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Durham, NC, United States

Roberts S.S.,University of North Carolina at Wilmington | Roberts S.S.,Kendle International Inc. | Miller R.K.,University of Rochester | Jones J.K.,Degge Group Ltd. | And 7 more authors.
Birth Defects Research Part A - Clinical and Molecular Teratology | Year: 2010

INTRODUCTION: Ribavirin, with interferons or pegylated interferons, is used to treat chronic hepatitis C. Ribavirin is contraindicated in pregnancy (FDA Pregnancy Category X) and in men whose partners may become pregnant. In 2003, the Ribavirin Pregnancy Registry was established to monitor pregnancy exposures to ribavirin and to evaluate the potential human teratogenicity of prenatal exposure. METHODS: This voluntary registry enrolls pregnant women who have been exposed to ribavirin during pregnancy or during the six months prior to conception either directly, by taking ribavirin, or indirectly through sexual contact with a man taking ribavirin. Women are followed until delivery; live born infants are followed for one year. The Registry aims to enroll 131 live births following direct (maternal) exposure to ribavirin and 131 live births following indirect (male) exposures. RESULTS: After more than five years of operation, the Registry has enrolled 49 live births with direct exposure and 69 live births following indirect exposure. Six outcomes with birth defects have been reported. All were among live born infants: torticollis (2), hypospadias (1), polydactyly and a neonatal tooth (1), glucose-6-phosphate dehydrogenase deficiency (1), ventricular septal defect and cyst of 4th ventricle of the brain (1). Three received direct exposures ([6.1% (95% CI: 1.2, 16.9)], three were exposed indirectly [4.3% (95% CI: 0.9, 12.2)]. CONCLUSIONS: Although current enrollment is far short of the required sample size, preliminary findings have not detected a signal indicating human teratogenicity for ribavirin. However, findings must be interpreted with caution concerning direct or indirect prenatal ribavirin exposures. © 2010 Wiley-Liss, Inc.

Ridder M.A.M.,Windesheim University of Applied Sciences | Ridder M.A.M.,Research Center for the Prevention of Overweight | Heuvelmans M.A.,Kendle International Inc. | Visscher T.L.S.,Research Center for the Prevention of Overweight | And 2 more authors.
Health Education | Year: 2010

Purpose: The purpose of this paper is to investigate perceptions of second grade lower vocational students concerning benefits, barriers and strategies of healthy eating and physical activity. Design/methodology/approach: Focus group discussions are conducted with 37 adolescents, from three schools in The Netherlands. A semi-structured questioning-scheme is used. Recorded data are transcribed, analysed using Atlas.ti and arranged in the EnRG-framework. Findings: Adolescents find health and a healthy weight important and like having a choice when it comes to health behaviour. The choices they make, however, are often unhealthy, especially when related to food. The risk perception of these adolescents is low; as long as they feel healthy, they feel no need to change their behaviour. Parents are held responsible for providing opportunities for healthy behaviour. At the same time, parental influence lessens and adolescents start to develop unhealthy habits, usually under the influence of a peer group. Adolescents accept the interference of school, meaning that there are good opportunities for school-based interventions. Research limitations/implications: The number (37) of respondents may not be representative for the different personalities of peer-students. Practical implications: Adolescents need to take on greater responsibility for their own health behaviour, especially in the school setting where they are more autonomous than at home. More information is needed about the perceptions of parents and school staff regarding stimulating healthy dietary and physical behaviour to develop, implement and preserve integral school health interventions successfully. Originality/value: The paper provides information on adolescents' perceptions on their responsibility for their health behaviour, which is needed to develop school-based health intervention consistent with their needs. © Emerald Group Publishing Limited.

Lu K.,Merck And Co. | Jiang L.,Kendle International Inc. | Tsiatis A.A.,North Carolina State University
Biometrics | Year: 2010

Often a binary variable is generated by dichotomizing an underlying continuous variable measured at a specific time point according to a prespecified threshold value. In the event that the underlying continuous measurements are from a longitudinal study, one can use the repeated-measures model to impute missing data on responder status as a result of subject dropout and apply the logistic regression model on the observed or otherwise imputed responder status. Standard Bayesian multiple imputation techniques (Rubin, 1987, in Multiple Imputation for Nonresponse in Surveys) that draw the parameters for the imputation model from the posterior distribution and construct the variance of parameter estimates for the analysis model as a combination of within- and between-imputation variances are found to be conservative. The frequentist multiple imputation approach that fixes the parameters for the imputation model at the maximum likelihood estimates and construct the variance of parameter estimates for the analysis model using the results of Robins and Wang (2000, Biometrika 87, 113-124) is shown to be more efficient. We propose to apply (Kenward and Roger, 1997, Biometrics 53, 983-997) degrees of freedom to account for the uncertainty associated with variance-covariance parameter estimates for the repeated measures model. © 2010, The International Biometric Society.

Abulkhair O.,King Saud bin Abdulaziz University for Health Sciences | Al Tahan F.,King Saud bin Abdulaziz University for Health Sciences | Young S.,King Saud bin Abdulaziz University for Health Sciences | Musaad S.,Kendle International Inc. | Jazieh A.-R.,King Saud bin Abdulaziz University for Health Sciences
Annals of Saudi Medicine | Year: 2010

Background and Objectives: Despite its relatively low incidence in Saudi Arabia, breast cancer has been the most common cancer among Saudi females for the past 12 consecutive years. The objective of this study was to report the results of the first national public breast cancer screening program in Saudi Arabia. Methods: Women 40 years of age or older underwent breast cancer screening. Mammograms were scored using the Breast Imaging-Reporting and Data System (BI-RADS). Correlations between imaging findings, risk factors and pathological findings were analyzed. Results: Between September 2007 and April 2008, 1215 women were enrolled. The median age was 45 years, and median body mass index was 31.6 kg/m 2. Sixteen cases of cancer were diagnosed. No cancer was diagnosed in 942 women with R1/R2 scores, and only 1 case of cancer was diagnosed in 228 women with R0/R3 scores. However, among 26 women with R4/R5 scores, 50% had malignant disease and 35% had benign lesions. No correlation was found between known risk factors and imaging score or cancer diagnosis. Conclusions: Public acceptance of the breast cancer screening program was encouraging. Longitudinal follow-up will help in better determining the risk factors relevant to our patient population.

Sietsema W.K.,Kendle International Inc.
Methods in molecular biology (Clifton, N.J.) | Year: 2010

Standardization of the measurement of pain in clinical trials will reduce variability, thus improving the quality of the data and reducing the number of patients needed to conduct pain trials. Standardization applies to the physical and psychosocial environment surrounding the patient, and there are many elements within this environment that can be effectively controlled. For example, the appearance of the examination room can be selected for neutrality and influences from visitors and staff can be minimized. Training is an important aspect of the standardization process and should be provided to all study staff. Staff training should first provide orientation on the protocol objectives and procedures and then a thorough discussion of the pain measures being used and how assessments will be conducted. Furthermore, as the patient is ultimately responsible for assessing his or her level of pain, it is important to train the patient to make reliable and accurate assessments of pain.

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