Lead Exposure and Associated Risk Factors among New Migrant Children Arriving in Greece.

Background: This study aims to assess lead exposure and associated risk factors among newly arrived migrant (M) (immigrant and refugees) children in Greece and a matched control of native (N) children. Methods: A prospective, cross-sectional study was performed in an outpatient clinic of a tertiary children’s hospital. Results: From 2010 to 2014, 598 children (M/N: 349/249) with a mean age of 6.96 years old (range 1⁻14, SD 3.76) were enrolled. Blood lead levels (BLLs) ranged from 0.7 to 21 μg/dL in migrant and from 0.4 to 10 μg/dL in native Greek children. Elevated BLLs ≥ 5 μg/dL were detected in 27.7% of migrants and 1.2% of natives (p < 0.001). A significant association was found between EBLLs and childrens’ age (≤5 years) (OR: 1.8, p-value 0.02) and EBLLs with Asian origin (OR: 3.63, p-value 0.023). Conclusion: New migrant children presented with increased BLLs when compared to their age- and sex-matched controls. Younger age and Asian origin were significant risk factors associated with elevated BLLs among children. Early screening, secondary prevention, and regular follow-up could prove useful in this vulnerable population.

Incidence and risk factors of herpes zoster among adult renal transplant recipients receiving universal antiviral prophylaxis.

BACKGROUND: Herpes zoster (HZ) is a significant cause of morbidity and complications in adult renal transplant recipients. We determined the incidence, complications and risk factors for the development of HZ after renal transplantation in a setting using universal antiviral prophylaxis. METHODS: The medical files of all adult renal transplants, performed between 2004 and 2008, were retrospectively reviewed to assess the clinical characteristics and risk factors of HZ. Incident cases of HZ were determined and the probability of developing post-transplant HZ for all subjects was calculated using the Kaplan Meier method. A multivariable Cox proportional hazards model was applied to assess the risk factors associated with the development of HZ. RESULTS: A total of 450 patients were eligible with a median follow up of 38 months. Twenty nine subjects (6.4%) developed HZ, the median time to onset was 18 months, only three of them (10.3%) required hospitalization, and none developed disseminated or visceral disease and death directly attributed to zoster. However, high rates of post-herpetic neuralgia (48.7%) were observed. Overall incidence was calculated at 20.6 cases per 1000 patient-years of follow-up. Following multivariate analysis, increased age ≥ 60 years old, positive pre-transplant history of varicella related disease and administration of rejection treatment conferred an increased risk of 4.00-fold (CI: 1.79-8.92), 16.00-fold (CI: 4.62-55.52), and 5.57-fold (CI: 1.56-19.84) respectively, for the development of post-transplant zoster. CONCLUSIONS: HZ remains a common complication after renal transplantation in adults under current immunosuppession protocols and universal antiviral prophylaxis.

Phase II design with sequential testing of hypotheses within each stage.

The main goal of a Phase II clinical trial is to decide, whether a particular therapeutic regimen is effective enough to warrant further study. The hypothesis tested by Fleming's Phase II design (Fleming, 1982) is [Formula: see text] versus [Formula: see text], with level [Formula: see text] and with a power [Formula: see text] at [Formula: see text], where [Formula: see text] is chosen to represent the response probability achievable with standard treatment and [Formula: see text] is chosen such that the difference [Formula: see text] represents a targeted improvement with the new treatment. This hypothesis creates a misinterpretation mainly among clinicians that rejection of the null hypothesis is tantamount to accepting the alternative, and vice versa. As mentioned by Storer (1992), this introduces ambiguity in the evaluation of type I and II errors and the choice of the appropriate decision at the end of the study. Instead of testing this hypothesis, an alternative class of designs is proposed in which two hypotheses are tested sequentially. The hypothesis [Formula: see text] versus [Formula: see text] is tested first. If this null hypothesis is rejected, the hypothesis [Formula: see text] versus [Formula: see text] is tested next, in order to examine whether the therapy is effective enough to consider further testing in a Phase III study. For the derivation of the proposed design the exact binomial distribution is used to calculate the decision cut-points. The optimal design parameters are chosen, so as to minimize the average sample number (ASN) under specific upper bounds for error levels. The optimal values for the design were found using a simulated annealing method.

Development of a knowledge assessment tool for dermatotoxicity caused by inhibitors of epidermal growth factor receptor.

PURPOSE: The aim of this study was the development of a knowledge assessment tool for dermatotoxicity caused by inhibitors of EGFR (intravenous regimens). METHODS: Five nurses with experience in oncology created a 25-item questionnaire. The questionnaire was presented to six experts for assessment of face and content validity. Item analysis and reliability testing were evaluated on the test results of 76 nurses. RESULTS: Face and content validity was achieved for 25 items. Two items with low biserial correlations were deleted. The values for item difficulty range from 0.2 to 0.7. The values for item discrimination ranged from 0.25 to 0.64. The complete post-tested 23-item questionnaire showed excellent internal consistency with Kuder-Richardson 20 score of 0.909. The Cohen κ tests showed that the questionnaire has very good test-retest reliability. The specific tool can be used in several studies, leading to the development of educational interventions.