National prevalence survey of hospital-acquired infections in Czechoslovakia

A nationwide 1-day prevalence survey of a total of 12,260 patients in 23 hospitals across Czechoslovakia yielded 751 cases of hospital-acquired infection (HAI), a prevalence of 6.1%. Analysis of the data revealed that the prevalence of HAI amongst surgical patients was almost twice that amongst medical patients (8.2% vs. 4.4%). Persons aged over 60 on the urological and surgical wards were at highest risk of acquiring infection. The most frequent site of HAI was the urinary tract (25%), followed by surgical wounds (15%) and the upper respiratory tract (13%). Fifty per cent of infection in gynaecological patients occurred within 6 days of admission compared with 15% in urological patients, and a wide variation was seen in other specialties.     

Net reclassification index at event rate: properties and relationships

The net reclassification improvement (NRI) is an attractively simple summary measure quantifying improvement in performance because of addition of new risk marker(s) to a prediction model. Originally proposed for settings with well‐established classification thresholds, it quickly extended into applications with no thresholds in common use. Here we aim to explore properties of the NRI at event rate. We express this NRI as a difference in performance measures for the new versus old model and show that the quantity underlying this difference is related to several global as well as decision analytic measures of model performance. It maximizes the relative utility (standardized net benefit) across all classification thresholds and can be viewed as the Kolmogorov–Smirnov distance between the distributions of risk among events and non‐events. It can be expressed as a special case of the continuous NRI, measuring reclassification from the ‘null’ model with no predictors. It is also a criterion based on the value of information and quantifies the reduction in expected regret for a given regret function, casting the NRI at event rate as a measure of incremental reduction in expected regret. More generally, we find it informative to present plots of standardized net benefit/relative utility for the new versus old model across the domain of classification thresholds. Then, these plots can be summarized with their maximum values, and the increment in model performance can be described by the NRI at event rate. We provide theoretical examples and a clinical application on the evaluation of prognostic biomarkers for atrial fibrillation. Copyright © 2016 John Wiley & Sons, Ltd.     

Key multiplicity issues in clinical drug development

Much progress has been made over the past decade with the development of novel methods for addressing increasingly more complex multiplicity problems arising in confirmatory Phase III clinical trials. This includes traditional problems with a single source of multiplicity, for example, analysis of multiple endpoints or dose–placebo contrasts. In addition, more advanced problems with several sources of multiplicity have attracted attention in clinical drug development. These problems include two or more families of objectives such as multiple endpoints evaluated at multiple dose levels or in multiple patient populations. This paper provides a review of concepts that play a central role in defining and solving multiplicity problems (error rate definitions) and introduces main classes of multiple testing procedures widely used in clinical trials (nonparametric, semiparametric, and parametric procedures). The paper also presents recent advances in multiplicity research, including gatekeeping procedures for clinical trials with multiple sets of objectives. The concepts and methods introduced in the paper are illustrated using several case studies on the basis of real clinical trials. Software implementation of commonly used multiple testing and gatekeeping procedures is discussed. Copyright © 2012 John Wiley & Sons, Ltd.     

A PIL for every ill? Patient information leaflets (PILs): a review of past, present and future use

This article reviews the usefulness and importance of written information, specifically leaflets, being given to patients. Evidence suggesting how both patient and doctor may benefit from the giving of written information is reviewed. Identification of good practice relating to the content and readability of leaflets is discussed. An argument is put forward that the giving of written information is an under-utilized resource in contributing to improving patient outcomes but that this may be changing with the increasing use of patient leaflet databases. The advantages and disadvantages of computer- generated patient leaflets are discussed and desirable further areas of research on computer-generated leaflets are proposed.      

Chromosomal aberrations in lymphocytes of healthy subjects and risk of cancer

There is evidence that increased frequency of chromosomal aberration (CA) in peripheral blood lymphocytes is a predictor of cancer, but further data are needed to better characterize CA as marker of cancer risk. From the archives of 15 laboratories we gathered cytogenetic records of 11,834 subjects who were free of cancer at the moment of blood drawing and who underwent cytogenetic examination for preventive purposes in the Czech Republic during 1975-2000. We linked these records to the national cancer registry, revealing a total of 485 cancer cases. Subjects were classified according to the percentiles of CA distribution within each laboratory as low (0-33rd percentile), medium (34-66th percentile), and high (66-100th percentile). Subjects were further classified by occupational exposure and by subclass of CA. We found a significant association between the overall cancer incidence and the presence of chromosome-type aberrations [relative risk (RR) for high vs. low CA level = 1.24; 95% confidence interval (CI), 1.03-1.50] but not chromatid-type aberrations. Stomach cancer showed a strong association with frequency of total CA (RR = 7.79; 95% CI, 1.01-60.0). The predictivity of CA observed in subjects exposed to various classes of carcinogens did not significantly differ from the group of nonexposed subjects. This study contributes to validation of CA as a predictive marker of cancer risk, in particular, of stomach cancer; the association between CA frequency and cancer risk might be limited to chromosome-type aberrations.     

Drug Use in a Rural Secondary School in Kenya

ABSTRACT

Alcohol abuse and alcohol-related use problems among adolescents are highly prevalent and are a major concern worldwide. This study estimated the prevalence of drug abuse, knowledge about drug abuse and its effect on psychosocial well-being and induced behavioral problems among students of a public rural secondary school that admitted both girls and boys which offered both boarding and day school facilities. The students filled out a self-reporting substance use tool which measures the prevalence, frequency, and general patterns of substance use. Alcohol, tobacco, khat (catha edulis) and bhang (cannabis) were the most commonly reported substance of use, with user prevalence rates of 5.2%, 3.8%, 3.2%, and 1.7%, respectively. Tobacco use was initiated at 10 years, while cannabis, hard drugs, khat, and alcohol were initiated at 11, 12, 13, and 15 years of age, respectively. Among the students 71% were aware that their schoolmates were on drugs and it was known by 49.8%, 41.7%, 37.6%, 44.3%, and 32.4% of these students that using alcohol, tobacco, khat, cannabis, and hard drugs, respectively was a behavioral problem in the school. Three quarters of the students were aware that use of drugs was harmful to their health, with majority (78.6%) indicating that drug users need help to stop the drug use behavior. However most (73.6%) of the students suggested drug users in school should be punished. The drug use behavioral problems included school dropout, poor scholastic attainment, drunken driving, delinquency, and adolescence pregnancy which threaten the stability of the education system, family as an institution (family difficulties) and society at large. Therefore, teachers have an added burden of playing an active role in guidance and counselling the survivors of drug abuse, a pandemic facing teaching institutions apart from instilling knowledge.     

The impact of polycyclic aromatic hydrocarbons and fine particles on pregnancy outcome

The relationship between intrauterine growth retardation (IUGR) and exposure to particulate matter [less than/equal to] 10 microm (PM(10)) and particulate matter [less than and equal to] 2.5 microm (PM(2.5))( )in early pregnancy was recently studied in the highly polluted district of Teplice (Northern Bohemia). From this observation rose the question about the possible role of the carcinogenic fraction of polycyclic aromatic hydrocarbons (c-PAHs), which are usually bound to fine particles. The impact of c-PAHs and fine particles on IUGR was analyzed in Teplice and in Prachatice, a region with similarly high c-PAH but low particle levels. All European, single live births occurring in a 4-year period in Teplice (n = 3,378) and Prachatice (n = 1,505) were included. Detailed personal data were obtained via questionnaires and medical records. Mean PM(10), PM(2.5,) and c-PAHs levels during the 9 gestational months (GM) were estimated for each mother. Adjusted odds ratios (AORs) of IUGR for three levels of c-PAHs (low, medium, and high) and for continuous data were estimated after adjustment for a range of covariates using logistic regression models. In the present 4-year sample from Teplice, previously published results about increasing IUGR risk after exposure to particles in the first GM were fully confirmed, but no such effects were found in Prachatice. The AOR of IUGR for fetuses from Teplice exposed to medium levels of c-PAHs in the first GM was 1.60 [confidence interval (CI), 1.06-2. 15], and to high levels 2.15 (CI, 27-3.63). An exposure-response relationship was established by analyzing the continuous data. For each 10 ng increase of c-PAHs in the first GM, the AOR was 1.22 (CI, 1.07-1.39). About the same relationship was observed in Prachatice in spite of the low particle levels. The results prove that exposure to c-PAHs in early gestation may influence fetal growth. The particulate matter-IUGR association observed earlier may be at least partly explained by the presence of c-PAHs on particle surfaces.     

Somatostatin receptor endoradiotherapy of neuroendocrine tumors: experience in Hungarian patients

Beside conventional therapies for the treatment of neuroendocrine tumors, a new therapeutical approach, peptide receptor radionuclide therapy has been developed recently. There are two important features which make this therapy feasible: somatostatin receptors are strongly over-expressed in most neuroendocrine tumors resulting in a high tumor-to-background ratio and internalization of the somatostatin-receptor complex in neuroendocrine cells. Due to these features, neuroendocrine tumors can be treated with radiolabelled somatostatin analogues. For peptide receptor radionuclide therapy, somatostatin analogues are conjugated to a chelator that can bind a radionuclide. The most frequently used radionuclides for neuroendocrine tumor treatment are the β-emitter Yttrium-90 (??Y) and the β+γ emitter Lutetium-177 (1??Lu). Candidates for somatostatin receptor endoradiotherapy are patients with progressive, metastatic, somatostatin-receptor positive neuroendocrine tumors. Many patients have been successively treated with this approach: according to international results major remission can be achieved in 25% of the cases. Although this therapy is still unavailable in Hungary, Hungarian patients can be treated with somatostatin receptor endoradiotherapy with financial support from the National Health Fund in a co-operation with the University of Basel since 2005. During the past 5 years, 51 Hungarian patients have been treated with this therapy. This review briefly summarizes the theoretical background, indications, effectiveness and side effects of somatostatin receptor endoradiotherapy and the authors present the first data obtained from Hungarian patients.     

Sponsorship transformation at Ascension Health

Two Catholic health systems, the Daughters of Charity National Health System and the Sisters of St. Joseph Health System, came together to create St. Louis-based Ascension Health in 1999. A third organization, Carondelet Health System, then merged with Ascension Health in December 2002. Ascension Health is sponsored by four provinces of the Daughters of Charity, the Sisters of St. Joseph of Nazareth, and the Sisters of St. Joseph of Carondelet. Ascension Health operates according to a concept it calls "sponsorship of the whole," which has been defined as follows: "The sponsors of Ascension Health exercise canonical responsibility to ensure that the health ministry sustains and strengthens Catholic identity while expressing the charisms of the present and future sponsors. The sponsors act as stewards of Ascension Health's mission and resources, and commit, in partnership with others, to educate, influence, nurture, and develop the combined health ministry to further the healing ministry of Jesus." After several years of serving together on the Sponsors Council-and following much prayer, theological reflection, and in-depth discussion-the sponsors decided to accept the "Sponsorship of the Whole" document. The document challenges sponsors to open their hearts and arms to embrace all of Ascension Health's local health ministries. When Ascension Health was formed in November 1999, it was with the intention of adding laypeople to the Sponsors Council. In late 2005, the system created a work group to explore key areas pertinent to the appointment of lay members to the council. The Sponsors Council then engaged in a rigorous identification and selection process, after which, on July 1, 2006, it welcomed two lay members. Ascension Health will continue to develop its own preferred culture and identity. As the system's metamorphosis unfolds, personal conversion, a new way of relating to others, and changes in both attitudes and values will be necessary.     

The exposure of nonsmoking and smoking mothers to environmental tobacco smoke during different gestational phases and fetal growth

We studied the impact of maternal exposure to environmental tobacco smoke (ETS) on birth weight (BW), low birth weight (LBW), and intrauterine growth retardation (IUGR) according to self-reported maternal smoking habits in a sample of 6,866 singleton births. We obtained data about parental characteristics and maternal active smoking (AS) and passive smoking at delivery via maternal questionnaires and medical records. We used three categories of smoking habits (nonsmokers and those who smoked 1-10 or >10 cigarettes per day) and defined ETS exposure as greater than or equal to 5 cigarettes per day smoked by others in the mother's presence. We used multiple regression and logistic regression procedures with adjustment for many associated covariates. We observed a significant reduction of the mean BW in infants of AS mothers. This reduction was only marginal for mothers who stopped smoking after recognizing their pregnancy. ETS exposure in 1,797 of 5,507 nonsmoking mothers reduced the mean BW of their infants by 53 g [95% confidence interval (CI), 24-82 g]. ETS exposure also significantly reduced BW in babies of AS mothers by 92 g (CI, 21-113 g) compared with BW of ETS-nonexposed AS mothers. The adjusted odds ratio (AOR) of LBW for ETS-exposed AS mothers was two times the LBW risk of ETS-nonexposed AS mothers(2.02; CI, 1.11-3.67); the AOR of ETS-exposed nonsmoking mothers was 1.51 (CI, 1.02-2.26). The AOR of IUGR for this group did not differ from unity (1.08; CI, 0.82-1.43). However, ETS exposure increased the AOR of IUGR for AS mothers from 1.64 (CI, 1.06-2.53) to 2.13 (CI, 1.70-2.67). ETS exposure reduced the BW of infants of nonsmoking mothers and contributed to additional BW reduction in infants of AS mothers. ETS exposure increased the risk of LBW but not that of IUGR in babies of nonsmoking mothers.