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Comparison Of Adaptive Randomized Trial Designs For Time-To-Event Outcomes That Expand Versus Restrict Enrollment Criteria, To Test Non-Inferiority, Josh Betz, Jon Arni Steingrimsson, Tianchen Qian, Michael Rosenblum 2017 Johns Hopkins Bloomberg School of Public Health, Department of Biostatistics

Comparison Of Adaptive Randomized Trial Designs For Time-To-Event Outcomes That Expand Versus Restrict Enrollment Criteria, To Test Non-Inferiority, Josh Betz, Jon Arni Steingrimsson, Tianchen Qian, Michael Rosenblum

Johns Hopkins University, Dept. of Biostatistics Working Papers

Adaptive enrichment designs involve preplanned rules for modifying patient enrollment criteria based on data accrued in an ongoing trial. These designs may be useful when it is suspected that a subpopulation, e.g., defined by a biomarker or risk score measured at baseline, may benefit more from treatment than the complementary subpopulation. We compare two types of such designs, for the case of two subpopulations that partition the overall population. The first type starts by enrolling the subpopulation where it is suspected the new treatment is most likely to work, and then may expand inclusion criteria if there is early ...


Optimized Adaptive Enrichment Designs For Multi-Arm Trials: Learning Which Subpopulations Benefit From Different Treatments, Jon Arni Steingrimsson, Joshua Betz, Tiachen Qian, Michael Rosenblum 2017 Department of Biostatistics, Brown School of Public Health

Optimized Adaptive Enrichment Designs For Multi-Arm Trials: Learning Which Subpopulations Benefit From Different Treatments, Jon Arni Steingrimsson, Joshua Betz, Tiachen Qian, Michael Rosenblum

Johns Hopkins University, Dept. of Biostatistics Working Papers

We propose a class of adaptive randomized trial designs for comparing two treatments to a common control in two disjoint subpopulations. The type of adaptation, called adaptive enrichment, involves a preplanned rule for modifying enrollment and arm assignment based on accruing data in an ongoing trial. The motivation for this adaptive feature is that interim data may indicate that a subpopulation, such as those with lower disease severity at baseline, are unlikely to benefit from a particular treatment, while uncertainty remains for the other treatment and/or subpopulation. We developed a new multiple testing procedure tailored to this design problem ...


Using Ranked Auxiliary Covariate As A More Efficient Sampling Design For Ancova Model: Analysis Of A Psychological Intervention To Buttress Resilience, Rajai Jabrah, Hani Samawi, Robert Vogel, Haresh Rochani, Daniel Linder 2017 Georgia Southern University

Using Ranked Auxiliary Covariate As A More Efficient Sampling Design For Ancova Model: Analysis Of A Psychological Intervention To Buttress Resilience, Rajai Jabrah, Hani Samawi, Robert Vogel, Haresh Rochani, Daniel Linder

Hani M. Samawi

Drawing a sample can be costly or time consuming in some studies. However, it may be possible to rank the sampling units according to some baseline auxiliary covariates, which are easily obtainable, and/or cost efficient. Ranked set sampling (RSS) is a method to achieve this goal. In this paper, we propose a modified approach of the RSS method to allocate units into an experimental study that compares L groups. Computer simulation estimates the empirical nominal values and the empirical power values for the test procedure of comparing L different groups using modified RSS based on the regression approach in ...


Inference On Overlapping Coefficients In Two Exponential Populations, Mohammad F. Al-Saleh, Hani M. Samawi 2017 Yarmouk University

Inference On Overlapping Coefficients In Two Exponential Populations, Mohammad F. Al-Saleh, Hani M. Samawi

Hani M. Samawi

Three measures of overlap, namely Matusita’s measureρ , Morisita’s measure λ and Weitzman’s measure Δ are investigated in this article for two exponential populations with different means. It is well that the estimators of those measures of overlap are biased. The bias is of these estimators depends on the unknown overlap parameters. There are no closed-form, exact formulas, for those estimators variances or their exact sampling distributions. Monte Carlo evaluations are used to study the bias and precision of the proposed overlap measures. Bootstrap method and Taylor series approximation are used to construct confidence intervals for the overlap ...


Evaluating The Efficiency Of Treatment Comparison In Crossover Design By Allocating Subjects Based On Ranked Auxiliary Variable, Yisong Huang, Hani Samawi, Robert Vogel, Jingjing Yin, Worlanyo E. Gato, Daniel Linder 2017 Georgia Southern University

Evaluating The Efficiency Of Treatment Comparison In Crossover Design By Allocating Subjects Based On Ranked Auxiliary Variable, Yisong Huang, Hani Samawi, Robert Vogel, Jingjing Yin, Worlanyo E. Gato, Daniel Linder

Hani M. Samawi

The validity of statistical inference depends on proper randomization methods. However, even with proper randomization, we can have imbalanced with respect to important characteristics. In this paper, we introduce a method based on ranked auxiliary variables for treatment allocation in crossover designs using Latin squares models. We evaluate the improvement of the efficiency in treatment comparisons using the proposed method. Our simulation study reveals that our proposed method provides a more powerful test compared to simple randomization with the same sample size. The proposed method is illustrated by conducting an experiment to compare two different concentrations of titanium dioxide nanofiber ...


Estimation Of P(X > Y) When X And Y Are Dependent Random Variables Using Different Bivariate Sampling Schemes, Hani M. Samawi, Amal Helu, Haresh Rochani, Jingjing Yin, Daniel Linder 2017 Georgia Southern University

Estimation Of P(X > Y) When X And Y Are Dependent Random Variables Using Different Bivariate Sampling Schemes, Hani M. Samawi, Amal Helu, Haresh Rochani, Jingjing Yin, Daniel Linder

Hani M. Samawi

The stress-strength models have been intensively investigated in the literature in regards of estimating the reliability θ = P (X > Y) using parametric and nonparametric approaches under different sampling schemes when X and Y are independent random variables. In this paper, we consider the problem of estimating θ when (X, Y) are dependent random variables with a bivariate underlying distribution. The empirical and kernel estimates of θ = P (X > Y), based on bivariate ranked set sampling (BVRSS) are considered, when (X, Y) are paired dependent continuous random variables. The estimators obtained are compared to their counterpart, bivariate simple random sampling (BVSRS ...


Correction Of Verication Bias Using Log-Linear Models For A Single Binaryscale Diagnostic Tests, Haresh Rochani, Hani M. Samawi, Robert L. Vogel, Jingjing Yin 2017 Georgia Southern University

Correction Of Verication Bias Using Log-Linear Models For A Single Binaryscale Diagnostic Tests, Haresh Rochani, Hani M. Samawi, Robert L. Vogel, Jingjing Yin

Hani M. Samawi

In diagnostic medicine, the test that determines the true disease status without an error is referred to as the gold standard. Even when a gold standard exists, it is extremely difficult to verify each patient due to the issues of costeffectiveness and invasive nature of the procedures. In practice some of the patients with test results are not selected for verification of the disease status which results in verification bias for diagnostic tests. The ability of the diagnostic test to correctly identify the patients with and without the disease can be evaluated by measures such as sensitivity, specificity and predictive ...


Prevalence And Trends In Transmitted And Acquired Antiretroviral Drug Resistance, Washington, Dc, 1999-2014., Annette M Aldous, Amanda D Castel, David M Parenti 2017 George Washington University

Prevalence And Trends In Transmitted And Acquired Antiretroviral Drug Resistance, Washington, Dc, 1999-2014., Annette M Aldous, Amanda D Castel, David M Parenti

Epidemiology and Biostatistics Faculty Publications

Background

Drug resistance limits options for antiretroviral therapy (ART) and results in poorer health outcomes among HIV-infected persons. We sought to characterize resistance patterns and to identify predictors of resistance in Washington, DC.

Methods

We analyzed resistance in the DC Cohort, a longitudinal study of HIV-infected persons in care in Washington, DC. We measured cumulative drug resistance (CDR) among participants with any genotype between 1999 and 2014 (n = 3411), transmitted drug resistance (TDR) in ART-naïve persons (n = 1503), and acquired drug resistance (ADR) in persons with genotypes before and after ART initiation (n = 309). Using logistic regression, we assessed associations ...


Nonparametric Variable Importance Assessment Using Machine Learning Techniques, Brian D. Williamson, Peter B. Gilbert, Noah Simon, Marco Carone 2017 Department of Biostatistics, University of Washington

Nonparametric Variable Importance Assessment Using Machine Learning Techniques, Brian D. Williamson, Peter B. Gilbert, Noah Simon, Marco Carone

UW Biostatistics Working Paper Series

In a regression setting, it is often of interest to quantify the importance of various features in predicting the response. Commonly, the variable importance measure used is determined by the regression technique employed. For this reason, practitioners often only resort to one of a few regression techniques for which a variable importance measure is naturally defined. Unfortunately, these regression techniques are often sub-optimal for predicting response. Additionally, because the variable importance measures native to different regression techniques generally have a different interpretation, comparisons across techniques can be difficult. In this work, we study a novel variable importance measure that can ...


Methods For Scalar-On-Function Regression, Philip T. Reiss, Jeff Goldsmith, Han Lin Shang, R. Todd Ogden 2017 Columbia University

Methods For Scalar-On-Function Regression, Philip T. Reiss, Jeff Goldsmith, Han Lin Shang, R. Todd Ogden

Philip T. Reiss

Recent years have seen an explosion of activity in the field of functional data analysis (FDA), in which curves, spectra, images, etc. are considered as basic functional data units. A central problem in FDA is how to fit regression models with scalar responses and functional data points as predictors. We review some of the main approaches to this problem, categorizing the basic model types as linear, nonlinear and nonparametric. We discuss publicly available software packages, and illustrate some of the procedures by application to a functional magnetic resonance imaging dataset.


Application Of Support Vector Machine Modeling And Graph Theory Metrics For Disease Classification, Jessica M. Rudd 2017 Kennesaw State University

Application Of Support Vector Machine Modeling And Graph Theory Metrics For Disease Classification, Jessica M. Rudd

Grey Literature from PhD Candidates

Disease classification is a crucial element of biomedical research. Recent studies have demonstrated that machine learning techniques, such as Support Vector Machine (SVM) modeling, produce similar or improved predictive capabilities in comparison to the traditional method of Logistic Regression. In addition, it has been found that social network metrics can provide useful predictive information for disease modeling. In this study, we combine simulated social network metrics with SVM to predict diabetes in a sample of data from the Behavioral Risk Factor Surveillance System. In this dataset, Logistic Regression outperformed SVM with ROC index of 81.8 and 81.7 for ...


Combining Biomarkers By Maximizing The True Positive Rate For A Fixed False Positive Rate, Allison Meisner, Marco Carone, Margaret Pepe, Kathleen F. Kerr 2017 University of Washington, Seattle

Combining Biomarkers By Maximizing The True Positive Rate For A Fixed False Positive Rate, Allison Meisner, Marco Carone, Margaret Pepe, Kathleen F. Kerr

UW Biostatistics Working Paper Series

Biomarkers abound in many areas of clinical research, and often investigators are interested in combining them for diagnosis, prognosis and screening. In many applications, the true positive rate for a biomarker combination at a prespecified, clinically acceptable false positive rate is the most relevant measure of predictive capacity. We propose a distribution-free method for constructing biomarker combinations by maximizing the true positive rate while constraining the false positive rate. Theoretical results demonstrate good operating characteristics for the resulting combination. In simulations, the biomarker combination provided by our method demonstrated improved operating characteristics in a variety of scenarios when compared with ...


Developing Biomarker Combinations In Multicenter Studies Via Direct Maximization And Penalization, Allison Meisner, Chirag R. Parikh, Kathleen F. Kerr 2017 University of Washington, Seattle

Developing Biomarker Combinations In Multicenter Studies Via Direct Maximization And Penalization, Allison Meisner, Chirag R. Parikh, Kathleen F. Kerr

UW Biostatistics Working Paper Series

When biomarker studies involve patients at multiple centers and the goal is to develop biomarker combinations for diagnosis, prognosis, or screening, we consider evaluating the predictive capacity of a given combination with the center-adjusted AUC (aAUC), a summary of conditional performance. Rather than using a general method to construct the biomarker combination, such as logistic regression, we propose estimating the combination by directly maximizing the aAUC. Furthermore, it may be desirable to have a biomarker combination with similar predictive capacity across centers. To that end, we allow for penalization of the variability in center-specific performance. We demonstrate good asymptotic properties ...


Burden Of Atopic Dermatitis In The United States: Analysis Of Healthcare Claims Data In The Commercial, Medicare, And Medi-Cal Databases, Sulena Shrestha, Raymond Miao, Li Wang, Jingdong Chao, Huseyin Yuce, Wenhui Wei 2017 STATinMED Research/SIMR, Inc.

Burden Of Atopic Dermatitis In The United States: Analysis Of Healthcare Claims Data In The Commercial, Medicare, And Medi-Cal Databases, Sulena Shrestha, Raymond Miao, Li Wang, Jingdong Chao, Huseyin Yuce, Wenhui Wei

Publications and Research

Comparative data on the burden of atopic dermatitis (AD) in adults relative to the general population are limited. We performed a large-scale evaluation of the burden of disease among US adults with AD relative to matched non-AD controls, encompassing comorbidities, healthcare resource utilization (HCRU), and costs, using healthcare claims data. The impact of AD disease severity on these outcomes was also evaluated.


Biomarker Combinations For Diagnosis And Prognosis In Multicenter Studies: Principles And Methods, Allison Meisner, Chirag R. Parikh, Kathleen F. Kerr 2017 University of Washington, Seattle

Biomarker Combinations For Diagnosis And Prognosis In Multicenter Studies: Principles And Methods, Allison Meisner, Chirag R. Parikh, Kathleen F. Kerr

UW Biostatistics Working Paper Series

Many investigators are interested in combining biomarkers to predict an outcome of interest or detect underlying disease. This endeavor is complicated by the fact that many biomarker studies involve data from multiple centers. Depending upon the relationship between center, the biomarkers, and the target of prediction, care must be taken when constructing and evaluating combinations of biomarkers. We introduce a taxonomy to describe the role of center and consider how a biomarker combination should be constructed and evaluated. We show that ignoring center, which is frequently done by clinical researchers, is often not appropriate. The limited statistical literature proposes using ...


Mixture Models For Undiagnosed Prevalent Disease And Interval-Censored Incident Disease: Applications To A Cohort Assembled From Electronic Health Records., Li C Cheung, Qing Pan, Noorie Hyun, Mark Schiffman, Barbara Fetterman, Philip E Castle, Thomas Lorey, Hormuzd A Katki 2017 George Washington University

Mixture Models For Undiagnosed Prevalent Disease And Interval-Censored Incident Disease: Applications To A Cohort Assembled From Electronic Health Records., Li C Cheung, Qing Pan, Noorie Hyun, Mark Schiffman, Barbara Fetterman, Philip E Castle, Thomas Lorey, Hormuzd A Katki

Epidemiology and Biostatistics Faculty Publications

For cost-effectiveness and efficiency, many large-scale general-purpose cohort studies are being assembled within large health-care providers who use electronic health records. Two key features of such data are that incident disease is interval-censored between irregular visits and there can be pre-existing (prevalent) disease. Because prevalent disease is not always immediately diagnosed, some disease diagnosed at later visits are actually undiagnosed prevalent disease. We consider prevalent disease as a point mass at time zero for clinical applications where there is no interest in time of prevalent disease onset. We demonstrate that the naive Kaplan-Meier cumulative risk estimator underestimates risks at early ...


Constructing A Confidence Interval For The Fraction Who Benefit From Treatment, Using Randomized Trial Data, Emily J. Huang, Ethan X. Fang, Daniel F. Hanley, Michael Rosenblum 2017 Johns Hopkins University School of Public Health, Department of Biostatistics

Constructing A Confidence Interval For The Fraction Who Benefit From Treatment, Using Randomized Trial Data, Emily J. Huang, Ethan X. Fang, Daniel F. Hanley, Michael Rosenblum

Johns Hopkins University, Dept. of Biostatistics Working Papers

The fraction who benefit from treatment is defined as the proportion of patients whose potential outcome under treatment is better than that under control. Statistical inference for this parameter is challenging since it is only partially identifiable, even in our context of a randomized trial. We propose and evaluate a new method for constructing a confidence interval for the fraction who benefit, when the outcome is ordinal-valued (with binary outcomes as a special case). This confidence interval procedure is proved to be pointwise consistent. Our method does not require any assumptions about the joint distribution of the potential outcomes, although ...


The Diagnostic Utility Of Induced Sputum Microscopy And Culture In Childhood Pneumonia., David R Murdoch, Susan C Morpeth, Laura L Hammitt, Amanda J Driscoll, Nora L Watson, Daniel E Park, +several additional authors 2017 George Washington University

The Diagnostic Utility Of Induced Sputum Microscopy And Culture In Childhood Pneumonia., David R Murdoch, Susan C Morpeth, Laura L Hammitt, Amanda J Driscoll, Nora L Watson, Daniel E Park, +Several Additional Authors

Epidemiology and Biostatistics Faculty Publications

Background.

Sputum microscopy and culture are commonly used for diagnosing the cause of pneumonia in adults but are rarely performed in children due to difficulties in obtaining specimens. Induced sputum is occasionally used to investigate lower respiratory infections in children but has not been widely used in pneumonia etiology studies. Methods.

We evaluated the diagnostic utility of induced sputum microscopy and culture in patients enrolled in the Pneumonia Etiology Research for Child Health (PERCH) study, a large study of community-acquired pneumonia in children aged 1–59 months. Comparisons were made between induced sputum samples from hospitalized children with radiographically confirmed ...


Association Of C-Reactive Protein With Bacterial And Respiratory Syncytial Virus-Associated Pneumonia Among Children Aged <5 Years In The Perch Study., Melissa M Higdon, Tham Le, Katherine L O'Brien, David R Murdoch, Christine Prosperi, Henry C Baggett, Daniel E Park, +several additional authors 2017 George Washington University

Association Of C-Reactive Protein With Bacterial And Respiratory Syncytial Virus-Associated Pneumonia Among Children Aged <5 Years In The Perch Study., Melissa M Higdon, Tham Le, Katherine L O'Brien, David R Murdoch, Christine Prosperi, Henry C Baggett, Daniel E Park, +Several Additional Authors

Epidemiology and Biostatistics Faculty Publications

Background.

Lack of a gold standard for identifying bacterial and viral etiologies of pneumonia has limited evaluation of C-reactive protein (CRP) for identifying bacterial pneumonia. We evaluated the sensitivity and specificity of CRP for identifying bacterial vs respiratory syncytial virus (RSV) pneumonia in the Pneumonia Etiology Research for Child Health (PERCH) multicenter case-control study. Methods.

We measured serum CRP levels in cases with World Health Organization–defined severe or very severe pneumonia and a subset of community controls. We evaluated the sensitivity and specificity of elevated CRP for “confirmed” bacterial pneumonia (positive blood culture or positive lung aspirate or pleural ...


Is Higher Viral Load In The Upper Respiratory Tract Associated With Severe Pneumonia? Findings From The Perch Study., Daniel R Feikin, Wei Fu, Daniel E Park, Qiyuan Shi, Melissa M Higdon, Henry C Baggett, +several additional authors 2017 George Washington University

Is Higher Viral Load In The Upper Respiratory Tract Associated With Severe Pneumonia? Findings From The Perch Study., Daniel R Feikin, Wei Fu, Daniel E Park, Qiyuan Shi, Melissa M Higdon, Henry C Baggett, +Several Additional Authors

Epidemiology and Biostatistics Faculty Publications

Background.

The etiologic inference of identifying a pathogen in the upper respiratory tract (URT) of children with pneumonia is unclear. To determine if viral load could provide evidence of causality of pneumonia, we compared viral load in the URT of children with World Health Organization–defined severe and very severe pneumonia and age-matched community controls.

Methods.

In the 9 developing country sites, nasopharyngeal/oropharyngeal swabs from children with and without pneumonia were tested using quantitative real-time polymerase chain reaction for 17 viruses. The association of viral load with case status was evaluated using logistic regression. Receiver operating characteristic (ROC) curves ...


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