Gene A. Pennello

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Gene expression data from microarrays are being applied to predict preclinical and clinical endpoints, but the reliability of these predictions has not been established. In the MAQC-II project, 36 independent teams analyzed six microarray data sets to generate predictive models for classifying a sample with respect to one of 13 endpoints indicative of lung(More)
Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers to measure changes in these features. Critical to the performance of a quantitative imaging biomarker in preclinical or clinical settings are three primary(More)
OBJECTIVE Silicone gel breast implants have been reported to rupture, but the prevalence of implant rupture in an unreferred population of women is not known. The objective of this study was to assess the prevalence of implant rupture and the presence of extracapsular silicone gel in an unreferred population of women without regard to the absence or(More)
OBJECTIVE To assess whether breast implant rupture or extracapsular silicone are associated with selected symptoms of self-reported physician-diagnosed connective tissue disease (CTD). METHODS Women with silicone gel breast implants responded to a questionnaire that included questions on health status, satisfaction with implants, symptoms of CTD, and(More)
BACKGROUND This study examined the prevalence of revision surgery in which silicone gel breast implants were either removed (explanted) or replaced in a cohort of women from Birmingham, Alabama. The main reason leading up to the surgery and the prevalence of ruptured implants reported after explantation are described. METHODS Data were collected from(More)
OBJECTIVE We sought to identify pitfalls in recognition of extracapsular silicone on MR imaging. MATERIALS AND METHODS Three experienced observers reviewed MR images from 359 women with current (n = 320), prior (n = 15), or both current and prior (n = 24) silicone gel implants. Axial and sagittal fast spin-echo T2-weighted images with water suppression,(More)
Clinical trials that compare strategies to optimize antibiotic use are of critical importance but are limited by competing risks that distort outcome interpretation, complexities of noninferiority trials, large sample sizes, and inadequate evaluation of benefits and harms at the patient level. The Antibacterial Resistance Leadership Group strives to(More)
The purpose of this paper is to present a statistical reviewer's perspective on some technical aspects of reviewing Bayesian medical device trials submitted to the Food and Drug Administration. The discussion reflects the experiences of the authors and should not be misconstrued as official guidance by the FDA. A variety of applications are described,(More)
At the Washington DC Pharmacogenomics in Drug Development and Regulatory Decision-Making: Workshop III - Three Years of Promise, Proposals and Progress on Optimizing the Benefit/Risk of Medicines (11-13 April 2005), one break-out session (Track 2) focused on co-development of therapeutic drug and diagnostic products. The Food and Drug Administration (FDA)(More)
Multireader multicase (MRMC) variance analysis has become widely utilized to analyze observer studies for which the summary measure is the area under the receiver operating characteristic (ROC) curve. We extend MRMC variance analysis to binary data and also to generic study designs in which every reader may not interpret every case. A subset of the(More)