Composite sequential Monte Carlo test for post-market vaccine safety surveillance.

abstract：:Blinded estimation of variance allows for changing the sample size without compromising the integrity of the trial. Some of the methods that estimate the variance in a blinded manner either make untenable assumptions or are only applicable to two-treatment trials. We propose a new method for continuous endpoints that ...

journal_title：Statistics in medicine

authors： Xing B,Ganju J

更新日期：2005-06-30 00:00:00

abstract：:Proportional hazards (or Cox) regression is a popular method for modelling the effects of prognostic factors on survival. Use of cubic spline functions to model time-by-covariate interactions in Cox regression allows investigation of the shape of a possible covariate-time dependence without having to specify a specifi...

journal_title：Statistics in medicine

authors： Hess KR

更新日期：1994-05-30 00:00:00

abstract：:Meta-analyses pooling continuous outcomes can use mean differences (MD), standardized MD (MD in pooled standard deviation units, SMD), or ratio of arithmetic means (RoM). Recently, ratio of geometric means using ad hoc (RoGM (ad hoc) ) or Taylor series (RoGM (Taylor) ) methods for estimating variances have been propos...

journal_title：Statistics in medicine

authors： Friedrich JO,Adhikari NK,Beyene J

更新日期：2012-07-30 00:00:00

abstract：:Virtually all clinical trials collect multiple endpoints that are usually correlated. Many methods have been proposed to control the family-wise type I error rate (FWER), but these methods often disregard the correlation among the endpoints, such as the commonly used Bonferroni correction, Holm procedure, Wiens' Bonfe...

journal_title：Statistics in medicine

authors： Xie C

更新日期：2012-02-20 00:00:00

abstract：:In a cluster randomized cross-over trial, all participating clusters receive both intervention and control treatments consecutively, in separate time periods. Patients recruited by each cluster within the same time period receive the same intervention, and randomization determines order of treatment within a cluster. ...

journal_title：Statistics in medicine

authors： Turner RM,White IR,Croudace T,PIP Study Group.

更新日期：2007-01-30 00:00:00

abstract：:Identification of treatment selection biomarkers has become very important in cancer drug development. Adaptive enrichment designs have been developed for situations where a unique treatment selection biomarker is not apparent based on the mechanism of action of the drug. With such designs, the eligibility rules may b...

journal_title：Statistics in medicine

authors： Simon R,Simon N

更新日期：2017-11-20 00:00:00

abstract：:Nutritional exposures are often measured with considerable error in commonly used surrogate instruments such as the food frequency questionnaire (FFQ) (denoted by Q(i) for the ith subject). The error can be both systematic and random. The diet record (DR) denoted by R(i) for the ith subject is considered an alloyed go...

journal_title：Statistics in medicine

authors： Rosner B,Michels KB,Chen YH,Day NE

更新日期：2008-08-15 00:00:00

abstract：:Members of a cohort of workers in chemical industry (the so-called Boehringer cohort) exposed to 2, 3, 7, 8-tetrachlorodibenzo-para-dioxin (TCDD) from 1950 to 1984 were subject in the years 1985-1986 and 1992-1994 to an extensive biomonitoring programme on the TCDD levels of the individual workers. For establishing a ...

journal_title：Statistics in medicine

authors： Heinzl H,Mittlböck M,Edler L

更新日期：2008-05-30 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：:A popular method to control multiplicity in confirmatory clinical trials is to use a so-called hierarchical, or fixed sequence, test procedure. This requires that the null hypotheses are ordered a priori, for example, in order of clinical importance. The procedure tests the hypotheses in this order using alpha-level t...

journal_title：Statistics in medicine

authors： Edwards D,Madsen J

更新日期：2007-12-10 00:00:00

abstract：:We compared eight nominal 95 per cent confidence intervals for the ratio of two Poisson parameters, both assumed small, on their true coverage (the probability that the interval includes the ratio of Poisson parameters) and median width. The commonly used log-linear interval, justified by asymptotic considerations, pr...

journal_title：Statistics in medicine

authors： Barker L,Cadwell BL

更新日期：2008-09-10 00:00:00

abstract：:There are inconsistencies between the formulas for the variance of standardized mean difference (SMD) in the Cochrane Handbook for Systematic Reviews and the variance reported in other sources. Instead of the variance appropriate for the SMD of a crossover experiment, the Cochrane Handbook uses the variance appropriat...

journal_title：Statistics in medicine

authors： Kitchenham B,Madeyski L

更新日期：2020-11-30 00:00:00

abstract：:Phase II studies in oncology are frequently conducted as two-stage single-arm trials with a binary endpoint indicating tumor response. As a common feature of these designs, the sample sizes of the two stages and the decision rules for the interim and the final analysis have to be pre-specified and adhered to strictly ...

journal_title：Statistics in medicine

authors： Englert S,Kieser M

更新日期：2015-06-15 00:00:00

abstract：:In designed longitudinal studies, information from the same set of subjects are collected repeatedly over time. The longitudinal measurements are often subject to missing data which impose an analytic challenge. We propose a functional multiple imputation approach modeling longitudinal response profiles as smooth curv...

journal_title：Statistics in medicine

authors： He Y,Yucel R,Raghunathan TE

更新日期：2011-05-10 00:00:00

abstract：:With the increasing availability of detailed clinical information, there is optimism that treatment choices can be selectively directed to those individuals most likely to benefit. While standard clinical trials can establish whether a treatment appears to be effective on average, subsequent work is needed to determin...

journal_title：Statistics in medicine

authors： Sitlani CM,Heagerty PJ

更新日期：2014-07-30 00:00:00

abstract：:We study prevalence-dependent diagnostic accuracy measures, specifically, positive and negative predictive values. These measures permit an assessment of the clinical utility of diagnostic tests across populations with different disease prevalences. In many cases, prevalence may not be known with certainty and the eva...

journal_title：Statistics in medicine

authors： Li J,Fine JP,Safdar N

更新日期：2007-07-30 00:00:00

abstract：:A new method is proposed for the surveillance of Down's syndrome among newborn. Despite the strong dependence of overall risk of Down's syndrome on maternal age, it has been suggested that an environmentally induced increase in risk may be additive over all maternal ages. The surveillance method introduced here is spe...

journal_title：Statistics in medicine

authors： Lie RT,Heuch I,Irgens LM

更新日期：1993-01-15 00:00:00

abstract：:Misclassification introduces errors in categorical variables. This paper presents a review of methods for misclassified categorical data in epidemiology. Different sampling schemes for a 2 x 2 x 2 table and methods of analyses will be discussed first. A misclassification matrix is defined, and the usual misclassificat...

journal_title：Statistics in medicine

authors： Chen TT

更新日期：1989-09-01 00:00:00

abstract：:Longitudinal biomarker data are often collected in studies, providing important information regarding the probability of an outcome of interest occurring at a future time. With many new and evolving technologies for biomarker discovery, the number of biomarker measurements available for analysis of disease progression...

journal_title：Statistics in medicine

authors： Zhao L,Murray S,Mariani LH,Ju W

更新日期：2020-11-20 00:00:00

abstract：:We discuss some of the fundamental concepts underlying the development of frailty and random effects models in survival. One of these fundamental concepts was the idea of a frailty model where each subject has his or her own disposition to failure, their so-called frailty, additional to any effects we wish to quantify...

journal_title：Statistics in medicine

authors： O'Quigley J,Stare J

更新日期：2002-11-15 00:00:00

abstract：:Bioequivalence assessment is an issue of great interest. Development of statistical methods for assessing bioequivalence is an important area of research for statisticians. Bioequivalence is usually determined based on the normal distribution. We relax this assumption and develop a semi-parametric mixed model for bioe...

journal_title：Statistics in medicine

authors： Ghosh P,Rosner GL

更新日期：2007-03-15 00:00:00

abstract：:Biomarkers, increasingly used in biomedical studies for the diagnosis and prognosis of acute and chronic diseases, provide insight into the effectiveness of treatments and potential pathways that can be used to guide future treatment targets. The measurement of these markers is often limited by the sensitivity of the ...

journal_title：Statistics in medicine

authors： Lee M,Kong L,Weissfeld L

更新日期：2012-07-30 00:00:00

abstract：:Most phase I dose-finding methods in oncology aim to find the maximum-tolerated dose from a set of prespecified doses. However, in practice, because of a lack of understanding of the true dose-toxicity relationship, it is likely that none of these prespecified doses are equal or reasonably close to the true maximum-to...

journal_title：Statistics in medicine

authors： Chu Y,Pan H,Yuan Y

更新日期：2016-09-10 00:00:00

abstract：:The most popular model used for survival analysis is the proportional hazards regression model proposed by Cox. This is mainly due to its exceptional simplicity. Nevertheless the fundamental assumption of the Cox model is the proportionality of the hazards. For many applications, however, this assumption is doubtful. ...

journal_title：Statistics in medicine

authors： Berger U,Schäfer J,Ulm K

更新日期：2003-04-15 00:00:00

abstract：:It is naive and incorrect to use the proportions of successful operations to compare the performance of surgeons because the patients' risk profiles are different. In this paper, we explore the use of risk-adjusted procedures to compare the performance of surgeons. One such risk-adjusted statistic is the standardized ...

journal_title：Statistics in medicine

authors： Tang X,Gan FF

更新日期：2017-07-20 00:00:00

abstract：:Crossover studies have been successfully conducted in the case of continuous responses. Existing procedures of analysis for ordinal responses, on the other hand, are rarely satisfactory unless strict, usually unrealistic, assumptions are made. In this paper we investigate a random effects model and show that the model...

journal_title：Statistics in medicine

authors： Ezzet F,Whitehead J

更新日期：1991-06-01 00:00:00

abstract：:There is a single-minded focus on events in survival analysis, and we often ignore longitudinal data that are collected together with the event data. This is due to a lack of methodology but also a result of the artificial distinction between survival and longitudinal data analyses. Understanding the dynamics of such ...

journal_title：Statistics in medicine

authors： Aalen OO

更新日期：2012-08-15 00:00:00

abstract：:This paper reviews methods for mapping geographical variation in disease incidence and mortality. Recent results in Bayesian hierarchical modelling of relative risk are discussed. Two approaches to relative risk estimation, along with the related computational procedures, are described and compared. The first is an em...

journal_title：Statistics in medicine

authors： Bernardinelli L,Montomoli C

更新日期：1992-06-15 00:00:00

abstract：:Clinical trials utilizing predictive biomarkers have become a research focus in personalized medicine. We investigate the effects of biomarker misclassification on the design and analysis of stratified biomarker clinical trials. For a variety of inference problems including marker-treatment interaction in particular, ...

journal_title：Statistics in medicine

authors： Liu C,Liu A,Hu J,Yuan V,Halabi S

更新日期：2014-08-15 00:00:00

abstract：:In this paper we examine the efficiency of a generalization of the traditional normal linear (LDA) or quadratic (QDA) discriminant analysis. This procedure (the generalized discriminant analysis, GDA) replaces each normal density used in the traditional classification rule by a Fourier series density estimator which '...

journal_title：Statistics in medicine

authors： Odom-Maryon T,Langholz B,Niland J,Azen S

更新日期：1991-03-01 00:00:00