Multilevel mixed effects parametric survival models using adaptive Gauss-Hermite quadrature with application to recurrent events and individual participant data meta-analysis.

abstract：:Box-Cox transformation is investigated for regression models for left-censored data. Examples are provided using coronary calcification data from the Multi-Ethnic Study of Atherosclerosis and pharmacokinetic data of a nicotine nasal spray. ...

journal_title：Statistics in medicine

authors： Han C,Kronmal R

更新日期：2004-12-15 00:00:00

abstract：:This paper investigates the design and analysis of dose-finding trials with two agents. The set of doses for each agent is fixed in advance. The goal of the trial is to find the set of dose combinations with probability of toxicity closest to a pre-specified value. For each of the two agents we assume that the probabi...

journal_title：Statistics in medicine

authors： Ivanova A,Wang K

更新日期：2004-06-30 00:00:00

abstract：:The use of the continual reassessment method (CRM) and other model-based approaches to design Phase I clinical trials has increased owing to the ability of the CRM to identify the maximum tolerated dose better than the 3 + 3 method. However, the CRM can be sensitive to the variance selected for the prior distribution ...

journal_title：Statistics in medicine

authors： Zhang J,Braun TM,Taylor JM

更新日期：2013-06-15 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：:The one-step (Peto) method for obtaining pooled effect estimates can yield extremely biased results when applied to unbalanced data. Even for balanced studies, the one-step estimate may incorporate an unacceptable degree of bias. In place of the one-step estimate, we recommend use of ordinary Mantel-Haenszel, weighted...

journal_title：Statistics in medicine

authors： Greenland S,Salvan A

更新日期：1990-03-01 00:00:00

abstract：:This paper introduces a new spatial scan statistic designed to adjust cluster detection for longitudinal confounding factors indexed in space. The functional-model-adjusted statistic was developed using generalized functional linear models in which longitudinal confounding factors were considered to be functional cova...

journal_title：Statistics in medicine

authors： Ahmed MS,Genin M

更新日期：2020-04-15 00:00:00

abstract：:Cancer immunotherapy trials have two special features: a delayed treatment effect and a cure rate. Both features violate the proportional hazard model assumption and ignoring either one of the two features in an immunotherapy trial design will result in substantial loss of statistical power. To properly design immunot...

journal_title：Statistics in medicine

authors： Wei J,Wu J

更新日期：2020-03-15 00:00:00

abstract：:Assessing the calibration of methods for estimating the probability of the occurrence of a binary outcome is an important aspect of validating the performance of risk-prediction algorithms. Calibration commonly refers to the agreement between predicted and observed probabilities of the outcome. Graphical methods are a...

journal_title：Statistics in medicine

authors： Austin PC,Steyerberg EW

更新日期：2019-09-20 00:00:00

abstract：:We extend the shared frailty model of recurrent events and a dependent terminal event to allow for a nonparametric covariate function. We include a Gaussian random effect (frailty) in the intensity functions of both the recurrent and terminal events to capture correlation between the two processes. We employ the penal...

journal_title：Statistics in medicine

authors： Zhangsheng Y,Liu L

更新日期：2011-09-30 00:00:00

abstract：:Composite endpoints are frequently used in clinical trials, but simple approaches, such as the time to first event, do not reflect any ordering among the endpoints. However, some endpoints, such as mortality, are worse than others. A variety of procedures have been proposed to reflect the severity of the individual en...

journal_title：Statistics in medicine

authors： Follmann D,Fay MP,Hamasaki T,Evans S

更新日期：2020-02-28 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：:The setting of a quarantine time for an emerging infectious disease will depend on current knowledge concerning incubation times. Methods for the analysis of information on incubation times are investigated with a particular focus on inference regarding a possible maximum incubation time, after which an exposed indivi...

journal_title：Statistics in medicine

authors： Farewell VT,Herzberg AM,James KW,Ho LM,Leung GM

更新日期：2005-11-30 00:00:00

abstract：:Patient compliance (adherence) with prescribed medication is often erratic, while clinical outcomes are causally linked to actual, rather than nominal medication dosage. We propose here a hierarchical Markov model for patient compliance. At the first stage, conditional upon individual random effects and a set of indiv...

journal_title：Statistics in medicine

authors： Girard P,Blaschke TF,Kastrissios H,Sheiner LB

更新日期：1998-10-30 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：:We present a method to estimate the time-dependent vaccine efficacy from the cohort-specific vaccination coverage and from data on the vaccination status of cases and apply it to a measles epidemic in Germany which involved 529 cases, 88 of whom were vaccinated and 370 unvaccinated (for the remaining 71 cases the vacc...

journal_title：Statistics in medicine

authors： Eichner M,Diebner HH,Schubert C,Kreth HW,Dietz K

更新日期：2002-08-30 00:00:00

abstract：:It has been increasingly common to analyze simultaneously repeated measures and time to failure data. In this paper we propose a joint model when the repeated measures are semi-continuous, characterized by the presence of a large portion of zero values, as well as right skewness of non zero (positive) values. Examples...

journal_title：Statistics in medicine

authors： Liu L

更新日期：2009-03-15 00:00:00

abstract：:A calibration line is used to define the relationship between a new clinical technique and a standard in vitro laboratory methodology. Discrimination intervals quantify the reliability of inverse estimates obtained from the calibration line. Applied to transcutaneous PCO2 monitoring, a new in vivo measurement, discrim...

journal_title：Statistics in medicine

authors： Kost GJ

更新日期：1986-07-01 00:00:00

abstract：:Drop-out often occurs in clinical trials with multiple visits and drop-out is often informative in the sense that the population of patients who dropped out is different from the population of patients who completed the study. To handle data with informative drop-out, an intention-to-treat analysis, which evaluates tr...

journal_title：Statistics in medicine

authors： Shao J,Zhong B

更新日期：2003-08-15 00:00:00

abstract：:We analyze data obtained from a study designed to evaluate training effects on the performance of certain motor activities of Parkinson's disease patients. Maximum likelihood methods were used to fit beta-binomial/Poisson regression models tailored to evaluate the effects of training on the numbers of attempted and su...

journal_title：Statistics in medicine

authors： Lora MI,Singer JM

更新日期：2008-07-30 00:00:00

abstract：:This paper presents a statistically optimal exact hypothesis testing procedure for detecting changes in sales adjusted adverse drug reaction (ADR) rates between historical and current periods, with a computer program that implements this test appended. We provide discussions and illustrations on how to monitor ADR rat...

journal_title：Statistics in medicine

authors： Norwood PK,Sampson AR

更新日期：1988-10-01 00:00:00

abstract：:In many community-based studies on the incidence of dementia, a target population is screened and a subsample is clinically evaluated at baseline and follow-up. Incidence rates are affected by missed cases at both exams and this complicates the estimation of these rates. Recent work proposes a regression-based techniq...

journal_title：Statistics in medicine

authors： Izmirlian G,Brock D,White L

更新日期：2000-06-15 00:00:00

abstract：:Mediation analyses can help us to understand the biological mechanism in which an exposure or treatment affects an outcome. Single mediator analyses have been used in various applications, but may not be appropriate for analyzing intricate mechanisms involving multiple mediators that affect each other. Thus, in this a...

journal_title：Statistics in medicine

authors： Lai EY,Shih S,Huang YT,Wang S

更新日期：2020-05-15 00:00:00

abstract：:Writing the variance of the Mantel-Haenszel estimator under the null of homogeneity and inverting the corresponding test, we arrive at an improved confidence interval for the common risk difference in stratified 2 × 2 tables. This interval outperforms a variety of other intervals currently recommended in the literatur...

journal_title：Statistics in medicine

authors： Klingenberg B

更新日期：2014-07-30 00:00:00

abstract：:Many randomized clinical trials include a data and safety monitoring board (DSMB) that is responsible for reviewing accruing data, monitoring performance of the trial, assuring safety of the participants in the trial, and assessing the efficacy of treatment. The DSMB often makes recommendations about continuation of t...

journal_title：Statistics in medicine

authors： Wittes J

更新日期：1993-03-01 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：:Bioequivalence or interaction trials are commonly studied in crossover design and can be analysed by nonlinear mixed effects models as an alternative to noncompartmental approach. We propose an extension of the population Fisher information matrix in nonlinear mixed effects models to design crossover pharmacokinetic t...

journal_title：Statistics in medicine

authors： Nguyen TT,Bazzoli C,Mentré F

更新日期：2012-05-20 00:00:00

abstract：:We simulated multinomial AIDS incidence counts from 27 'representative' AIDS epidemics that spanned a period corresponding to previous applications of backcalculation (1 January 1977 to 1 July 1987) and assessed mean square error for several back-calculated estimators of HIV prevalence and short-term AIDS projections....

journal_title：Statistics in medicine

authors： Rosenberg PS,Gail MH,Pee D

更新日期：1991-08-01 00:00:00

abstract：:We present some practical extensions and applications of a strategy proposed by Thall, Simon and Estey for designing and monitoring single-arm clinical trials with multiple outcomes. We show by application how the strategy may be applied to construct designs for phase IIA activity trials and phase II equivalence trial...

journal_title：Statistics in medicine

authors： Thall PF,Sung HG

更新日期：1998-07-30 00:00:00

abstract：:The sample size required for a cluster randomised trial is inflated compared with an individually randomised trial because outcomes of participants from the same cluster are correlated. Sample size calculations for longitudinal cluster randomised trials (including stepped wedge trials) need to take account of at least...

journal_title：Statistics in medicine

authors： Hooper R,Teerenstra S,de Hoop E,Eldridge S

更新日期：2016-11-20 00:00:00

abstract：:It is often of interest to use observational data to estimate the causal effect of a target exposure or treatment on an outcome. When estimating the treatment effect, it is essential to appropriately adjust for selection bias due to observed confounders using, for example, propensity score weighting. Selection bias du...

journal_title：Statistics in medicine

authors： Parast L,Griffin BA

更新日期：2020-08-15 00:00:00