A practical approach for the assessment of bioequivalence under selected higher-order cross-over designs.

abstract：:Regression to the mean arises often in statistical applications where the units chosen for study relate to some observed characteristic in the extreme of its distribution. Gardner and Heady attribute the effect of regression to the mean to measurement errors. They assume the model Yi = U + ei, where U is a fixed withi...

journal_title：Statistics in medicine

authors： Johnson WD,George VT

更新日期：1991-08-01 00:00:00

abstract：:This paper discusses the benefits and limitations of adaptive sample size re-estimation for phase 3 confirmatory clinical trials. Comparisons are made with more traditional fixed sample and group sequential designs. It is seen that the real benefit of the adaptive approach arises through the ability to invest sample s...

journal_title：Statistics in medicine

authors： Mehta CR,Pocock SJ

更新日期：2011-12-10 00:00:00

abstract：:When designing a study to develop a new prediction model with binary or time-to-event outcomes, researchers should ensure their sample size is adequate in terms of the number of participants (n) and outcome events (E) relative to the number of predictor parameters (p) considered for inclusion. We propose that the mini...

journal_title：Statistics in medicine

authors： Riley RD,Snell KI,Ensor J,Burke DL,Harrell FE Jr,Moons KG,Collins GS

更新日期：2019-03-30 00:00:00

abstract：:In multivariate network meta-analysis (NMA), the piecemeal nature of the evidence base means that there may be treatment-outcome combinations for which no data is available. Most existing multivariate evidence synthesis models are either unable to estimate the missing treatment-outcome combinations, or can only do so ...

journal_title：Statistics in medicine

authors： Waddingham E,Matthews PM,Ashby D

更新日期：2020-10-30 00:00:00

abstract：:To construct a confidence interval for the mean of a log-normal distribution in small samples, we propose likelihood-based approaches - the signed log-likelihood ratio and modified signed log-likelihood ratio methods. Extensive Monte Carlo simulation results show the advantages of the modified signed log-likelihood ra...

journal_title：Statistics in medicine

authors： Wu J,Wong AC,Jiang G

更新日期：2003-06-15 00:00:00

abstract：:Conditional power based on summary statistic by comparing outcomes (such as the sample mean) directly between 2 groups is a convenient tool for decision making in randomized controlled trial studies. In this paper, we extend the traditional summary statistic-based conditional power with a general model-based assessmen...

journal_title：Statistics in medicine

authors： Zou B,Cai J,Koch GG,Zhou H,Zou F

更新日期：2017-12-30 00:00:00

abstract：:The problem of testing symmetry about zero has a long and rich history in the statistical literature. We introduce a new test that sequentially discards observations whose absolute value is below increasing thresholds defined by the data. McNemar's statistic is obtained at each threshold and the largest is used as the...

journal_title：Statistics in medicine

authors： Laska E,Meisner M,Wanderling J

更新日期：2012-11-20 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：:For many HIV-infected patients, use of antiretroviral therapy (ART) results in a sustained suppression of plasma viral load to undetectable levels. However, due to lack of antigenic stimulation, this may also result in a gradual loss of cell-mediated immune (CMI) responses that help control HIV infection. In concept, ...

journal_title：Statistics in medicine

authors： Mogg R,Mehrotra DV

更新日期：2007-02-10 00:00:00

abstract：:A considerable number of the clinical reports which are presented to the Dutch Board for the Evaluation of Drugs, have deficiencies and/or shortcomings. A number of these, including loose description of the target population and sampling method, methodological flaws, incorrect treatment of withdrawals, confounding of ...

journal_title：Statistics in medicine

authors： De Jonge H

更新日期：1983-04-01 00:00:00

abstract：:The intraclass correlation coefficient rho plays a key role in the design of cluster randomized trials. Estimates of rho obtained from previous cluster trials and used to inform sample size calculation in planned trials may be imprecise due to the typically small numbers of clusters in such studies. It may be useful t...

journal_title：Statistics in medicine

authors： Ukoumunne OC,Davison AC,Gulliford MC,Chinn S

更新日期：2003-12-30 00:00:00

abstract：:Antimicrobial resistance has become one of the main public health burdens of the last decades, and monitoring the development and spread of non-wild-type isolates has therefore gained increased interest. Monitoring is performed based on the minimum inhibitory concentration (MIC) values, which are collected through the...

journal_title：Statistics in medicine

authors： Jaspers S,Aerts M,Verbeke G,Beloeil PA

更新日期：2014-01-30 00:00:00

abstract：:Binary matched-pairs data occur commonly in longitudinal studies, such as in cross-over experiments. Many analyses for comparing the matched probabilities of a particular outcome do not utilize pairs having the same outcome for each observation. An example is McNemar's test. Some methodologists find this to be counter...

journal_title：Statistics in medicine

authors： Agresti A,Min Y

更新日期：2004-01-15 00:00:00

abstract：:A common problem encountered in many medical applications is the comparison of survival curves. Often, rather than comparison of the entire survival curves, interest is focused on the comparison at a fixed point in time. In most cases, the naive test based on a difference in the estimates of survival is used for this ...

journal_title：Statistics in medicine

authors： Klein JP,Logan B,Harhoff M,Andersen PK

更新日期：2007-10-30 00:00:00

abstract：:In many studies, a K degree of freedom large sample chi2 test is used to assess the effect of treatment on a multivariate response, such as an omnibus T2-like test of a difference between two treatment groups in any of K repeated measures. Alternately, a K df chi2 test may be used to test the equality of K+1 groups in...

journal_title：Statistics in medicine

authors： Lachin JM,Greenhouse SW,Bautista OM

更新日期：2003-11-15 00:00:00

abstract：:The case-control study is a simple and an useful method to characterize the effect of a gene, the effect of an exposure, as well as the interaction between the two. The control-free case-only study is yet an even simpler design, if interest is centered on gene-environment interaction only. It requires the sometimes pl...

journal_title：Statistics in medicine

authors： Lee WC,Wang LY,Cheng KF

更新日期：2010-10-30 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：:In genetic association studies, mixed effects models have been widely used in detecting the pleiotropy effects which occur when one gene affects multiple phenotype traits. In particular, bivariate mixed effects models are useful for describing the association of a gene with a continuous trait and a binary trait. Howev...

journal_title：Statistics in medicine

authors： Zhang Q,Yi GY

更新日期：2020-11-20 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：:The randomized clinical trial, LU19, conducted by the Medical Research Council Lung Cancer Working Party, was designed to compare ACE (doxorubicin, cyclophosphamide and etoposide) chemotherapy plus G-CSF (granulocyte colony-stimulating factor) at 2-week intervals versus ACE chemotherapy alone at standard 3-week interv...

journal_title：Statistics in medicine

authors： Qian W,Parmar MK,Sambrook RJ,Fayers PM,Girling DJ,Stephens RJ

更新日期：2000-10-15 00:00:00

abstract：:Evaluating treatment effects within different subsets of patients is a common practice in the analysis of individual randomized clinical trials. Such analyses are limited, however, by the number of patients available. Overviews, by providing evidence based on large numbers of patients, can be useful for overcoming the...

journal_title：Statistics in medicine

authors： Gelber RD,Goldhirsch A

更新日期：1987-04-01 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：:Among subjects who have experienced a biological event, such as menarche, menopause or a delivery, one cannot distinguish the effects of time since the event from age at the event due to the linear dependency among these time variables and age at study ('current age'). This is a well-known problem that also exists in ...

journal_title：Statistics in medicine

authors： Hsieh CC,Lan SJ

更新日期：1996-07-30 00:00:00

abstract：:Determination of the equation that relates an ordered dependent variable to ordered independent variables is sought. One solution, non-parametric discriminant analysis (NPD), involves obtaining the best monotonic step function by means of a computer search procedure. Although one can use alternative selection criteria...

journal_title：Statistics in medicine

authors： Johnston B,Seshia SS

更新日期：1992-06-15 00:00:00

abstract：:In this paper, we define a modified version τ(b) of Kendall's tau to measure the association in a pair (X,Y) of random variables subject to fixed left censoring due to known lower detection limits. We provide a nonparametric estimator of τ(b) and investigate its asymptotic properties. We then assume an Archimedean cop...

journal_title：Statistics in medicine

authors： Romdhani H,Lakhal-Chaieb L

更新日期：2011-11-20 00:00:00

abstract：:We examine different methods to pool binary outcomes used both in parallel and cross-over trials. Odds ratio (OR) estimators obtained from joint conditional probabilities in cross-over trials, such as the Mantel-Haenszel and Peto methods, are compared to an OR estimator using marginal results of cross-over trials. Whe...

journal_title：Statistics in medicine

authors： Curtin F,Elbourne D,Altman DG

更新日期：2002-08-15 00:00:00

abstract：:We propose a probability distribution for an equivalence class of classification trees (that is, those that ignore the value of the cutpoints but retain tree structure). This distribution is parameterized by a central tree structure representing the true model, and a precision or concentration coefficient representing...

journal_title：Statistics in medicine

authors： Shannon WD,Banks D

更新日期：1999-03-30 00:00:00

abstract：:Two features commonly exhibited by randomized trials of health promotion interventions are cluster randomization and stratification. Ignoring correlations between individuals within clusters can lead to an inflated type I error rate and hence a P-value which overstates the significance of the result. This paper compar...

journal_title：Statistics in medicine

authors： Dobbins TA,Simpson JM

更新日期：2002-12-30 00:00:00

abstract：:Comparative calibration is the broad statistical methodology used to assess the calibration of a set of p instruments, each designed to measure the same characteristic, on a common group of individuals. Different from the usual calibration problem, the true underlying quantity measured is unobservable. Many authors ha...

journal_title：Statistics in medicine

authors： Lu Y,Ye K,Mathur AK,Hui S,Fuerst TP,Genant HK

更新日期：1997-08-30 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