Regulatory oversight and safety of probiotic use

Depending on intended use of a probiotic (drug vs. dietary supplement), regulatory requirements differ greatly. For dietary supplements, premarketing demonstration of safety and efficacy and approval by the Food and Drug Administration are not required; only premarket notification is required. Saccharomyces boulardii is a probiotic regulated as a dietary supplement intended for use by the general healthy population, not as a drug to prevent, treat, or mitigate disease. However, since recent increases in incidence and severity of Clostridium difficile infection, probiotics have been used to treat recurrent and/or refractory disease in hospitalized patients. Saccharomyces fungemia secondary to use of the probiotic has been described for patients who are critically ill, are receiving nutrition enterally, or have a central venous catheter. Before use of a probiotic is considered for hospitalized patients, careful assessment of risk versus benefit must be made. To ensure patient safety, probiotics should be properly handled during administration.     

Peer Reviewed: Identifying Populations at High Risk for Diabetes With the Behavioral Risk Factor Surveillance System,Rhode Island, 2003

Introduction

We evaluated the feasibility of applying a previously validated diabetes risk score (DRS) to state-based surveillance data from the Behavioral Risk Factor Surveillance System (BRFSS) to assess population risk for developing type 2 diabetes or having undiagnosed type 2 diabetes.

Methods

We conducted a cross-sectional analysis of 1,969 adults aged 30 to 60 years who self-reported never having been diagnosed with diabetes. The Danish DRS was applied to the 2003 Rhode Island BRFSS data by using 6 categorical variables: age, sex, body mass index, known hypertension, leisure-time physical activity, and family history of diabetes. The DRS was the sum of these individual scores, which ranged from 0 to 60; a score of 31 or more was considered high-risk.

Results

We found that 436 study participants, representing 23% of Rhode Island adults aged 30 to 60 years, had a high DRS. In the final model, adults with at least some college education were 43% less likely to have a high DRS, compared to adults with a high school diploma. Adults with no health insurance were 54% more likely to have a high DRS compared with insured adults.

Conclusion

By adding a family history question in odd years to correspond to the hypertension module in the BRFSS, routinely available state-level surveys can be used with a DRS to monitor populations at high risk for developing type 2 diabetes. In Rhode Island, almost one-fourth of adults aged 30 to 60 years were at high risk for having undiagnosed diabetes or developing diabetes. Adults with lower education and without health insurance were at highest risk.     

Development of a nomogram for predicting a positive repeat prostate biopsy

AIM: To fi nd risk factors of cancer in patients who had a repeat biopsy and to develop the nomogram using our cohort. METHODS: Among 3500 patients who had a prostate biopsy over 11 years between 2000 and 2010 at our hospital, we studied a total of 807 repeat biopsy sessions in 459 patients who had at least 1 initial negative biopsy. At each biopsy session, we recorded patient age, number of previous biopsy sessions, number of biopsy cores, number of previously negative biopsy cores, months from the initial biopsy, months from the previous biopsy, serum PSA, PSA slope, digital rectal examination fi ndings, hypoechoic lesions suspicious for a cancer on transrectal ultrasonography, total prostate volume, transitional zone(TZ) volume, PSA density, PSA TZ density and history of high grade prostatic intraepithelial neoplasia(HGPIN) or atypical small acinar proliferation(ASAP). Clinical and pathological variables were correlated with the outcome of repeat biopsies. A nomogram was developed based on logistic regression analyses and calibration was performed.RESULTS: Overall, 17% of repeat biopsies had a cancer. With receiver operating characteristics analyses, the highest area under the curve(AUC) was obtained based on all available 13 variables, which were age, PSA, digital rectal examination, PSA density, prostate volume, TZ volume, PSA TZ density, cumulative number of biopsy cores, HGPIN, ASAP, months from previous negative biopsy, initial negative biopsy and number of biopsy cores. Based on multivariable logistic regression analysis, a nomogram was constructed with an AUC of 0.74, which was greater than that of any single risk factor. The calibration plot seemed to be good.CONCLUSION: Our nomogram for predicting a positive repeat biopsy can provide probabilities for cancer and may help clinical judgment on whether to do a repeat prostate biopsy.     

Trends in preterm birth in singleton deliveries in a Hong Kong population

Objective

To examine trends in preterm birth and its relationship with perinatal mortality in Hong Kong.

Methods

In a retrospective cohort study, data were reviewed from singletons delivered between 1995 and 2011 at a university teaching hospital. Trends in preterm birth (between 24 and 36 weeks of pregnancy), perinatal mortality, and subtypes of preterm birth (spontaneous, iatrogenic, and following preterm premature rupture of membranes [PPROM]) were examined via linear regression.

Results

There were 103 364 singleton deliveries, of which 6722 (6.5%) occurred preterm, including 1835 (1.8%) early preterm births (24–33 weeks) and 4887 (4.7%) late preterm births (34–36 weeks). Frequency of preterm birth remained fairly consistent over the study period, but that of spontaneous preterm birth decreased by 25% (β = –0.83; P < 0.001), from 4.5% to 3.8%. Frequency of preterm birth following PPROM increased by 135% (β = 0.82; P < 0.001), from 0.7% to 1.7%. The perinatal mortality rate decreased from 56.7 to 37.0 deaths per 1000 deliveries before 37 weeks (β = –0.16; P = 0.54). Early preterm birth contributed to 16.0% of all deaths.

Conclusion

Although the overall rate of preterm birth in Hong Kong has remained constant, the frequencies of its subtypes have changed. Overall perinatal mortality is gradually decreasing, but early preterm birth remains a major contributor.     

Incidence and recurrent work-related violence towards healthcare workers and subsequent health effects. A one-year follow-up study

AIMS: The aim of the present study was to analyse the incidence of violence and threats of violence during the first year at work after graduating as a healthcare worker, the risk of re-exposure and health effects among respondents previously exposed to violence or threats. METHODS: We analysed baseline data from 5,696 healthcare students and conducted prospective multinomial regression analyses following 2,847 respondents during their first year of employment. RESULTS: At baseline we found that nearly a third of the respondents had been exposed to violence or threats of violence, 8.7% during trainee periods. At follow-up, we found that 24.6% of the healthcare workers had been exposed to violence and 33.4% to threats during the first year at work after graduation. Exposure to violence or threats during trainee periods was a strong predictor of violence (Odds ratio (OR)=3.3) and threats (OR=4.2) at follow-up. The results showed that violence or threats in previous jobs or at other places had a significant impact on the health of the victims at follow-up independent of gender, age, sense of coherence, self-efficacy and health at baseline. Exposure during trainee periods had a small but not quite significant (p=0.06) impact on the health of the victims at follow-up. CONCLUSIONS: The study shows a high risk of violence and threats of violence among healthcare workers during training and the first year at work after graduation, indicating a need for violence prevention planning involving both college and workplaces.     

A clinical grading system for retinal inflammation in the chronic model of experimental autoimmune uveoretinitis using digital fundus images

Experimental autoimmune uveoretinitis (EAU), a widely used animal model of human posterior/pan-uveitis, is extremely valuable in allowing understanding of the pathogenesis of uveitis as well as in developing new treatments. Depending on the animal strain and immunization protocol used, the clinical course of EAU can be acute, severe and involving the anterior and posterior part of the eye, or chronic, mild and involving only the posterior part of the eye. Clinical signs of EAU can be examined by bio-microscopy. Using appropriate criteria EAU can be quantitatively evaluated clinically in living animals. However, correlation of research within different laboratories is difficult since clinical grading systems are subjective and susceptible to considerable variability. In this study, we have developed a recordable, image-based clinical grading system for the chronic models of EAU. Fundus images were taken from EAU mice using an endoscopic imaging system. Fundus changes were classified as (1) inflammatory changes (including optic disc inflammation, vasculitis and retinal tissue inflammation) and (2) retinal structural damage. Each element was scored separately based on the severity of the lesions, and the average score of the three inflammatory elements was used as the overall EAU clinical inflammation grade of the eye. The validity and reproducibility of the grading system was tested using a set of images scored independently in a masked manner by 5 individuals. The grading system proved robust, easy to use and reliable. We offer this image-based EAU clinical grading system as a useful quantitative evaluation method for clinical grading of the severity of inflammation in the chronic EAU model, in which the inflammation can be mild and mainly involves posterior part of the eye.     

Rethinking theoretical approaches to stigma: a Framework Integrating Normative Influences on Stigma (FINIS)

A resurgence of research and policy efforts on stigma both facilitates and forces a reconsideration of the levels and types of factors that shape reactions to persons with conditions that engender prejudice and discrimination. Focusing on the case of mental illness but drawing from theories and studies of stigma across the social sciences, we propose a framework that brings together theoretical insights from micro, meso and macro level research: Framework Integrating Normative Influences on Stigma (FINIS) starts with Goffman's notion that understanding stigma requires a language of social relationships, but acknowledges that individuals do not come to social interaction devoid of affect and motivation. Further, all social interactions take place in a context in which organizations, media and larger cultures structure normative expectations which create the possibility of marking "difference". Labelling theory, social network theory, the limited capacity model of media influence, the social psychology of prejudice and discrimination, and theories of the welfare state all contribute to an understanding of the complex web of expectations shaping stigma. FINIS offers the potential to build a broad-based scientific foundation based on understanding the effects of stigma on the lives of persons with mental illness, the resources devoted to the organizations and families who care for them, and policies and programs designed to combat stigma. We end by discussing the clear implications this framework holds for stigma reduction, even in the face of conflicting results.