Assessing time-by-covariate interactions in proportional hazards regression models using cubic spline functions.

abstract：:Clinical trials often assess therapeutic benefit on the basis of an event such as death or the diagnosis of disease. Usually, there are several additional longitudinal measures of clinical status which are collected to be used in the treatment comparison. This paper proposes a simple non-parametric test which combines...

journal_title：Statistics in medicine

authors： Finkelstein DM,Schoenfeld DA

更新日期：1999-06-15 00:00:00

abstract：:In the analysis of composite endpoints in a clinical trial, time to first event analysis techniques such as the logrank test and Cox proportional hazard test do not take into account the multiplicity, importance, and the severity of events in the composite endpoint. Several generalized pairwise comparison analysis met...

journal_title：Statistics in medicine

authors： Verbeeck J,Spitzer E,de Vries T,van Es GA,Anderson WN,Van Mieghem NM,Leon MB,Molenberghs G,Tijssen J

更新日期：2019-12-30 00:00:00

abstract：:This paper models monthly AIDS diagnosis counts in terms of smooth secular trend, calendar month effects, and the number of workdays per month. A parameterization of month effects allows separation of true seasonal effects from a linear trend over the calendar year and an arbitrary June effect. There is strong evidenc...

journal_title：Statistics in medicine

authors： Bacchetti P

更新日期：1994-10-15 00:00:00

abstract：:In many chronic diseases, therapy aims to prevent or reduce the frequency of episodes of a disease manifestation, for example cardiac ischaemic episodes or epileptic seizures. Entry criteria for clinical trials typically include a minimum number of episodes within a baseline period, and regression to the mean should b...

journal_title：Statistics in medicine

authors： McMahon RP,Proschan M,Geller NL,Stone PH,Sopko G

更新日期：1994-04-30 00:00:00

abstract：:Testing the equality of 2 proportions for a control group versus a treatment group is a well-researched statistical problem. In some settings, there may be strong historical data that allow one to reliably expect that the control proportion is one, or nearly so. While one-sample tests or comparisons to historical cont...

journal_title：Statistics in medicine

authors： Gabriel EE,Nason M,Fay MP,Follmann DA

更新日期：2018-03-30 00:00:00

abstract：:Many models for clinical prediction (prognosis or diagnosis) are published in the medical literature every year but few such models find their way into clinical practice. The reason may be that since in most cases models have not been validated in independent data, they lack generality and/or credibility. In this pape...

journal_title：Statistics in medicine

authors： Royston P,Parmar MK,Sylvester R

更新日期：2004-03-30 00:00:00

abstract：:Systematic reviews often provide recommendations for further research. When meta-analyses are inconclusive, such recommendations typically argue for further studies to be conducted. However, the nature and amount of future research should depend on the nature and amount of the existing research. We propose a method ba...

journal_title：Statistics in medicine

authors： Roloff V,Higgins JP,Sutton AJ

更新日期：2013-01-15 00:00:00

abstract：:We studied the problem of testing a hypothesized distribution in survival regression models when the data is right censored and survival times are influenced by covariates. A modified chi-squared type test, known as Nikulin-Rao-Robson statistic, is applied for the comparison of accelerated failure time models. This st...

journal_title：Statistics in medicine

authors： Tahir MR,Tran QX,Nikulin MS

更新日期：2017-05-30 00:00:00

abstract：:We consider counting process methods for analysing time-to-event data with multiple or recurrent outcomes, using the models developed by Anderson and Gill, Wei, Lin and Weissfeld and Prentice, Williams and Peterson. We compare the methods, and show how to implement them using popular statistical software programs. By ...

journal_title：Statistics in medicine

authors： Therneau TM,Hamilton SA

更新日期：1997-09-30 00:00:00

abstract：:In many chronic disease processes subjects are at risk of two or more types of events. We describe a bivariate mixed Poisson model in which a copula function is used to model the association between two gamma distributed random effects. The resulting model is a bivariate negative binomial process in which each type of...

journal_title：Statistics in medicine

authors： Cook RJ,Lawless JF,Lee KA

更新日期：2010-03-15 00:00:00

abstract：:Confidence intervals for a standardized effect are derived after stabilizing the variance of the Welch t-statistic. Simulation studies demonstrate the viability of the resulting intervals for a wide range of parameter values and sample sizes as small as five. The methodology is extended to the combination of results f...

journal_title：Statistics in medicine

authors： Kulinskaya E,Staudte RG

更新日期：2007-06-30 00:00:00

abstract：:Combinatorial drugs have been widely applied in disease treatment, especially chemotherapy for cancer, due to its improved efficacy and reduced toxicity compared with individual drugs. The study of combinatorial drugs requires efficient experimental designs and proper follow-up statistical modeling techniques. Linear ...

journal_title：Statistics in medicine

authors： Xiao Q,Wang L,Xu H

更新日期：2019-01-30 00:00:00

abstract：:Cross-sectional designs are often used to monitor the proportion of infections and other post-surgical complications acquired in hospitals. However, conventional methods for estimating incidence proportions when applied to cross-sectional data may provide estimators that are highly biased, as cross-sectional designs t...

journal_title：Statistics in medicine

authors： Fluss R,Mandel M,Freedman LS,Weiss IS,Zohar AE,Haklai Z,Gordon ES,Simchen E

更新日期：2013-06-30 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：:Important differences between explanatory and pragmatic studies were originally argued by Schwartz and Lellouch. Three important differences between the two types of study involve study control, study violators and inclusion criteria. It was originally argued that explanatory studies are highly controlled, and pragmat...

journal_title：Statistics in medicine

authors： McMahon AD

更新日期：2002-05-30 00:00:00

abstract：:Service on the Data Monitoring Committee of the CPEP (Calcium for Pre-eclampsia Prevention) has led us to four conclusions about clinical trials which we should like to present to this gathering of biostatisticians for their reactions: (i) meta-analyses of the pertinent published trials of the same therapy should alwa...

journal_title：Statistics in medicine

authors： Chalmers TC,Lau J

更新日期：1996-06-30 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：:Exploring the possible reasons for heterogeneity between studies is an important aspect of conducting a meta-analysis. This paper compares a number of methods which can be used to investigate whether a particular covariate, with a value defined for each study in the meta-analysis, explains any heterogeneity. The main ...

journal_title：Statistics in medicine

authors： Thompson SG,Sharp SJ

更新日期：1999-10-30 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：:Instrumental variable estimates of causal effects can be biased when using many instruments that are only weakly associated with the exposure. We describe several techniques to reduce this bias and estimate corrected standard errors. We present our findings using a simulation study and an empirical application. For th...

journal_title：Statistics in medicine

authors： Davies NM,von Hinke Kessler Scholder S,Farbmacher H,Burgess S,Windmeijer F,Smith GD

更新日期：2015-02-10 00:00:00

abstract：:We investigate a binary partitioning algorithm in the case of a continuous repeated measures outcome. The procedure is based on the use of the likelihood ratio statistic to evaluate the performance of individual splits. The procedure partitions a set of longitudinal data into two mutually exclusive groups based on an ...

journal_title：Statistics in medicine

authors： Abdolell M,LeBlanc M,Stephens D,Harrison RV

更新日期：2002-11-30 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

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：: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：:To study the spread of sexually transmitted diseases (STDs) using social/sexual mixing models, one must have quantitative information about sexual mixing. An unavoidable complication in gathering such information by survey is that members of the surveyed population will almost certainly have sexual contacts outside th...

journal_title：Statistics in medicine

authors： Rubin G,Umbach D,Shyu SF,Castillo-Chavez C

更新日期：1992-09-15 00:00:00

abstract：:The FDA permits marketing of a generic formulation of a drug G for the same indications as a standard preparation S if one can show that G is bioequivalent to S. Present implementation requires convincing evidence that the population mean difference in bioavailability (drug exposure) between the two preparations lies ...

journal_title：Statistics in medicine

authors： Sheiner LB

更新日期：1992-09-30 00:00:00

abstract：:Measures that quantify the impact of heterogeneity in univariate meta-analysis, including the very popular I(2) statistic, are now well established. Multivariate meta-analysis, where studies provide multiple outcomes that are pooled in a single analysis, is also becoming more commonly used. The question of how to quan...

journal_title：Statistics in medicine

authors： Jackson D,White IR,Riley RD

更新日期：2012-12-20 00:00:00

abstract：:Patient non-compliance and drop-out can bias analyses of clinical trial data. I describe a parametric model for treatment cross-over and drop-out and demonstrate how the concept of ignorability, originally defined for incomplete-data problems, can elucidate sources of bias in clinical trials. I discuss some implicatio...

journal_title：Statistics in medicine

authors： Heitjan DF

更新日期：1999-09-15 00:00:00

abstract：:Hierarchical regression analysis holds much promise for epidemiologic analysis, but has as yet seen limited application because of lack of easily used software and the relatively lengthy run times of preferred fitting methods (such as true maximum likelihood and Bayesian approaches). This paper compares three relative...

journal_title：Statistics in medicine

authors： Greenland S

更新日期：1997-03-15 00:00:00

abstract：:Both traditional phase I designs and the increasingly popular continual reassessment method (CRM) designs select an estimate of maximum tolerable dose (MTD) from among a set of prespecified dose levels. Although CRM designs use an implied dose-response model to select the next dose level, in general it is neither assu...

journal_title：Statistics in medicine

authors： Storer BE

更新日期：2001-08-30 00:00:00