A hierarchical testing approach for detecting safety signals in clinical trials.

abstract：:This paper, arising out of an event to honour the statistical and scientific contributions of Professor Peter Armitage, is concerned with research strategies and needs for chronic disease prevention. A few highlights from recent intervention trials for the prevention of cancer, cardiovascular disease, fractures and di...

journal_title：Statistics in medicine

authors： Prentice RL

更新日期：2004-11-30 00:00:00

abstract：:There is a rich literature that considers whether an observed relation between treatment and response is due to an unobserved covariate. In order to quantify this unmeasured bias, an assumption is made about the distribution of this unobserved covariate; typically that it is either binary or at least confined to the u...

journal_title：Statistics in medicine

authors： Wang L,Krieger AM

更新日期：2006-07-15 00:00:00

abstract：:The article is motivated by a nephrology study in Taiwan, which enrolled hemodialysis patients who suffered from vascular access thrombosis. After treatment, some patients were cured of thrombosis, while some may experience recurrence of either type (acute or nonacute) of vascular access thrombosis. Our major interest...

journal_title：Statistics in medicine

authors： Chen CM,Shen PS,Lin CC,Wu CC

更新日期：2020-11-30 00:00:00

abstract：:In many epidemiological studies it is common to resort to regression models relating incidence of a disease and its risk factors. The main goal of this paper is to consider inference on such models with error-prone observations and variances of the measurement errors changing across observations. We suppose that the o...

journal_title：Statistics in medicine

authors： de Castro M,Galea M,Bolfarine H

更新日期：2008-11-10 00:00:00

abstract：:In many studies, interest lies in determining whether members of the study population will undergo a particular event of interest. Such scenarios are often termed 'mover-stayer' scenarios, and interest lies in modelling two sub-populations of 'movers' (those who have a propensity to undergo the event of interest) and ...

journal_title：Statistics in medicine

authors： O'Keeffe AG,Tom BD,Farewell VT

更新日期：2013-02-20 00:00:00

abstract：:Differences between arm-based (AB) and contrast-based (CB) models for network meta-analysis (NMA) are controversial. We compare the CB model of Lu and Ades (2006), the AB model of Hong et al(2016), and two intermediate models, using hypothetical data and a selected real data set. Differences between models arise prima...

journal_title：Statistics in medicine

authors： White IR,Turner RM,Karahalios A,Salanti G

更新日期：2019-11-30 00:00:00

abstract：:Parameters for latent transition analysis (LTA) are easily estimated by maximum likelihood (ML) or Bayesian method via Markov chain Monte Carlo (MCMC). However, unusual features in the likelihood can cause difficulties in ML and Bayesian inference and estimation, especially with small samples. In this study we explore...

journal_title：Statistics in medicine

authors： Chung H,Lanza ST,Loken E

更新日期：2008-05-20 00:00:00

abstract：:We propose an innovative and practically relevant clustering method to find common task-related brain regions among different subjects who respond to the same set of stimuli. Using functional magnetic resonance imaging (fMRI) time series data, we first cluster the voxels within each subject on a voxel by voxel basis. ...

journal_title：Statistics in medicine

authors： Ye J,Li Y,Lazar NA,Schaeffer DJ,McDowell JE

更新日期：2016-07-10 00:00:00

abstract：:Pearson's chi-squared, the likelihood-ratio, and Fisher-Freeman-Halton's test statistics are often used to test the association of unordered r x c tables. Asymptotical, exact conditional, or exact conditional with mid-p adjustment methods are commonly used to compute the p-value. We have compared test power and signif...

journal_title：Statistics in medicine

authors： Lydersen S,Pradhan V,Senchaudhuri P,Laake P

更新日期：2007-10-15 00:00:00

abstract：:We applied a two-stage random effects model to pulmonary function data from 31 sarcoidosis patients to illustrate its usefulness in analysing unbalanced longitudinal data. For the first stage, repeated measurements of percentage of predicted forced vital capacity (FVC%) from an individual were modelled as a function o...

journal_title：Statistics in medicine

authors： Vacek PM,Mickey RM,Bell DY

更新日期：1989-02-01 00:00:00

abstract：:Prediction performance of a risk scoring system needs to be carefully assessed before its adoption in clinical practice. Clinical preventive care often uses risk scores to screen asymptomatic population. The primary clinical interest is to predict the risk of having an event by a prespecified future time t0 . Accuracy...

journal_title：Statistics in medicine

authors： Yuan Y,Zhou QM,Li B,Cai H,Chow EJ,Armstrong GT

更新日期：2018-05-10 00:00:00

abstract：:Before introducing a new measurement tool it is necessary to evaluate its performance. Several statistical methods have been developed, or used, to evaluate the reliability and validity of a new assessment method in such circumstances. In this paper we review some commonly used methods. Data from a study that was cond...

journal_title：Statistics in medicine

authors： White SA,van den Broek NR

更新日期：2004-05-30 00:00:00

abstract：:Methods for dealing with tied event times in the Cox proportional hazards model are well developed. Also, the partial likelihood provides a natural way to handle covariates that change over time. However, ties between event times and the times that discrete time-varying covariates change have not been systematically s...

journal_title：Statistics in medicine

authors： Xin X,Horrocks J,Darlington GA

更新日期：2013-06-30 00:00:00

abstract：:Motivated by a study about prompt coronary angiography in myocardial infarction, we propose a method to estimate the causal effect of a treatment in two-arm experimental studies with possible noncompliance in both treatment and control arms. We base the method on a causal model for repeated binary outcomes (before and...

journal_title：Statistics in medicine

authors： Bartolucci F,Farcomeni A

更新日期：2013-11-10 00:00:00

abstract：:Longitudinal designs are important in medical research and in many other disciplines. Complete longitudinal studies, in which each subject is evaluated at each measurement occasion, are often very expensive and motivate a search for more efficient designs. Recently developed statistical methods foster the use of inten...

journal_title：Statistics in medicine

authors： Helms RW

更新日期：1992-10-01 00:00:00

abstract：:Group sequential hypothesis testing is now widely used to analyze prospective data. If Monte Carlo simulation is used to construct the signaling threshold, the challenge is how to manage the type I error probability for each one of the multiple tests without losing control on the overall significance level. This paper...

journal_title：Statistics in medicine

authors： Silva IR

更新日期：2016-04-30 00:00:00

abstract：:A new testing approach is described for improving statistical tests of independence in sets of tables stratified on one or more relevant factors in case of categorical (nominal or ordinal) variables. Common tests of independence that exploit the ordinality of one of the variables use a restricted-alternative approach....

journal_title：Statistics in medicine

authors： Iannario M,Lang JB

更新日期：2016-11-10 00:00:00

abstract：:Linear mixed effects (LME) models are increasingly used for analyses of biological and biomedical data. When the multivariate normal assumption is not adequate for an LME model, then a robust estimation approach is preferable to the maximum likelihood one. M-estimators were considered before for robust estimation of t...

journal_title：Statistics in medicine

authors： Chervoneva I,Vishnyakov M

更新日期：2011-06-30 00:00:00

abstract：:With reference to a real data on cataract surgery, we discuss the problem of zero-inflated circular-circular regression when both covariate and response are circular random variables and a large proportion of the responses are zeros. The regression model is proposed, and the estimation procedure for the parameters is ...

journal_title：Statistics in medicine

authors： Jha J,Biswas A

更新日期：2018-01-15 00:00:00

abstract：:We examine the properties of several tests for goodness-of-fit for multinomial logistic regression. One test is based on a strategy of sorting the observations according to the complement of the estimated probability for the reference outcome category and then grouping the subjects into g equal-sized groups. A g x c c...

journal_title：Statistics in medicine

authors： Fagerland MW,Hosmer DW,Bofin AM

更新日期：2008-09-20 00:00:00

abstract：:When the accrual rate is low and the treatment period is long, a long observational period is required before information concerning the primary end point, such as binary response, becomes available in the study. Simon's two-stage designs are often employed in Phase II clinical trials to avoid giving patient an ineffe...

journal_title：Statistics in medicine

authors： Chi Y,Chen CM

更新日期：2008-12-20 00:00:00

abstract：:In drug-drug interaction (DDI) research, a two drug interaction is usually predicted by individual drug pharmacokinetics (PK). Although subject-specific drug concentration data from clinical PK studies on inhibitor/inducer or substrate's PK are not usually published, sample mean plasma drug concentrations and their st...

journal_title：Statistics in medicine

authors： Li L,Yu M,Chin R,Lucksiri A,Flockhart DA,Hall SD

更新日期：2007-09-10 00:00:00

abstract：:Suppose that two graders classify all eyes in a sample of patients for the presence or absence of a specified abnormality. In the statistical analysis of the data, possible correlation between the observations in the right and left eyes should be taken into account. Recently, general methods have been developed to ana...

journal_title：Statistics in medicine

authors： Schouten HJ

更新日期：1993-12-15 00:00:00

abstract：:Correct specification of the inverse probability weighting (IPW) model is necessary for consistent inference from a marginal structural Cox model (MSCM). In practical applications, researchers are typically unaware of the true specification of the weight model. Nonetheless, IPWs are commonly estimated using parametric...

journal_title：Statistics in medicine

authors： Karim ME,Platt RW,BeAMS study group.

更新日期：2017-06-15 00:00:00

abstract：:In analysis of longitudinal data, the variance matrix of the parameter estimates is usually estimated by the 'sandwich' method, in which the variance for each subject is estimated by its residual products. We propose smooth bootstrap methods by perturbing the estimating functions to obtain 'bootstrapped' realizations ...

journal_title：Statistics in medicine

authors： Li Y,Wang YG

更新日期：2008-03-30 00:00:00

abstract：:In US states with small subpopulations, the observed mortality rates are often zero, particularly among young ages. Because in life tables, death rates are reported mostly on a log scale, zero mortality rates are problematic. To overcome the observed zero death rates problem, appropriate probability models are used. U...

journal_title：Statistics in medicine

authors： Voulgaraki A,Wei R,Kedem B

更新日期：2015-05-20 00:00:00

abstract：:Epidermal nerve fibre (ENF) density and morphology are used to study small fibre involvement in diabetic, HIV, chemotherapy induced and other neuropathies. ENF density and summed length of ENFs per epidermal surface area are reduced, and ENFs may appear more clustered within the epidermis in subjects with small fibre ...

journal_title：Statistics in medicine

authors： Andersson C,Guttorp P,Särkkä A

更新日期：2016-10-30 00:00:00

abstract：:To update the British growth reference, anthropometric data for weight, height, body mass index (weight/height2) and head circumference from 17 distinct surveys representative of England, Scotland and Wales (37,700 children, age range 23 weeks gestation to 23 years) were analysed by maximum penalized likelihood using ...

journal_title：Statistics in medicine

authors： Cole TJ,Freeman JV,Preece MA

更新日期：1998-02-28 00:00:00

abstract：:Inference for randomized clinical trials is generally based on the assumption that outcomes are independently and identically distributed under the null hypothesis. In some trials, particularly in infectious disease, outcomes may be correlated. This may be known in advance (e.g. allowing randomization of family member...

journal_title：Statistics in medicine

authors： Proschan M,Follmann D

更新日期：2008-03-15 00:00:00

abstract：:In different fields of applications including, but not limited to, behavioral, environmental, medical sciences, and econometrics, the use of panel data regression models has become increasingly popular as a general framework for making meaningful statistical inferences. However, when the ordinary least squares (OLS) m...

journal_title：Statistics in medicine

authors： Hamiye Beyaztas B,Bandyopadhyay S

更新日期：2020-12-20 00:00:00