Identifying optimal risk windows for self-controlled case series studies of vaccine safety.

abstract：:The validity and practical utility of observational medical research depends critically on good study design, excellent data quality, appropriate statistical methods and accurate interpretation of results. Statistical methodology has seen substantial development in recent times. Unfortunately, many of these methodolog...

journal_title：Statistics in medicine

authors： Sauerbrei W,Abrahamowicz M,Altman DG,le Cessie S,Carpenter J,STRATOS initiative.

更新日期：2014-12-30 00:00:00

abstract：:The Wilcoxon-Mann-Whitney (WMW) test is often used to compare the means or medians of two independent, possibly nonnormal distributions. For this problem, the true significance level of the large sample approximate version of the WMW test is known to be sensitive to differences in the shapes of the distributions. Base...

journal_title：Statistics in medicine

authors： Fagerland MW,Sandvik L

更新日期：2009-05-01 00:00:00

abstract：:Multilevel and longitudinal studies are frequently subject to missing data. For example, biomarker studies for oral cancer may involve multiple assays for each participant. Assays may fail, resulting in missing data values that can be assumed to be missing completely at random. Catellier and Muller proposed a data ana...

journal_title：Statistics in medicine

authors： Ringham BM,Kreidler SM,Muller KE,Glueck DH

更新日期：2016-07-30 00:00:00

abstract：:Recently, Wu and Follmann developed summary measures to adjust for informative drop-out in longitudinal studies where drop-out depends on the underlying true value of the response. In this paper we evaluate these procedures in the common situation where drop-out depends on the observed responses. We also discuss vario...

journal_title：Statistics in medicine

authors： Wu MC,Albert PS,Wu BU

更新日期：2001-01-15 00:00:00

abstract：:Tumour registry linkage, chart review and patient self-report are all commonly used ascertainment methods in cancer epidemiology. These methods are used for estimating the incidence or prevalence of different cancer types in a population, and for investigating the effects of possible risk factors for cancer. Tumour re...

journal_title：Statistics in medicine

authors： Bernatsky S,Joseph L,Bélisle P,Boivin JF,Rajan R,Moore A,Clarke A

更新日期：2005-08-15 00:00:00

abstract：:Much has been published on various aspects of data analysis and reporting from clinical trials within the biopharmaceutical environment. This ranges from regulatory guidelines on the format and content of registration dossiers to recommendations on data presentation and the statistical methodologies that are appropria...

journal_title：Statistics in medicine

authors： Huster WJ,Enas GG

更新日期：1998-08-15 00:00:00

abstract：:In this article we develop flexible regression models in two respects to evaluate the influence of the covariate variables on the mixed Poisson and continuous responses and to evaluate how the correlation between Poisson response and continuous response changes over time. A scenario for dealing with regression models ...

journal_title：Statistics in medicine

authors： Yang Y,Kang J,Mao K,Zhang J

更新日期：2007-09-10 00:00:00

abstract：:I derive the locally most powerful rank tests for acceleration against semi-parametric alternatives when some patients are cured of the disease. I consider some particular classes of alternatives and present simulation results to verify the validity of the proposed tests. Real data from clinical trials for childhood l...

journal_title：Statistics in medicine

authors： Lee JW

更新日期：1995-10-15 00:00:00

abstract：:Risk prediction procedures can be quite useful for the patient's treatment selection, prevention strategy, or disease management in evidence-based medicine. Often, potentially important new predictors are available in addition to the conventional markers. The question is how to quantify the improvement from the new ma...

journal_title：Statistics in medicine

authors： Uno H,Tian L,Cai T,Kohane IS,Wei LJ

更新日期：2013-06-30 00:00:00

abstract：:A general method is presented that allows the researcher to change statistical design elements such as the residual sample size during the course of an experiment, to include an interim analysis for early stopping when no formal rule for early stopping was foreseen, to increase or reduce the number of planned interim ...

journal_title：Statistics in medicine

authors： Müller HH,Schäfer H

更新日期：2004-08-30 00:00:00

abstract：:In repeated measures settings, modeling the correlation pattern of the data can be immensely important for proper analyses. Accurate inference requires proper choice of the correlation model. Optimal efficiency of the estimation procedure demands a parsimonious parameterization of the correlation structure, with suffi...

journal_title：Statistics in medicine

authors： Simpson SL,Edwards LJ,Muller KE,Sen PK,Styner MA

更新日期：2010-07-30 00:00:00

abstract：:This paper describes compliance with the completion of a quality of life questionnaire in the Breast Cancer Prevention Trial, a large multi-centre randomized trial that is studying the efficacy of Tamoxifen in preventing breast cancer. In the first 4875 women enrolled in the control arm of the study, there was a very ...

journal_title：Statistics in medicine

authors： Ganz PA,Day R,Costantino J

更新日期：1998-03-15 00:00:00

abstract：:The present study investigates the performance of several statistical tests to detect publication bias in diagnostic meta-analysis by means of simulation. While bivariate models should be used to pool data from primary studies in diagnostic meta-analysis, univariate measures of diagnostic accuracy are preferable for t...

journal_title：Statistics in medicine

authors： Bürkner PC,Doebler P

更新日期：2014-08-15 00:00:00

abstract：:We propose a semiparametric method for estimating ROC surfaces for continuous diagnostic tests based on two test measurements. Such a three-class diagnostic problem based on two test measurements arises naturally from some DNA amplification-related diagnostic scenarios. Simulation results show that our proposed semipa...

journal_title：Statistics in medicine

authors： Wan S,Zhang B

更新日期：2009-08-15 00:00:00

abstract：:Recent studies have indicated variation in the infectivity beta of HIV among heterosexual couples. We represent this heterogeneity by modelling beta as a random variable. Using data on the number of contacts and seroconversion of couples, we fit the model by maximum-likelihood estimation with a beta distribution and a...

journal_title：Statistics in medicine

authors： Wiley JA,Herschkorn SJ,Padian NS

更新日期：1989-01-01 00:00:00

abstract：:In this paper, we consider a full likelihood method to analyze continuous longitudinal responses with non-ignorable non-monotone missing data. We consider a transition probability model for the missingness mechanism. A first-order Markov dependence structure is assumed for both the missingness mechanism and observed d...

journal_title：Statistics in medicine

authors： Liao K,Freres DR,Troxel AB

更新日期：2012-12-10 00:00:00

abstract：:In this paper, an approach to estimating the cumulative mean function for history process with time dependent covariates and right censored time-to-event variable is developed using the combined technique of joint modeling and inverse probability weighting method. The consistency of proposed estimator is derived. Theo...

journal_title：Statistics in medicine

authors： Deng D

更新日期：2016-11-10 00:00:00

abstract：:Population dynamic models, commonly used tools in the study of epidemics and other complex population processes, are implicit non-linear mathematical equations. Inference based on such models can be difficult due to the problems associated with high dimensional parameters that may be non-identified and complex likelih...

journal_title：Statistics in medicine

authors： Brookhart MA,Hubbard AE,van der Laan MJ,Colford JM Jr,Eisenberg JN

更新日期：2002-12-15 00:00:00

abstract：:The problem for assessing biosimilarity and drug interchangeability of follow-on biologics (biosimilar products) is studied. Unlike the generic products, the development of biosimilar products is much more complicated because of fundamental differences in functional structures and manufacturing processes. As a result,...

journal_title：Statistics in medicine

authors： Chow SC,Wang J,Endrenyi L,Lachenbruch PA

更新日期：2013-02-10 00:00:00

abstract：:Paired count data usually arise in medicine when before and after treatment measurements are considered. In the present paper we assume that the correlated paired count data follow a bivariate Poisson distribution in order to derive the distribution of their difference. The derived distribution is shown to be the same...

journal_title：Statistics in medicine

authors： Karlis D,Ntzoufras I

更新日期：2006-06-15 00:00:00

abstract：:The mixed effect models for repeated measures (MMRM) analysis is sometimes used as a primary analysis in longitudinal randomized clinical trials. The SE for the treatment effect in the MMRM analysis is usually estimated by assuming the orthogonality of the fixed effect and variance-covariance parameters, which is the ...

journal_title：Statistics in medicine

authors： Maruo K,Ishii R,Yamaguchi Y,Doi M,Gosho M

更新日期：2020-04-30 00:00:00

abstract：:The time-dependent change of HIV particle load, i.e. HIV dynamics, is likely to be controlled by a multitude of quantitative trait loci (QTL) that interact with each other as well as with various developmental and environmental factors in a coordinated manner. In this article, we have derived a new statistical model f...

journal_title：Statistics in medicine

authors： Wu S,Yang J,Wu R

更新日期：2006-11-30 00:00:00

abstract：:Screening and diagnostic tests are important in disease prevention or control. The predictive values of positive and negative (PPV and NPV) test results are two of four operational characteristics of a screening test. We review an existing method based on the generalized estimating equation (GEE) methodology for compa...

journal_title：Statistics in medicine

authors： Wang W,Davis CS,Soong SJ

更新日期：2006-07-15 00:00:00

abstract：:Tree-based methods have become popular for analyzing complex data structures where the primary goal is risk stratification of patients. Ensemble techniques improve the accuracy in prediction and address the instability in a single tree by growing an ensemble of trees and aggregating. However, in the process, individua...

journal_title：Statistics in medicine

authors： Banerjee M,Ding Y,Noone AM

更新日期：2012-07-10 00:00:00

abstract：:Interim analyses are conducted to allow for early termination of the trial, for ethical as well as economical reasons. Here we consider interim analyses in repeated measurements studies where the measurements are binary. Two methods for analysing this kind of data are compared according to their operating characterist...

journal_title：Statistics in medicine

authors： Spiessens B,Lesaffre E,Verbeke G

更新日期：2003-02-28 00:00:00

abstract：:Shared random effects models have been increasingly common in the joint analyses of repeated measures (e.g. CD4 counts, hemoglobin levels) and a correlated failure time such as death. In this paper we study several shared random effects models in the multi-level repeated measures data setting with dependent failure ti...

journal_title：Statistics in medicine

authors： Liu L,Ma JZ,O'Quigley J

更新日期：2008-11-29 00:00:00

abstract：:The risk that a drug newly introduced into medical use will occasionally cause adverse reactions is neither negligible nor totally avoidable. Only well organized systems of monitoring can bring early detection and appropriate action. These in turn require either detailed supervision or spontaneous reporting. The paper...

journal_title：Statistics in medicine

authors： Finney DJ

更新日期：1982-04-01 00:00:00

abstract：:In a typical bioequivalence trial, summary measures of the plasma concentration versus time profile are used to compare two formulations of a drug product. Commonly used measures include area under the curve (AUC), maximum plasma concentration (C(max)) and time to maximum concentration (T(max)). Equivalence of these s...

journal_title：Statistics in medicine

authors： Mauger DT,Chinchilli VM

更新日期：2000-10-30 00:00:00

abstract：:When estimating the probability of natural conception from observational data on couples with an unfulfilled child wish, the start of assisted reproductive therapy (ART) is a competing event that cannot be assumed to be independent of natural conception. In clinical practice, interest lies in the probability of natura...

journal_title：Statistics in medicine

authors： van Geloven N,Geskus RB,Mol BW,Zwinderman AH

更新日期：2014-11-20 00:00:00

abstract：:A significant source of missing data in longitudinal epidemiological studies on elderly individuals is death. Subjects in large scale community-based longitudinal dementia studies are usually evaluated for disease status in study waves, not under continuous surveillance as in traditional cohort studies. Therefore, for...

journal_title：Statistics in medicine

authors： Harezlak J,Gao S,Hui SL

更新日期：2003-05-15 00:00:00