter, Joel; Grant, Bridget F.; Hasin, Deborah

    2013-01-01

    Childhood adversity and genetic variant ADH1B-rs1229984 have each been shown to influence heavy alcohol consumption and disorders. However, little is known about how these factors jointly influence these outcomes. We assessed the main and additive interactive effects of childhood adversity (abuse, neglect, parental divorce) and the ADH1B-rs1229984 on the quantitative phenotypes “maximum drinks in a day” (Maxdrinks) and DSM-Alcohol Use Disorder (AUD) severity, adjusting for demographic variables, in an Israeli sample of adult household residents (n=1,143) evaluated between 2007–2009. Childhood adversity and absence of the protective ADH1B-rs1229984 A allele were associated with greater mean Maxdrinks [Mean Differences: 1.50; 1.13 respectively] and AUD severity [Mean Ratios: 0.71; 0.27 respectively]). In addition, childhood adversity moderated the ADH1B-rs1229984 effect on Maxdrinks (p<0.01) and AUD severity (p<0.05), in that there was a stronger effect of ADH1B-rs1229984 genotype on Maxdrinks and AUD severity among those who had experienced childhood adversity compared to those who had not. ADH1B-rs1229984 impacts alcohol metabolism. Therefore, among those at risk for greater consumption, e.g., those who experienced childhood adversity, ADH1B-rs1229984 appears to have a stronger effect on alcohol consumption and consequently on risk for AUD symptom severity. Evidence for the interaction of genetic vulnerability and early life adversity on alcohol-related phenotypes provides further insight into the complex relationships between genetic and environmental risk factors. PMID:24164917

  18. Using Registries to Identify Adverse Events in Rheumatic Diseases

    PubMed Central

    Lionetti, Geraldina; Kimura, Yukiko; Schanberg, Laura E.; Beukelman, Timothy; Wallace, Carol A.; Ilowite, Norman T.; Winsor, Jane; Fox, Kathleen; Natter, Marc; Sundy, John S.; Brodsky, Eric; Curtis, Jeffrey R.; Del Gaizo, Vincent; Iyasu, Solomon; Jahreis, Angelika; Meeker-O’Connell, Ann; Mittleman, Barbara B.; Murphy, Bernard M.; Peterson, Eric D.; Raymond, Sandra C.; Setoguchi, Soko; Siegel, Jeffrey N.; Sobel, Rachel E.; Solomon, Daniel; Southwood, Taunton R.; Vesely, Richard; White, Patience H.; Wulffraat, Nico M.; Sandborg, Christy I.

    2013-01-01

    The proven effectiveness of biologics and other immunomodulatory products in inflammatory rheumatic diseases has resulted in their widespread use as well as reports of potential short- and long-term complications such as infection and malignancy. These complications are especially worrisome in children who often have serial exposures to multiple immunomodulatory products. Post-marketing surveillance of immunomodulatory products in juvenile idiopathic arthritis (JIA) and pediatric systemic lupus erythematosus is currently based on product-specific registries and passive surveillance, which may not accurately reflect the safety risks for children owing to low numbers, poor long-term retention, and inadequate comparators. In collaboration with the US Food and Drug Administration (FDA), patient and family advocacy groups, biopharmaceutical industry representatives and other stakeholders, the Childhood Arthritis and Rheumatology Research Alliance (CARRA) and the Duke Clinical Research Institute (DCRI) have developed a novel pharmacosurveillance model (CARRA Consolidated Safety Registry [CoRe]) based on a multicenter longitudinal pediatric rheumatic diseases registry with over 8000 participants. The existing CARRA infrastructure provides access to much larger numbers of subjects than is feasible in single-product registries. Enrollment regardless of medication exposure allows more accurate detection and evaluation of safety signals. Flexibility built into the model allows the addition of specific data elements and safety outcomes, and designation of appropriate disease comparator groups relevant to each product, fulfilling post-marketing requirements and commitments. The proposed model can be applied to other pediatric and adult diseases, potentially transforming the paradigm of pharmacosurveillance in response to the growing public mandate for rigorous post-marketing safety monitoring. PMID:24144710

  19. Association of adverse childhood experiences with shaking and smothering behaviors among Japanese caregivers.

    PubMed

    Isumi, Aya; Fujiwara, Takeo

    2016-07-01

    Shaking and smothering in response to infant crying are life-threatening child abuse. Parental childhood abuse history is known to be one of the most robust risk factors for abusing their offspring. In addition to childhood abuse history, other adverse childhood exposures (ACEs) need to be considered due to co-occurrence. However, few studies have investigated the impact of ACEs on caregivers shaking and smothering their infant. This study aims to investigate the association of ACEs with shaking and smothering among caregivers of infants in Japan. A questionnaire was administered to caregivers participating in a four-month health checkup between September 2013 and August 2014 in Chiba City, Japan, to assess their ACEs (parental death, parental divorce, mentally ill parents, witness of intimate partner violence, physical abuse, neglect, psychological abuse and economic hardship), and shaking and smothering toward their infants (N=4297). Logistic regression analysis was used to examine the cumulative and individual impacts of ACEs on shaking and smothering. Analyses were conducted in 2015. A total of 28.3% reported having experienced at least one ACE during their childhood. We found that only witness of IPV had a significant association with shaking of infant (OR=1.93, 95% CI: 1.03-3.61). The total number of ACEs was not associated with either shaking or smothering. Our findings suggest that shaking and smothering in response to crying can occur regardless of ACEs. Population-based strategies that target all caregivers to prevent shaking and smothering of infants are needed. PMID:27262606

  20. Patient-reported missed nursing care correlated with adverse events.

    PubMed

    Kalisch, Beatrice J; Xie, Boqin; Dabney, Beverly Waller

    2014-01-01

    The aim of this study was to determine the extent and type of missed nursing care as reported by patients and the association with patient-reported adverse outcomes. A total of 729 inpatients on 20 units in 2 acute care hospitals were surveyed. The MISSCARE Survey-Patient was used to collect patient reports of missed care. Patients reported more missed nursing care in the domain of basic care (2.29 ± 1.06) than in communication (1.69 ± 0.71) and in time to respond (1.52 ± 0.64). The 5 most frequently reported elements of missed nursing care were the following: (a) mouth care (50.3%), (b) ambulation (41.3%), (c) getting out of bed into a chair (38.8%), (d) providing information about tests/procedures (27%), and (e) bathing (26.4%). Patients who reported skin breakdown/pressure ulcers, medication errors, new infections, IVs running dry, IVs infiltrating, and other problems during the current hospitalization reported significantly more overall missed nursing care. PMID:24006031

  1. Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea

    PubMed Central

    Holmes, Anna D.; Waite, Kimberly A.; Chen, Michael C.; Palaniswamy, Kiruthi; Wiser, Thomas H.; Draelos, Zoe D.; Rafal, Elyse S.; Werschler, W. Philip; Harvey, Alison E.

    2015-01-01

    Background: The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse events of worsened redness have occasionally been reported with its use. Objective: A detailed analysis of adverse events is needed to accurately define worsening erythema and the adverse-events profile associated with brimonidine gel treatment. Methods and measurements: A retrospective review of related dermatological adverse events occurring in subjects enrolled in the two pivotal four-week Phase 3 studies and the 52-week long-term safety study for brimonidine gel was conducted. Measurements included total adverse-event incidences; number of subjects experiencing adverse events; study discontinuation due to adverse events, severity, onset, episodic duration period; and correlation of adverse events to subject disposition, and rosacea profile. Results: Flushing and erythema were the most commonly reported adverse events, occurring in a total of 5.4 percent of subjects in the Phase 3 studies and in 15.4 percent in the long-term study. Most adverse events were mild or moderate in severity, transient, and intermittent. Adverse events occurred early in treatment, and duration was short-lived in the majority of cases. Adverse-event patterns were not remarkably altered with regard to subject disposition in the long-term study. Conclusion: Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel. PMID:26345379

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

    PubMed Central

    Ackroyd-Stolarz, Stacy; Bowles, Susan K; Giffin, Lorri

    2014-01-01

    Older hospitalized patients are at risk of experiencing adverse events including, but not limited to, hospital-acquired pressure ulcers, fall-related injuries, and adverse drug events. A significant challenge in monitoring and managing adverse events is lack of readily accessible information on their occurrence. Purpose The objective of this retrospective cross-sectional study was to validate diagnostic codes for pressure ulcers, fall-related injuries, and adverse drug events found in routinely collected administrative hospitalization data. Methods All patients 65 years of age or older discharged between April 1, 2009 and March 31, 2011 from a provincial academic health sciences center in Canada were eligible for inclusion in the validation study. For each of the three types of adverse events, a random sample of 50 patients whose records were positive and 50 patients whose records were not positive for an adverse event was sought for review in the validation study (n=300 records in total). A structured health record review was performed independently by two health care providers with experience in geriatrics, both of whom were unaware of the patient’s status with respect to adverse event coding. A physician reviewed 40 records (20 reviewed by each health care provider) to establish interrater agreement. Results A total of 39 pressure ulcers, 56 fall-related injuries, and 69 adverse drug events were identified through health record review. Of these, 34 pressure ulcers, 54 fall-related injuries, and 47 adverse drug events were also identified in administrative data. Overall, the diagnostic codes for adverse events had a sensitivity and specificity exceeding 0.67 (95% confidence interval [CI]: 0.56–0.99) and 0.89 (95% CI: 0.72–0.99), respectively. Conclusion It is feasible and valid to identify pressure ulcers, fall-related injuries, and adverse drug events in older hospitalized patients using routinely collected administrative hospitalization data. The

  3. Culture as a mediator of gene-environment interaction: Cultural consonance, childhood adversity, a 2A serotonin receptor polymorphism, and depression in urban Brazil.

    PubMed

    Dressler, William W; Balieiro, Mauro C; Ferreira de Araújo, Luiza; Silva, Wilson A; Ernesto Dos Santos, José

    2016-07-01

    Research on gene-environment interaction was facilitated by breakthroughs in molecular biology in the late 20th century, especially in the study of mental health. There is a reliable interaction between candidate genes for depression and childhood adversity in relation to mental health outcomes. The aim of this paper is to explore the role of culture in this process in an urban community in Brazil. The specific cultural factor examined is cultural consonance, or the degree to which individuals are able to successfully incorporate salient cultural models into their own beliefs and behaviors. It was hypothesized that cultural consonance in family life would mediate the interaction of genotype and childhood adversity. In a study of 402 adult Brazilians from diverse socioeconomic backgrounds, conducted from 2011 to 2014, the interaction of reported childhood adversity and a polymorphism in the 2A serotonin receptor was associated with higher depressive symptoms. Further analysis showed that the gene-environment interaction was mediated by cultural consonance in family life, and that these effects were more pronounced in lower social class neighborhoods. The findings reinforce the role of the serotonergic system in the regulation of stress response and learning and memory, and how these processes in turn interact with environmental events and circumstances. Furthermore, these results suggest that gene-environment interaction models should incorporate a wider range of environmental experience and more complex pathways to better understand how genes and the environment combine to influence mental health outcomes. PMID:27270123

  4. An Overview of Vascular Adverse Events Associated With Facial Soft Tissue Fillers: Recognition, Prevention, and Treatment.

    PubMed

    Ferneini, Elie M; Ferneini, Antoine M

    2016-08-01

    Minimally invasive facial cosmetic surgery procedures have seen an exponential increase in numbers over the past decade. The most commonly performed procedures are neuromodulator and soft tissue filler procedures. Although soft tissue fillers have a high safety and predictability profile, these procedures recently have been associated with serious and dire adverse events. This article will discuss some of the vascular complications associated with facial soft tissue fillers. Management and prevention of these adverse events also will be discussed. PMID:27067061

  5. Traumatic and Adverse Attachment Childhood Experiences are not Characteristic of OCD but of Depression in Adolescents.

    PubMed

    Ivarsson, Tord; Saavedra, Fanny; Granqvist, Pehr; Broberg, Anders G

    2016-04-01

    We investigated whether adverse attachment experience might contribute to the development of obsessive-compulsive disorder (OCD). We interviewed 100 adolescents, 25 each with primary OCD, depressive disorder (DD), OCD plus DD and general population controls (CTRs) using the adult attachment interview to assess attachment experiences (AEs), including traumatic and adverse AE (TAE). Adolescents with OCD, OCD+DD and DD had little evidence of secure base/safe haven parental behaviour and their childhood attachment needs judged to be rejected as compared to the controls. Overprotection was not characteristic of OCD, and parents using the child for their own needs (elevated levels of involving/role reversal) occurred only in DD, with low levels in OCD, OCD+DD and CTR. Traumatic experiences, often multiple, and/or attachment related were reported significantly more often in the DD group, and was less common in OCD+DD, CTR and particularly in the OCD group. In OCD, little TAE was reported and adverse AE were less serious and seem unlikely to contribute directly to OCD aetiology. In DD and to some degree in OCD+DD serious AE/TAE may have some etiological significance for the depressive states. PMID:26115697

  6. Clinical picture and outcome of Serious Adverse Events in the treatment of Onchocerciasis

    PubMed Central

    Awadzi, Kwablah

    2003-01-01

    Ivermectin (Mectizan®) is the only drug currently recommended for the treatment and control of onchocerciasis. Serious adverse events rarely occur during treatment, except in subjects heavily infected with Loa Loa. This review of drug-related serious adverse events in the treatment of onchocerciasis therefore revisited the pre-Mectizan® reference drugs, DEC and suramin, and other candidate drugs studied extensively for the treatment of human onchocerciasis. The benzimidazole carbamate derivatives and the antibiotic doxycycline were excluded, since no serious adverse events have been reported regarding their use. Using recommended definitions, serious adverse events reported or observed after the use of each drug were summarised, the level of attribution determined, and the results tabulated. Prominence was given to treatment-related deaths. The clinical picture of severe symptomatic postural hypotension is described and used to illustrate the difference between the severity and the seriousness of an adverse event. The epidemiology, management and outcome of serious adverse events are presented. The role of future research is discussed. PMID:14975063

  7. Analysis of adverse events of sunitinib in patients treated for advanced renal cell carcinoma

    PubMed Central

    Cedrych, Ida; Jasiówka, Marek; Niemiec, Maciej; Skotnicki, Piotr

    2016-01-01

    Introduction Treatment of the metastatic stage of renal cell carcinoma is specific because classical chemotherapy is not applicable here. The treatment is mainly based on molecularly targeted drugs, including inhibitors of tyrosine kinases. In many cases the therapy takes many months, and patients often report to general practitioners due to adverse events. In this article, the effectiveness and side effects of one of these drugs are presented. The aim of the study was to analyse of the toxicity and safety of treatment with sunitinib malate in patients with clear cell renal cell carcinoma in the metastatic stage. Material and methods Adverse events were analyzed using retrospective analysis of data collected in a group of 39 patients treated in the Department of Systemic and Generalized Malignancies in the Cancer Center in Krakow, Poland. Results Toxicity of treatment affected 50% of patients. The most common side effects observed were hypertension, thrombocytopenia, stomatitis, diarrhea and weakness. Grade 3 serious adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 4 affected up to 10% of patients. The most common serious adverse events were hypertension and fatigue. Conclusions Sunitinib malate is characterized by a particular type of toxicity. Knowledge of the types and range of adverse events of this drug is an important part of oncological and internal medicine care. PMID:27186181

  8. The Scars of Childhood Adversity: Minor Stress Sensitivity and Depressive Symptoms in Remitted Recurrently Depressed Adult Patients

    PubMed Central

    Burger, Huibert; Elgersma, Hermien; Riper, Heleen; Cuijpers, Pim; Dekker, Jack; Smit, Filip; Bockting, Claudi

    2014-01-01

    Background Childhood adversity may lead to depressive relapse through its long-lasting influence on stress sensitivity. In line with the stress sensitization hypothesis, minor (daily) stress is associated with depressive relapse. Therefore, we examine the impact of childhood adversity on daily stress and its predictive value on prospectively assessed depressive symptoms in recurrently depressed patients. Method Daily stress was assessed in recurrently depressed adult patients, enrolled into two randomized trials while remitted. The reported intensity and frequency of dependent and independent daily stress was assessed at baseline. Independent stress is externally generated, for example an accident happening to a friend, while dependent stress is internally generated, for example getting into a fight with a neighbor. Hierarchical regression analyses were performed with childhood adversity, independent and dependent daily stress as predictor variables of prospectively measured depressive symptoms after three months of follow-up (n = 138). Results We found that childhood adversity was not significantly associated with a higher frequency and intensity of daily stress. The intensity of both independent and dependent daily stress was predictive of depressive symptom levels at follow-up (unadjusted models respectively: B = 0.47, t = 2.05, p = 0.041, 95% CI = 0.02–0.92; B = 0.29, t = 2.20, p = 0.028, 95% CI = 0.03–0.55). No associations were found between childhood adversity and depressive symptoms at follow-up. Conclusion No evidence was found supporting stress sensitization due to the experience of childhood adversity in this recurrently depressed but remitted patient group. Nevertheless, our research indicates that daily stress might be a target for preventive treatment. Trial Registration Trial A: Nederlands Trial Register NTR1907 Trial B: Nederlands Trial Register NTR2503 PMID:25393812

  9. Intra- and extra-familial adverse childhood experiences and a history of childhood psychosomatic disorders among Japanese university students

    PubMed Central

    Masuda, Akinori; Yamanaka, Takao; Hirakawa, Tadatoshi; Koga, Yasuyuki; Minomo, Ryosuke; Munemoto, Takao; Tei, Chuwa

    2007-01-01

    Background Japan has been witnessing a considerable increase in the number of children with psychosomatic disorders. The purpose of this study is to examine the relationship between the risk of psychosomatic disorder in adolescents and intra- and extra-familial adverse childhood experiences (ACEs). Methods A retrospective cohort study of 1592 Japanese university students (52% male, mean age 19.9 years) who completed a survey about intra- and extra-familial ACEs and the incidence of childhood psychosomatic disorders. Intra-familial ACEs included domestic violence, physical violence, emotional abuse, illness in household, parental divorce, no parental affection, and dysfunctional family. Extra-familial ACEs included physical violence or negative recognition by teachers, being bullied in elementary or junior high school, or sexual violence. Results The frequency of psychosomatic disorders among the respondents was 14.8%. Among the 7 intra-familial ACEs, emotional abuse (relative risk, RR = 1.9) and illness in household (RR = 1.7) increased the risk of psychosomatic disorders. Estimates of the relative risk for the 5 extra-familial ACEs were statistically significant and ranged from 1.5 for being bullied in elementary school or physical violence from teachers to 2.4. Students who had 3 or more intra-familial ACEs and 2 or more extra-familial ACEs had a 3.0 relative risk for psychosomatic disorder. Conclusion These results suggest that intra- and extra-familial ACEs are associated with the development of psychosomatic disorders. Therefore, sufficient evaluation of ACEs should be performed in adolescent patients with psychosomatic disorder. PMID:17407551

  10. Identification of patients at high risk for adverse coronary events while awaiting routine coronary angioplasty.

    PubMed Central

    Chester, M.; Chen, L.; Kaski, J. C.

    1995-01-01

    BACKGROUND--Identification of patients at risk for progression of coronary stenosis and adverse clinical events while awaiting coronary angioplasty is desirable. OBJECTIVE--To determine the standard clinical or angiographic variables, or both, present at initial angiography associated with the development of adverse coronary events (unstable angina, myocardial infarction, and angiographic total coronary occlusion) in patients awaiting routine percutaneous transluminal coronary angioplasty (PTCA). PATIENTS AND METHODS--Consecutive male patients on a waiting list for routine PTCA. Routine clinical details were obtained at initial angiography. Stenosis severity was measured using computerised angiography. OUTCOME MEASURES--Development of one or more of myocardial infarction, unstable angina, or angiographic total coronary occlusion while awaiting PTCA were recorded as an adverse event. RESULTS--Some 214 of 219 patients underwent a second angiogram. One had a fatal myocardial infarction and four (2%) were lost to follow up. Fifty patients (23%) developed one or more adverse events (myocardial infarction five, unstable angina 35, total coronary occlusion 23) at a median (range) interval of 8 (3-25) months. Twenty (57%) of the 35 patients with unstable angina developed adverse events compared with 30 (17%) of the 180 with stable angina (P = 0.0001). Plasma triglyceride concentration was 2.6 (1.2) mmol/l in patients with adverse coronary events compared with 2.2 (1.1) mmol/l in those without such events (P < 0.05). Patients with adverse events were younger than those without (54 (9) years v 58 (9) years, P < 0.01). The relative risk of an adverse event in patients with unstable angina and increased plasma triglyceride concentrations was 6.9 compared with those presenting with stable angina and a normal triglyceride concentration (P < 0.02). CONCLUSIONS--The study shows that adverse events are not uncommon in patients awaiting PTCA. Patients at high risk for adverse events

  11. The Logic of Surveillance Guidelines: An Analysis of Vaccine Adverse Event Reports from an Ontological Perspective

    PubMed Central

    Courtot, Mélanie; Brinkman, Ryan R.; Ruttenberg, Alan

    2014-01-01

    Background When increased rates of adverse events following immunization are detected, regulatory action can be taken by public health agencies. However to be interpreted reports of adverse events must be encoded in a consistent way. Regulatory agencies rely on guidelines to help determine the diagnosis of the adverse events. Manual application of these guidelines is expensive, time consuming, and open to logical errors. Representing these guidelines in a format amenable to automated processing can make this process more efficient. Methods and Findings Using the Brighton anaphylaxis case definition, we show that existing clinical guidelines used as standards in pharmacovigilance can be logically encoded using a formal representation such as the Adverse Event Reporting Ontology we developed. We validated the classification of vaccine adverse event reports using the ontology against existing rule-based systems and a manually curated subset of the Vaccine Adverse Event Reporting System. However, we encountered a number of critical issues in the formulation and application of the clinical guidelines. We report these issues and the steps being taken to address them in current surveillance systems, and in the terminological standards in use. Conclusions By standardizing and improving the reporting process, we were able to automate diagnosis confirmation. By allowing medical experts to prioritize reports such a system can accelerate the identification of adverse reactions to vaccines and the response of regulatory agencies. This approach of combining ontology and semantic technologies can be used to improve other areas of vaccine adverse event reports analysis and should inform both the design of clinical guidelines and how they are used in the future. Availability Sufficient material to reproduce our results is available, including documentation, ontology, code and datasets, at http://purl.obolibrary.org/obo/aero. PMID:24667848

  12. Long-term adverse outcomes in survivors of childhood bone sarcoma: the British Childhood Cancer Survivor Study

    PubMed Central

    Fidler, M M; Frobisher, C; Guha, J; Wong, K; Kelly, J; Winter, D L; Sugden, E; Duncan, R; Whelan, J; Reulen, R C; Hawkins, M M

    2015-01-01

    Background: With improved survival, more bone sarcoma survivors are approaching middle age making it crucial to investigate the late effects of their cancer and its treatment. We investigated the long-term risks of adverse outcomes among 5-year bone sarcoma survivors within the British Childhood Cancer Survivor Study. Methods: Cause-specific mortality and risk of subsequent primary neoplasms (SPNs) were investigated for 664 bone sarcoma survivors. Use of health services, health and marital status, alcohol and smoking habits, and educational qualifications were investigated for survivors who completed a questionnaire. Results: Survivors were seven times more likely to experience all-cause mortality than expected, and there were substantial differences in risk depending on tumour type. Beyond 25 years follow-up the risk of dying from all-causes was comparable to the general population. This is in contrast to dying before 25 years where the risk was 12.7-fold that expected. Survivors were also four times more likely to develop a SPN than expected, where the excess was restricted to 5–24 years post diagnosis. Increased health-care usage and poor health status were also found. Nonetheless, for some psychosocial outcomes survivors were better off than expected. Conclusions: Up to 25 years after 5-year survival, bone sarcoma survivors are at substantial risk of death and SPNs, but this is greatly reduced thereafter. As 95% of all excess deaths before 25 years follow-up were due to recurrences and SPNs, increased monitoring of survivors could prevent mortality. Furthermore, bone and breast SPNs should be a particular concern. Since there are variations in the magnitude of excess risk depending on the specific adverse outcome under investigation and whether the survivors were initially diagnosed with osteosarcoma or Ewing sarcoma, risks need to be assessed in relation to these factors. These findings should provide useful evidence for risk stratification and updating

  13. 78 FR 54469 - Solicitation of Written Comments on Draft National Action Plan for Adverse Drug Event Prevention

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

    ... HUMAN SERVICES Solicitation of Written Comments on Draft National Action Plan for Adverse Drug Event... Action Plan for Adverse Drug Event Prevention. DATES: Comments on the draft National Action Plan for Adverse Drug Event Prevention must be received no later than 5 p.m. on October 4, 2013. This...

  14. Vagal Regulation and Internalizing Psychopathology among Adolescents Exposed to Childhood Adversity

    PubMed Central

    McLaughlin, Katie A.; Alves, Sonia; Sheridan, Margaret A.

    2014-01-01

    Childhood adversity (CA) is strongly associated with youth psychopathology. Identifying factors that reduce vulnerability following CA is critical for developing preventive interventions. Vagal tone and vagal reactivity reactivity following psychosocial stressors might influence psychopathology among youths exposed to CA. We acquired heart period and impedance cardiography data to calculate respiratory sinus arrhythmia (RSA) and pre-ejection period (PEP) from 157 adolescents aged 13–17 years at rest and during the Trier Social Stress Test (TSST). Internalizing and externalizing symptoms and multiple forms of CA were assessed. Resting RSA and RSA reactivity interacted with CA in predicting internalizing but not externalizing psychopathology; CA was unassociated with internalizing problems in adolescents with high resting RSA and RSA reactivity. No interactions were observed with PEP. High resting RSA predicted greater vagal rebound and accelerated heart rate recovery following the TSST, highlighting one potential mechanism underlying low internalizing symptoms following CA among youths with high RSA. PMID:24338154

  15. Materialistic Desires or Childhood Adversities as Explanations for Girls' Trading Sex for Benefits.

    PubMed

    Song, Juyoung; Morash, Merry

    2016-01-01

    This study investigates whether high school and younger South Korean girls trade sex with middle-aged men for benefits due to cultural emphasis on materialism/consumerism, childhood adversities, or both. This form of prostitution, referred to as "compensated dating," is common in economically developed East Asian Countries, where there is debate about its causes. Purposeful sampling was used to select a diverse group of 25 girls who described involvement in compensated dating, and a life calendar method was used to guide the interview. The rich data were subjected to thematic analysis to show the nature of prostitution involvement, precursors, and motivations. Data analysis revealed that sole reliance on materialistic desire as an explanation of prostitution obscures the influence of peer pressure and family dysfunction. Findings suggest the need for social services rather than punitive responses to girls involved in compensated dating. PMID:25053795

  16. Adverse childhood experiences influence white matter microstructure in patients with schizophrenia.

    PubMed

    Poletti, Sara; Mazza, Elena; Bollettini, Irene; Locatelli, Clara; Cavallaro, Roberto; Smeraldi, Enrico; Benedetti, Francesco

    2015-10-30

    Integrity of brain white matter (WM) tracts in adulthood could be detrimentally affected by exposure to adverse childhood experiences (ACE). Changes of diffusion tensor imaging (DTI) measures suggesting WM disruption have been reported in patients with schizophrenia together with a history of childhood maltreatment. We therefore hypothesized that ACE could be associated with altered DTI measures of WM integrity in patients with schizophrenia. We tested this hypothesis in 83 schizophrenia patients using whole brain tract-based spatial statistics in the WM skeleton with threshold-free cluster enhancement of DTI measures of WM microstructure: axial, radial, and mean diffusivity (MD), and fractional anisotropy (FA). We observed an inverse correlation between severity of ACE and DTI measures of FA, and a positive correlation with MD in several WM tracts including corona radiata, thalamic radiations, corpus callosum, cingulum bundle, superior longitudinal fasciculus, inferior fronto-occipital fasciculus, uncinate fasciculus. Lower FA and higher MD are indexes of a reduction in fibre coherence and integrity. The association of ACE to reduced FA and increased MD in key WM tracts contributing to the functional integrity of the brain suggests that ACE might contribute to the pathophysiology of schizophrenia through a detrimental action on structural connectivity in critical cortico-limbic networks. PMID:26341951

  17. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... an individual adverse event report? (a) What form must I complete and submit? There are two versions... must attach a copy of that form to your report form. If you are a manufacturer and the information...

  18. 77 FR 17076 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ... event reports for dietary supplements. In the Federal Register of July 14, 2009 (74 FR 34024), FDA..., or Holding Operations for Dietary Supplements'' (72 FR 34752, June 25, 2007) that there were 1,460... Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required...

  19. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... individual reports of adverse events. If you are a health professional or consumer, you may use the FDA Form.... Persons qualified to make a medical judgment include physicians, nurses, risk managers, and...

  20. 21 CFR 803.20 - How do I complete and submit an individual adverse event report?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... event report? 803.20 Section 803.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... individual reports of adverse events. If you are a health professional or consumer, you may use the FDA Form.... Persons qualified to make a medical judgment include physicians, nurses, risk managers, and...

  1. 6 CFR 5.47 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 6 Domestic Security 1 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 5.47 Section 5.47 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY DISCLOSURE OF RECORDS AND INFORMATION Disclosure of Information in Litigation § 5.47 Procedure in the event...

  2. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  3. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  4. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  5. 5 CFR 2417.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 2417.210 Section 2417.210 Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY, GENERAL... PROCEEDINGS Demands or Requests for Testimony and Production of Documents § 2417.210 Procedure in the event...

  6. 5 CFR 295.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 295.210 Section 295.210 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 295.210 Procedure in the event...

  7. 6 CFR 5.47 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 6 Domestic Security 1 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 5.47 Section 5.47 Domestic Security DEPARTMENT OF HOMELAND SECURITY, OFFICE OF THE SECRETARY DISCLOSURE OF RECORDS AND INFORMATION Disclosure of Information in Litigation § 5.47 Procedure in the event...

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

    PubMed Central

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

    2014-01-01

    Background Former studies suggest that prior exposure to adverse experiences such as violence or sexual abuse increases vulnerability to posttraumatic stress reactions in victims of subsequent trauma. However, little is known about how such a history affects responses to terror in the general adolescent population. Objective To explore the role of prior exposure to adverse experiences as risk factors for posttraumatic stress reactions to the Oslo Terror events. Method We used data from 10,220 high school students in a large cross-sectional survey of adolescents in Norway that took place seven months after the Oslo Terror events. Prior exposure assessed was: direct exposure to violence, witnessing of violence, and unwanted sexual acts. We explored how these prior adversities interact with well-established risk factors such as proximity to the events, perceived life threat during the terror events, and gender. Results All types of prior exposure as well as the other risk factors were associated with terror-related posttraumatic stress reactions. The effects of prior adversities were, although small, independent of adolescents’ proximity to the terror events. Among prior adversities, only the effect of direct exposure to violence was moderated by perceived life threat. Exposure to prior adversities increased the risk of posttraumatic stress reactions equally for both genders, but proximity to the terror events and perceived life threat increased the risk more in females. Conclusions Terror events can have a more destabilizing impact on victims of prior adversities, independent of their level of exposure. The findings may be relevant to mental health workers and others providing post-trauma health care. PMID:24872862

  9. A Systematic Review of the Reporting of Adverse Events Associated With Medical Herb Use Among Children

    PubMed Central

    Adams, Denise; Filippelli, Amanda C.; Nasser, Hafsa; Saper, Robert; White, Laura; Vohra, Sunita

    2013-01-01

    Purpose: Information about the safety of herbal medicine often comes from case reports published in the medical literature, thus necessitating good quality reporting of these adverse events. The purpose of this study was to perform a systematic review of the comprehensiveness of reporting of published case reports of adverse events associated with herb use in the pediatric population. Methods: Electronic literature search included 7 databases and a manual search of retrieved articles from inception through 2010. We included published case reports and case series that reported an adverse event associated with exposure to an herbal product by children under the age of 18 years old. We used descriptive statistics. Based on the International Society of Epidemiology's “Guidelines for Submitting Adverse Events Reports for Publication,” we developed and assigned a guideline adherence score (0-17) to each case report. Results: Ninety-six unique journal papers were identified and represented 128 cases. Of the 128 cases, 37% occurred in children under 2 years old, 38% between the ages of 2 and 8 years old, and 23% between the ages of 9 and 18 years old. Twenty-nine percent of cases were the result of an intentional ingestion while 36% were from an unintentional ingestion. Fifty-two percent of cases documented the Latin binomial of the herb ingredients; 41% documented plant part. Thirty-two percent of the cases reported laboratory testing of the herb, 20% documented the manufacturer of the product, and 22% percent included an assessment of the potential concomitant therapies that could have been influential in the adverse events. Mean guideline adherence score was 12.5 (range 6-17). Conclusions: There is considerable need for improvement in reporting adverse events in children following herb use. Without better quality reporting, adverse event reports cannot be interpreted reliably and do not contribute in a meaningful way to guiding recommendations for medicinal herb use

  10. Medicare payment for selected adverse events: building the business case for investing in patient safety.

    PubMed

    Zhan, Chunliu; Friedman, Bernard; Mosso, Andrew; Pronovost, Peter

    2006-01-01

    This study estimates that Medicare extra payments under the hospital prospective payment system (PPS) range from about $700 per case of decubitus ulcer to $9,000 per case of postoperative sepsis in the five types of adverse events identifiable in Medicare claims. Medicare extra payment for the five types of events totals more than $300 million per year, accounting for 0.27 percent of annual Medicare hospital spending. But these extra payments cover less than a third of the extra costs incurred by hospitals in treating these adverse events. We conclude that both Medicare and hospitals gain financially by improving patient safety. PMID:16966737

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

    PubMed Central

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

    2016-01-01

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

  12. Adverse Events of Extracorporeal Ultrasound-Guided High Intensity Focused Ultrasound Therapy

    PubMed Central

    Yu, Tinghe; Luo, Jun

    2011-01-01

    Background High-intensity focused ultrasound (HIFU) is considered to be an alternative to surgery. Extracorporeal ultrasound-guided HIFU (USgFU) has been clinically used to treat solid tumors. Preliminary trials in a small sample of a Western population suggested that this modality was safe. Most trials are performed in China thereby providing comprehensive data for understanding the safety profile. The aim of this study was to evaluate adverse events of USgFU therapy. Methods and Findings Clinical data were searched in 2 Chinese databases. Adverse events of USgFU were summarized and compared with those of magnetic resonance-guided HIFU (MRgFU; for uterine, bone or breast tumor) and transrectal ultrasound-guided HIFU (for prostate cancer or benign prostate hyperplasia). USgFU treatment was performed using 7 types of device. Side effects were evaluated in 13262 cases. There were fewer adverse events in benign lesions than in malignant lesions (11.81% vs. 21.65%, p<0.0001). Rates of adverse events greatly varied between the disease types (0–280%, p<0.0001) and between the applied HIFU devices in both malignant (10.58–44.38%, p<0.0001) and benign lesions (1.67–17.57%, p<0.0001). Chronological analysis did not demonstrate a decrease in the rate of adverse events. Based upon evaluable adverse events, incidences in USgFU were consistent with those in MRgFU or transrectal HIFU. Some side effects frequently occurred following transrectal HIFU were not reported in USgFU. Several events including intrahepatic metastasis, intraoperative high fever, and occlusions of the superior mesenteric artery should be of particular concern because they have not been previously noted. The types of adverse events suggested that they were ultrasonic lesions. Conclusion The frequency of adverse events depended on the location of the lesion and the type of HIFU device; however, side effects of USgFU were not yet understood. USgFU did not decrease the incidence of adverse events compared

  13. Dying to be famous: retrospective cohort study of rock and pop star mortality and its association with adverse childhood experiences

    PubMed Central

    Bellis, Mark A; Hughes, Karen; Sharples, Olivia; Hennell, Tom; Hardcastle, Katherine A

    2012-01-01

    Objectives Rock and pop fame is associated with risk taking, substance use and premature mortality. We examine relationships between fame and premature mortality and test how such relationships vary with type of performer (eg, solo or band member) and nationality and whether cause of death is linked with prefame (adverse childhood) experiences. Design A retrospective cohort analysis based on biographical data. An actuarial methodology compares postfame mortality to matched general populations. Cox survival and logistic regression techniques examine risk and protective factors for survival and links between adverse childhood experiences and cause of death, respectively. Setting North America and Europe. Participants 1489 rock and pop stars reaching fame between 1956 and 2006. Outcomes Stars’ postfame mortality relative to age-, sex- and ethnicity-matched populations (USA and UK); variations in survival with performer type, and in cause of mortality with exposure to adverse childhood experiences. Results Rock/pop star mortality increases relative to the general population with time since fame. Increases are greater in North American stars and those with solo careers. Relative mortality begins to recover 25 years after fame in European but not North American stars. Those reaching fame from 1980 onwards have better survival rates. For deceased stars, cause of death was more likely to be substance use or risk-related in those with more adverse childhood experiences. Conclusions Relationships between fame and mortality vary with performers’ characteristics. Adverse experiences in early life may leave some predisposed to health-damaging behaviours, with fame and extreme wealth providing greater opportunities to engage in risk-taking. Millions of youths wish to emulate their icons. It is important they recognise that substance use and risk-taking may be rooted in childhood adversity rather than seeing them as symbols of success. PMID:23253869

  14. Suffering in silence: a qualitative study of second victims of adverse events

    PubMed Central

    Ullström, Susanne; Andreen Sachs, Magna; Hansson, Johan; Øvretveit, John; Brommels, Mats

    2014-01-01

    Introduction The term ‘second victim’ refers to the healthcare professional who experiences emotional distress following an adverse event. This distress has been shown to be similar to that of the patient—the ‘first victim’. The aim of this study was to investigate how healthcare professionals are affected by their involvement in adverse events with emphasis on the organisational support they need and how well the organisation meets those needs. Methods 21 healthcare professionals at a Swedish university hospital who each had experienced an adverse event were interviewed. Data from semi-structured interviews were analysed by qualitative content analysis using QSR NVivo software for coding and categorisation. Results Our findings confirm earlier studies showing that emotional distress, often long-lasting, follows from adverse events. In addition, we report that the impact on the healthcare professional was related to the organisation’s response to the event. Most informants lacked organisational support or they received support that was unstructured and unsystematic. Further, the formal investigation seldom provided adequate and timely feedback to those involved. The insufficient support and lack of feedback made it more difficult to emotionally process the event and reach closure. Discussion This article addresses the gap between the second victim's need for organisational support and the organisational support provided. It also highlights the need for more transparency in the investigation of adverse events. Future research should address how advanced support structures can meet these needs and provide learning opportunities for the organisation. These issues are central for all hospital managers and policy makers who wish to prevent and manage adverse events and to promote a positive safety culture. PMID:24239992

  15. 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. PMID:26928768

  16. Assessing adverse experiences from infancy through early childhood in home visiting programs.

    PubMed

    McKelvey, Lorraine M; Whiteside-Mansell, Leanne; Conners-Burrow, Nicola A; Swindle, Taren; Fitzgerald, Shalese

    2016-01-01

    The general aim of early intervention and home visiting programs is to support families to minimize Adverse Childhood Experiences (ACEs). However, assessing children's exposure to these risks is complicated because parents serve as the conduit for both measurement and intervention. The primary aims of the study were to develop an assessment of children's exposure to ACEs and to examine concurrently measured parental child abuse and neglect potential and child social-emotional functioning. Home visiting programs in a southern state implemented the Family Map Inventories (FMI) as comprehensive family assessment and child screenings (N=1,282) within one month of enrollment. Children (M=33 months of age, SD=20) were exposed at rates of 27% to one, 18% to two, 11% to three, and 12% to four or more FMI-ACEs. FMI-ACEs were associated with increased parental beliefs and behaviors associated with child abuse and neglect. FMI-ACEs also significantly predicted the likelihood of the child having at-risk social-emotional development; children with 4 or more FMI-ACEs were over 6 times more likely than those with none to have at-risk scores. The findings add to our understanding of the negative impact of trauma on children and families. Assessing these risks as they occur in a family-friendly manner provides a platform for early intervention programs to work with families to increase family strengths and reduce the impacts of adverse experiences for their children. PMID:26455263

  17. Adverse Events of Anti-Tumor Necrosis Factor α Therapy in Ankylosing Spondylitis

    PubMed Central

    Tong, Qiang; Cai, Qing; de Mooij, Tristan; Xu, Xia; Dai, Shengming; Qu, Wenchun; Zhao, Dongbao

    2015-01-01

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

  18. Effects of Childhood Adversity on Bullying and Cruelty to Animals in the United States: Findings from a National Sample

    ERIC Educational Resources Information Center

    Vaughn, Michael G.; Fu, Qiang; Beaver, Kevin M.; DeLisi, Matt; Perron, Brian E.; Howard, Matthew O.

    2011-01-01

    This study examined effects of type of and cumulative burden of childhood adversities on bullying and cruelty to animals in the United States. Data were derived from Waves I and II of the National Epidemiologic Survey on Alcohol and Related Conditions, a nationally representative sample of U.S. adults. Structured psychiatric interviews were…

  19. Impact of Childhood Adversity and Vasopressin receptor 1a Variation on Social Interaction in Adulthood: A Cross-Sectional Study

    PubMed Central

    Liu, Jia Jia; Lou, Fenglan; Lavebratt, Catharina; Forsell, Yvonne

    2015-01-01

    Background Arginine vasopressin (AVP) plays a role in social behavior, through receptor AVPR1A. The promoter polymorphism AVPR1A RS3 has been associated with human social behaviors, and with acute response to stress. Here, the relationships between AVPR1A RS3, early-life stressors, and social interaction in adulthood were explored. Methods Adult individuals from a Swedish population-based cohort (n = 1871) were assessed for self-reported availability of social integration and social attachment and for experience of childhood adversities. Their DNA samples were genotyped for the microsatellite AVPR1A RS3. Results Among males, particularly those homozygous for the long alleles of AVPR1A RS3 were vulnerable to childhood adversity for their social attachment in adulthood. A similar vulnerability to childhood adversity among long allele carriers was found on adulthood social integration, but here both males and females were influenced. Limitation Data were self-reported and childhood adversity data were retrospective. Conclusions Early-life stress influenced the relationship between AVPR1A genetic variants and social interaction. For social attachment, AVPR1A was of importance in males only. The findings add to previous reports on higher acute vulnerability to stress in persons with long AVPR1A RS3 alleles and increased AVP levels. PMID:26295806

  20. Suicidal Ideation, Parent-Child Relationships, and Adverse Childhood Experiences: A Cross-Validation Study Using a Graphical Markov Model

    ERIC Educational Resources Information Center

    Hardt, Jochen; Herke, Max; Schier, Katarzyna

    2011-01-01

    Suicide is one of the leading causes of death in many Western countries. An exploration of factors associated with suicidality may help to understand the mechanisms that lead to suicide. Two samples in Germany (n = 500 and n = 477) were examined via Internet regarding suicidality, depression, alcohol abuse, adverse childhood experiences, and…

  1. Associations between Childhood Adversity and Depression, Substance Abuse and HIV and HSV2 Incident Infections in Rural South African Youth

    ERIC Educational Resources Information Center

    Jewkes, Rachel K.; Dunkle, Kristin; Nduna, Mzikazi; Jama, P. Nwabisa; Puren, Adrian

    2010-01-01

    Objectives: To describe prevalence of childhood experiences of adversity in rural South African youth and their associations with health outcomes. Methods: We analyzed questionnaires and blood specimens collected during a baseline survey for a cluster randomized controlled trial of a behavioral intervention, and also tested blood HIV and herpes…

  2. Risk Factors for Major Adverse Events of Video-Assisted Thoracic Surgery Lobectomy for Lung Cancer

    PubMed Central

    Yang, Jie; Xia, Yan; Yang, Yang; Ni, Zheng-zheng; He, Wen-xin; Wang, Hai-feng; Xu, Xiao-xiong; Yang, Yu-ling; Fei, Ke; Jiang, Ge-ning

    2014-01-01

    Aims: The purpose of this study was to identify the risk factors for major adverse events of VATS (Video-Assisted Thoracic Surgery) lobectomy for primary lung cancer. Methods: 1806 Patients (1032 males, 57.1%) planned to undergo VATS lobectomy for stage IA-IIIA lung cancer from July 2007 to June 2012. The Thoracic Morbidity and Mortality Classification TM&M system was used to evaluate the presence and severity of complications. Postoperative complications were observed during a 30-day follow up. Univariate and multivariate analysis were used to analyze the independent risk factors for major adverse events. Results: Successful rate of VATS lobectomy was 97.6% (1763/1806). Major complications occurred in 129 patients (7.3%), with a mortality of 0.3% (5/1763). Pulmonary complications contribute up to 90.7% of the major complications and 80% of mortality. Logistic regression indicated that comorbidities, elder age ≥70y, operative time ≥240min and hybrid VATS were predictors for major adverse events (P<0.05). Hybrid and converted VATS lobectomy result in higher major adverse events compared with complete VATS, 15.1%, 20.9% and 7.4% respectively (P=0.013). Conclusions: The overall complication rate and mortality of VATS lobectomy are low, while major complications sometimes occur. Pulmonary complications are the most common major complications and cause of mortality. Age ≥70y, comorbidities, operative time ≥240min and Hybrid VATS are predictors of major adverse events. PMID:25013365

  3. New thoughts on the "forgotten" aspect of antimicrobial stewardship: adverse event reporting.

    PubMed

    Hoffmann, Charles; Khadem, Tina; Schweighardt, Anne; Brown, Jack

    2015-01-01

    Antimicrobial stewardship is an activity that optimizes patient care through selection of the most appropriate antimicrobial therapy. Antimicrobial stewardship programs strive to enhance patient care and reduce preventable consequences of antimicrobial use. They are also vital in monitoring for the development of adverse events occurring as a result of antimicrobial therapy, although literature reviews of this activity are scarce. Although randomized controlled trials are considered the gold standard to study the efficacy of a medication, these trials are not designed to test safety end points and often are only able to identify the most commonly occurring and acute adverse events. In addition, prior to a drug going to market, it is difficult to detect rare adverse events because the associated costs are economically untenable given the limited pipeline of novel agents. These limitations in some ways may be resolved with the use of postmarketing surveillance and spontaneous reporting systems such as the United States Food and Drug Administration Adverse Event Reporting System. The focus of this commentary is to highlight the importance of adverse event reporting by antimicrobial stewardship programs to spontaneous reporting systems as a means to improve patient care. PMID:25615401

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

    PubMed

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

    2013-01-01

    The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses. PMID:23794943

  5. Vaxtracker: Active on-line surveillance for adverse events following inactivated influenza vaccine in children.

    PubMed

    Cashman, Patrick; Moberley, Sarah; Dalton, Craig; Stephenson, Jody; Elvidge, Elissa; Butler, Michelle; Durrheim, David N

    2014-09-22

    Vaxtracker is a web based survey for active post marketing surveillance of Adverse Events Following Immunisation. It is designed to efficiently monitor vaccine safety of new vaccines by early signal detection of serious adverse events. The Vaxtracker system automates contact with the parents or carers of immunised children by email and/or sms message to their smart phone. A hyperlink on the email and text messages links to a web based survey exploring adverse events following the immunisation. The Vaxtracker concept was developed during 2011 (n=21), and piloted during the 2012 (n=200) and 2013 (n=477) influenza seasons for children receiving inactivated influenza vaccine (IIV) in the Hunter New England Local Health District, New South Wales, Australia. Survey results were reviewed by surveillance staff to detect any safety signals and compare adverse event frequencies among the different influenza vaccines administered. In 2012, 57% (n=113) of the 200 participants responded to the online survey and 61% (290/477) in 2013. Vaxtracker appears to be an effective method for actively monitoring adverse events following influenza vaccination in children. PMID:25077424

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

    PubMed Central

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

    2009-01-01

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

  7. Adverse health events and late mortality after pediatric allogeneic hematopoietic SCT-two decades of longitudinal follow-up.

    PubMed

    Wilhelmsson, M; Vatanen, A; Borgström, B; Gustafsson, B; Taskinen, M; Saarinen-Pihkala, U M; Winiarski, J; Jahnukainen, K

    2015-06-01

    Treatment-related late toxicities after pediatric allogeneic hematopoietic SCT (allo-HSCT) are increasingly important as long-term survival has become an expected outcome for many transplanted children and adolescents. In a retrospective cohort study, we assessed long-term health outcomes in 204 allo-HSCT survivors transplanted in childhood or adolescence (<20 years) between 1978 through 2000 after a median follow-up time of 12 (range 4-28) years. Data on conditioning regimen, adverse health events (AE) and growth and hormonal substitutions (hormone replacement therapies (HRTs)) were obtained from medical records. AEs were graded retrospectively according to Common Terminology Criteria for Adverse Events v3.0. Late deaths (⩾48 months after allo-HSCT) were evaluated separately. Multivariate analysis demonstrated that chronic GVHD (P<0.000) and longer follow-up time (P<0.05) correlated with AEs, whereas CY-based conditioning was inversely correlated (P<0.002). TBI and longer follow-up duration predicted more severe AEs (P<0.001 and P<0.001, respectively). HRTs were more frequent after TBI. Diabetes type II, dyslipidemia and hypertension were detected in 9, 7 and 7% of the survivors, respectively. Late deaths (n=22) were most frequently due to pulmonary failure (n=7), followed by secondary malignancy (n=5). The occurrence of AEs after pediatric allo-HSCT is high and likely to increase during extended follow-up, particularly in patients who have received TBI. PMID:25798676

  8. Examining the association between early life social adversity and BMI changes in childhood: a life course trajectory analysis

    PubMed Central

    Northstone, K.; Howe, L. D.

    2015-01-01

    Summary Background A number of studies have found associations between multiple aspects of social adversity and obesity in childhood, yet this research has largely been limited to cross‐sectional data. Objectives This study aimed to address this limitation by using life course trajectory methods to determine whether multiple aspects of social adversity in early childhood are associated with changes in body mass index (BMI) throughout childhood. Methods Associations between multiple measures of social adversity from birth to 4 years and subsequent BMI trajectories to age 17 were examined in 7021 children in the Avon Longitudinal Study of Parents and Children. Results Higher BMI throughout ages 12–17 were observed for children whose parents had separated, were exposed to frequent residential mobility or who experienced moderate or great household financial difficulty in early childhood. After adjustment for confounding variables, associations were attenuated but remained for both moderate (two moves) and high (≥3 moves) residential mobility (mean % difference in BMI at age 17 for children experiencing moderate and high residential mobility before age 4 compared with those experiencing no moves: 2.3; 95% CI: 0.5–4.2; P = 0.015 and 4.2; 95% CI: 1.4–7.0; P = 0.004, respectively). Conclusions Associations between BMI and social adversity in childhood are present but largely explained by background socioeconomic position. However, there remain small but important differences between the BMI of children who are exposed to frequent residential mobility in early childhood after adjustment for socioeconomic and other confounders. PMID:26305573

  9. Novel algorithms for improved pattern recognition using the US FDA Adverse Event Network Analyzer.

    PubMed

    Botsis, Taxiarchis; Scott, John; Goud, Ravi; Toman, Pamela; Sutherland, Andrea; Ball, Robert

    2014-01-01

    The medical review of adverse event reports for medical products requires the processing of "big data" stored in spontaneous reporting systems, such as the US Vaccine Adverse Event Reporting System (VAERS). VAERS data are not well suited to traditional statistical analyses so we developed the FDA Adverse Event Network Analyzer (AENA) and three novel network analysis approaches to extract information from these data. Our new approaches include a weighting scheme based on co-occurring triplets in reports, a visualization layout inspired by the islands algorithm, and a network growth methodology for the detection of outliers. We explored and verified these approaches by analysing the historical signal of Intussusception (IS) after the administration of RotaShield vaccine (RV) in 1999. We believe that our study supports the use of AENA for pattern recognition in medical product safety and other clinical data. PMID:25160375

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

    PubMed Central

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

    2000-01-01

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

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

    PubMed

    Beable, Anne

    2013-09-01

    A patient with apparently well-controlled epilepsy with a painful musculoskeletal condition was treated successfully with two sessions of acupuncture. However, 4 h after the first treatment and during the second, an adverse event involving impairment of consciousness occurred. The patient subsequently experienced an increased frequency of complex partial seizures resulting in the loss of his driving licence. A detailed retrospective review of the past medical history indicated that the patient probably had comorbidities in the form of rapid eye movement sleep behaviour disorder and dysfunctional somatosensory/vestibular processing. Acupuncture may have triggered the adverse event via shared neurosubstrates. This adverse event raises possible implications regarding safe clinical acupuncture practice. PMID:23660010

  12. Association of adverse childhood experiences, age of menarche, and adult reproductive behavior: does the androgen receptor gene play a role?

    PubMed

    Jorm, Anthony F; Christensen, Helen; Rodgers, Bryan; Jacomb, Patricia A; Easteal, Simon

    2004-02-15

    Previous research has reported associations between adverse childhood experiences, early menarche, and early sexual activity. One hypothesis to account for these findings is that an X-linked androgen receptor GGC-repeat polymorphism predisposes fathers to behaviors which include family abandonment and their daughters to earlier menarche and sexual activity and less stable relationships. Retrospective data relevant to this theory were examined from a community survey involving 3,702 women in the age groups 20-24, 40-44, and 60-64 years, and another involving 908 women aged 18-79 years. Earlier age of menarche was found to be associated with adverse childhood experiences and earlier sexual activity. However, the androgen receptor gene polymorphism was unrelated to adverse fathering behavior or to marital breakdown. PMID:14755454

  13. Mobility therapy and central or peripheral catheter-related adverse events in an ICU in Brazil*

    PubMed Central

    Lima, Natália Pontes; da Silva, Gregório Marques Cardim; Park, Marcelo; Pires-Neto, Ruy Camargo

    2015-01-01

    OBJECTIVE: To determine whether mobility therapy is associated with central or peripheral catheter-related adverse events in critically ill patients in an ICU in Brazil. METHODS: A retrospective analysis of the daily medical records of patients admitted to the Clinical Emergency ICU of the University of São Paulo School of Medicine Hospital das Clínicas Central Institute between December of 2009 and April of 2011. In addition to the demographic and clinical characteristics of the patients, we collected data related to central venous catheters (CVCs), hemodialysis (HD) catheters and indwelling arterial catheters (IACs): insertion site; number of catheter days; and types of adverse events. We also characterized the mobility therapy provided. RESULTS: Among the 275 patients evaluated, CVCs were used in 49%, HD catheters were used in 26%, and IACs were used in 29%. A total of 1,268 mobility therapy sessions were provided to patients while they had a catheter in place. Catheter-related adverse events occurred in 20 patients (a total of 22 adverse events): 32%, infection; 32%, obstruction; and 32%, accidental dislodgement. We found that mobility therapy was not significantly associated with any catheter-related adverse event, regardless of the type of catheter employed: CVC-OR = 0.8; 95% CI: 0.7-1.0; p = 0.14; HD catheter-OR = 1.04; 95% CI: 0.89-1.21; p = 0.56; or IAC-OR = 1.74; 95% CI: 0.94-3.23; p = 0.07. CONCLUSIONS: In critically ill patients, mobility therapy is not associated with the incidence of adverse events involving CVCs, HD catheters, or IACs. PMID:26176520

  14. Antipsychotics-Associated Serious Adverse Events in Children: An Analysis of the FAERS Database

    PubMed Central

    Kimura, Goji; Kadoyama, Kaori; Brown, J.B.; Nakamura, Tsutomu; Miki, Ikuya; Nisiguchi, Kohshi; Sakaeda, Toshiyuki; Okuno, Yasushi

    2015-01-01

    Objective: The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess serious adverse events induced by the administration of antipsychotics to children. Methods: Following pre-processing of FAERS data by elimination of duplicated records as well as adjustments to standardize drug names, reports involving haloperidol, olanzapine, quetiapine, clozapine, ziprasidone, risperidone, and aripiprazole were analyzed in children (age 0-12). Signals in the data that signified a drug-associated adverse event were detected via quantitative data mining algorithms. The algorithms applied to this study include the empirical Bayes geometric mean, the reporting odds ratio, the proportional reporting ratio, and the information component of a Bayesian confidence propagation neural network. Neuroleptic malignant syndrome (NMS), QT prolongation, leukopenia, and suicide attempt were focused on as serious adverse events. Results: In regard to NMS, the signal scores for haloperidol and aripiprazole were greater than for other antipsychotics. Significant signals of the QT prolongation adverse event were detected only for ziprasidone and risperidone. With respect to leukopenia, the association with clozapine was noteworthy. In the case of suicide attempt, signals for haloperidol, olanzapine, quetiapine, risperidone, and aripiprazole were detected. Conclusions: It was suggested that there is a level of diversity in the strength of the association between various first- and second-generation antipsychotics with associated serious adverse events, which possibly lead to fatal outcomes. We recommend that research be continued in order to gather a large variety and quantity of related information, and that both available and newly reported data be placed in the context of multiple medical viewpoints in order to lead to improved levels of care. PMID:25589889

  15. A prognostic model for short term adverse events in normotensive patients with pulmonary embolism.

    PubMed

    Agterof, Mariette J; Schutgens, Roger E G; Moumli, Noureddine; Eijkemans, M J C; van der Griend, René; Tromp, Ellen A M; Biesma, Douwe H

    2011-08-01

    Risk stratification of patients with PE has gained interest in terms of the identification of patients in whom treatment on an outpatient base can be considered. Previous studies are of limited value due to their focus on adverse clinical events within several months after diagnosis of PE. We developed a prognostic model, based on easily accessible, clinical, and laboratory parameters, to predict adverse events during the first 10 days after the diagnosis of acute PE. We have analyzed the data of 210 outpatients with confirmed PE. Collected data included medical history, pulse rate, blood pressure, NT-proBNP, and D-dimer concentrations. The primary outcome was the occurrence of adverse clinical events in a 10 day follow-up period. Our final prognostic model to predict short-term adverse events consists of NT-proBNP levels, D-dimer concentrations, pulse rate, and the occurrence of active malignancy; the total score ranges from 0 to 37 points. Patients with a low score (no active malignancy, pulse rate <90 bpm, NT-proBNP <500 pg/ml, and D-dimer <3,000 μg/l FEU) have a 10-day adverse event risk <1.5%. This risk increases to over 30% in patients with a maximum score, based on high pulse rate, D-dimer concentrations, and NT-proBNP levels. Our prognostic model, once prospectively validated in an independent sample of patients, can be used in the early risk stratification of PE to estimate the risk of adverse events and to differentiate between candidates for in- or out- hospital treatment. PMID:21630313

  16. Glaucoma-related Adverse Events in the Infant Aphakia Treatment Study (IATS) : One Year Results

    PubMed Central

    Beck, AD; Freedman, SF; Lynn, MJ; Bothun, ED; Neely, D; Lambert, SR

    2012-01-01

    Objective To report the incidence of glaucoma and glaucoma suspects in the Infant Aphakia Treatment Study (IATS). To evaluate risk factors for the development of a glaucoma-related adverse event in IATS in the first year of follow-up. Methods 114 infants with a unilateral congenital cataract were assigned to undergo cataract surgery between 1 to 6 months of age either with (IOL) or without IOL implantation (CL). Standardized definitions of glaucoma and glaucoma suspect were created and used in the IATS. Results Ten patients (9%) developed glaucoma and 4 patients (4%) were glaucoma suspects for a total of 14 patients (12%) with a glaucoma-related adverse event in the treated eye through the first year of follow-up. Five CL patients (9%) and 9 IOL patients (16%) developed a glaucoma-related adverse event. The odds of developing a glaucoma-related adverse event was 3.1 times higher for a child with persistent fetal vasculature (PFV), and 1.6 times higher for each month of age younger at cataract surgery. Conclusions Modern surgical techniques do not eliminate the early development of glaucoma following congenital cataract surgery with or without an intraocular lens. Younger patients with or without PFV seem more likely to develop a glaucoma-related adverse event in the first year of follow-up.Vigilance for the early development of glaucoma is needed following congenital cataract surgery, especially when surgery is performed during early infancy or with PFV. Five year follow-up data for the IATS will likely reveal more glaucoma-related adverse events. PMID:22084157

  17. Unexpected adverse childhood experiences and subsequent drug use disorder: a Swedish population study (1995–2011)

    PubMed Central

    Giordano, Giuseppe N.; Ohlsson, Henrik; Kendler, Kenneth S.; Sundquist, Kristina; Sundquist, Jan

    2014-01-01

    Aims Exposure to extraordinary traumatic experience is one acknowledged risk factor for drug use. We aim to analyse the influence of potentially life-changing childhood stressors, experienced second-hand, on later drug use disorder in a national population of Swedish adolescent and young adults (aged 15–26 years). Design We performed Cox Proportional Hazard regression analyses, complemented with co-relative pair comparisons. Setting Sweden Participants All individuals in the Swedish population born 1984 to 1995, who were registered in Sweden at the end of the calendar year they turned 14 years of age. Our follow-up time (Mean: 6.2 years; Range 11 years) started at the year they turned 15 and continued to December 2011 (N=1,409,218). Measurements Our outcome variable was drug use disorder, identified from medical, legal and pharmacy registry records. Childhood stressors, as per DSM-IV stressor criteria, include death of an immediate family member and second-hand experience of diagnoses of malignant cancer, serious accidental injury, and victim of assault. Other covariates include parental divorce, familial psychological well-being, and familial drug and alcohol use disorders. Findings After adjustment for all considered confounders, individuals exposed to childhood stressors ‘parental death’ or ‘parental assault’ had over twice the risk of drug use disorder than those who were not (HR = 2.63 (2.23–3.09) and 2.39 (2.06–2.79), respectively). Conclusions Children under 15 who experience second-hand an extraordinary traumatic event (such as a parent or sibling being assaulted, diagnosed with cancer, or dying) appear to have approximately twice the risk of developing a drug use disorder than those who do not. PMID:24612271

  18. 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

  19. Automating identification of adverse events related to abnormal lab results using standard vocabularies.

    PubMed

    Brandt, C A; Lu, C C; Nadkarni, P M

    2005-01-01

    Laboratory data need to be imported automatically into central Clinical Study Data Management Systems (CSDMSs), and abnormal laboratory data need to be linked to clinically related adverse events. This import of laboratory data can be automated through mapping to standard vocabularies with HL7/LOINC mapping to the metadata within a CSDMS. We have designed a system that uses the UMLS metathesaurus as a common source to map or link abnormal laboratory values to adverse event CTCAE coded terms and grades in the metadata of TrialDB, a generic CSDMS. PMID:16779190

  20. Additive contributions of childhood adversity and recent stressors to inflammation at midlife: Findings from the MIDUS study.

    PubMed

    Hostinar, Camelia E; Lachman, Margie E; Mroczek, Daniel K; Seeman, Teresa E; Miller, Gregory E

    2015-11-01

    We examined the joint contributions of self-reported adverse childhood experiences (ACEs) and recent life events (RLEs) to inflammation at midlife, by testing 3 competing theoretical models: stress generation, stress accumulation, and early life stress sensitization. We aimed to identify potential mediators between adversity and inflammation. Participants were 1,180 middle-aged and older adults from the Midlife in the United States (MIDUS) Biomarker Project (M age = 57.3 years, SD = 11.5; 56% female). A composite measure of inflammation was derived from 5 biomarkers: serum levels of C-reactive protein, interleukin-6, fibrinogen, E-selectin, and ICAM-1. Participants provided self-report data regarding ACEs, RLEs, current lifestyle indices (cigarette smoking, alcohol consumption, physical exercise, waist circumference), current depressive symptoms, and demographic/biomedical characteristics. We also used indices of hypothalamic-pituitary-adrenocortical outflow (12-hr urinary cortisol) and sympathetic nervous system output (12-hr urinary norepinephrine and epinephrine). Analyses indicated that ACEs and RLEs were independently associated with higher levels of inflammation, controlling for each other's effects. Their interaction was not significant. The results were consistent with the hypothesis that associations between ACEs and inflammation were mediated through higher urinary norepinephrine output, greater waist circumference, smoking, and lower levels of exercise, whereas higher waist circumference and more smoking partially mediated the association between RLEs and inflammation. In support of the stress accumulation model, ACEs and RLEs had unique and additive contributions to inflammation at midlife, with no evidence of synergistic effects. Results also suggested that norepinephrine output and lifestyle indices may help explain how prior stressors foster inflammation at midlife. PMID:26389605

  1. Adverse Childhood Experiences and Use of Cigarettes and Smokeless Tobacco Products.

    PubMed

    Alcalá, Héctor E; von Ehrenstein, Ondine S; Tomiyama, A Janet

    2016-10-01

    Adverse childhood experiences (ACEs) have been linked to increased use of tobacco products later in life. However, studies to date have ignored smokeless tobacco products. To address this, data from the 2011 Behavioral Risk Factor Surveillance System, which interviewed adults 18 years and over (N = 102,716) were analyzed. Logistic regression models were fit to estimate odds ratios of ever smoking, current smoking and current smokeless tobacco use in relation to ACEs. Results showed that less than 4 % of respondents currently used smokeless tobacco products, while 44.95 and 18.57 % reported ever and current smoking, respectively. Physical abuse (OR 1.40; 95 % CI 1.14, 1.72), emotional abuse (OR 1.41; 95 % CI 1.19, 1.67), sexual abuse (OR 0.70; 95 % CI 0.51, 0.95), living with a drug user (OR 1.50; 95 % CI 1.17, 1.93), living with someone who was jailed (OR 1.50; 95 % CI 1.11, 2.02) and having parents who were separated or divorced (OR 1.31; 95 % CI 1.09, 1.57) were associated with smokeless tobacco use in unadjusted models. After accounting for confounders, physical abuse (OR 1.43; 95 % CI 1.16, 1.78), emotional abuse (OR 1.32; 95 % CI 1.10, 1.57), living with a problem drinker (OR 1.30; 95 % CI 1.08, 1.58), living with a drug user (OR 1.31; 95 % CI 1.00, 1.72) and living with adults who treated each other violently (OR 1.30; 95 % CI 1.05, 1.62) were associated with smokeless tobacco use. Living with someone who was mentally ill (OR 0.70; 95 % CI 0.53, 0.92) was associated with smokeless tobacco use after accounting for confounders and all ACEs. Results indicated that some childhood adversities are associated with use of smokeless tobacco products. Special attention is needed to prevent tobacco use of different types among those experiencing ACEs. PMID:27000040

  2. Impact of Adverse Childhood Experiences on Intimate Partner Violence Perpetration among Sri Lankan Men.

    PubMed

    Fonseka, Ruvani W; Minnis, Alexandra M; Gomez, Anu Manchikanti

    2015-01-01

    In Sri Lanka, over one in three women experience intimate partner violence (IPV) victimization in their lifetime, making it a serious public health concern. Adverse childhood experiences (ACEs) such as child abuse and neglect, witnessing domestic violence, parental separation, and bullying are also widespread. Studies in Western settings have shown positive associations between ACEs and IPV perpetration in adulthood, but few have examined this relationship in a non-Western context. In the present study, we examined the association of ACEs with IPV perpetration among Sri Lankan men surveyed for the UN Multi-Country Study on Men and Violence in Asia and the Pacific. We found statistically significant positive associations between the number of ACE categories (ACE score) and emotional, financial, physical, and sexual IPV perpetration among Sri Lankan men. We analyzed the contributions of each ACE category and found that childhood abuse was strongly associated with perpetration of IPV in adulthood, with sexual abuse associated with the greatest increase in odds of perpetration (Adjusted odds ratio 2.36; 95% confidence interval: 1.69, 3.30). Witnessing abuse of one's mother was associated with the greatest increase in the odds of perpetrating physical IPV (AOR 1.82; 95% CI: 1.29, 2.58), while lack of a male parental figure was not associated with physical IPV perpetration (AOR 0.76; 95% CI: 0.53, 1.09). These findings support a social learning theory of IPV perpetration, in which children who are exposed to violence learn to perpetrate IPV in adulthood. They also suggest that in Sri Lanka, being raised in a female-headed household does not increase the risk of IPV perpetration in adulthood compared to being raised in a household with a male parental figure. The relationship between being raised in a female-headed household (the number of which increased dramatically during Sri Lanka's recent civil war) and perpetration of IPV warrants further study. Interventions that

  3. Impact of Adverse Childhood Experiences on Intimate Partner Violence Perpetration among Sri Lankan Men

    PubMed Central

    Fonseka, Ruvani W.; Minnis, Alexandra M.; Gomez, Anu Manchikanti

    2015-01-01

    In Sri Lanka, over one in three women experience intimate partner violence (IPV) victimization in their lifetime, making it a serious public health concern. Adverse childhood experiences (ACEs) such as child abuse and neglect, witnessing domestic violence, parental separation, and bullying are also widespread. Studies in Western settings have shown positive associations between ACEs and IPV perpetration in adulthood, but few have examined this relationship in a non-Western context. In the present study, we examined the association of ACEs with IPV perpetration among Sri Lankan men surveyed for the UN Multi-Country Study on Men and Violence in Asia and the Pacific. We found statistically significant positive associations between the number of ACE categories (ACE score) and emotional, financial, physical, and sexual IPV perpetration among Sri Lankan men. We analyzed the contributions of each ACE category and found that childhood abuse was strongly associated with perpetration of IPV in adulthood, with sexual abuse associated with the greatest increase in odds of perpetration (Adjusted odds ratio 2.36; 95% confidence interval: 1.69, 3.30). Witnessing abuse of one’s mother was associated with the greatest increase in the odds of perpetrating physical IPV (AOR 1.82; 95% CI: 1.29, 2.58), while lack of a male parental figure was not associated with physical IPV perpetration (AOR 0.76; 95% CI: 0.53, 1.09). These findings support a social learning theory of IPV perpetration, in which children who are exposed to violence learn to perpetrate IPV in adulthood. They also suggest that in Sri Lanka, being raised in a female-headed household does not increase the risk of IPV perpetration in adulthood compared to being raised in a household with a male parental figure. The relationship between being raised in a female-headed household (the number of which increased dramatically during Sri Lanka’s recent civil war) and perpetration of IPV warrants further study. Interventions

  4. Hematological Parameters Improve Prediction of Mortality and Secondary Adverse Events in Coronary Angiography Patients

    PubMed Central

    Gijsberts, Crystel M.; den Ruijter, Hester M.; de Kleijn, Dominique P.V.; Huisman, Albert; ten Berg, Maarten J.; van Wijk, Richard H.A.; Asselbergs, Folkert W.; Voskuil, Michiel; Pasterkamp, Gerard; van Solinge, Wouter W.; Hoefer, Imo E.

    2015-01-01

    Abstract Prediction of primary cardiovascular events has been thoroughly investigated since the landmark Framingham risk score was introduced. However, prediction of secondary events after initial events of coronary artery disease (CAD) poses a new challenge. In a cohort of coronary angiography patients (n = 1760), we examined readily available hematological parameters from the UPOD (Utrecht Patient Oriented Database) and their addition to prediction of secondary cardiovascular events. Backward stepwise multivariable Cox regression analysis was used to test their ability to predict death and major adverse cardiovascular events (MACE). Continuous net reclassification improvement (cNRI) and integrated discrimination improvement (IDI) measures were calculated for the hematological parameters on top of traditional risk factors to assess prediction improvement. Panels of 3 to 8 hematological parameters significantly improved prediction of death and adverse events. The IDIs ranged from 0.02 to 0.07 (all P < 0.001) among outcome measures and the cNRIs from 0.11 to 0.40 (P < 0.001 in 5 of 6 outcome measures). In the hematological panels red cell distribution width (RDW) appeared most often. The multivariable adjusted hazard ratio of RDW per 1 standard deviation (SD) increase for MACE was 1.19 [1.08–1.32], P < 0.001. Routinely measured hematological parameters significantly improved prediction of mortality and adverse events in coronary angiography patients. Accurately indicating high-risk patients is of paramount importance in clinical decision-making. PMID:26559287

  5. Risky Health Behaviors among Mothers-to-Be: The Impact of Adverse Childhood Experiences

    PubMed Central

    Chung, Esther K.; Nurmohamed, Laila; Mathew, Leny; Elo, Irma T.; Coyne, James C.; Culhane, Jennifer F.

    2010-01-01

    Objectives Adverse childhood experiences (ACEs) are risk factors for health problems later in life. This study aims to 1) assess the influence of ACEs on risky health behaviors among mothers-to-be, and 2) determine whether a dose response occurs between ACEs and risky behaviors. Methods Prospective survey of women attending health centers conducted at the first prenatal care visit, and 3 and 11 months postpartum. Surveys obtained information on maternal sociodemographic and health characteristics, and 7 ACEs prior to age 16. Risky behaviors included smoking, alcohol use, marijuana use and other illicit drug use during pregnancy. Results Our sample (n=1,476) consisted of low-income (mean annual personal income: $8272), young (mean age: 24 yrs), African American (71%), single (75%) women. Twenty-three percent of women reported smoking even after finding out they were pregnant, 7% reported alcohol use, and 7% reported illicit drug use during pregnancy. Nearly three-fourths (71%) had one or more ACE(s). There was a higher prevalence of each risky behavior among those exposed to each ACE than among those unexposed. The exception was alcohol use during pregnancy where there was not an increased risk among those exposed when compared to those unexposed to witnessing a shooting or having a guardian in trouble with the law or in jail. The adjusted odds ratio for each risky behavior was greater than 2.5 for those with ≥ 3 ACEs when compared to those without. Conclusions ACEs were associated with risky health behaviors reported by mothers-to-be. Greater efforts should target the prevention of ACEs to lower the risk for adverse health behaviors that have serious consequences for adults and their children. PMID:20599179

  6. Association between childhood adversities and long-term suicidality among South Africans from the results of the South African Stress and Health study: a cross-sectional study

    PubMed Central

    Bruwer, Belinda; Govender, Ravi; Bishop, Melanie; Williams, David R; Stein, Dan J; Seedat, Soraya

    2014-01-01

    Objective Suicide and suicidal behaviours are significant public health problems and a leading cause of death worldwide and in South Africa. We examined the association between childhood adversities and suicidal behaviour over the life course. Methods A national probability sample of 4351 South African adult participants (aged 18 years and older) in the South African Stress and Health (SASH) study was interviewed as part of the World Mental Health Surveys initiative. Respondents provided sociodemographic and diagnostic information, as well as an account of suicide-related thoughts and behaviours. Suicidality or suicidal behaviour were defined as were defined as suicide attempts and suicidal ideation in the total sample, and suicide plans and attempts among ideators. Childhood adversities included physical abuse, sexual abuse, parental death, parental divorce, other parental loss, family violence, physical illness and financial adversity. The association between suicidality and childhood adversities was examined using discrete-time survival models. Results More than a third of the respondents with suicidal behaviour experienced at least one childhood adversity, with physical abuse, parental death and parental divorce being the most prevalent adversities. Physical abuse, sexual abuse and parental divorce were identified as significant risk markers for lifetime suicide attempts, while physical abuse and parental divorce were significantly correlated with suicidal ideation. Two or more childhood adversities were associated with a twofold higher risk of lifetime suicide attempts. Sexual abuse (OR 9.3), parental divorce (OR 3.1) and childhood physical abuse (OR 2.2) had the strongest associations with lifetime suicide attempts. The effect of childhood adversities on suicidal tendencies varied over the life course. For example, sexual abuse was significantly associated with suicide attempts during childhood and teen years, but not during young and later adulthood

  7. National household survey of adverse childhood experiences and their relationship with resilience to health-harming behaviors in England

    PubMed Central

    2014-01-01

    Background Epidemiological and biomedical evidence link adverse childhood experiences (ACEs) with health-harming behaviors and the development of non-communicable disease in adults. Investment in interventions to improve early life experiences requires empirical evidence on levels of childhood adversity and the proportion of HHBs potentially avoided should such adversity be addressed. Methods A nationally representative survey of English residents aged 18 to 69 (n = 3,885) was undertaken during the period April to July 2013. Individuals were categorized according to the number of ACEs experienced. Modeling identified the proportions of HHBs (early sexual initiation, unintended teenage pregnancy, smoking, binge drinking, drug use, violence victimization, violence perpetration, incarceration, poor diet, low levels of physical exercise) independently associated with ACEs at national population levels. Results Almost half (47%) of individuals experienced at least one of the nine ACEs. Prevalence of childhood sexual, physical, and verbal abuse was 6.3%, 14.8%, and 18.2% respectively (population-adjusted). After correcting for sociodemographics, ACE counts predicted all HHBs, e.g. (0 versus 4+ ACEs, adjusted odds ratios (95% confidence intervals)): smoking 3.29 (2.54 to 4.27); violence perpetration 7.71 (4.90 to 12.14); unintended teenage pregnancy 5.86 (3.93 to 8.74). Modeling suggested that 11.9% of binge drinking, 13.6% of poor diet, 22.7% of smoking, 52.0% of violence perpetration, 58.7% of heroin/crack cocaine use, and 37.6% of unintended teenage pregnancy prevalence nationally could be attributed to ACEs. Conclusions Stable and protective childhoods are critical factors in the development of resilience to health-harming behaviors in England. Interventions to reduce ACEs are available and sustainable, with nurturing childhoods supporting the adoption of health-benefiting behaviors and ultimately the provision of positive childhood environments for future generations

  8. Adverse Health Events Following Intermittent and Continuous Androgen Deprivation in Metastatic Prostate Cancer Patients

    PubMed Central

    Hershman, Dawn L.; Unger, Joseph M.; Wright, Jason D.; Ramsey, Scott; Till, Cathee; Tangen, Catherine M.; Barlow, William E.; Blanke, Charles; Thompson, Ian M; Hussain, Maha

    2016-01-01

    Importance Although intermittent androgen deprivation therapy (ADT) has not been associated with better overall survival in prostate cancer (PC), it has the potential for lower side effects. The incidence of long-term adverse health events has not been reported. Objective Given that older patients are more likely to suffer long-term complications from ADT, we examined long-term late events in elderly patients randomized to intermittent or continuous ADT. Our hypothesis was that late cardiovascular and endocrine events would be lower in patients on intermittent ADT. Design Linkage between patient trial data and corresponding Medicare claims. Setting Multicenter clinical trial. Participants Patients from S9346, a randomized SWOG trial of intermittent vs. continuous ADT in men with metastatic PC. Main Outcomes and Measures The main outcome was to identify long-term adverse health events by treatment arm. Patients were classified as having an adverse health event if they had any hospital claim – or at least 2 physician or outpatient claims at least 30 days apart – for any of the following diagnoses: ischemic and thrombotic events; endocrine events; sexual dysfunction, dementia and depression. To incorporate time from beginning of observation through evidence of an event, we determined the cumulative incidence of each event. Competing risks Cox regression was used, adjusting for covariates. Results In total, n=1134 eligible U.S.-based patients with metastatic PC were randomized to continuous vs. intermittent ADT on S9346. A total of 636 (56%) of trial participants had ≥1 year of continuous Medicare parts A & B coverage and no HMO participation. The median age was 71.3 years. The most common long-term events were hypercholesterolemia (31%) and osteoporosis (19%). The 10-year cumulative incidence of ischemic and thrombotic events differed by arm; 24% for continuous and 33% for intermittent ADT (Hazard Ratio=0.69, p=.02). There were no statistically significant

  9. Effects of Childhood Adversity on Bullying and Cruelty to Animals in the United States: Findings From a National Sample

    PubMed Central

    Vaughn, Michael G.; Fu, Qiang; Beaver, Kevin M.; DeLisi, Matt; Perron, Brian E.; Howard, Matthew O.

    2012-01-01

    This study examined effects of type of and cumulative burden of childhood adversities on bullying and cruelty to animals in the United States. Data were derived from Waves I and II of the National Epidemiologic Survey on Alcohol and Related Conditions, a nationally representative sample of U.S. adults. Structured psychiatric interviews were completed by trained lay interviewers between 2001–2002 and 2003–2004. Although the effects of childhood adversity diminished with the inclusion of confounding variables, several adversities remained significant. For bullying, these included being made to do chores that were too difficult or dangerous, threatening to hit or throw something, pushing, shoving, slapping, or hitting, and hitting that left bruises, marks, or injuries. With respect to cruelty to animals, swearing and saying hurtful things, having a parent or other adult living within the home that went to jail or prison, and adult/other person fondling/touching in a sexual way were significant. The final models indicated that the cumulative burden of childhood adversities had strong effects on the increased likelihood of bullying behavior but not cruelty to animals. PMID:21602208

  10. Effects of childhood adversity on bullying and cruelty to animals in the United States: findings from a national sample.

    PubMed

    Vaughn, Michael G; Fu, Qiang; Beaver, Kevin M; Delisi, Matt; Perron, Brian E; Howard, Matthew O

    2011-11-01

    This study examined effects of type of and cumulative burden of childhood adversities on bullying and cruelty to animals in the United States. Data were derived from Waves I and II of the National Epidemiologic Survey on Alcohol and Related Conditions, a nationally representative sample of U.S. adults. Structured psychiatric interviews were completed by trained lay interviewers between 2001-2002 and 2003-2004. Although the effects of childhood adversity diminished with the inclusion of confounding variables, several adversities remained significant. For bullying, these included being made to do chores that were too difficult or dangerous, threatening to hit or throw something, pushing, shoving, slapping, or hitting, and hitting that left bruises, marks, or injuries. With respect to cruelty to animals, swearing and saying hurtful things, having a parent or other adult living within the home that went to jail or prison, and adult/other person fondling/touching in a sexual way were significant. The final models indicated that the cumulative burden of childhood adversities had strong effects on the increased likelihood of bullying behavior but not cruelty to animals. PMID:21602208

  11. 12 CFR 404.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 404.33 Section 404.33 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES INFORMATION DISCLOSURE Demands for Testimony of Current and Former Ex-Im Bank Personnel and for Production of Ex-Im Bank Records § 404.33 Procedure in the event of...

  12. 12 CFR 404.33 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 404.33 Section 404.33 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES INFORMATION DISCLOSURE Demands for Testimony of Current and Former Ex-Im Bank Personnel and for Production of Ex-Im Bank Records § 404.33 Procedure in the event of...

  13. Epidermal Growth Factor Receptor Inhibitors: A Review of Cutaneous Adverse Events and Management

    PubMed Central

    Chanprapaph, K.; Vachiramon, V.; Rattanakaemakorn, P.

    2014-01-01

    Epidermal growth factor inhibitors (EGFRI), the first targeted cancer therapy, are currently an essential treatment for many advance-stage epithelial cancers. These agents have the superior ability to target cancers cells and better safety profile compared to conventional chemotherapies. However, cutaneous adverse events are common due to the interference of epidermal growth factor receptor (EGFR) signaling in the skin. Cutaneous toxicities lead to poor compliance, drug cessation, and psychosocial discomfort. This paper summarizes the current knowledge concerning the presentation and management of skin toxicity from EGFRI. The common dermatologic adverse events are papulopustules and xerosis. Less common findings are paronychia, regulatory abnormalities of hair growth, maculopapular rash, mucositis, and postinflammatory hyperpigmentation. Radiation enhances EGFRI rash due to synergistic toxicity. There is a positive correlation between the occurrence and severity of cutaneous adverse effects and tumor response. To date, prophylactic systemic tetracycline and tetracycline class antibiotics have proven to be the most effective treatment regime. PMID:24723942

  14. Adverse childhood experiences among Hawai'i adults: Findings from the 2010 Behavioral Risk Factor Survey.

    PubMed

    Ye, Dailin; Reyes-Salvail, Florentina

    2014-06-01

    The prevalence of adverse childhood experiences (ACEs) among Hawai'i adults and their impact on the health of affected individuals are unknown. Aiming to provide Hawai'i State baseline information on ACEs and their associations with health conditions and risk behaviors, the 2010 Hawai'i Behavioral Risk Factor Surveillance System (BRFSS) included the ACE module. Using 5,928 survey respondents who completed the module, demographic attributes were estimated and multivariate logistic regression analysis was performed to examine the association between ACEs and sixteen selected health indicators. In 2010, approximately 57.8% of Hawai'i adults reported experiencing at least one ACE. Native Hawaiians had the highest prevalence followed by Whites. Adults aged ≥ 65 years had the lowest prevalence on all ACEs. The prevalence of ACEs was inversely related to education and household income levels. Compared to those without ACEs, adults with ACEs had higher odds for a number of health conditions and risk behaviors. Moreover, as the number of ACEs increased, the odds for these health conditions and risk behaviors increased. Hawai'i adults with ACEs were more likely to report dissatisfaction with life compared to those without ACEs. Men were more likely to report having a family member in prison, while women were more likely to report experiencing sexual abuse. Recommendations include further research on the unbiased contributions of ACEs to diseases and risk behaviors, and the development of culturally-appropriate interventions to reduce the prevalence of ACEs in Hawai'i. PMID:24959392

  15. Enhanced emotion regulation capacity and its neural substrates in those exposed to moderate childhood adversity.

    PubMed

    Schweizer, Susanne; Walsh, Nicholas D; Stretton, Jason; Dunn, Valerie J; Goodyer, Ian M; Dalgleish, Tim

    2016-02-01

    Individuals exposed to childhood adversities (CA) present with emotion regulation (ER) difficulties in later life, which have been identified as risk and maintenance factors for psychopathologies. However, it is unclear if CA negatively impacts on ER capacity per se or whether observed regulation difficulties are a function of the challenging circumstances in which ER is being deployed. In this longitudinal study, we aimed to clarify this association by investigating the behavioral and neural effects of exposure to common moderate CA (mCA) on a laboratory measure of ER capacity in late adolescence/young adulthood. Our population-derived samples of adolescents/young adults (N = 53) were administered a film-based ER-task during functional magnetic resonance imaging that allowed evaluation of ER across mCA-exposure. mCA-exposure was associated with enhanced ER capacity over both positive and negative affect. At the neural level, the better ER of negative material in those exposed to mCA was associated with reduced recruitment of ER-related brain regions, including the prefrontal cortex and temporal gyrus. In addition mCA-exposure was associated with a greater down-regulation of the amygdala during ER of negative material. The implications of these findings for our understanding of the effects of mCA on the emergence of resilience in adolescence are discussed. PMID:26341903

  16. Adverse Childhood Experiences Among Hawai‘i Adults: Findings from the 2010 Behavioral Risk Factor Survey

    PubMed Central

    Ye, Dailin

    2014-01-01

    The prevalence of adverse childhood experiences (ACEs) among Hawai‘i adults and their impact on the health of affected individuals are unknown. Aiming to provide Hawai‘i State baseline information on ACEs and their associations with health conditions and risk behaviors, the 2010 Hawai‘i Behavioral Risk Factor Surveillance System (BRFSS) included the ACE module. Using 5,928 survey respondents who completed the module, demographic attributes were estimated and multivariate logistic regression analysis was performed to examine the association between ACEs and sixteen selected health indicators. In 2010, approximately 57.8% of Hawai‘i adults reported experiencing at least one ACE. Native Hawaiians had the highest prevalence followed by Whites. Adults aged ≥ 65 years had the lowest prevalence on all ACEs. The prevalence of ACEs was inversely related to education and household income levels. Compared to those without ACEs, adults with ACEs had higher odds for a number of health conditions and risk behaviors. Moreover, as the number of ACEs increased, the odds for these health conditions and risk behaviors increased. Hawai‘i adults with ACEs were more likely to report dissatisfaction with life compared to those without ACEs. Men were more likely to report having a family member in prison, while women were more likely to report experiencing sexual abuse. Recommendations include further research on the unbiased contributions of ACEs to diseases and risk behaviors, and the development of culturally-appropriate interventions to reduce the prevalence of ACEs in Hawai‘i. PMID:24959392

  17. Women convicted for violent offenses: Adverse childhood experiences, low level of education and poor mental health

    PubMed Central

    2009-01-01

    Background In past years, the female offender population has grown, leading to an increased interest in the characteristics of female offenders. The aim of this study was to assess the prevalence of female violent offending in a Swiss offender population and to compare possible socio-demographic and offense-related gender differences. Methods Descriptive and bivariate logistic regression analyses were performed for a representative sample of N = 203 violent offenders convicted in Zurich, Switzerland. Results 7.9% (N = 16) of the sample were female. Significant gender differences were found: Female offenders were more likely to be married, less educated, to have suffered from adverse childhood experiences and to be in poor mental health. Female violent offending was less heterogeneous than male violent offending, in fact there were only three types of violent offenses females were convicted for in our sample: One third were convicted of murder, one third for arson and only one woman was convicted of a sex offense. Conclusions The results of our study point toward a gender-specific theory of female offending, as well as toward the importance of developing models for explaining female criminal behavior, which need to be implemented in treatment plans and intervention strategies regarding female offenders. PMID:20028499

  18. Examination of the Factorial Structure of Adverse Childhood Experiences and Recommendations for Three Subscale Scores

    PubMed Central

    Ford, Derek C.; Merrick, Melissa T.; Parks, Sharyn E.; Breiding, Matthew J.; Gilbert, Leah K.; Edwards, Valerie J.; Dhingra, Satvinder S.; Barile, John P.; Thompson, William W.

    2015-01-01

    Objective The purpose of the current investigation is to assess and validate the factor structure of the Behavioral Risk Factor Surveillance System’s (BRFSS) Adverse Childhood Experience (ACE) module. Method ACE data available from the 2009 BRFSS survey were fit using exploratory factor analysis (EFA) to estimate an initial factorial structure. The exploratory solution was then validated using confirmatory factor analysis (CFA) with data from the 2010 BRFSS survey. Lastly, ACE factors were tested for measurement invariance using multiple group factor analysis. Results EFA results suggested that a 3-factor solution adequately fit the data. Examination of factor loadings and item content suggested the factors represented the following construct areas: Household Dysfunction, Emotional/Physical Abuse, and Sexual Abuse. Subsequent CFA results confirmed the 3-factor solution and provided preliminary support for estimation of an overall latent ACE score summarizing the responses to all available items. Measurement invariance was supported across both gender and age. Conclusions Results of this study provides support for the use of the current ACE module scoring algorithm, which uses the sum of the number of items endorsed to estimate exposure. However, the results also suggest potential benefits to estimating 3 separate composite scores to estimate the specific effects of exposure to Household Dysfunction, Emotional/Physical Abuse, and Sexual Abuse. PMID:26430532

  19. Sugar-Sweetened Beverage Consumption Is Adversely Associated with Childhood Attention Deficit/Hyperactivity Disorder

    PubMed Central

    Yu, Ching-Jung; Du, Jung-Chieh; Chiou, Hsien-Chih; Feng, Chun-Cheng; Chung, Ming-Yi; Yang, Winnie; Chen, Ying-Sheue; Chien, Ling-Chu; Hwang, Betau; Chen, Mei-Lien

    2016-01-01

    Attention deficit/hyperactivity disorder (ADHD) is one of the most common childhood neurobehavioral conditions. Evidence of the negative effects of sugar-sweetened beverages (SSBs) on mental health has not been convincing, although a few studies have found an association between high SSB levels and attention problems in children. This study aimed to test the hypothesis that SSB consumption is associated with ADHD among children. Doctor-diagnosed ADHD cases (n = 173) and non-ADHD controls (n = 159) between age 4 to 15 were recruited. SSB consumption, socio-demographic and lifestyle characteristics of the children, as well as of their mothers’ characteristics during pregnancy, were collected using a questionnaire. Blood lead levels and polymorphisms of two commonly verified dopaminergic-related genes (the D4 dopamine receptor gene DRD4 and the dopamine transporter gene DAT1) were also analyzed. There was a dose-response relationship between SSB consumption and ADHD. After covariates were adjusted, children who consumed SSBs at moderate levels and high levels had 1.36 and 3.69 odds, respectively, of having ADHD, compared with those who did not consume SSBs (p for trend < 0.05). Similar results were obtained when females were excluded. Our findings highlighted the adverse correlation between SSB consumption and ADHD and indicated a dose-response effect even after covariates were adjusted. PMID:27384573

  20. Sugar-Sweetened Beverage Consumption Is Adversely Associated with Childhood Attention Deficit/Hyperactivity Disorder.

    PubMed

    Yu, Ching-Jung; Du, Jung-Chieh; Chiou, Hsien-Chih; Feng, Chun-Cheng; Chung, Ming-Yi; Yang, Winnie; Chen, Ying-Sheue; Chien, Ling-Chu; Hwang, Betau; Chen, Mei-Lien

    2016-01-01

    Attention deficit/hyperactivity disorder (ADHD) is one of the most common childhood neurobehavioral conditions. Evidence of the negative effects of sugar-sweetened beverages (SSBs) on mental health has not been convincing, although a few studies have found an association between high SSB levels and attention problems in children. This study aimed to test the hypothesis that SSB consumption is associated with ADHD among children. Doctor-diagnosed ADHD cases (n = 173) and non-ADHD controls (n = 159) between age 4 to 15 were recruited. SSB consumption, socio-demographic and lifestyle characteristics of the children, as well as of their mothers' characteristics during pregnancy, were collected using a questionnaire. Blood lead levels and polymorphisms of two commonly verified dopaminergic-related genes (the D4 dopamine receptor gene DRD4 and the dopamine transporter gene DAT1) were also analyzed. There was a dose-response relationship between SSB consumption and ADHD. After covariates were adjusted, children who consumed SSBs at moderate levels and high levels had 1.36 and 3.69 odds, respectively, of having ADHD, compared with those who did not consume SSBs (p for trend < 0.05). Similar results were obtained when females were excluded. Our findings highlighted the adverse correlation between SSB consumption and ADHD and indicated a dose-response effect even after covariates were adjusted. PMID:27384573

  1. Enhanced emotion regulation capacity and its neural substrates in those exposed to moderate childhood adversity

    PubMed Central

    Schweizer, Susanne; Walsh, Nicholas D.; Stretton, Jason; Dunn, Valerie J.; Goodyer, Ian M.; Dalgleish, Tim

    2016-01-01

    Individuals exposed to childhood adversities (CA) present with emotion regulation (ER) difficulties in later life, which have been identified as risk and maintenance factors for psychopathologies. However, it is unclear if CA negatively impacts on ER capacity per se or whether observed regulation difficulties are a function of the challenging circumstances in which ER is being deployed. In this longitudinal study, we aimed to clarify this association by investigating the behavioral and neural effects of exposure to common moderate CA (mCA) on a laboratory measure of ER capacity in late adolescence/young adulthood. Our population-derived samples of adolescents/young adults (N = 53) were administered a film-based ER-task during functional magnetic resonance imaging that allowed evaluation of ER across mCA-exposure. mCA-exposure was associated with enhanced ER capacity over both positive and negative affect. At the neural level, the better ER of negative material in those exposed to mCA was associated with reduced recruitment of ER-related brain regions, including the prefrontal cortex and temporal gyrus. In addition mCA-exposure was associated with a greater down-regulation of the amygdala during ER of negative material. The implications of these findings for our understanding of the effects of mCA on the emergence of resilience in adolescence are discussed. PMID:26341903

  2. Exploring the relationship between childhood adversity and oral health: An anecdotal approach and integrative view.

    PubMed

    Kirkengen, Anna Luise; Lygre, Henning

    2015-08-01

    During the past two decades, increasing recognition has been given to a relationship between oral health and systemic diseases. Associated systemic conditions include cardiovascular disease, diabetes, low birth weight and preterm births, respiratory diseases, rheumatoid arthritis, obesity, osteoporosis, and, in particular among oral conditions, periodontal disease. Low-grade inflammation is a common denominator linking these disorders. Applying an anecdotal approach and an integrative view, the medical and dental histories of two women document increasing ill health subsequent to incidences of maltreatment and sexual abuse, including oral penetration, at an early age. Comprehensive oral rehabilitation was required in both cases. These cases open for medical insight with regard to their implicit patho-physiology, when integrated with current evidence from neuroscience, endocrinology, and immunology, converging in the concepts of allostasis and allostatic load. In cases such as those presented in this paper, primary care physicians (family doctors, General Practitioners) and dentists may be the first to identify an etiological pattern. This report underlines the importance of increased and enhanced multidisciplinary research cooperation among health professionals. Our hypothesis is that childhood adversity may affect all aspects of human health, including adult oral health. PMID:25978926

  3. Adverse Events during 2 Years of Daily Wear of Silicone Hydrogels in Children

    PubMed Central

    Sankaridurg, Padmaja; Chen, Xiang; Naduvilath, Thomas; de la Jara, Percy Lazon; Lin, Zhi; Li, Li; Smith, Earl L.; Ge, Jian; Holden, Brien A.

    2015-01-01

    Purpose Type and incidence of adverse events and rate of discontinuations for 2 years of daily wear with silicone hydrogel contact lenses in Chinese children with myopia. Methods Two hundred forty children aged 7 to 14 years were enrolled in a prospective randomized clinical trial from November 2008 to April 2009. Children with myopia of up to −3.50 diopters (D) spherical equivalent with astigmatism less than or equal to −0.75 D were randomized to one commercial and three experimental lens designs of Lotrafilcon B silicone hydrogel lenses (four groups) used bilaterally on a daily wear, monthly replacement schedule. The main outcome measures were incidence per 100 patient-years (incidence, in percentage) of adverse events and rate of discontinuations. Results There were no events of microbial keratitis. Fifty-five adverse events (incidence, 14.2%) were seen. There were also 12 recurrent events. The type and incidence percentage were contact lens papillary conjunctivitis (16 events, 4.1%), superior epithelial arcuate lesions (SEALs, six events, 1.5%), corneal erosions (eight events, 2.1%), infiltrative keratitis (five events, 1.3%), asymptomatic infiltrative keratitis (seven events, 1.8%), and asymptomatic infiltrates (13 events, 3.42%). There were differences in the incidence of SEALs between groups (p = 0.023), with the incidence of SEALs being greater with one of the experimental designs. No event resulted in any vision loss. Seventy participants (29.2%) discontinued, with one-third (26 participants, 10.8%) occurring in the first month of lens wear. Discomfort and non–lens-related reasons such as safety concern and disinterest were frequently cited reasons for discontinuations. Conclusions Adverse events with daily wear of silicone hydrogels in children were mainly mechanical in nature, and significant infiltrative events were few. The large number of dropouts in the early days of lens wear and their reasons for discontinuation suggest that adaptation and

  4. Comparison of the risk of adverse events between risperidone and haloperidol in delirium patients.

    PubMed

    Miyaji, Shingo; Yamamoto, Kenji; Hoshino, Syunya; Yamamoto, Hiroaki; Sakai, Yoshiro; Miyaoka, Hitoshi

    2007-06-01

    The aim of this study was to determine the risk of adverse events for risperidone and haloperidol in delirium patients. The authors conducted a retrospective study with medical records of 266 Japanese delirium inpatients who were referred to them between July 2001 and May 2005. Information on gender, age, delirium, drug therapy, adverse events, death, and other relevant factors was collected and analyzed for each patient. As a primary antipsychotic drug for the treatment of delirium, risperidone was used in 93 patients; oral haloperidol was used in 95; and intravenous or intramuscular haloperidol was used in 61. The incidence of adverse events was 6.5% for risperidone, 31.4% for oral haloperidol, and 32.8% for haloperidol injection. The incidence of death during delirium was 3.2% for risperidone, 2.1% for oral haloperidol, and 13.1% for haloperidol injection. The incidence of death within 1 year after the onset of delirium was 30.1% for risperidone, 29.5% for oral haloperidol, and 45.9% for haloperidol injection. Between risperidone, oral haloperidol, and intravenous or intramuscular haloperidol the incidence of adverse events was significantly lowest for risperidone, and the incidence of death during delirium was significantly highest for intravenous or intramuscular haloperidol. The use of haloperidol as a first-line drug in delirium patients who can receive the drug orally will not contribute to the establishment of drug therapy for delirium based on risk-benefit assessment of the therapy. PMID:17472596

  5. 76 FR 57045 - Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ...Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post- market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The ``Reporting Device Adverse Events Challenge'' asks multi-disciplinary teams......

  6. 41 CFR 105-60.607 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Procedure in the event of an adverse ruling. 105-60.607 Section 105-60.607 Public Contracts and Property Management Federal Property Management Regulations System (Continued) GENERAL SERVICES ADMINISTRATION Regional...

  7. Semantic Processing to Identify Adverse Drug Event Information from Black Box Warnings

    PubMed Central

    Culbertson, Adam; Fiszman, Marcelo; Shin, Dongwook; Rindflesch, Thomas C.

    2014-01-01

    Adverse drug events account for two million combined injuries, hospitalizations, or deaths each year. Furthermore, there are few comprehensive, up-to-date, and free sources of drug information. Clinical decision support systems may significantly mitigate the number of adverse drug events. However, these systems depend on up-to-date, comprehensive, and codified data to serve as input. The DailyMed website, a resource managed by the FDA and NLM, contains all currently approved drugs. We used a semantic natural language processing approach that successfully extracted information for adverse drug events, at-risk conditions, and susceptible populations from black box warning labels on this site. The precision, recall, and F-score were, 94%, 52%, 0.67 for adverse drug events; 80%, 53%, and 0.64 for conditions; and 95%, 44%, 0.61 for populations. Overall performance was 90% precision, 51% recall, and 0.65 F-Score. Information extracted can be stored in a structured format and may support clinical decision support systems. PMID:25954348

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

    ERIC Educational Resources Information Center

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

    2007-01-01

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

  9. Serious Adverse Events in Randomized Psychosocial Treatment Studies: Safety or Arbitrary Edicts?

    ERIC Educational Resources Information Center

    Petry, Nancy M.; Roll, John M.; Rounsaville, Bruce J.; Ball, Samuel A.; Stitzer, Maxine; Peirce, Jessica M.; Blaine, Jack; Kirby, Kimberly C.; McCarty, Dennis; Carroll, Kathleen M.

    2008-01-01

    Human subjects protection policies developed for pharmaceutical trials are now being widely applied to psychosocial intervention studies. This study examined occurrences of serious adverse events (SAEs) reported in multicenter psychosocial trials of the National Institute on Drug Abuse Clinical Trials Network. Substance-abusing participants (N =…

  10. Comparison of Increasingly Detailed Elicitation Methods for the Assessment of Adverse Events in Pediatric Psychopharmacology.

    ERIC Educational Resources Information Center

    Greenhill, Laurence L.; Vitiello, Benedetto; Fisher, Prudence; Levine, Jerome; Davies, Mark; Abikoff, Howard; Chrisman, Allan K.; Chuang, Shirley; Findling, Robert L.; March, John; Scahill, Lawrence; Walkup, John; Riddle, Mark A.

    2004-01-01

    Objective: To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods. Method: Trained clinicians administered the Safety Monitoring Uniform Report Form (SMURF) to 59 parents and outpatients (mean age [+ or -] SD = 11.9 [+ or -] 3.2 years)…

  11. 10 CFR 202.26 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 3 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 202.26 Section 202.26 Energy DEPARTMENT OF ENERGY OIL PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION Production or Disclosure in Response to Subpoenas or Demands of Courts or Other Authorities §...

  12. 10 CFR 202.26 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 3 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 202.26 Section 202.26 Energy DEPARTMENT OF ENERGY OIL PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION Production or Disclosure in Response to Subpoenas or Demands of Courts or Other Authorities §...

  13. Adverse events associated with chloramphenicol use in dogs: a retrospective study (2007-2013).

    PubMed

    Short, J; Zabel, S; Cook, C; Schmeitzel, L

    2014-11-29

    Chloramphenicol is a broad spectrum antibiotic that has been increasingly utilised since the emergence of methicillin-resistant staphylococcal infections. Due to toxicities in humans, use of the drug has been limited. In dogs, gastrointestinal signs are common adverse events described, and bone marrow suppression is possible. The aim of this study was to evaluate the adverse events associated with chloramphenicol in dogs seen by one specialty practice from January 2007 through June 2013. The database was searched for all dogs prescribed chloramphenicol during the time period. Dosage, length of treatment, age and body weight of the dogs were recorded as well as any adverse events that occurred during treatment. A total of 105 cases were evaluated. Thirty-nine dogs experienced at least one adverse event while on the medication. The most commonly noted were gastrointestinal signs and hindlimb weakness. The mean body weight for dogs with hindlimb weakness was 35.3 kg, which was significant. Resolution was documented in 54 per cent of cases when the drug was discontinued. Methicillin-resistant Staphylococcus pseudintermedius on bacterial culture was listed as the reason for chloramphenicol use in 76 per cent of the cases. Based on this information, further prospective studies are recommended to evaluate the reproducibility of this report. PMID:25096589

  14. Hepatitis B vaccine adverse events in China: risk control and regulation.

    PubMed

    Meina, Li; Xiaodong, Liu; Lulu, Zhang

    2014-01-01

    The death of 17 children raised public fears over infant hepatitis B vaccination in China. Though the relation between hepatitis B and children's death was denied after prudent investigation, the negative impact remained. In order to prevent or minimize adverse events after vaccination, special strategy including regulation and reimbursement should be developed. PMID:25483642

  15. Efficacy and adverse events of cold vs hot polypectomy: A meta-analysis

    PubMed Central

    Fujiya, Mikihiro; Sato, Hiroki; Ueno, Nobuhiro; Sakatani, Aki; Tanaka, Kazuyuki; Dokoshi, Tatsuya; Fujibayashi, Shugo; Nomura, Yoshiki; Kashima, Shin; Gotoh, Takuma; Sasajima, Junpei; Moriichi, Kentaro; Watari, Jiro; Kohgo, Yutaka

    2016-01-01

    AIM: To compare previously reported randomized controlled studies (RCTs) of cold and hot polypectomy, we systematically reviewed and clarify the utility of cold polypectomy over hot with respect to efficacy and adverse events. METHODS: A meta-analysis was conducted to evaluate the predominance of cold and hot polypectomy for removing colon polyps. Published articles and abstracts from worldwide conferences were searched using the keywords “cold polypectomy”. RCTs that compared either or both the effects or adverse events of cold polypectomy with those of hot polypectomy were collected. The patients’ demographics, endoscopic procedures, No. of examined lesions, lesion size, macroscopic and histologic findings, rates of incomplete resection, bleeding amount, perforation, and length of procedure were extracted from each study. A forest plot analysis was used to verify the relative strength of the effects and adverse events of each procedure. A funnel plot was generated to assess the possibility of publication bias. RESULTS: Ultimately, six RCTs were selected. No significant differences were noted in the average lesion size (less than 10 mm) between the cold and hot polypectomy groups in each study. Further, the rates of complete resection and adverse events, including delayed bleeding, did not differ markedly between cold and hot polypectomy. The average procedural time in the cold polypectomy group was significantly shorter than in the hot polypectomy group. CONCLUSION: Cold polypectomy is a time-saving procedure for removing small polyps with markedly similar curability and safety to hot polypectomy. PMID:27340361

  16. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  17. 5 CFR 2608.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure in the event of an adverse ruling. 2608.210 Section 2608.210 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND... LEGAL PROCEEDINGS Requests for Testimony and Production of Documents § 2608.210 Procedure in the...

  18. 41 CFR 105-60.607 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 41 Public Contracts and Property Management 3 2011-01-01 2011-01-01 false Procedure in the event of an adverse ruling. 105-60.607 Section 105-60.607 Public Contracts and Property Management Federal... Subpoenas or Similar Demands in Judicial or Administrative Proceedings § 105-60.607 Procedure in the...

  19. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  20. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  1. 14 CFR 1263.108 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Procedure in the event of an adverse ruling. 1263.108 Section 1263.108 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEMAND FOR INFORMATION OR TESTIMONY SERVED ON AGENCY EMPLOYEES; PROCEDURES § 1263.108 Procedure in the...

  2. 41 CFR 105-60.607 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 41 Public Contracts and Property Management 3 2012-01-01 2012-01-01 false Procedure in the event of an adverse ruling. 105-60.607 Section 105-60.607 Public Contracts and Property Management Federal... Subpoenas or Similar Demands in Judicial or Administrative Proceedings § 105-60.607 Procedure in the...

  3. 22 CFR 206.5 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Procedure in the event of an adverse ruling. 206.5 Section 206.5 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT TESTIMONY BY EMPLOYEES AND THE PRODUCTION OF DOCUMENTS IN PROCEEDINGS WHERE A.I.D. IS NOT A PARTY § 206.5 Procedure in the...

  4. 22 CFR 206.5 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Procedure in the event of an adverse ruling. 206.5 Section 206.5 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT TESTIMONY BY EMPLOYEES AND THE PRODUCTION OF DOCUMENTS IN PROCEEDINGS WHERE A.I.D. IS NOT A PARTY § 206.5 Procedure in the...

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

    ERIC Educational Resources Information Center

    Taft, Laritza M.

    2010-01-01

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

  6. 5 CFR 1216.210 - Procedure in the event of an adverse ruling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Procedure in the event of an adverse ruling. If the court or other competent authority fails to stay a... General Counsel, will appear, if necessary, at the stated time and place, produce a copy of this part... documents, and respectfully decline to comply with the demand or request, citing United States ex...

  7. 78 FR 71620 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-29

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

  8. Disparities in Adverse Childhood Experiences among Sexual Minority and Heterosexual Adults: Results from a Multi-State Probability-Based Sample

    PubMed Central

    Andersen, Judith P; Blosnich, John

    2013-01-01

    Background Adverse childhood experiences (e.g., physical, sexual and emotional abuse, neglect, exposure to domestic violence, parental discord, familial mental illness, incarceration and substance abuse) constitute a major public health problem in the United States. The Adverse Childhood Experiences (ACE) scale is a standardized measure that captures multiple developmental risk factors beyond sexual, physical and emotional abuse. Lesbian, gay, and bisexual (i.e., sexual minority) individuals may experience disproportionately higher prevalence of adverse childhood experiences. Purpose To examine, using the ACE scale, prevalence of childhood physical, emotional, and sexual abuse and childhood household dysfunction among sexual minority and heterosexual adults. Methods Analyses were conducted using a probability-based sample of data pooled from three U.S. states’ Behavioral Risk Factor Surveillance System (BRFSS) surveys (Maine, Washington, Wisconsin) that administered the ACE scale and collected information on sexual identity (n = 22,071). Results Compared with heterosexual respondents, gay/lesbian and bisexual individuals experienced increased odds of six of eight and seven of eight adverse childhood experiences, respectively. Sexual minority persons had higher rates of adverse childhood experiences (IRR = 1.66 gay/lesbian; 1.58 bisexual) compared to their heterosexual peers. Conclusions Sexual minority individuals have increased exposure to multiple developmental risk factors beyond physical, sexual and emotional abuse. We recommend the use of the Adverse Childhood Experiences scale in future research examining health disparities among this minority population. PMID:23372755

  9. '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

  10. What Can Hospitalized Patients Tell Us About Adverse Events? Learning from Patient-Reported Incidents

    PubMed Central

    Weingart, Saul N; Pagovich, Odelya; Sands, Daniel Z; Li, Joseph M; Aronson, Mark D; Davis, Roger B; Bates, David W; Phillips, Russell S

    2005-01-01

    Purpose Little is known about how well hospitalized patients can identify errors or injuries in their care. Accordingly, the purpose of this study was to elicit incident reports from hospital inpatients in order to identify and characterize adverse events and near-miss errors. Subjects We conducted a prospective cohort study of 228 adult inpatients on a medicine unit of a Boston teaching hospital. Methods Investigators reviewed medical records and interviewed patients during the hospitalization and by telephone 10 days after discharge about “problems,”“mistakes,” and “injuries” that occurred. Physician investigators classified patients' reports. We calculated event rates and used multivariable Poisson regression models to examine the factors associated with patient-reported events. Results Of 264 eligible patients, 228 (86%) agreed to participate and completed 528 interviews. Seventeen patients (8%) experienced 20 adverse events; 1 was serious. Eight patients (4%) experienced 13 near misses; 5 were serious or life threatening. Eleven (55%) of 20 adverse events and 4 (31%) of 13 near misses were documented in the medical record, but none were found in the hospital incident reporting system. Patients with 3 or more drug allergies were more likely to report errors compared with patients without drug allergies (incidence rate ratio 4.7, 95% CI 1.7, 13.4). Conclusion Inpatients can identify adverse events affecting their care. Many patient-identified events are not captured by the hospital incident reporting system or recorded in the medical record. Engaging hospitalized patients as partners in identifying medical errors and injuries is a potentially promising approach for enhancing patient safety. PMID:16117751

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

    PubMed Central

    Mirza, Sohail K; Deyo, Richard A; Heagerty, Patrick J; Turner, Judith A; Lee, Lorri A; Goodkin, Robert

    2006-01-01

    Background Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery. Methods We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases. Results During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35), but agreement was substantial (kappa ≥ 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted kappa = 0.44). Adverse

  12. Assessing Reliability of Medical Record Reviews for the Detection of Hospital Adverse Events

    PubMed Central

    Ock, Minsu; Lee, Sang-il; Jo, Min-Woo; Lee, Jin Yong; Kim, Seon-Ha

    2015-01-01

    Objectives: The purpose of this study was to assess the inter-rater reliability and intra-rater reliability of medical record review for the detection of hospital adverse events. Methods: We conducted two stages retrospective medical records review of a random sample of 96 patients from one acute-care general hospital. The first stage was an explicit patient record review by two nurses to detect the presence of 41 screening criteria (SC). The second stage was an implicit structured review by two physicians to identify the occurrence of adverse events from the positive cases on the SC. The inter-rater reliability of two nurses and that of two physicians were assessed. The intra-rater reliability was also evaluated by using test-retest method at approximately two weeks later. Results: In 84.2% of the patient medical records, the nurses agreed as to the necessity for the second stage review (kappa, 0.68; 95% confidence interval [CI], 0.54 to 0.83). In 93.0% of the patient medical records screened by nurses, the physicians agreed about the absence or presence of adverse events (kappa, 0.71; 95% CI, 0.44 to 0.97). When assessing intra-rater reliability, the kappa indices of two nurses were 0.54 (95% CI, 0.31 to 0.77) and 0.67 (95% CI, 0.47 to 0.87), whereas those of two physicians were 0.87 (95% CI, 0.62 to 1.00) and 0.37 (95% CI, -0.16 to 0.89). Conclusions: In this study, the medical record review for detecting adverse events showed intermediate to good level of inter-rater and intra-rater reliability. Well organized training program for reviewers and clearly defining SC are required to get more reliable results in the hospital adverse event study. PMID:26429290

  13. ICD-10 codes used to identify adverse drug events in administrative data: a systematic review

    PubMed Central

    Hohl, Corinne M; Karpov, Andrei; Reddekopp, Lisa; Stausberg, Jürgen

    2014-01-01

    Background Adverse drug events, the unintended and harmful effects of medications, are important outcome measures in health services research. Yet no universally accepted set of International Classification of Diseases (ICD) revision 10 codes or coding algorithms exists to ensure their consistent identification in administrative data. Our objective was to synthesize a comprehensive set of ICD-10 codes used to identify adverse drug events. Methods We developed a systematic search strategy and applied it to five electronic reference databases. We searched relevant medical journals, conference proceedings, electronic grey literature and bibliographies of relevant studies, and contacted content experts for unpublished studies. One author reviewed the titles and abstracts for inclusion and exclusion criteria. Two authors reviewed eligible full-text articles and abstracted data in duplicate. Data were synthesized in a qualitative manner. Results Of 4241 titles identified, 41 were included. We found a total of 827 ICD-10 codes that have been used in the medical literature to identify adverse drug events. The median number of codes used to search for adverse drug events was 190 (IQR 156–289) with a large degree of variability between studies in the numbers and types of codes used. Authors commonly used external injury (Y40.0–59.9) and disease manifestation codes. Only two papers reported on the sensitivity of their code set. Conclusions Substantial variability exists in the methods used to identify adverse drug events in administrative data. Our work may serve as a point of reference for future research and consensus building in this area. PMID:24222671

  14. Adverse Respiratory Events Associated With Hypnotics Use in Patients of Chronic Obstructive Pulmonary Disease

    PubMed Central

    Chung, Wei-Sheng; Lai, Ching-Yuan; Lin, Cheng-Li; Kao, Chia-Hung

    2015-01-01

    Abstract Insomnia is prevalent in patients with chronic obstructive pulmonary disease (COPD). We conducted a population-based case-control study to evaluate the effects of hypnotics on the risk of adverse respiratory events in patients with COPD. The case-control study was investigated using data retrieved from the Taiwan National Health Insurance Research Database. Patients with newly diagnosed adverse respiratory events (pneumonia, COPD with acute exacerbation, acute respiratory failure, and cardiopulmonary arrest) were included in the case group. Patients with COPD and no history of adverse respiratory events were randomly selected for the control group, which was frequency-matched with the case group according to index date, age (per 10 years), and sex. Patients who had used hypnotics within 1 month meant active users. The odds ratios (ORs) and 95% confidence intervals (CIs) of were calculated using univariable and multivariable logistic regression models. Most of the study participants were male (71.6%), and the mean ages of the participants in the case and control groups were 69.2 (±12.4) and 67.5 (±12.3) years, respectively. After potential confounding factors were adjusting for, the adjusted ORs of adverse respiratory events were 12.0 for active users of benzodiazepines (95% CI, 8.11–17.6) and 10.5 for active users of nonbenzodiazepines (95% CI, 7.68–14.2) compared with the adjusted ORs of those who never used hypnotics. The results of this epidemiological study suggested that hypnotics increased the risk of adverse respiratory events in patients with COPD. PMID:26166105

  15. Methods for estimating causal relationships of adverse events with dietary supplements

    PubMed Central

    Ide, Kazuki; Yamada, Hiroshi; Kitagawa, Mamoru; Kawasaki, Yohei; Buno, Yuma; Matsushita, Kumi; Kaji, Masayuki; Fujimoto, Kazuko; Waki, Masako; Nakashima, Mitsuyoshi; Umegaki, Keizo

    2015-01-01

    Objective Dietary supplement use has increased over past decades, resulting in reports of potentially serious adverse events. The aim of this study was to develop optimised methods to evaluate the causal relationships between adverse events and dietary supplements, and to test these methods using case reports. Design Causal relationship assessment using prospectively collected data. Setting and participants 4 dietary supplement experts, 4 pharmacists and 11 registered dietitians (5 men and 14 women) examined 200 case reports of suspected adverse events using the modified Naranjo scale and the modified Food and Drug Administration (FDA) algorithm. Primary outcome measures The distribution of evaluation results was analysed and inter-rater reliability was evaluated for the two modified methods employed using intraclass correlation coefficients (ICC) and Fleiss’ κ. Results Using these two methods, most of the 200 case reports were categorised as ‘lack of information’ or ‘possible’ adverse events. Inter-rater reliability among entire assessors ratings for the two modified methods, based on ICC and Fleiss’ κ, were classified as more than substantial (modified Naranjo scale: ICC (95% CI) 0.873 (0.850 to 0.895); Fleiss’ κ (95% CI) 0.615 (0.615 to 0.615). Modified FDA algorithm: Fleiss’ κ (95% CI) 0.622 (0.622 to 0.622). Conclusions These methods may help to assess the causal relationships between adverse events and dietary supplements. By conducting additional studies of these methods in different populations, researchers can expand the possibilities for the application of our methods. PMID:26608636

  16. 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. PMID:26159627

  17. Childhood maltreatment, stressful life events, and alcohol craving in adult drinkers

    PubMed Central

    Kim, June H.; Martins, Silvia S.; Shmulewitz, Dvora; Santaella, Julian; Wall, Melanie M.; Keyes, Katherine M.; Eaton, Nicholas R.; Krueger, Robert; Grant, Bridget F.; Hasin, Deborah S.

    2014-01-01

    Background Little is known about the relationship of stressful life events and alcohol craving in the general population, and whether a history of childhood maltreatment sensitizes individuals to crave alcohol after adult stressors. Methods Participants were 22,147 past-year drinkers from Wave 2 (2004-2006) of the National Epidemiologic Survey on Alcohol and Related Conditions. A structured, face-to-face interview assessed past-year stressful life events, alcohol craving, and history of childhood maltreatment. Logistic regression was used to generate adjusted odds ratios (aOR) to evaluate the relationship between stressful life events and craving, adjusting for demographic characteristics and parental history of alcoholism. Interaction between stressful life events and childhood maltreatment was also assessed. Results Compared to participants with no stressful life events, those with ≥3 events had increased odds of moderate alcohol craving (aOR=3.15 [95% CI=2.30-4.33]) and severe craving (aOR=8.47 [95% CI=4.78-15.01]). Stressful life events and childhood maltreatment interacted in predicting severe craving (p=0.017); those with ≥3 events were at higher risk for craving if they had been exposed to childhood maltreatment. Conclusion A direct relationship between stressful life events and risk for alcohol craving was observed. Further, history of childhood maltreatment increased the salience of stressful life events in adulthood. Future studies should examine the role of psychiatric comorbidity in more complex models of stress sensitization and alcohol craving. PMID:24961735

  18. Disclosure of adverse events and errors in healthcare: an ethical perspective.

    PubMed

    Hébert, P C

    2001-01-01

    Adverse events and medical errors affecting patient care are recognised internationally as major problems in medicine. The failure of health care professionals and health institutes to address this problem has threatened to undermine public confidence in the health care system as a whole. Less focus has been directed at the ethical issues raised by negative outcomes of care, specifically the issue of disclosure. Efforts to prevent negative outcomes of care must be supplemented by policies of increased honesty and openness with patients and their families about adverse incidents. Disclosure should be made easier, not riskier, for healthcare practitioners so clinicians can learn from mistakes and improve patient care. Ethical guidelines for error disclosure must distinguish between disciplinary action and reporting of adverse incidents. Disclosure of negative outcomes requires tact and good communication skills. Healthcare institutions should provide training for the clinicians in this area, if necessary. As a general rule, patients should be informed of unexpected adverse incidents as soon as possible. Medical staff should be rewarded for adverse event reporting and protected from institutional retaliation on account of errors made in health care. PMID:11772143

  19. The role of adverse childhood experiences in cardiovascular disease risk: a review with emphasis on plausible mechanisms.

    PubMed

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

    2015-10-01

    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

  20. Sex-specific relationships between adverse childhood experiences and chronic obstructive pulmonary disease in five states

    PubMed Central

    Cunningham, Timothy J; Ford, Earl S; Croft, Janet B; Merrick, Melissa T; Rolle, Italia V; Giles, Wayne H

    2014-01-01

    Purpose Adverse childhood experiences (ACEs) before age 18 have been repeatedly associated with several chronic diseases in adulthood such as depression, heart disease, cancer, diabetes, and stroke. We examined sex-specific relationships between individual ACEs and the number of ACEs with chronic obstructive pulmonary disease (COPD) in the general population. Materials and methods Data from 26,546 women and 19,015 men aged ≥18 years in five states of the 2011 Behavioral Risk Factor Surveillance System were analyzed. We used log-linear regression to estimate prevalence ratios (PRs) and their corresponding 95% confidence intervals (CIs) for the relationship of eight ACEs with COPD after adjustment for age group, race/ethnicity, marital status, educational attainment, employment, asthma history, health insurance coverage, and smoking status. Results Some 63.8% of women and 62.2% of men reported ≥1 ACE. COPD was reported by 4.9% of women and 4.0% of men. In women, but not in men, there was a higher likelihood of COPD associated with verbal abuse (PR =1.30, 95% CI: 1.05, 1.61), sexual abuse (PR =1.69, 95% CI: 1.36, 2.10), living with a substance abusing household member (PR =1.49, 95% CI: 1.23, 1.81), witnessing domestic violence (PR =1.40, 95% CI: 1.14, 1.72), and parental separation/divorce (PR =1.47, 95% CI: 1.21, 1.80) during childhood compared to those with no individual ACEs. Reporting ≥5 ACEs (PR =2.08, 95% CI: 1.55, 2.80) compared to none was associated with a higher likelihood of COPD among women only. Conclusion ACEs are related to COPD, especially among women. These findings underscore the need for further research that examines sex-specific differences and the possible mechanisms linking ACEs and COPD. This work adds to a growing body of research suggesting that ACEs may contribute to health problems later in life and suggesting a need for program and policy solutions. PMID:25298732

  1. Mixed-effects Poisson regression analysis of adverse event reports: the relationship between antidepressants and suicide.

    PubMed

    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

    2008-05-20

    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

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

    PubMed Central

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

    2016-01-01

    Sorafenib is the standard treatment for patients with hepatocellular carcinoma (HCC) with advanced stage disease. Although its effectiveness has been demonstrated by randomized clinical trials and confirmed by field practice studies, reliable markers predicting therapeutic response have not yet been identified. Like other tyrosine kinase inhibitors, treatment with sorafenib is burdened by the development of adverse effects, the most frequent being cutaneous toxicity, diarrhoea, arterial hypertension and fatigue. In recent years, several studies have analysed the correlation between off-target effects and sorafenib efficacy in patients with HCC. In this review, an overview of the studies assessing the prognostic significance of sorafenib-related adverse events is provided. PMID:26929785

  3. Childhood adversities and first onset of psychiatric disorders in a national sample of adolescents

    PubMed Central

    McLaughlin, Katie A.; Green, Jennifer Greif; Gruber, Michael J.; Sampson, Nancy A.; Zaslavsky, Alan M.; Kessler, Ronald C.

    2012-01-01

    Context Although childhood adversities (CAs) are known to be highly co-occurring, most research examines their associations with mental disorders one at a time. Recent evidence from adult studies suggests, though, that the associations of multiple CAs with mental disorders are non-additive, arguing for the importance of multivariate analysis of multiple CAs. No attempt has yet been made to carry out a similar kind of analysis among children or adolescents. Objective To examine the multivariate associations of 12 CAs with first onset of mental disorders in a national sample of US adolescents. Design US national survey of adolescents (ages 13–17) assessing DSM-IV anxiety, mood, behavior, and substance disorders and CAs. The CAs include parental loss (death, divorce, other separations), maltreatment (physical, sexual, and emotional abuse, neglect), parental maladjustment (psychopathology, substance abuse, criminality, violence) and economic adversity. Setting Dual-frame household-school samples. Participants 6,483 adolescents-parent pairs. Main outcome measure Lifetime DSM-IV disorders assessed with the WHO Composite International Diagnostic Interview. Results 58.3% of adolescents reported at least one CA, among whom 59.7% reported multiple CAs. CAs reflecting maladaptive family functioning (MFF) were more strongly associated than other CAs with disorder onsets. The best-fitting model included terms for type and number of CAs and distinguished between MFF and Other CAs. CAs predicted behavior disorders most strongly and fear disorders least strongly. The joint associations of multiple CAs were sub-additive. The population-attributable risk proportions for disorder classes ranged from 15.7% for fear disorders to 40.7% for behavior disorders. CAs were associated with 28.2% of all onsets. Conclusions CAs are common, highly co-occurring, and strongly associated with onset of mental disorders among US adolescents. The sub-additive multivariate associations of CAs with

  4. Planned Repeat Cesarean Section at Term and Adverse Childhood Health Outcomes: A Record-Linkage Study

    PubMed Central

    Black, Mairead; Bhattacharya, Siladitya; Philip, Sam; Norman, Jane E.; McLernon, David J.

    2016-01-01

    Background Global cesarean section (CS) rates range from 1% to 52%, with a previous CS being the commonest indication. Labour following a previous CS carries risk of scar rupture, with potential for offspring hypoxic brain injury, leading to high rates of repeat elective CS. However, the effect of delivery by CS on long-term outcomes in children is unclear. Increasing evidence suggests that in avoiding exposure to maternal bowel flora during labour or vaginal birth, offspring delivered by CS may be adversely affected in terms of energy uptake from the gut and immune development, increasing obesity and asthma risks, respectively. This study aimed to address the evidence gap on long-term childhood outcomes following repeat CS by comparing adverse childhood health outcomes after (1) planned repeat CS and (2) unscheduled repeat CS with those that follow vaginal birth after CS (VBAC). Methods and Findings A data-linkage cohort study was performed. All second-born, term, singleton offspring delivered between 1 January 1993 and 31 December 2007 in Scotland, UK, to women with a history of CS (n = 40,145) were followed up until 31 January 2015. Outcomes assessed included obesity at age 5 y, hospitalisation with asthma, learning disability, cerebral palsy, and death. Cox regression and binary logistic regression were used as appropriate to compare outcomes following planned repeat CS (n = 17,919) and unscheduled repeat CS (n = 8,847) with those following VBAC (n = 13,379). Risk of hospitalisation with asthma was greater following both unscheduled repeat CS (3.7% versus 3.3%, adjusted hazard ratio [HR] 1.18, 95% CI 1.05–1.33) and planned repeat CS (3.6% versus 3.3%, adjusted HR 1.24, 95% CI 1.09–1.42) compared with VBAC. Learning disability and death were more common following unscheduled repeat CS compared with VBAC (3.7% versus 2.3%, adjusted odds ratio 1.64, 95% CI 1.17–2.29, and 0.5% versus 0.4%, adjusted HR 1.50, 95% CI 1.00–2.25, respectively). Risk of obesity

  5. Adjuvant Chemotherapy Use and Adverse Events among Older Patients with Stage III Colon Cancer

    PubMed Central

    Kahn, Katherine L.; Adams, John L.; Weeks, Jane C.; Chrischilles, Elizabeth A.; Schrag, Deborah; Ayanian, John Z.; Kiefe, Catarina I.; Ganz, Patricia A.; Bhoopalam, Nirmala; Potosky, Arnold L.; Harrington, David P.; Fletcher, Robert H.

    2010-01-01

    Context Randomized trials suggest adjuvant chemotherapy is effective for elderly patients with stage III colon cancer. However, the elderly are less likely to receive this therapy than younger patients, perhaps because of concern about adverse effects. Objective To evaluate adjuvant chemotherapy use and outcomes for older patients with stage III colon cancer from well-defined population-based settings and healthcare systems. Design Observational study of adjuvant chemotherapy use and outcomes by age, using Poisson regression to estimate the number of adverse events adjusted for demographic and clinical factors, including comorbid illness and specific elements of chemotherapy regimens documented with clinically detailed medical record reviews and patient and surrogate surveys. Setting Five geographically defined regions (Alabama, Iowa, Los Angeles County, Northern California, and North Carolina), five integrated health-care delivery systems, and 15 Veterans hospitals. Patients All 675 patients diagnosed with stage III colon cancer during 2003-2005 who underwent surgical resection were followed up to 15 months post-diagnosis. Main outcome measures Chemotherapy regimen, dose, duration and annualized mean number of adverse events stratified by age. Results Half of the 202 patients >=75 years received adjuvant chemotherapy compared with 87% of 473 younger patients (diff 37%, 95% CI 30%-45%). Among adjuvant chemotherapy users, 14 (14%) of patients >=75 years and 178 (44%) of younger patients received a regimen containing oxaliplatin (diff 30%, 95% CI 21%-38%). Older patients were less likely to continue. By 150 days, 99 (40%) patients >= 65 years and 68 (25%) younger patients had discontinued chemotherapy (diff 15%, 95% CI 7%-23%). Overall, 162 (24%) patients had at least one adverse clinical event, with more events among patients treated with vs. without adjuvant chemotherapy (mean 0.394 vs. 0.160, diff 0.234, 95% CI 0.11-0.36, p<0.001). Among adjuvant chemotherapy

  6. Impact of depression and anxiety on adverse event profiles in Korean people with epilepsy.

    PubMed

    Kim, Soo-Kyoung; Park, Sung-Pa; Kwon, Oh-Young

    2015-05-01

    Previous studies have shown that depression and anxiety worsen the adverse events associated with antiepileptic drugs (AEDs) in people with epilepsy. These studies used the Liverpool Adverse Events Profile (LAEP) to screen adverse events. The LAEP incorporates items associated with emotion, which may themselves influence the reporting of adverse events. We investigated whether depression and anxiety still displayed an effect on adverse events when items related to emotion were excluded from the analysis. A total of 453 consecutive patients with epilepsy who took AEDs for at least 1year completed self-report questionnaires, including the Korean versions of the LAEP (K-LAEP), the Beck Depression Inventory (K-BDI), and the Beck Anxiety Inventory (K-BAI). Firstly, we performed a discrimination analysis to identify the items affected by depression and/or anxiety among the 19 items included in the K-LAEP. Among these items, dizziness, nervousness and/or agitation, restlessness, and upset stomach had relatively higher levels of significance. Secondly, we performed a factor analysis to determine the subclass taxonomy of all items in the K-LAEP. The analysis segregated the items into three subclasses: cephalgia/coordination/sleep, emotion/cognition, and tegument/mucosa/weight. Lastly, we performed stepwise multiple regressions to demonstrate the predictors determining the K-LAEP and subclass scores. According to the regressions, the K-BAI and K-BDI scores and the duration of treatment of the antiepileptic medication were significant predictors. Specifically, the K-BAI score was a predictor of the scores of all three subclasses as well as the total K-LAEP score; the K-BDI score was a predictor of the total K-LAEP score and the emotion/cognition score; and the duration of treatment of the antiepileptic medication was a predictor of the tegument/mucosa/weight score. The K-BAI score was the strongest predictor of all the scores. Although this study showed a similar impact of

  7. Intravenous immune globulin and thromboembolic adverse events: A systematic review and meta-analysis of RCTs.

    PubMed

    Ammann, Eric M; Haskins, Cole B; Fillman, Kelsey M; Ritter, Rebecca L; Gu, Xiaomei; Winiecki, Scott K; Carnahan, Ryan M; Torner, James C; Fireman, Bruce H; Jones, Michael P; Chrischilles, Elizabeth A

    2016-06-01

    Prior case reports and observational studies indicate that intravenous immune globulin (IVIg) products may cause thromboembolic events (TEEs), leading the FDA to require a boxed warning in 2013. The effect of IVIg treatment on the risk of serious TEEs (acute myocardial infarction, ischemic stroke, or venous thromboembolism) was assessed using adverse event data reported in randomized controlled trials (RCTs) of IVIg. RCTs of IVIg in adult patients from 1995 to 2015 were identified from Pubmed, Embase, ClinicalTrials.Gov, and two large prior reviews of IVIg's therapeutic applications. Trials at high risk of detection or reporting bias for serious adverse events were excluded. 31 RCTs with a total of 4,129 participants (2,318 IVIg-treated, 1,811 control) were eligible for quantitative synthesis. No evidence was found of increased TEE risk among IVIg-treated patients compared with control patients (odds ratio = 1.10, 95% CI: 0.44, 2.88; risk difference = 0.0%, 95% CI: -0.7%, 0.7%, I(2)  = 0%). No significant increase in risk was found when arterial and venous TEEs were analyzed as separate endpoints. Trial publications provided little specific information concerning the methods used to ascertain potential adverse events. Care should be taken in extrapolating the results to patients with higher baseline risks of TEE. Am. J. Hematol. 91:594-605, 2016. © 2016 Wiley Periodicals, Inc. PMID:26973084

  8. Management of adverse events in the treatment of patients with immunoglobulin therapy: A review of evidence.

    PubMed

    Cherin, Patrick; Marie, Isabelle; Michallet, Mauricette; Pelus, Eric; Dantal, Jacques; Crave, Jean-Charles; Delain, Jean-Christophe; Viallard, Jean-François

    2016-01-01

    Immunoglobulin (IG) therapy is actually used for a broad range of diseases including primary and secondary immunodeficiency disorders, and autoimmune diseases. This therapy is available for intravenous (IV) and subcutaneous (SC) administration. The efficacy of the IG therapy has been demonstrated in numerous studies and across different diseases. Generally, IG infusions are well tolerated; however some well-known adverse reactions, ranging from mild to severe, are associated with the therapy. The most common adverse reactions including headache, nausea, myalgia, fever, chills, chest discomfort, skin and anaphylactic reactions, could arise immediately during or after the infusion. Delayed events could be more severe and include migraine headaches, aseptic meningitis, haemolysis renal impairment and thrombotic events. This paper reviews all the potential adverse events related to IG therapy and establishes a comprehensive guideline for the management of these events. Moreover it resumes the opinions and clinical experience of expert endorsers on the utilization of the treatment. Published data were classified into levels of evidence and the strength of the recommendation was given for each intervention according to the GRADE system. PMID:26384525

  9. Adverse events to monoclonal antibodies used for cancer therapy: Focus on hypersensitivity responses.

    PubMed

    Baldo, Brian A

    2013-10-01

    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

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

    PubMed Central

    2012-01-01

    Background The U.S. FDA/CDC Vaccine Adverse Event Reporting System (VAERS) provides a valuable data source for post-vaccination adverse event analyses. The structured data in the system has been widely used, but the information in the write-up narratives is rarely included in these kinds of analyses. In fact, the unstructured nature of the narratives makes the data embedded in them difficult to be used for any further studies. Results We developed an ontology-based approach to represent the data in the narratives in a “machine-understandable” way, so that it can be easily queried and further analyzed. Our focus is the time aspect in the data for time trending analysis. The Time Event Ontology (TEO), Ontology of Adverse Events (OAE), and Vaccine Ontology (VO) are leveraged for the semantic representation of this purpose. A VAERS case report is presented as a use case for the ontological representations. The advantages of using our ontology-based Semantic web representation and data analysis are emphasized. Conclusions We believe that representing both the structured data and the data from write-up narratives in an integrated, unified, and “machine-understandable” way can improve research for vaccine safety analyses, causality assessments, and retrospective studies. PMID:23256916

  11. Spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia

    PubMed Central

    Chen, Esa Y. H.; Diug, Basia; Bell, J. Simon; Mc Namara, Kevin P.; Dooley, Michael J.; Kirkpatrick, Carl M.; McNeil, John J.; Caughey, Gillian E.; Ilomäki, Jenni

    2016-01-01

    Objectives: The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. Methods: Data were sourced from the Australian Therapeutic Goods Administration (TGA) Database of Adverse Event Notifications between June 2009 and May 2014. Records of haemorrhagic adverse events in which rivaroxaban or dabigatran was considered as a potential cause were analysed. Results: There were 240 haemorrhagic adverse events associated with rivaroxaban and 504 associated with dabigatran. Age was specified for 164 (68%) haemorrhages associated with rivaroxaban, of which 101 occurred in people aged ⩾75 years. Age was specified for 437 (87%) haemorrhages associated with dabigatran, of which 300 occurred in people aged ⩾75 years. Time from treatment initiation to haemorrhage was specified for 122 (51%) haemorrhages associated with rivaroxaban, with 69 (57%) haemorrhages occurring within 30 days of rivaroxaban initiation. Time from treatment initiation to haemorrhage was specified for 253 (50%) haemorrhages associated with dabigatran, with 123 (49%) haemorrhages occurring within 30 days of dabigatran initiation. Gastrointestinal (GI) haemorrhages were the most frequent type of haemorrhages associated with both rivaroxaban (n = 105, 44%) and dabigatran (n = 302, 60%). Data were available on the severity of haemorrhage for 101 (42%) haemorrhages associated with rivaroxaban, with haemorrhage leading to death in 17 people. The severity of haemorrhage was specified for 384 (76%) haemorrhages associated with dabigatran, with haemorrhage leading to death in 61 people. Conclusions: Our study highlights the need for research on the haemorrhagic complications of anticoagulation in clinical care. A considerable proportion of reported haemorrhagic events occurred within 30 days of rivaroxaban and dabigatran initiation. This highlights the importance of considering bleeding risk at the time of treatment

  12. Cardiovascular and pulmonary adverse events in patients treated with BCR-ABL inhibitors: Data from the FDA Adverse Event Reporting System.

    PubMed

    Cortes, Jorge; Mauro, Michael; Steegmann, Juan Luis; Saglio, Giuseppe; Malhotra, Rachpal; Ukropec, Jon A; Wallis, Nicola T

    2015-04-01

    Rare but serious cardiovascular and pulmonary adverse events (AEs) have been reported in patients with chronic myeloid leukemia treated with BCR-ABL inhibitors. Clinical trial data may not reflect the full AE profile of BCR-ABL inhibitors because of stringent study entry criteria, relatively small sample size, and limited duration of follow-up. To determine the utility of the FDA AE Reporting System (FAERS) surveillance database for identifying AEs possibly associated with the BCR-ABL inhibitors imatinib, dasatinib, and nilotinib in the postmarketing patient population, we conducted Multi-Item Gamma Poisson Shrinker disproportionality analyses of FAERS reports on AEs in relevant system organ classes. Signals consistent with the known safety profiles of these agents as well as signals for less well-described AEs were detected. Bone marrow necrosis, conjunctival hemorrhage, and peritoneal fluid retention events were uniquely associated with imatinib. AEs that most commonly reached the threshold for dasatinib consisted of terms relating to hemorrhage and fluid retention, including pleural effusion and pericardial effusion. Most terms that reached the threshold solely with nilotinib were related to peripheral and cardiac vascular events. Although this type of analysis cannot determine AE incidence or establish causality, these findings elucidate the AEs reported in patients treated with BCR-ABL inhibitors across multiple clinical trials and in the community setting for all approved and nonapproved indications, suggesting drug-AE associations warrant further investigation. These findings emphasize the need to consider patient comorbidities when selecting amongst BCR-ABL inhibitors. PMID:25580915

  13. Regular treatment with formoterol versus regular treatment with salmeterol for chronic asthma: serious adverse events

    PubMed Central

    Cates, Christopher J; Lasserson, Toby J

    2014-01-01

    Background An increase in serious adverse events with both regular formoterol and regular salmeterol in chronic asthma has been demonstrated in previous Cochrane reviews. Objectives We set out to compare the risks of mortality and non-fatal serious adverse events in trials which have randomised patients with chronic asthma to regular formoterol versus regular salmeterol. Search methods We identified trials using the Cochrane Airways Group Specialised Register of trials. We checked manufacturers’ websites of clinical trial registers for unpublished trial data and also checked Food and Drug Administration (FDA) submissions in relation to formoterol and salmeterol. 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 with any severity of asthma if they randomised patients to treatment with regular formoterol versus regular salmeterol (without randomised inhaled corticosteroids), and were of at least 12 weeks’ duration. Data collection and analysis Two authors independently selected trials for inclusion in the review and extracted outcome data. We sought unpublished data on mortality and serious adverse events from the sponsors and authors. Main results The review included four studies (involving 1116 adults and 156 children). All studies were open label and recruited patients who were already taking inhaled corticosteroids for their asthma, and all studies contributed data on serious adverse events. All studies compared formoterol 12 μg versus salmeterol 50 μg twice daily. The adult studies were all comparing Foradil Aerolizer with Serevent Diskus, and the children’s study compared Oxis Turbohaler to Serevent Accuhaler. There was only one death in an adult (which was unrelated to asthma) and none in children, and there were no significant differences in non-fatal serious adverse events comparing formoterol to salmeterol in adults (Peto odds ratio (OR) 0.77; 95

  14. Superior Mesenteric Arterial Flow Pattern is Associated with Major Adverse Events in Adults with Fontan Circulation.

    PubMed

    Mori, Makoto; Shioda, Kayoko; Elder, Robert W; Pernetz, Maria A; Rodriguez, Fred H; Rangosch, Alicia; Kogon, Brian E; Book, Wendy M

    2016-08-01

    Factors contributing to the failure of Fontan circulation in adults are poorly understood. Reduced superior mesenteric arterial (SMA) flow has been identified in pediatric Fontan patients with protein-losing enteropathy. SMA flow has not been profiled in an adult Fontan population and its association with adverse events is unknown. We aimed to examine associations between SMA flow patterns and adverse events in adult Fontan patients. We performed a retrospective review of adult Fontan patients who underwent echocardiograms between 2008 and 2014. SMA Doppler data included peak systolic and end-diastolic velocity and velocity time integral (VTI). Systolic/diastolic (S/D) ratio and resistive index were calculated. The relationship between SMA flow parameters and major adverse events (death or transplantation) was examined using proportional hazard Cox regression analyses. Kaplan-Meyer analysis was conducted to construct survival curve of patients with and without adverse events. 91 post-Fontan adult patients (76 % systemic left ventricle, 20 % atriopulmonary Fontan, mean age 27.9 years) were analyzed. Adverse events occurred in nine patients (death = 4, transplant = 5). When compared with the non-event group, the event group had increased end-diastolic velocity [hazard ratio (HR) 1.5, 95 % confidence interval (CI) 1.1-1.8; p = 0.002], increased systolic VTI (HR 1.5, 95 % CI 1.1-2.2, p = 0.02), increased diastolic VTI (HR 1.7, 95 % CI 1.2-2.4, p = 0.004), decreased S/D velocity ratio (HR 0.32, 95 % CI 0.14-0.71, p = 0.006), decreased S/D VTI ratio (HR 0.76, 95 % CI 0.61-0.97, p = 0.02), and decreased resistive index (HR 0.29, 95 % CI 0.14-0.60, p = 0.0007). Increased end-diastolic velocity and VTI in mesenteric arterial flow, with lower systolic/diastolic ratio and resistive index, were associated with death and need for heart transplant in adult Fontan patients. The mesenteric hyperemic flow was also associated with clinical signs of portal

  15. Diurnal Cortisol Rhythm Is Associated With Adverse Cardiac Events and Mortality in Coronary Artery Bypass Patients

    PubMed Central

    Kidd, Tara; Poole, Lydia; Leigh, Elizabeth; Jahangiri, Marjan; Steptoe, Andrew

    2015-01-01

    Purpose: There is growing evidence that the hypothalamic-pituitary-adrenal axis plays a role in the progression of cardiovascular disease. We examined the relationship between diurnal cortisol rhythm and adverse events in patients undergoing coronary artery bypass graft (CABG) surgery. We hypothesized that a flatter presurgical diurnal cortisol slope would be associated with higher rates of adverse cardiac events and death in the years following the CABG procedure. Methods: Repeated measures of saliva were taken over the day from 250 CABG patients 1 month before surgery to assess diurnal cortisol slope and overall output (area under the curve). Long-term clinical outcomes were occurrence of a major adverse cardiac event (MACE) and death, and were collected up to 2.68 (SD = 0.40) years after surgery. Cox proportional hazard models were used to determine relationships between presurgical cortisol and clinical outcomes. EuroSCORE, chronic illness burden, and whether or not the patient had undergone cardiopulmonary bypass were included as covariates in the models. Results: Diurnal cortisol slope predicted the occurrence of MACE or death after surgery (hazard ratio = 0.73; 95% confidence interval = 0.56–0.96; P = .023). Patients with a steeper slope were at reduced risk of adverse outcomes. This association was driven by changes in both waking and evening cortisol levels. Conclusion: These results provide evidence for a link between diurnal cortisol rhythm and recovery after CABG. Measuring diurnal cortisol slope before surgery may help to identify those patients at risk of adverse outcomes in the years after the procedure. PMID:26305622

  16. Pathways from childhood abuse and other adversities to adult health risks: The role of adult socioeconomic conditions.

    PubMed

    Font, Sarah A; Maguire-Jack, Kathryn

    2016-01-01

    Adverse childhood experiences (ACEs), including child abuse, have been linked with poor health outcomes in adulthood. The mechanisms that explain these relations are less understood. This study assesses whether associations of ACEs and health risks are mediated by adult socioeconomic conditions, and whether these pathways are different for maltreatment than for other types of adversities. Using the Behavioral Risk Factor Surveillance System 2012 survey (N=29,229), we employ structural equation modeling to (1) estimate associations of the number and type of ACEs with five health risks-depression, obesity, tobacco use, binge drinking, and self-reported sub-optimal health; and (2) assess whether adult socioeconomic conditions-marriage, divorce and separation, educational attainment, income and insurance status-mediate those associations. Findings suggest both direct and indirect associations between ACEs and health risks. At high numbers of ACEs, 15-20% of the association between number of ACEs and adult health risks was attributable to socioeconomic conditions. Associations of three ACEs (exposure to domestic violence, parental divorce, and residing with a person who was incarcerated) with health risks were nearly entirely explained by socioeconomic conditions in adulthood. However, child physical, emotional, and sexual abuse were significantly associated with several adult health risks, beyond the effects of other adversities, and socioeconomic conditions explained only a small portion of these associations. These findings suggest that the pathways to poor adult health differ by types of ACEs, and that childhood abuse is more likely than other adversities to have a direct impact. PMID:26059537

  17. [Analysis of the cardiac side effects of antipsychotics: Japanese Adverse Drug Event Report Database (JADER)].

    PubMed

    Ikeno, Takashi; Okumara, Yasuyuki; Kugiyama, Kiyotaka; Ito, Hiroto

    2013-08-01

    We analyzed the cases of side effects due to antipsychotics reported to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) from Jan. 2004 to Dec. 2012. We used the Japanese Adverse Drug Event Report Database (JADER) and analyzed 136 of 216,945 cases using the defined terms. We also checked the cardiac adverse effects listed in the package inserts of the antipsychotics involved. We found cases of Ikr blockade resulting in sudden death (49 cases), electrocardiogram QT prolonged (29 cases), torsade de pointes (TdP, 19 cases), ventricular fibrillation (VF, 10 cases). M2 receptor blockade was observed in tachycardia (8 cases) and sinus tachycardia (3 cases). Calmodulin blockade was involved in reported cardiomyopathy (3 cases) and myocarditis (1 case). Multiple adverse events were reported simultaneously in 14 cases. Our search of package inserts revealed warnings regarding electrocardiogram QT prolongation (24 drugs), tachycardia (23), sudden death (18), TdP (14), VF (3), myocarditis (1) and cardiomyopathy (1). We suggest that when an antipsychotic is prescribed, the patient should be monitored regularly with ECG, blood tests, and/or biochemical tests to avoid adverse cardiac effects. PMID:25069255

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

    SciTech Connect

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

    2015-03-15

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

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

    PubMed

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

    2012-01-01

    Surgery in sub-Saharan Africa is widely known to be done against a background of poverty and illiteracy, late presentation with complicated pathologies, and a desperate lack of infrastructure. In addition, patient autonomy and self determination are highly flavored by cultural practices and religious beliefs. Any of these factors can influence the pattern and disclosure of adverse events and errors. The impact of these in the relationships between surgeons and patients, and between health institutions and patients must be considered as it may affect disclosure and response to errors. This article identifies the peculiar socioeconomic and cultural challenges that may hinder disclosure and proposes strategies for instituting disclosure of errors and adverse events services in Sub-Saharan Africa. PMID:23077703

  20. Biclustering of Adverse Drug Events in FDA’s Spontaneous Reporting System

    PubMed Central

    Harpaz, Rave; Perez, Hector; Chase, Herbert S.; Rabadan, Raul; Hripcsak, George; Friedman, Carol

    2012-01-01

    In this paper we present a new pharmacovigilance data mining technique based on the biclustering paradigm, which is designed to identify drug groups that share a common set of adverse events in FDA’s spontaneous reporting system. A taxonomy of biclusters is developed, revealing that a significant number of bone fide adverse drug event (ADE) biclusters are identified. Statistical tests indicate that it is extremely unlikely that the discovered bicluster structures as well as their content arose by chance. Some of the biclusters classified as indeterminate provide support for previously unrecognized and potentially novel ADEs. In addition, we demonstrate the importance of the proposed methodology to several important aspects of pharmacovigilance such as: providing insight into the etiology of ADEs, facilitating the identification of novel ADEs, suggesting methods and rational for aggregating terminologies, highlighting areas of focus, and as a data exploratory tool. PMID:21191383

  1. Recent Literature on Medication Errors and Adverse Drug Events in Older Adults.

    PubMed

    Naples, Jennifer G; Hanlon, Joseph T; Schmader, Kenneth E; Semla, Todd P

    2016-02-01

    Medication errors and adverse drug events are common in older adults, but locating literature addressing these issues is often challenging. The objective of this article is to summarize recent studies addressing medication errors and adverse drug events in a single location to improve accessibility for individuals working with older adults. A comprehensive literature search for studies published in 2014 was conducted, and 51 potential articles were identified. After critical review, 17 studies were selected for inclusion based on innovation; rigorous observational or experimental study designs; and use of reliable, valid measures. Four articles characterizing potentially inappropriate prescribing and interventions to optimize medication regimens were annotated and critiqued in detail. The authors hope that health policy-makers and clinicians find this information helpful in improving the quality of care for older adults. PMID:26804210

  2. Extraction Of Adverse Events From Clinical Documents To Support Decision Making Using Semantic Preprocessing.

    PubMed

    Gaebel, Jan; Kolter, Till; Arlt, Felix; Denecke, Kerstin

    2015-01-01

    Clinical documentation is usually stored in unstructured format in electronic health records (EHR). Processing the information is inconvenient and time consuming and should be enhanced by computer systems. In this paper, a rule-based method is introduced that identifies adverse events documented in the EHR that occurred during treatment. For this purpose, clinical documents are transformed into a semantic structure from which adverse events are extracted. The method is evaluated in a user study with neurosurgeons. In comparison to a bag of word classification using support vector machines, our approach achieved comparably good results of 65% recall and 78% precision. In conclusion, the rule-based method generates promising results that can support physicians' decision making. Because of the structured format the data can be reused for other purposes as well. PMID:26262330

  3. Glacial Acetic Acid Adverse Events: Case Reports and Review of the Literature

    PubMed Central

    Doles, William; Wilkerson, Garrett; Morrison, Samantha

    2015-01-01

    Glacial acetic acid is a dangerous chemical that has been associated with several adverse drug events involving patients over recent years. When diluted to the proper concentration, acetic acid solutions have a variety of medicinal uses. Unfortunately, despite warnings, the improper dilution of concentrated glacial acetic acid has resulted in severe burns and other related morbidities. We report on 2 additional case reports of adverse drug events involving glacial acetic acid as well as a review of the literature. A summary of published case reports is provided, including the intended and actual concentration of glacial acetic acid involved, the indication for use, degree of exposure, and resultant outcome. Strategies that have been recommended to improve patient safety are summarized within the context of the key elements of the medication use process. PMID:26448660

  4. Developing a taxonomy for research in adverse drug events: potholes and signposts.

    PubMed

    Nebeker, J R; Hurdle, J F; Hoffman, J; Roth, B; Weir, C R; Samore, M H

    2001-01-01

    Computerized decision support and order entry shows great promise for reducing adverse drug events (ADEs). The evaluation of these solutions depends on a framework of definitions and classifications that is clear and practical. Unfortunately the literature does not always provide a clear path to defining and classifying adverse drug events. While not a systematic review, this paper uses examples from the literature to illustrate problems that investigators will confront as they develop a conceptual framework for their research. It also proposes a targeted taxonomy that can facilitate a clear and consistent approach to the research of ADEs and aid in the comparison to results of past and future studies. The taxonomy addresses the definition of ADE, types, seriousness, error, and causality. PMID:11825237

  5. Impact of Adverse Events Following Immunization in Viet Nam in 2013 on chronic hepatitis B infection.

    PubMed

    Li, Xi; Wiesen, Eric; Diorditsa, Sergey; Toda, Kohei; Duong, Thi Hong; Nguyen, Lien Huong; Nguyen, Van Cuong; Nguyen, Tran Hien

    2016-02-01

    Adverse Events Following Immunization in Viet Nam in 2013 led to substantial reductions in hepatitis B vaccination coverage (both the birth dose and the three-dose series). In order to estimate the impact of the reduction in vaccination coverage on hepatitis B transmission and future mortality, a widely-used mathematical model was applied to the data from Viet Nam. Using the model, we estimated the number of chronic infections and deaths that are expected to occur in the birth cohort in 2013 and the number of excessive infections and deaths attributable to the drop in immunization coverage in 2013. An excess of 90,137 chronic infections and 17,456 future deaths were estimated to occur in the 2013 birth cohort due to the drop in vaccination coverage. This analysis highlights the importance of maintaining high vaccination coverage and swiftly responding to reported Adverse Events Following Immunization in order to regain consumer confidence in the hepatitis B vaccine. PMID:26055296

  6. Recent Literature on Medication Errors and Adverse Drug Events in Older Adults

    PubMed Central

    Naples, Jennifer G.; Hanlon, Joseph T.; Schmader, Kenneth E.; Semla, Todd P.

    2015-01-01

    Medication errors and adverse drug events are common in older adults, but locating literature addressing these issues is often challenging. The objective of this article was to summarize recent studies addressing medication errors and adverse drug events in a single location to improve accessibility for individuals working with older adults. The authors conducted a comprehensive literature search for studies published in 2014 and identified 51 potential articles. After critical review, 17 studies were selected for inclusion based on innovation, rigorous observational or experimental study designs, and use of reliable, valid measures. Four articles characterizing potentially inappropriate prescribing and interventions to optimize medication regimens were annotated and critiqued in detail. We hope that health policy makers and clinicians find this information helpful in improving the quality of care for older adults. PMID:26804210

  7. Factors Associated with Early Adverse Events after Coronary Artery Bypass Grafting Subsequent to Percutaneous Coronary Intervention

    PubMed Central

    Kamal, Yasser Ali; Mubarak, Yasser Shaban; Alshorbagy, Ashraf Ali

    2016-01-01

    Background A previous percutaneous coronary intervention (PCI) may affect the outcomes of patients who undergo coronary artery bypass grafting (CABG). The objective of this study was to compare the early in-hospital postoperative outcomes between patients who underwent CABG with or without previous PCI. Methods The present study included 160 patients who underwent isolated elective on-pump CABG at the department of cardiothoracic surgery, Minia University Hospital from January 2010 to December 2014. Patients who previously underwent PCI (n=38) were compared to patients who did not (n=122). Preoperative, operative, and early in-hospital postoperative data were analyzed. The end points of the study were in-hospital mortality and postoperative major adverse events. Results Non-significant differences were found between the study groups regarding preoperative demographic data, risk factors, left ventricular ejection fraction, New York Heart Association class, EuroSCORE, the presence of left main disease, reoperation for bleeding, postoperative acute myocardial infarction, a neurological deficit, need for renal dialysis, hospital stay, and in-hospital mortality. The average time from PCI to CABG was 13.9±5.4 years. The previous PCI group exhibited a significantly larger proportion of patients who experienced in-hospital major adverse events (15.8% vs. 2.5%, p=0.002). On multivariate analysis, only previous PCI was found to be a significant predictor of major adverse events (odds ratio, 0.16; 95% confidence interval, 0.03 to 0.71; p=0.01). Conclusion Previous PCI was found to have a significant effect on the incidence of early major adverse events after CABG. Further large-scale and long-term studies are recommended. PMID:27298794

  8. Usefulness of mycophenolic acid monitoring with PETINIA for prediction of adverse events in kidney transplant recipients.

    PubMed

    Ham, Ji Yeon; Jung, Hee-Yeon; Choi, Ji-Young; Park, Sun-Hee; Kim, Yong-Lim; Kim, Hyung-Kee; Huh, Seung; Kim, Chan-Duck; Won, Dong Il; Song, Kyung Eun; Cho, Jang-Hee

    2016-07-01

    Background Therapeutic drug monitoring of mycophenolic acid (MPA) is required to optimize the immunosuppressive effect and minimize toxicity. We validated a new particle-enhanced turbidimetric inhibition immunoassay (PETINIA) for the determination of MPA levels and evaluated the relationship of MPA trough level with drug-related adverse events. Methods PETENIA and liquid chromatography-mass spectrometry (LC-MS) were used to determine MPA concentrations from 54 kidney transplant recipients (KTRs). Agreement between PETINIA and LC-MS results was assessed by Passing-Bablok regression and the Bland-Altman plot method. The association of adverse events with MPA trough level obtained by PETINIA was analyzed. Results PETINIA revealed a good agreement with the LC-MS; Regression analysis gave an equation of y = 1.27x - 0.12 (r(2) = 0.975, p < 0.001). PETINIA showed a systemic positive bias with a mean difference of 0.66 mg/L compared to LC-MS. However, the magnitude of the positive bias decreased to 0.44 mg/L within the therapeutic range of MPA. Multiple logistic regression showed that MPA trough level determined by PETINIA was an independent risk factor for adverse events (odds ratio 2.28, 95% CI 1.25-4.16, p = 0.007). MPA trough level predicted adverse events with a sensitivity of 77.8% and a specificity of 86.7% using a cut-off level of 5.25 mg/L. Conclusions Good correlation between the two methods indicates that PETINIA is an acceptable method for the monitoring of MPA therapeutic levels. Furthermore, MPA trough level obtained by PETINIA is a useful monitoring tool to minimize toxicity in KTRs. PMID:26981890

  9. Novel data-mining methodologies for adverse drug event discovery and analysis.

    PubMed

    Harpaz, R; DuMouchel, W; Shah, N H; Madigan, D; Ryan, P; Friedman, C

    2012-06-01

    An important goal of the health system is to identify new adverse drug events (ADEs) in the postapproval period. Datamining methods that can transform data into meaningful knowledge to inform patient safety have proven essential for this purpose. New opportunities have emerged to harness data sources that have not been used within the traditional framework. This article provides an overview of recent methodological innovations and data sources used to support ADE discovery and analysis. PMID:22549283

  10. Adverse Events in Affiliated Hospitals of Mazandaran University of Medical Sciences

    PubMed Central

    Saravi, Benyamin Mohseni; Siamian, Hasan; Nezhad, Ayyob Barzegar; Asghari, Zoleleykha; Kabirzadeh, Azar

    2014-01-01

    Due to the complexity of the hospital environment, its structure faces with multiple hazards. The risks whether by providing the care and whether by hospital environment endanger patients, relatives and care providers. Therefore, a more accurate reporting and analysis of the report by focusing on access to preventative methods is essential. In this study, hospitals' adverse event that has sent by affiliated hospitals of Mazandaran University of Medical Sciences to deputy for treatment has studied. PMID:24944536

  11. Novel Data Mining Methodologies for Adverse Drug Event Discovery and Analysis

    PubMed Central

    Harpaz, Rave; DuMouchel, William; Shah, Nigam H.; Madigan, David; Ryan, Patrick; Friedman, Carol

    2013-01-01

    Introduction Discovery of new adverse drug events (ADEs) in the post-approval period is an important goal of the health system. Data mining methods that can transform data into meaningful knowledge to inform patient safety have proven to be essential. New opportunities have emerged to harness data sources that have not been used within the traditional framework. This article provides an overview of recent methodological innovations and data sources used in support of ADE discovery and analysis. PMID:22549283

  12. Evaluating Predictive Pharmacogenetic Signatures of Adverse Events in Colorectal Cancer Patients Treated with Fluoropyrimidines

    PubMed Central

    Skinner, Jane; Keane, Melanie; Chu, Gavin S.; Turner, Richard; Epurescu, Daniel; Barrett, Ann; Willis, Gavin

    2013-01-01

    The potential clinical utility of genetic markers associated with response to fluoropyrimidine treatment in colorectal cancer patients remains controversial despite extensive study. Our aim was to test the clinical validity of both novel and previously identified markers of adverse events in a broad clinical setting. We have conducted an observational pharmacogenetic study of early adverse events in a cohort study of 254 colorectal cancer patients treated with 5-fluorouracil or capecitabine. Sixteen variants of nine key folate (pharmacodynamic) and drug metabolising (pharmacokinetic) enzymes have been analysed as individual markers and/or signatures of markers. We found a significant association between TYMP S471L (rs11479) and early dose modifications and/or severe adverse events (adjusted OR = 2.02 [1.03; 4.00], p = 0.042, adjusted OR = 2.70 [1.23; 5.92], p = 0.01 respectively). There was also a significant association between these phenotypes and a signature of DPYD mutations (Adjusted OR = 3.96 [1.17; 13.33], p = 0.03, adjusted OR = 6.76 [1.99; 22.96], p = 0.002 respectively). We did not identify any significant associations between the individual candidate pharmacodynamic markers and toxicity. If a predictive test for early adverse events analysed the TYMP and DPYD variants as a signature, the sensitivity would be 45.5 %, with a positive predictive value of just 33.9 % and thus poor clinical validity. Most studies to date have been under-powered to consider multiple pharmacokinetic and pharmacodynamic variants simultaneously but this and similar individualised data sets could be pooled in meta-analyses to resolve uncertainties about the potential clinical utility of these markers. PMID:24167597

  13. Use of internet search logs to evaluate potential drug adverse events.

    PubMed

    Sarntivijai, S; Abernethy, D R

    2014-08-01

    Internet search logs provide an abundant source of data that can be explored for purposes such as identifying drug exposure-adverse event relationships. The methodology to rigorously conduct such evaluations is not well characterized, and the utility of such analyses is not well defined. In this issue, White and colleagues propose an approach using Internet search logs for this purpose and compare it to parallel analyses conducted using the US Food and Drug Administration's spontaneous reporting database. PMID:25056395

  14. [Drug-induced adverse events in the elderly: a traveler's guide].

    PubMed

    Barez, Thierry; Monod, Stéfanie; Livio, Françoise; Renard, Delphine

    2013-11-01

    Elderly people are prone to drug-induced adverse events (AEs), which often manifest as an atypical clinical picture. The differential diagnosis of any new symptom or alteration in the general state of health in the elderly must, therefore, include AEs. This article offers a practical tool designed to help clinicians to rapidly identify which drugs may induce which kind of frequent symptoms or syndromes. PMID:24308143

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

    PubMed

    Pirozzi Farina, Furio; Pischedda, Antonella

    2015-12-01

    Treatment-induced sexual dysfunctions (SD) are a recurrent and controversial topic in recent literature on the adverse events related to the use of 5-alpha-reductase inhibitors (5ARIs) (1, 2). In order to deal adequately with the various aspects of this topic, it is necessary to first cover some of the steps that allow a better definition and understanding of the subject. PMID:26766804

  16. Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety.

    PubMed

    Alicino, Cristiano; Merlano, Caterina; Zappettini, Simona; Schiaffino, Sergio; Della Luna, Giovanni; Accardo, Cristina; Gasparini, Roberto; Durando, Paolo; Icardi, Giancarlo

    2015-01-01

    Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines.   Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate. PMID:25483520

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

    PubMed

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

    2015-01-01

    The detection of adverse drug events (ADEs) is an important aspect of improving patient safety. The iMedication system employs predefined triggers associated with significant events in a patient's clinical data to automatically detect possible ADEs. We defined four clinically relevant conditions: hyperkalemia, hyponatremia, renal failure, and over-anticoagulation. These are some of the most relevant ADEs in internal medical and geriatric wards. For each patient, ADE risk scores for all four situations are calculated, compared against a threshold, and judged to be monitored, or reported. A ward-based cockpit view summarizes the results. PMID:26262252

  18. Hair and nail adverse events during treatment with targeted therapies for metastatic melanoma.

    PubMed

    Dika, Emi; Patrizi, Annalisa; Ribero, Simone; Fanti, Pier Alessandro; Starace, Michela; Melotti, Barbara; Sperandi, Francesca; Piraccini, Bianca Maria

    2016-06-01

    Targeted therapies for melanoma have shown clinical benefit in increasing the survival of metastatic patients. Cutaneous adverse events have been reported, but hair and nail data have been rarely detailed. Patients treated with BRAF and MEK inhibitors for metastatic melanoma underwent dermatological evaluation before the start of each treatment and after every four weeks. Pull test, global photography, dermoscopy/trichoscopy and scalp biopsy were performed. Appendages adverse events were graded using the National Cancer Institute's Common Terminology Criteria. Of the 24 patients included, 14 underwent treatment with a selective BRAF inhibitor; 10 received a combined treatment (dabrafenib/trametinib). Adnexal adverse events were common in the group of patients receiving vemurafenib, and included hair kinking, acute hair loss, and hair colour changes, often present in association, classified as G2 in three patients and G1 in eight. Dabrafenib alone induced hair kinking and colour changes in 60% of the patients. Combined treatment with dabrafenib/trametinib did not induce hair changes. Onycholysis was the most common nail side effect, and the unique side effect of dabrafenib (alone or in combination). Vemurafenib also induced acute paronychia and brittle nails. All nail side effects were graded as G1. Hair and nail side effects during targeted therapy for melanoma are not rare. The early recognition and cure of such side effects by dermatologists is of benefit to ensure the need for dose reduction or drug discontinuation. PMID:27019511

  19. Opioid Therapy Pharmacogenomics for Noncancer Pain: Efficacy, Adverse Events, and Costs

    PubMed Central

    Johnson, Ana

    2013-01-01

    Chronic non-cancer pain is a debilitating condition associated with high individual and societal costs. While opioid treatment for pain has been available for centuries, it is associated with high variability in outcome, and a considerable proportion of patients is unable to attain relief from symptoms while suffering adverse events and developing medication dependence. We performed a review of the efficacy of pharmacogenomic markers and their abilities to predict adverse events, dependence, and associated economic costs, focusing on two genes: OPRM1 and CYP2D6. Data sources were articles indexed by PubMed on or before August 6, 2013. Articles were first selected after review of their titles and abstracts, and full papers were read to confirm eligibility. Initially, fifty-two articles were identified. Of these, 17 were relevant to biological actions of pharmacogenomic markers and their effect on therapeutic efficacy, 16 to adverse events, 15 to opioid dependence, and eight to economic costs. In conclusion, increasing costs of opioid therapy have made the advances in pharmacogenomics an attractive solution to personalize care with unclear repercussions related to the impact on costs, morbidity, and outcomes. This intersection of pharmacoeconomics and pharmacogenomics presents a unique platform to further examine current advances in clinical medicine and their utility in cost-effective treatment of chronic pain. PMID:24167729

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

    PubMed

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

    2015-10-01

    For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce. PMID:26291578

  1. Evaluating the potential effectiveness of using computerized information systems to prevent adverse drug events.

    PubMed Central

    Anderson, J. G.; Jay, S. J.; Anderson, M.; Hunt, T. J.

    1997-01-01

    In this study a dynamic computer simulation model is used to estimate the effectiveness of various information systems applications designed to detect and prevent medication errors that result in adverse drug events (ADEs). The model simulates the four stages of the drug ordering and delivery system: prescribing, transcribing, dispensing and administering drugs. In this study we simulated interventions that have been demonstrated in prior studies to decrease error rates. The results demonstrated that a computerized information system that detected 26% of medication errors and prevented associated ADEs could save 1,226 days of excess hospitalization and $1.4 million in hospital costs annually. Those results suggest that such systems are potentially a cost-effective means of preventing ADEs in hospitals. The results demonstrated the importance of viewing adverse drug events from a systems perspective. Prevention efforts that focus on a single stage of the process had limited impact on the overall error rate. This study suggests that system-wide changes to the drug-ordering and delivery system are required to significantly reduce adverse drug events in a hospital setting. PMID:9357622

  2. The reasons of the nursing staff to notify adverse events 1

    PubMed Central

    de Paiva, Miriam Cristina Marques da Silva; Popim, Regina Célia; Melleiro, Marta Maria; Tronchim, Daisy Maria Rizatto; Lima, Silvana Andréa Molina; Juliani, Carmen Maria Casquel Monti

    2014-01-01

    OBJECTIVE: this research aimed to understand the motivation for reporting adverse events from the perspective of nursing staff in the work environment. METHOD: qualitative study that used the phenomenology of Alfred Schutz for reference, which offers a systematic approach to understand the social aspects of human action. Data were collected by open interviews with 17 nurses and 14 technicians/assistant nurses in a university hospital. RESULTS: motivation was revealed through six categories: all types of occurrences must be reported; the incident report is an auxiliary instrument to health care provision management; the culture of punishment in transition; nurses as the agents responsible for voluntary reporting; sharing problems with higher management and achieving quality in the work process. DISCUSSION: it was unveiled that, when reporting adverse events, team members perceived themselves to be in a collaborative relationship with the institution and trusted that they would receive administrative support and professional security, which encouraged them to continue reporting. Reporting allows health care professionals to share responsibilities with managers and encourages corrective actions. FINAL CONSIDERATIONS: the study revealed the nursing staff's motivation for adverse event reporting, contributing to reflections on institutional policies aimed at patient safety in health care. PMID:25493669

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

    PubMed Central

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

    2015-01-01

    Abstract: Background: Despite considerable loss of life by deliberate self-burning in low and middle-income countries, few scholars have examined psychiatric factors such as adverse life events that may be related to self-immolation. Methods: This case-control study investigated adverse life-events as risk factors for self-immolation patients admitted to a burn center serving the western region of Iran. Variables investigated included the following adverse life-events: unplanned pregnancy, infertility, homelessness, financial hardship, problems with friends, intimate relationship break-up , school or university failure, anxiety about school/university performance, problems at work, personal history of suicide attempts, family history of suicide attempts, individual history of mental disorders, and malignant disease. Results: Financial hardship (OR=3.35, 95% CI=1.19-9.90), intimate relationship break-up (OR=5.45, 95% CI=1.20-11.99), and personal history of suicide attempts (OR=7.00, 95% CI=1.38-35.48) were associated with increased risk of self-immolation. Conclusions: This study suggests that financial hardship, intimate relationship break-ups, and personal history of suicide attempts are risk factors for self-immolation. Other variables studied did not play a role as individually protective or risk factors for self-immolation. Further study is needed to substantiate findings of this study and direct research toward tailoring culturally sensitive, empirically-supported interventions for prevention of self-immolation. PMID:25618437

  4. Doctors' experiences of adverse events in secondary care: the professional and personal impact.

    PubMed

    Harrison, Reema; Lawton, Rebecca; Stewart, Kevin

    2014-12-01

    We carried out a cross-sectional online survey of fellows and members of the Royal College of Physicians to establish physicians' experiences of adverse patient safety events and near misses, and the professional and personal impact of these. 1,755 physicians answered at least one question; 1,334 answered every relevant question. Of 1,463 doctors whose patients had an adverse event or near miss, 1,119 (76%) believed this had affected them personally or professionally. 1,077 (74%) reported stress, 995 (68%) anxiety, 840 (60%) sleep disturbance and 886 (63%) lower professional confidence. 1,192 (81%) became anxious about the potential for future errors. Of 1,141 who had used NHS incident reporting systems, only 315 (28%) were satisfied with this process. 201 (14%) received useful feedback, 201 (19%) saw local improvements and 277 (19%) saw system changes. 364 (25%) did not report an incident that they should have. Adverse safety events affect physicians, but few formal sources of support are available. Most doctors use incident-reporting systems, but many describe a lack of useful feedback, systems change or local improvement. PMID:25468840

  5. Negative emotionality and disconstraint influence PTSD symptom course via exposure to new major adverse life events.

    PubMed

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

    2015-04-01

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

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

    PubMed Central

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

    2015-01-01

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

  7. Should we continue using amphotericin B deoxycholate for the treatment of fungal infections? Adverse events and clinical outcomes.

    PubMed

    Garbino, Jorge; Markham, Lydia; Matulionyte, Raimonda; Rives, Vincent; Lew, Daniel

    2006-01-01

    Amphotericin B deoxycholate (AmBd) has been a standard therapy for IFI but is associated with high adverse event and mortality rates. A retrospective review was undertaken to describe adverse events and clinical outcomes in adult patients with IFI treated with only AmBd as initial therapy. PMID:16449001

  8. Childhood Victimization: Early Adversity, Later Psychopathology. National Institute of Justice Journal, 2000.

    ERIC Educational Resources Information Center

    Widom, Cathy Spatz

    2000-01-01

    Childhood physical abuse, sexual abuse, and neglect have both immediate and long-term effects. Different types of abuse have a range of consequences for a childs later physical and psychological well-being, cognitive development, and behavior. This article discusses what is known about the long-term consequences of childhood victimization and the…

  9. Childhood adversity is linked to differential brain volumes in adolescents with alcohol use disorder: a voxel-based morphometry study.

    PubMed

    Brooks, Samantha J; Dalvie, Shareefa; Cuzen, Natalie L; Cardenas, Valerie; Fein, George; Stein, Dan J

    2014-06-01

    Previous neuroimaging studies link both alcohol use disorder (AUD) and early adversity to neurobiological differences in the adult brain. However, the association between AUD and childhood adversity and effects on the developing adolescent brain are less clear, due in part to the confound of psychiatric comorbidity. Here we examine early life adversity and its association with brain volume in a unique sample of 116 South African adolescents (aged 12-16) with AUD but without psychiatric comorbidity. Participants were 58 adolescents with DSM-IV alcohol dependence and with no other psychiatric comorbidities, and 58 age-, gender- and protocol-matched light/non-drinking controls (HC). Assessments included the Childhood Trauma Questionnaire (CTQ). MR images were acquired on a 3T Siemens Magnetom Allegra scanner. Volumes of global and regional structures were estimated using SPM8 Voxel Based Morphometry (VBM), with analysis of covariance (ANCOVA) and regression analyses. In whole brain ANCOVA analyses, a main effect of group when examining the AUD effect after covarying out CTQ was observed on brain volume in bilateral superior temporal gyrus. Subsequent regression analyses to examine how childhood trauma scores are linked to brain volumes in the total cohort revealed a negative correlation in the left hippocampus and right precentral gyrus. Furthermore, bilateral (but most significantly left) hippocampal volume was negatively associated with sub-scores on the CTQ in the total cohort. These findings support our view that some alterations found in brain volumes in studies of adolescent AUD may reflect the impact of confounding factors such as psychiatric comorbidity rather than the effects of alcohol per se. In particular, early life adversity may influence the developing adolescent brain in specific brain regions, such as the hippocampus. PMID:24496784

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

    PubMed Central

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

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

  11. Sleep Disturbances and Adverse Driving Events in a Predominantly Male Cohort of Active Older Drivers

    PubMed Central

    Vaz Fragoso, Carlos A.; Araujo, Katy L.B.; Van Ness, Peter H.; Marottoli, Richard A.

    2010-01-01

    OBJECTIVES To evaluate the association between sleep disturbances and adverse driving events among active older drivers. DESIGN Longitudinal. PARTICIPANTS 430 older persons (mean age 78.5 years, 84.9% male), who drove at least once-a-week. MEASUREMENTS Baseline measures included self-reported driving patterns and sleep questionnaires—Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Sleep Apnea Clinical Score (SACS). The primary outcome was an adverse driving event, based on self-report and driving records, and categorized as a crash or traffic-infraction (composite-I), or as a crash, traffic-infraction, near-crash, or getting lost (composite-II). RESULTS Participants reported driving a median of 17.0 miles/day, with 96.7% (416/430) driving daily or every-other-day. Although 26.0% (112/430) had insomnia (ISI≥8), 19.3% (83/430) had daytime drowsiness (ESS≥10), and 19.9% (84/422) had high sleep apnea risk (SACS>15), the median scores for the ISI, ESS, and SACS were normal at 3.0, 6.0, and 8.0, respectively, and drowsy-driving was reported by only 5.1%. Over a period of up to 2-years, 24.9% (104/418) and 51.4% (215/418) of participants had a composite-I and -II driving event, respectively. In unadjusted and adjusted multivariable models, insomnia, daytime drowsiness, and high sleep apnea risk were not associated with a composite-I or –II driving event. CONCLUSION In a predominantly male