Safety and Efficacy of New-Generation Drug-Eluting Stents in Women at High Risk for Atherothrombosis: From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis

BACKGROUND The safety and efficacy of new-generation drug-eluting stents (DES) in women with multiple atherothrombotic risk (ATR) factors is unclear. METHODS AND RESULTS We pooled patient-level data for women enrolled in 26 randomized trials. Study population was categorized based on the presence or absence of high ATR, which was defined as having history of diabetes mellitus, prior percutaneous or surgical coronary revascularization, or prior myocardial infarction. The primary end point was major adverse cardiovascular events defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Out of 10 449 women included in the pooled database, 5333 (51%) were at high ATR. Compared with women not at high ATR, those at high ATR had significantly higher risk of major adverse cardiovascular events (15.8% versus 10.6%; adjusted hazard ratio: 1.53; 95% confidence interval: 1.34-1.75; P=0.006) and all-cause mortality. In high-ATR risk women, the use of new-generation DES was associated with significantly lower risk of 3-year major adverse cardiovascular events (adjusted hazard ratio: 0.69; 95% confidence interval: 0.52-0.92) compared with early-generation DES. The benefit of new-generation DES on major adverse cardiovascular events was uniform between high-ATR and non-high-ATR women, without evidence of interaction (Pinteraction=0.14). At landmark analysis, in high-ATR women, stent thrombosis rates were comparable between DES generations in the first year, whereas between 1 and 3 years, stent thrombosis risk was lower with new-generation devices. CONCLUSIONS Use of new-generation DES even in women at high ATR is associated with a benefit consistent over 3 years of follow-up and a substantial improvement in very-late thrombotic safety.

Taking up national safety alerts to improve patient safety in hospitals: The perspective of healthcare quality and risk managers.

BACKGROUND National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? METHODS A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. RESULTS The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. CONCLUSIONS To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts.

The local safety net, health insurance, preventable hospitalizations and costs: Harris County (Houston), Texas

The aim of this study was to examine the association between determinants of access to healthcare and preventable hospitalizations, based on Davidson et al.'s framework for evaluating the effects of individual and community determinants on access to healthcare. The study population consisted of the low income, non-elderly, hospitalized adults residing in Harris County, Texas in 2004. The objectives of this study were to examine the proportion of the variance in preventable hospitalizations at the ZIP-code level, to analyze the association between the proximity to the nearest safety net clinic and preventable hospitalizations, to examine how the safety net capacity relates to preventable hospitalizations, to compare the relative strength of the associations of health insurance and the proximity to the nearest safety net clinic with preventable hospitalizations, and to estimate and compare the costs of preventable hospitalizations in Harris County with the average cost in the literature. The data were collected from Texas Health Care Information Collection (2004), Census 2000, and Project Safety Net (2004). A total of 61,841 eligible individuals were included in the final data analysis. A random-intercept multi-level model was constructed with two different levels of data: the individual level and the ZIP-code level. The results of this study suggest that ZIP-code characteristics explain about two percent of the variance in preventable hospitalizations and safety net capacity was marginally significantly associated with preventable hospitalizations (p= 0.062). Proximity to the nearest safety net clinic was not related to preventable hospitalizations; however, health insurance was significantly associated with a decreased risk of preventable hospitalization. The average direct cost was $6,466 per preventable hospitalization, which is significantly different from reports in the literature. ^

Evaluation of obesity interventions targeting adults in the occupational setting

The study of obesity and its causes has evolved into one of the most important public health issues in the United States (Office of Disease Prevention and Health Promotion, 2007). Obesity is linked to several chronic conditions, such as cardiovascular disease, diabetes and some cancers (National Center for Chronic Disease Prevention and Health Promotion, 2008b) and the public health concern resides in the present morbidity and mortality associated with obesity and related conditions (National Heart, Lung and Blood Institute, 1998). Furthermore, obesity and its related conditions present economic challenges to employers in terms of medical health care, sick leave, short-term disability and long-term disability benefits utilized by employees (Østbye, Dement, and Krause, 2007). Recently, articles covering intervention programs targeting obesity in the occupational setting have surfaced in the body of scientific literature. The increased interest in this area stems from the fact that employees in the United States spend more time in the work environment than many industrialized nations, including Japan and most of Western Europe (Organisation for Economic Co-operation and Development, 2006). Moreover, scientific literature supports the idea of investing in healthy human capital to promote productivity and output from employees (Berger, Howell, Nicholson, & Sharda, 2003). The time spent in the work environment, the business need for healthy employees, and the public health concern create an opportunity for planning, implementation and analysis of interventions for effectiveness. This paper aims to identify those intervention programs that focus on the occupational setting related to obesity, to analyze the overall effect of diet, physical fitness and behavioral change interventions targeting overweight and obesity in the occupational setting, and to evaluate the details and effectiveness of components, such as, intervention setting, target participant group, content, industry and length of follow up. Once strengths and weaknesses of the interventions are evaluated, ideas will be suggested for implementation in the future.^

Evaluation of oxidative damage and renal distal tubule cell stress response following exposure to lindane

Lindane, or γ-hexachlorocyclohexane, is a chlorinated hydrocarbon pesticide that was banned from U.S. production in 1976, but until recently continued to be imported and applied for occupational and domestic purposes. Lindane is known to cause central nervous system (CNS), immune, cardiovascular, reproductive, liver, and kidney toxicity. The mechanism for which lindane interacts with the CNS has been elucidated, and involves antagonism of the γ-aminobutyric acid/benzodiazepine (GABAA/BZD) receptor. Antagonism of this receptor results in the inhibition of Cl- channel flux, with subsequent convulsions, seizures, and paralysis. This response makes lindane a desirable defense against arthropod pests in agriculture and the home. However, formulation and application of this compound can contribute to human toxicity. In conjunction with this exposure scenario, workers may be subject to both heat and physical stress that may increase their susceptibility to pesticide toxicity by altering their cellular stress response. The kidneys are responsible for maintaining osmotic homeostasis, and are exposed to agents that undergo urinary excretion. The mechanistic action of lindane on the kidneys is not well understood. Lindane, in other organ systems, has been shown to cause cellular damage by generation of free radicals and oxidative stress. Previous research in our laboratory has shown that lindane causes apoptosis in distal tubule cells, and delays renal stress response under hypertonic stress. Characterizing the mechanism of action of lindane under conditions of physiologic stress is necessary to understand the potential hazard cyclodiene pesticides and other organochlorine compounds pose to exposed individuals under baseline conditions, as well as under conditions of physiologic stress. We demonstrated that exposure to lindane results in oxidative damage and dysregulation of glutathione response in renal distal tubule (MDCK) cells. We showed that under conditions of hypertonic stress, lindane-induced oxidative stress resulted in early onset apoptosis and corresponding down-regulated expression of the anti-apoptotic protein, Bcl-xL. Thus, the interaction of lindane with renal peripheral benzodiazepine receptors (PBR) is associated with attenuation of cellular protective proteins, making the cell more susceptible to injury or death. ^

Assessment of occupational exposures to organic chemicals in a plastics manufacturing facility

The objective of this dissertation was to design and implement strategies for assessment of exposures to organic chemicals used in the production of a styrene-butadiene polymer at the Texas Plastics Company (TPC). Linear statistical retrospective exposure models, univariate and multivariate, were developed based on the validation of historical industrial hygiene monitoring data collected by industrial hygienists at TPC, and additional current industrial hygiene monitoring data collected for the purposes of this study. The current monitoring data served several purposes. First, it provided information on current exposure data, in the form of unbiased estimates of mean exposure to organic chemicals for each job title included. Second, it provided information on homogeneity of exposure within each job title, through the use of a carefully designed sampling scheme which addressed variability of exposure both between and within job titles. Third, it permitted the investigation of how well current exposure data can serve as an evaluation tool for retrospective exposure estimation. Finally, this dissertation investigated the simultaneous evaluation of exposure to several chemicals, as well as the use of values below detection limits in a multivariate linear statistical model of exposures. ^

Infectious diseases, immune status, and health insurance among child care providers in Houston, Texas

The objectives of this study were to compare female child-care providers with female university workers and with mothers of children in child-care centers for: (1) frequency of illness and work loss days due to infectious diseases, (2) prevalence of antibodies against measles, rubella, mumps, hepatitis B, hepatitis A, chickenpox and cytomegalovirus (CMV), and (3) status regarding health insurance and job benefits.^ Subjects from twenty child-care centers and twenty randomly selected departments of a university in Houston, Texas were studied in a cross-sectional fashion.^ A cluster sample of 281 female child-care providers from randomly selected child-care centers, a cluster sample of 286 university workers from randomly selected departments and a systematic sample of 198 mothers of children from randomly selected child-care centers.^ Main outcome measures were: (1) self-reported frequency of infectious diseases and number of work-days lost due to infectious diseases; (2) presence of antibodies in blood; and (3) self-reported health insurance and job benefits.^ In comparison to university workers, child-care providers reported a higher prevalence of infectious diseases in the past 30 days; lost three times more work-days due to infectious diseases; and were more likely to have anti-core antibodies against hepatitis B (odds ratio = 3.16 95% CI 1.27-7.85) and rubella (OR 1.88, 95% CI 1.02-3.45). Child-care providers had less health insurance and job-related benefits than mothers of children attending child-care centers.^ Regulations designed to reduce transmission of vaccine and non-vaccine preventable diseases in child-care centers should be strictly enforced. In addition policies to improve health insurance and job benefits of child-care providers are urgently needed. ^

A nested case-control study of radiation exposure and brain cancer incidence in the United States Air Force

A nested case-control study design was used to investigate the relationship between radiation exposure and brain cancer risk in the United States Air Force (USAF). The cohort consisted of approximately 880,000 men with at least 1 year of service between 1970 and 1989. Two hundred and thirty cases were identified from hospital discharge records with a diagnosis of primary malignant brain tumor (International Classification of Diseases, 9th revision, code 191). Four controls were exactly matched with each case on year of age and race using incidence density sampling. Potential career summary extremely low frequency (ELF) and microwave-radiofrequency (MWRF) radiation exposures were based upon the duration in each occupation and an intensity score assigned by an expert panel. Ionizing radiation (IR) exposures were obtained from personal dosimetry records.^ Relative to the unexposed, the overall age-race adjusted odds ratio (OR) for ELF exposure was 1.39, 95 percent confidence interval (CI) 1.03-1.88. A dose-response was not evident. The same was true for MWRF, although the OR = 1.59, with 95 percent CI 1.18-2.16. Excess risk was not found for IR exposure (OR = 0.66, 45 percent CI 0.26-1.72).^ Increasing socioeconomic status (SES), as identified by military pay grade, was associated with elevated brain tumor risk (officer vs. enlisted personnel age-race adjusted OR = 2.11, 95 percent CI 1.98-3.01, and senior officers vs. all others age-race adjusted OR = 3.30, 95 percent CI 2.0-5.46). SES proved to be an important confounder of the brain tumor risk associated with ELF and MWRF exposure. For ELF, the age-race-SES adjusted OR = 1.28, 95 percent CI 0.94-1.74, and for MWRF, the age-race-SES adjusted OR = 1.39, 95 percent CI 1.01-1.90.^ These results indicate that employment in Air Force occupations with potential electromagnetic field exposures is weakly, though not significantly, associated with increased risk for brain tumors. SES appeared to be the most consistent brain tumor risk factor in the USAF cohort. Other investigators have suggested that an association between brain tumor risk and SES may arise from differential access to medical care. However, in the USAF cohort health care is universally available. This study suggests that some factor other than access to medical care must underlie the association between SES and brain tumor risk. ^

Survey analysis on dental infection control & occupational safety from India---1999 & 2010

The objective was to study knowledge, attitudes, practice (KAP) and needs regarding infection control measures using two cross-sectional surveys from 1999 and 2010 conducted in India. Both data collection instruments had only about 35 comparable variables in common. In 1999, there were 456 respondents (dentists) who completed a self-administered survey instrument compared to 272 respondents in 2010. Both the 1999 and 2010 samples were mutually independent with no overlap, had regional differences, and therefore, were not completely comparable for changes in KAP over time. While almost all respondents from both surveys felt that education in dental safety was needed and wanted mandatory dental safety curriculum in dental schools, severe inadequacies in dental safety knowledge, protection against immunizable diseases, and practice of universal precaution were noted. Data from the study demonstrated that there is a substantial opportunity to improve the knowledge, attitude and practice of dental infection control and occupational safety in India. Few respondents (27%) reported that the infectious disease status of a patient is always known and a significant number reported that they had the right to refuse care for patients of known infectious disease status. This indicates that Stigma in treating HIV/AIDS patients remains a concern, which in turn suggests that a stronger focus on educating dentists about dental safety and on stigma and infectious disease is needed. Information obtained from this study could be utilized for developing policies oriented towards increasing dental safety educational efforts, in both dental schools as curriculum, and for practicing dentists through professional updates or continuing dental education.^

Effect of primary care availability and health insurance coverage on risk and cost of Preventable Hospitalizations in Harris County

Preventable Hospitalizations (PHs) are hospitalizations that can be avoided with appropriate and timely care in the ambulatory setting and hence are closely associated with primary care access in a community. Increased primary care availability and health insurance coverage may increase primary care access, and consequently may be significantly associated with risks and costs of PHs. Objective. To estimate the risk and cost of preventable hospitalizations (PHs); to determine the association of primary care availability and health insurance coverage with the risk and costs of PHs, first alone and then simultaneously; and finally, to estimate the impact of expansions in primary care availability and health insurance coverage on the burden of PHs among non-elderly adult residents of Harris County. Methods. The study population was residents of Harris County, age 18 to 64, who had at least one hospital discharge in a Texas hospital in 2008. The primary independent variables were availability of primary care physicians, availability of primary care safety net clinics and health insurance coverage. The primary dependent variables were PHs and associated hospitalization costs. The Texas Health Care Information Collection (THCIC) Inpatient Discharge data was used to obtain information on the number and costs of PHs in the study population. Risk of PHs in the study population, as well as average and total costs of PHs were calculated. Multivariable logistic regression models and two-step Heckman regression models with log-transformed costs were used to determine the association of primary care availability and health insurance coverage with the risk and costs of PHs respectively, while controlling for individual predisposing, enabling and need characteristics. Predicted PH risk and cost were used to calculate the predicted burden of PHs in the study population and the impact of expansions in primary care availability and health insurance coverage on the predicted burden. Results. In 2008, hospitalized non-elderly adults in Harris County had 11,313 PHs and a corresponding PH risk of 8.02%. Congestive heart failure was the most common PH. PHs imposed a total economic burden of $84 billion at an average of $7,449 per PH. Higher primary care safety net availability was significantly associated with the lower risk of PHs in the final risk model, but only in the uninsured. A unit increase in safety net availability led to a 23% decline in PH odds in the uninsured, compared to only a 4% decline in the insured. Higher primary care physician availability was associated with increased PH costs in the final cost model (β=0.0020; p<0.05). Lack of health insurance coverage increased the risk of PH, with the uninsured having 30% higher odds of PHs (OR=1.299; p<0.05), but reduced the cost of a PH by 7% (β=-0.0668; p<0.05). Expansions in primary care availability and health insurance coverage were associated with a reduction of about $1.6 million in PH burden at the highest level of expansion. Conclusions. Availability of primary care resources and health insurance coverage in hospitalized non-elderly adults in Harris County are significantly associated with the risk and costs of PHs. Expansions in these primary care access factors can be expected to produce significant reductions in the burden of PHs in Harris County.^

A case-comparison interview study of brain tumors and employment in occupations with presumed electric and magnetic field exposures

Results from epidemiologic studies suggest that persons working in occupations with presumed electric and magnetic field (EMF) exposures are at increased risk of brain cancer. This study utilized data from a completed, population-based, interview case-control study of central nervous system (CNS) tumors and employment in the petrochemical industry to test the hypothesis that employment in EMF-related occupations increases CNS tumor risk. A total of 375 male residents of the Texas-Louisiana Gulf Coast Area, age 20 to 79, with primary neuroglial CNS tumors diagnosed during the period 1980-84 were identified. A population-based comparison group of 450 age, race and geographically matched males was selected. Occupational histories and potential risk factor data were collected via personal interviews with study subjects or their next-of-kin.^ Adjusted odds ratios were less than 1.0 for persons ever employed in an electrical occupation (OR = 0.65; 95% CI = 0.40-1.09) or whose usual occupation was electrical (OR = 0.76; 95% CI = 0.33-1.73). Relative risk estimates did not increase significantly as time since first employment or duration of employment increased. Examination of CNS tumor risk by high (OR = 0.80), medium (OR = 0.88) and low (OR = 0.45) exposure categories for persons whose usual occupation was electrical did not indicate a dose-response pattern. In addition, the mean age of exposed cases was not significantly younger than that for unexposed cases. Analysis of risk by probability of exposure to EMFs showed non-significant elevations in the adjusted odds ratio for definite exposed workers defined by their usual occupation (OR = 1.78; 95% CI = 0.70-4.51) and ever/never employed status (OR = 1.54; 95% CI = 0.17-4.91).^ These findings suggest that employment in occupations with presumed EMF exposures does not increase CNS tumor risk as was suggested by previous investigations. The results of this study also do not support the EMF-tumor promotion hypothesis. ^

The success of worksite nutrition and physical activity interventions with environmental modifications A systematic review

Background: As obesity increases among U.S. workers, employers are implementing programs to increase physical activity and improve diets. Although programs to address individual determinants of obesity have been evaluated, less is known about the effects of workplace programs that change environmental factors, because most reviews have not isolated environmental programs; the one that did was published in 2005. ^ Objective: To update the 2005 review to determine the effectiveness of workplace environmental interventions. ^ Methods: The Medline database was searched for published English language reports (2003-2011) of randomized controlled (RCTs) or quasi-experimental trials (NRCTs) that evaluated strategies to modify physical activity opportunities or food services, targeting employees at least 18 years, not including retirees and that provided data for at least one physical activity, dietary, or health risk indicator. Three coders independently extracted study characteristics and scored the quality of study methods. Program effectiveness was determined using the 2005 review's best evidence approach. ^ Results: Seven studies represented in nine reports met eligibility criteria; three focused on diet and the remainder targeted diet and physical activity interventions. All but one study received a high quality score for internal validity. The evidence for the effectiveness of workplace environmental interventions was at best, inconclusive for diet and physical activity and limited for health risk indicators. The outcome constructs were inconsistent across the studies. ^ Conclusions: Limitations in the methods of the 2005 review made it challenging to draw conclusions about findings for this review that include: variation in outcome measures, reliance on distal measures without proximal behavior change measures, no distinction between changes at the workplace versus outside the workplace, and inappropriate analyses of cluster designs that biased findings toward statistical significance. The best evidence approach relied on vote-counting, using statistical significance alone rather than effect size and confidence intervals. Future research should address these limitations and use more rigorous methods; systematic reviews should use methods of meta-analysis to summarize study findings. These recommendations will help employers to better understand how environmental modifications in the workplace can support their efforts to combat the effects of obesity among employees.^

Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review

OBJETIVO: Comparar la efectividad, la seguridad y la aceptación de los abortos médicos practicados en el domicilio con aquellos realizados en la clínica. MÉTODOS: Se realizó una búsqueda sistemática de ensayos clínicos controlados aleatorizados y de estudios de cohortes prospectivos, comparando los abortos médicos realizados en el domicilio y en la clínica. Se realizaron búsquedas en el Registro Central de Cochrane de Ensayos Controlados, EMBASE, MEDLINE y Popline. Los resultados de interés principales fueron el fracaso para abortar completamente, los efectos secundarios y la aceptabilidad. Se calcularon las tasas de probabilidad y sus intervalos de confianza (IC) del 95%. Se reunieron los cálculos aproximados utilizando un modelo de efectos aleatorios. RESULTADOS: Nueve estudios cumplieron los criterios de inclusión (n=4522 participantes).Todos fueron estudios de cohortes prospectivos que utilizaron mifepristona y misoprostol para inducir al aborto. El aborto completo se consiguió en el 86- 97% de las mujeres que se sometieron a un aborto en el domicilio (n=3478) y entre el 80% y el 99% de aquellas mujeres que se sometieron a un aborto en una clínica (n = 1044). Los análisis agrupados de todos los estudios no mostraron diferencias en las tasas de aborto completo entre los grupos (tasa de probabilidad=0,8; IC del 95%: 0,5-1,5). Las complicaciones graves del aborto fueron poco frecuentes. El dolor y los vómitos duraron 0,3 días más en aquellas mujeres a las que se les administró misoprostol en el domicilio, en comparación con las que recibieron el tratamiento en la clínica. Las mujeres que optaron por un aborto médico en el domicilio mostraron un mayor grado de satisfacción, que las llevaría a elegir el método de nuevo y recomendárselo a una amiga, que aquellas mujeres que abortaron en la clínica. CONCLUSIÓN: El aborto en el domicilio es seguro siempre que el lugar cuente con las condiciones incluidas en los estudios. Los estudios de cohortes prospectivos por país no han mostrado diferencias en cuanto a efectividad o aceptabilidad entre abortos médicos en el domicilio y en la clínica.